cyrilzakka/clinical-trials huggingface dataset:
A Proof-of-concept Study to Reduce Treatment Burden in Haemophilia Participants Receiving Factor VIII and Factor IX Infusions

The main aim is to describe how the treatment burden and challenges of participants, relatives, and doctors during regular Factor VIII and Factor IX infusions to treat hemophilia evolve using a virtual-reality (VR) based solution. The study also aims to find out how well the VR based solution is tolerated and how satisfied the participants, relatives, and doctors are with it.

The VR-based solution includes a mobile phone app and a 3D mask.

Participants will use the VR-based solution while receiving prophylactic Factor VIII and Factor IX infusions for 4 weeks at home. Participants will visit the clinic for the last infusion; at this time data will be collected from participants, relatives, and doctors


Eligibility Criteria:
Inclusion criteria:

1. Male participant over the age of 6 years, with diagnosed Congenital Hemophilia A or B, whatever the severity is
2. Participant under long-term prophylaxis with intravenous Factor VIII or Factor IX infusions
3. Participant (or the legal guardians if participant age \<18 years) able and willing to give written informed consent and to comply with the requirements of the study protocol
4. Participant affiliated to the national social security or beneficiary to such insurance

Exclusion criteria:

1. Participant with known or suspected hypersensitivity to virtual-reality based tools
2. Participant with central venous line for the administration of Factor VIII or Factor IX
3. Participant (and the legal guardians if participant age \<18 years) with history of unreliability or non-cooperation (including for completion of self-reported questionnaires)
4. Participant (and the legal guardians if participant age \<18 years) with insufficient comprehension of French language
5. Participant taking part in another clinical trial
6. Participant deprived of his liberty by judicial or administrative order

NB: participants with haemophilia A having participated in the test phase of the study could be included in the clinical study itself after a period of 4 months minimum with no use of the virtual-reality based solution.
PH iWell Study to Compare an Online Interactive Technology to Self-directed Care in Overweight or Obese Individuals

This is a six month lifestyle management study to compare the effects of iWell; a dynamic online interactive technology to a self-directed program in overweight or obese individuals.

The primary aim is to test the hypothesis that dynamic online interactive technology intervention is more effective than self-directed program in obtaining and maintaining weight loss and other biometric improvements.

Optimal health behavior is difficult to sustain over extended periods. This study seeks to demonstrate that technology can be a low cost scaleable solution that will provide the user with sufficient customization and personalization through social networking approaches such that sustainability of optimal health behavior is realized.

Eligibility Criteria:
Inclusion Criteria:

* age 18-70 years old
* overweight or obese men and women with BMI between 24 and 38, inclusive
* concerned about weight/health (and motivated in losing weight)
* stable medications for past 3 months
* willing/able to use Web-based services
* willingness not to use weight loss medications for the duration of the trial
* able and willing to give informed consent and participate in the interventions
* willing to come to three sessions and visits
* willingness to be randomized to intervention or control group

Exclusion Criteria:

* contraindication to weight loss (e.g., malignancy or other serious illness)
* Type 1 DM and Type 2 DM with other end organ compromise (renal, retinal or other)
* Recent (within 6 months) cardiovascular event (MI or stroke)
* current symptoms of angina
* heart, renal, or liver disease (excluding kidney stone)
* cancer or active neoplasm (excluding skin cancers)
* hyperthyroidism
* mental conditions that would preclude full participation
* prior weight-loss (bariatric) surgery or plan for these procedures
* liposuction surgery in past 12 months or plan for these procedures
* recent weight loss in the past 3 months (\>20 lbs)
* use of prescription weight loss medication in 3 months prior to screening
* current use of medications for treatment of psychosis or manic-depressive illness
Clinical Phenotyping and Genotyping of HIV-Associated Sensory Neuropathy: The HIV-POGO Study

This study aims to recruit a cohort of HIV patients with and without HIV-SN and to identify genetic risk factors for the development of HIV-SN and neuropathic pain. It also aims to more deeply phenotype the condition, using well validated questionnaires, and to identify any influence that early neurocognitive dysfunction may have on the reporting, diagnosis and treatment of neuropathic pain in the HIV population.

HIV associated sensory neuropathy (HIV-SN) is a frequent complication of HIV infection, affecting between 20 and 57% of infected individuals. The advent of better antiretroviral treatment for HIV has meant that mortality from HIV has decreased dramatically in the UK. This means however, that chronic, age-related conditions associated with HIV, such as HIV-SN and cognitive impairment, are increasing in prevalence and becoming a significant disease burden.

The classification, diagnosis and treatment of HIV-SN remains poor. Currently, little is known about the genetic basis of the disorder and what risk factors mean that some patients with HIV develop neuropathy and pain, whilst others do not. It is hoped that by further characterising or 'phenotyping' the disorder, it will be easier to identify which patients are at risk of developing neuropathy and chronic pain. It may also mean that treatment can be more individualised as currently patients often undergo a frustrating 'trial and error' protocol of treatment, as clinicians can not yet predict who will respond to which treatment.

It has also been suggested that there is a link between HIV-SN and HIV associated neurocognitive disorder (HAND), which is another common, age-related complication of HIV infection. It may be that the existence of one pathology could predict the development of the other, or that the presence of HAND may impair the diagnosis or treatment of chronic pain associated with HIV-SN.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or over
* HIV infection

Exclusion Criteria:

* co-incident severe neurological disease
* co-incident severe psychiatric illness
* limited english language skills so as not able to conduct quantitative sensory testing
* pregnancy
* pain of greater than 3/10 on an NRS due to pathology other than HIV-SN
Sex Differences in E-cig Perception: Study 1

The primary objective is to examine the influence of sex on sensory effects, appeal, and reinforcing value of nicotine containing e-cigs in popular flavor components; sweet and cooling.

This study looks at the effect of sex on the sensory effects of flavor components in e-cigarettes. Regular combustible tobacco users will sample 3 different flavored e-cigarettes containing nicotine in a human lab paradigm.

Eligibility Criteria:
Inclusion Criteria:

* 21-44 years old
* Able to read/write
* Current cigarette smoking
* Recent E-cig Exposure (\>/= 10 uses in past 6 mo.)
* Urine cot \>200ng/ml
* Willing to abstain from nicotine/tobacco 6-8hrs prior to lab session
* Not looking to quit

Exclusion Criteria:

* Untreated chronic medical conditions
* Non-stable Rx medication
* Illicit drug use
* Pregnant, trying to become pregnant, breastfeeding
* Not fully vaccinated for Coronavirus (e.g. COVID-19)
Home Versus Hospital Based NIV Care in MND

Non-invasive ventilation (NIV) is commonly offered to people with Motor Neurone Disease (MND) who have breathing difficulties. It improves their quality of life and can prolong life by 6 months or more. It is initially used at night and typically set up during a hospital admission. By the time that they develop respiratory failure and need to start NIV, however, most patients require wheelchairs or have other significant health problems. Repeated travel to hospitals is increasingly difficult with increasing disability. It is possible to start and monitor NIV treatment at home. This may be more convenient for selected patients, though starting NIV is quite complex; it is not known if home treatment is as safe and effective as hospital-based treatment.

To establish this, 60 patients with MND who have indications for NIV will be recruited. They will be randomly allocated to a home-based treatment (home NIV set up plus home visits supported by telemonitoring) or hospital-based care (inpatient NIV set up plus outpatient NIV monitoring) and followed up at 1, 4 and 7 months. Alongside measures of treatment effectiveness, assessment of patient and carer preferences, quality of life, and cost-effectiveness will be undertaken.

In the additional qualitative part on this study, interviews with patients who took part in the main study and their carers will be conducted to understand in more depth their perspective on what makes for a good or bad experience with NIV, how the environment (home vs hospital) influences their NIV experience and what personal factors determine NIV use. Findings from the interviews will inform the design of a truly patient-centred NIV service.


Eligibility Criteria:
Inclusion Criteria:

* Adults with a diagnosis of Motor Neurone Disease confirmed by a neurologist specialising in MND.
* Indications to NIV: daytime pCO2 \>6.0 kPa or/and symptoms of ventilatory failure (e.g. orthopnoea, paroxysmal nocturnal dyspnoea, morning drowsiness) in the presence of significant diaphragmatic weakness confirmed by respiratory muscle tests

Exclusion Criteria:

* Cognitive impairment precluding understanding of the study protocol and valid consent
* Severe co-morbidities (e.g. decompensated heart failure, severe chronic obstructive pulmonary disease (COPD), morbid obesity) causing or contributing to respiratory failure
* Immediate need to start NIV (\<24hrs) and/or acute illness requiring inpatient treatment e.g. intravenous antibiotics for pneumonia (in addition to the need for NIV)
* Lack of a sufficient social/professional network to support NIV application at home
* Not wishing to accept home NIV
Real-world Effectiveness and Cost-effectiveness of Leading Inhaled Corticosteroids in Asthma Management

The objective of the study was to compare the effectiveness, cost-effectiveness and direct healthcare costs of managing asthma in patients with evidence of persistent asthma, following the initiation and increased dose of inhaled corticosteroid (ICS) therapy using HFA-BDP (Qvar®) (either as initial therapy or as a step-up therapy) compared with the most commonly prescribed alternative ICS in the UK, CFC-beclometasone (BDP) and fluticasone (FP) as metered dose inhalers (MDIs). Qvar vs FP analyses were split between adults (12-60yrs) and paediatrics (5-11yrs).

While current UK asthma guidelines are underpinned with evidence from RCTs, much of this evidence has been undertaken in patients who are not representative of the majority of the current UK asthma population. In fact it has been estimated that fewer than 10% of the patients seen in everyday clinical practice would be eligible for inclusion in such trials. The poor representation of the asthma population is due to a number of factors, such as tightly-controlled inclusion criteria for RCTs. There is therefore a need for more representative RCTs and real-life and observational studies to inform existing guidelines and help optimise asthma outcomes. A more holistic approach to respiratory research would see RCT evidence complimented by "real-life" data from pragmatic trials and observational studies.

A number of trends are emerged in asthma prescribing that warrant further investigation to ascertain their benefit to both the patient and the NHS. In particular, significant pressure exists to use the cheapest inhaler devices and formulations. An analysis of a pragmatic trial of Qvar versus standard CFC-BDP undertaken by Research in Real Life suggested that Qvar may be offer greater effectiveness in.5,6 In light of these data, the following report details the findings of a study designed to examine the effectiveness of Qvar in real-life clinical practice using the General Practice Research Database (GPRD).

Eligibility Criteria:
Inclusion Criteria:

Included patients must:

* aged 5-60 years
* evidence of asthma: a diagnostic code of asthma or ≥2 prescriptions for asthma in baseline year at different points in time including one of ICS
* on current therapy at the IPD, defined as ≥1 ICS script and ≥1 other asthma prescriptions in the 12 months prior to first change in therapy
* had definite dosing instructions
* have at least 1 year of up-to-standard (UTS) baseline data before IPD
* have at least 1 year of UTS outcome data after IPD.

Exclusion Criteria:

* had a diagnostic read code for chronic obstructive pulmonary disease (COPD) at any time
* had a diagnostic read code for chronic respiratory disease at any time
* For the therapy increase patient cohort, any patients receiving a combination inhaler in addition to their separate ICS inhaler in the year prior to IPD were also excluded.
Brazilian Total Neoadjuvant Therapy Trial

Standard therapy for localized rectal cancer includes chemotherapy and radiation therapy, followed by a "recovery" period of 7-12 weeks, surgery and adjuvant chemotherapy for 3-6 months. Even though this protocol achieves high cure rates, many patients need a rectal amputation with placement of definitive colostomies. About 10-20% of patients have a complete clinical response to chemo-radiation and no tumor can be found in the surgical specimen. These patients can be followed with close surveillance and avid surgery. The aim of this study is to evaluate if a strategy including the use of a highly active chemotherapy called "FOLFIRINOX" during the 12 weeks between the end of radiation therapy and evaluation for surgery increases the rates of complete response and, therefore, allows more patients to undergo non-surgical management.

Adult patients with locally advanced rectal cancer who have completed conventional long-course chemo-radiation of 54Gy with capecitabine will be randomized 1:1 to a total neo-adjuvant therapy (TNT) protocol or to a control group. Patients in the TNT arm will receive 4 cycles of interval chemotherapy with FOLFIRINOX (5-FU, irinotecan, oxaliplatin) between the end of chemo-radiation and re-staging and those in the control group will undergo standard post-radiation care during this period. All patients will be re-staged with colonoscopy and pelvic MRI 12 weeks after the end of chemo-radiation. Those with a complete clinical response will be placed under a watch-and-wait protocol with digital rectal examinations every 2 months and pelvic MRI and sigmoidoscopy every 6 months. Those wih residual tumors will undergo resection with total mesorectal excision (TME). Patients with a "near complete response", as defined by a multidisciplinary tumor board, will be re-staged at week 16 or 18 after chemo-radiation before undergoing surgery. Adjuvant chemotherapy will be done following the local standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 y/o
* Biopsy-confirmed rectal adenocarcinoma
* Tumor Stage T3+ or N+ M0
* Adequate liver function (total bilirubin \< = 4.0)
* Adequate kidney function (calculate creatinine-clearance \>=30ml/m2/min)
* Adequate bone marrow function (Platelet counts \>=90.000, hemoglobin \>=8mg/dl, neutrophile count \>= 1.500/cm3)
* Completed chemo-radiation with at least 54Gy and capecitabine 1650mg/m2/d

Exclusion Criteria:

* Prior tumor resection
* Prior radiation to the pelvis
* Prior chemotherapy for rectal cancer
* Life expectancy \< 6 months
* Unfit for surgery
* Need for urgent/ immediate surgery
An Open, Single-center Clinical Study of Surufatinib Combined With Temozolomide and S-1 in the First-line Treatment of Advanced Neuroendocrine Tumors

This is a prospective, open, single-center study evaluating the efficacy and safety of surufatinib Combined With Temozolomide and S-1 as the first-line treatment of advanced neuroendocrine tumors


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75years (inclusive);
* Histopathologically confirmed diagnosis of advanced MGMT0/1+ (G1, G2 or G3) neuroendocrine tumor (locally advanced, unresectable or distant metastasis);
* Previously untreated with systemic therapy;
* Have at least one measurable lesion according to RECIST v1.1;
* ECOG performance status: 0-2(determined by investigator);
* Expected survival time \> 3 months;
* Adequate hepatic, renal, heart, and hematologic functions;
* Urine protein \< ++ . If Urine protein ≥ ++ ,the amount of urine protein in 24 hours ≤1.0g;
* Before the first dose, serum HCG examination of potential childbearing-women must be negative; Men/Women of childbearing potential must agree to use a highly effective contraceptive method (such as double barrier contraceptive method, condom, oral or injectable contraceptives and intrauterine device) throughout treatment and for at least 90 days after study completion.

Exclusion Criteria:

* Neuroendocrine cancer, adenocarcinoid, goblet cell carcinoid,
* Functional NETs which need to control symptoms by long-acting somatostatin analogues;
* Received a major surgery which requires at least 3 weeks after recovery time, to undergo surgery on treatment of this research within 4 weeks prior to treatment;
* Have uncontrolled hypertension, defined as systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mm Hg, while under anti-hypertension treatment;
* Patients with active ulcer, intestinal perforation and intestinal obstruction;
* With active bleeding or bleeding tendency;
* Severe history of cardiovascular and cerebrovascular diseases;
* Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection.
G7 Acetabular System vs. Exceed ABT Acetabular System in THA

Evaluate the safety and effectiveness of patients who received G7 Acetabular system in conjunction with Ceramic on Ceramic articulation and Taperloc Complete Microplasty stem compared to patients who received the Exceed ABT Acetabular system with the same combination

This study will be a multi-center randomized controlled study. Eligible patients will be randomly assigned to receive a combination of G7 Acetabular system with CoC articulation and Taperloc Complete Microplasty stem or Exceed ABT Acetabular system with CoC articulation and Taperloc Complete Microplasty stem. Patient demographics, preoperative clinical outcomes, operative information, postoperative clinical outcome, radiographic assessment, incidence of squeaking, incidence of dislocation, implant survivorship and adverse events will be collected prospectively.

Eligibility Criteria:
Inclusion Criteria:

1. Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
5. Revision of previously failed total hip arthroplasty.
6. age over 20 years old

Exclusion Criteria:

1. uncooperative patient or patient with neurologic disorders who are incapable of following directions,
2. osteoporosis,
3. metabolic disorders which may impair bone formation,
4. osteomalacia,
5. distant foci of infections which may spread to the implant site,
6. rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and
7. vascular insufficiency, muscular atrophy, or neuromuscular disease.
A Study of Zomacton in Children With Growth Hormone Deficiency

This trial is set up to compare Zomacton to Genotropin for the treatment of growth hormone deficiency in children. The children will be treated for 1 year. Half of the patients will be treated with Genotropin and half with Zomacton. During this time they will be dosed every day by themselves or their parents at home in the evening. There will be 138 patients in the trial from age 3 to age 11. The patients cannot have been treated before with growth hormone and the patients must have a proven growth hormone deficiency, this will be shown by a specific test that will be performed before the trial in the local clinic and once during the trial. During the time of the treatment the patients will come to visit the clinic every 3 months. At these visits their heights will be measured, blood samples will be taken, physical examinations will be performed and questions about their health will be asked. At 2 times in the trial they will have a hand x-ray taken to measure the bone age. At the end of the trial the patients will stop the treatment and continue on one of the marketed products available to treat growth hormone deficiency.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Children aged ≤3yrs old and not above 10 yrs for girls or 11 yrs for boys
3. Idiopathic growth hormone deficiency confirmed during the pre-screening period by a standard GH stimulation test (defined as peak level of \<10ng/ml pr lower if so required by the country specific board(s)
4. Height SDS \<-2 SD of ref value for CA
5. Height velocity SDSCA ≤ 0 SD of ref value for at lease 6 months prior to pre-screening
6. Height recorded for at least 6 months but not more than 18 months of pre-screening
7. The difference between CA-BA≥ 1
8. A positive locally performed GH stimulation test (defined as a peak plasma level of\<9ng/ml or lower if so required by the country specific board(s)) prior to the pre-screening

Exclusion Criteria:

1. BA above 9 yrs for girls and 10 yrs for boys
2. Puberty Tanner stage \>1
3. Weight \<12 Kg at screening
4. Any prior treatment with GH
5. Closed epiphysis
6. Any diagnosed or suspected syndrome (e.g. Silver -Russell, Turner's or seckel syndrome) which possibly could affect growth
7. Any other diagnosed or suspected endocrine or metabolic disorder
8. Any diagnosed or suspected sever chronic disease
9. Clinical signs of dysmorphic features, malformations or mental retardations
10. Growth failure due to other disorders
11. Previous or present use of drugs that could interfere with GH treatment (e.g. steroids)
12. Diagnosed malignant disease
13. Any abnormal CS lab results that requires further investigation
14. Receipt of an investigational drug within the last 28 days preceding screening or longer if considered possible to influence the outcome of the current trial
15. Any knowledge of hypersensitivity to somatropin or any of the excipients of Zomacton or Genotropin