cyrilzakka/clinical-trials huggingface dataset:
Prediction of Post-stroke Motor Recovery

The prediction of motor recovery in the acute phase of stroke is crucial for several clinical reasons: (i) informing the patient and his relatives, (ii) helping to identify the patient's endorsement (return home or rehabilitation) as well as the adaptation of the rehabilitation program to what can be expected from it. To date, an algorithm (decision tree) proposed by C. Stinear's team named PREP2 is the best predictive tool with 75% of patients well classified at 3 months. It predicts the functional recovery of the upper limb after stroke 3 months before the episode by categorizing recovery as "excellent", "good", "limited" as well as "minor" (poor). With two data (SAFE score, age) or three (SAFE score, Motor evoked potential, NIHSS), the prediction is effective three times out of 4. In the study the team is proposing "PREP-UCV", it would like to validate this algorithm as it is with patients in the active file who are victims of stroke. The expected accuracy is 75% or more. As a secondary objective, the team would like to confirm that it find the same algorithm starting from the initial data from PREP 2 (side of the stroke, type of stroke (ischemic and / or hemorrhagic), involvement of the corticospinal tract on MRI, sex at birth ) as well as two other factors which are also very important: cognitive status (dysexecutive / aphasia / neglect), as well as the neutrophils on lymphocytes ratio.

Retrospective cohort of stroke patients with a upper limb deficit.Clinical scores such as SAFE score, NIHSS; demographic data such as age and electrophysiological data (such as the absence/presence of Motor evoked potential) will determine the predictive functional outcome of the upper limb deficit according to the PREP2 algorithm. The accuracy of this prediction will be verified according to the actual state of the patient at 3-6 months. Second, another algorithm will be built taking in account cognitive deficits and biological data to determine if the accuracy is higher. All data will be acquired during the clinical routine work-up.

Eligibility Criteria:
Inclusion criteria:

* age ≥ 18 y-o,
* admitted in the Pitié-Salpêtrière stroke unit,
* stroke with a upper limb motor deficit,
* agree to participate;

Exclusion criteria:

* contra-indication to MRI or TMS,
* patients under legal guardianship ,
* patients without healthcare insurance
Integrated Treatment Program for Osteoarthritis of the Knee

The purpose of this study is to determine the ability to assimilate and implement an integrated treatment program osteoarthritis of the knee, including the diagnosis and follow-up by a family physician in primary care clinics, combined with patient self-care training and physiotherapy program


Eligibility Criteria:
Inclusion Criteria:

* Active complaint of knee pain
* Diagnosis of knee osteoarthritis according to X-ray
* Morning stiffness of less than 30 minutes AND/OR crepitus in active movement
* Ability to read Hebrew

Exclusion Criteria:

* Previous participation in physiotherapy treatment program
* Gout in knee, rheumatoid arthritis, fibromyalgia
* Complaints that appear in a knee which was operated in the past
* Dementia
* Severe limitations in mobility
Effectiveness and Safety of Once or Twice Daily Mometasone Nasal Spray Versus Amoxicillin Versus Placebo for Treatment of Acute Rhinosinusitis (Study P02683)

This study was conducted to compare the effectiveness and safety of mometasone nasal spray once daily or twice daily with amoxicillin or with placebo in treating the signs and symptoms of acute rhinosinusitis. Patients received mometasone nasal spray 2 sprays per nostril once daily, 2 sprays per nostril twice daily, amoxicillin 500 mg three times a day, or placebo three times a day. Patients on nasal spray were treated for 15 days and patients on amoxicillin or placebo were treated for 10 days. All patients were followed-up with a 14-day no-treatment observation period.


Eligibility Criteria:
Inclusion Criteria:

Subjects must:

* have been diagnosed with acute rhinosinusitis
* have had signs and symptoms of rhinosinusitis for at least 7 but not more than 28 days prior to Baseline
* have had a major symptom score \>=5 and \<=12 at the Screening and Baseline, and no more than 3 of the 5 major individual symptoms were to be rated as "severe"
* be \>=12 years old
* be in good health overall and normal laboratory tests
* not be pregnant, intending to become pregnant or intending to impregnate.

Exclusion Criteria:

Subjects who:

* have a history of chronic rhinosinusitis or who had undergone sinus or nasal surgery for chronic rhinosinusitis in the 6 months prior to Screening
* have fever \>=101°F and/or persistent severe unilateral facial pain/tooth pain; and/or orbital or peri-orbital facial swelling; and/or dental involvement; and/or worsening symptoms after initial improvement
* have a history of symptomatic seasonal allergic rhinitis who were exposed to allergenic pollens
* have asthma with FEV1\<65% of predicted volume in the past 3 months or who have had an exacerbation within the past 30 days
* have nasal polyps, Kartagener's syndrome, and otitis or atrophic rhinitis
* have certain comorbid conditions or contraindications to certain drug therapies
Injection Technique in Subacromial Impingement Syndrome

Since pain is usually accompanied by a substantial effect on daily life that results in the extensive use of healthcare resources. In subacromial impingement syndrome, shoulder pain affects the quality of life negatively by affecting upper extremity functions and interrupting night sleep. It is very important to control the pain in order to reduce the loss to the labor force and prevent the pain from becoming chronic. Various physical treatment methods such as ultrasound, hot pack, transcutaneous electrical nerve stimulation, etc., and injections or medical agents are recommended. This study aimed to compare the effects of ultrasound (US)-guided in comparison to landmark guided subacromial corticosteroids injection on shoulder range of motion (ROM), pain, and functional status in patients with subacromial impingement syndrome (SAIS).

Patients were assigned to two groups: Group-1 included patients who received US-guided subacromial corticosteroid injections; Group-2 included patients who underwent blind subacromial corticosteroid injections. The primary Outcome Measure was a Visual analog scale. Secondary Outcome Measures were Shoulder joint range of motion (ROM), Shoulder Pain and Disability Index (SPADI), The Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (Quick DASH).

Eligibility Criteria:
Inclusion Criteria:

1. Shoulder posterolateral pain that increased with shoulder abduction,
2. Restriction of the shoulder passive and active range of motion (ROM),
3. Patients with positive Neer and Hawkins impingement test,
4. Patients with SAIS whose diagnosis was confirmed by magnetic resonance imaging (MRI), and
5. Patients with SAIS whose application of corticosteroid in their injections were the same in terms of type and dose (1 ml betamethasone dipropionate + betamethasone sodium phosphate).

Exclusion Criteria:

* Patients who received corticosteroid, local anesthetic, hyaluronic acid, and platelet-rich plasma injections in the shoulder in the last one year,
* patients who had previous history of surgery or fracture in their thorax, neck, upper extremity or shoulder joint,
* patients with a rheumatological, cognitive or psychiatric, central or peripheral neurological disease (stroke, spinal cord injury, brachial plexus injury, etc.),
* patients whose MRI presented a partial or complete rotator cuff tear, calcific tendinitis or labral tear.
Strategies for Recovery of Dexterity Post Stroke

Motor learning can be affected by the sensory difficulties that may be experienced as a result of a stroke. This study will help us better understand what kinds of sensory information can help with the re-learning of grasping with the affected hand despite the sensory difficulties produced by the stroke.

The purpose of this study is to develop, refine and test the 'alternate hand training strategy' to facilitate adaptation, repetition and relearning to restore hand function after stroke. The three aims are: to restore adaptation (Aim 1), facilitate grasp efficiency and normal directional biases during repetition (Aim 2), and enhance the rate of learning to improve hand function and quality of life post stroke (Aim 3).

Hypotheses: We hypothesize that alternate hand training will increase the rate of learning and lead to greater improvement in hand function. The results will inform dosing of therapy for optimal relearning.

Eligibility Criteria:
Inclusion Criteria:

* Ability to read/write in English
* Age \> 18 yrs
* Radiologically verified stroke \> 4 months old (3T structural MRI)
* Moderate arm motor impairment (Fugl-Meyer Scale \< 60/66)
* Ability to reach, grasp and lift the test objects with the affected side as assessed by the PI
* Willingness to complete all clinical assessments and MRI, and comply with training protocols
* Ability to give informed consent and HIPPA certificationsPlease list all exclusion criteria for study:

Exclusion Criteria:

* Sensorimotor impairments in the unaffected hand
* Severe visual or sensory impairment, including neglect on the affected side
* Significant cognitive dysfunction (score \< 24 on Folstein's Mini Mental Status Examination)
* Severe or unstable spasticity on treatment with Botulinum toxin or intrathecal baclofen
* Depression (Geriatric Depression Scale score \<11)
* Major disability (modified Rankin Scale \> 4)
* Previous neurological illness, complicated medical condition, or significant injury to either upper extremity
The Effectiveness of Locomotor Therapy Using Robot-Driven Gait Orthosis System in Multiple Sclerosis Patients

Objective: To evaluate the efficacy of robot-assisted gait training (RAGT) in MS patients with severe walking disabilities (Expanded Disability Status Scale \[EDSS\] 5.5-7) as compared to regular physiotherapy.

Methods: Prospective, randomized, controlled clinical trial comparing RAGT with conventional walking training (CWT) in a group of stable MS patients (n=40) during an outpatient rehabilitation program. Inclusion criteria are chronic or secondary progressive MS patients with EDSS between 5.5-7, stable treatment 3 months before study entry, without generalized diseases. All patients will sign an informed consent. Following randomization, 20 patients will be treated with RAGT, 12 sessions over three weeks. The control group will be treated by CWT, 12 sessions in three weeks. The primary outcome measures will be the Functional Ambulatory Capacity (FAC) scale and the 6-minutes walking distance. The secondary outcome measures will be the Time up \& Go (TUG) test, 10 Meter Walking test, Berg balance test, EDSS score, FIM score and RAND questioner for quality of life. All tests will be performed by an external blinded assessor at baseline, after three weeks, and at follow-up after 3 months and six months.

Importance: We anticipated that Robot-assisted gait training will be found as feasible and may be an effective therapeutic option in MS patients with severe walking disabilities.


Eligibility Criteria:
Inclusion Criteria:

1. chronic or secondary progressive MS patients with EDSS between 5.5-7,
2. stable treatment 3 months before study entry.

Exclusion Criteria:

1. Other generalized diseases.
2. Pregnancy.
PET/CT Evaluation of Treatment Response in Breast Cancer

The purpose of this study is to develop Positron Emission Tomography (PET) - Computed Tomography (CT) PET/CT imaging methods for looking at the effects of chemotherapy in breast cancer.


Eligibility Criteria:
Inclusion Criteria

* Subjects must have histologically proven breast cancer
* Subjects are being considered for preoperative chemotherapy
* Subjects must be ≥ 18 years old. Sensor Sub-Study Only
* Palpable subcutaneous or known disease with one surface \<1cm below surface of skin.
* A subset of patients who have a mass located on any surface of the breast that is accessible for Lucerno sensor placement will have additional testing.

Exclusion Criteria

* Children will be excluded from this study.
* Pregnant women and women who are breast feeding will be excluded from this study. (The Vanderbilt University Medical Center radiology "PET Procedure Screening Form" will be used to identify and exclude subjects who are pregnant or breastfeeding. A urine pregnancy test/or serum beta HCG will also be performed for women of child bearing potential).
* Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study.
* Intraluminal lesions will be excluded from the sensor sub-study.
* Non biopsy proven malignancy will be excluded from this study.
* Palpable subcutaneous or known disease with one surface \>1cm below surface of skin will be excluded from the sensor sub-study.
* Draining or exposed malignant tumor will be excluded from the sensor sub-study.
Psychosocial and Economic Impacts of Narrative Exposure Therapy for Violence Survivors in Eastern DRC

The objective of the study is to evaluate the impact of Narrative Exposure Therapy (NET) delivered by local counselors, on the mental health and socio-economic empowerment of survivors of Sexual and Gender Based Violence (SGBV) who suffer Post-Traumatic Stress Disorder (PTSD), in North and South Kivu in Eastern DRC. The counselors will be trained and supervised by clinical experts from the NGO Vivo International. The therapy is expected to reduce the symptoms of PTSD, depression, and anxiety in SGBV survivors. The project is expected to directly impact and improve the beneficiaries' mental health outcomes of interest, and to indirectly impact and enhance their economic empowerment in the medium term and social functioning both in the short and medium term. This proposed impact evaluation will answer the following research questions: 1) What is the impact of NET on survivors' psychosocial wellbeing, economic empowerment and social functioning and participation? 2) Does the impact of NET differ depending on individual and household characteristics as well as context-specific factors?


Eligibility Criteria:
Inclusion Criteria:

* GBV survivors who are screened for commonly found conditions of mental distress

Exclusion Criteria:

* More severe cases of mental disorders are ineligible. They are referred to the General Referral Hospitals or specialized mental health clinics to receive immediate treatment.
Real-world of AI in Diagnosing Retinal Diseases

The objective of this study is to apply an artificial intelligence algorithm to diagnose multi-retinal diseases in real-world settings. The effectiveness and accuracy of this algorithm are evaluated by sensitivity, specificity, positive predictive value, negative predictive value, and area under curve.

The objective of this study is to apply an artificial intelligence algorithm to diagnose referral diabetes retinopathy, referral age-related macular degeneration, referral possible glaucoma, pathological myopia, retinal vein occlusion, macular hole, macular epiretinal membrane, hypertensive retinopathy, myelinated fibers, retinitis pigmentosa and other retinal lesions from fundus photography. tic 45-degree fundus cameras, trained operators took binocular fundus photography on participants. Operators were then asked to identify gradable images and unload for algorithm diagnosis. The effectiveness and accuracy of this algorithm are evaluated by sensitivity, specificity, positive predictive value, negative predictive value, area under curve, and F1 score.

Eligibility Criteria:
Inclusion Criteria:

* fundus photography around 45° field which covers optic disc and macula
* complete identification information

Exclusion Criteria:

* insufficient information for diagnosis
Safety and Efficacy of ESWL for Geriatric Patients With Chronic Pancreatitis

Pancreatic extracorporeal shock wave lithotripsy (P-ESWL) is recommended as the first-line treatment for pancreatic stones. However, how well P-ESWL performs in geriatric patients remains unclear. The investigators aimed to evaluate the safety and efficacy of P-ESWL for geriatric patients with chronic pancreatitis.

This prospective observational study was conducted in patients with painful chronic pancreatitis who underwent P-ESWL. Patients aged over 65 years were included in the geriatric group; patients aged under 65 years who underwent P-ESWL in the same period were assigned to the control group. For investigation of long-term follow-up, the geriatric group were matched with patients from the control group in a 1:1 ratio. The primary outcomes were P-ESWL complications and pain relief. The secondary outcomes included: stone clearance, physical and mental health, quality of life score, and body weight.

Eligibility Criteria:
Inclusion Criteria:

* Patients with painful chronic pancreatitis and radiopaque stones of ≥5mm.

Exclusion Criteria:

* Patients with a suspected or established malignant mass or pancreatic ascites, and pregnant patients.
COVID-19 Impact on the Lombardy Region's Emergency System

This study has 3 main goals:

* to quantitavely describe the Covid-19 impact on the organization and functioning of the Lombardy's emergency system;
* to create statistical model able to predict the flow of patients to the emergency room during the epidemic period and their destination (ex: discharge, hospitalization, death);
* to value the impact on the non Covid-19 patients, both for their possibility to receive medical treatment and as an outcome on their health

The aim of this study is to evaluate the impact that Covid-19 had on the Emergency System of Lombardy. For instance, it affected the job organization and the possibility of responding to general health needs.

First of all, the study will consider the calls to the Emergency Medical Service, the number of accesses to the Emergency Department, the waiting time before hospitalization, the ED output home (discharge, hospitalization, death, self-discharge before the end of the visit).

Secondly, a statistical model will be implemented, in order to predict the number of patients in need of hospitalization for each day during the pandemic period. This model could help the re-organization of the hospital itself in case of a new Covid-19 outbreak.

Finally, it will evaluate the impact on non-Covid patients, to see the difference in the mortality trends and their possiblity to be cured in a proper way.

Eligibility Criteria:
Inclusion Criteria:

* over 18y

Exclusion Criteria:

* none
HFNC Alone or Associated With NIV for Immunocompromised Patients Admitted to ICU for Acute Respiratory Failure

Acute respiratory failure is the leading cause of ICU admission of immunocompromized patients. In this subgroup of patients, the need for intubation and invasive mechanical ventilation occurs in about 50% of cases and is associated with very a high mortality rate, reaching 70% of cases. Therefore, noninvasive oxygenation strategies have been developed to avoid intubation.

More than 15 years ago, 2 trials have suggested that NIV could decrease intubation and mortality rates of immunocompromized patients as compared to standard oxygen through a mask. However these results have not been confirmed in a recent large trial.

HFNC is a recent and well-tolerated oxygenation technique. In a recent trial, HFNC alone could decrease mortality and intubation rates in patients with ARF as compared to NIV. Similar findings have been reported in a post-hoc analysis on immunocompromized patients excluding those with profound neutropenia. Likewise in a retrospective monocentric cohort of immunocompromized patients, we reported better outcomes with HFNC than with NIV.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Admission to ICU for acute respiratory failure defined by all of the following criteria:

  * Dyspnea at rest with RR ≥ 25 breaths/min
  * PaCO2 ≤ 50 mm Hg
  * PaO2/FiO2 ≤ 300 mm Hg under oxygen ≥ 10 l/min through a mask or HFNC or NIV (for patients under oxygen FiO2 will be calculated using the following formula: oxygen flow in liters per minute x 3 + 21)
* Immunosuppresion defined by 1 of the following criteria:

  * Hematological malignancy (active or remitting \< 5 years)
  * Allogenic stem cell transplantation \< 5 years
  * Solid cancer (active)
  * Leucopenia \< 1 G/l or neutropenia ≤ 0.5 G/l after chemotherapy
  * Solid organ transplantation
  * AIDS (not only HIV)
  * Treatment with immunosuppressive or immunomodulatory drugs
  * Systemic steroids ≥ 0.5 mg/kg/d of prednisone-equivalent for ≥ 3 weeks
* Non opposition to participate obtained from the patient or their legally acceptable representative.

Exclusion Criteria:

* Contraindication of NIV (patient refusal, cardiac arrest, coma, not drained pneumothorax, unresolving vomiting, upper airways obstruction, hematemesis, severe facial trauma)
* Chronic respiratory failure with altered pulmonary function tests
* Overt cardiogenic pulmonary edema
* Urgent need for intubation
* Severe shock (vasopressors \> 0.3 µg/kg/min to maintain SAP \> 90 mm Hg)
* Impaired consciousness (Glasgow coma scale score ≤ 12) or agitation
* Surgery under general anesthesia \< 7 days
* Previously included in the trial
* Do-not-intubate order
* Pregnancy or breastfeeding
* Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection
Ibrutinib and Rituxan for Chronic GVHD

This is a phase II trial evaluating the safety and efficacy of the combination of Ibrutinib and Rituximab as primary treatment of chronic GVHD. We plan to enroll 35 patients on this study. Patients will be formally monitored monthly for 12 months to evaluate for outcome and safety endpoints. All other assessments will be done at the physician's discretion or institutional standards. All patients, responders and treatment failures, will be followed for a period of one year from the time of initiation of therapy. The primary endpoint will be the proportion of patients that are alive and off all systemic IST at 12 months following initiation of treatment.


Eligibility Criteria:
Inclusion Criteria:

* First episode of systemic immunosuppression-requiring cGVHD, defined as classic or overlap cGVHD by the NIH consensus criteria.
* Previously untreated cGVHD, defined by having received \<10 days of corticosteroids or alternative systemic immunosuppressive agent started specifically for a new diagnosis of cGVHD.
* KPS 70% or greater

Exclusion Criteria:

* Late persistent or recurrent acute GVHD
* Active uncontrolled infection
* History of HIV infection; active HBV or HCV infection
* Inability to tolerate oral medications
* Progressive or recurrent malignancy following allogeneic transplant
* Exposure to BTK inhibitor following transplant
* Received prior treatment with ECP for cGVHD