cyrilzakka/clinical-trials huggingface dataset:
The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark (CAP-D)

The aim of this randomised controlled trial is to identify the optimal treatment duration with phenoxymethylpenicillin for community-acquired pneumonia diagnosed in general practice.

Eligible participants are adults (≥18 years) presenting in general practice with symptoms of an acute LRTI (i.e., acute illness (≤ 21 days) usually with cough and minimum one other symptom such as dyspnea, sputum production, wheezing, chest discomfort or fever) in whom the GP finds it relevant to treat with antibiotics.

Consenting patients who meet all the eligibility criteria will be randomised (1:1:1:1:1) to either three, four, five, six or seven days of treatment with phenoxymethylpenicillin 1.2 MIE four times daily.


Eligibility Criteria:
Inclusion Criteria:

Eligible participants are adults (≥18 years) presenting in general practice with symptoms of an acute LRTI (i.e., acute illness (≤ 21 days) usually with cough and minimum one other symptom such as dyspnoea, sputum production, wheezing, chest discomfort or fever) in whom the GP finds it relevant to treat with antibiotics.

Exclusion Criteria:

1. Need for immediate hospitalisation at the time of diagnosis.
2. Known allergy to beta-lactam antibiotics.
3. Any coinfection necessitating antibiotic treatment.
4. Use of systemic antibiotics or antivirals within the last month.
5. Pre-existing lung disease (e.g., chronic obstructive pulmonary disease, bronchiectasis, asthma, lung cancer).
6. Known immunosuppression (i.e., long term treatment with corticosteroid, chemotherapy, or immune disorder).
7. Pregnant or lactating.
8. Patients not capable of consenting and/or patients deemed non-suitable for participation by the healthcare professional.
Chemoembolization for Hepatocellular Carcinoma

The aim of the current study is to study the safety and effectiveness of TACE using a high dose of cisplatin for treatment of HCC. It is hypothesized that the formulation is safe and it improves the therapeutic effect of conventional TACE.

Most patients with HCC are diagnosed at an intermediate and advanced stage when the tumors become unresectable, transcatheter arterial chemoembolisation (TACE) has been widely accepted as a standard treatment for them in most international management protocols. The therapeutic effect of TACE in terms of objective tumor response is variable and modest (27%-40%), indicating that there is actually much room for improvement in the treatment. Internationally, high doses and combination of chemotherapeutic agents are being routinely and widely used for TACE in major medical centers. Locally, a low dose of cisplatin (10mg) has been used as the chemotherapeutic agent for TACE in Hong Kong. There is evidence showing that the component of chemotherapeutic agent in TACE does play a significant role in the treatment effect of TACE. In an attempt to improve the treatment effect of TACE, the investigators propose a formulation of TACE using a high dose of cisplatin as chemotherapeutic agent.

Eligibility Criteria:
Inclusion Criteria:

Patient factor

1. Age \> 18
2. Child-Pugh A or B cirrhosis
3. ECOG performance status Grade 2 or below
4. No serious concurrent medical illness
5. No prior treatment for HCC except for liver resection
6. Creatinine clearance \>55ml/min.

Tumor factor

1. HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology.
2. Unresectable and locally advanced disease without extra-hepatic disease
3. Massive expansive tumor type with measurable lesion on CT
4. Total tumor mass \< 50% liver volume
5. Largest tumor of greatest dimension ≤ 15cm

Exclusion Criteria:

Patient factor

1. Serum creatinine level \> 130 umol/L
2. Presence of biliary obstruction not amenable to percutaneous drainage
3. Child-Pugh C cirrhosis

Evidence of impaired liver function

1. History of hepatic encephalopathy, or
2. Intractable ascites not controllable by medical therapy, or
3. History of variceal bleeding within last 3 months, or
4. Serum total bilirubin level \> 40 umol/L, or
5. Serum albumin level \< 30g/L, or
6. INR \> 1.3

Tumor factor

1. Presence of extrahepatic metastasis
2. Infiltrative lesion
3. Diffuse lesion

Vascular complications

1. Hepatic artery thrombosis, or
2. Partial or complete thrombosis of the main portal vein, or
3. Tumor invasion of portal branch of contralateral lobe, or
4. Hepatic vein tumor thrombus, or
5. Significant arterioportal shunt, or
6. Significant arteriovenous shunt
Effect of Rotablator on Balloon Resistant Calcified Coronary Lesion

The optimal treatment of calcified coronary lesion remained to be elucidated. A Prospective, randomized controlled trial was perform to explore the immediate effect and long-term outcome of rotational atherectomy in patients with balloon resistant coronary lesion.

The inclusion criteria included patients presenting drug-resistant angina pectoris who underwent balloon resistant angioplasty.

The exclusion criteria included:

1. Acute myocardial infarction within the 28 days;
2. Intolerance to aspirin, clopidogrel, contrast media, or statins;
3. Angiographic visible thrombus, or dissection;
4. Left ventricular ejection fraction (LVEF)\<35%;
5. Any type of cancer
6. Hemorrhagic stroke

Eligibility Criteria:
Inclusion Criteria:

* Drug-resistant angina pectoris
* Balloon resistant and angiographic calcified coronary lesion

Exclusion Criteria:

* Acute myocardial infarction within 28 days;
* Intolerance to aspirin, clopidogrel, contrast media, or statins;
* Angiographic visible thrombus, dissection;
* LVEF \<35%;
* Any type of cancer;
* Hemorrhagic stroke
ActivOnline: Physical Activity in Cystic Fibrosis Trial UK

Increased level of physical activity (PA) are of benefit in the management of cystic fibrosis (CF). This randomised control tial will assess whether three-months use of an online platform can help increase PA levels in people with CF (compared to a control group continuing routine treatment).

Cystic fibrosis (CF) is a genetic condition that predominantly affects the lungs through an accumulation of thick mucus. As there is no cure for CF, it is a disease that is managed through intensive medication, nutrition, physiotherapy, exercise and physical activity (PA).

Increased levels of PA are of benefit to people with CF, and therefore interventions that promote PA are warranted, particularly in adolescence, whereby PA levels decrease. Telehealth interventions are of particular interest in CF, whereby strict cross-infection guidelines prevent patients meeting in person, and allowing patients to overcome geographical barriers at the same time.

Previous research has shown engagement with an online platform (www.activonline.com.au), specifically designed to monitor PA in CF, is feasible and acceptable to people with CF. Therefore, a full randomised control trial is warranted to assess the efficacy of this intervention in changing PA.

UPDATE JUNE 2021: Due to ongoing restrictions placed upon research by the global COVID-19 pandemic, modifications to the protocol are necessary.

Recruitment and consenting will now take place online, and testing procedures will be completed by participants in their own homes. The nature, and length of, intervention remains unchanged.

Changes to protocol approved by ethics board on May 4th 2021.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CF
* Aged 12-35 years (inclusive)
* Able to provide informed consent/assent
* Able to access the internet via computer or mobile device

Exclusion Criteria:

* Presence of severe co-morbidity limiting mobilisation or physical activity participation (e.g. orthopaedic, cardiac or neurological condition)
* Previous lung transplantation
* Pregnancy
* Unable to provide informed consent/assent
China ATTUNE® Study

The study was designed as prospective, single-arm, multi-center which was intended to broadly capture all patients as the technology is adopted.

The primary objective is to evaluate the implant survivorship of ATTUNE primary, cemented Knee system in Chinese patients using Kaplan Meier Survivorship at 2 yrs. The subject population is male and female subjects who are candidates for primary, total knee arthroplasty between 18 and 80 years of age, inclusive, willing to consent with indications consistent with the Instructions for Use. A total of 120 subjects will be enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with Subjects with Osteoarthritis (OA), post-trauma arthritis.
2. Subject is male or female and between the ages of 18 and 80 years old, inclusive.
3. Subject requires a primary total knee replacement with or without un-resurfaced patella and is considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol.
4. Subject requires unilateral knee replacement or the first knee with ATTUNE system during the study will be enrolled for bilateral knee replacement.
5. Subject, or with the aid of a family member, is able to understand the Informed Consent Document and patient questionnaires.
6. Subject, with the aid of a family member as needed, has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to the Sponsor.
7. Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures.

Exclusion Criteria:

1. The Subject has, in the opinion of the Investigator, an existing condition that would compromise their participation and follow-up in this study, e.g. living in distant areas or having difficulty to return to the site, incooperative to surgeons' medical instructions and suggestions.
2. The Subject is a woman who is pregnant or lactating.
3. The Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect follow-up care or treatment outcomes.
4. The Subject has participated in a clinical investigation with an investigational product in the last 3 months that could impact/affect the outcome of the current procedure and follow-ups judged by the investigator.
5. The Subject has previous prosthetic knee replacement (any type including unicompartmental, total knee arthroplasty, patellofemoral arthroplasty or ipsilateral Upper Tibial Osteotomy (UTO)/ High Tibial Osteotomy (HTO)) of the affected knee or a previous patellectomy.
6. Subject has significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot disease, avascular necrosis).
7. The Subject requires a device not specified in the protocol or the surgeon determines that the ATTUNE Knee System is not a suitable treatment.
Vitamin A Value of Spirulina Carotenoids in Humans

The goal of this protocol is to determine the vitamin A value (equivalence) of spirulina. The investigation will use intrinsically deuterium labeled spirulina and an isotope vitamin A reference dose, 13C10- retinyl acetate (13C10 RAc), in males (n=20). Up to 45 blood samples (10 ml/sample) will be collected from each subject over a two-month period to evaluate the bioavailability and bioconversion of spirulina ß-carotene to vitamin A.

By utilizing novel stable isotope dilution techniques recently developed in our laboratory, we will trace deuterium labeled ß-carotene in intrinsically labeled spirulina, which is harvested from a hydroponic system. In the mean time, we will track 13C10 labeled vitamin A in humans. In this way we will determine absorption of ß-carotene from spirulina matrix and the conversion of the spirulina ß-Carotene to retinol. This will enable us quantitatively determine the vitamin A equivalence of spirulina.

The specific aims of this study are:

1. To determine labeled ß-C blood response kinetics following an acute dose of intrinsically labeled spirulina;
2. To determine labeled retinol blood response from the intrinsically labeled spirulina;
3. To determine 13C10 retinol blood response from the isotope reference material 13C10 retinyl acetate;
4. To determine s spirulina-vitamin A equivalence.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer

Exclusion Criteria:

* Not has GI track problems
* Any medical condition that will affect the intestinal absorption
Homocysteine After Nitrous Oxide Anesthesia

Our study looks at the interaction of a common mutation in the MTHFR gene and the risk of developing higher homocysteine levels after nitrous oxide (N2O) anesthesia.

Specifically, we want to test the hypothesis that healthy patients carrying the MTHFR 677C\>T haplotype develop abnormal homocysteine levels after nitrous oxide anesthesia.

Nitrous oxide - laughing gas - is a widely used anaesthetic gas with many favourable but also some dangerous properties. Among the latter is the increase in homocysteine levels after nitrous oxide (N2O) exposure by inhibition of enzymes in the vitamin B12 pathway. Elevated homocysteine levels have been found to be an independent risk factor for ischemic events and are associated with an increased risk for perioperative myocardial ischemia. If a patient carries one or more loss-of-function mutations in enzymes of the methionine/homocysteine/folate pathway he is at an increased risk for hyperhomocysteinemia and if exposed to N2O might suffer severe, sometimes disastrous neurological damage. Recently, a case report in the New England Journal of Medicine reported the death of a child with an enzyme defect in the MTHFR gene after anaesthesia with nitrous oxide (NEJM 2003;349:45-50).

Thus, we are convinced that if we can determine the risk of patients who carry mutations in the MTHFR gene and undergo anaesthesia with N2O for developing pathological levels of homocysteine, we can add an important piece of information to the safety profile of N2O.

Our study tests the hypothesis that patients who carry the 677C\<T mutation in the MTHFR gene (the most common mutation) have a higher risk of developing hyperhomocysteinemia after N2O anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for general anaesthesia (\> 2 hours)
* Age \> 18 years
* ASA status I-II

Exclusion Criteria:

* Pregnancy
* Age \< 18 years
* contraindication against N2O: pneumothorax, mechanical bowel obstruction, middle ear occlusion, laparoscopic surgery
* recent use of vitamin preps (B12, B6, folate)
PMCF Investigation of Medical Device ChitoCare® Medical

This is a post-marketing observational clinical investigation conducted as part of the post-market clinical follow-up of ChitoCare® Medical, aimed to confirm safety and efficacy according to the requirements of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, for the following indications:

Gel - scars, conditions after dermatosurgical procedures, dermatitis, acne

Spray - conditions after dermatosurgical procedures, dermatitis, acne


Eligibility Criteria:
The inclusion criteria are fully according to indications:

* Gel - scars, conditions after dermatosurgical procedures, dermatitis, acne
* Spray - conditions after dermatosurgical procedures, dermatitis, acne

The criteria for exclusion are fully according to contraindications:

* Allergy to any of the ingredients of the product
Efalizumab in the Treatment of Alopecia, Phase II

Determine the effect that treatment with efalizumab has on scalp hair re-growth in younger adults affected by severe variants of alopecia areata, including alopecia totalis, alopecia universalis, and severe ophiasis variants.

This is a Phase II trial (single-center, open-label, prospective study) where subjects with severe forms of alopecia areata, namely alopecia totalis, universalis, and severe ophiasis, will be treated with efalizumab (Raptiva), a humanized monoclonal anti-CD11a antibody that reversibly inhibits T cell activation and migration, weekly for 48 weeks. We will assess for effect on hair and body re-growth as well as record any serious adverse events such as serious infections, thrombocytopenia, development of malignancy, and severe arthralgias to monitor for safety outcome data. Subjects will have regular physical examinations and laboratory studies throughout the study, as well as telephone interviews.

Eligibility Criteria:
Inclusion Criteria:

* ability to provide written informed consent and comply with study assessments for the full duration of the study.
* clinical diagnosis of alopecia totalis, alopecia universalis, or severe ophiasis variant of alopecia areata.
* 18-40 years of age.
* if a female of childbearing potential, a negative pregnancy test and commitment to the use of two forms of effective contraception (birth control) for the duration of the study are necessary.
* if a non-sterile male, commitment to the use of two forms of effective contraception (birth control) for the duration of the study is necessary.

Exclusion Criteria:

* known hypersensitivity to efalizumab (Raptiva) or any of its components.
* known liver disease, including active hepatitis
* history of autoimmune diseases causing alopecia other than alopecia areata.
* prior biologic therapy within 6 months prior to study initiation.
* history of any malignancy within last ten years, except treated non-melanoma skin cancers.
* any woman currently pregnant or lactating.
* intake of systemic immunosuppressive agents, including oral corticosteroids, within 3 months prior to study initiation.
* history of positive PPD and/or tuberculosis.
* history of HIV/AIDS
* prior enrollment in any efalizumab study
* any condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
* participation in another simultaneous clinical trial involving investigational agents.
* positive HIV screening test obtained at screening visit.
* positive QuantiFERON-TB test obtained at screening visit.
* positive hepatitis screen obtained at screening visit.
* platelet count 150 x 10(9)/L at baseline visit.
* presence of any abnormal laboratory value obtained at screening visit assessed as clinically significant by principal investigator.
Topiramate for Hospitalized Patients With Alcoholism: a 12-week Study

12-week, open-label study of topiramate in hospitalized patients with alcoholism


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized due to alcohol-related problems
* DSM-IV-TR alcohol dependence
* \>/= 35 drinks/week (male) or \>/= 28 drinks/week (female) for \>/= 1 week during four weeks prior to the admission
* AUDIT score \>/= 8
* Mild or no alcohol withdrawal
* Body mass index \> 18 kg/m2
* No pregnancy and no plan for pregnancy (female)
* Intention to decrease or stop drinking

Exclusion Criteria:

* Severe psychiatric and cognitive disorders
* Other substance dependence, except nicotine and caffeine dependence, during 6 months prior to enrollment
* Taking antipsychotics, mood stabilizers, anticonvulsants, opioid analgesics, systematic steroids, carbonic anhydrase inhibitors, hydrochlorthiazide, metformin, pioglitazone, or disulfiram
* Moderate to high risk of suicide
* Medical history of narrow angle glaucoma, renal impairment, kidney stones, and seizures
* Unstable medical conditions
* Plan to receive a formal treatment for alcoholism from other treatment settings
* Under legal process
* Pregnancy and nursing woman
* Abnormal laboratory tests, including blood urea nitrogen, creatinine, electrolytes, and fasting blood sugar
Investigating the Preventative Ability of Massage Therapy on Paclitaxel Induced Peripheral Neuropathy

Feasibility study to examine the preventative ability of massage therapy on paclitaxel induced peripheral neuropathy in breast cancer


Eligibility Criteria:
Inclusion Criteria:

1) Breast cancer diagnosis 2) Planning to receive chemotherapy treatment with paclitaxel in the curative setting (adjuvant or neoadjuvant) on a weekly or bi-weekly schedule

Exclusion Criteria:

1)Diabetes or other neurological disorder 2) Current or previous peripheral neuropathy 3)Previous treatment with paclitaxel 4)Active deep vein thrombosis (DVT) within last 12 months or history of untreated lower extremity DVT
Radiotherapy for Oligometastatic Prostate Cancer

The purpose of this phase II study is to evaluate the outcomes of patients treated with an investigational radiation regimen using stereotactic radiotherapy for oligometastatic prostate cancer and to establish efficacy (producing a desired result or effect) and safety in this setting.

This study will serve as a component of a larger program investigating the benefits of stereotactic radiotherapy in patients with metastatic disease.

This particular study will serve as a benchmark analysis.

All patients will receive stereotactic radiotherapy directed at metastatic tumors.

If primary prostate cancer is active and has not previously been treated with radiation therapy, conventional radiation therapy (6-8 weeks of daily treatment) may be recommended. The metastatic tumor will be treated at the same time.

Hormone therapy will be recommended for all patients.

Patients will be asked to complete questionnaires at regular intervals.

Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic cancer of the prostate,
* Patients may have received prior surgery,
* Prior radiation therapy, androgen deprivation therapy (ADT), immunotherapy, bone metastasis directed therapy, or chemotherapy for prostate cancer.

Exclusion Criteria:

* End-stage heart disease,
* End-stage liver disease,
* End-stage renal disease,
* End stage pulmonary disease
* Current brain or central nervous system metastasis.
Using Cardiac MRI to Characterise the Dynamic Changes Which Occur in the Acutely Reperfused STEMI Patient

There is an optimal day on which to perform the CMR scan which allows one to capture the information required to assess the dynamic changes in the reperfused STEMI patient. The main objective is to characterise the dynamic changes in LV function, MI size, myocardial edema, MVO, IMH, interstitial volume in the remote myocardium over the first 10 days of an acute reperfused STEMI in order to identify the optimal day for performing the CMR scan.

This will be a prospective observational study with serial CMR imaging only.

CMR scan Each patient will receive one CMR scan performed on Day 1, Day 3, Day 5, Day 10 following the PPCI procedure on a 3T Philips scanner (see study flow below). All CMR scans will be analysed at a central CMR corelab.

For Day 1, 3, 5, 7 and 10 CMRs, parameters will be collected as follows:

* Left ventricle (LV) ejection fraction and indexed LV end systolic and diastolic volumes and mass using short-axis SSFP cine imaging and myocardial tagging sequences).
* The AAR by T1 and T2 mapping18 as a percentage of the LV over time.
* Signal intensity of T1 and T2 mapping in the MI zone, MI core and remote myocardium over time.
* The incidence of intramyocardial haemorrhage (IMH)(hypo-enhancement on T2\* mapping sequence)26.
* The volume of microvascular obstruction (MVO) defined as signal intensity 2 standard deviated below the mean signal intensity of the remote myocardium on the T2\* maps.

Additional sequence for Day 3 and 7 CMR scans:

• All the above plus MI size (measured in mass of LGE and expressed as a percentage of the LV mass).

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed STEMI as per PPCI procedure reports/ clinical notes
2. Proximal to mid coronary artery occlusion.
3. Ability to provide informed consent

Exclusion Criteria:

1. Previous myocardial infarction or coronary artery bypass graft surgery
2. Contraindication for CMR (e.g. ferromagnetic implants, claustrophobia, estimated glomerular filtration rate \<30mL/min)