cyrilzakka/clinical-trials huggingface dataset:
Heat and Acupuncture Randomised Controlled Trial to Manage Osteoarthritis of the Knee

Knee osteoarthritis (KOA) is one of the largest and fast-growing causes of pain, impaired mobility, and poor quality of life in the elderly worldwide. Despite a significant increase in Traditional Chinese Medicine (TCM) utilisation, in particular acupuncture, as first or second-line treatment among local KOA patients, there exists a lack of high-quality evidence on its efficacy and local practice guidelines for TCM use in KOA tailored to our specific population demographic.

HarmoKNEE trial aims to address these gaps by evaluating the short and medium-term clinical and cost-effectiveness of TCM acupuncture with far-infrared heat therapy in addition to standard care, compared to standard care alone. Through a robust process and economic evaluation, the investigators aim to inform evidence-based practice for KOA patients in Singapore to facilitate the large-scale implementation of a comprehensive and holistic model of care which harmonises elements from Western medicine and TCM.

The investigators hypothesize that acupuncture with heat therapy as an adjunct to standard care is clinically more effective than standard care alone.

This will be a multi-centre pragmatic, parallel-arm, single-blinded, effectiveness-implementation hybrid randomised control trial. KOA patients will be randomised to either the control arm (standard care only) or intervention arm (biweekly sessions of acupuncture with heat therapy over 6 weeks, in addition to standard care).

A mixed-method approach through an embedded process evaluation will facilitate large scale implementation. An economic evaluation will be performed to evaluate financial sustainability


Eligibility Criteria:
Inclusion Criteria:

1. 45 to 99 years old
2. Independent Community Mobilizers with or without walking aids
3. Conversant in English or Chinese
4. NICE clinical criteria for OA knee

Exclusion Criteria:

1. Alternative diagnosis to KOA e.g., referred pain from the spine or hip
2. Other forms of arthritis eg., inflammatory, post-traumatic
3. Inability to comply with study protocol e.g., cognitive impairment
4. Previous knee arthroplasty
5. Wheelchair-bound patients
6. Medical conditions that will medically interfere with study involvement e.g., decompensated heart failure, stroke, end-stage renal failure
7. Allergies to metal (needles)
Clinical Trial on Binge Eating Disorder, Treatment With Naloxone Spray

The investigators are studying a new treatment for one subtype of obesity. Obesity is not a disease. It is a symptom of several different diseases. These diseases have distinct etiologies, being caused by aberrations in different mechanisms. Forms of obesity caused by such non-critical mechanisms might be corrected fairly easily and safely. The investigators are interested in overeating and obesity that is caused by the opioidergic system. The opioidergic system appears to be responsible for a subtype of obesity associated with binge eating disorder (BED). People, especially with the right genetic predisposition, can become addicted to foods that release endorphins, in the way that people become addicted to exogenous opiates and other drugs that release endorphins. The particular application in our proposed clinical trial is for intranasal (IN) naloxone. The peak levels of naloxone were similar and the bioavailability of naloxone intranasally was 100% (the same) of that available IV." IN administration of naloxone has since been broadly tested in humans, as well, where it has been shown to be safe, with pharmacokinetics similar to those of naloxone given by injection .


Eligibility Criteria:
Inclusion Criteria:

* Binge eating disorder (DSM-IV) and body mass index (BMI) \> 25
* Binge eating screen \> 20

Exclusion Criteria:

* Pregnancy
* Drug usage
* Retarded
* Severe mental illness
Postoperative Sleep Quality of Patients Sedation With i.v. Dexmedetomidine or Midazolam Undergoing TURP

The investigators designed a study to determine whether dexmedetomidine versus midazolam combined with spinal anesthesia would provide same postoperative sleep quality in patients undergoing transurethral prostatic resection.

The investigators designed a study to determine whether dexmedetomidine versus midazolam combined with spinal anesthesia would provide same postoperative sleep quality in patients undergoing transurethral prostatic resection.The bispectral index score (BIS) was monitored during the operation and the first postoperative night

Eligibility Criteria:
Inclusion Criteria:

* Participants were deemed eligible if they were candidates for spinal anesthesia undergoing TURP

Exclusion Criteria:

* The exclusion criteria were body mass index exceeding 30 kg/m2, preoperative Pittsburgh Sleep Quality Index global scores higher than 6, anesthesia time longer than 3 hours, allergy to drugs used in the study and treatment with sedatives and analgesics during the postoperative BIS-Vista monitoring period.
Diastolic Function in Myotonic Dystrophy Type 1

Myotonic dystrophy type 1 (DM1) is a neuromuscular disorder in relation with an unstable expansion of CTG repeat. Patients with DM1 are at risk of arrhythmia and conduction disorders. Mortality are mainly related to respiratory failure and sudden death. Patients with DM1 may suffer from obesity, arterial hypertension, diabetes mellitus and sleep apnea. These comorbidities are classically associated with left ventricular diastolic dysfunction (DD) .

The investigators aim to assess the prevalence of left ventricular diastolic dysfunction in patients with myotonic dystrophy type 1 , the distribution of DD grading as well as the long-term prognosis of DM1 patients with a left ventricular diastolic dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* patients with genetic proven myotonic dystrophy type 1
* who experienced a Doppler- Echocardiography including an assessment of the left ventricular diastolic function

Exclusion Criteria:

* wall motion basal abnormalities
* significant valvular disease
Treatment Satisfaction With Ra-223 in Japan

This study aims to answer the research question: Are Japanese bone metastatic CRPC patients satisfied with their Ra-223 treatment, and what factors drive such satisfaction? It also aims to determine patient anxiety regarding prostate cancer while on treatment with Ra-223, and assess the effect on quality of life.

This is a local, Japanese, prospective, longitudinal, observational, company-sponsored, multi-center, single arm study that will describe treatment satisfaction with Ra-223 in 150 bone metastatic CRPC patients on 1st to 3rd line CRPC therapy. All outcomes will be obtained using PRO questionnaires at 4 time points: before treatment, during treatment, and at 1-month after the last treatment cycle.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥20 years old (age of maturity in Japan)
* Male, diagnosed with CRPC
* With ≥2 bone metastases and no visceral metastasis based on the most recent imaging procedure
* Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 0-1, not in end-stage palliative care
* Designated by examining physician to undergo Ra-223 treatment either in the 1st, 2nd, or 3rd line of CRPC therapy
* Has provided written, informed consent (in Japanese)
* Has ≥6 months life expectancy

Exclusion Criteria:

* Participation in an investigational program with interventions outside of routine clinical practice
* Currently receiving any chemotherapy for CRPC or any new hormone therapy (enzalutamide, abiraterone acetate) at enrolment
* Where any of the below conditions apply:

  * Started or switched to new androgen deprivation therapy (ADT) (e.g., LHRH agonists and antagonists, anti-androgens, estrogens,) within 4 weeks prior to enrolment or planning to start new treatment prior to 1st Ra-223 injection
  * Treatment with anticancer-chemotherapy within previous 4 weeks, or planned before the 1st Ra-223 injection, or failure to recover from adverse events (AEs) (CTCAE Grade \>2) due to anticancer chemotherapy administered more than 4 weeks prior
  * Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the previous 24 weeks
  * Previous hemi-body external radiotherapy
* Imminent or established spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI)
* Presence of other maligancy at enrolment
* Otherwise deemed incapable of participating by examining physician
Blood Titanium Analysis of Patients With MAGEC Spine Rods in the COVID-19 Environment

Magnetic Expansion Control (MAGEC) growth rods are used in the surgical treatment of children with scoliosis; the primary constituent metal alloy in these is titanium.

Since June 2019, the manufacturer has released two Urgent Field Safety Notices (FSN) relating to known issues with the function of the rods that increase the risk of early failure and unplanned revisions. The UK MHRA has issued two similar Medical Device Alerts (MDA) with the most recent MDA issued on 1st April 2020, stating that (1) MAGEC rods must not be implanted in the UK until further notice and (2) all patients already implanted with this device should be followed up as soon as is possible.

At the time of writing, hospitals across the world are facing incredible challenges in dealing with the COVID-19 pandemic. Due to this, virtually all planned clinic visits for MAGEC rod patients and X-ray appointments have been postponed to help reduce the risk of the virus spreading.

Recent retrieval studies have shown that mechanical wear and corrosion of these rods is common, with a risk that the debris generated is released into surrounding tissue. This wear and corrosion is thought to be the primary cause of implant failures and the underlying implant factors leading to the issuing of FSNs and MDAs.

Whilst titanium is known to be highly biocompatible, the baseline and toxic levels of this alloy in biological fluids are poorly understood. Additionally, a better understanding of blood titanium levels in patients with MAGEC rods may enable this to become a biomarker of wear and corrosion of the rods. This may help surgeons identify earlier those patients who may develop implant related problems.

Furthermore, in the current COVID-19 environment, a blood test to measure titanium levels may be one of the most suitable ways in which to continue patient monitoring (and identify those at greatest risk of implant related issues), in the absence of regular clinic visits.

Previous work from the RNOH involved a similar study investigating patients with titanium hip implants.


Eligibility Criteria:
Inclusion Criteria:

* Patients that have been treated with, and still have, a MAGEC rod.

Exclusion Criteria:

* Patients that do not have a MAGEC rod implant.
Study of Clinical and Molecular Manifestations of Genetic Disorders

This study will investigate the cause and natural history (medical problems that appear over time) of certain genetic disorders. It will also try to locate the abnormal genes responsible for these conditions and eventually develop tests to predict who is likely to be affected and to what degree.

Patients with known or suspected genetic disorders in certain categories, such as those involving chromosomal or metabolic abnormalities, immune system or blood disorders, abnormal growth, benign tumors, and others may be eligible for this study. Participants will be interviewed by specialists in genetics about their condition and family history. They may also be asked to have a physical examination and certain tests needed for study of the specific individual's condition. These may include collection of blood samples (up to 3 tablespoons); imaging studies, such as computerized tomography (CT), magnetic resonance imaging (MRI), ultrasound and echocardiography; skin biopsy (removal of a small sample of skin tissue under local anesthetic), and other procedures. DNA testing may reveal the genetic abnormality responsible for the disorder. Participants who so wish will have an opportunity to talk with experts about the health implications of the test results.

This study may provide information that will lead to improved treatment or management of these inherited disorders, as well as more effective genetic counseling for families.

Individuals and their families affected by disorders with a potentially genetic basis within six broad categories will be evaluated over time to characterize the natural and clinical history of various specific disorders. Medical and laboratory evaluations will be completed to identify areas of management concern that have not been previously described. Further protocols will be developed addressing specific disorders once a number of affected individuals have been investigated and is sufficient to query various aspects of those disorders. Issues for both diagnosis and medical management of those affected with certain genetic disorders will be collated and addressed within a national consensus conference format. In addition, phenotype to genotype correlation will be established to further understanding of specific molecular alterations on phenotypic expression. This broad-based protocol will also facilitate the training of fellows in medical genetics, graduate and post graduate training in genetics and genetic counseling.

Eligibility Criteria:
Patients and their families with known or suspected genetic disorders within the following categories will be recruited:

Hereditary connective tissue disorders;

Phacomatoses;

Chromosomal disorders;

Dysmorphic syndromes;

Neuromuscular or neurological disorders;

Inherited immunological and hematologic disorders.
Protection Response to Cellular Stress in BPAN's Patient Study

BPAN (beta-propeller associated neurodegeneration) is caused by mutations in the autophagy gene WDR45, also known as WIPI4, located on the X chromosome. Mutations in WDR45 result in neurodevelopmental impairment in girls and early-onset epileptic encephalopathy in boys, followed by neurodegeneration in adults (SENDA). This condition is a subtype of neurodegeneration with brain iron overload (NBIA). BPAN is the most recently identified subtype of NBIA and it is important to understand how mutations in WDR45, present in patients∙e∙s, cause cell death.

Autophagy is a cell survival mechanism responsible for the degradation and recycling of cell contents. It has been proposed that autophagy becomes less efficient during normal aging, which could cause neuronal death and thus lead to neurodegeneration.

Reduced autophagic activity has been observed in lymphoblastic cells of BPAN patients and in brains of KO mice for WDR45. The current hypothesis to explain the pathology associated with WDR45 mutations is that a defect in autophagy leads to neurodegeneration. However, we do not know if the autophagy defect is causal or if other deregulations of cellular responses contribute to neurodegeneration. Preliminary results from Pr. Bertrand Mollereau's team suggest that a global deregulation of cellular stress responses may be induced in patient cells. This includes in particular the endoplasmic reticulum response to stress (UPR response) as well as lipid storage mechanisms.

The investigators hypothesize that cells from patients carrying pathogenic variants of WDR45 will exhibit deregulation of cellular stress response pathways.


Eligibility Criteria:
Inclusion Criteria:

* Weight ≥ 12.5kg
* Presence of WDR45 pathogenic variant gene
* Children or adults (no upper limit for age)
* Patient under guardianship could be included if they are assisted by their guardian/adviser in compliance with article L1122-2 of the Public Health Code by virtue of the protection of vulnerable populations

Exclusion Criteria:

- According to the order of 12/04/2018 of the Public Health Code : Weight ≤ 12.5 kg for a 10mL sample or For 2 male and 2 female Lyon patients : Weight ≤ 25 kg for a 20mL sample

* No French Social Insurance Regimen
* Refusal of participation by the legal representative of the patient
Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery

To compare the safety and effectiveness of oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) in glaucoma surgery.

To compare the safety and effectiveness in between oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) for glaucoma surgery. The surgery is performed by the gold standard of trabeculectomy. Mitomycin-C(MMC) is applied for those who not collagen matrix implanted.

Eligibility Criteria:
Inclusion Criteria:

* Open angle glaucoma
* Maxima anti-glaucoma medication failed
* Age\>18
* Able to complete the follow up

Exclusion Criteria:

* Topical eye inflammation
* Angle closure glaucoma
* Deformity glaucoma
* One eye glaucoma
* Previous conjunctiva opened
* Allergy to collagen
Percutaneous Discectomy to Treat Symptomatic Lumbar Disc Herniation : Evaluation of Clinical Efficiency, Patient Reported Outcomes and Economical Impact by Assessing Time Before Return to Work and Duration of Hospitalization Stay

This study aims to evaluate the clinical (pain) and functional (patient reported outcomes) efficacy of percutaneous discectomies under CT guidance to treat lumbar disc herniations resistant to conservative treatment and nerve root infiltrations.

The aim is also to evaluate the economic impact of the procedure, mainly through the length of hospitalization and the time to return to work.

Patients were evaluated initially before surgery and then at 1, 3 and 6 months.


Eligibility Criteria:
Inclusion Criteria:

* radiculalgia related to lumbar disc herniation with clinical radiological concordance
* age \> 18
* resistance to conservative treatment and nerve root infiltrations

Exclusion Criteria:

* prior discal surgery at the same level,
* lumbar canal stenosis,
* extruded discal herniation,
* neurological deficit,
* no capacity to answer to follow-up calls
A Non-interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with moderate to severe rheumatoid arthritis. Data will be collected from each eligible participant initiated on RoActemra/Actemra treatment by their treating physician according to local label for 6 months from start of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis
* Participants initiating treatment with RoActemra/Actemra on their physician's decision (in accordance with the local label), including participants who started treatment with RoActemra/Actemra in the 8 weeks prior to the enrolment visit

Exclusion Criteria:

* RoActemra/Actemra treatment more than 8 weeks prior to the enrolment visit
* Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
* Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
* History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia

The purpose of this study is to evaluate the safety of lenalidomide and to define the maximum tolerated escalation dose level (MTEDL) when administered by a stepwise dose-escalation schedule in subjects with relapsed or refractory B-cell CLL.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of B-cell CLL that has relapsed after or is refractory to at least one prior regimen. The prior regimen(s) must have included an alkylating agent and fludarabine (used in combination or separately)
* ECOG \< or = 2
* Willing to agree to follow the pregnancy precautions.

Exclusion Criteria:

* Pregnant or nursing women
* Systemic treatment for B-cell CLL within 28 days of study start
* Central nervous system involvement
* History of renal failure requiring dialysis
* Prior treatment with lenalidomide
* Alemtuzumab therapy within 56 days of initiating lenalidomide treatment
* ANC \< 1000 / ul
* Platelet count \< 50,000 / ul
* Calculated creatinine clearance \< 60 mL/min (Cockroft-Gault method)
* AST or ALT \> 3.0 x upper limit of normal
* Serum total bilirubin \> 2.0 mg/dl
* Neuropathy \> or = Grade 2
* Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
* Richter's transformation (active)
Health and Employment After Gastro Intestinal Surgery - HEAGIS1

By using the M.A.D.I.T. methodology and the Dialogics science, SALVO Project aims to develop operational guidelines to support oncological target patients in the resumption of their daily post-operative activities. The research will implement an instrument for the purpose of measuring the health need of participants who are admitted to the surgical ward. Therefore, targeted interventions will be implemented with participants, and efficacy will be evaluated in order to define treatment guidelines.

The principal aim of this study is to create a validated and replicable intervention model for supporting patients who undergone surgery for esophagus and gastro intestinal cancer.

Several studies highlight how patients diagnosed with a digestive tract cancer, experience difficulties in returning to work after treatment, leading to socio-economic spill-over effects.

A specific 16 questions questionnaire had been developed for this study, the "Health and Employment After Gastro Intestinal Surgery Dialogical Questionnaire" (HEADS-DQ). It investigate peculiar patient competences involved after surgery: future forethought; context evaluation; consequences of own actions forethought; use of available resources, each relevant to four areas: clinical; familiar; working; daily-activities.

Through this questionnaire patient ability in dealing with after surgery consequences will be evaluated in order to define targeted support, which will be offered by professional psychologists. These interventions efficacy will be evaluated through another administration of the HEADS-DQ.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old;
* Comprehension of Italian language;
* Esophageal or gastro intestinal cancer diagnosis;
* Curative surgery for neoplasm;
* No metastasis;

Exclusion Criteria:

* \<18 years old
* Non comprehension of Italian language;
* No esophageal or gastro intestinal cancer diagnosis;
* Palliative ;
* Cancer recurrence or metastasis.