cyrilzakka/clinical-trials huggingface dataset:
AC-11 Supplement and Biological Aging

This is a prospective non-randomized clinical study of 24 patients to evaluate the effects of the AC-11®. The study will evaluate the effectiveness of the supplement's ability to reverse epigenetic markers of biological age. The duration of the study will be 6 months.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women of any ethnicity.
2. Age Range 55 years and older
3. The patient must be able to comply with the treatment plan and laboratory tests

Exclusion Criteria:

1. Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
2. No immune system issues or immunodeficiency disease
3. No history of viral illness which could be reactivated by immune downregulation
4. Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke)
5. Diagnosis of a transient ischemic attack in the 6 months prior to screening
6. Patients infected with hepatitis C or HIV
7. Patients with Body Mass Index (BMI) \> 40 kg/m2
8. Presence of active infection
9. Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study
10. Unable or unwilling to provide a required blood sample for testing
11. As for the male-participants they are recommended to avoid fertilization for the first 6 months after the clinical trial.
12. If the patient has previously used AM/PM HealthSpan system supplements at any time before the start of the trial.
Biomarker Discovery in Patients With Advanced Biliary Tract Cancer

Biliary tract cancer is a rare gastrointestinal malignant neoplasm and includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gall bladder cancer. Curative surgical resection offers the only chance for cure. However, most patients with BTC are diagnosed at an unresectable stage. Therefore, the survival outcomes of patients with advanced biliary tract cancer remain dismal.

The combination of gemcitabine and cisplatin has become the current standard for advanced BTCs since the landmark ABC-02 trial in 2010. However, the median overall survival of Gem/Cis chemotherapy is less than 1 year. Recently, a triplet regimen of gemcitabine, cisplatin, and nab-paclitaxel showed promising results in a single-arm phase II multicenter study.

However, biliary tract cancer is a group of heterogenous diseases by site and genetic alteration, and this diversity may lead differences in response to systemic chemotherapy.

Transcriptome analysis through RNA-sequencing has rarely been performed in advanced biliary tract cancer, and even if it has performed, only small number of patients were included. Further research on multi-omics data is needed on the necessity and clinical significance in treatment of biliary tract cancer.

Using biopsy specimen (formalin fixed paraffin embedded tissue), in-house NGS and RNA-sequencing will be performed simultaneously. Through this, investigators will discover biomarkers based on multi-omics data that predict response to systemic chemotherapy (nab-paclitaxel plus gemcitabine-cisplatin). In addition, blood sampling will be performed in parallel to conduct research on cell-free DNA and circulating tumor cell analysis related to response and progression on chemotherapy; before administration of chemotherapy, 3 months after chemotherapy, 6 months after chemotherapy, the time of disease progression (if possible), before curative resection (if possible).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 19 years old
* Capable of understanding and complying with the protocol requirements and signed informed consent
* The patients were confirmed as bilary tract cancer (gall bladder cancer, extrahepatic cholangiocarcinoma, intrahepatic cholangiocarcinoma) by histopathology or cytology
* Patients with inoperable or metastatic or recurrent biliary tract cancer
* Patients who underwent in-house next-generation sequencing
* Patients planning to receive Gemcitabine, Cisplatin, nab-paclitaxel triplet chemotherapy
* At least one measurable objective lesion was identified based on the RECIST 1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* The expected survival a ≥3 months

Exclusion Criteria:

* The subject has uncontrolled, significant intercurrent or recent illness including infection for organ failure
* Prior palliative chemotherapy for biliary tract cancer
* Dementia, altered mental state, or any mental illness that prevents understanding or informed consent
* Other conditions that researchers not think to be suitable for enrollment.
Opioid Based Anaesthesia vs Opioid Free Anesthesia in Cleft Lip, Palate ,Alveolus Surgery.

Peri-operative opioid administration has long been one of the three pillars of 'balanced anaesthesia',over the span of just a few years,opioids were widely used in perioperative analgesia because of pain as the fifth vital sign.However, opioid administration is not without concern and is associated with many side-effects such as constipation, urinary retention, respiratory depression and postoperative nausea and vomiting .Cleft lip,palate,alveolus are common craniofacial abnormalities and usually require surgical repair.These patients have risks for various perioperative complications due to their young age and craniofacial abnormalities.

This study was designed to compare the effects of opioid based anesthesia（OBA） and opioid free anesthesia(OFA )on perioperative complications in patients with in cleft lip,palate,alveolus surgery, including respiratory depression, postoperative nausea and vomiting, hemodynamic effects, etc.


Eligibility Criteria:
Inclusion Criteria:

* American Society Anesthesia I, II；
* Age between 3 months and 12 years;

Exclusion Criteria:

* allergy to anesthetic and analgesic drugs;
* history of neuromuscular;
* renal, neurological, hepatic disease;
* cardiopulmonary diseases;
* bradycardia
A Study Observing the Long-term, Effectiveness and Safety of Odevixibat (Bylvay) in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment

This study will collect information from patients with Alagille syndrome (ALGS) as they use odevixibat (Bylvay) in their daily lives.

Odevixibat is a medicine that helps patients with ALGS, a rare disease that harms their liver and causes itching.

The main aim of this study is to observe the long-term, everyday effectiveness and safety of the drug odevixibat in patients with ALGS who are receiving ongoing treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ALGS.
* On (or starting) active odevixibat treatment.
* Signed informed consent and assent, as appropriate. Consent/assent from the participant or legal representative should be obtained, as appropriate, before any study data collection is conducted. Participants who turn 18 years of age (or legal age per country) while participating in the study will be required to provide consent for themselves.

Exclusion Criteria:

* Currently participating in a clinical trial with odevixibat.
* Currently participating in any interventional clinical trial for ALGS.
* Have any contraindication to odevixibat as per the locally approved label.
* Had liver transplant before enrolment
Identification of Pre-surgical Phenotypic Indicators Predictive of Quality of Life Trajectories in Obese Patients Following Bariatric Surgery

This study aims to identify pre-operative phenotypic determinants predictive of quality of life trajectories in post-bariatric surgery patients. In addition, this study will have as a secondary objective the highlighting of a potential link between post-surgery quality of life trajectories and those of anxiety/depression scores, eating behaviors and body mass indices.

This study will be conducted during the usual care of patients undergoing the GEROM73 program, lasting a total of 30 months.

The GEROM73 program includes care for the six months preceding bariatric surgery and the 24 months following surgery. This program supports patients throughout their bariatric care..

Throughout the GEROM73 program, patients will complete questionnaires on anxiety, depression, eating disorders, Impact of Weight on Quality Of Life.

Patients' weight, body mass index and body schema will also be measured throughout the GEROM program.


Eligibility Criteria:
Inclusion Criteria:

* Integrated into the GEROM73 surgical program and starting the intra-hospital program

Exclusion Criteria:

Patients in a state of psychiatric decompensation Patients with cognitive disorders Patients with difficulties understanding the French language, spoken or written Pregnant, parturient, or breastfeeding women
An Interactive Preventive Health Record to Increase Colorectal Cancer Screening

This study involves 3 phases that modifies current Interactive Preventative Health Record-Colorectal Cancer Screening (IPHR-CRCS) modules to address each patient's individual colorectal cancer screening (CRCS) knowledge, attitudes, preferences, and test-specific barriers. The study will engage patients, ages 50-75 years who are non-adherent to CRCS, to assess their CRCS test preferences and corresponding test-specific barriers in "real time". Based on patient characteristics (e.g. age, personal and family history, physician CRCS recommendation, CRCS test preferences, top test-specific barriers), tailored messages/videos will appear in the pop-up screens to address/reduce the top patient-reported, test-specific CRCS barriers while incorporating an action plan for CRCS adherence. The investigators hypothesize that modifying the IPHR-CRCS module to address each patient's individual CRCS knowledge, attitudes, preferences, and test-specific barriers will further increase CRCS.


Eligibility Criteria:
Inclusion Criteria:

* Adults 50-75 years
* Non-adherent to CRCS guidelines (i.e., no FOBT in last year, no sigmoidoscopy or barium enema in last 5 years, and no colonoscopy in last 10 years)
* English-speaking
* Have computer access (e.g. home, work, library)
* Additional eligibility for Phase I: focus group participants will be ineligible for the subsequent prototype testing and cognitive/usability testing interviews
* Additional eligibility for Phase I: prototype testing participants will be ineligible for the cognitive/usability testing interviews
* Additional eligibility for Phase II: Seen in the clinic in the last 2 years

Exclusion Criteria:

* Personal CRC history
* Additional exclusion for Phase III: Patients seen at any clinic participating in Phase II
ASPirin in Immune thRombocytopenia Patients With Cardiovascular disEase

The incidence of immune thrombocytopenia increases with older age. This population is at risk for arterial thrombosis. Due to an increased turn-over of platelets, low-dose aspirin once daily may be insufficient in this population to protect against arterial thrombosis. This study is aimed at assessing the pharmacodynamics of aspirin once daily on platelet function in these patients.

The incidence of immune thrombocytopenia increases with older age. About 20% of patients who develop immune thrombocytopenia are exposed to low-dose aspirin for arterial thrombosis prophylaxis. Moreover, immune thrombocytopenia patients have an increased risk for developing arterial thrombosis as compared with matched controls from the general population. Because ITP patients have an increased turn-over of platelets and aspirin is an irreversible inhibitor of cyclooxygenase-1, aspirin taken once daily may be insufficient to provide stable inhibition of platelet function. This has been demonstrated in myeloproliferative neoplasms with a higher platelet turn-over as well; aspirin is given twice daily to these patients. In immune thrombocytopenia, epidemiological findings sustain this assumption because aspirin is not associated to an increased risk of bleeding. The primary aim of this study is to assess the residual platelet function after 75 mg aspirin intake (H24). Secondary objectives are to assess the kinetics of platelet function after daily 75 mg aspirin intake and the relation with arterial thrombosis.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* non-treated immune thrombocytopenia or immune thrombocytopenia with stable treatment (at least 1 month)
* treated with aspirin daily for a cardiovascular disease; stable platelet count \< 100 x 109/L
* at least one month following an arterial thrombosis
* no other antiplatelet drug and anticoagulant
* female patient with childbearing potential must have acceptable method of birth control
* affiliated or benefiting from public health insurance

Exclusion Criteria:

* opposition to participate
* adults under guardianship or other legal protection
* deprived of their liberty by judicial or administrative decision
* pregnancy or breastfeeding
Evaluation and Reconditioning of Marginal Lung Donors to Transplantation by ex Vivo Lung Perfusion

Only about 15% of the potential candidates for lung donation are considered suitable for transplantation. A new method for ex vivo lung perfusion (EVLP) has been developed and can be used for evaluation and reconditioning of "marginal" and unacceptable lungs. The ´purpose of this study is to analyse the executability and safety of ex vivo lung perfusion pulmonary ex vivo in marginal donors.

Donor Inclusion criteria:

* Age \< 55 years-old;
* Smoking history \< 20 pack-year;
* Clear chest radiograph;
* Absence of significant chest trauma;
* Absence of purulent secretions and gastric contents at bronchoscopy;
* PaO2 \< 300 mm Hg (FIO2 1.0, PEEP 5 cmH2O)

Exclusion criteria:

* Lungs presenting PO2 \< 400 mmHg after ex vivo lung perfusion

Eligibility Criteria:
Inclusion Criteria:

* Age \< 55 years-old;
* Smoking history \< 20 pack-year;
* Clear chest radiograph;
* Absence of significant chest trauma;
* Absence of purulent secretions and gastric contents at bronchoscopy;
* PaO2 \< 300 mm Hg (FIO2 1.0, PEEP 5 cmH2O)

Exclusion Criteria:

* Lungs presenting PO2 \< 400 mmHg after ex vivo lung perfusion
The Technical and Operational Performance of the QuidelOrtho Savanna RVP4 Analyzer

The purpose of this study is for the research team to become familiar with and evaluate the technical and operational performance of the QuidelOrtho Savanna RVP4 analyzer by testing 120 archived specimens that were previously tested at the Wisconsin State Laboratory of Hygiene (WSLH) by RT-PCR and multiplex respiratory pathogen panel within the last year.

To test the technical and operational performance of the QuidelOrtho Savanna RVP4 analyzer, the investigator proposes to test samples archived from the ORegon CHild Absenteeism due to Respiratory Disease Study (ORCHARDS) study (HSC 2013-1357), a study that had the goal to "develop and implement a system for daily school-based monitoring of ILI (influenza-like illness) and CLI (COVID-like illness) student absenteeism in kindergarten (K) through grade 12 schools, and assess the system's usability for early detection of accelerated influenza, SARS-CoV-2 and other respiratory pathogen transmission in schools and surrounding communities".

The deidentified paired (WSLH vs. Savanna RVP4) results will be used by QuidelOrtho Corporation to evaluate the technical and operational performance of the analyzer.

Eligibility Criteria:
Inclusion Criteria:

* Previously collected specimens from the ORCHARDS study.

Exclusion Criteria:

* Specimens not collected as part of the ORCHARDS study.
Feasibility of ESWT Treatment in Post-stroke Patients With Triceps Sural Spasticity

The main objective is to evaluate the feasibility of two different rehabilitation protocols that differed from the number of treatment sessions (1 session of ESWT versus 3 weekly sessions of ESWT), in patients with triceps surae spasticity after stroke. In both arms the other ESWT parameters (types of ESWT, intensity, frequency, location) and stretching sessions are the same.

Secondary objectives: to compare functional performances in these two groups of patients receiving the different rehabilitation protocol with ESWT, using the following parameters:

- Six Minutes walking test (6MWT) ; - Time Up \& Go (TUG); - Modified Ashworth scale (MAS); - Lower Extremity Functional Scale (LEFS); - passive ankle range of motion (p-ROM), pain (NRS); and presence of ankle clonus. These parameters are assessed during baseline (T0), after 4 weeks (T1) and after 12 weeks (T2).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of legal age
* Time elapsed since the stroke between 6 and 60 months
* Autonomous or supervised walking with or without aids
* Spasticity of the sural triceps\> 1 on the MAS scale

Exclusion Criteria:

* Joint stiffness of the lower limbs due to other pathologies (ex orthopedic or rheumatological);
* Conditions that interfere with evaluation or collaboration in rehabilitation treatment (major psychiatric illnesses, clearly detectable cognitive deficits, severe pre-existing disabilities, sensory disturbances, etc.)
* Focal antispasmodic toxin treatments in the previous 3 months or phenolic blocks in the previous 9 months in the treatment region
* Treatments with central antispasmodic drugs with dosage modifications in the last week of starting treatment
* Individual neurorehabilitation treatments in progress
Topical r-Hirudin ( Thrombexx ) Efficacy in Treatment of Haematomas

Single centre ,Phase IV , interventional, The study includes :

200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will have placebo .

The patients will be randomized to the active product (arm 1) or to placebo (arm 2).

The study consists of 4 visits as the following :

* Visit 1 : on day 1 to check patient eligibility and also for randomization .
* Visit 2 : on day 4 to assess target parameters
* Visit 3 : on day 8 to assess target parameters
* Visit 4 : on day 16 to assess target parameters

Single centre ,Phase IV , interventional, The study includes :

\* 200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will have placebo .

The patients will be randomized to the active product (arm 1) or to placebo (arm 2).

The study consists of 4 visits as the following :

* Visit 1 : on day 1 to check patient eligibility and also for randomization .
* Visit 2 : on day 4 to assess target parameters
* Visit 3 : on day 8 to assess target parameters
* Visit 4 : on day 16 to assess target parameters

  * Study objective :Assessment the Efficacy of Topical r-Hirudin in treatment of haematomas ,also in resolving of the associated oedema
  * Study duration : 6 months
  * Selection of trial subjects:

Inclusion Criteria :

1. Age of patients between 20 and 60 years old.
2. Patients with all types of haematomas.

Exclusion Criteria:

1. Presence of infected wound requiring hospitalization or surgical intervention.
2. History of allergy or hypersensitivity to any of the ingredients.
3. Patients with coagulation disorders like haemophilia.
4. Patients who are on anticoagulants like Warfarin and Acetylsalicylic acid .
5. Patients who are taking digestive enzymes like alfa chemotrypsin.

   * Target parameters :

1.Size of haematoma.( Measured by ruler) , The ruler will measure the longest 2 intersecting line.

2.Size of oedema : by measurement of oedema circumference

3.Pain (by Vas score).

4.Change in colour ( by colour grade scale ) .

Eligibility Criteria:
Inclusion Criteria:

* Age of patients between 20 and 60 years old.
* Patients with all types of haematoma.

Exclusion Criteria:

* Presence of infected wound requiring hospitalization or surgical intervention.
* History of allergy or hypersensitivity to any of the ingredients.
* Patients with coagulation disorders like haemophilia.
* Patients who are on anticoagulants like Warfarin and Acetylsalicylic acid .
* Patients who are taking digestive enzymes like alfa chemotrypsin.
MicroRNA Expression in Everolimus-based Versus Tacrolimus-based Regimens in Kidney Transplantation

The calcineurin inhibitor drugs including cyclosporin and tacrolimus are well-known as nephrotoxicity. However, these drugs are essential for kidney transplant especially in high immunological risks. To date, however, there is an alternative regimen by using of everolimus-based which showing less toxicity than tacrolimus-based regimen by its mechanisms. Of note, this study aims to evaluate the toxicity by using microRNA profiles detection between everolimus-based and tacrolimus-based immunosuppressive regimen in kidney transplantation.

The author aims to evaluate the effects of two regimens (everolimus-based versus tacrolimus-based) in kidney transplantation recipients. Both of regimens are prescribed only in recipents who have low immunologicla risks. After informed consent, all eligible recipients will be collected blood and urine sample for microRNA profile testing during study periods.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have given informed consent to participate in the study
* Actual eGFR \> 20-25 ml/min/1.73 m2

Exclusion Criteria:

* Multi-organ transplantation
* Pregnancy
* ABO incompatible blood group
* Second, third, fouth kidney transplantation
* HIV positive, active or carrier in any infections
Lurasidone and Cognition in Bipolar I Disorder

This is a 6 week, randomized, open-label, parallel group study in patients with Bipolar-I disorder (manic depression), who are in remission from an episode. Participants who show cognitive impairment at baseline will be randomized to receive open-label Lurasidone added on to their current medication(s) or continue their usual treatment for 6 weeks. Participants will have 3 clinical visits and 2 telephone appointments during the study. Given the preliminary evidence for efficacy of Lurasidone in improving cognition in schizophrenia, we propose to examine the efficacy of Lurasidone in improving cognition in bipolar patients.


Eligibility Criteria:
Inclusion Criteria:

1. All patients must be taking either lithium or valproate or one of the atypical antipsychotics for mood stabilization.
2. Patients who show cognitive impairments (-0.25 standard deviations (SD) or below) on either the Trail Making Test- trial B (TMT-B) or California Verbal Learning Test (CVLT) trials 1 to 5, or CVLT long delay free recall, at baseline visit.
3. Males or females aged 19 to 65 years inclusive.
4. Diagnostic and Statistical Manual IV edition (DSM-IV TR) diagnosis of Bipolar Type I Disorder, with or without a history of psychosis.
5. Clinically stable with a Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) score less than or equal to 8.
6. A sufficient level of English using a language screening questionnaire.
7. Capability of understanding, consenting to, and complying with the requirements of the study.

Exclusion Criteria:

1. A history of unstable or inadequately treated medical illnesses, including moderate to severe brain injury, or neurological illnesses impacting cognitive function.
2. Treatment with Electroconvulsive Therapy (ECT) within eight weeks prior to enrolment; or treatment with an experimental drug within 30 days prior to enrolment.
3. Axis I diagnosis of substance abuse or dependence within the past month.
4. Significant risk of harm to self or others, in the opinion of the investigator.
5. Pregnancy or lactation in female subjects.
6. Liver function tests (AST and ALT) three times the upper limit of normal. -