cyrilzakka/clinical-trials huggingface dataset:
GADGET-PD Genetic and Digital Diagnosis of Essential Tremor and Parkinson's Disease Trial

The proposed study will capitalize on the early predictive information stored in an individual's genetic risk for Parkinson Disease (PD) in combination with the subtle features of tremors that can be extracted from movement data gathered by modern compact accelerometers in order to determine if accurate discrimination of essential tremor (ET) from PD can be achieved. Both of these technologies have a proven but somewhat limited ability to inform diagnosis of PD or differentiation of PD from ET - especially at early stages of the disease. The investigators hypothesize that a combination of prior genetic risk and current disease symptomology can synergize for accurate and early discrimination of PD from ET and ultimately inform a cost effective approach to movement disorder diagnosis.

In this study, the investigators will collect blood from individuals with confirmed late-onset diagnosis of PD and ET. Gold standard diagnosis status will be determined via the Unified Parkinson's Disease Rating Scale (UPDRS) - the accepted clinical gold standard for Parkinson's Disease diagnosis. DNA will be extracted from blood samples to characterize the genetic risk of individuals for PD via proven genetic risk models. In addition, participants will wear a wristwatch-like accelerometer device that will track their movements (tremors) at high temporal resolution and transmit movement data via a smartphone. Cognitive distraction tasks will be administered via mobile phones while simultaneously collecting movement data. Predictive tremor features will be extracted from movement data via signal processing approaches - e.g. discrete wavelet transformation. A final predictive model combining movement tracking information and genetic information will be designed in attempt to distinguish PD from ET individuals.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's Disease as defined by the UK brain bank criteria and history of resting tremor, or:
* Essential Tremor with history of resting tremor. Diagnosis made by a movement disorder specialist.
* Midstage in disease process for Parkinson's disease with history of resting tremor

Exclusion Criteria:

* Dementia as defined by a mini-mental state examination cutoff score of 27
* Atypical Parkinsonism
* Akinesia/ rigidity Parkinson's Disease
* Movement Disorders - Stiff-Person syndrome, choreatic disease, dystonia, progressive supranuclear palsy
* Motor neuron disease - Multiple sclerosis, amyotrophic lateral sclerosis, motor neuritis, progressive bulbar palsy, progressive muscular atrophy, spinal muscular atrophy
* Significant neurological comorbidities:

  * Stroke
  * Brain cancer or brain metastases
* History of bone marrow transplant
* Cerebral palsy and spastic paraplegia
VR-PAT for Pain and Anxiety Management During Pediatric Dermatologic Laser Procedures

This study will assess the feasibility and efficacy of our Virtual Reality Pain Alleviation Therapy (VR-PAT) for pain management during pediatric and young adult outpatient laser procedures and evaluate the impact of VR use on reducing anxiety in patients undergoing dermatologic laser procedures. The investigators hypothesize that patients using VR-PAT will report less pain and anxiety during the laser procedure than patients who do not play the game.

In this two-group crossover randomized clinical trial, patients will be randomly assigned to either the VR-PAT intervention group or control group (same VR google without game) at the first laser procedure and will then cross-over to the alternative group for the second laser procedure. Survey questions to assess pain and anxiety and control for confounding factors will be asked before and after each procedure.

Eligibility Criteria:
Inclusion Criteria:

* dermatology patients (5+ years) who are undergoing first laser procedure at the Nationwide Children's Outpatient Laser
* have a legal guardian present for patients less than 18 years old for the procedure (for informed consent)
* can communicate orally

Exclusion Criteria:

* any wounds that may interfere with study procedures
* usage of a diode laser (VR safety has not been established yet)
* vision, hearing, or cognitive/motor impairments preventing valid administration of study measures
* history of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras
* minors in foster care
* unable to communicate in English
* pregnant women
* prisoners
Ventilation's Parameters Applied in Emergency Medicine. A Prospective Observational Study

To prospectively assess the mechanical ventilation management when its provided by Emergency Physicians in French Hospital, and to assess complications and outcome of these patients.

The study could be measure the proportion of patients developing an Acute Respiratory Failure Distress after a take care of by French Emergency Departments.


Eligibility Criteria:
Inclusion Criteria:

* Age equal or over 18 years old
* Needing a invasive or noninvasive mechanical ventilation
* Mechanical ventilation initiated in Prehospital or IntraHospital Emergency Department by an Emergency Physician

Exclusion Criteria:

- Age under 18 years old
Infliximab Blood Test in Crohn's Disease

Ano-perineal lesions are the first signs of Crohn's disease in 1/3 to 1/2 of cases. They are most often associated with a poor prognosis of the disease and their management is complex and difficult because of the dilapidated and recurrent nature of lesions with significant repercussions on continence and quality of life.

The treatment of these lesions is most often medical and surgical, consisting of drainage of the suppurative lesions and/or the use of biotherapy +/- combined with an immunosuppressant.

Pharmacological dosages of biotherapies show a significant correlation between the highest rates and the achievement of clinical and endoscopic remission. Therapeutic monitoring by dosing the residual levels of these biotherapies and specific antibodies, particularly in the event of loss of response in order to adapt the treatment, has become common for luminal damage. Among these biotherapies, infliximab is the first-line treatment, particularly for ano-perineal disease. Effective therapeutic levels are known for luminal damage and must be between 3 and 7 mcg/ml but these levels have not yet been determined for ano-perineal damage. There are only two recently published studies available that suggest levels probably significantly higher than those required for luminal damage ≥ 10 mcg/l

Eligibility Criteria:
Inclusion Criteria:

* All patients followed for Chron's diseases within Groupe Hospitalier Paris Saint-Joseph (GHPSJ) and treated with Infliximab for at least 6 months.

Exclusion Criteria:

* All patients with therapeutic compliance problems
Studies in Patients With Low Anterior Resection Syndrome (LARS)

Colorectal Cancer is the commonest cancer diagnosed for both genders combined in Hong Kong. In 2015 16.6% of all new cancer cases registered on the Hong Kong registry were cancer of colon and rectum. With recent development in oncological and surgical treatments for rectal cancer, many patients are receiving sphincter-preserving surgery with low colorectal or coloanal anastomosis to avoid permanent stoma.

Up to 80% of patients who has undergone low anterior resection (LAR), suffer from severe bowel dysfunction post operatively. Patients may suffer from a wide range of symptoms from incontinence, frequency, and urgency to constipation and feelings of incomplete emptying. This combination of symptoms after LAR is referred to as Low Anterior Resection Syndrome (LARS) which is associated with negative impact on quality of life (QoL). Originally, it was thought that these symptoms were due to early postoperative changes. Many studies report that the majority of patients experience longterm changes in quality of life after LAR. Therefore, a large number of patients worldwide are suffering from unpredictable, poor bowel function postoperatively affecting their day-to-day activity and quality of life. The cause of LARS is often multifactorial and difficult to define. Unfortunately, there is no cure for LARS at present. This trial is designed to use Fecobionics, a new Hong Kong based innovation of a simulated stool, to provide new mechanistic insights regarding anorectal physiological function post low anterior resection to understand the condition better to improve their treatment options.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older with history of LARS over 3 months.
* Informed, written consent by the patient

Exclusion Criteria:

* Patients who are not willing to undergo the specified tests in this study
* Pregnant women
All-Inside Single-Bundle for Anterior Cruciate Ligament Reconstruction With Full Thickness of the Peroneus Longus Tendon Compared to the Six-strand-hamstring Autograft (ACL)

Anterior cruciate ligament reconstruction is the current gold standard for restoring knee stability. Hamstring tendon (HT) autograft is the most popular graft choice for ACL reconstruction worldwide. Other autografts include bone-patellar tendon-bone and quadriceps tendon, yet no globally accepted gold standard of graft choice exists for use in ACL reconstruction.

The peroneus longus tendon (PLT) has been reported as an autograft choice for ligament reconstruction\[2\], but there is little information regarding the clinical outcomes using the peroneus longus tendon (AHPLT) compared with hamstring tendon autograft. Therefore, we are interested in investigating whether the clinical outcomes of the PLT autograft were equivalent to the Six-strand- hamstring tendon autograft.

prospective randomized clinical study to compare the results of all-inside anatomical ACL reconstruction using the AHPLT and using Six-strand- tendon autograft.

Randomization will be done with inclusion criteria of primary ACL rupture in adult patients and exclusion criteria of serious osteoarthritis, revision cases, and multiple ligament injuries.

Preoperatively, physical examinations including the anterior drawer test and the pivot shift Test were performed to judge the stability of the knee joint. All of the patients will be evaluated with an International Knee Documentation Committee (IKDC) 2000 subjective score, a Visual Analogue Scale (VAS), and an American Orthopedic Foot and Ankle Score (AOFAS).a knee joint arthrometers was also used with knee flexion of 30° at 134 N.

All of the tests will be performed three times by another experienced orthopedic surgeon who is not involved in the surgery, and the mean of the three measurements will be taken as the final value.

Eligibility Criteria:
Inclusion Criteria:

* primary ACL rupture in adult patients

Exclusion Criteria:

* serious osteoarthritis
* revision cases
* multiple ligament injuries
* ankle injuries
A Study to Provide RoActemra/Actemra (Tocilzumab) to Patients With Multicentric Castleman's Disease Who Demonstrated Benefit From Previous RoActemra/Actemra Treatment

This open-label, single center study will provide RoActemra/Actemra (tocilizumab) to a maximum of 4 patients with Multicentric Castelman's Disease who have demonstrated benefit from RoActemra/Actemra in study MRA004US (Chugai Pharma USA) without major toxicities or significant adverse events. Patients will receive their most effective maintenance dose until disease progression or significant toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Evidence of improvement of one or more clinical benefit criteria with acceptable tolerability to RoActemra/Actemra in Protocol MRA001US, maintained clinical benefit in MRA004US, and completion of MRA004US
* Life expectancy \> 12 weeks
* Zubrod performance status \</= 3

Exclusion Criteria:

* Serious toxicity including anaphylactic reactions to tocilizumab during the MRA004US trial
* Any treatment for Multicentric Castleman's Disease except for corticosteroids within 2 weeks prior to Day 1
* Active infection requiring iv antibiotics for \> 1 month and not resolving at least 1 week prior to Day 1; iv antibiotics prophylaxis for infections of implanted venous access portals is allowed
* Active viral infection within 28 days prior to Day 1
* Treatment with any investigational agent other than RoActemra/Actemra within 30 days prior to baseline
Prognosis and Risk Factors of Gastric Cancer in Patients With Intestinal Metaplasia

This prospective cohort study aims to assess the incidence of gastric cancer in patients with intestinal metaplasia in body of stomach or angular incisure.

As secondary objectives, among the patients included in the cohort, the study will:

* assess the incidence of low grade dysplasia,
* assess the incidence of high grade dysplasia in patients with low grade dysplasia,
* identify risk factors of progression to dysplasia and gastric cancer.

This is a French nationwide prospective study. 2000 patients will be enrolled by 3500 gastroenterologists, either in private or public healthcare settings.

All patients will undergo an endoscopy with gastric sampling in order to biopsy:

* 1 sample each in anterior and posterior surfaces of antrum
* 1 sample in lesser curvature
* 1 sample each in anterior and posterior surfaces of body of stomach

Patients will be contacted every 12 months and followed up for 3 years by their gastroenterologist. The follow-up will be performed according to the 2012 European Guideline on Management of Precancerous Conditions and Lesions in the stomach (Endoscopy 2012, Jan; 44(1): 74-94). Patients will also receive a 6-monthly phone call from their gastroenterologist in order to know if any gastric symptom has appeared. At any time, patients should contact their gastroenterologist to inform them about new gastric symptoms.

During follow-up, the frequency of gastroscopy with biopsy depends on the stage of lesions:

* patients with intestinal metaplasia: gastroscopy at 36 months.
* patients with dysplasia: an annual gastroscopy will be performed.

In case of low grade dysplasia confirmed by pathologist at inclusion, patients will undergo 1 year later another endoscopy with gastric sampling in order to biopsy:

* 4 circumferential samplings of antrum
* 1 sampling of curvature
* 4 circumferential samplings of body of stomach

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Gastroscopic examination with biopsy in the 6 months preceding inclusion, with intestinal metaplasia in body of stomach or angular incisure.
* Patient does not oppose to participate to the study.

Exclusion Criteria:

* Progressive concomitant disease with life expectancy less than 3 years.
* Gastric cancer at the time of inclusion.
* Patient with previous oesophageal cancer.
* Patient with previous gastric surgery.
* Anticipated obstacles to follow-up during the study (e.g., understanding difficulties, homelessness).
Pelvic Floor Muscle Training(PFMT) on Lower Urinary Tract Symptoms (LUTS) in Men With Stroke

The aim of this study is to evaluate the effect of pelvic floor muscle training (PFMT) on Lower Urinary Tract Symptoms (LUTS) in men after stroke.

120 men with LUTS or increased LUTS after stroke is included and randomized into a treatment group or a control group. The subjects in the treatment group follows a 12 week standard PFMT program, while the control group is not given specific treatment of their LUTS but like the treatment group follows the standard rehabilitation program for stroke patient. Outcome are measured by

* 5 questionnaires
* Voiding diary
* 24-hour pad test
* pelvic floor muscle assessment test


Eligibility Criteria:
Inclusion Criteria:

1. Men, diagnosed with stroke clinical defined according World Health Organisation (WHO 1989) and confirmed by CT and MRI scan
2. Onset of last stroke ≥ 1 month
3. Normal cognitive function (minimal mental examination score \> 25 ) (Folstein, Folstein et al. 1976).
4. LUTS according to ICS definition (Abrams, Cardozo et al. 2002), with start or aggravation in close relation to the stroke
5. Independent walking abilities indoor \> 100 m with/without aids
6. Independence in toilet visits
7. Age \> 18 years

Exclusion Criteria:

1. Prior history of LUTS surgery, pelvic surgery or trauma
2. More than 2 hospital diagnosed stroke
3. Other severe neurological diseases including dementia
4. Severe dysphasia
5. Severe psychiatric disease
6. Prostate cancer
7. Do not speak Danish or English
Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin

This study will be available to any participant who has received or is currently receiving belantamab mafodotin treatment through either a clinical trial, an access program, or a physician prescription. Participants do not need to be on active treatment. The purpose of this study is to gain a more complete understanding of the pathophysiology of the corneal events seen in some participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. A superficial corneal epithelial tissue specimen will be obtained by performing impression cytology (IC) or superficial keratectomy (SK) procedure in participants treated with belantamab mafodotin. The procedure will only be performed in one eye, most affected by the corneal epithelial changes. This specimen will undergo pathologic examination and composition analysis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 years or older (at the time consent is obtained).
* Capable of providing signed written informed consent, which includes compliance with the requirements and restrictions listed on the consent form.
* Participants with RRMM who have received or are currently receiving treatment with belantamab mafodotin and diagnosed with microcyst-like epithelial changes (MECs) on slit-lamp examination or confocal microscopy, with or without symptoms, in at least one eye.

  a) If participants only had superficial punctate keratopathy with no evidence of MEC's they are not eligible.
* If undergoing SK procedure, treating provider has determined there is no excessive risk to the participant.

Exclusion Criteria:

* Any serious and or/unstable medical or psychiatric disorder, or other conditions that could interfere with the participant's safety.
* Any excess risk of delayed wound healing (For example, diabetes mellitus).
* Do not meet criteria specified by the study or program through which they would receive belantamab mafodotin.
* Any participant taking concurrent medication that may affect the cornea (that is. amiodarone, some chloroquines).
* Any participant with decreased corneal sensation.
* Eye infections, including infectious keratopathy, stye, blepharitis, and conjunctivitis.
* An active uveitis including anterior, posterior, or panuveitis in either eye.
* Permanent legal blindness in the fellow (non-study) eye.
IL17 in Systemic Lupus Erythematosus Patients: Association With Disease Activity and Organ Damage

Many laboratory markers can be measured for assessment of Lupus activity as aberrant manufacturing and imbalance of the cytokines of T-helper cell which already have been implicated within autoimmunity pathogenesis as IL-18 and IL-10 levels are usually elevated in lupus sufferers and correlated with SLEDAI score IL-17 has been linked to immune-mediated organ damage in several autoimmune diseases and recently it has been linked to pathogenesis of a murine model of lupus and human lupus Diverse cytokine abnormalities which common in lupus patients may skew T cells differentiation into IL-17-producing CD4+ and double negative T cells. This could promote the autoimmune process by activation of immune cells \&stimulation of proliferation of B-cell and production of antibody


Eligibility Criteria:
Inclusion Criteria:

* SLE will be diagnosed according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE
* Age ≥ 18 years.
* Patients who are able and willing to give written informed consent

Exclusion Criteria:

-Any other autoimmune disease rather than SLE. -

* Systemic diseases
* Malignancy
* pregnancy
CETUXIMAB Given for 3 Weeks as Neoadjuvant Treatment in Locally Advanced Tongue Cancer ; A NEW PARADIGM OF TREATMENT

To compare the Disease free survival (DFS) rate of a preoperative cetuximab treatment followed by operation and postoperative radiation-cisplatin-cetuximab treatment paradigm for advanced oral cavity cancer, , with the DFS rate of historical controls (from the RTOG 9501 and EORTC 22931 studies in which treatment was with surgery followed by radiotherapy and cisplatin) with a similar stage of the disease.

This non-randomized, open-label, single center phase II study, will determine if patients with advanced oral tongue cancer that are treated with induction doses of cetuximab followed by treatment with radiation therapy concurrently with cetuximab and cisplatin (when indicated by positive margins or extra-capsular extension), will have improved PFS and improved survival and feasible toxicity, compared with patients treated in previous clinical trials (RTOG 9501 and EORTC 22931) with standard therapy: radiotherapy of 60 Gy with or without a 6-Gy boost (RTOG 9501) or 66 Gy (EORTC 22931) delivered through a conventional fractionation regimen of five once-daily sessions per week, and cisplatin in a dose of 100 mg/m2 on days 1, 22, and 43.. Twenty five patients will be recruited. Cetuximab treatment will be started (day 0) with 400 mg/m2 followed by two doses of 250 mg/m2 (once weekly on day 7 and 14). Surgery will be performed on day 31 followed by treatment with radiation therapy concurrently with cetuximab (250 mg/m2, once weekly) and cisplatin 35 mg/m2 (days 70-112; when indicated by positive margins or lymph nodes with extra-capsular extension). PET-CT and biopsies will be performed before starting with cetuximab, just before surgery and after chemo-cetuximab-RT to determine efficacy of treatment, and to compare the diagnostic properties of the PET-CT with that of the biopsies. The changes, before and after treatment with cetuximab, of protein levels in saliva, and tumor tissue and of microRNA levels in tumor tissue will be studied and correlated with PFS. The quality of life will be assessed. Data from clinical trials RTOG 9501 and EORTC 22931 will be used as historical controls.

Eligibility Criteria:
Inclusion Criteria:

Pathologically confirmed, previously untreated, resectable squamous cell carcinoma of the tongue at disease stage III or IV; Age ≥18 to ≤80; Eastern Cooperative Oncology Group (ECOG) Performance status 0-1;willingto give written informed consent for participation in this study -

Exclusion Criteria:

Any prior head and neck malignancy or other malignancy in the last 5 years but BCC; Prior head and neck radiation; Documented evidence of distant metastases; Pregnancy or lactation; Clinically significant cardiovascular disease; Known hypersensitivity to any of the components of the treatment; Legal incapacity; Clinically relevant neuropathy; Any medical or psychiatric illness which would compromise the patient's ability to tolerate this treatment, or interfere with the study objectives. -