cyrilzakka/clinical-trials huggingface dataset:
Service User and Staff Views on Digital Remote Monitoring for Psychosis

Psychosis is a severe mental health problem. Symptoms of psychosis include hallucinations (e.g. hearing voices that others cannot hear) and delusions (unusual, often troubling beliefs). People who experience psychosis often have times when their symptoms are relatively stable. At other times, their symptoms may increase and become much more problematic (a 'relapse'). Helping people with psychosis to stay well (preventing relapses) is an important and time-consuming challenge for mental health services.

Smartphones and other digital technologies are now widespread. This offers a solution to help tackle the overwhelming demand on services and to enable people with psychosis to access mental health support when they need it most (e.g. when relapsing). Research shows that people with psychosis are often willing to report their symptoms using a smartphone app. Apps like this can alert health professionals when someone needs extra support, but can be burdensome to use long-term. The investigators want to make a system that is less burdensome and is personalised to users' needs and experiences (a 'complex digital remote monitoring system'). Recent research shows that information gathered routinely by individuals' smartphones (e.g. GPS, step count) might help predict relapses of psychosis. The investigators want to use this method in a complex digital remote monitoring system. First, the investigators need to know what people with psychosis and mental health staff think about this idea.

The investigators will interview around sixty adults with psychosis and around forty staff, recruited from UK mental health services (Manchester, Glasgow, Edinburgh, Cardiff, London, Sussex). These one-off, audio-recorded interviews will last up to 60 minutes. The interviewer will ask about participants' views on complex digital remote monitoring. The investigators will then systematically analyse the interviews. Findings will inform the design of the investigators' own complex digital remote monitoring system and future digital tools designed by other researchers. NIHR and Wellcome are funding this study.


Eligibility Criteria:
SERVICE USER PARTICIPANTS

Inclusion Criteria:

* Clinical diagnosis of schizophrenia spectrum disorder (ICD10 F20-29) OR meets the early Intervention for Psychosis Service entry criteria, operationally defined using the Positive and Negative Syndrome Scale (PANSS) and/or the psychosis transition criteria of the Comprehensive Assessment of At-Risk Mental States (CAARMS).
* In contact with mental health services
* Over 16 years of age
* Ability to give informed consent

Exclusion Criteria:

* Not sufficiently stable to take part in an interview
* Not sufficiently fluent in English to take part in an interview

STAFF PARTICIPANTS

Inclusion Criteria:

* Work within an adult NHS service providing mental health support to people who experience psychosis / severe mental health problems
* Ability to give informed consent

Exclusion Criteria:

- Not sufficiently fluent in English to take part in an interview
The Relationship Between Operative and Radiologic Stem Version

Investigators prospectively evaluate the accuracy of intraoperative stem anteversion in 40consecutive total hip arthroplasties.

In all hips, investigators measure femoral stem anteversion postoperatively with three-dimensional computed tomography reconstruction of the femur, using both the distal femoral epicondyles and the posterior femoral condyles to determine the femoral diaphyseal plane. And investigators compare the surgeon's estimate of intraoperative stem version and stem version of CT scan.

Eligibility Criteria:
Inclusion Criteria:

* Investigators recruited 40 consecutive patients who underwent THR between October 2015 and December 2015

Exclusion Criteria:

* patients who could not extend the hip because of a residual flexion contracture.

who had a flexion contracture of the knee or who could not flex the hip to 90° even after THR were excluded because participants could not adopt the posture required for the particular radiographs and CT scans.
Shade Matching and Patient Satisfaction of Yttria Stabilized Multilayered Zirconia and Lithium Disilicate Restorations

The aim of the study is to determine whether Yttria stabilized multilayered zirconia restorations will differ from lithium disilicate restorations in shade matching and patient satisfaction in patients requiring full coverage restorations.

Steps in short: Single tooth in the esthetic zone requiring full coverage crown is prepared to receive an all-ceramic crown, The restorations will be divided into two groups: I: Teeth receiving restorations fabricated from Lithium disilicate II: Teeth receiving restorations fabricated from yttria stabilized multilayered zirconia. Shade will be measured using intraoral spectrophotometer and evaluated. The colour difference (ΔE) will be calculated for each sample using the following equation: ΔE =\[(ΔL) ²+(Δa) ² + (Δb) ²\] ½, ΔE (perceptibility threshold) will be evaluated for each group. Participant timeline the patient will be treated in visits designated as follows: Visit 1: Preoperative records, face-to-face adherence reminder session, clinical, radiographic for examination, intraoral photographs and primary impression (Alginate impression) diagnostic cast construction. Visit 2: teeth preparation and secondary impression using addition silicone rubber base material and temporary restoration. Visit 3: placement and permanent cementation of the final restoration using resin cement.

Eligibility Criteria:
Inclusion criteria:

1. Age range of the patients from 20-60 years old; able to read and sign the informed consent document, illiterate patient will be avoided.
2. Patients able physically and psychologically to tolerate conventional restorative procedures.
3. Patients with no active periodontal or pulpal diseases, having teeth with good restorations.
4. Patients with teeth problems indicated for full coverage restoration (coronal fracture where partial coverage would lack retention, malposed or malformed teeth).
5. Patients with root canal treated teeth requiring full coverage restorations.
6. Patients willing to return for follow-up examinations and evaluation.

Exclusion Criteria:

1. Patients in the growth stage with partially erupted teeth.
2. Patients with poor oral hygiene and motivation.
3. Patients with psychiatric problems or unrealistic expectations (patient that has phobia from dental treatments or needle bunch).
4. Patients suffer from parafunctional habits.
Vorinostat and Bortezomib as Third-line Treatment in Advanced Non-small Cell Lung Cancer

The purpose of this study is to evaluate the efficacy of vorinostat and bortezomib in the third line treatment of advanced NSCLC, as well as to assess toxicity (including neuropathy) and tolerability of this regimen.

Current treatment for non-small cell lung cancer (NSCLC) remains inadequate. Vorinostat is a novel agent that inhibits the enzymatic activity of histone deacetylases (HDACs). Bortezomib is a small molecule proteasome inhibitor. Preclinical and clinical studies have shown the advantages of combining these two agents in the treatment of NSCLC

Eligibility Criteria:
Inclusion Criteria:

* Pathologically/histologically confirmed NSCLC
* Advance NSCLC (stage IIIB w/ effusion, stage IV, or recurrent disease)
* Measurable disease
* Two prior systemic anti-cancer (cytotoxic or biologic) regimens for advanced/metastatic disease, including one (1) platinum-based chemotherapy
* Prior treatment allowed if side effects have resolved and 3 weeks has passed since last dose of treatment (1 week for palliative radiation therapy)
* ECOG performance status 0, 1, or 2
* Patients with brain metastases are allowed, if clinically stable after treatment
* Normal liver, kidney, and marrow function
* 18 years of age or older
* Negative pregnancy test for women of child-bearing potential.
* Life expectancy 3 months or more
* No concurrent use of other antitumor agents

Exclusion Criteria:

* Prior therapy with vorinostat, HDAC inhibitors, or bortezomib
* Pre-existing neuropathy grade \>/= 2
* Myocardial infarction within 6 months prior to enrollment or have NY Heart Association Class III or Class IV heart failure
* Have taken valproic acid \</= 4 weeks prior to enrollment
* Previous or current malignancies of other histologies within the past 5 years, except cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
* Hypersensitivity to bortezomib, boron, or mannitol
* Serious medical or psychiatric illness likely to interfere with participation in the clinical study
* Pregnant women
* HIV positive patients
* Hepatitis infection (HCV or HBV) patients
A Trial of Echinacea in Children

This is a randomized trial to determine if echinacea is effective in shortening the length and/or lessening the severity of colds in children 2 through 11 years old.

Upper respiratory tract infections (URI's) are a significant health burden in childhood. URI's are a major reason for visits to health care providers, and up to 35 percent of young children at any given time are taking some over-the-counter cold medication. Unfortunately, data suggest that most of these medications have limited effectiveness. Alternative medical therapies are growing in popularity; in a recent survey of parents of children being seen by pediatricians in Seattle, Washington, 24.2 percent indicated that their child had been seen by an alternative medicine health care provider, and 53.3 percent received therapies for the treatment of URI's in children. The proposed study is a randomized, double blind, placebo controlled trial of Echinacea for the treatment of URI's in children 2-11 years old. The aims of the project are: to determine if Echinacea shortens the duration and/or lessens the severity of URI's, if children receiving Echinacea for treatment of URI's have a reduced rate of secondary bacterial infections, and to determine if the use of Echinacea in patients 2-11 years old is associated with any significant side effects. A two-year study of 600 children is planned. Not only will the results of this study determine if Echinacea, the most popular medicinal herb sold in the United States, is an effective therapy for URI's in children, the study will provide a design framework for further assessment on the efficacy of other complementary and alternative medicines in children.

Eligibility Criteria:
Inclusion Criteria:

* Parent available to observe child during the night
* Parent peaks and reads English

Exclusion Criteria:

* History of asthma or allergic rhinitis
* History of auto-immune disease
* History of chronic lung disease
* Allergy to sunflower species
Evaluation of Prevalence, Molecular and Genetic Backgrounds of Calcium-Based Stones Among Patients With Renal Calcular Disease in Mansoura Urology and Nephrology Center

Evaluation of Prevalence, Molecular and Genetic Backgrounds of Calcium-Based stones among Patients with Renal Calcular Disease in Mansoura Urology and Nephrology Center

Back ground: Nephrolithiasis is a prevalent disease with high morbidity, the incidence and prevalence of nephrolithiasis has risen worldwide. Calcium nephrolithiasis may be considered as a complex disease having multiple pathogenic mechanisms and characterized by various clinical manifestations. Both genetic and environmental factors may increase susceptibility to calcium stones. Polymorphisms of vitamin D receptor (VDR), calcium-sensing receptor gene (CASR) and AGXT have been associated with risk of urolithiasis, but, with inconsistent results and lack data from Egyptian population.

Objective: Therefore, the present study aims to investigate the prevalence, mutational profile for these genes in patients with Ca-based stones, admitted to Mansoura Urology and Nephrology Center.

Methodology: In this study, employing sequencing of the coding exons of the calcium-sensing receptor gene (CASR), vitamin D receptor (VDR) and AGXT for a 50 of Egyptian calcium kidney stone-formers and 20 control subjects. The results of the mutational profile data will be correlated with risk of stone recurrence over 2 years.

Eligibility Criteria:
Inclusion Criteria:

* All patients with unilateral or bilateral renal stones (de novo or recurrent) who were candidates for endoscopic or surgical intervention were included. Metabolic workup was done for selected patients with radio-opaque stones, while genetic testing was done for those with dominant Ca composition proven by postoperative stone analysis. Thirty healthy individuals with no urologic abnormalities were involved as control cases. Patients with renal calculi for whom metabolic and genetic testing were performed are designated "α" cases.

Exclusion Criteria:

* For metabolic and genetic testing, patients with a well-known lesion precipitating stone disease were excluded e.g. ureteric stricture, ureteropelvic or ureterovesical junction obstruction, urinary diversion, history of ureterovesical re-implantation as well as patients with non-Ca stones by post-operative stone analysis
Study of Pretargeted Radioimmunotherapy of a Anti-CEA Bispecific Antibody and Lu177-labeled Peptide in Colorectal Cancer

This study will investigate the toxicity, safety and pharmacokinetics of pretargeted radioimmunotherapy with anti-CEA x anti-hapten bispecific antibody TF2 and Lu-177-labeled di-HSG-DOTA peptide IMP-288. Furthermore, the sensitivity of pretargeted imaging with In-111-labeled IMP-288 as compared to standard methods of tumor detection, and the preliminary efficacy of the therapy.

Pretherapy cycle with IMP-288 labeled In111.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CEA expressing advanced colorectal tumors for which no standard treatment is available
* WHO performance status: 0 or 1
* Having normal hematological function: Neutrophils \> 1.5 x 109/l; Platelet count \> 150 x 109/l, without transfusion during the previous month; Hemoglobin \> 5.6 mmol/l
* Total bilirubin \< 2 x upper limit of normal (ULN)
* ASAT, ALAT \< 3 x ULN
* Serum creatinine \< 2 x ULN
* Cockcroft clearance \> 50 ml/min
* Negative pregnancy test for women of child¬bearing potential (urine or serum)
* Age over 18 years
* Ability to provide written informed consent

Exclusion Criteria:

* Known metastases to the brain
* Chemotherapy, external beam radiation or immunotherapy within 4 weeks prior to study. Limited field external beam radiotherapy to prevent pathological fractures is allowed, when unirradiated, evaluable lesions elsewhere are present.
* Prior angiogenesis inhibitors within 4 weeks; bevacizumab within 8 weeks
* Cardiac disease with New York Heart Association classification of III or IV
* Patients who are pregnant, nursing or of reproductive potential and are not practicing an effective method of contraception
* Any unrelated illness, e.g. active infection, inflammation, medical condition or laboratory abnormalities, which in the judgement of the investigator will significantly affect patients' clinical status
* Life expectancy shorter than 6 months.
Ex Vivo Immunotherapy for Hyperglycemia in Type 2 Diabetes Mellitus

Diabetes mellitus type 2 is a long-term metabolic disorder that is primarily characterized by insulin resistance, relative insulin deficiency and hyperglycemia. Our hypotheses is that liver would be the primary organ responsible for the metabolic disorder because of some unknown defects, where sugar would not be efficiently converted to glycogen and fat, leading to hyperglycemia. The constant hyperglycemia would keep pressure on beta-cells in the pancreas to eventually exhaust their ability to produce and secret sufficient amount of insulin, exacerbating the disease. The Immunotherapy would enhance the liver functions and correct the abnormal sugar metabolism. In addition, the ex vivo activated cells produce and secret growth factors which would help endothelial cells of blood vessels to reproduce and grow, resulting in reduced arteriosclerosis.

We plan to recruit 20 patients with type 2 diabetes mellitus who suffer hyperglycemia with or without medication. The patients will come to our hospitals for the treatment. A small amount of peripheral blood will be drawn and processed and cultured in our laboratory. The cultured cells (autologous) will be infused intravenously back to patients. Levels of plasma hemoglobin A1c (HbA1c) and other metabolic parameters before and after the therapy will be compared. The therapy is planned to take four weeks for each patient.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients diagnosed with type 2 diabetes mellitus.
* 2. 25 years of age or older. Both sexes.
* 3. HbA1c ≧6.5% for more than 6 months with or without medication.
* 4. Capability of providing informed consent.

Exclusion Criteria:

* 1. History of malignancy.
* 2. Patients with active infections.
* 3. Seropositivity for HIV infection.
* 4. History of myocardial infarction or unstable angina in the previous 3 months.
* 5. Pregnancy or nursing.
Metformin-Dipyridamole Interaction Trial

The antihyperglycemic drug metformin and the thrombocyte aggregation inhibitor dipyridamole are often used concomitantly in patients with diabetes who have suffered a transient ischemic attack or stroke. It has recently been suggested that the gastrointestinal absorption of metformin is mediated by the equilibrative nucleoside transporter 4 (hENT4). Dipyridamole has been reported to inhibit hENT4 transport in vitro. The aim of this research proposal is to study the pharmacokinetic interaction between metformin and dipyridamole. The investigators hypothesize that dipyridamole reduces the gastrointestinal absorption of metformin. If this hypothesis can be confirmed, then the results of this study can explain in part the high variability in plasma metformin concentrations in patients treated with diabetes, and can be used to optimize pharmacotherapy in patients with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-50 years
* Written informed consent

Exclusion Criteria:

* Smoking
* Hypertension (systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg)
* Diabetes Mellitus (fasting glucose \>7.0 mmol/L or random glucose \>11 mmol/L)
* History of any cardiovascular disease
* Concomitant use of medication
* Renal dysfunction (MDRD \<60 ml/min)
* ECG abnormalities, other than firs grade AV-block or right bundle branch block
Effects of Tofacitinib on Body Composition, Bone Mineral Density and Bone Marrow Adiposity in Patients With Rheumatoid Arthritis: the TOFAT Project

Inflammatory rheumatic diseases (IRD), such as rheumatoid arthritis, are characterized by adverse changes in body composition. Lean mass and bone mineral density are usually reduced while adiposity (total fat mass, visceral adiposity...) is increased in comparison with healthy controls. Many factors may influence the body composition of those patients such as aging, Disease Modifying Anti-Rheumatic Drugs (DMARDs), nutrition and physical activity.

However, data on body composition and adverse changes under DMARDs in patients with rheumatoid arthritis (RA) are actually scarce. This is the case with tofacitinib (targeted synthetic DMARD or tsDMARD) while preliminary data let us think that this treatment may influence body composition and bone mineral density.

This study is going to be the first to focus on changes in body composition (fat mass and lean mass), bone mineral density and bone marrow adiposity under tofacitinib.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient's ≥18 years old with moderately to severely active Rheumatoid Arthritis (RA) (ACR/EULAR criteria )
* Previously untreated with Janus Kinase (JAK) inhibitors
* With an indication for tofacitinib will be eligible.
* All patients will have to be treated with tofacitinib either alone or with methotrexate. -Healthy volunteers should be ≥18 years old.

Exclusion Criteria:

* • treatment with more than three anti-Tumor Necrosis Factor alpha (TNFα). Patients who were receiving anti-TNFα will be required a washout period lasting at least five-half-lives before to start tofacitinib,

  * previously exposed to JAK inhibitors,
  * patients who were receiving non-anti-TNFα biologics (abatacept, tocilizumab, sarilumab or rituximab) will be required a washout period lasting at least five-half-lives before to start tofacitinib
  * Concomitant methotrexate (MTX) will be permitted if started ≥3 months prior to study start and at a stable dose (≤25 mg/week) for ≥4 weeks.
  * history or discovery of an osteoporotic fracture AND/OR T-score≤-3 if ≥50 years AND/OR Z-score ≤-3 if \<50 years during the screening phase,
  * current treatment with oral corticosteroids higher than 10 mg prednisone/day,
  * pathologies or treatments that could affect the bone metabolism (breast cancer with aromatase inhibitors, gastrointestinal malabsorption, stomach cancer, primary hyperparathyroidism, uncontrolled hyperthyroidism...),
  * weight\> 160 kg,
  * patients on restrictive diets or considering such a diet during the study period,
  * patients with an intense exercise program or planning to benefit from it during the study period,
Single Cell Acute Leukemia Analysis

Numerous chemotherapy and immunotherapy resistance genes have been identified in cancers in general and acute myeloid leukemia in particular. As a preliminary to this study, the investigators hypothesized the co-expression of these genes in the same cell as a major factor in relapse. This hypothesis was supported in vitro by the study of the evolution of these co-expressions after incubation with chemotherapy drugs. The current study aims to verify this hypothesis by studying the expression of these genes in single-cell samples from relapsed acute myeloid leukemia patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Patient who has received information about the study and has not expressed opposition,
* Patients who are beneficiaries of a social security plan,
* Patient with relapsed or refractory acute myeloid leukemia, whatever the previous treatment, the therapeutic line and the time between the previous treatment and the relapse.

Exclusion Criteria:

* Persons who do not understand the French language if there is no translator available to translate for them.
* Absence of circulating blastosis.
Improvement of Compliance for High Doses of EPA Amongst Patients With Colorectal Cancer

Several studies indicate beneficial effects of eicosapentanoic acid (EPA) on cancer cachexia. However, compliance is generally low. This case control study is conducted in order to investigate if compliance depends upon the physical properties of the supplement (capsules vs. drinks). In order to further investigate how compliance can be improved, a possible correlation between sideeffects and rate of increased polyunsaturated fatty acid concentration in blood is also tested

Patients with abdominal cancer in active chemotherapeutic were allocated to either EPA in an oral nutritional drink (commercial) or capsules with fish oil. The dose of EPA was the same in both groups, and diets were adjusted as iso-caloric. Compliance to the fish oil treatment was the primary outcome. Blood concentrations of EPA secondary.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving chemotherapy on Rigshospitalet due to colorectal cancer
* Not terminally ill
* Subjects must be18 years of age (or older)

Exclusion Criteria:

* Subjects who do not read/speak/understand Danish
* Familial hypercholesterolemia
* Predialytic patients (GFR \< 15 ml/min/1,73 m2 or creatinine ≥ 500 mmol/L)
* Use of blood thinners
* Bleeder's disease