cyrilzakka/clinical-trials huggingface dataset:
Arginase Inhibition in Ischemia-reperfusion Injury

The present project is designed to test the hypothesis that arginase contributes to endothelial dysfunction induced by ischemia-reperfusion in patients with coronary artery disease.

Background: Arginase competes with nitric oxide synthase for their common substrate L-arginine. Up-regulation of arginase in coronary artery disease (CAD) and diabetes mellitus may reduce nitric oxide bioavailability contributing to endothelial dysfunction and ischemia-reperfusion injury. Arginase inhibition reduces infarct size in animal models. Therefore the aim of the current study was to investigate if arginase inhibition protects from endothelial dysfunction induced by ischemia-reperfusion in patients with CAD with or without type 2 diabetes.

Methods: Male patients with CAD (n=12) or CAD + type 2 diabetes (n=12), were included in this cross-over study with blinded evaluation. Endothelium-dependent vasodilatation was assessed by flow-mediated dilatation (FMD) of the radial artery before and after 20 min ischemia-reperfusion during intra-arterial infusion of the arginase inhibitor (N-hydroxy-nor-L-arginine, 0.1 mg/min) or saline.

Results: The forearm ischemia-reperfusion was well tolerated. Endothelium-independent vasodilatation was assessed by sublingual nitroglycerin. Ischemia-reperfusion decreased FMD in patients with CAD from 12.7±5.2% to 7.9±4.0% during saline administration (P\<0.05). N-hydroxy-nor-L-arginine administration prevented the decrease in FMD in the CAD group (10.3±4.3% at baseline vs. 11.5±3.6% at reperfusion). Ischemia-reperfusion did not significantly reduce FMD in patients with CAD + type 2 diabetes. However, FMD at reperfusion was higher following nor-NOHA than following saline administration in both groups (P\<0.01). Endothelium-independent vasodilatation did not differ between the occasions.

Conclusions: Inhibition of arginase protects against endothelial dysfunction caused by ischemia-reperfusion in patients with CAD. Arginase inhibition may thereby be a promising therapeutic strategy in the treatment of ischemia-reperfusion injury.

Eligibility Criteria:
Inclusion Criteria:

* Coronary artery disease

Exclusion Criteria:

* Age \>80 years, Myocardial infarction/unstable angina within 6 weeks prior to the study, Raynaud's phenomenon, peripheral vasculopathies, arterial shunting or other vascular surgery of the study arm, Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol, Participant in an ongoing study, Unwillingness to participate following oral and written information.
Effects of Low-Level Laser Stimulation With and Without Fear Extinction Training

There are two specific aims for this study. Aim 1 is to test whether low-level laser therapy (LLLT) can enhance the efficacy of fear extinction training in the modification of pathological fear. Aim 2 is to investigate the efficacy of low-level laser therapy (LLLT) as a stand-alone intervention for anxiety/phobias.

Preliminary research with non-human animals suggests that LLLT (i.e., ultra low doses of transcranial infrared light) can enhance the retention of fear extinction learning by up regulating neuronal metabolic activity when applied to the ventromedial prefrontal cortex (vmPFC). Furthermore, evidence from a previous uncontrolled trial with humans suggests that LLLT (outside the context of extinction training) can lead to a significant decrease in symptoms of depression and anxiety when applied to the right and left dorsolateral prefrontal cortices (dlPFC). The first aim of this study is to test whether LLLT can boost fear reduction after extinction training in humans. A second aim of this study is to investigate the efficacy of LLLT as a stand-alone anxiolytic intervention in a randomized controlled trial.

Individuals between the ages of 18-65 with elevated fear in any of one of four domains (e.g., fear of enclosed spaces, fear of contamination, fear of public speaking, or anxiety sensitivity) are randomly assigned to one of four treatment arms (1) Extinction Training with LLLT, (2) Extinction Training with Sham LLLT, (3) LLLT alone, or (4) Sham LLLT alone.

To determine eligibility, all participants undergo an online prescreen and a face-to-face screening assessment. Participants who qualify for the study then complete a baseline (pre-treatment) assessment, followed immediately by the treatment procedure and a post-treatment assessment. Participants return to the lab an average of 14 days after treatment to complete a follow-up assessment. Participants complete two behavioral approach tests (in the treatment context and in the generalization context) at baseline, post-treatment, and follow-up, and a battery of self-report questionnaires at baseline and follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 18-65
2. Behavioral Approach Test (BAT) peak fear rating equal to or greater than 50/100 on both BATs (i.e., treatment and generalization contexts).

Exclusion Criteria:

1. High risk for suicide as determined by a clinical assessment, which will occur if a participant indicates that they are currently experiencing suicidal ideation on the depression module of the Mini International Neuropsychiatric Inventory, or on item 9 of the Beck Depression Inventory.
2. Psychotropic medication taken within the past 4 weeks.
3. Currently Receiving treatment for the fear domain in question.
4. Presence of a medical condition (i.e., pregnancy, seizure disorder, respiratory disorder, cardiovascular disease) that would contraindicate participation in one or more treatment or assessment activities as determined by a Medical History Questionnaire.
5. Active neurological condition (such as epilepsy or stroke) as determined by a Medical History Questionnaire.
The Swedish Study of Liver Transplantation for Non-resectable Colorectal Cancer Metastases

To evaluate if the addition of liver transplantation primarily utilizing liver grafts from extended criteria donors not utilized for approved indications to conventional treatment of non-resectable/ non-abatable colorectal liver metastases (CLM) increases overall survival compared to best alternative care.


Eligibility Criteria:
Inclusion Criteria:

* Patients with non-resectable, non-ablatable liver metastases from colorectal adenocarcinoma.
* Male or female 18 years or above.
* Primary tumour removed with an R0 resection, and histologically verified adenocarcinoma from colon or rectum
* Liver metastases measurable by MRI or CT according to RECIST version 1.1 Imaging within 4 weeks prior to inclusion.
* No signs of extrahepatic metastatic disease or local recurrence according to MRI and CT of thorax/abdomen and whole body Positron-emission tomography (PET)/ computed tomography (CT) scan.
* A colonoscopy performed within the last 12 months in order to exclude multifocal colorectal cancer (CRC) tumours.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Satisfactory blood tests: Hb ≥ 90 g/L (transfusions are permitted to achieve baseline hemoglobin level), White blood cell Count (WBC) \>3,0x109/L, Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L, platelet Count (PLT) \>75, Bilirubin\<2 x upper normal level, Aspartate aminotransferase (ASAT), Alanine aminotransferase (ALAT)\<5 x upper normal level, Calculated Creatinine clearance ≥ 50 mL/min(MDRD).
* Received at least 2 months of chemotherapy with no signs of progressive disease according to RECIST-criteria at the last evaluation before randomization.
* One year or more from the initial CRC diagnosis to the date of inclusion in the study
* Patient accepted for transplantation by a national study board
* Signed and dated written informed consent before the start of specific protocol procedures.

Exclusion Criteria:

* Evidence of extrahepatic disease by PET-CT or CT-thorax/abdomen.
* Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study.
* Weight loss \>10% the last 6 months
* Other malignancies within the last 5 years, except CRC and low risk tumours such as basaliomas.

  \* Liver metastases larger than 10 cm.
* Pathological lymphatic nodes in the abdomen. If a patient has pathological lymphatic nodules in the hepatoduodenal ligament, a staging operation with histo-pathological examination from the nodules with no signs of tumour cell involvement has to be performed before inclusion.
* BRAF (a gene that encodes a protein called b-raf) mutation in primary tumour
* microsatellite instability (MSI-H) in primary tumour
* Previous organ transplantation
Efficacy and Safety of Guduchi Ghan Vati for Covid-19 Asymptomatic Patients

Coronavirus disease 2019 (Covid-19) has been declared global emergency with immediate safety, preventative and curative measures to control the spread of virus. Confirmed cases are treated with clinical management as they are diagnosed but so far, there is no effective treatment or vaccine yet for Covid-19.

With recommended guidelines of AYUSH Ministry, India, the use of Ayurveda for Covid-19 has increased; however, its efficacy and safety in Covid-19 confirmed patients remain unclear.

Present study examined the efficacy and safety of one of the recommended Ayurveda drug (Guduchi Ghan Vati) compared with standard care for patients with asymptomatic Covid-19 patients.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* A person diagnosed with COVID-19
* Asymptomatic at the time of admission

Exclusion Criteria:

* Patients over 75 years
* Taking antibiotics or antiretroviral for any reason
* Mild to Moderate symptoms at the time of hospital admission
GDFT Based on PPV Compared With Standard Fluid Therapy in Patients Undergoing Complex Spine Surgery: RCT

The investigators will do the Goal directed fluid therapy by protocolized fluid management in the experimental group, using PPV to guide the fluid administration, compare with standard fluid management in patients undergoing complex spine surgery.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1-3
* elective surgery
* thoracic/lumbar spine surgery \>= 3 levels and duration \>= 3 hours

Exclusion Criteria:

* Cr \>2 mg/dl or eGFR \< 60 ml/min
* coronary artery disease, congestive heart failure or cardiac arrhythmia
* BMI \>30 kg/m2
* hemodynamic unstable, preoperatively
* uncontrolled hypertension
* respiratory system compliance \< 30 ml/cmH2O
Study Evaluating Pneumococcal Meningitis in the Paediatric Population in Spain Four Years After the Marketing of Prevenar.

The aim of this study is to determine the prevalence of pneumococcal meningitis in the paediatric population in Spain four years after the marketing of Prevenar. Also secondary objectives are: 1) to determine the clinical characteristics and outcome of the disease; and 2) to determine serotypes and antibiotic resistance patterns.


Eligibility Criteria:
Inclusion Criteria:

* All children from 0 up to 14 years with diagnosis of confirmed or probable pneumococcal meningitis or with diagnosis of suspected bacterial meningitis without bacterial or viral isolation will be included into the study.
Multi-CAR T Cell Therapy in the Treatment of Multiple Myeloma

The aim of this clinical trial is to assess the feasibility, safety and efficacy of autologous CAR T cell immunotherapy targeting multiple cancer cell surface antigens in relapsed and refractory multiple myeloma patients. Another goal of the study is to learn more about the persistence and function of CAR T cells in the body.

Multiple myeloma (MM) is a malignancy of plasma cells, which remains a clinical challenge despite advanced therapeutic interventions including novel molecular therapies and stem cell transplantation (SCT). This trial is to test the safety and efficacy of T cells genetically modified to specifically target several MM surface antigens, including BCMA, CD38, CD56, CD138 or alternative MM surface antigens, based on a multi-CAR T cell immunotherapy approach. Another goal of the study is to investigate the persistence and function of CAR T cells in the body after CAR T cell infusion.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with surface antigen confirmed multiple myeloma with no available curative treatment options (including autologous or allogeneic SCT).
* Complete remission (CR) cannot be achieved after at least 4 prior combination therapy regimens.
* MM in CR2 or CR3 and not eligible for allogeneic SCT because of age, comorbid diseases, or lack of available donor.
* Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \< 1 year).
* Relapsed after prior autologous or allogenic SCT MM patients with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic SCT.
* Residual disease after primary therapy and not eligible for ASCT
* Expected survival \> 12 weeks
* Creatinine \< 2.5 mg/dl
* ALT (alanine aminotransferase)/AST (aspartate aminotransferase) \< 3x normal
* Bilirubin \< 2.0 mg/dl
* Any relapse after prior SCT is eligible regardless of other prior therapy
* Adequate venous access for apheresis, and no other contraindications for leukapheresis
* Voluntary informed consent is given

Exclusion Criteria:

* Pregnant or lactating women
* Uncontrolled active infection
* Active hepatitis B or hepatitis C infection
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
* Previous related CAR-T cell therapy Any uncontrolled active medical disorder that would preclude participation
* HIV infection
Irinotecan Study For Cervical Cancer

The purpose of the study is to evaluate the efficacy and safety of Irinotecan plus cisplatin as first-line chemotherapy for advanced or recurrent cervical cancer


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented, advanced or recurrent squamous cell carcinoma of uterine cervix. Patients may have received concurrent (with radiotherapy) or (neo)adjuvant (before or after local treatment) chemotherapy for primary tumor providing that at least 6 months have passed from the completion of previous therapy and the diagnosis of recurrent disease was documented
* Having measurable lesion(s), without previous radiation therapy.

Exclusion Criteria:

* Patients had ever received primary chemotherapy for cervical cancer other than mentioned previously (in the inclusion criteria).
* Patients ever received cisplatin with total dose \> 300 mg/m2 and received radiotherapy or local treatment delivered to the target lesion.
Towards Better Understanding of FCE Performance in Different Societal Contexts

Purposes of this research:

* To study similarities and differences in FCE performances between participants from different countries, jurisdictions, and evaluators.
* To study determinants of FCE performance.

A considerable amount of research has been made on the safety, reliability and validity of the Functional Capacity Evaluation (FCE). Evidence is accumulating on different aspects of validity of FCE in healthy workers and in different patient groups, which has indicated that we are measuring a complex construct consisting of biological, psychological and social variables. However, this knowledge is still unstable as the majority of studies stem from a limited amount of countries. The present project focuses on the biopsychosocial factors that influence FCE performance. Participants undergoing an FCE perform differently depending on biological, psychological and social variables, although the latter has been under-researched. Clinicians are currently unable to predict which factors determine the differences in patient's FCE results. In this project, in addition to biological and psychological variables, investigators include a variety of social variables from different countries, jurisdictions, and evaluators, which may help investigators to identify important determinants of FCE performance. Knowing which characteristics and behaviors are associated with better or poorer participant performances may help clinicians to deliver improved FCE services.

Eligibility Criteria:
Inclusion Criteria:

* Musculoskeletal pain including: back pain, neck pain (including Whiplash-Associated Syndrome grade I or II), upper extremity pain, lower extremity pain.
* Non-specific pain: without specific medical diagnosis, see also exclusion criteria) .
* Complaints' duration \> 6 weeks
* Employed or self-employed
* Language skills sufficient to communicate with the FCE-clinician and fill out the required questionnaires

Exclusion Criteria:

* Pregnancy
* Tumours
* Fractures
* Radicular syndromes
* Spondylolisthesis grade 3 or 4)
* Whiplash-Associated Syndrome grade III or IV
* Other specific diagnoses related to the musculoskeletal System
* Unstable cardiovascular conditions and other co-morbidity affecting performance or safety during the FCE (i.e. severe depression needing psychiatric referral).
Study of Vitamin D Supplementation on Improvement of Gums Health

There is a gap in knowledge regarding the effects of Vitamin D supplementation on periodontal status in pregnant wome. The investigators aim to evaluate the potential benefit, if any of vitamin D supplementation during pregnancy on periodontal disease and relevant outcomes including burden of infections and prematurity rates.

the investigators hypothesize that

1. Vitamin D supplementation during pregnancy improves the periodontal health.
2. There is an association between inflammatory biomarkers and periodontal health of pregnant females.
3. Vitamin D supplementation improves the outcomes of pregnancy such as prematurity rates and birth weight

Periodontal disease is one of the most common chronic infectious diseases known to humans, with a reported prevalence varying between 10%-60% in adults. Periodontal health is commonly affected in pregnancy. The prevalence of pregnancy gingivitis varies widely, ranging from around 35%- 100%. Although, most of the periodontal changes during pregnancy are reversible but females with preexisting periodontitis or those who have metabolic disease such as diabetes may suffer increased periodontal destruction and may exhibit significantly greater probing pocket depth and attachment level. Periodontal disease, as a source of persistent infection, may induce systemic inflammatory responses that increase the risk of adverse pregnancy outcomes. However, so far the results have been mixed. As vitamin D metabolites may also alter the inflammatory response and have antimicrobial effects thus the use of vitamin D may affect periodontal status. Evidence is there which suggests that an association exists between low serum levels of Vitamin D and periodontal attachment loss. If the investigators take all of the above factors in consideration, the broad picture reveals that as vitamin D deficiency is prevalent in Pakistan, the pregnant females here are likely to have compromised periodontal health and probably poor pregnancy outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant females from 12-20 weeks of gestation who agree to participate in the study.
* Presence of at least 20 natural teeth in mouth excluding third molars.
* For controls: Non pregnant, healthy females matched with pregnant with respect to age and education.

Exclusion Criteria:

* Pregnant females with high Vitamin D levels,
* Women with metabolic diseases such as diabetes (type 1 or 2).
* Presence of acute dental or periodontal disease
* Presence of systemic disease and/or medication affecting the periodontium;
* Receipt of systemic antibiotic treatment or dental prophylaxis in the previous 3 months and those who do not provide informed consent
Tubeless Intersegmentectomy Plane Identification With Fluorography

Background: We aimed to evaluate the combination of inflation- deflation method and fluorography with the ICG injection in the tubeless minimally invasive segmentectomy (no intubation, VATS or Robotic).

Methods: A one- armed, prospective randomized controlled study was designed. The intersegmental plane was not so clear during the tubeless minimally invasive segmentectomy, and the presentation of the plane sometimes cost more time. This study will evaluate consecutive patients with the combination of inflation- deflation method and fluorography with the ICG injection.


Eligibility Criteria:
Inclusion Criteria:

1. cardio- pulmonary function can tolerate the minimally invasive surgery (including VATS and robotic surgery);
2. benign pulmonary lesion considering for segmentectomy;
3. ≤2cm pulmonary adenocarcinoma with ground- glass components, considering for segmentectomy.

Exclusion Criteria:

1. cardio- pulmonary function can not tolerate the minimally invasive surgery (including VATS and robotic surgery);
2. segmentectomy is not considered as the surgery plan.
Ganaxolone Treatment in Children With Fragile X Syndrome

This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled, crossover study to investigate ganaxolone treatment in children with fragile x syndrome (FXS). The objective of the study is to assess the safety, tolerability and efficacy of ganaxolone in the treatment of anxiety and attention in subjects with FXS.

This is a single center study conducted at University of California Davis (UCD) MIND Institute. Children with FXS between the ages of 6-17 years, inclusive will be randomized at a 1:1 ratio to receive ganaxolone or placebo treatment for 6 weeks, discontinue treatment and washout for 2 weeks, and then cross over to the opposite treatment for another 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* molecular documentation of FMR1 full mutation
* ages 6-17 yrs, inclusive
* sexually active subjects are required to use a medically acceptable form of birth control

Exclusion Criteria:

* non-English or Spanish speaking subjects
* concomitant systemic steroid, vigabatrin, felbamate and ketoconazole
* changes in medications within last 2 months
* clinically unstable medical disease, progressive CNS disease/disorder
* history of recurrent status epilepticus
* unwilling to withhold grapefruit or grapefruit juice for the duration of the study
* actively suicidal
Identifying Risk Factors for Falls in Patients With a High Risk of Fracture Using Connected Insoles (FeetMe Monitor® Device)

The objective of this study is to determine which gait parameters measured at home using e FeetMe® Insoles are associated with a risk for falls in a patient population suffering from osteoporosis and a higher with high risk of fractures and falls.

Each patient will be asked to go to 3 visits at the Cochin hospital, and to wear the soles after each of these visits during 3 days, at home, to record the data, so that it reflects walking patterns of the patient in his/her daily life and activities.

At the eachvisit, clinical tests to assess fall risk will be performed (Timed Up and Go test, one foot stance, Short Physical Performance Battery and 6 minutes walking test ).

The patients will be supplied with a pair of FeetMe® Monitor Insoles, return home and walking parameters will be recorded for 3 to 10 consecutive days.


Eligibility Criteria:
Inclusion Criteria:

* male and female subjects aged 60 years and above
* with a high fracture and fall risk defined by osteoporosis (low-trauma fracture within the last 5 years and/or osteoporotic bone density)
* a fall within the last year, who own a smartphone.

Exclusion Criteria:

* cognitive deficit or concomitant disorder limiting communication or participation in the study
* simultaneous participation in another study
* deprivation of liberty due to a legal or administrative decision
* patients receiving psychiatric care
* adults beyond the age of majority under legal protection measures or unable to express their consent
* patients admitted to a health or social establishment for reasons other than research.