cyrilzakka/clinical-trials huggingface dataset:
Specific Protocoled Physiotherapy Treatment for Subjects Surgically Treated for Femoroacetabular Syndrome

Physiotherapy treatment protocols described in the bibliography after hip surgery are most of them nonspecific. An experimental study is proposed to determine the effectiveness of a protocolized treatment of physiotherapy in the postoperative treatment of femoroacetabular impingement treated by arthroscopy. This study tries to adapt the non-specific post-surgical physiotherapy treatment protocols of the hip to the characteristics of the femoroacetabular impingement and its arthroscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Having suffered hip / groin pain for at least 3 months.
* Be a patient diagnosed with femoroacetabular syndrome by an orthopedic surgeon based on symptoms, clinical signs and diagnostic imaging.
* To have signed the informed consent.
* Have time available to follow a 14-week physiotherapy treatment program.
* Be programmed for hip arthroscopy.
* Be able to speak and understand the Spanish language.
* Be between 18 and 50 years of age.

Exclusion Criteria:

* To have received physiotherapy treatment in the last three months.
* Having previously received hip surgery.
* Subjects with previous deformities in the femur that severely alter joint mobility such as Perthes disease, gliding of the upper femoral epiphysis or avascular necrosis, acetabular fracture, hip dislocation or fracture of the femoral neck.
* Evidence of preexisting osteoarthritis, defined as Tonnis grade\> 2
* Subjects with previous deformities in the pelvis that severely alter joint mobility.
* Any other cardiovascular, psychological and / or cognitive diagnosed pathology that impedes the correct understanding of the study and prevents objective study variables.
* Subjects that are under the effects of anesthetics or muscle relaxants that mask the sensation of the patient before the techniques of the study.
* Professional athletes.
* Subjects in which hip arthroscopy is contraindicated.
Alterations in Spinal Alignment and Mobility in Individuals With Arthroscopic Rotator Cuff Repair

The aim of this observational study was to the alterations in spinal alignment in individuals who have undergone RC surgery and revealed the differences compared to healthy individuals.

Shoulder dysfunctions are thought to be predisposed by poor posture and muscle imbalances. The shoulder functionality could be limited or worsened by a restricted range of motion (ROM) of the spine. Evidence from studies evaluating both people with shoulder pain and asymptomatic participants indicates a relationship between a decreased thoracic kyphosis and an increased shoulder ROM. Therefore, a higher thoracic kyphosis may be linked to a lower ROM in the shoulder. Shoulder dysfunction becomes more common after the age of 40, and the relationship between spinal posture and shoulder dysfunction is crucially needed to be assessed.

The aim of this observational study was to the alterations in spinal alignment and mobility in individuals who have undergone RC surgery and revealed the differences compared to healthy individuals.

This cross-sectional observational study was conducted with patients who underwent arthroscopic RM surgery and healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* those who had undergone the same arthroscopic RM surgical procedure and technique
* had undergone acromioplasty and/or tenodesis with RM repair
* had undergone arthroscopic RM surgery from the upper extremity of the dominant side;
* had completed six months following surgery; were able to perform active shoulder elevation movements of 90° or more
* were between the ages of 40 and 75
* were volunteers to participate in the study.

Exclusion Criteria:

* who had undergone previous shoulder surgery or revision surgery, subscapularis tendon repair in addition to RM repair, scoliosis surgery, or any surgeries to limit spine motion, as well as those with a history of upper extremity fractures, diabetes mellitus, hypertension, cardiovascular disease, or chronic respiratory diseases that could limit the test's ability to be accomplished
Neostigmine as an Adjuvant in Tranversus Abdominis Plane (TAP) Block in Cesarean Section Under Spinal Anesthesia

Cesarean birth is a common surgical procedure. After cesarean birth, postsurgical pain may delay recovery, interfere with maternal-newborn bonding, and reduce the breastfeeding if not adequately controlled. Postpartum analgesia has become a common concern.

Many adjuvant drugs used for peripheral nerve blocks as( N-methyl-d-aspartate (NMDA) receptor antagonists , Magnesium , Ephedrine , Dexamesathone , Fentanyl , Midazolam and Neostigmine) The potential of neostigmine as an adjuvant in peripheral nerve block is through its action to increase acetylcholine at muscarinic junctions of peripheral nerves. 500 mcg neostigmine was used as adjuvant to local anesthetic in an axillary brachial plexus block leads to decreased pain and less use of analgesics in the first 24 hours postoperatively with no incidence of adverse effects.

This prospective double-blinded randomized controlled study will be done on parturients that are scheduled for elective cesarean delivery under spinal anesthesia to assess the efficacy of neostigmine as an adjuvant to isobaric bupivacaine inTranversus abdominis plane (TAPB) for postoperative analgesia in cesarean section under spinal anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Age from 19 to 40 years old
* American Society of Anesthesiologists (ASA) physical status II patients
* Singleton pregnancies with a gestational age of at least 37 weeks.
* Patients undergoing spinal anesthesia for cesarean delivery via a Pfannenstiel incision with exteriorization of the uterus.

Exclusion Criteria:

* Age \< 19 or \> 40 years.
* Height\<150 cm, weight \< 60 kg, body mass index (BMI) ≥40 kg/m2.
* Inability to comprehend or participate in the pain scoring system.
* Contraindications to spinal anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
* Hypersensitivity to any drug used in the study.
* Any hypertensive disorders of pregnancy.
* Renal impairment or other contraindications to non-steroidal anti-infilamatory drugs (NSAIDS).
* Significant cardiovascular, renal or hepatic abnormalities.
* Patients with history of opioid intake, drug abusers or psychiatric patients
biomArkers to differeNtiate bacTerial From vIral iNfEctions

ANTOINE is a prospective trial which aims to assess diagnostic performance of 7 biomarkers for the diagnosis of severe bacterial infections (SBI) in children aged from 7 days to 36 months.

Fever is a frequent cause of consultation in pediatric emergency departments. Clinical diagnostic tools are rare and discrimination between severe bacterial infection and viral infection is difficult to confidently state. The prevalence of severe bacterial infections (IBS) varies from 10 to 25% according to the studies. Biological markers such as procalcitonin (PCT) and C-reactive protein (CRP) are commonly used in clinical practice. These markers have bacterial specificity but share a wide range of values with viral infections and do not make it possible to exclude or to confirm definitively the diagnosis of IBS. The use of new markers to improve the diagnosis of bacterial and viral infections is increasingly studied in adults. The diagnostic value of these new markers has been demonstrated by associating their dosage with that of CRP for example. This is the case for IP-10, TRAIL or MxA. However, very few pediatric studies have been carried out to date on these new biomarkers. However, in pediatrics, these diagnostic tools based on the combination of biomarkers to discriminate against viral and bacterial infections could be a major help in the suspicions of IBS. 7 biomarkers were selected to be evaluated in this study. This study is designed to determine the best biomarkers combination for the SBI diagnosis on a cohort of 800 patients.


Eligibility Criteria:
Inclusion Criteria:

* Febrile children:

  * Between 7 days and 3 months old : fever \>38°C for more than 6 hours (late neonatal fever suspected) for which the physician prescribed venipuncture
  * Between 3 months and 36 months old : fever ≥38,5°C for more than 6 hours and less than 7 days for which the physician prescribed venipuncture for suspected severe bacterial infection
* Patient with national health cover
* Consent form signed by at least one parent

Exclusion Criteria:

* Children treated by antibiotherapy within the past 48h
* Children with congenital or acquired immunodeficiency syndrome or long-term immunosuppression treatment
* Vaccinated children within 48h by an inactivated vaccine or within 10 days for the MMR vaccines
* Children with a chronic disease
* undergoing surgery within 7 days before inclusion
Biological Collection of Kidney Cells

Our objective is to obtain human induced pluripotent stem cells from urine samples of PXE patients for further proteomic and metabolomic studies and treatment screening.

Pseudoxanthoma elasticum (PXE) is a genetic multysystem disorder with cutaneous, ophtalmological and cardiovascular involvement.

PXE is associated with mutations of ABCC6 gene coding for the membrane transporter ABCC6 protein. This transporter is normally expressed in hepatocytes and epithelial cells of renal proximal convoluted tubules.

Thus, PXE could be regarded as a metabolic disease of hepatic and renal origin, with clinical and biological involvement/consequences for remote organs.

The substance transported by ABCC6 protein being still unknown, ethiological PXE treatment does not exist yet. However, ABCC6 deficiency is associated with low level of blood PPi (pyrophosphate), which is natural inhibitor of calcium-phosphate deposition.

The aim of the project is to obtain the renal cells derived from PXE patients for their further usage in proteomic and metabolomic studies, as well as for screening of treatment modalities aimed to correct ABCC6 functional deficiency.

Eligibility Criteria:
Inclusion Criteria:

* Patient with PXE diagnosed on clinical and histological criteria, according to current guidelines
* Patient aged over 18
* Patient informed, having understood the purpose and means of the study and signed the consent of participation
* Patient affiliated to the French social welfare system

Exclusion Criteria:

* Pregnant or nursing PXE woman
* Patient under guardianship, deprived of liberty by court or administrative decision, hospitalized without consent or admitted to a health or social institution for purposes other than research
Treatment of Nonalcoholic Fatty Liver Disease With Probiotics and Prebiotics

The investigators' aim is to determine whether probiotic and prebiotic treatment plus lifestyle advice is more effective in reducing hepatic fat content than lifestyle advice alone in patients with Nonalcoholic Fatty Liver Disease (NAFLD).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 70 years
* Fatty liver identified by imaging studies including ultrasound, computer tomography or magnetic resonance imaging
* Elevated alanine aminotransferase (ALT) according to Prati's criteria (\>30 IU/l in men and \>19 IU/l in women)18
* Written informed consent obtained

Exclusion Criteria:

* Positive hepatitis B surface antigen, anti-hepatitis C virus antibody, or anti-nuclear antibody titer above 1/160
* Alcohol consumption above 30 g per week in men or 20 g per week in women
* ALT above 10 times the upper limit of normal
* Liver decompensation, as evidenced by bilirubin above 50 µmol/l, platelet count below 100 × 109/l, prothrombin time above 1.3 times the upper limit of normal, albumin below 35 g/l, presence of ascites or varices
* Use of systemic corticosteroids and methotrexate in the last 6 months
* Evidence of hepatocellular carcinoma
* Terminal illness or cancer, unless in complete remission for more than 5 years
Use of CAM by Hospice Oncology Patients During Ambulatory Palliative Care

The aim of the study is to assess Prevalence of complementary and alternative therapy use by adult patients from the area of Silesian agglomeration (Poland) with advanced, metastatic cancer disease who were admitted to "Pro Salute" Hospice for ambulatory palliative care between July 2017 and September 2018

The research team developed the CAT (complementary and alternative therapy) screening tool to obtain information about CAM use from patients. The screening tool was based on a The National Center for Complementary and Alternative Medicine's (NCCAM) classification of CAM. CAT were grouped into five main categories: (1) biologically based therapies , (2) mind/body therapies, (3) manipulative and body-based therapies, (4) Energy therapies and (5) alternative medical systems.

The questionaire was tailored to meet the objectives of this study and to be adjusted to hospice patients specifics. It was piloted on the group of 25 patients, resulting in some vocabulary changes. The final questionnaire consists of 25 multiple-choice, semi-structured questions and takes about 15 min to complete. For each general CAM category the detailed information was collected on the type of specific therapy that was used. Patients were considered as CAM users if they have used at least one therapy from at least one of the categories during the period of 12 months prior to the screening. Patients were asked to specify the reasons for CAT usage, experienced effects of the therapy, stage at which patients considered using CAM

Eligibility Criteria:
Inclusion Criteria:

* adult patients from the area of Silesian agglomeration (Poland) with advanced, metastatic cancer disease who were admitted to "Pro Salute" Hospice for ambulatory palliative care between July 2017 and September 2018

Exclusion Criteria:

* Patients were excluded from the survey if they presented cognitive disturbances disabling credible answers in the questionnaire
Acute Effects of SATIOSTAT Ingestion on Satiation Hormones, Gastric Emptying, Subjective Feelings of Appetite and Energy Intake

SATIOSTAT is a composition comprising a specific dietary fibre component (a mixture of hydrocolloids with excellent safety profiles and a long history of use in humans) and a lipid component (long-chain fatty acids). The goal of this combination is to achieve long-acting delivery of long-chain fatty acids to the intestinal lining, triggering the sustained release of satiety-signals from intestinal cells, and consequently reducing appetite and lowering food intake in humans.

Effects of acute ingestion of SATIOSTAT vs. a control will be examined. On a first and second study day, volunteers receive a preload of either SATIOSTAT or a control and then an oral glucose load of 75g enriched with C13 sodium acetate. Gastric emptying will be measured by means of a breath test, and insulin, glucose and satiation hormones will be assessed. On the third and fourth study day, volunteers receive a preload of either SATIOSTAT or a control and are then presented a test meal. Total calorie intake is measured as well as subjective feelings of satiation. In addition satiation hormones are measured.


Eligibility Criteria:
Inclusion Criteria:

* Obese volunteers (BMI \> 30kg/m2)
* Otherwise healthy
* Informed Consent as documented by signature (Appendix Informed Consent Form)

Exclusion Criteria:

* Food allergies, food intolerance
* Evidence of relevant cardiovascular, pulmonary, renal, hepatic, pancreatic, gastrointestinal, metabolic, endocrinological, neurological, psychiatric or other diseases at screening
* Chronic or clinically relevant acute infections
* Clinically relevant abnormalities in chemical, haematological or any other laboratory parameters
* Participation in drug trials within 2 months before start of the study
* Neurological or psychiatric disease or drug or alcohol abuse, which would interfere with the subjects proper completion of the protocol assignment
* Pregnancy: although no contraindication pregnancy might influence metabolic state. Women who are pregnant or have the intention to become pregnant during the course of the study are excluded. In female participants of childbearing age not using safe contraception (oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) a urine pregnancy test is carried out upon screening.
* Antibiotic therapy within the last 3 months before inclusion
* Substance abuse, alcohol abuse
* Inability to follow procedures due to psychological disorders, dementia or insufficient
* Knowledge of project language (German).
* Participation in another study with investigational drug within the 30 days preceding and during the present study.
A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures

Outcomes for displaced midshaft clavicle fractures in adolescents are not defined. The current method of treatment for these fractures is non-operative management. There is recent Level 1 evidence in the adult literature to suggest that outcomes are superior when these fractures are managed surgically with open reduction and internal fixation.

The study is a prospective observational cohort design of the natural history of adolescent clavicle fractures treated at the McGill University Health Centre. Surgeon choice will dictate treatment. There is no difference from the current normal therapy choice of each individual surgeon. Patients will be offered either operative or conservative management.

Operative Treatment: Patients with displaced midshaft clavicle fractures will be offered operative treatment which involves open reduction and internal fixation with a plate. This is the standard treatment for completely displaced fractures in the adult population at our Institution based on Level 1 evidence.

Conservative care: Patients will be treated in a sling for the acute phase of two weeks with progressive physiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Age 12-18 years old
* The only fracture present in that upper extremity
* Individual and/or parents able to comply with follow-up

Exclusion Criteria:

* Head injury
* Prior injury, degenerative condition or congenital condition of the upper extremities
* Systemic disease that may impair healing
* Incapable of ensuring follow-up
Endovascular Treatment With Versus Without Intravenous rhTNK-tPA in Stroke

The purpose of this trial is to investigate whether intravenous rhTNK-tPA prior to endovascular treatment can improve 90-day functional outcome of stroke patients with large vessel occlusion who are thrombolysis-eligible within 4.5 hours of symptom onset.

The DEVT, SKIP and DIRECT-MT trials showed that endovascular treatment alone is not inferior to intravenous alteplase bridging with endovascular treatment in terms of achieving 90-day functional independence for stroke patients with large vessel occlusion. The EXTEND-IA TNK part 1 and part 2 demonstrated that intravenous thrombolysis with tenecteplase is superior to alteplase before endovascular treatment. However, it is unclear whether intravenous tenecteplase bridging with endovascular treatment is superior to endovascular treatment alone. The purpose of this trial is to investigate whether intravenous rhTNK-tPA bridging with endovascular treatment is better than endovascular treatment alone for stroke patients with large vessel occlusion who are thrombolysis-eligible within 4.5 hours of onset.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or older;
2. Patient with acute ischemic stroke who is eligible for intravenous thrombolysis treatment within 4.5 hours of time last known well;
3. No significant prestroke functional disability: for age \<80 years, prestroke modified Rankin scale (mRS) ≤2; for age ≥80 years, prestroke mRS ≤1;
4. MCA-M1 or -M2, basilar artery, or posterior cerebral artery-P1 occlusion proved by CTA/MRA;
5. EVT is planned by clinical care team;
6. Written informed consent is obtained from patients and/or their legal representatives.

Exclusion Criteria:

1. Intracranial hemorrhage on baseline CT or MR
2. Contraindication to intravenous thrombolytics
3. Already received intravenous thrombolytic after index stroke
4. Known pregnancy, or breastfeeding, or serum beta human chorionic gonadotropin test is positive on admission
5. Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys
6. Current participation in another investigational drug clinical trial
7. Arterial tortuosity and/or other arterial disease that would lead to unstable access platform or prevent the thrombectomy device from reaching the target vessel
8. Patient with a preexisting neurological or psychiatric disease that would confound the outcome assessments
9. Patient with occlusions in two or more vascular territories (e.g. bilateral territories, or anterior and posterior circulation)
10. Mass effect or intracranial neoplasm on baseline CT or MR (except small meningioma)
11. Intracranial arteriovenous malformation or aneurysm on baseline CT or MR angiography
12. Any terminal disease with a life expectancy less than half a year
13. Unlikely to be available for follow-up at 90 days.
Compassionate Use (CU) of REGN5458 for Patients With Relapsed or Refractory Multiple Myeloma (MM)

Provide Compassionate Use' of REGN5458 for Patients with Relapsed or Refractory Multiple Myeloma

Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Dendritic Cell Vaccination to Prevent Hepatocellular Carcinoma Recurrence After Liver Resection-phase II Clinical Trial

Hepatocellular carcinoma (HCC) is the most common primary liver tumors. Surgical resection remains the first choice of early stage HCC because the result is superior to other treatments and not limited to liver donation. However, liver resection is criticized that tumor recurrent rate is more than 50% in 5 years although the tumors are completely resected. In our large scale study including 1639 patients with liver resection for HCC, the 1-, 3-, and 5-year disease survival were 73.7%, 58.3% and 53.3%, respectively. Currently there are no effective treatment used as adjuvant therapy to prevent HCC recurrence. Dendritic cells (DC) are the most potent professional antigen-presenting cells, and can capture tumor antigens to provoke antigen-specific cytotoxic T-cells. DC pulsed by tumor associated antigens can be used to proceed tumor-specific immunotherapy. Thereafter, DC pulsed HCC tumor-antigens may be used as an adjuvant therapy to prevent HCC recurrence.


Eligibility Criteria:
Inclusion Criteria:

* The patients have curative liver resection for primary or recurrent HCCs which are diagnosed by pathological figures, and the risk nomogram scores of tumor recurrence are ≥ 101 \[Hepatitis, score 57; platelet \< 100x103 , score72 ; multiple tumors, score 69 ; cirrhosis, score 62 ; microvascular invasion, score 100 ; total tumor volume \> 43.3cm3 ,score 90\]
* Age ≧20 years old and sign informed consent.
* BCLC stage A-C
* Child-Pugh sore ≤ 6
* Percentage of lymphocytes in peripheral blood ≧12%.
* Performance status ECOG ≦2
* AST and ALT ≦ 5x upper limit of normal.
* Platelet ≥ 80000/mm3
* WBC ≥ 3000/uL
* RBC ≥ 2.5x106/uL
* eGFR ≥ 30ml/min/1.73m2
* The patients must be disease-free after liver resection, which is confirmed by dynamic CT or MRI within 14 days.
* The participates must have early stage or intermediate stage of HCC and receive liver resections to remove the tumors completely.
* The participates must agree to harvest and preserve tumor specimens during operation.

Exclusion Criteria:

* Subjected having other malignancy except HCC are excluded.
* Uncontrolled or clinical significant cardiac diseases.
* Positive for HIV.
* Active bacterial of fungal infections.
* Prior chemotherapy within one month.
* Use of other investigational drug within one month.
* Subjects with systemic steroid treatment within 14 days.
* Subjects in the status of immune deficiency.
* Subjects in the status of autoimmune diseases.
* Subjects with Long-term use of immunosuppressive agents.
* Subjects with checkpoint inhibitor immunotherapy within one month.
* Subjects with local reginal therapy within one month.