cyrilzakka/clinical-trials huggingface dataset:
Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells Exosomes for Trigeminal Neuralgia

This trial will study the safety and efficacy of instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes for the treatment of Trigeminal Neuralgia.

This patient funded trial aims to study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cell (UC-MSCs) exosomes for the treatment of Trigeminal Neuralgia. Patients will receive an intranasal instillation of UC-MSCs exosomes. The total dose will be approximately 800 billion exosomes split evenly between both nasal cavities via Tian Syringe through 4 CCs of AlloEx. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Trigeminal Neuralgia or Peripheral Neuropathy
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur
Assessment of Left and Right Ventricular Function in Patients With Ebstein Anomaly With Different Echocardiographic Methods

Ebstein anomaly is a rare congenital heart disease. It encompasses abnormalities of the tricuspid valve, the right atrium and the right ventricle (RV).

Currently, cardiac magnetic resonance imaging (MRI) is considered the method of choice for the assessment of RV volume and function. To evaluate the right heart function VentriPoint method was designed to assess the RV in a fraction of the time, resulting in better efficacy and lower costs. VentriPoint is approved for Tetralogy of Fallot patients as well as patients with systemic RV in d-transposition of the great arteries. This method uses 2 dimensional standard ultrasound views linked to a VentriPoint Medical Systems unit. After acquisition, the physician identifies anatomical landmarks with dots on a number of the 2D ultrasound views through the heart. With a sensor (magnetic tracking system: GPS) on the ultrasound probe we know where the 2D plane is in 3D space. In this way the precise anatomical landmark is located in 3D space.

The aim of the present study is to assess the feasibility, reliability and accuracy of the echocardiographic knowledge-based 3D reconstruction method to measure RV volume and function in patients with Ebstein anomaly. The accuracy of the method will be assessed by comparison with measurements obtained by cardiac MRI.

In addition to the right ventricle the investigators want to assess the left ventricular function in patients with Ebstein anomaly in this study. By using speckle tracking echocardiography the investigators would like to investigate on the left ventricular contractility, rotation and synchrony of the left ventricle together with the RV. Not seldom the left ventricle is neglected in a patient with Ebstein anomaly by impressive findings of the right ventricle. Changes in the myocardial left ventricular structure (non compaction) are also described and may have negative impact on the function.

The investigators want to analyze 25-30 patients with Ebstein anomaly including children starting at 11 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Ebstein anomaly
* male and female 11 years to 80 years of age
* Unoperated or operated on the heart, including 1 1/2 chamber palliation
* Wolff-Parkinson-White Syndrome

Exclusion Criteria:

* moderate or severe mitral valve insufficiency, moderate or severe aortic insufficiency, moderate or severe aortic stenosis
* Univentricular palliation (Fontan)
* St.n. myectomy of the left ventricle
* Concomitant L-transposition of the great arteries
TMC125-C227: A Phase II Randomized, Active-Controlled, Open Label Trial to Investigate the Efficacy and Tolerability of TMC125 in HIV-1 Infected Subjects, Who Are PI-Naive and With Documented Genotypic Evidence of NNRTI Resistance From Previous NNRTI Use

The purpose of this study is to determinate the effectiveness, safety and tolerability (how well the body accepts the drug) of an investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) called TMC125.

Patients who have previously received a first HIV NNRTI containing regimen or who have received an NNRTI containing treatment for prevention of mother to child transmission (MTCT), and who have never used a protease inhibitor (PI) may be eligible to participate. TMC125 (at 800 mg b.i.d. of the old formulation and after the formulation switch, 200 mg b.i.d. of the new formulation) will be studied versus an active control (investigator selected PI). All patients will receive an underlying therapy containing 2 investigator selected NRTIs. 300 patients will be enrolled in Argentina, Brazil, Mexico, Peru, Chile, Costa Rica, Russia, South-Africa, Spain, Thailand, UK, USA, Thailand, India and Malaysia. The duration of the study is 48 weeks with an optional extension for patients in the TMC125 treatment group until virologic failure or commercial availability of the drug. TMC125 at 800mg twice daily of the old formulation; after the formulation switch, TMC125 at 200mg twice daily of the new formulation. The initial duration is 48 weeks with an optional extension for patients in the TMC125 treatment group until virologic failure or commercially availability.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 years or older
* Documented HIV-1 infection
* Stable NNRTI-containing ART (minimum 12 weeks) at screening OR treatment interruption (minimum 4 weeks) at screening OR having received an NNRTI alone or in combination with other ARVs for prevention of MTCT
* Plasma viral load at screening above 1000 HIV-1 RNA copies/ml
* Prior NNRTI-experience with documented genotypic evidence of resistance to currently available NNRTIs (defined as at least one NNRTI-associated mutation per IAS-USA Drug resistance Mutation guidelines)
* Sensitive to the 2 NRTIs to be used as underlaying ART
* Subject has given informed consent

Exclusion Criteria:

* Previous treatment with Protease Inhibitors
* Presence of any currently active AIDS defining illness except stable cutaneous Kaposi's Sarcoma and Wasting syndrome due to HIV infection
* Current or past history of alcohol and/or drug use which, in the investigator's opinion, would compromise the subject's safety or compliance to the study protocol procedures
* Acute Hepatitis A, B or C or chronic hepatitis B or C with elevated LFTs of \> 3 times ULN
A Phase I, Randomized, Placebo-controlled, Double Blind, Repeat Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Gastrointestinal Transit Time and Pharmacodynamic Biomarkers of GSK3179106 in Normal Subjects

The current study is designed to assess the safety, tolerability, pharmacokinetics (PK), gastrointestinal (GI) transit time and pharmacodynamic (PD) biomarkers of repeat oral doses of GSK3179106 administered for 14 days in normal healthy subjects. It is a randomized, double-blind, placebo-controlled, ascending cohort study. A total of 48 subjects will be randomized (8 subjects/cohort) with 3:1 allocation to GSK3179106 or matching placebo.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 55 years of age inclusive, at the time of signing the informed consent.
* Healthy as determined by the investigator based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. History of regular bowel habits
* Male or Female of non-childbearing potential.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions

Exclusion Criteria:

* ALT and bilirubin \>1.5xupper limit of normal (ULN) (isolated bilirubin \>1. ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
* Estimated Glomerular Filtration Rate \<60 milliliter per minute per 1.73 square meter (mL/min/1.73m\^2)
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
* History of Gastroesophageal reflux disease (GERD), dyspepsia, GI bleeding, GI surgery that could affect motility
Retrospective Analysis of 2nd-line Nab-Paclitaxel + Gemcitabine After 1st-line FOLFIRINOX in Pancreatic Cancer

In this study, clinical data of patients who received 2nd-line Nab-paclitaxel plus Gemcitabine (nab-P+GEM) after progression on 1st-line FOLFIRINOX will be reviewed retrospectively.

FOLFIRINOX is one of standard 1 st-line regimens for patients with advanced PDAC. However, there is no globally established 2 nd-line regimen after the failure of FOLFIRINOX. Although gemcitabine-based regimens are recommended by multiple guidelines and widely used in daily practice, further analysis is needed to reveal the magnitude of clinical benefit with these regimens. Nab-paclitaxel plus Gemcitabine (Nab-P+Gem) is another standard 1 st-line regimen for PDAC, but there are limited data as 2 nd-line therapy in PDAC. Therefore, the investigators are conducting a multicenter retrospective analysis of 2 nd-line nab-P+Gem after progression on FOLFIRINOX in patients with advanced PDAC.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed pancreatic ductal adenocarcinoma
* Administration of 2nd-line nab-paclitaxel plus gemcitabine
* Progression on 1st-line FOLFIRINOX

Exclusion Criteria:

* Pathologic diagnosis other than pancreatic ductal adenocarcinoma
* Administration of nab-paclitaxel plus gemcitabine as 3rd or greater lines of therapy
Study of NGM395 in Adult Participants

Study of NGM395 in adult participants.


Eligibility Criteria:
Inclusion Criteria:

Part 1:

1. Body mass index (BMI) in the range of 27 - 45 kg/m², inclusive, at screening, with maximum body weight of 140 kg.

   Part 2:
2. Liver fat ≥8% as assessed by MRI-PDFF.
3. BMI in the range of 27 - 45 kg/m2, inclusive, with maximum body weight of 140 kg at screening.
4. Waist circumference \> 40 inches for males or \> 35 inches for females.

Exclusion Criteria:

Part 1:

1. Diagnosed with type 2 diabetes (T2D) and/or the use of metformin, dipeptidyl peptidase-4 (DPP4) inhibitors, sodium/glucose cotransporter 2 (SGLT2) inhibitors, sulfonylurea agents, acarbose, or insulin for T2D within 3 months prior to Screening.
2. Subjects with T2D managed with diet alone with HbA1c level \> 6.5% or fasting glucose ≥ 126 mg/dL at Screening.
3. History of bariatric surgery.
4. Fasting triglycerides \> 400 mg/dL at Screening.

   Part 2:
5. Diagnosed with type 2 diabetes with a HbA1c \>9.5%, on thiazolidinediones, sodium/glucose cotransporter 2 (SGLT2) inhibitors, acarbose, or insulin for T2D within 3 months prior to Screening.
Treatment of Osteoporosis - TOP1 Clinical Study

This study investigates the effect of zeolite on bone mineral metabolism. The clinical parameters include bone mineral density, bone remodelling markers, fractures and fallings, the subjective evaluation of the overall health status and intensity of the musculoskeletal pain measured by VAS.

Randomized, placebo-controlled, double-blind study. The Study lasts 12 months. Study Population: The study population will consist of 100 patients with osteoporosis defined according BMD (bone mineral density) criteria: T score -2, 5 on the femoral neck, and, or T -2, 5 on L1-L5, who has not been treated before, or in whom privies treatment did not been successful, despite a gender or age. Subjects will be randomized in each cohort to receive PMA-zeolite (Panaceo) or placebo (1:1). All of them will receive Vit D3 800 j daily.

The double blind design can be reached by a "third party blinding" where a qualified person, not being involved in the assessment of the study, will administer the study treatment.

Follow up DXA, Ca, P, ALP, Osteocalcin, Cross laps, Creatinin will be done to each subject before the treatment, 6 months later and after 12 months. IVA (vertebral deformity assessment) will be performed before the treatment and after 12 months.

Eligibility Criteria:
Inclusion Criteria:

* 100 subjects with osteoporosis Among those, as a subgroup, 20 subjects with diabetes type 2 and osteoporosis

  * The osteoporosis- was diagnosed by standard DXA measurement (BMD T-score: - 2.5 or below )

Exclusion Criteria:

* chronic renal failure, secondary osteoporosis
A Study of the Efficacy and Safety of Efgartigimod in Patients with Primary Sjögren's Syndrome

The main purpose of the proposed study is to evaluate the efficacy of efgartigimod PH20 SC in patients with moderate-to-severe Primary Sjögren's Disease (pSjD). The study consists of a double-blinded placebo-controlled treatment period and an open-label treatment period. The maximum study duration for participants in both study parts is approximately 105 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF.
* Meets the following criteria at screening: ACR/EULAR classification criteria 2016 PSjD; clinESSDAI ≥ 6; Anti-Ro/SS-A positive at central laboratory; Unstimulated residual salivary flow (≥ 0.01 mL/min)

Exclusion Criteria:

* Secondary Sjögren's disease where another confirmed autoimmune rheumatic or systemic inflammatory condition (eg, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, and inflammatory bowel disease) is the primary diagnosis.
* Active fibromyalgia which is not adequately controlled in the judgment of the investigator, or participant is receiving fibromyalgia treatment that has not been stable treatment for at least 12 weeks before screening.
* Any severe systemic PSjD manifestation that is not adequately controlled at baseline that may put the participant at undue risk based on the investigator's opinion.
* Use of cyclophosphamide ≤ 24 weeks prior to screening
* Anti-CD20 or anti-CD19 antibody received \< 6 months before screening
Pharmacokinetic, Safety, Tolerability, and Immunogenicity Study of SB8 in Healthy Male Subjects

Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab

A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab (SB8, EU Sourced Avastin®, and US Sourced Avastin®) in Healthy Male Subjects

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects
* Have body weight between 65.0-90.0 kg (inclusive) and body mass index between 20.0-29.9 kg/m2 (inclusive)

Exclusion Criteria:

* Have a history of hypersensitivity or allergic reactions to bevacizumab or to any of the excipients
* Have a history of and/or current clinically significant gastrointestinal, renal, hepatic, cardiovascular, haematological, pulmonary, neurologic, metabolic, psychiatric, or allergic disease excluding mild asymptomatic seasonal allergies
* Have a history of arterial thromboembolic events including cerebrovascular accidents, transient ischaemic attacks, and myocardial infarction
* Have a history of and/or current cardiac disease
* Have previously been exposed to vascular endothelial growth factor (VEGF) antibody, any other antibody, or protein targeting the VEGF receptor
* Have a history of cancer including lymphoma, leukaemia, and skin cancer.
* Have received live vaccine(s) within 30 days prior to Screening visit or who will require a vaccine(s) between Screening and the end of study visit
* Have taken medication with a half-life of \> 24 hours within 30 days or 10 half-lives of the medication prior to the IP administration
Martial Arts Therapy in Autism Spectrum Disorders

The purpose of the present study was to determine whether teaching Karate techniques training leads to reduction in communication deficit of children with autism spectrum disorders.


Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed as autism spectrum disorders according to the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition, Text Revision.
* Age range in 5 to 16.

Exclusion Criteria:

* Not participating in up to 3 intervention sessions.
Study to Evaluate the Relative Bioavailability of Fixed-dose Combination Tablet Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) as a Whole Tablet, as a Split Tablet, and as Crushed Tablet in Healthy Adult Participants

The purpose of this study is to evaluate the single-dose pharmacokinetics and relative bioavailability of Darunavir (DRV) 800 milligram (mg), Cobicistat (COBI) 150 mg, Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed-dose combination (FDC) (D/C/F/TAF) tablet in healthy adult participants when given as Treatment A (reference): a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet swallowed as a whole, intact tablet with 240milliliter (mL) of noncarbonated water.Treatment B (test): a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet as a split tablet swallowed with 240 mL of noncarbonated water. Treatment C (test): a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet as a crushed tablet mixed in 4 ounces (oz) of applesauce.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoker for at least 3 months prior to selection
* Body mass index (BMI) of 18.0 to 32 kilogram per square meter (kg/m\^2), inclusive
* Woman must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) pregnancy test at screening and a negative sensitive urine pregnancy test on Day -1 before the first dose of study drug
* Woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 90 days after receiving the last dose of study drug
* During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug, a non-vasectomized man who is sexually active with a woman of childbearing potential must agree to use a highly effective barrier method of contraception

Exclusion Criteria:

* Positive human immunodeficiency virus -1 (HIV-1) or HIV-2 test at screening
* Hepatitis A, B, or C infection, confirmed by a positive hepatitis A antibody immunoglobulin M (IgM), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV) test, respectively, at screening
* History of renal insufficiency
* History of significant drug-induced skin reactions (such as, but not limited, to Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and/or erythema multiforme) or history of allergies to drugs (such as, but not limited to, sulfonamides and penicillins)
* Previously participated in a multiple-dose study with Darunavir (DRV), Cobicistat (COBI), Emtricitabine (FTC), Tenofovir Alafenamide (TAF), or Tenofovir Disoproxil Fumarate (TDF)
Carbon Dioxide Surgical Field Flooding and Aortic No-touch Off-pump Coronary Artery Bypass Grafting to Reduce Neurological Injuries After Surgical Coronary Revascularization (CANON): a Randomised, Controlled, Investigator and Patient Blinded Single Center Superiority Trial With Three Parallel Arms.

The objective of this study is to investigate the value of employing the aortic no-touch off-pump coronary artery bypass technique and the practice of carbon dioxide surgical field flooding for the prevention of type 1 and 2 neurological injuries following surgical coronary revascularization.

Neurological injuries remain a major concern following coronary artery bypass grafting (CABG) that offset survival benefit of CABG over percutaneous coronary interventions. Among numerous efforts to combat this issue, is off-pump CABG (OPCABG) that obviates the need for extracorporeal circulation and is associated with improved outcomes. The objective of this study is to examine whether the neuroprotective effect of OPCABG can be further pronounced by the use of two state-of-the-art operating techniques.

In this randomised, controlled, investigator and patient blinded single center superiority trial with three parallel arms a total of 360 patients will be recruited. They will be allocated in a 1:1:1 ratio to two treatment and one control arms. Treatment arms undergoing either aortic no-touch OPCABG or OPCABG with a partial clamp applying carbon dioxide surgical field flooding will be compared against control arm undergoing OPCABG. The primary endpoint will be the appearance of new lesions on control brain magnetic resonance imaging 3 days after surgery. Secondary endpoints will include the prevalence of new focal neurological deficits in the first 7 days after surgery, the occurrence of postoperative cognitive dysfunction at either 1 week or 3 months after surgery and the incidence of delirium in the first 7 days after surgery. Data will be analysed on intention-to-treat principles and a per protocol basis.

Eligibility Criteria:
Inclusion Criteria:

* elective and/or urgent coronary artery bypass

Exclusion Criteria:

* emergent and salvage setting
* score below age- and education-adjusted cut-off scores in mini mental state examination
* score above 8 on the subscales of hospital anxiety and depression scale
* neurologic deficit of any etiology
* previous psychiatric illness
* use of tranquilizers or antipsychotics
* alcohol or drug abuse
* history of cardiac surgery
* left ventricular ejection fraction less than 30%
* extracranial carotid artery stenosis of more than 70%
* body mass index of more than 35 kg/m2
* any contraindication for magnetic resonance imaging (e.g., magnetic resonance imaging - incompatible implantable device and claustrophobia)