cyrilzakka/clinical-trials huggingface dataset:
HIRREM for Stage 1 Primary Hypertension

The purpose of this study is to determine that effects of an intervention called High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM), on Stage 1 Primary Hypertension (systolic BP 130-139, and/or diastolic BP 80-89).

The purpose of this research study is to determine the effects of a technique called High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®), for hypertension. HIRREM uses scalp sensors to monitor brain electrical activity, and computer software algorithms translate selected brain frequencies into audible tones in real time. Those tones are reflected back to participants via ear buds in as little as four to eight milliseconds, providing the brain an opportunity for self-adjustment of its electrical pattern.

This study will compare acoustic stimulation linked to brainwave activity (HIRREM, along with continued current care, HCC), with continued current clinical care alone (CCC). Both groups will continue their other current care throughout, including non-pharmacological, and lifestyle modification therapies.

Eligibility Criteria:
Inclusion Criteria:

* Adults, age 18 and above
* Systolic BP ranging from 130-139mmHg and/or diastolic BP ranging from 80-89mmHg

Exclusion Criteria:

* Unable, unwilling, or incompetent to provide informed consent
* Physically unable to come to the study visits, or to sit comfortably in a chair for up to two hours at a time
* Weight is over the chair limit (285 pounds)
* Known atherosclerotic cardiovascular disease
* Cardiovascular risk score of ≥ 10% (per http://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate/)
* Prior diagnosis of stage 2 hypertension
* Ongoing need for treatment of hypertension with medications
* Known seizure disorder
* Known or anticipated pregnancy
* Severe hearing impairment (because the subject will be using headphones during the interventions)
* Ongoing need for treatment with opiate, benzodiazepine, or anti-psychotic medications, anti-depressant medications such as SSRI, SNRI, or tricyclic, and sleep medications such as zolpidem or eszopiclone
* Anticipated and ongoing use of recreational drugs, alcohol, or energy drinks
* Ongoing need for treatment with thyroid medications
* Are enrolled in another research study that includes an active intervention
* Have previously received brainwave optimization (BWO), used a B2 or B2v2 wearable device, or previously participated in a HIRREM research study
Memory Flexibility Training for Depression

Our collection of memories for personal experiences plays an important role in shaping our sense of who we are as people. These memories, termed autobiographical memories, can also be helpful in social situations, for sharing the details of our experiences with other people, reminiscing about pleasant times and solving problems by remembering what has and hasn't worked in the past. Different types of autobiographical memory are helpful to us depending on the particular situation the investigators are in at the time. Recent research has shown that experiencing depressed mood can affect how we relate to our autobiographical memories, so that instead of providing a rich source of personal information in a helpful and flexible way, the types of memories that come to mind are more narrowly focused on difficult or negative experiences. This can cause low mood to persist over time.

The purpose of this study is to test a newly-developed therapeutic training package for depressed mood (MemFlex), designed to encourage helpful and flexible ways of relating to autobiographical memories. The MemFlex programme consists of a one-to-one orientation session with the researcher to introduce the training package, followed by a workbook that is completed at home.


Eligibility Criteria:
Inclusion Criteria:

* Currently experiencing Major Depressive Episode, indexed on the Structured Clinical Interview for the DSM-IV (SCID; First et al., 1996).
* Score of 13 or above on the Beck Depression Inventory (Beck et al., 1996)

Exclusion Criteria:

* SCID assessment indicates they are experiencing another mood disorder, psychosis, current alcohol or substance dependence/abuse.
* Diagnosed Axis II disorder or brain injury (assessed by participant report)
Effects of Breathing and Attention Training (BAT) on Pain Modulation

The hypersensitivity of fibromyalgia is associated with abnormal pain modulation within the CNS, but not with peripheral or central sensitization. Many brain areas that contribute to modulation of pain are known, but their testing is complex and expensive. Quantitative sensory testing is easier to perform and repeatable. Therefore, it will be used to evaluate the effects of Breathing Attention Training (BAT) on the hypersensitivity of FM participants. BAT is a form of mindfulness meditation shown to decrease FM symptoms and possibly pain sensitivity. We hypothesize that pain modulation of chronic pain patients is improved by BAT.


Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with fibromyalgia will have pain of duration \> 6 months and meeting the 1990 Research Diagnostic Criteria for FM (ACR)
* Healthy, pain-free age matched controls without chronic pain

Exclusion Criteria:

* Personal or family history of photosensitive epilepsy
* Prior history of cancer or diabetes
* Patients must be willing to discontinue their analgesics, hypnotics, anxiolytics, or anti-depressants during the study period for at least 5 half-lives.
Dose-reduced Versus Standard Conditioning in MDS/sAML

In this trial dose reduced conditioning is compared to standard conditioning followed by allogeneic stem cell transplantation from related or unrelated donors in patients with MDS or secondary AML.

Conditioning is the very high dose chemotherapy treatment that is given in the days before the stem cell transplant.

The hypothesis is that a dose reduced conditioning will reduce the non-relapse mortality from 40% to 20% at one year after allogeneic stem cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Disease: Cytologically proven primary or therapy-related myelodysplastic syndrome (MDS), either as

  * refractory anaemia (RA) according FAB or RA with or without dysplasia according WHO,
  * refractory anaemia with ringsideroblasts (RARS) according FAB or RARS with or without dysplasia according WHO,
  * refractory anaemia with excess of blasts (RAEB) according FAB or RAEB I or RAEB II according WHO,
  * refractory anaemia with excess of blast in transformation (RAEB T) according FAB,
  * CMML (dysplastic type) according WHO,
* or secondary acute myeloid leukaemia (sAML).
* Blast count \< 20 percent in bone marrow with or without chemotherapy at time of transplantation.
* Patient eligible for standard and dose-reduced conditioning as per local guideline.
* Patient age 18 - 60 years if donor is a HLA-matched unrelated donor (HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1) (one mismatch allowed):
* Patient age 18 - 65 years if donor is a HLA-matched related donor ((HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1) (one anti¬gen-mismatch allowed):
* No major organ dysfunction.
* Written informed consent of the patient.

Exclusion Criteria:

* Blasts \> 20 % in bone marrow at time of transplantation
* No written informed consent.
* Central nervous involvement.
* Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
* Total bilirubin, SGPT or SGOT \> 2 times upper the normal level.
* Left ventricular ejection fraction \< 30 %.
* Creatinine clearance \< 30 ml/min.
* DLCO \< 35 % and/or receiving supplementary continuous oxygen.
* Positive serology for HIV.
* Pregnant or lactating women.
* Patients with a life-expectancy of less than six months because of another debilitating disease.
* Serious psychiatric or psychological disorders.
* Invasive fungal infection at time of registration.
Assessment of Repeat Ascending Doses of GSK2018682 in Healthy Volunteers

The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of repeat ascending doses of GSK2018682. The study will also provide further evidence of the potential therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on Absolute Lymphocyte Counts (ALC).

The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of repeat ascending doses of GSK2018682. The study will also provide further evidence of the potential therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on Absolute Lymphocyte Counts (ALC).

Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
* Females must be of non-childbearing potential.
* BMI within the range 19 - 29 kg/m2 (inclusive).

Exclusion Criteria:

* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* A positive pre-study drug/alcohol screen.
* A positive test for HIV antibody.
* History of regular alcohol consumption within 6 months of the study.
* The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
* History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
* Were participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
* Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
* Unwillingness or inability to follow the procedures outlined in the protocol.
* Other exclusion criteria to be detailed at the time of physical screening by the Investigator
An Evaluation of the Safety and Clinical Utility of Handheld ECG Technology in Psychiatry

Acetylcholinesterase inhibitors and antipsychotics are drugs commonly prescribed in psychiatry, the former for dementia and the latter for acute and chronic psychotic illness. Both can cause cardiac arrhythmia therefore 12 lead ECG's are recommended before prescribing. The test is often difficult to obtain however, leading to either patients being inconvenienced or drugs prescribed without the test. There are two parts of this study, but both examine the utility of single lead ecg monitoring, one in the memory clinic and the other in inpatient psychiatry wards. The aim to to evaluate the safety and efficacy of the handheld ecg versus the 12 lead and 6 lead ecg, and whether the handheld ecg can be used to screen for ecg abnormalities that would generally lead to a caution or contra-indication for acetylcholinesterase inhibitors and anti-psychotic medication.

Patients will either be recruited from the outpatient memory clinic or in patient psychiatry wards. Following informed consent baseline demographic data will be collected, and patients will undergo a 12 lead and 6 lead ECG as well as a rhythm strip using the handheld device. Data from this point will be annonymised for future analysis. The psychiatrists ECG report will also be recorded, and a subset of patients will undergo an echocardiogram (to see what proportion of patients with psychiatric disorders have structural heart disease.)


Eligibility Criteria:
Inclusion Criteria:

Any patient attending the memory clinic Any patient admitted to the acute psychiatric ward requiring antipsychotic medication

Exclusion Criteria:

Patients who lack capacity and do not have a personal consultee to provide assent
QIST Collaborative - Arthroplasty Research Cohort (ARC) Study

The ARC Study is a national observational cohort study to investigate patient reported and clinical outcomes after hip and knee replacements. The study has the following objectives:

1. To evaluate outcomes following hip and knee replacements.
2. To determine risk factors for adverse outcomes in primary hip and knee replacements.
3. To identify targets for future research and intervention in patients undergoing primary hip and knee replacements
4. To provide a resource from which to identify potential participants for future clinical trials, and to use data collected in the ARC Study as comparison or control data for trial participants who have been randomised to receive one or more interventions.

Participants are recruited and consented online. Patients are invited to participate by collaborating surgical teams nationally in outpatient clinics at the time of being added to a waiting list, in addition to an advertising campaign to recruit patients. They are directed to an online portal where they will be able to review further information.

Consent and data collection is completed electronically through patients entering data online. Baseline demographics and characteristics are recorded, including details of socio-demographics, lifestyle, health status and patient reported outcome measures (PROMs). Patients then undergo hip/knee replacement and postoperative rehabilitation according to the standard care and protocols of the hospital and the preferences of their treating surgeon.

Follow-up data, including PROMs, is collected via online questionnaires up to two years following surgery. The study will ultimately also enable multiple trials to be embedded within the cohort study, using a 'Trials within Cohorts' (TwiCs) methodology.


Eligibility Criteria:
Inclusion Criteria:

Participants must meet all of the inclusion criteria:

1. UK Resident
2. Able to read and understand documentation and questionnaires in English language
3. Undergoing elective primary hip or knee arthroplasty (THR, TKR or UKR)
4. Age 18 years or over
5. Provides the necessary consents relating to data collection and use of study data, data linkage, future research and invitation to involvement in future trials

Exclusion Criteria:

Provided a participant meets all of the inclusion criteria, there are no exclusion criteria for the cohort study.
Comparison Between Laparoscopic Ovarian Diathermy and Clomiphene Citrate in Women With Anovulatory PCOS

Laparoscopic ovarian diathermy (LOD) is currently offered to infertile women with polycystic ovarian syndrome (PCOS) who fail to conceive on clomiphene citrate (CC). However, using LOD before CC may result in a better reproductive outcome since LOD may reduce risks associated with CC such as miscarriages and multiple pregnancies. The aim of the study is to evaluate the effectiveness of LOD and its potential value in improving the success rates in infertile women with PCOS. This study will recruit 72 women with PCOS suffering from infertility due to lack of ovulation from the infertility clinic. After initial assessment, patients will be given explanation about the study and will receive an information leaflet. They will then be randomized into two groups: Group1 (36 patients) will receive CC as per infertility clinic protocol to induce ovulation for up to 6 months. Group 2 (36 patients) will undergo laparoscopic ovarian diathermy under general anaesthetic. Blood samples will be taken from both groups before any treatment, shortly after treatment and at 3 and 6 months after treatment to measure various hormones. Patients will be contacted every month after treatment for follow up. The reproductive outcomes particularly the pregnancy and livebirth rates will be compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 19 - 39
2. BMI \< 32
3. Anovulatory Infertility \> 1 year
4. Diagnostic criteria for
5. No previous treatment for induction of ovulation
6. Normal semen analysis of partner
7. Proven patency of at least one Fallopian tube

Exclusion Criteria:

1. Inability to give informed consent
2. Contraindication to CC
3. Contraindication to general anaesthetic or laparoscopy
TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up

This study is a multi-center, prospective and randomized trial. The primary objective of this study is to demonstrate that the use of the BIOTRONIK Home Monitoring system (HM) can safely reduce the number of regularly scheduled office follow-up visits, compared to the conventional method of implantable cardioverter defibrillator (ICD) follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Implanted within the last 45 days or being considered for implant with a BIOTRONIK ICD with Home Monitoring (HM)/Intracardiac Electrogram (IEGM)-Online technology, or legally marketed future generation device with HM/IEGM Online.
* Able to utilize the HM system throughout the study
* Ability to give informed consent
* Geographically stable and able to return for regular follow-ups for fifteen (15) months
* At least 18 years old

Exclusion Criteria:

* Patients who do not fulfill all inclusion criteria
* Pacemaker dependent
* Currently enrolled in any other cardiac clinical investigation
Practice of Scuba Diving by as Many People as Possible: Effect of Medical Assessment to Provide a Suitable and Individualised Framework for Practice (Plongée Santé)

The study focuses on the practice of recreational scuba diving by people who have obtained medical advice for their practice in the hyperbaric and underwater medicine department of the Brest University Hospital. These people may have no health problem or on the contrary consult because they have a pathology and want a medical advice on the impact of this health problem on their practice: this is the case for about the half of these consultants.

For the latter, there are no data concerning the relevance of a medical advice response and a proposal for an appropriate technical practice framework (restriction of dive depth, duration, etc.). A relevant answer results in a practice without diving accidents or decompensation of the pathology and a decision accepted and respected by the practitioner.

This study aims to analyze the state of health of the service's consultants and medical recommendations formulated at the end of this consultation, by retrospective analysis of the consultation files, and to interview the consultants on their practice of diving, their state of health and any problems encountered since their consultation.

The purpose is to validate the hypothesis that a practice of underwater diving is possible and beneficial, with an acceptable risk in case of a risk factor or pathology using a framework of advice and restrictions of adapted and individualized practice ("sport for health").

This is a single-center retrospective study on health data. The methodology includes a collection of data on health and practice of scuba diving, figuring on the medical consultation files and then carrying out a telephone interview of people seen in diving medicine consultation between 01/01/2015 and on 12/31/2018 in the hyperbaric and underwater medicine department of the Brest University hospital.

One month before the start of these interviews, an information letter on the study is sent by post, giving the possibility of opposing it.

The main evaluation criteria are the number of dives carried out since the consultation (and the average number of dives per year of practice), and the number of accidents or incidents during the practice of recreational scuba diving in the framework proposed, during the months or years following the medical consultation The secondary evaluation criteria are the evolution of the chronic pathology, the evolution of health status in general, the number of hours of practice of a physical and sport activity per week, the respect of the technical practice framework recommended.

Eligibility Criteria:
Inclusion Criteria:

* People who asked for a medical advice for the diving practice in a consultation in the hyperbaric and underwater medicine department of the Brest University hospital from 2015/01/01 to 2018/12/31

Exclusion Criteria:

* refusal
Clinician Burnout and Social Determinants

Although clinicians recognize the impact of the social determinants of health (SDH) on patient care, clinicians feel they do not have the time or knowledge to effectively address patients' unmet social needs in the clinic. This can lead to feelings of distress and helplessness. The objective of this study is to test the impact of a tablet-based platform that enhances the role of support staff to address SDH on clinician burnout.

Clinician burnout has risen over the last decade, and studies have found that almost 50% of U.S. physicians show signs of burnout. Burnout is characterized by emotional exhaustion, feelings of cynicism, and patient detachment. Clinicians at the front lines of care, such as family medicine and internal medicine, are at highest risk, and burnout is associated with an increased risk of cardiovascular disease, alcoholism, and suicide. Burnout also negatively impacts patient care. The drivers of burnout are complex, and a growing body of research has focused on developing strategies to address both clinician and organizational factors. One potential contributor to clinician burnout that has received less attention is their patients' SDH.

The SDH, or the circumstances in which people are born, grow, live, and age, have a profound impact on morbidity and mortality. Increasingly, national organizations have called for healthcare systems to address SDH, such as food and housing insecurity, to improve population health. Although clinicians recognize the importance of SDH on patient care, clinicians feel they do not have the time, knowledge, or tools to effectively address SDH, which can leading to feelings of distress and helplessness in addressing patients' unmet social needs. The SDH can lead to increased patient complexity and clinician workload. Also, the seemingly insurmountable social needs faced by many patients are a major contributor to the decline in medicine residents choosing a career in primary care. Thus, the lack of a tool to assist the primary care team in addressing SDH is a critical problem that can negatively affect both patients and clinicians.

Our long-term goal is to enhance the primary care teams' ability to address the SDH by utilizing a mobile health tool that can assist the team in addressing patients' unmet social needs in clinical settings. Mobile health tools, such as tablets, have shown promise in reducing disparities in care and addressing unmet social needs in pediatric practices. However, there is little data about how addressing SDH affects physician burnout. Mobile health tools have the potential to collect patient-reported data and connect patients to appropriate support personnel without interfering with clinic workflow and enhance the primary care teams' ability to provide patients with resources. The objective of this study is to test the impact of a tablet-based platform that enhances the role of support staff to address SDH on clinician burnout.

Eligibility Criteria:
Inclusion Criteria:

* All clinicians and primary care teams at participating sites will be eligible

Exclusion Criteria:

* There are no specific exclusion criteria