cyrilzakka/clinical-trials huggingface dataset:
Microsurgical Resection of Intramedullary Spinal Cord Metastases

The aim of the study is to establish a multi-center, retrospective database for patients with intramedullary spinal cord metastases (ISCM) and analyse the functional outcome in surgically treated ISCM patients.

The hypothesis is that the surgical treatment of selected ISCM patients does not lead to persistent morbidity and does not increase mortality, compared to patients that are treated non-operatively.

Secondary objectives are to assess pre- to postoperative neurological deficits, ambulatory status, and overall survival of surgically treated ISCM patients.

The investigators intend to include a control cohort of patients with ISCM from participating centers, who underwent non-surgical oncological treatment (radiotherapy with or without chemotherapy). This control cohort of patients will be used to match patients with and without surgical treatment.

Primary endpoint (analysed in surgically treated ISCM patients):

Functional outcome at 90 days after treatment initiation, measured by the modified McCormick Scale. This is a score for grading of neurological function in spinal cord conditions.

The McCormick scale ranges from Grade I (neurologically intact) to grade V (paraplegic or quadriplegic). The McCormick scale is suitable for our retrospective study because of its good reproducibility and comparability.

Secondary endpoints (analysed in surgically treated ISCM patients and analysed in matched patients with and without surgical treatment):

* Functional outcome by the McCormick scale and the modified Japanese Orthopaedic Association scale (mJOA) at 6 and 12 months. This is a score evaluating motor function of upper and lower extremities, sensory function of upper extremities and sphincter function / voidance. The mJOA ranges from 0 - 18 points, with higher score values representing better functional outcome. The minimum clinically important difference of the mJOA is 1-2 points, and scores lower than 14 indicate moderate myelopathy, scores lower than 11 indicate severe myelopathy.
* Ambulatory status and continence at 90 days, 6 \& 12 months (determined by mJOA subscores)
* Neurological outcome, measured by American Spinal Cord Injury Association (ASIA)
* Impairment Scale at 90 days, 6 and 12 months
* Rate \& type of complications at 90 days after treatment according to The Novel Therapy
* Disability-Neurology Grade (TDN grade)16
* Overall survival (in days)


Eligibility Criteria:
Inclusion Criteria:

* Adult patients admitted to one of the participating centres and treated for ISCM
* Available documentation of admission and postoperative status

Exclusion Criteria:

- Patients under the age of 18
Anxiety Assessment Before Regional Anesthesia.

We want to assess the level of anxiety of patients who arrive in the operating room before performing regional anesthesia.

When patients arrive in the operating room, we want to submit them a validated questionnaire (APAIS score and STAI-6 score) to assess their anxiety. After that, the care (anesthesia and surgeries) will take place in a very usual way and similar to our standards of care.

Eligibility Criteria:
Inclusion Criteria:

* patient\> 18 years
* surgery performed under general anesthesia or not but preceded by a regional anesthesia.

Exclusion Criteria:

* refusal of the patient
* psychiatric disorders (pathological anxiety, psychosis, depression)
* language barrier
* major drug impregnation.
Study Of JAK3 Inhibitor For The Prevention Of Acute Rejection In Kidney Transplant Patients

A new immunosuppressive drug based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months in addition to other standard transplant medications such as prednisone.


Eligibility Criteria:
Inclusion Criteria:

* Recipient of first time kidney transplant
* Between the ages of 18 and 70 years, inclusive

Exclusion Criteria:

* Recipient of any non-kidney transplant
Chinese Herbal Formula for COVID-19

This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate a 21-herb formula named modified Qing Fei Pai Du Tang (mQFPD) to treat COVID-19-positive outpatients with mild-to-moderate symptoms assigned to self-quarantined and home management. This the study aims to establish the safety and feasibility of the use of mQFPD vs placebo in 66 total subjects. Subsequent trials will evaluate other therapeutics as well as the efficacy of mQFPD in a larger study population.

Study participants will be assigned to one of two groups, either placebo or mQFPD. Participants will be screened and consented remotely. Both groups will receive blood draws at days 1 and 14, and will be sent study medication directly to their home from the investigational pharmacy. Baseline and end-of-study laboratory draws will be done at home via mobile phlebotomy. Adverse events and symptoms scores will be monitored by entry into a daily diary along with regular phone calls with the study coordinators.

At the end of the study, safety will be assessed by laboratory measures and adverse event reporting.

Eligibility Criteria:
Inclusion Criteria:

* Positive COVID-19 diagnosis within the prior 72 hours or within 9 days of symptom onset
* Age 18 years and older
* Women of childbearing potential must have a negative urine or serum hCG.
* Women of childbearing potential must have a negative serum pregnancy test at screening and agree to use contraception throughout the study period.
* Capable of documenting vitals, symptoms, and study product intake daily and communicating this information to the study team
* Willing to try to minimize alcohol, cannabis, and dairy products during the study period.

Exclusion Criteria:

1. Any of the following symptoms which, according to the CDC, require hospitalization:

   1. Trouble breathing
   2. Persistent pain or pressure in the chest
   3. New confusion or inability to arouse
   4. Bluish lips or face
2. Current use of investigational agents to prevent or treat COVID-19
3. Known liver disease (ALT/AST \>3x ULN or diagnosis of cirrhosis)
4. Known renal disease (eGFR \< 60 ml/min) or acute nephritis.
5. Uncontrolled hypertension (SBP\>140 or DBP\>90 while on medications)
6. Allergy to tree nuts
7. Bleeding dyscrasia or on anticoagulation (aspirin and/or clopidogrel is allowed)
8. Pregnant or breastfeeding women
9. Use of Tolbutamide
10. Use of systemic corticosteroids (hydrocortisone, cortisone, prednisolone, betamethasone, methylprednisolone, prednisone, dexamethasone). Inhaled budesonide is to be allowed.
11. Use of digoxin
12. Use of Oxacillin
13. Use of Interferon
14. Use of Vincristine
15. Use of Cyclosporine
16. Use of Amiodarone
17. Patients with a past medical history of epilepsy
18. Use of monoamine oxidase inhibitors (MAOI)
19. Use of Methamphetamine within the prior 30 days
20. Use of Cocaine within the prior 30 days
21. Use of aminoglycosides, carbamazepine, flecainide, lithium, phenytoin, phenobarbital, rifampicin, theophylline and warfarin
Virtual Reality Hypnosis for Thoracic Drain Insertion

The main objective of this study is to evaluate, in vigilant resuscitation patients, the effect of the use of HYPNO VR on the pain felt during the insertion of a thoracic drain.

This is a prospective, randomized, open-label, monocentric, prospective study of two parallel groups of patients in whom a chest tube is to be inserted:

* Group 1: Insertion of the drain according to the usual management protocol.
* Group 2: Insertion of the drain according to the usual management protocol supplemented by the use of a hypnosis software application (HYPNO-VR).

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age or older, having read and signed the consent form for participation in the study
* Patient admitted to intensive care whose state of health requires the insertion of a thoracic drain according to the doctor in charge of the patient.

Exclusion Criteria:

* Patient under legal protection, guardianship or trusteeship
* Pregnant or breastfeeding patient
* Patient not affiliated to the French social security system
* Hearing or visual disturbances contraindicating the use of virtual reality headphones
* Inability to provide the subject with informed information and/or written informed consent: dementia, psychosis, consciousness disorders, non-French speaking patient
* Unbalanced epilepsy
* Contraindication to local anaesthesia, one of the analgesics or sleeping pills used in the protocol
* Need for drainage in a life-threatening emergency (respiratory distress or compressive pleural effusion)
* Concurrent participation in other research or during a period of exclusion from previous research
A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA)

The purpose of this study is to evaluate the relative bioavailability, food effect, and dose proportionality of a granule formulation of VNZ/TEZ/D-IVA.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m\^2), both inclusive
* A total body weight greater than (\>)50 kg

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption
* Female participants who are pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of the study drug
* Male participants with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of the study drug

Other protocol defined Inclusion/Exclusion criteria may apply.
Analgesic Contribution of the Suprazygomatic Maxillary Nerve Block for Cleft Palate Surgery in Children

This is a monocentric prospective randomized simple-blind designed study evaluating the superiority of the suprazygomatic maxillary nerve block in analgesia after cleft palate surgery compared with a control group. Every two hours, nurses systematically reassess the patient's pain and adjust the analgesic medications. Analgesic requirement, incidence of respiratory complications, re-feeding time and the duration of hospitalization are evaluated.

Cleft palate is the most common congenital malformation and requires early surgery given the complications it generates. The surgical site involving the upper airways and the use of morphine are providers of respiratory complications. The suprazygomatic maxillary nerve block could considerably reduce the use of morphine in the postoperative period and thus the respiratory complications in addition to an optimal comfort for the patient. The primary endpoint was to evaluate morphine consumption during the first postoperative 48 hours after cleft palate surgery.

Eligibility Criteria:
Inclusion Criteria:

* children between 5 months and 12 years old
* weight \>5kg
* children undergoing cleft palate repair surgery with or without upper lip surgery

Exclusion Criteria:

* inappropriate age
* weight \<5kg
* abnormal blood coagulation
* local anesthetic contraindication (including levobupivacaine, as well as any other associated treatment administered in this clinical study, including opioids, general anesthetics such as ketamine or propofol, paracetamol or corticosteroids)
* local infection
The Use of Stromal Vascular Fraction for Knee Arthrosis

A trial to investigate the safety and efficacy of SVF for the treatment of knee arthrosis.

Patients will undergo a single liposuction to obtain the SVF. The SVF will then be isolated and frozen in our laboratory. The SVF will then be injected up to 2 times into the fat pad of the patient's knee.

Stromal Vascular Fraction (SVF) from adipose tissue is increasingly being used in the clinic for a variety of conditions (skin disorders, joint pain, etc.). SVF is a collective term for cells that can be obtained from liposuction fat. These cells can be separated from the fat by mechanical processing of the liposuction fat combined with an additional centrifugation.

Despite the fact that enough SVF can be isolated after such a liposuction for multiple treatments (\>3), our research group has found a way to safely freeze SVF without significant loss of SVF cells. In this way, a patient would only have to undergo one liposuction and associated anesthesia to be able to obtain multiple SVF treatments.

Eligibility Criteria:
Inclusion Criteria:

* Legal capacity
* Osteochondral lesions
* Inflammatory complaints
* (Peri)tendinitis or tendinopathies and ligamentous injuries
* Impingement complaints
* Arthrofibrosis
* Anterior knee pain
An Evaluation of Maternal Position During Cesarean Delivery

During Cesarean Delivery pregnant women are frequently tilted to the left 15 degress to reduce compression of the major blood vessels by the uterus. Despite this common practice, there is no conclusive evidence to support this practice. In fact it may even be deleterious to have women positioned in this position. The aim of the study is to determine whether or not tilting women to the left during cesarean section (CS) is helpful or detrimental. The authors hypothesize that left uterine displacement of 15 degrees, which is commonly employed, is useless for preventing compression of these blood vessels. To investigate this question, women will be randomly assigned to either be tilted 15 degrees to the left during CS or positioned flat on the table. Fetal acid base status, vasopressor/phenylephrine use, patient satisfaction, maternal complications, and fetal complications will all be collected and compared.


Eligibility Criteria:
Inclusion Criteria:

* term pregnant women with an uncomplicated pregnancy course undergoing scheduled cesarean delivery

  * ≥18 years old
  * ASA 1 and 2 (i.e., patient is completely healthy (1) or has mild systemic disease (2)
  * Able and willing to consent to participate

Exclusion Criteria:

* Males

  * \<18 years old
  * maternal cardiac/pulmonary/hematologic disorders/renal failure
  * drug/alcohol/tobacco use during pregnancy
  * essential or pregnancy-induced hypertension
  * diabetes greater than 10 years
  * pre-eclampsia or abruptio placenta
  * \<37 weeks gestation
  * hemoglobin \< 7 g/dL
  * intrauterine growth retardation
  * fetal distress or fetal anomaly
  * Transverse lie
  * Ruptured membranes
  * Severe polyhydramnios or oligohydramnios
  * Multiple gestation
  * severe scoliosis or kyphosis,
  * uterine abnormalities (e.g., large fibroids, bicornuate uterus)
  * Failed spinal (sensory level \< T6 after 15 minutes)
  * need to convert to general anesthesia before delivery
Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism

This is an open-label, multinational, multicenter, long-term safety and efficacy extension trial in patients with Congenital Hyperinsulinism (CHI) who completed either ZP4207-17103 or ZP4207-17109 (defined as lead-in trials).

The primary objective is to evaluate the long-term safety of dasiglucagon administered as subcutaneous (SC) infusion in children with CHI.


Eligibility Criteria:
Inclusion Criteria:

* Completed treatment in either Trial ZP4207-17103 or ZP4207-17109
* Expected to continue to have a positive benefit-risk assessment for treatment with dasiglucagon (based on considerations of glycemic effect, tolerability, and nature and frequency of adverse events experienced in the lead-in trial)

Exclusion Criteria:

* The patient developed any conditions prohibited by the lead-in trial, requires medication prohibited by the lead-in trial, or has other new complications that preclude participation in the investigator's opinion.
Design Improvements With SONNET 3

Measuring user-reported satisfaction with the latest behind-the-ear (BTE) audio processor model.

This prospective study will use a single-arm, repeated measures design with subjects serving as their own control. Participants will be experienced cochlear implant (CI) users wearing an approved BTE MED-EL audio processor. Participants will complete a take-home trial with the latest audio processor and then complete a custom questionnaire comparing design and usability to their existing audio processor.

Eligibility Criteria:
Inclusion Criteria:

* Implanted with a MED-EL cochlear implant in at least one ear
* ≥ 12 months since activation of the MED-EL audio processor
* Consistently using a SONNET (EAS) or SONNET 2 (EAS) Audio Processor
* Ability to complete all study procedures
* Participant and parental (if applicable) commitment to comply with all study procedures for the duration of the study

Exclusion Criteria:

* Evidence that hearing loss is retrocochlear in origin
* Unable to provide reliable feedback during cochlear implant programming
* Skin or scalp condition precluding use of the study device
* Unrealistic participant or parent (if applicable) motivation or expectations
* Participants without a stable fitting map at enrollment e.g., due to changes in hearing, global health status, etc.
Study Comparing Discontinuation Symptoms Of DVS SR In Subjects With Major Depressive Disorder (MDD)

Study Comparing Discontinuation Symptoms in subjects with Major Depressive Disorder treated for 24 Weeks with Open-label 50 mg Desvenlafaxine Succinate Sustained-Release Formulation (DVS SR)


Eligibility Criteria:
Inclusion Criteria:

* Primary Diagnosis of Major Depressive Disorder
* Hamilton Psychiatric Rating Scale for Depression-17-Item score of greater than or equal to 14 at baseline

Exclusion Criteria:

* Current psychoactive substance abuse or dependence, manic episode, or a lifetime diagnosis of bipolar or psychotic disorder
* Potentially violent to others or is at significant risk for suicide
* History or current evidence of gastrointestinal disease or history of surgery known to interfere with absorption or excretion
* Known presence of raised intraocular pressure or history of narrow angle glaucoma
A Study of Venetoclax in Combination With Obinutuzumab in Participants With Chronic Lymphocytic Leukemia

This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics as well as the preliminary efficacy of venetoclax (GDC-0199; ABT-199) administered in combination with obinutuzumab to participants with relapsed/refractory or previously untreated chronic lymphocytic leukemia (CLL). The study is comprised of two stages for each participant population: a dose-finding stage and a safety-expansion stage. The dose-finding stage will explore multiple doses of venetoclax to be used in combination with a fixed dose of obinutuzumab. The dose-finding stage will also explore two schedules for drug administration, Schedule A (venetoclax introduced before obinutuzumab) and Schedule B (venetoclax introduced after obinutuzumab).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of relapsing/refractory or previously untreated chronic lymphocytic leukemia
* Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to (\</=) 1
* Adequate bone marrow function
* Adequate coagulation, renal and hepatic function
* For all participants, agreement to remain abstinent or use contraceptive methods that result in a failure rate of less than (\<) 1% per year during the treatment period and for at least 90 days (30 days for women) after the last dose of venetoclax or 18 months after the last dose of obinutuzumab, whichever is longer

Exclusion Criteria:

* Participants who have undergone allogenic stem cell transplant are ineligible unless they meet the following criteria, a) participants who are off all immunosuppressive therapy, b) participants who have no signs and/or symptoms of acute or chronic graft versus host disease, or c) participants must have appropriate hematology counts
* Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
* Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
* Investigational or anti-cancer therapy within 5 half-lives prior to the first dose of study drug
* History of significant renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease
Is the Short Physical Performance Battery a Useful Outcome Measure in Chronic Obstructive Pulmonary Disease

Patients with Chronic Obstructive Lung Disease (COPD) often develop muscle problems, particularly in their legs which makes them more limited in what they can do. The Short Physical Performance Battery (SPPB) is a simple test of standing balance, usual walking speed and ability to stand from a chair. The SPPB may be a useful measure to predict leg function.

This study aims to evaluate whether the SPPB is comparable with current exercise tests used in COPD patients, and whether it is useful in predicting disability, death and health resource usage over time.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD

Exclusion Criteria:

* Any patient in whom mobility and lower limb function have been significantly affected by a neuromuscular cause (eg. motor neurone disease), severe peripheral vascular disease or amputation
* Any patient whom is deemed unsafe to exercise
* Patients unable to complete the SPPB, walking tests and leg strength assessments.