cyrilzakka/clinical-trials huggingface dataset:
COMpassion FOcused Therapy and Breathing Pattern REtraining After Cancer Recurrence

The purpose of this study is to investigate how effective a particular psychological intervention is at reducing psychological distress for people who were diagnosed with cancer 'recurrence' since the beginning of the COVID pandemic.

This study plans to study how effective a particular psychological intervention is at reducing psychological distress for people who were diagnosed with cancer 'recurrence' since the beginning of the pandemic, having previously been diagnosed with cancer. We know that a cancer diagnosis can often result in significant psychological distress. After or during treatment for cancer, individuals often experience a 'fear of recurrence', which should it occur, often results in a state of mental anguish that is described as being more punishing than the initial diagnosis itself. Being diagnosed with a cancer recurrence diagnosis can trigger marked negative psychological symptoms, including distress, uncertainty, traumatic distress and adjustment problems, with psychological recovery from this diagnosis often being slower than that of the initial cancer diagnosis. The COVID-19 pandemic has affected these patients further, in terms of restricted access to healthcare, reduced social supports, and greater levels of treatment uncertainty. Our research team has designed a psychological intervention that is specifically aimed to help some of these issues. It's a 6-week online group intervention using a 'compassion focused therapy' approach, coupled with specialised breathing techniques to reduce bodily distress. It is being done online due to ongoing concerns around COVID but also to eliminate geographical and/or commuting barriers. It is our expectation that those receiving the psychological intervention will experience noticeable reductions in measures of psychological distress compared to those who are receiving regular treatment. It is our hope that the outcomes of this study will inform how best to help patients facing into cancer recurrence at a national level.

Eligibility Criteria:
Inclusion Criteria:

* adults aged 18 or older
* pre-existing cancer diagnosis
* diagnosis of cancer recurrence during COVID-19 (March 2020 onwards)
* Living in Ireland
* English speaking / fluency
* Access to web / tech support

Exclusion Criteria:

* A score \<4 on the Distress Thermometer
* Patient non-consent
* The presence of a severe mental illness (such as schizophrenia, personality disorder or active illness)
* Known or suspected drug or alcohol abuse problems within past 3 months
* Inability to follow the study procedures e.g. dementia or non-fluency of English
* Life expectancy \<3 months
Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer

A study of palbociclib in combination with letrozole as treatment of post-menopausal women with hormone receptor-positive, her2-negative advanced breast cancer for whom letrozole therapy is deemed appropriate.

To provide access to palbociclib to post-menopausal patients with hormone receptor-positive \[HR(+)\], HER2-negative \[HER2(-)\] ABC who are deemed appropriate for letrozole therapy.

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women (\>=18 years of age) with proven diagnosis of advanced carcinoma of the breast (ER(+) and/or PgR(+) and HER2(-)) who are appropriate for letrozole therapy (in the first-line advanced/metastatic disease setting).
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Adequate bone marrow, liver, and renal function.

Exclusion Criteria:

* Prior treatment with any CDK inhibitor .
* QTc \>480 msec; history of QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes.
* High cardiovascular risk, including, but not limited to myocardial infarction, severe/unstable angina, severe cardiac dysrhythmias, and symptomatic pulmonary embolism in the past 6 months of enrollment.
Effect of Progestin-Induced Withdrawal Bleed on Ovulation Induction Cycles With Clomiphene Citrate

Women with polycystic ovary syndrome (PCOS) can suffer from infertility because they do not produce an egg each month, resulting in irregular periods. As a result, these women often need a medication called clomiphene citrate (clomiphene) to induce ovulation. A traditional 'clomiphene protocol' begins with a short course of progestin treatment to bring on a period (termed a 'withdrawal bleed') before starting the clomiphene medication. Newer evidence, however, has suggested that this progestin-induced shedding of the uterine lining (i.e., withdrawal bleed) may decrease the chances of pregnancy. The purpose of our study is to determine whether withdrawal bleeding has an impact on pregnancy rates for patients with PCOS undergoing a clomiphene cycle.

It is hypothesized that patients who undergo ovulation induction with clomiphene citrate without prior endometrial shedding will have higher clinical pregnancy rates than those who begin with a progestin-induced withdrawal bleed.


Eligibility Criteria:
Inclusion Criteria:

* Polycystic ovary syndrome (Rotterdam 2003 Consensus Criteria) and a diagnosis of anovulatory infertility
* Age 18-38 years
* At least 1 patent fallopian tube (as demonstrated by hysterosalpingogram, hydrotubation or hysterosonogram within the last year)
* Normal semen analysis (total motile sperm count \>20million/ml)
* Normal uterine cavity (as demonstrated by hysterosalpingogram, hydrotubation or hysterosonogram within the last year)
* Undergoing ovulation-induction with clomiphene citrate without intra-uterine insemination (IUI)

Exclusion Criteria:

* Body mass index (BMI) \< 17 kg/m2 or \> 40 kg/m2
* Prior treatment with clomiphene citrate
* Presence of a hydrosalpinx (as seen on ultrasound, hysterosalpingogram, hydrotubation or hysterosonogram)
* Those with systemic disease such as diabetes mellitus, uncontrolled thyroid disease, systemic lupus erythematosus and antiphospholipid antibody syndrome
* Any other cause of infertility other than anovulation
The Big Breakfast Study

This weight loss study will investigate the impact of diet composition and meal size (large breakfast meals and smaller evening meals) on body weight, energy balance and eating behaviour, by altering calorie (meal) distribution.

The aim of this study is to further strengthen our understanding of the role of dietary components (in particular fibre and protein) in a healthy diet. The information gained from this research will lead to better policy advice, particularly in relation to healthy weight management, metabolic control, mental health and intestinal health. It will also lay the foundations to produce healthier primary products and aid the food industry in developing new and healthier products (e.g. products that aid hunger control and satiety). This will be addressed through four interlinked objectives:

O1: Healthy weight management and improved metabolic and mental health O2: Identification of gut bacteria and compounds of relevance to vascular and gut health O3: Linking fibre consumption to intestinal microbial communities and health O4: Mathematical modelling of interactions between diet and gut microbial communities

Eligibility Criteria:
Inclusion Criteria:

* BMI ranging from 27-42 kg/m2;
* those habitually consuming breakfast (at least 5 times a week).

Exclusion Criteria:

* women who are pregnant, planning to be pregnant or breastfeeding
* subjects with food allergy
* diagnosis of diabetes, hypertension, renal, hepatic, haematological disease or coronary heart disease
* having given a pint of blood for transfusion purposes within the last month
* unsuitable veins for blood sampling
* inability to understand the participant information sheet
* inability to speak, read and understand the English language
* those on any prescription medications (other than oral contraceptives)
* those on any specific diet regimes
* those on any weight loss programmes (that may be affecting lifestyle, physical activity and diet).
Umbilical Cord Blood Use For Admission Blood Tests of Very Low Birth Weight Preterm Neonates: A Multi-center Randomized Clinical Trial

The goal of this protocol is to establish a randomized clinical trial comparing the use of cord blood vs. infant blood with the primary outcome of comparing both the absolute hemoglobin concentration and the percent change in hemoglobin concentration from baseline around 24 hours of life.


Eligibility Criteria:
Inclusion Criteria:

* Birth weight less than 1200g or Gestational Age less than 30 weeks born at participating medical centers

Exclusion Criteria:

* No specific exclusion criteria
Opioid Induced Swallowing Difficulties and Risk for Pulmonary Aspiration

The purpose of this study is to determine weather remifentanil induced swallowing difficulties increase risk for pulmonary aspiration.

Remifentanil and other opioids are widely used as anesthetic sedation during minor surgical procedures and as pain relief in icu-patients when the patient is spontaneously breathing and the airway is not secured by endotracheal intubation. In these circumstances inability to clear the pharynx by swallowing may increase risk for aspiration.In a previous study ( not yet published) we showed that remifentanil induce subjective swallowing difficulties in healthy volunteers and the aim of this study is to determine weather remifentanil infusion in healthy non-intubated volunteers increase risk for pulmonary aspiration. To assess this question we are going to study 14 volunteers who are randomised to receive remifentanil infusion with target concentration 3 ng/ml during 60 minutes at one occasion and an equal amount of saline at the other. Radioactive Technetium colloid solution is parallelly infused through a pliable catheter transnasally. After remifentanil infusion is stopped the transnasal catheter is removed and the volunteer is asked to swallow water to clear the remaining radioactivity from upper gastrointestinal tract. Thereafter lung scanning with a gamma camera is performed. Through which mechanism remifentanil cause swallowing difficulties is not known.To determine weather remifentanil induce general muscle weakness in volunteers measurements of grip strength using Jamar dynamometer are performed before, during and 15 minutes after remifentanil infusion.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 40 year old healthy volunteers from both sexes.
* Have signed and dated Informed Consent.
* Willing and able to comply with the protocol for the duration of the trial.

Exclusion Criteria:

* Pharyngoesophageal dysfunction
* Anamnesis of pharyngoesophageal dysfunction
* Known history of cardiac, pulmonary or neurological disease
* Ongoing medication
* Allergies to or history of reaction to naloxone, remifentanil, fentanyl analogues or other ingredients
* History of reaction to products containing human albumine
* Pregnancy or breast feeding
* BMI \> 30
* Previous participation in a medical clinical trial where opioid has been used or have during last 30 days participated in any other medicinal clinical trial or in a trial where follow-up in not completed
Investigation of Validity and Reliability of Post-COVID-19 Functional Status Scale

The new type of Coronavirus (SARS-CoV-2) epidemic puts great pressure on health systems around the world. A large number of people are hospitalized in intensive care units due to acute respiratory distress syndrome due to SARS-CoV-2. Common symptoms seen with SARS-CoV-2 include fever, cough, and dyspnea, as well as pneumonia, severe acute respiratory distress syndrome, renal failure, and even death. Many patients develop mild to moderate disease without pneumonia. The respiratory condition of some patients continues to worsen gradually and develop acute respiratory distress syndrome, which usually requires mechanical ventilation support.

Exercise capacity and health status of individuals who survived severe acute respiratory distress syndrome are lower than the general population. Persistent physical, cognitive, and psychosocial disorders can be seen in people who have survived acute respiratory distress syndrome.

Given the clinical and radiological heterogeneity of COVID-19, it is important to have a simple tool for the disease to monitor the course of symptoms and the impact of symptoms on patients' functional status.

Klok FA et al. developed the Post-COVID-19 Functional Status Scale (PCFS). PCFS can be evaluated for functional sequelae after discharge from the hospital, at 4 and 8 weeks after discharge, to directly monitor recovery, and at 6 months. The aim of this study is to investigate the validity and reliability of PCFS in Turkish population. Research permission to investigate the validity and reliability of PCFS in the Turkish population was obtained from the developer of the PCFS.


Eligibility Criteria:
Inclusion Criteria:

* clinically stable,
* being 18 years of age or older,
* having education level at least primary school,
* whose local language is Turkish,
* being discharged after COVID-19
* giving consent on a voluntary basis.

Exclusion Criteria:

* having an unstable clinical condition,
* being stayed in intensive care,
* having severe neuromuscular and musculoskeletal problems,
* not being able to cooperate to fill questionnaires,
* having a cognitive problem,
* not being able to read,
* not being willing to participate in the study.
Ultraslow Full-power SWL Versus Slow Power-ramping SWL in Stones With High Attenuation Value

Ultraslow full-power SWL versus slow power-ramping SWL in stones with high attenuation value

To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL.

Eligibility Criteria:
Inclusion Criteria:

* single renal stone less than or equal to 3 cm (2 cm for lower calyceal stones)
* radio-opaque stone
* high attenuation value (≥ 1000 HU) stone

Exclusion Criteria:

* Abnormal renal anatomy
* renal insufficiency
* solitary kidney
* coagulopathies
* uncontrolled hypertension
* renal artery or aortic aneurysm
* active urinary tract infection
* pregnancy
* severe skeletal malformations (spinal deformity) precluding proper stone localization
* skin to stone distance (SSD) \> 11 cm
* BMI \> 30 Kgm/m2
A Study to Evaluate Effectiveness of Imiquimod 5% Cream in Superficial Basal Cell Carcinoma

The purpose of this study is to evaluate the long-term sustained clearance rate of superficial basal cell carcinoma during a 5 year period following treatment with imiquimod


Eligibility Criteria:
Inclusion Criteria:

* Have one superficial BCC - primary tumour
* Minimum tumour area of 0.5cm2, maximum diameter of 2.0cm.
* If female and of child bearing potential, negative pregnancy test and willing to use medically acceptable method of contraception.

Exclusion Criteria:

* Evidence of clinically significant, unstable medical conditions.
* Evidence of Gorlin syndrome, metastatic tumour or tumour with high probability of metastatic spread, have or have had within last 5 years other malignant cancers of the skin at target tumour site.
* Have received defined treatments in tumour site or surrounding area.
* Any dermatological disease in the target tumour site or surrounding area.
* Have had a systemic bacterial or viral infection within 2 weeks prior to study initiation.
Over and Under/Aneugraft Pericardium Covered Stent Long Term Follow up Registry

The purpose of this study is to track the clinical safety and effectiveness of the Pericardium Covered Stent in "real world" use.

This is a multi-center registry of 75 patients treated with the Over and Under/Aneugraft Pericardium Covered Stent (PCS) (IGTI, Israel). The registry will involve the collection of demographic, clinical, and angiographic data on the treated patient population, including in-hospital, 30 day, 6-month, 1 year, 2 years and 3 years clinical follow-up data.

Eligibility Criteria:
Inclusion Criteria:

* Patient is older than 18 years
* Patient must be available for follow-up
* Patient must be fully informed, provided with the patient information sheet and sign the Informed Consent Form prior to the procedure.
* The lesion to be treated should be suitable for treatment with a PCS in that:

  * A. A suitable length and diameter PCS should be available
  * B. For SVG disease a single or multiple PCS may be used
  * C. For native coronary artery aneurysms the operator should be confident that the aneurysm may be excluded by the implantation of a single PCS

Exclusion Criteria:

* Significant co-morbidity precluding clinical follow-up.
* Pregnancy; pregnancy test negative in women with child bearing potential
* Acute ST-elevation myocardial infarction within the preceding 48 hours
* Previous stent implantation in the target vessel
* Left main coronary artery disease
* Contra-indication to dual anti-platelet therapy.
* Planned surgery which will lead to discontinuation of antiplatelet therapy
* Thrombocytopenia (\<100,000/mm3)
* Ejection fraction \<30%.
* Renal failure (creatinine \>180 µmol/L \[2 mg/dL\])
* Prior brachytherapy
* Recipient of heart transplant
* Acute infections
Effectiveness of Spirometry as a Motivational Tool to Quit Smoking

The aim of the study is to asses the efficacy of the spirometry and a minimal smoking cessation counselling intervention to quit smoking after a year in patients older than 40 years, smokers of more than 10 packs-year and without a chronic obstructive pulmonary disease (COPD) diagnosis.


Eligibility Criteria:
Inclusion Criteria:

- Active smokers over 40 years and more than 10 pack-years

Exclusion Criteria:

* Previous diagnosis of respiratory disease (asthma, COPD, interstitial lung disease) that cause alteration of spirometric pattern.
* Patients with limitations in performing spirometry
* Age greater than 80 years
* Institutionalized patients
* Patients with a life expectancy less than 1 year
* Spirometry in the past 2 years
A Study of Visual Attention Training to Improve Balance and Mobility

The purpose of this study is to determine if training visual attention improves balance and mobility, and reduces falls in older adults.

Visual training in visual attention is compared with activity as usual.

Eligibility Criteria:
Inclusion Criteria:

* healthy older adults
* Visual acuity 6/12 or better
* able to speak English

Exclusion Criteria:

* No known dementia or cognitive impairment
* not dependent on a walker or cane
Estimating the Use of Resources and the Costs of Treating Patients With Asthma in the Autonomous Community of Valencia

This study has been conceived in the context of Health Outcomes Research where the outcomes of health interventions in routine clinical practice constitute the main objective of the research process. In the case of asthma in Spain, the investigators do not clearly know the use of resources generated by the patient with asthma, its impact on the effectiveness of the current approach of asthmatic patients and the overall efficiency of health interventions on asthmatic patients. This observational, retrospective and multicenter study aims to estimate the use of health care resources in managing patients with asthma and to determine the management of the disease in the usual clinical practice in Valencia Autonomous Region. The data will be obtained at primary care level from the Electronic Health Record SIA+GAIA data base and at hospital level from allergologists and pneumologists clinical records. The investigators plan to introduce 289 ambulatory patients followed-up in Primary or Specialized Care Services, older than 15 years of age, diagnosed of asthma at least one year before the beginning of the study. The inclusion period will be of 3 months and the retrospective data of 12 previous months of follow-up will be collected.

The direct and indirect use of resources will be collected in order to estimate the management and use of health care resources in managing patients with asthma in the Autonomous region of Valencia as primary endpoint and also to estimate the mean cost of asthmatic patient healthcare; to determine the global effectiveness and the efficiency of the actual asthmatic patient healthcare and to model the health budget according to different objectives of effectiveness for the next five years.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory patients (Primary and Specialized Care)
* Patients with a diagnose of asthma in the Outpatients' Electronic Health Record \[Historia Clínica Ambulatoria electrónica (SIA + GAIA) database

Exclusion Criteria:

* Patients who have participated in a clinical trial in the last 12 months.
Constraint-Induced Movement Therapy in Chronic Stroke Patients

The aim of this study is to evaluate the feasibility of a Home-based Constraint-Induced Movement Therapy (hCIMT) compared to a Modified Constraint-Induced Movement Therapy (mCIMT) delivered in a outpatient setting on upper limb motor recovery in stroke survivors.

Home-based Constraint Induced Modified Therapy (hCIMT) consist of 2 hours intensive upper limb practice with shaping techniques + 2 hours ADLs supervised by a caregiver. Patients are supposed to wear a mitt on the unaffected hand for 4 hours daily.

Modified Constraint Induced Modified Therapy (mCIMT) consist of 2 hours intensive upper limb practice with shaping techniques supervised by an experienced physiotherapist + 2 hours ADLs at home (supervised by a caregiver) Patients are supposed to wear a mitt on the unaffected hand for 4 hours daily.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years and \< 80 years
* diagnosis of first ischemic stroke
* stroke onset \> 6 months prior to study enrollment
* upper extremity hemiparesis with impairment of hand and/or arm:
* active wrist extension ≥20º
* active metacarpophalangeal- and interphalangeal-joints extension ≥ 10°
* muscle tone assessed by the Modified Ashworth Scale (MAS) ≤ 2
* pain assessed by the Visual Analogue Scale (VAS) \<4

Exclusion Criteria:

* anyone who does not have adequate understanding of verbal or written information in Italian sufficient to complete any test
* impaired cognitive functioning: score less than 24 on the Mini Mental Status Examination (MMSE)
* contraindications to single-pulse transcranial magnetic stimulation (TMS)(TMS will be used to measure cortical excitability): presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants)
* neurological or psychiatric pathology
* severe cardio-pulmonary, renal, hepatic diseases
* pregnancy
Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adult Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures

The objective of this study is to identify the following in adult epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa:

1. unknown adverse drug reactions (ADRs);
2. occurrence of ADRs;
3. factors that are likely to affect safety and efficacy;
4. occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items;
5. occurrence of psychiatric adverse events as priority investigation items (eg, aggression).


Eligibility Criteria:
Inclusion Criteria:

* Epilepsy participants at least 18 years of age with:

  * Partial seizures (with or without secondary generalized seizures)
  * Primary generalized Tonic-clonic seizures

Exclusion Criteria:

* Participants previously treated with Fycompa
Prognostic Value of Three New Biomarkers of Multiple Sclerosis in Patients With Radiologically Isolated Syndrome

To look at the prognostic value of new biomarkers in CSF and serum for characterisation of multiple sclerosis


Eligibility Criteria:
Inclusion criteria

* Patients have given their free consent for use of their samples in research
* Patients have at least 2 years of clinical and radiological follow-up data available Exclusion criterion
* No follow-up of patients