cyrilzakka/clinical-trials huggingface dataset:
Participatory Action Research to Evaluate the Delivery of the MISSION ABC Service Model and Assess Health Service and Clinical Outcomes

Innovations aimed at improving new patient identification, diagnosis, nonpharmacological treatment, supported self-management, and remote monitoring, together with new methods of clinical support could improve outcomes in patients with respiratory disease. The Investigators have developed a model of care incorporating key innovations for patients with asthma, COPD and undifferentiated breathlessness. This service is being implemented within Wessex CCGs. The investigators will assess whether the implementation of the service is effective, and how it can be adjusted, in addition to introducing innovations to assess whether the expected benefits for patients are realised.

A combination of study designs are required to evaluate all aspects of the service:

* Participatory action research approach, involving real-time evaluation at each clinic to inform subsequent clinics
* Before-and-after study for patient outcomes pre-clinic attendance and post-clinic attendance.
* Qualitative methods (interviews, focus groups)

Evaluation of the clinic cycles will include consideration of qualitative data from patients, carers and healthcare professionals, in addition to quantitative outcomes for service implementation and patient factors (i.e. uptake of the service and benefits realised in-session), including those in the following areas:

* Clinic process
* Education and supported self-management
* Added value of diagnostic tools (new diagnoses)
* Applicability and use of treatment tools and treatment tailoring
* Self-monitoring appropriateness and uptake
* Balance measures (e.g. increased secondary care traffic)

The longer-term impact of the service will be evaluated using clinical and health service outcomes such as:

* Hospitalisations for airways disease
* perceived disease control (symptom scores etc)
* exacerbation frequency
* health-related quality of life
* Patient Activation Measures (PAM)
* Treatments used
* Healthcare resource use (primary and secondary care)

Eligibility Criteria:
Inclusion Criteria:

* Attendance at a MISSION ABC clinic or training session as a patient, carer or Healthcare Professional

Exclusion Criteria:

* Unable to give informed consent
* Level of literacy precludes inclusion in questionnaire-based study
A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP

Currently there no standard sedation techniques for performing ERCP. It is not clear whether sedation administered by anesthetist is better than anesthesia with intratracheal intubation. To clarify which of these sedative methods are better we plan to conduct a randomized trial comparing anesthetist administered sedation with general anesthesia in patients with ASA ≤3.

ERCP is a relatively complex and lengthy endoscopic procedure. It is increasingly performed in elderly patients with multiple comorbidities and carries serious complications including death in about 0.33% of patients. An important aspect of endoscopy is sedation. The role of sedation is to make the procedure tolerable and acceptable to the patient by reducing anxiety and discomfort. It ensures that the patient is relatively still to avoid injury and enhance the chances of an efficient and successful procedure. Hence, adequate and appropriate sedation is of utmost importance to maximize patient comfort and minimize adverse events in ERCP.

The debate between anesthetist and gastroenterologist continues, as there is dearth of evidence evaluating the best form of sedative technique for ERCP.

Three prospective studies have tried to compare AAS with general anesthesia. Despite the fact that significantly more patients who had a higher body mass index (BMI) and were of ASA class 3 and above in the general anesthesia group, hypoxic events of less than 84% were much more common in patients having AAS then those who had general anesthesia (15% in AAS vs 6.7% in general anesthesia). On the other hand, hypotension (34% in general anesthesia vs 4% in AAS,) and arrhythmias (8% in general anesthesia vs 3% in AAS) were much more frequent in general anesthesia group than AAS. Upto 4% of patients had to be converted to general anesthesia due to cardiopulmonary compromise. However, the conclusion drawn was that AAS is as safe and effective as general anesthesia. Major caveats bring into question the conclusion. The studies were observational and non-randomized which introduces selection bias.

A recent randomized controlled trail that looked at general anesthesia versu AAS during ERCP concluded general anesthesia had a better safety profile than AAS (17). However, this study included only patient who were high risk for sedation related adverse events with ASA class \>3 and the anesthesia was provided by nurse anesthetist. Hence, these results cannot be generalized. There are no randomized trials comparing AAS with general anesthesia in patients with ASA ≤3, which includes the vast majority of patients having ERCP

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Referred for ERCP
* Assessed by anesthetist
* ASA 1-3

Exclusion Criteria:

* Emergency situation (upper GI bleed, on mechanical ventilation)
* ASA class ≥4
* Distorted anatomy - like partial or total gastrectomy
* Pregnancy
* Unable to give or obtain consent and/ or disturbed level of consciousness
* Suspected difficult intubation using Ganzouri score \> than 5 (18).
* Allergy to any study medication.
KRT-232 Compared to Ruxolitinib in Patients With Phlebotomy-Dependent Polycythemia Vera

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with phlebotomy-dependent polycythemia vera (PV). Inhibition of MDM2 in PV is a new mechanism of action in PV. In Part A, patients must be resistant or intolerant to hydroxyurea or have undergone treatment with interferon. In Part B, patients must be resistant or intolerant to hydroxyurea.

This study is a global, open-label Phase 2a/2b study to determine the efficacy and safety of KRT-232. In Part A of the study, patients will be randomly assigned to 5 arms with 2 different doses and 3 different dosing schedules of KRT 232. In Part B of the study, patients will be randomized either to treatment with KRT-232 administered at the recommended dose and schedule from Part A or to treatment with ruxolitinib.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of PV (WHO 2016)
* ECOG ≤ 2
* Part A: patients with and without splenomegaly are eligible
* Part A: patients must be resistant or intolerant to hydroxyurea or have undergone treatment with interferon
* Part B: only patients with splenomegaly are eligible
* Part B: patients must be resistant or intolerant to hydroxyurea

Exclusion Criteria:

* Diagnosis of post-PV myelofibrosis (IWG-MRT)
* Prior treatment with MDM2 inhibitors, p53-directed therapies, HDAC, BCL 2 inhibitors
* Splenic irradiation within 3 months prior to the first dose of study treatment
* Clinically significant thrombosis within 3 months of screening
* Grade 2 or higher QTc prolongation
* Part B: prior treatment with a JAK inhibitor
A Study to Evaluate the Effect of CCX140-B on Urinary Albumin Excretion in Subjects With Type 2 Diabetes and Albuminuria

The purpose of this study is to evaluate the effect of treatment with CCX140-B on urinary albumin excretion in subjects with type 2 diabetes mellitus and albuminuria, as well as to study the safety and efficacy of the medication in this patient population.

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Eligibility Criteria:
Key Inclusion Criteria:

* Aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (per American Diabetes Association \[ADA\] criteria), and treated with oral antidiabetic drugs
* Albumin:creatinine ratio (ACR) of 200 to 3000 mg/g creatinine, inclusive, based on two values obtained from two first morning urine samples taken on two separate days during the screening period
* Estimated glomerular filtration rate based on serum creatinine (eGFR, determined by Modification of Diet in Renal Disease \[MDRD\] equation) of ≥ 25 mL/min/1.73 m(2)
* Must be on a stable dose of an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) for at least 8 weeks prior to screening
* Fasting plasma glucose less than 270 mg/dL at screening

Key Exclusion Criteria:

* Type 1 diabetes mellitus or history of diabetic ketoacidosis
* Previous renal transplant or known non-diabetic renal disease, except related to hypertension
* Undergone renal dialysis at any time in the past
* Received chronic (more than 7 days continuously) systemic glucocorticoid or other immunosuppressive treatment within 8 weeks of screening
* Use of bardoxolone, atrasentan or other endothelin antagonist within 8 weeks of screening
* Received chronic (more than 7 days continuously) non-steroidal anti-inflammatory drug (NSAID) treatment within 2 weeks of screening
* Cardiac failure (class III or IV), history of unstable angina, symptomatic coronary artery disease, myocardial infarction or stroke within 12 weeks of screening
* Poorly-controlled blood pressure (systolic blood pressure \>155 or diastolic blood pressure \>95, with blood pressure measured in the seated position after at least 5 minutes of rest)
Antibacterial-coated Sutures at Time of Cesarean

Abdominal closure with antibacterial-coated sutures has been shown to reduce wound infections after a number of surgical procedures, but none of the previous trials included cesarean delivery. Our objective is to determine whether use of antibacterial-coated sutures reduces surgical site infection (SSI) after cesarean delivery.

A review of 18 studies demonstrated a significant benefit of antimicrobial coated sutures in reducing SSI (RCTs: OR 0.72; 95% CI 0.59-0.88; observational studies: OR 0.58; 95% CI 0.40-0.83). As there are no clinical trials focusing on cesarean delivery, and because the risk factors and pathogenesis for post-cesarean SSI may not mirror other procedures, further data is needed before generalizing the WHO recommendations to cesarean procedures.

Eligibility Criteria:
Inclusion Criteria:

* 18-50 years of age.
* Women ≥ 24 weeks' viable gestation.
* To undergo cesarean delivery.

Exclusion Criteria:

* Patient unwilling or unable to provide consent.
* No prenatal care or a non-resident patient who is unlikely to be followed-up after delivery.
* Immunosuppressed patients: i.e., taking systemic immunosuppressant or steroids (e.g. transplant patients; not including steroids for lung maturity), HIV with CD4\<200, or other.
* Decision to use other than suture closure (e.g. secondary wound closure, mesh closure).
* Skin infection.
* Coagulopathy.
* High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, bowel or adnexal surgery).
* Allergy to Triclosan.
* Incarcerated individuals.
Breast Mesh Used in Two-staged Breast Reconstruction

This is the first prospective randomized and controlled study on the efficacy and safety of TiLOOP® Bra mesh in patients with expander-implant breast reconstruction. The investigators hypothesize that incoporating TiLOOP Bra mesh with tissue expanders will reduce the rates of capsular contraction, improve the efficiency of expansion and provide better aesthetic result.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with breast cancer
2. More than 18 years old
3. Karnofsky Performance Status (KPS) larger than 80
4. No clinical or imaging evidence of distant metastasis
5. BMI \< 35kg/m2
6. Patients with no or mild breast ptosis
7. No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.
8. Mental Health Patient

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   Exclusion Criteria:

1. Patients with distant metastasis of breast cancer or local recurrence; 2. Past ipsilateral breast/chest wall radiation; 3. Inflammatory breast cancer, stage IV breast cancer 4. History of severe allergic or specific constitution; 5. Mental illness; 6. Drug/alcohol abuse; 7. Pregnancy, lactation, or impregnated during the trial period; 8. Non-eligible to the study enrollment based on researchers' discretion

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Conception of an ICF Core Set for Systemic Sclerosis

The purpose of this study is to create and validate an ICF core Set for Systemic sclerosis

In 2002 was published WHO's International Classification of Functioning, Disability and Health (ICF). ICF defines disability as "the negative aspects of the interaction between an individual (with a health condition) and that individual's contextual factors (personal and environmental factors)". Interactions are specified in five domains, classified from body, individual and societal perspectives by means of two lists: a list of body functions and structure, and a list of domains of activity and participation. Since an individual's functioning and disability occurs in a context, the ICF also includes a list of environmental factors.

ICF core sets, which are short lists of ICF categories relevant for specific conditions, serve as practical tools for clinical practice and allow standardisation of data for health information and research. Core sets have already been developed and validated for several musculoskeletal diseases, such as low back pain, osteoarthritis, or osteoporosis, but not yet for systemic sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 and older
* Diagnosis of ScS made according to ACR and/or Leroy et Medsger criteria
* Patient giving his informed consent to participate in the study

Exclusion Criteria:

* Severe chronic disease associated with ScS : stroke, multiple sclerosis, Parkinson's disease,...
* Cognitive or behavioral disorders making assessment impossible
* Inability to speak and write French
Vibration Training and Muscles Properties

Application dose standards have not yet been determined for Whole Body Vibration Training which is subject to studies with different frequencies and amplitudes. Our objective was to examine acute responses of two different vibration training doses on muscle tone, strength, and flexibility.

Application dose standards have not yet been determined for Whole Body Vibration Training which is subject to studies with different frequencies and amplitudes. Our objective was to examine acute responses of two different vibration training doses on muscle tone, strength, and flexibility.

Eligibility Criteria:
Inclusion Criteria:

* Healthy and untrained participants.
* Dominant side of the participants was recorded and only right dominant individuals were included.

Exclusion Criteria:

* Participants with body weight over 120 kg.
* Participants had lower extremity trauma and lower extremity movement restriction.
* Participants who had any cardiovascular or neurological conditions, dizziness or vertigo
Activation of Hepatitis B Virus (HBV) in Hepatitis B Surface Antigen (HBsAg) - Negative But Hepatitis B Core Antibody (Anti-HBc) - Positive Patients

Individuals with resolved hepatitis B, characterized as hepatitis B surface antigen (HBsAg)-negative and hepatitis B core antibody-positive, have latent hepatitis B virus (HBV) infection in their liver tissue. Cytotoxic chemotherapy and hematopoietic stem cell transplantation sometimes trigger the reactivation of latently infected HBV, resulting in de novo hepatitis B. Although de novo hepatitis B could cause acute liver failure or chronic hepatitis, an effective management strategy for de novo hepatitis B has not been well established. Risk factors and effective management for de novo hepatitis B will be clarified.


Eligibility Criteria:
Inclusion Criteria:

* HBsAg-negative but anti-HBc-positive

Exclusion Criteria:

* Serum HBV DNA-negative
The Evaluation Of Bone Width Gain Following Split Crest Technique With Or Without Platelet Rich Fibrin( PRF)

Split crest technique is a technique for horizontal bone augmentation used in case of narrow alveolar ridges as an alternative to the more aggressive techniques such as onlay bone grafting, guided bone regeneration (GBR) and distraction osteogenesis

The study goal is to evaluate whether if there will be any benefit of using platelet rich fibrin (PRF) with the split crest technique regarding bone width gain and healing response in comparison with split crest technique alone, where PRF is considered an autologous, growth factor containing material which is easy to collect and is of low cost.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with at least one missing tooth in the maxillary region
2. All the selected patients have a bucco-palatal width of the edentulous alveolar ridge from 3.5-5.5mm.
3. All the selected patients have at least 12 mm residual bone height at the edentulous area
4. The recipient site of the implant should be free from any pathological conditions.
5. No diagnosed bone disease or medication known to affect bone metabolism.
6. Patients who are cooperative, motivated, and hygiene conscious.

Exclusion Criteria:

1. Patients unable to undergo minor oral surgical procedures.
2. Patients with a history of drug abuse or catabolic drugs.
3. Patients with a history of psychiatric disorder.
4. Patients with unrealistic expectations about the esthetic outcome of implant therapy.
5. Patients with insufficient vertical inter-arch space, upon centric occlusion, to accommodate the available restorative components.
6. Patients in the growth stage with partially erupted teeth.
7. Patients who have any systemic condition that may contraindicate implant therapy.
8. Patients who have any habits that might jeopardize the osseointegration process, such as smoking and alcoholism.
9. Patients with parafunctional habits that produce overload on the implant, such as bruxism and clenching.
The Effects of Spinal Mobilizations on Neck Pain and Sympathetic Nervous System Activity in People With Neck Pain

This study investigates the effects of spinal mobilizations on neck symptoms and sympathetic nervous system activity in people with neck pain.


Eligibility Criteria:
Inclusion Criteria:

* Primary complaint of neck pain
* Non-traumatic history of onset
* Pain has a clear mechanical aggravating and easing positions or movements
* Limited range of motion
* Local provocation tests produce recognisable symptoms
* A positive expectation that mobilisations will help

Exclusion Criteria:

* No neurological deficit
* No signs of central hyperexcitability
* Referral to other health professional to exclude red flags not required
Green Light Effect on Sleep

The main goal of this study is to determine whether exposure to a narrow band of green light (NBGL) improved sleep quality in healthy subjects.

This is a within-subject study design that examines NBGL effects on sleep onset, sleep fractures (i.e., how many times per night the subjects wake up), total sleep duration, and sleep quality using high-resolution assessments. To complete the study, each participant will complete a 30-day, daily sleep diary while using white light (i.e., being in regular room light) during the last 2 hours of their waking period. This period will be defined as the baseline/control arm of the study. After completing this phase 1, subjects will receive a lamp designed to emit the narrow band of green light and again be asked to complete a 30-day, daily sleep diary, but this timer while using the NBGL light (i.e., being in what appears green light) during the last 2 hours of their waking period. This period will be defined as the active arm of the study. After completing this phase 2,

Sleep quality will be assessed using the Consensus sleep diary \[Carney et al., (2012)\] The consensus sleep diary: Standardizing prospective sleep self-monitoring, Sleep Vol.35, No.2, pp.287-302\], the latter of which captures total sleep time, sleep latency, wake after sleep onset, number of awakenings, quality, sleep efficiency, and trouble staying awake.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers who wish to improve their sleep quality

Exclusion Criteria:

* Subjects diagnosed with sleep disorders and are currently on medications and/or devices that aid their sleep ( eg trazadone as medication, CPAP)
Sitagliptin and the Risk for Hypoglycaemia in Type 2 Diabetes Patients

Sitagliptin, through its effects on sensitizing alpha-cell sensitivity to glucose, can initiate counter-regulatory glucagon responses at higher glycemic thresholds, thus reducing the number of clinically apparent hypoglycemic episodes, and/or ameliorating the severity of hypoglycemic episodes in the case that they should occur. The endpoints have defined such that consequences of this hypothesis can be measured.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject with diabetes mellitus type 2.
* Age between 18 and 64 years, both inclusive.
* HbA1c \<= 8.5%.
* Stable treatment with insulin glargine (any dose) and metformin (\>= 1500 mg/day or at highest tolerated dose) for at least 3 months prior to inclusion into the trial with or without additional oral glucose-lowering agents (except thiazolidinediones).
* Considered generally healthy (apart from diabetes mellitus type 2 and associated conditions such as hypertension, hyperlipidaemia and hyperuricaemia) upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, as judged by the Investigator.

Exclusion Criteria:

* Known or suspected hypersensitivity to sitagliptin or related products.
* More than one episode of severe hypoglycaemia with seizure, coma or requiring medical assistance of another person during the past 6 months or hypoglycaemic unawareness as judged by the Investigator.
* Current or previous treatment (less than 3 months prior to screening) with insulin products other than insulin glargine and/or with Glucagon-like peptide (GLP) 1 receptor agonists and/or with thiazolidinediones.
* Unwillingness to wash-off any oral glucose-lowering agents other than metformin.