cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Multidimensional Management of Mild Traumatic Brain Injury

Unfavorable outcomes (UO) are seen in 15 to 20% of patients with mild traumatic brain injury (mTBI). Early identification of patients at risk for UO is crucial for suitable management to be initiated, increasing their chances for a return to a normal life. The investigators previously developed a diagnostic tool enabling early identification (8 to 21 days after the injury) of patients likely to develop UO. In the present study, the investigators examined the value and beneficial effects of early multidimensional management (MM) on prognosis. The investigators used a diagnostic tool to classify 221 mTBI patients as UO (97) or FO (favorable outcome) (124). Patients whose initial risk factors point to UO are at risk of developing post-concussion syndrome (PCS). UO patients were randomized into 2 groups: a group that underwent MM (cognitive-behavioral rehabilitation) (34) and a group with no specific management (46). At 6 months, these 2 groups were compared and the impact of MM on outcome was assessed. Among patients initially classified as FO (101), 95% had FO at 6 months and only 5 had PCS as defined by DSM-IV classification. Of the UO patients who received MM, 94% had no PCS 6 months after injury, whereas 52% of the UO patients who did not receive MM had persistent PCS. The effect of MM on the recovery of patients at 6 months, once adjusted for the main confounding factors, was statistically significant (p\<0.001). These results show that the initiation of MM after early identification of at-risk mTBI patients can considerably improves their prognosis.


Eligibility Criteria:
Inclusion Criteria:

- Patients aged 18 to 65 who have suffered mTBI, have health care coverage, who understand French, who can be followed for 6 months, and who are able to understand, reply, and cooperate.

Exclusion Criteria:

* Patient intubated and/or ventilated and/or sedated upon arrival at hospital
* Patient with injury to the medulla and with neurological signs or multiple injuries (at least 1 of which is life-threatening)
* Brain injury incurred during a suicide attempt
* Patient presenting psychiatric or psychological disorders that are debilitating and/or interfere with follow-up and/or evaluation
* Psychoactive treatment ongoing at the time of injury
* History of hospitalization in specialized a psychiatric setting and/or sick leave for psychological reasons
* Patient with a neurological disorder
* Patient with substance dependence
* Subject under guardianship or wardship
Oxygen Requirements and Use in Patients With COVID-19 in LMICs

This observational cohort study will enroll patients in LMICs with suspected or confirmed COVID-19 on oxygen or deemed to require oxygen therapy based on objective criteria. Demographics and risk factor information will be collected from participants. Participants will be followed for 7 days or until outcome (hospital discharge or death). Facility level metrics on oxygen availability will also be collected at the beginning of site enrolment.

The COVID-19 pandemic has highlighted, more than ever, the acute need for scale up of oxygen therapy. WHO has provided an inventory tool to quantify facility-level provision of infrastructure to deliver oxygen therapy. However, data on the use of oxygen therapy at the patient-level remains lacking. This observational cohort study will enroll patients in LMICs with suspected or confirmed COVID-19 on oxygen or deemed to require oxygen therapy based on objective criteria. Demographics and risk factor information will be collected from participants. Participants will be followed for 7 days or until outcome (hospital discharge or death). Facility level metrics on oxygen availability will also be collected at the beginning of site enrolment.

Eligibility Criteria:
Inclusion Criteria:

1. Suspected SARS-CoV-2 infection as determined by treating clinical provider, or confirmed SARS-CoV-2 infection confirmed virologically in the lab by RT-PCR via nasopharyngeal or oropharyngeal sample or by SARS-CoV-2 Ag-RDTs that meet the minimum performance requirements of ≥80% sensitivity and ≥97% specificity compared to a NAAT reference assay.
2. Receiving supplemental oxygen or showing clinical evidence of need for supplemental respiratory support as reflected in a respiratory rate ≥30 breaths per minute or an SpO2 ≤ 90%, SpO2 \< 94 % if any emergency signs are present
3. Admitted to health care facility

Exclusion Criteria:

1. Is not receiving oxygen or does not have clinical criteria for oxygen treatment specified above oxygen therapy
2. Does not have suspected or confirmed COVID-19 (as per criteria above)
3. Patient younger than 12 years of age
4. Lack of commitment to full supportive care
Addressing Psychosocial Comorbidities in HIV Treatment and Prevention

Project AProaCH is an open pilot trial of a cognitive behavioral therapy (CBT) for individuals with HIV with various psychological comorbidities, which the investigators call "syndemics". Syndemics are co-occurring psychosocial problems that interact with each other and with health behavior such as HIV sexual transmission risk behavior and adherence to self care.


Eligibility Criteria:
Inclusion Criteria:

* HIV+ individuals
* Uncontrolled virus (plasma HIV RNA concentrations that reach detectable limits) or being diagnosed with a sexually transmitted infection (STI) (gonorrhea, chlamydia, syphilis, trichomoniasis (female only)) currently or within the past 3 months.

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Active untreated, unstable, major mental illness (i.e., untreated psychosis or mania) that would interfere with study participation
* Opinion of the PI that the participant would be at risk for harm to himself or others as a result of study participation,
* Under the age of 18 or over the age of 65,
* Current CBT for a psychiatric disorder, or a course of CBT in the past year.
Long-Term Follow-up of Subjects Who Were Treated with ST-920

Long-term follow-up of subjects who received ST-920 in a previous trial (ST-920-201) and completed at least 52 weeks post-infusion follow-up in their primary protocol. Enrolled subjects will be followed for a total of up to 5 years following ST-920 infusion.

Non-interventional, multi-center, long-term follow-up (LTFU) study of subjects dosed with ST-920 in the clinical study ST-920-201. All subjects dosed in the study who completed at least 52 weeks post-infusion follow-up in their primary protocol will be offered to participate. Subjects who enroll will be monitored for a total of up to 5 years following ST-920 infusion.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who received ST-920 therapy in a separate parent trial
* Subjects who have consented to participate in this LTFU study.

Exclusion Criteria:

-This study has no exclusion criteria
Study Of Angiomax In Infants Under Six Months With Thrombosis

The goals of this study are:

1. To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis;
2. To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis;
3. To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).

The goals of this study are:

1. To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis;
2. To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis;
3. To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).

Eligibility Criteria:
Inclusion Criteria:

* Parent/legal-guardian has provided written informed consent before initiation of any study related procedures.
* Objectively confirmed thrombotic event by either doppler ultrasound, echocardiogram, CT scan, MRI, MR angiogram, MR venogram, venogram or arteriogram.
* Age less than 6 months .
* Gestational age greater than 35 weeks
* Expected life expectancy at least 14 days.
* No contraindication to anticoagulation i.e. bleeding complications.

Exclusion Criteria:

* Active or recent (less than 7 days) bleeding.
* Known allergy to Angiomax or hirudin, or known sensitivity to any component of the product.
* Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment.
* Refusal to undergo blood transfusion should it become necessary.
* Any other disease or condition, which, in the judgment of the Investigator would place a patient at undue risk by being enrolled in the trial.
* Baseline prolonged PT (\>18 secs) or aPTT (\>55 secs)
* Platelet count \< 50,000 cells/mm3
* Birth Trauma
* Planned or indicated surgery within 30 days
* Major or minor bleeding event
Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT

The main objective of RIGHT-CRT is to assess the impact/efficacy of CRT on functional capacity in ACHD patients with SRV.

This study will be the first to bring evidence on CRT efficacy in ACHD patients with heart failure and SRV. If results are positives, CRT may improve functional capacities and quality of life of patients and will become an option of choice in this population. If results are negatives, futile CRT implantation may be avoided in this population in particular considering potential adverse effects and CRT-related complications.

Double blind randomized cross-over trial. 40 patients will be enroled. Their follow-up will be 6 months.

Eligibility Criteria:
Inclusion Criteria:

* systemic right ventricle (SRV),
* CRT-P or CRT-D device implanted for at least 1 month,
* Age ≥18 years old,
* One of the two following CRT indications:

  * NYHA II-IV, right ventricular ejection fraction ≤ 35% and spontaneous QRS duration ≥ 150 ms Or
  * NYHAI-IV, atrioventricular conduction disorders with ventricular pacing \> 40% (regardless right ventricular ejection fraction).
* Affiliation to a french social security system (beneficiary or legal)
* Informed and signed consent

Exclusion Criteria:

* Pregnancy or breastfeeding
* Women of childbearing potential who do not have a negative pregnancy test and do not use one of the following methods of birth control: hormonal contraception or intrauterine device or bilateral tubal occlusion
* Patient benefiting from a measure of legal protection (guardianship, curatorship, under judicial safeguard, activated future protection mandate and family authorization),
* Cardiac surgery during the last 3 months or planned during the next 6 months,
* Percutaneous structural cardiac intervention planned during the next 6 months,
* Persistent atrial arrhythmia with catheter ablation planned during the next 6 months,
* Acute congestive heart failure,
* Dysfunction of at least one CRT device lead that compromise biventricular pacing,
* Patient on AME
* Current participation in another interventional clinical study or being in the exclusion period at the end of a previous study.
Study of Ampion for the Treatment of Adult COVID-19 Patients Requiring Oxygen Supplementation

This is a Phase 1 randomized study to evaluate the safety, tolerability and efficacy of IV Ampion in improving the clinical course and outcomes of patients hospitalized with COVID-19 infection who require supplemental oxygen.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 years to 89 years old (inclusive).
2. Hospitalized and diagnosed with COVID-19, as evaluated by PCR test confirming infection with SARS-COV-2.
3. Patient is receiving supplemental oxygen (e.g. oxygen saturation (SpO2) \<88%, labored breathing, increased respiratory rate, dyspnea on rest or exertion).
4. A signed informed consent form from the patient or the patient's legal representative must be available.

Exclusion Criteria:

1. In the opinion of the clinical team, progression to death is imminent and inevitable, irrespective of the provision of treatments.
2. Patient has severe chronic obstructive pulmonary disease (COPD), chronic renal failure, or significant liver abnormality (e.g. cirrhosis, transplant, etc.).
3. Patient is on chronic immunosuppressive medication.
4. As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study.
5. A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate).
6. Patient has known pregnancy or is currently breastfeeding.
7. Participation in another clinical trial.
8. Baseline QT prolongation.
Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer

The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®) added to two concurrent chemoradiotherapy platforms of different intensity in locally advanced head and neck cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Stage III and IV head and neck cancer
* Patients with squamous cell carcinoma of unknown primary and suspected origin in the head and neck area
* No prior chemotherapy or radiotherapy
* Prior surgical therapy of incisional or excisional biopsy and organ-sparing procedures only
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
* Normal organ and marrow function

Exclusion Criteria:

* Unequivocal demonstration of metastatic disease
* Known severe hypersensitivity to drugs used in the study
* Treatment with a non-approved or investigational drug within 30 days before Day 1
* Incomplete healing from previous surgery
* Pregnancy or breast feeding
* Uncontrolled intercurrent illness including
* Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF
* Acute hepatitis or known HIV
* Severe baseline neurologic deficits
* Prior therapy which specifically and directly targets the EGFR pathway
* Prior severe infusion reaction to a monoclonal antibody
The Effect of a Telerehabilitaion Program on Gait and Balance in Patients After Hip Surgery

The purpose of the present study is to examine whether an intervention plan based on exercise through remote rehabilitation system leads to improvement in characteristics of walking and balance among patients after hip replacement surgery compared to the current conventional way of exercise among these patients.

Osteoarthritis is the main and most common reason for replacing hip joint and in forecast for 2020s this will be the fourth reason that causes disabilities throughout the world. Osteoarthritis causes not only physical limitation but also damage to the quality of life. Pain and functional limitation appear among about 10% of men and 18% of women over the age of 60. Pain and limitation in range of movement, functional decrease in daily functioning such as walking distance and endurance, difficulty in climbing up and down stairs are typical signs among those patients before surgery and treatment.

Other physical defects following hip replacement surgery last for over a year and they include a decrease in muscle strength round the operated hip, a defect in keeping balance in the operated leg and a functional decrease that includes decrease in walking speed, damage in the ability of climbing up and down stairs and difficulty in standing up.

Physical rehabilitation has importance among patients after hip joint surgery. Rehabilitation begins on the first stage at the rehabilitation hospital and continues after discharge at the community, at home or at the clinic. Often, the need for a continuing rehabilitation treatment after discharge exceeds the treatment provided actually by healthcare in Israel because of various reasons e.g. residence in remote areas, loads of patients who need treatment and high costs of manpower and reaching the treatments.

Remote Therapy is an alternative means to the present therapy in clinics which is provided at the patient's home and thus solving these problems. Remote Therapy employs technological communication and thus enables the patient to continue the rehabilitation process independently with no need for reaching the clinic which makes it easier for the patient and saves economic costs for the financial agent.

The purpose of the present study is to examine whether an intervention plan based on exercise through remote rehabilitation system leads to improvement in characteristics of walking and balance among patients after hip replacement surgery compared to the current conventional way of exercise among these patients

Eligibility Criteria:
Inclusion Criteria:

* One to three months after hip surgery
* Age 50-85

Exclusion Criteria:

* Individuals with central neurological disability
* Dependent individuals in passing from bed to wheelchair
* Significant cognitive disability according to the attendant physician
* Individuals with vascular-based pathologies
Coping With Glioblastoma: A Study of Communication Between Physicians, Patients, and Caregivers

The purpose of this study is to learn more about the way physicians communicate with brain tumor patients. This study will look at how oncologists provide information about brain tumors, brain scan results, and treatment options. This study will look at how oncologists provide information about brain tumors, brain scan results, and treatment options. Ultimately, the investigators hope to use these findings to improve communication between patients, caregivers and their doctors.


Eligibility Criteria:
Inclusion Criteria:

Patient Inclusion Criteria:

* 18 years or older
* Pathologic diagnosis of WHO grade IV glioma, as per MSKCC medical record or outside medical record.
* In the judgment of the consenting professional, proficiency in English that will allow the participant to be able to complete study questionnaires and assessments. Many of the study assessments are available only in English.
* At the time of consent, orientation to self, place, month and year

Caregiver Inclusion Criteria:

* 18 years or older
* Identified by the patient as a relative, friend, or partner with whom he or she has a significant relationship and who provides him or her informal (unpaid) care (i.e., physical or emotional assistance).
* In the judgment of the consenting professional, proficiency in English that will allow to complete study questionnaires and assessments. Many of the study assessments are available only in English.

Oncologist Inclusion Criteria:

* Treating Neuro-Oncologist in the Department of Neurology

Exclusion Criteria:

Patient Exclusion Criteria:

* A patient will be excluded if in the opinion of his/her attending neuro-oncologist or the covering neuro-oncologist, he does not have the capacity to consent to the study based on clinical evaluation
* Aphasia precluding comprehension and verbalization of consent to participate, in the estimation of the attending physician.

Caregiver Exclusion Criteria:

* There are no caregiver exclusion criteria.
Effectiveness of Pain Relief Between Adductor Canal Block and Femoral Nerve Block in Total Knee Arthroplasty

This study aims to compare the effectiveness of adductor canal block and femoral nerve block in total knee arthroplasty in general anesthesia. Two block techniques were proved safe and effective in pain control after total knee arthroplasty. But some authors insist that quadriceps muscle power was decreased by femoral nerve block. The study design is a double-blind randomized controlled trial. Fifty patients planed to undergo simultaneously bilateral total knee arthroplasty are randomised to receive ultrasound-guided femoral nerve block on one leg and adductor canal block on the other, in addition to combined general anaesthesia. The primary outcome was comparative postoperative pain in either extremity at four, eight, 12, 24, 72 hours and 7days postoperatively. Secondary comparative outcomes included motor strength by cybex test.

Total knee arthroplasty(TKA) is very popular in nowadays. But almost patients complained of postoperative pain and it affect the delay of early mobilization which prevent knee stiffness, lessens hospital stay and improves overall patient satisfaction and outcome of TKA. Intravenous patient-controlled analgesia (PCA) or epidural analgesia is a conventional postoperative analgesia. Recently other block techniques like a adductor canal block and femoral nerve block were known for good methods of pain relief after TKA. However, femoral nerve block reduces quadriceps muscle strength thereby potentially compromising postoperative mobilization. Therefore, it is necessary to evaluate the effectiveness of pain treatment and the preservation of muscle function after the procedure of adductor canal block and femoral nerve block.

The present study aimed to determine and compare the efficacy of adductor canal block and femoral nerve block combined with general anesthesia on (1) postoperative pain control, (2) early patient ambulation and functional recovery and (3) change of muscle power after total knee arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Patients for total knee arthroplasty having medicare insurance

Exclusion Criteria:

* Alcohol, drug abuser Narcotics addiction