cyrilzakka/clinical-trials huggingface dataset:
Assessment of Patient Reported Health Status Questions Via Four Different Methods of Administration, in Stroke Survivors.

A Patient Reported Outcome Measure (PROM) is a questionnaire that asks patients for their views on their own health or the impact of healthcare they have received on their health and quality of life (RCN, 2011). The benefit of PROMS is that they gather information from the patient's perspective, which offers great potential to improve the quality and outcomes of health services (Department of Health 2011).

There is a PROM (the PROMIS-10 Global Health) and a number of extra questions that are recommended for use in people who have had a stroke by the International Consortium for Health Outcomes Measurement, but the best way of delivering these questions for stroke survivors is unknown.

At present, the NHS in England, Scotland and Wales are required to offer every stroke survivors a 6 month post stroke follow-up appointment. Currently, the information collected at the 6 month review is not from the patient's perspective and the best method of collecting this information has not been established. The Sentinel Stroke National Audit Programme (SSNAP) which is led by the Royal College of Physicians in London promote the 6 month follow-up assessment. SSNAP recognise that currently 4 different methods of 6 month follow-up appointment occur. The current methods in use are face-to-face assessment, telephone interview, online questionnaire or postal questionnaire.

The aim of this research is to understand if there is a difference between these 4 methods of delivering these questions in people who have had a stroke.

As part of the 6 month review this research study will assess the response rate for 15 Patient Reported Health Status questions across the 4 recognised methods of delivery;

* Face-to-Face
* Telephone
* Online
* Post

To conduct this research study a sample of 808 stroke survivors will be asked to take part in the research. From these 808 people, 202 participants will be randomly assigned to each method of administration (Face-to-Face Interview, Telephone Interview, Postal Questionnaire and Online Questionnaire).

The questionnaires received by the research team will not record any personally identifiable information. The data will then be utilised by the researchers for statistical analysis in order to identify, which method of the 4 methods of administration, under investigation, is the most acceptable for stroke survivors. The conclusions of this research will inform the roll-out of the most appropriate method of delivering the 6 month stroke follow-up review for stroke survivors.


Eligibility Criteria:
Inclusion Criteria:

* Clinically confirmed diagnosis of stroke either Cerebral Infarct (ICD I63), Cerebrovascular Haemorrhage (ICD161) or Stroke, not specified as haemorrhage or infarction (ICD I64).
* Patients over 18 years old (≥ 18 years old)
* Had a diagnosis of stroke within the last 4-8 months (Stroke diagnosis ≥ 4months to ≤ 8 months)

Exclusion Criteria:

* Diagnosis of a Transient Ischaemic Attack (ICD G45)
* Diagnosis of a Subarachnoid Haemorrhage (ICD I60)
The Captivator EMR Registry

To confirm performance of the Captivator™ EMR device for resection of early neoplasia in Barrett's Esophagus.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 years.
2. Barrett's esophagus with a visible abnormality confirmed upon prior endoscopy. A visible abnormality is described as meeting one or more of the following definitions:

   * Lesion is detected as visible based on white light imaging with any macroscopic appearance according to the Paris Classification and is also endoscopically resectable.
   * Lesion is detected by narrow band imaging (NBI), but without any other specific characteristics for a visible lesion.
   * Lesion is confirmed to contain high grade dysplasia and/or carcinoma upon prior biopsy.
3. Subject is scheduled for endoscopic resection of present neoplasia
4. Subject is amenable to EMR with no suspicion of submucosal invasion, based on the macroscopic appearance and/or endosonography upon earlier endoscopy.
5. Subject is taking PPI (Proton Pump Inhibitor) BID (Twice Daily) 40 mg (or equivalent dosage).
6. Subject is willing to participate, fully understands the content of the informed consent form, and signs the informed consent form.

Exclusion Criteria:

1. Subject has previously undergone endoscopic therapy for esophageal neoplasia, including (but not limited to) cryospray therapy, laser treatment, photodynamic therapy, endoscopic mucosal resection, radiofrequency ablation, argon plasma coagulation or radiotherapy.
2. Presence of esophageal stenosis preventing passage of a therapeutic gastroscope.
3. Endoscopically visible scarring by any cause of the intended treatment zone.
4. Esophageal varices.
5. Subject has known or suspected esophageal perforation.
6. Coagulation disorders or anti-coagulant therapy which cannot be discontinued (aspirin allowed).
Evaluation of Adverse Long-term Effects in Young Adult Survivors of Acute Leukemia

Taking into account the specificities of adolescent and young adult cancer patients led agencies (in particular the French National Cancer Institute INCa, through the last Cancer Plan), to initiate projects targeting this population. Acute leukemia is among the most common cancers in adolescents and young adults. Recent therapeutic advances now allow hope for a cure in about 50% of this population. The issue of post-cancer is therefore of particular importance for young adults with cancer. Our aim is to establish the health determinants in young adult leukemia survivors and to compare the frequency of these effects and their explanatory factors to the data collected in children or adolescent leukemia survivors program (LEA). 90 patients followed up at the Institut Paoli-Calmettes cancer center and Nice University Hospital have been identified and would be included in this study.Collected data will include information on the initial disease and its treatments, physical sequelae (fertility, thyroid function, heart function, visual function, secondary tumors, viral infections, lung function, bone metabolism, iron metabolism, metabolic syndrome, osteonecrosis, alopecia ... ), quality of life, social and occupational integration and relationship with care system.


Eligibility Criteria:
Inclusion Criteria:

* Young adult (18-40 years) Leukemia survivor, in complete remission.
* Acute leukemia diagnosed since January 1980 .
* Patient Affiliated to social security or beneficiary
* Signed Informed Consent prior to any screening procedures

Exclusion Criteria:

* Emergency
* Patient unable to abide by the study protocol (for geographical, social or psychological reasons)
Performance and Usability Evaluation of the Atomo HIV Self-Test

The study seeks to enroll 501+ patients to use a HIV self testing device to test for HIV in a blood sample drawn by finger prick. The purpose of the trial is to assess the usability of the device by providing participants with video and written instructions on how to correctly obtain a result from the device.


Eligibility Criteria:
Inclusion Criteria The inclusion criteria are informed by the indications for HIV testing contained in the National HIV Testing Policy, which states that HIV testing is indicated in the following groups: MSM; people who inject drugs; people with multiple sex partners or recent partner change; people having travelled to countries of high prevalence and engaged in risk behavior; people from high prevalence countries; partners of the above; and partners of people living with HIV infection.

Recruitment will be restricted to people who satisfy the following criteria:

1. Attending health clinic or community-based testing study sites
2. Aged 18 years or more
3. Requesting HIV testing and/or in whom HIV testing is indicated
4. Willing and able to give their own informed consent
5. Willing to participate in and comply with the study procedures

Exclusion Criteria

The following people will be excluded from the study:

1. People in whom HIV testing is not indicated or not appropriate
2. People not fluent in English in whom provision of informed consent or compliance with the study procedures may be problematic
3. People who have participated in the study previously
Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation

The purpose of this study is to determine the efficacy of the Definity (perflutren lipid microsphere Injectable Suspension) ultrasound contrast agent in identifying small tumors (hepatomas \& metastases) within the liver.

Primary objective: To estimate the increase in conspicuity of small intrahepatic tumors with contrast-enhanced sonography

Secondary Objectives: To estimate the effect of tumor type, size, location and depth on the conspicuity of small tumors on contrast-enhanced sonography

An estimated 75 patients (age 18 years of age or older) will be enrolled from the population of patients who present for ultrasound-guided radiofrequency ablation (RFA) of CT or MRI-confirmed multiple primary hepatocellular carcinoma (HCC) or metastatic carcinoma, with at least one of the tumors being ≤ 1.5 cm in diameter.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary hepatocellular carcinoma (HCC) or secondary (metastatic) carcinoma of the liver who have been referred for ultrasound-guided radiofrequency ablation (RFA) treatment
* Recent (within 90 days) CT or MRI scan with report of one or more tumors ≤ 1.5 cm in diameter
* Patient is stable and is to be managed conservatively (i.e. non-surgically)
* 18 years of age or older
* Ability and willingness to provide written informed consent

Exclusion Criteria:

* Known or suspected cardiac shunt(s)
* Known sensitivity to octafluoropropane
* Pregnant or breastfeeding
Add-on Nighttime Bracing in Adolescent Idiopathic Scoliosis

Bracing is an accepted standard therapy for idiopathic scoliosis at Cobb angle ranges between 25° and 45°. However, it is unclear, if a specifically tailored regimen of daytime and nighttime braces (=double brace) yields superior results compared to the standard treatment (single brace for day and night). These two treatment regimens were investigated in the study.

One-hundred-fifteen patients with adolescent idiopathic scoliosis (AIS) were assessed before initiation of bracing treatment and at the final follow-up 2 years after deposition of the brace. They were divided into two groups: double-brace group and single-brace group. Each patient underwent clinical and radiological examinations and Cobb angles were measured.

Eligibility Criteria:
Inclusion Criteria:

* AIS
* age between 10 and 15 years (y)
* Risser's sign of 0-2
* Cobb curvature angle of 25-40°
* no previous treatment
* compliance (at least 23 h wearing time)

Exclusion Criteria:

* non-idiopathic scoliosis
* Cobb curvature angle \>40°
* \<10 years and \>15 years for initial treatment
Conventional Collagen Crosslinking in Young Keratoconus

Keratoconus is a chronic progressive non - inflammatory disorder characterised by progressive steepening and thinning of cornea and high myopic astigmatism, accounting for poor visual acuity in such individuals. Keratoconus seems to be more advanced on presentation, in young patients.

The investigators intend to evaluate the effectiveness of conventional collagen cross linking in young patients diagnosed with keratoconus.

Keratoconus is progressive ectatic corneal disorder characterised by progressive corneal thinning, steep corneal curvatures and usually associated with high irregular myopic astigmatism.

The major problems concerning keratoconus in young patients are;

1. Rapid rates of progression in young keratoconic corneas as compared to adults.
2. Poor biomechanical properties of young corneas.
3. Poor quality of vision, which predisposes to a very poor quality of life.
4. High rates of complications and failure post keratoplasty in young patients.

The investigators intend to evaluate the effectiveness of conventional collagen crosslinking in young patients with keratoconus with regards to keratometric indices and visual acuity.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and below.
* Patients diagnosed to have keratoconus at presentation and willing for follow - up at regular intervals post treatment.

Exclusion Criteria:

* Any disease causing abnormal topography other than keratoconus.
* Any ocular condition predisposing towards poor vision (retinal , lens problems)
Treatment of Patients With Recently Exacerbated Schizophrenia With Paliperidone Palmitate

The purpose of this study is to explore the efficacy of paliperidone palmitate administered as a once monthly injection in patients with an acute exacerbation of schizophrenia.

This is an open-label (patients and study staff will know the identity of treatments assigned) study of paliperidone palmitate in patients with acute an exacerbation of schizophrenia. The total duration of the study will be approximately 4 months. Eligible patients without a documented history of exposure to oral risperidone or paliperidone extended-release (ER), or intramuscular (IM) RISPERDAL CONSTA or paliperidone palmitate will receive oral risperidone 1 mg/day or extended release (ER) OROS paliperidone 3 mg/day for at least 3 days before the first injection of the study drug (paliperidone palmitate) for tolerability testing. Paliperidone palmitate will be administered to patients as an intramuscular (IM) injection in the deltoid (upper arm) or gluteal (buttocks) muscle.

Eligibility Criteria:
Inclusion Criteria:

* Be otherwise healthy on the basis of physical examination and vital signs at Screening (Baseline) and have a current diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for at least 1 year before screening and no longer than 5 years (early diagnosed patients)
* Have acute exacerbation of psychosis defined as: less than 4 weeks but more than 4 days, PANSS total score of 70 to 120 (inclusive) at screening (moderate symptomatology), a score of 4 or more (at least moderately ill) at screening on the severity scale of the CGI-S
* If a woman, before entry she must be postmenopausal for at least 1 year, surgically sterile or abstinent. If sexually active, agree to practice an effective method of birth control before entry and throughout the study as specified in the protocol; If a man is heterosexually active with a woman of childbearing potential, he must agree to use a double-barrier method of birth control and to not donate sperm during the study and for 50 days after receiving the last dose of the study drug

Exclusion Criteria:

* Has evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal, neurological, endocrine, metabolic or pulmonary disease in the past 6 months (as determined by medical history, clinical laboratory or electrocardiogram \[ECG\] results, or physical examination) that would increase the risk associated with taking study medication or would confound the interpretation of the study
* The psychiatric diagnosis is due to direct pharmacological effects of a substance (eg, a drug of abuse or medication) or a general medical condition (eg, clinically notable hypothyroidism, delirium)
* Meets the DSM-IV definition of substance dependence (except for nicotine and caffeine) within 6 months prior to entry
* Has history or current symptoms of tardive dyskinesia (involuntary repetitive body movements)
* Has history of neuroleptic malignant syndrome
Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP

Adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) who have completed study 161403 will be able to take part in this study.

The main aim of the study is to evaluate side effects in the long-term treatment with HYQVIA/HyQvia.

All participants will receive HYQVIA/HyQvia in the same way as they were receiving in study 161403. The dosing interval of HYQVIA/HyQvia can be adjusted after 12 weeks of treatment in study 161505 if the study doctor determines that it is safe to do so.

Participants will visit the clinic within 1 week after the first and second dose of HYQVIA/HyQvia and then every 12 weeks for the duration of the study.


Eligibility Criteria:
Inclusion Criteria:

1. Has completed Epoch 1 of Study 161403 without CIDP worsening.
2. If female of childbearing potential, the participant must have a negative pregnancy test at baseline and agree to employ adequate birth control measures (eg, birth control pills/patches, intrauterine device, or diaphragm or condom \[for male partner\] with spermicidal jelly or foam) throughout the course of the study.

Exclusion Criteria:

1. Participant has a serious medical condition such that the participant's safety or medical care would be impacted by participation in this Extension Study.
2. New medical condition that developed during participation in study 161403 that, in the judgment of the investigator, could increase risk to the participant or interfere with the evaluation of investigational medicinal product (IMP) and/or conduct of the study.
3. Participant is scheduled to participate in another non-Baxalta clinical study involving an IP or investigational device during the course of this study.
4. The participant is nursing or intends to begin nursing during the course of the study
5. Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study (with the exception of study 161403) involving an IP or investigational device during the course of this study.
6. The participant is a family member or employee of the investigator.
Study to Investigate the Effect of the A1 Agonist Capadenoson on Ventricular HR in Patients With Persistent or Permanent Atrial Fibrillation.

This trial has the primary goal to show that BAY68-4986 can lower the ventricular rate in patients with the indication persistent atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Male and/or female (without childbearing potential) white patients
* History of persistent or permanent atrial fibrillation
* 18 to 75 years of age

Exclusion Criteria:

* Patients with high-risk cardiovascular diseases
* Stroke or myocardial infarction
* Relevant pathological changes in the ECG or echocardiography
* Medication affecting ventricular response in Afib
Timing of Umbilical Cord Occlusion in Premature Babies( <33 w). Delayed vs Early.

Early cord clamping after delivery has been common practice for many decades as part of the active management of the third stage of labour. However in recent years, several studies have shown that delayed cord clamping may offer important benefits to the newborn. The data gathered indicate that delayed cord clamping may be particularly useful in premature babies, between 26 and 32 weeks of gestational age, reducing the need for blood transfusion and the incidence of intraventricular haemorrhage.

However it is argued that the described potential benefits of delayed cord clamping could be negated by the increased risk of polycythaemia and jaundice in the newborn, as well as by potential interference with the postpartum haemorrhage management, initial care and reanimation of the premature newborn, and the possibility of cord blood donation. These factors, together with as the lack of homogeneity among existing studies regarding the delayed cord clamping technique create the need, in our opinion, for further research, to establish the proper place of this measure.

Our hypothesis is that delayed cord clamping in the premature newborn significatively reduces the need for blood transfusions and intraventricular haemorrhage, compared with usual early cord clamping.

Secondary outcomes:

* To define the impact of delayed cord clamping on neonatal assessment parameters after delivery: APGAR score, cord pH, need for mechanical ventilation or reanimation.
* Neonatal mortality and morbidity
* Effect of the procedure on the incidence and severity of maternal postpartum haemorrhage
* To study the correlation between Iron metabolism and reticulocitary haemoglobin levels in cord and infant blood.


Eligibility Criteria:
Inclusion Criteria:

* Deliveries ( either vaginal or by C-section) between 26 and 32.6 weeks of gestation.
* Patients must be over 18 years old.
* Patient understands and signs informed consent.

Exclusion Criteria:

* Urgent C-section
* gestational age under 22 or over 33 weeks
* Major fetal anomalies (requiring surgery or with a high risk of neonatal death or incapacity)
* Major uterine malformations
* Placenta previa.
* Multiple gestations
* Fetal hydrops
* Severe Iso- Immunization
* HIV-positive mother
* Severe Intrauterine growth restriction ( Reverse atrial Flow in DV)
* Intrauterus Ventricular haemorrhage
A Study Comparing a New Dosing Regimen of Clot-dissolving Drug for Mechanical Heart Valves Which Show Clots

The optimal dosage and duration of administration of clot-dissolving medications for the treatment of patients with mechanical heart valves with clots is not known. We hypothesized that a large dose of the clot-dissolving medicine given initially (akin to the dose given in the treatment of heart attacks), might speed up the dissolution of the clot and rapidly restore the functioning of the mechanical heart valve.

The optimal fibrinolytic strategy for left sided prosthetic valve thrombosis (PVT) is not known. A large initial bolus dose of streptokinase (SK) might accelerate fibrinolysis and restore valve function more rapidly.

This is a prospective, randomized trial comparing 2 fibrinolytic protocols in a first episode of PVT. In the rapid fibrinolytic protocol (RFP) 1.5 MU of SK is given over 1 hour, followed if required by a 0.1 MU/h infusion. In the standard protocol (SP) 0.25 MU is given over 30 minutes, followed by an infusion of 0.1 MU/h. Serial echocardiography and fluoroscopy will be done to monitor therapy. The primary end point is the occurrence of a complete clinical response (CCR, complete hemodynamic response without any major complication). 58 patients are required in each arm for detecting a 30% difference with 80% power at α=0.05.

Eligibility Criteria:
Inclusion Criteria:

* First episode of left sided prosthetic valve thrombosis

Exclusion Criteria:

* Contraindication to thrombolysis
* Refusal to give informed consent
* Pregnant women
* age less than 12 years or more than 70 years
* previous treatment for prosthetic valve thrombosis
Matching Cognitive Remediation to Cognitive Deficits in Substance-Abusing Inmates

This is a 2 -year NIDA funded grant (Co-PIs: Joseph P. Newman, John Curtin, and Carl Lejuez) that examines whether recent progress in characterizing the cognitive deficits associated with psychopathic and externalizing offenders may be used to develop better therapeutic interventions to treat their substance abuse and other self-control problems. Inmates with externalizing or psychopathy will receive one of two computer-based interventions to remediate the core cognitive skills that have been linked to self-regulation deficits in the two groups. One intervention (ACC) targets the affective cognitive control deficits associated with externalizing offenders whereas the other intervention (ATC) targets the attention to context deficits associated with psychopathic offenders. The specific components of the project include: selection and randomization of inmates; pre- and post-treatment behavioral and brain-related (ERP and Startle) measures to evaluate the impact and specificity of the ACC and ATC treatments; and 6 sessions of behavioral (e.g. computerized) and verbal training in ACC or ATC.


Eligibility Criteria:
Inclusion Criteria:

* Male,
* ages 18-45 years,
* elevated scores of psychopathy or externalizing measures

Exclusion Criteria:

* currently taking psychotropic medication,
* below a 4th grade reading level,
* history or current learning disability,
* history of head trauma with lasting effects,
* current diagnosis of PTSD,
* Bipolar, or
* psychosis