cyrilzakka/clinical-trials huggingface dataset:
An Evaluation of the Active Herts Physical Activity Programme

There is a high prevalence of inactive adults in the United Kingdom (UK), many of whom suffer from conditions such as diabetes, cardiovascular disease, and poor mental health. These problems often co-exist more frequently in areas of higher socio-economic deprivation. There is an ongoing need to test the effectiveness, acceptability, and sustainability of community physical activity interventions. The Active Herts programme is a community physical activity programme aimed at inactive adults aged 16 and over who have one or more risk factors for cardiovascular disease (CVD) and/or a mild to moderate mental health condition. The programme uses the latest evidence-based behaviour change techniques to target physical activity, wellbeing, and key drivers of behaviour from the COM-B ('Capability', 'Opportunity', 'Motivation' and 'Behaviour') model of behaviour change.

This evaluation will follow a mixed-methods longitudinal (baseline, and 3, 6 and 12 month follow-ups) pragmatic observational design. Two types of programme are being delivered, each in a different area. In one, group participants will receive a behaviour change technique booklet, consultations (baseline, and optional at 3, 6, and 12 months), a booster phone call (week 2), motivational text messages (weeks 3, 6, and 12), and signposting to 12 weeks of exercise classes. In the other 'enhanced delivery' group, participants will receive the same but the 12 weeks of exercise will be free and tailored to their needs, and there will be optional exercise 'buddies' available. An outcome evaluation will assess changes in physical activity as the primary outcome, and sporting participation, sitting, wellbeing, psychological capability, and reflective motivation as secondary outcomes. A process evaluation will use both one-to-one interviews and focus groups to explore the views of stakeholders, delivery staff, and participants over three phases (set-up, deviations in the delivery of the intervention, and looking back over the intervention). Economic evaluation will examine the costs of the Active Herts programme against the benefits gained in terms of reduced risk of morbidity from a range of chronic conditions.

This study will measure key drivers of physical activity using up to date behaviour change theory, allowing evaluation of not only whether physical activity has increased but also why. The research will inform the future development of a scalable intervention that can be more robustly tested in a randomised controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* inactive adults and do less than 30mins of physical activity per week
* aged 16 or over
* resident of Hertfordshire boroughs, including Broxbourne, Hertsmere, Stevenage or Watford

Referred patients and clients may also have:

* a long term medical condition such as type 2 diabetes, hypertension, high cholesterol etc.
* a mild to moderate mental health condition such as anxiety, depression or stress
* a history or family history of heart disease

Exclusion Criteria:

* participants not able to give informed consent
Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)

When the upper chambers of a person's heart receive or generate irregular electrical signals, it causes abnormal rhythm in the heartbeat. This is called atrial fibrillation.

Atrial fibrillation goes along with blood clots that may cause mainly strokes and less often other diseases, such as a heart attack. Some patients with atrial fibrillation have other heart disease, such as heart valves that may need to be replaced using catheters.

Often doctors give patients drugs that reduce those blood clots. These are either vitamin K antagonist (VKA) or direct anticoagulants, such as edoxaban. In these patients, it is unclear which of the drugs is better for reducing stroke without increasing severe bleedings.

Use of Edoxaban in patients with atrial fibrillation (AF) and indication to chronic oral anticoagulation (OAC) after transcatheter aortic valve implantation (TAVI)

Objective:

* To assess the effect of Edoxaban versus vitamin K antagonist (VKA) on net adverse clinical events (NACE), i.e., the composite of all-cause death, myocardial infarction (MI), ischemic stroke, systemic thromboembolism (SEE), valve thrombosis, and major bleeding (International Society on Thrombosis and Haemostasis \[ISTH\] definition).
* To assess the effect of Edoxaban versus VKA on major bleeding (ISTH definition).

Eligibility Criteria:
Inclusion Criteria:

* Meets protocol-specified criteria for qualification and contraception
* Is willing and able to comply with any restrictions related food, drink and medications
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

* Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  1. the safety or well-being of the participant or study staff
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  3. the analysis of results
Observational Study to Evaluate Long-Term Outcome in Hip Arthroplasty

This long-term outcomes study is designed to collect safety and efficacy data on designated, commercially available, hip arthroplasty products.

Outcome data collected from this study will be used for Post Market Surveillance (PMS) and Clinical Evaluations on Corin hip devices and will support peer-reviewed publications on products performance and safety at long term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman \>18 years
* Subjects with indication of arthroplasty surgery with Corin hip devices which are under assessment as part of this PMCF study
* Subjects who agreed for study participation.

Exclusion Criteria:

* Subjects with existing tumour and/or particularly high surgical risk-
* Subjects with anaesthetic risk class IV or higher
* Subjects under guardianship and/or unable to follow procedures or matters related to the study (examples: Illiterate, recent psychotic or mania disorders and / or inability to comply with usual follow-up visits.)
* Contraindications for arthroplasty with a Corin hip devices as per product IFU
Effect of Rifampin on the Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors

This is a phase 1, open-label study designed to determine the interaction of rifampin with linifanib.

This study is designed to explore the drug interaction between rifampin and linifanib to determine the potential effect of rifampin on the metabolism of linifanib. Linifanib will be taken alone or in combination with rifampin. The safety of a single dose administration of linifanib when administered alone and in combination with rifampin will be assessed. Subjects may enroll in a separate extension study to continue receiving linifanib after completion of this study.

Eligibility Criteria:
Inclusion Criteria

1. Age is greater than or equal to 18 years.
2. Subject must have a histologically or cytologically confirmed non-hematologic malignancy other than HCC.
3. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
4. Subject must have adequate bone marrow, renal and hepatic function.

   * Bone Marrow: Absolute neutrophil count (ANC) \>= 1,500/mm\^3 (1.5 X 10\^9/L); Platelets \>= 75,000/mm\^3 (75 X 10\^9/L); Hemoglobin \>= 9.0 g/dL (1.4 mmol/L)
   * Renal function: serum creatinine \<= 2.0 mg/dL (0.81 mmol/L);
   * Hepatic function: AST and ALT \<= 1.5 X ULN unless liver metastases are present, then AST and ALT \<= 5.0 X ULN; bilirubin \<= 1.5 mg/dL (0.026 mmol/L).
5. Subject must have Partial Thromboplastin Time (PTT) \</= 1.5 X Upper Limit of Normal ( ULN) and International Normalized Ratio (INR) \</= 1.5.

Exclusion Criteria

1. Subject has received anti-cancer therapy including investigational agents, cytotoxic chemotherapy, radiation therapy or biologic therapy within 21 days or within a period defined by 5 half lives, whichever is shorter, prior to study drug administration. In addition subject has not recovered to less than or equal to Grade 1 clinically significant adverse effects/toxicities of the previous therapy.
2. Subject has undergone major surgery within 21 days of Study Day 1.
3. Subject has untreated brain or meningeal metastases. Subjects with treated brain metastases that are radiographically or clinically stable (for at least 4 weeks after therapy) and who have no evidence of cavitation or hemorrhage in the brain lesion, are eligible provided that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 week prior to Study Day 1).
4. Subject has received potential inhibitors of the metabolism of linifanib within 21 days prior to initial study drug administration. Such drugs include CYP3A inhibitors, CYP1A2 inhibitors, CYP2C19 inhibitors, CYP2C8 substrates and CYP3A inducers.
5. Current enrollment in another clinical trial..
Investigating the Effect of Topical Imiquimod on Sebaceous Hyperplasia

This study is being completed to determine if 8 weeks of treatment with imiquimod can shrink sebaceous hyperplasia.


Eligibility Criteria:
Inclusion Criteria:

* Patient has sebaceous hyperplasia lesions on both sides of the face. At least one sebaceous hyperplasia lesion on each side of the face is 1 mm or more in size.
* If of child-bearing potential, subject agrees to the use of highly effective contraception during study participation. For women of childbearing potential, acceptable pregnancy prevention measures will include abstinence, barrier methods, chemical methods, or surgical.
* Ability to understand and willingness to sign a written informed consent

Exclusion Criteria:

* Current use or prior use of a retinoid (e.g. tretinoin) within the last 4 weeks.
* Prior use of imiquimod on the treated area.
* Concurrent use of 5-fluorouracil, aminolevulinic acid (photodynamic therapy), or psoralen therapy, or use of any of these within the last 4 weeks.
* Concurrent facial peels or cosmetic laser therapy on the treated areas.
* Nursing, pregnant or planning to become pregnant.
* Immunocompromised status (e.g. organ transplantation recipients or patients on cyclosporine).
* Current participation in other investigational trials.
* Known or suspected history of a clinically significant systemic disease (e.g., immunological deficiencies), unstable medical disorders (e.g., unstable diabetes), life-threatening disease or current malignancies.
* Known hypersensitivity to any of the following (in any dosage form): imiquimod or any component of the study medications.
* Received radiation therapy and/or anti-neoplastic agents within 3 months prior to study entry.
Bemiparin Versus Enoxaparin in the Prevention of Venous Thromboembolism Among ICU Patients

The purpose of this study is to compare two types of low-molecular-weight heparin, enoxaparin and bemiparin, as regards their efficacy and safety in venous thromboembolism prevention among intensive care unit patients.

A prospective randomized trial to compare thromboprophylaxis using bemiparin and enoxaparin in critically ill patients in ICU. The study included one hundred bedridden patients in intensive care unit who are at high risk for developing venous thromboembolism and require long term anticoagulation

Patients were divided into two groups each one consists of 50 patients. One group received bemiparin 3500 IU subcutaneous once daily and the other group received enoxaparin 40 mg subcutaneous once daily as a prophylaxis against thromboembolism.

Patients were followed up for 60 days for the development of deep venous thrombosis, pulmonary embolism and complications related to the injected anticoagulant.

Eligibility Criteria:
Inclusion Criteria:

* Sepsis , stroke , major burn , respiratory failure , traumatic brain injury , malignancy and post arrest who are intubated and mechanically ventilated on continuous IV sedation

Exclusion Criteria:

* Hypersensitivity to low molecular weight heparins , hypercoagulability , congenital or acquired bleeding disorder, prolongation of activated partial thromboplastin time or prothrombin time by 20% compared to normal values; thrombocytopenia (platelet count \<100,000/mm3); macroscopic hematuria; uncontrolled hypertension \[systolic blood pressure \>200 mmHg; diastolic blood pressure \>100 mmHg\]; impaired kidney function: serum creatinine \> 2.0 mg/ dL and bleeding gastrointestinal ulcer.
Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital

Retrospective study of all patients diagnosed with primary biliary cholangitis during January 2001 to July 2016 at West China Hospital by review of medical records. The following variables will be retrospectively studied: age, sex, first symptoms, clinical characteristics, pathology, treatment, stage, complications of cirrhosis, other autoimmune diseases and long-term outcome.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosis of PBC at West China Hospital during January 2001 to July 2016.

Exclusion Criteria:

* Simultaneously diagnosed of autoimmune hepatitis or primary sclerosing cholangitis.
Radiotherapy of the Prostate and the Pelvic Lymph Nodes After Neoadjuvant Antihormonal Treatment

For patients with prostate cancer and a high risk of lymph node involvement or confirmed pelvic lymph node metastases, radiotherapy of the whole pelvis is a treatment option. However, conventional radiotherapy of the pelvis has limited by gastrointestinal and urogenital side effects. The PLATIN trial investigates an intensity-modulated radiotherapy of the pelvic lymphatic drainage that spares small bowel, bladder and rectum. A higher dose is given during each session to the prostate or the prostate bed and to confirmed lymph node metastases. Prior to radiotherapy, two months of neoadjuvant antihormonal treatment are required, and continuation during radiotherapy and for a further two years are strongly recommended.

The PLATIN trial is designed as a prospective, non-randomized, five-arm trial. Arm 1: Definitive radiotherapy of the pelvic lymphatic drainage with integrated boost to the prostate.

Arm 2: As arm 1, with additional boost to macroscopic lymph node metastases. Arm 3: Postoperative radiotherapy of the pelvic lymphatic drainage with integrated boost to the prostate bed.

Arm 4: As arm 3, additional boost to macroscopic lymph node metastases. Arm 5: Patients with previous radiotherapy to the prostate bed. Radiotherapy of the pelvic lymphatic drainage above the previous treatment fields with integrated boost to macroscopic lymph node metastases.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed prostate cancer with Gleason Score
* risk of lymph node involvement \>20% (according to Roach Formula), pelvic lymph node metastases in CT/MRI or histologically confirmed lymph node involvement
* Karnofsky Index \>/= 70%
* age 18-75 years
* neoadjuvant antihormonal treatment for 2 months, continuation until the end of radiotherapy
* written informed consent

Exclusion Criteria:

* stage IV (distant metastases)
* lymph node metastases outside the pelvis
* rising prostate-specific antigen (PSA) under antihormonal treatment
* severe wound complications after laparatomy
* severe lymph edema of the legs, elephantiasis, postthrombotic syndrome
* decompensated comorbidity of the lungs, heart, metabolic system, hematopoetic system or kidneys, coagulopathy
* history of other malignancy within the last 5 years (except for basal cell carcinoma or squamous carcinoma of the skin)
* previous irradiation of the pelvic lymph nodes
* concurrent participation in a clinical trial that might influence the results of either trial
Tension of THERABAND® Kinesiology Tape on Shoulder Pain

The purpose of this study is to determine the effectiveness of standard tension of Thera-Band® Kinesiological Tape (TB-KT) application versus varied tension on shoulder pain, disability, and recovery speed during an in-office rehabilitative program. A convenience sample size of 38 new patients with current shoulder pain will be recruited for this study. The outcome measures will include the Numeric Pain Rating Scale (NPRS) and the Penn Shoulder Score (PENN). After completing the initial paperwork, patients will be randomized into two groups, control (0% tension) and intervention(increasing tension). At the beginning of each week the tape will be reapplied, and pain rating will be recorded. At the conclusion of 4 weeks patients will complete the PENN.

The purpose of this study is to determine the effectiveness of standard tension of Thera-Band® Kinesiological Tape (TB-KT) application versus varied tension on shoulder pain, disability, and recovery speed during an in-office rehabilitative program. A convenience sample size of 38 new patients with current shoulder pain will be recruited for this study. Patients must be tested within the first 2 to 3 therapy visits, have a diagnosis of shoulder pain, be 18-64 years old, no corticosteroid treatment within the last two weeks, post-surgical cases will be excluded, and patients may not be pregnant. Upon agreeing to the study, patients will sign an informed consent, complete a demographics questionnaire, and complete specific outcome measure assessments. The outcome measures will include the Numeric Pain Rating Scale (NPRS) and the Penn Shoulder Score (PENN). After completing the initial paperwork, patients will be randomized into two groups, control and intervention. The Control group will receive standard FUNHAB® in-office care in addition to standard TB-KT taping technique. The Intervention group will receive standard FUNHAB® in-office care plus varying tension application of TB-KT. The TB-KT will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The tape will be applied in an "I" strip from the vertebral border of the scapula to the lesser tubercle of the humerus. Over the course of the 4 weeks, the tension of the tape will systemically increase. At the beginning of each week the tape will be reapplied, and pain rating will be recorded. At the conclusion of 4 weeks patients will complete the PENN.

Eligibility Criteria:
Inclusion Criteria:

* tested within the first 2 to 3 therapy visits, have a diagnosis of shoulder pain, and be 18-64 years old

Exclusion Criteria:

* Corticosteroid treatment within the last two weeks, post-surgical cases, and pregnancy
Improving Survey Procedures for Young Men Who Have Sex With Men in Web-based HIV Prevention: Retention Study

The purpose of this study is to test the efficacy of alternative methods to improve survey completion.

Men who have sex with men (MSM) are the risk population most heavily impacted by HIV in the United States by any measure; in 2009, at least 61% of new HIV infections were estimated to have occurred in MSM. MSM are experiencing an increase in HIV transmission that has been occurring since at least 1990, and accelerated in multiple North American and European countries from 2000-2005. The expansion of the HIV epidemic has been proposed to be attributable, in part, to the extent to which the internet has facilitated sexual connectivity among MSM.

Researchers have attempted to reach MSM for HIV prevention research and intervention on the internet. In the past 10 years, there has been a proliferation of internet surveys and HIV research studies among men who have sex with men that utilize the internet for data collection and, in some cases, the delivery of HIV prevention content. The development of internet-based interventions has been recently identified as especially promising because of its potential for scalability. However, there are also important limitations to internet-based data collections and prevention studies. The most important of these relate to representativeness and opportunities to introduce bias to data collections and differences in access to and use of internet among different subgroups of MSM. Equally important, although less discussed, are the unique ethical and human research protections challenges posed by online sexual health prevention studies.

The investigators will conduct an experiment to improve knowledge of how to conduct internet-based HIV prevention research with MSM in ways that decrease biases in data collections. The design will consist of a randomized controlled trials of MSM recruited online. A total of 1000 MSM will be enrolled to determine how to best improve retention in online surveys.

Eligibility Criteria:
Inclusion Criteria:

* male
* aged 18 to 34 years
* have had sex with another man in the past 12 months

Exclusion Criteria:

* female or transgender
* younger than 18 years of age
* older than 34 years of age
* have not had sex with another man in the past 12 months.
Sleep Impairments in Refugees Diagnosed With PTSD

The aim of this study is to examine sleep architecture in refugees with PTSD. Polysomnography (PSG) will be carried out to study the occurrence of sleep disorders in patients and healthy controls.

There is little knowledge on treatment of sleep disturbances in trauma-affected refugees and this study will be the first to record the biophysiological changes that occur during sleep in refugees with PTSD. The study is a proof-of-concept study and this will contribute with new and potentially crucial knowledge of sleep disturbances in these patients.

The project is designed as a cross-sectional study with 20 refugees with PTSD referred to the specialised outpatient clinic, Competence Centre for Transcultural Psychiatry (CTP), and 20 healthy control subjects.

All patients referred to CTP will be invited to an initial consultation with a doctor. During this consultation a diagnostic assessment will be performed and the clinical history will be obtained. Patients who give informed consent will be invited to participate in the project and have sleep measurements performed by PSG. Furthermore self-administered questionnaires and semi-structured interviews will be used to collect information on mental health, sleep quality, sleep length and nightmares.

Each patient will be equipped with PSG equipment to do measurements at home for one night (12 hours). Healthy control subjects will fill out the same CTP standard ratings and have the same diagnostic assessment and PSG measurement.

The hypothesis is that the sleep architecture in refugees with PTSD differ from healthy controls. It is suggested that refugees with PTSD have increased dream activity as well as increased incidence of sleep disorders such as rapid eye movement (REM) sleep without atonia (RSWA), REM sleep behaviour disorder (RBD), sleep apnea and periodic limb movement disorder (PLM).

The study is performed in collaboration with Danish Centre for Sleep Medicine in Denmark.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years old or above)
* Refugee or family reunification refugees
* PTSD according to the ICD-10 criteria's
* Signed informed concent

Exclusion Criteria:

* Severe psychotic disorder (defined as patients with ICD-10 diagnoses F2x and F30.1-F30.9)
* Harmful use of alcohol (ICD-10 diagnosis F1x.1)
* Serious or progressive somatic illnesses that the lead investigator finds interfering for the study
* Medical treatment with antipsychotics, benzodiazepine, opioids, CNS stimulants or regular use of anti histamine
* BMI \>35
* Pregnancy
Sunface Mirroring RCT in Brazil

Randomized trial looking at the effects of a behavioral photoaging software intervention on sunscreen use in the city of Itauna, Brazil.


Eligibility Criteria:
Inclusion Criteria:

Visiting a secondary school in Brazil.

Exclusion Criteria:

Not visiting a secondary school in Brazil.