cyrilzakka/clinical-trials huggingface dataset:
The Effect of Prednisone on Physical Exercise in COPD Patients

The objective of this study is to investigate if there is an effect on exercise performance og of the anti inflammatory drugs prednisone and solu-medrol in patints with chronic obstructive pulmonary disease(COPD)

RCT study with 4 days of steroid

Eligibility Criteria:
Inclusion Criteria:FEV1\< 60% FEV1/FVC ratio \<70 %

* able to use a ergometer bike

Exclusion Criteria: Haemodynamicaly unstable heart conditions

* exacerbations before 6 week entry of the study exacerbation during the study period treatment with beta blockers malignancy the last 5 years allergi toward IMP
Direct Acting Antivirals for HCV Infection in Kidney Transplant Recipients

Chronic hepatitis C virus (HCV) infection, an important cause of morbidity and mortality worldwide, is a significant problem in kidney transplant recipients (KTRs) given its high prevalence in patients undergoing hemodialysis. Interferon based regimens were cornerstone of treatment of HCV infection in the past; however, due to their low efficacy and high rates of adverse effects, they have been abandoned in the new era of direct acting antivirals (DAAs). Several studies demonstrated the efficacy and safety of DAAs, yet data regarding clinical practice of these agents in KTRs is still needed. Therefore, we conducted a study using our registry data to evaluate the efficacy and safety of DAAs in KTRs.


Eligibility Criteria:
Inclusion Criteria:

* Being a kidney transplant recipient.
* Having a detectable level of HCV RNA.
* Having direct acting antivirals for 12 or 24 weeks.

Exclusion Criteria:

* Withdrawing or not providing consent.
Low Dose Naltrexone (LDN) Immune Monitoring

We have found that low dose naltrexone (LDN) can substantially reduce pain associated with fibromyalgia syndrome. We believe LDN may work via novel anti-inflammatory channels. The purpose of this study is to determine if LDN lowers inflammatory markers in individuals with fibromyalgia.

Eligible women with Fibromyalgia (FM) will be enrolled into a 10-week drug trial. During the first two weeks, a baseline phase will be used to collect data on immune function and symptoms. LDN will be administered for 8 weeks. Although there is no placebo arm built-in, participants will be advised that they may receive a placebo during the trial. Participants will provide twice daily symptom reports using an android tablet device and Dooblo SurveyToGo survey software. Participants will also provide a blood sample twice every week for the duration of the study. Plasma inflammatory markers will be tested using a luminex based 63-plex inflammatory assay panel.

The primary aim of the study is to test if 8 weeks of LDN administration is associated with a reduction in pro-inflammatory markers in plasma in women with FM.

Eligibility Criteria:
Inclusion Criteria:

* Females age 18-65
* Meets criteria for 1990 ACR criteria for fibromyalgia
* Able to receive venous blood draw twice a week for 16 weeks
* Sufficient symptom variability during baseline report
* Patient completes daily report during 2 week baseline period at least 80% completion rate.

Exclusion Criteria:

* Opioid use
* Significant psychological comorbidity that in the discretion of the investigator compromises study integrity
* Location prohibits travel to Stanford
* Blood or clotting disorder
* Rheumatologic or autoimmune disease
* Acute infection
* Baseline blood ESR \>60, CRP greater than 3.0mg/L, positive rheumatoid factor, or positive ANA
* Use of blood thinning medication
* Pregnant or currently planning to become pregnant
* Current use of aspirin, ibuprofen, naproxen, or other confounding-anti-inflammatory medication as part of regular medication regimen.
* Known allergy to Naltrexone or Naloxone
* Currently participating in another treatment-based research study
* Self-reported inability to refrain from alcohol for the duration of the study period
Comparing Accuracy Between Cuffless Wrist Worn and Cuffed Ambulatory BP Monitoring Devices

Wrist worn devices can help record Blood Pressure (BP) throughout the day. As such devices are becoming increasingly affordable, they could help improve awareness, early diagnosis, and treatment of high and uncontrolled BP.

The goal of Continuum BP is to evaluate how BP readings from two different types of wrist-worn cuffless devices available on the market (Aktiia and Healthstats BPro Evo) compare with BP taken using an ambulatory BP monitor which records readings over 24h using a standard upper arm cuff. This interventional study will recruit balanced numbers of male and female participants within different age group, who will sequentially wear the Aktiia Bracelet and the Heathstats BPro Evo for a period of 24h, alongside the cuffed ambulatory BP monitor.

If wrist worn devices are found to measure BP reliably, future research will assess if artificial intelligence can use continuous BP readings from these devices to learn patterns and changes in BP; and develop digital twin models to guide better, more precise BP management for individuals.


Eligibility Criteria:
Inclusion Criteria:

1. Participant is aged ≥21 years and \<85 years at the time of screening visit.
2. Able to speak and understand English.
3. Able and willing to give informed consent.
4. Independent and mobile.
5. Willing and able to wear devices/no upper limb restrictions.

Exclusion Criteria:

1. Individuals who are or have been involved in interventional research within a period of 3 months.
2. Vulnerable individuals including those with mental ill-health or who are care dependant.
3. Individuals with serious comorbidities or end organ damage (e.g., previously diagnosed heart failure with New York Heart Association class III/IV, verbal or documented evidence of renal failure or history of dialysis, stroke or myocardial infarction within the last 1-year, previous stroke with residual deficit); and doctor diagnosed hyperthyroidism.
4. Individuals with arterio-venous fistula; or reduced peripheral perfusion identified by a history of Raynaud's syndrome or a pulse pressure of \<30mmHg or a capillary refill time of \>3s in the dominant arm.
5. Individuals with heart rhythm disorders e.g., persistent Atrial Fibrillation and those who have tachycardia \> 120 after 5 minutes of rest.
6. Individuals with skin irritation injury or damage.
7. Self-reported pregnancy. Participation will be withdrawn in the event of pregnancy following enrolment.
8. Life threatening or terminal illness with limited lifespan of \<12months.
9. Obesity (Body Mass Index 35kg/m2 or higher) or arm/wrist circumferences outside the range highlighted in each device's specification.
10. Those with very high office BP (greater than Stage 3 hypertension).
11. Interarm difference \>15mmHg in Systolic BP and \>10mmHg in Diastolic BP.
12. Where the PI thinks that it would be technically difficult to obtain or interpret blood pressures measurements.
A Study to Evaluate the Efficacy and Safety of Alglucosidase Alfa Produced at the 4000 L Scale for Pompe Disease

The objective of this study was to evaluate the efficacy and safety of treatment with 4000 litre (L) alglucosidase alfa (Lumizyme®) in Pompe participants.


Eligibility Criteria:
Inclusion Criteria:

A participant might meet all of the following criteria to be eligible for this study.

1. The participant and/or their parent/legal guardian was willing and able to provide signed informed consent.
2. The participant might be at least 1 year of age at the time of informed consent.
3. The participant had a diagnosis of Pompe disease and might have received treatment with 160 L alglucosidase alfa prior to screening.
4. The participant, if female and of childbearing potential, might have a negative pregnancy test (urine beta-human chorionic gonadotropin) at baseline. Note: all female participants of childbearing potential and sexually mature males might agree to use a medically accepted method of contraception throughout the study.

Exclusion Criteria:

A participant who met any of the following criteria were to be excluded from this study.

1. The participant had within the past 3 months received or was currently receiving any investigational product other than 160 L alglucosidase alfa or was currently participating in another clinical treatment study.
2. The participant, in the opinion of the Investigator, was clinically unstable and would not be expected to survive to completion of the 52-week treatment period.
3. The participant and/or their parent/legal guardian, in the opinion of the Investigator, was unable to adhere to the requirements of the study.
Phase II Trial of Neo-adjuvant Temozolomide Prior to Combined Temozolomide and Concurrent Accelerated Hypofractionated External Beam Radiotherapy Followed by Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

Patients with GBM, who were deemed ineligible for any active protocols at our centre, received accelerated hypofractionation EBRT if 60Gy/20Fx using an IMRT technique with conventional dose of concomitant and adjuvant TMX as per the STUPP's TMZ schedule. Thirty five patients, 15 females and 20 males with a median age of 63 (range 31-78) were treated with a median KPS of 90 (range 50-100). Four patients had multicentric disease at presentation. Eight patients had biopsy only while the rest had a near total resection (n=14) and partial resection (n=13) with a median follow-up of 12.1 months, the median survival was 14.4 months.

In this proposal, the total cumulative dose of TMZ is unchanged as compared to the doses used in the Stupp protocol. In this proposal, the dose of TMZ is the same, with the sole difference that TMZ will be given in a neo-adjuvant setting for two weeks and then continued at the same dose concurrently with the accelerated hypofractionated EBRT delivering 60Gy in 4 weeks. The adjuvant component of TMZ remains unchanged from current standard practice.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years or older
* Histological confirmation of supratentorial GBM
* KPS \> 60
* Neurological function 0 or 1
* Adequate bone marrow as defined below:
* absolute neutrophil count (ANC) \> 1500 cells/mm3
* platelets \> 100,000 cells/mm3
* hemoglobin \> 10g/dl
* Adequate renal function as defined below:
* BUN \< 25mg/dl within 14 days prior to study registration
* creatinine of 63 to 103 umol/L within 14 days prior to study registration
* Adequate hepatic function as defined below:
* Bilirubin of 3 to 21 umol/L within 14 days prior to study registration
* ALT \& AST \< 3xnormal range within 14 days prior to study registration
* Neoadjuvant TMZ to start within 3 weeks of surgery/biopsy if no resection was deemed feasible
* A diagnostic contrast-enhanced MRI or CT scan of the brain must be performed preoperatively and postoperatively.
* History, physical and neurological examination within 14 days prior to study registration.
* For females of child-bearing potential, negative pregnancy test within 72 hours prior to starting TMZ.
* Able to sign an informed study-specific consent

Exclusion Criteria:

* Margin of contrast-enhanced residual mass closer than 15mm from the optic chiasm or optic nerves.
* Prior invasive malignancy, unless disease-free for \>3years
* Recurrent or multifocal GBM
* Severe co-morbidities such as
* unstable angina
* transmural myocardial infarction within 6 months
* COPD at the time of registration
* Hepatic insufficiency
* Bacterial or fungal infection requiring IV antibiotics at the time of registration
* Acquired Immune Deficiency Syndrome (AIDS)
* Major medical illnesses or psychiatric impairments
* Pregnant women or lactating women
The Effect of Hand Hygiene on Colonization Rates With Multidrug Resistant Enteric Pathogens in Travellers

Travelling to tropical and subtropical countries is a known risk factor for becoming colonized with extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae. Especially travellers returning from the Indian subcontinent show high colonization rates of up to almost 90%.

While risk factors for becoming colonized have been identified in several studies, no preventive measure has been tested so far.

One of the factors associated with becoming colonized while travelling is suffering from travellers' diarrhoea. Earlier studies looking at diarrhoea in childhood as well as school and/or work absenteeism because of diarrhoeal diseases have shown protective effects through good hand hygiene. Furthermore, a recent retrospective study has shown lower rates of travellers' diarrhoea in people using hand gel sanitizers. Improving hand hygiene in travellers through increased hand washing and the use of hand gel sanitizers might therefore not only decrease the rate of travellers' diarrhoea but the carriage rate with ESBL-producing Enterobacteriaceae as well. However, there is no prospective data available to prove the usefulness of such an intervention, neither in the prevention of travellers' diarrhoea nor in the prevention of colonization.

In the current study, investigators plan to compare colonization rates with ESBL-producing Enterobacteriaceae in travellers receiving pre-travel advice on improved hand hygiene (including the use of hand gel sanitizers) with travelers receiving standard advice.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* travelling to the Indian subcontinent (India, Bhutan and/or Nepal) for up to 4 weeks

Exclusion Criteria:

* age \< 18 years
* travelling to other destinations than India, Bhutan and/or Nepal
* antibiotic treatment at the time of the first sampling
Chronic Clinical Effect of Acetazolamide

The study seeks primarily to determine the chronic clinical effect of AZA on exercise capacity (6MWD) compared to placebo.

Pulmonary hypertension (PH) of various etiologies causes dyspnea, impairs exercise performance and is associated with reduced quality of life (QoL) and survival. Treatment options include therapy for any underlying causes, pulmonary vasodilator drugs, oxygen and, in selected cases, pulmonary endarterectomy or lung transplantation. Unfortunately, PH specific drugs are expensive, associated with side effects and even combined pharmacological treatment is often not sufficient to achieve clinical benefits. Therefore, novel therapeutic drugs are needed. We have recently demonstrated that sleep related breathing disorders, which are common in PH patients, can be improved by both nocturnal oxygen therapy and acetazolamide (AZA). AZA is a carbonic anhydrase (CA) inhibitor that acts as a respiratory stimulant thereby improving oxygenation and possibly PH. There are even data suggesting that CA-inhibitors have a direct pulmonary vasodilator effect. However, the potential role of AZA in the treatment of PH has not been conclusively studied. Therefore, the purpose of the current project is to investigate, the chronic clinical effects of AZA in PH patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing right heart catheterisation (RHC) for a clinical indication and who are diagnosed with precapillary PH (mean pulmonary arterial pressure (mPAP) ≥25 mmHg, pulmonary wedge pressure (PAWP) ≤15mmHg)
* Patients have to be in a stable condition, on the same medication for \>4 weeks

Exclusion Criteria:

* Patients in whom a RHC is clinically not indicated
* pregnant women
* PH in left heart disease or with more than mild chronic obstructive pulmonary disease or restrictive lung disease
Long-term Follow-up Durability (Efficacy) Study of EN3835 for the Treatment of AC of the Shoulder (Frozen Shoulder)

This is a long-term follow-up study to evaluate the safety and durability (efficacy) of response to EN3835 compared to placebo in participants who were treated in EN3835-210 or the pivotal Phase 3 parent studies for the treatment of AC of the shoulder (frozen shoulder).


Eligibility Criteria:
Inclusion Criteria:

1. Have been enrolled and completed the EN3835-210 or pivotal Phase 3 parent studies (for Study EN3835-223 eligibility, completed participants are those who were assessed for safety and obtained ASES scores at Day 95/EOS Visit; does not include early terminated participants).
2. Be willing not to use pain medications for the duration of the study period and for 2 weeks prior to the Day 180 visit. Pain medications include but are not limited to: barbiturates, benzodiazepines, methadone, buprenorphine, opioids (e.g., codeine, heroin, hydrocodone, hydromorphone, morphine, oxycodone), and cannabis.

   Note: NSAIDs (ibuprofen, etc.) are allowed.
3. Be willing to undergo MRI of the affected shoulder as required by the protocol.
4. Be able to read, understand, and independently complete patient reported outcome instruments in English.
5. Be willing and able to cooperate with the requirements of the study.
6. Be adequately informed and understand the nature and risks of the study and be able to provide consent.

Exclusion Criteria:

1. Is from a vulnerable population, as defined by the US Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc.) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the IRB/IEC.
2. Plans to receive (or received prior to Day 180) any invasive or minimally invasive (ie, steroid injections, shoulder manipulation, surgery, etc.) procedures to the affected shoulder during study participation.

   Note: PT is allowed. Any PT received should be captured in the respective electronic case report form (eCRF).
3. Has any contraindications for MRI (implant containing metal, internal metallic object, permanent cosmetics/make-up/tattoos-with exemption of the area to be treated/reviewed, claustrophobia, syncope, low blood pressure, epilepsy, asthma, anemia, or sickle cell disease) as determined by the technologist, the radiologist, and/or investigator performing imaging.
4. Has any other conditions that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.
Evaluation of Serum Levels and Pharmacokinetics of a New Hepatitis B Immune Globulin Following Liver Transplantation

The purpose of this study is to determine whether protective anti-HB serum levels are maintained after 6 months of uninterrupted treatment with IGIV-HB Grifols, a new specific hepatitis B immune globulin, in patients having previously undergone liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients having undergone a liver transplantation due to liver disease associated with hepatitis B virus, at least 1 year before and no more than 5 years before inclusion in the study.
2. Patients who have required treatment with HBIG, or are receiving it at present.
3. Patients from 18 to 70 years of age.
4. The patient agrees to participate and comply with all aspects of the protocol, including the planned blood sample collection, and has signed the informed consent form.

Exclusion Criteria:

1. Presence of HBV DNA or HBeAg indicating virus replication.
2. Patients with known allergies to some component of HB-IVIG, such as sorbitol (e.g. patients presenting intolerance to fructose).
3. Patients with a known background of severe or frequent reactions to products derived from plasma.
4. Patients presenting arterial hypertension that is not clinically controlled.
5. Patients presenting a creatinine value \>2 mg/dl, nephrotic syndrome or renal failure.
6. Patients presenting anaemia (haemoglobin \< 11 g/dl).
7. Patients being treated with interferon.
8. The patient suffers some acute or chronic medical condition that the investigator believes may interfere with the development or interpretation of the study.
9. The patient is known to abuse of alcohol, opiates, psychotropic agents or other drugs or chemical substances; or has done so in the past 12 months.
10. Pregnant women at the time of inclusion or that may be pregnant in the next 7 months or breast-feeding women.
11. Patients participating in another clinical study, or who have received another investigational product in the last 3 months.
12. Possibility that the patient may be treated with other products containing immunoglobulins in a period of 7 months.
13. Suspicion of conditions that may affect the patient's compliance, including an expected survival of less than 1 year.
14. Any patient that does not have a frozen serum sample previous to the first study medication infusion.
15. Patients with selective IgA deficiency.
Comparison of Subgingival Mechanotherapy With and Without the Use of a Perioscope: Clinical Trial

The study aims to comparatively assess clinical parameters, biochemical and microbiological parameters after treatment of periodontitis using subgingival mechanotherapy traditional and subgingival mechanotherapy using a perioscope.

Non-surgical treatment is the basic form of disease treatment periodontitis. Its first stage is the mechanical removal of dental plaque along with the control of risk factors. Subgingival mechanotherapy, also known as scaling and root planing (SRP) is the next stage, aimed at the subgingival area. Perioscopy makes possible direct real-time visualization of the root surface during the procedure. The research results published so far indicate improvement or no significant differences clinical parameters after SRP procedure using a perioscope vs traditional subgingival instrumentation. The aim of this study is to indicate, or not, clinical, biochemical (level of pro-inflammatory cytokines) and microbiological (A. actinomycetemcomitans, P. gingivalis, T. denticola) differences after periodontitis treatment using the traditional method vs. using a perioscope.

Eligibility Criteria:
Inclusion Criteria:

* age 20-60; (II)
* preserved lateral and anterior teeth;
* no periodontal treatment in the last 12 months;
* intermediate or advanced periodontitis (Stage II / III / IV)
* in each quadrant at least three teeth with PPD\>5 mm after initial treatment (scaling, motivation, instruction)

Exclusion Criteria:

* antibiotic therapy in the last 6 months;
* smoking;
* systemic diseases affecting periodontal tissues;
* pregnancy or lactation;
* orthodontic treatment;
* tooth mobility II / III degree;
* involvement of third degree furcations according to Hamp classification;
* endodontic issues