cyrilzakka/clinical-trials huggingface dataset:
Post-Approval Study of the Implantable Miniature Telescope

The objective of the PAS-01 study is to assess the safety of the intraocular as measured by the cumulative incidence of patients who within 5 years after implantation experience persistent vision-impairing corneal edema (corneal edema leading to persistent loss of best corrected distance visual acuity \>2 lines from pre-surgery baseline level).

The study will test the null hypothesis that the percentage of patients who experience persistent vision-impairing corneal edema is \>17% against the alternative that the percentage is \<17%. The null hypothesis will be rejected if the upper bound of the two-sided 95% confidence integral for the observed percentage is \<17%.

ECD sub-study. At investigative sites participating in the ECD Sub-Group study, corneal endothelial cell density will be measured by non-contact specular microscopy in a subgroup of 150 patients enrolled in the IMT-PAS-01 in the eye schedule for and implanted with the intraocular telescope at study entry, 3 months, 12, months, 24 months, 36 months, 48 months and 60 months.

Eligibility Criteria:
Inclusion Criteria:

* stable severe (BVDCA of 10/160 or poorer) to profound (BCDVA of 20/800 or better) vision impairment caused by bilateral central scotomas associated with end-stage age-related macular degeneration.
* 65 years of age or older
* retinal findings of geographic atrophy or disciform scar with foveal involvement
* visually significant cataract
* agree to undergo pre- and post-surgery training and assessment
* achieve at least a 5-letter improvement with external telescope
* have adequate peripheral vision in the eye not scheduled for surgery

Exclusion Criteria:

* Stargardt's macular dystrophy
* Anterior chamber depth \< 3.0mm
* Presence of corneal guttate
* Do not meet minimum age and endothelial cell density requirements
* evidence of CNV or treatment of CNV within the past 6 months
* cognitive impairment that would interfere with ability to understand and complete Acceptance of Risk and Informed Decision Agreement or prevent proper training/rehabilitation
* previous intraocular or cornea surgery of any kind in operative eye, including any type of surgery for either refractive or therapeutic purposes or who have prior or expected ophthalmic related surgery within 30 days preceding intraocular telescope surgery
* history of steroid-responsive rise in intraocular pressure, uncontrolled glaucoma, or preoperative IOP \>22 mm Hg while on maximum medication
* known sensitivity to post-operative medications
* history of eye rubbing or an ocular condition that predisposes eye rubbing
* myopia \>6.0 D
* hyperopia \>4.0D
* axial length \<21mm
* narrow angle, i.e., \<Schaffer grade 2
* cornea stromal or endothelian dystrophies, including guttate
* inflammatory ocular disease
* zonular weakness/instability of crystalline lens, or pseudoexfoliation
* diabetic retinopathy
* untreated retinal tears
* retinal vascular disease
* optic nerve disease
* history of retinal detachment
* intraocular tumor
* retinitis pigmentosa
Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma

The purpose of this study is to evaluate the safety, tolerability, and efficacy of JX-594 (Pexa-Vec) administered intravenously either alone or in combination with Irinotecan in colorectal carcinoma patients who are refractory to or intolerant to standard therapy.

This was a Phase 1/2a, open-label, dose-escalation study in patients with advanced colorectal cancer (CRC)

Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed, advanced metastatic colorectal cancer failed treatment with fluoropyrimidine (fluoruracil or capecitabine) and oxaliplatin based therapies or had contradictions to treatment with these drugs as determined by the investigator
* Failed treatment with irinotecan
* Kras mutant tumor or Kras wild-type having failed cetuximab (Erbitux) or panitumumab (Vectibix) or had contradictions to treatment
* Regorafenib-naïve (have not received regorafenib)
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
* Measurable tumor (≥1 cm longest diameter)
* Acceptable health status as determined by the investigator and blood work (Chemistry, Complete Blood Count, Coagulation)

Exclusion Criteria:

* Intolerant to Irinotecan (if assigned to the combination arm: Cohort 3, Cohort 4 or Combination Expansion Arm)
* Treatment with ketoconazole, enzyme-inducing anticonvulsants and St. John's Wort (if assigned to combination arm)
* Significant immunodeficiency due to underlying illness and/or medication
* History of severe exfoliative skin condition requiring systemic therapy within the past 2 years
* Clinically significant and/or rapidly accumulating ascites, pericardial and/or pleural effusions
* Active cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months
* Viable Centrual Nervous System (CNS) malignancy associated with clinical symptoms
* Received anti-cancer therapy within 4 weeks prior to first treatment (6 weeks for mitomycin c or nitrosoureas)
* Prior participation in any other research protocol involving an investigational medicinal product within 4 weeks prior to first treatment
* Use of prohibited anti-viral medication, interferon/pegylated interferon (PEG-IFN) or ribavirin that cannot be discontinued within 14 days prior to any JX 594 dose
* Inability to suspend treatment with anti-hypertensive medication for 48 hours prior to and 48 hours after all JX-594 treatments.
* Pregnant or nursing an infant
* Diagnosis of chronic inflammatory bowel disease and/or bowel obstruction.
The Pathogenesis of Hepatitis C Virus Vertical Transmission

To evaluate for the presence of HCV Core protein, HCV RNA and SPP in the placenta and fetal membranes using paraffin-embedded sections and post-delivery specimens respectively. In parallel, we will assess placental tissue for evidence of HCV infection using a novel in situ hybridization technique and translate our in vitro findings to these in vivo samples.

Our overall hypothesis is that cytotrophoblasts at the maternal-fetal interface within the placenta serve as a "barrier" that must be crossed during vertical transmission and that cytotrophoblasts are permissive to HCV at a low level that may be enhanced under certain conditions. By comparing the regulation of key steps in the intracellular life cycle of HCV in cytotrophoblasts to highly permissive hepatocytes, significant differences in HCV regulation should be revealed.

Based on our preliminary data, our working hypothesis is that HCV Core protein is differentially processed in cytotrophoblasts compared to hepatocytes.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with HCV infection
* Pregnant women without HCV infection

Exclusion Criteria:

* None
Intervention Effect of Yizhi Baduanjin on Patients With Mild Cognitive Impairment

With mild cognitive impairment (MCI) as the research object, the intervention effect of Yizhi Baduanjin on mild cognitive impairment was evaluated by using the Montreal Cognitive Assessment (MoCA) scale, human-computer interactive electronic cognitive function score, multi-measure EEG data and other evaluation indicators, with the intervention measures of Yizhi Baduanjin created by the Tai Chi Health Center in the early stage. This project is based on the preliminary study, followed the principles and methods of clinical epidemiology and evidence-based medicine, and designed a prospective, randomized, single-blind, parallel controlled trial to make up for the deficiency of existing drugs in the intervention of mild cognitive impairment, and to provide evidence for the clinical and community promotion and application of effective and safe traditional Chinese medicine non-pharmaceuticals in the prevention and treatment of mild cognitive impairment.

Mild cognitive impairment（MCI） is a critical state between normal aging and dementia, with its core symptom being age-related cognitive decline. This critical state provides a window of opportunity for preventing Alzheimer's disease. At present, there is a lack of sufficient intervention methods to improve MCI.

Yizhi Baduanjin is an adaptation of traditional Baduanjin, which is more suitable for middle-aged and elderly people to practice and optimize for improving cognitive function. Previous observations and studies have provided some evidence to prove the beneficial effect of Yizhi Baduanjin on MCI.

This is a two-group prospective, randomized, assessor-blinded trial, planning to enroll 100 participants.They will randomly divided into two groups: the training group with 50 cases and the control group with 50 cases. The training group will receive intervention with the Yizhi Baduanjin, and various evaluation indicators will test before and 4、12、24 weeks after the intervention. The control group is a waiting control group, and after 24 weeks, they will continue to learn the Yizhi Baduanjin. The control group and the practice group will be tested simultaneously at four time points. Finally, the intervention effect will be evaluated through inter group and intra group comparisons of test data.

The main research purpose is to evaluate the clinical effect of Yizhi Baduanjin on MCI.The secondary research objective is to explore the possible mechanism of Yizhi Baduanjin in improving MCI.

Eligibility Criteria:
Inclusion Criteria:

* Subjective symptoms include memory loss
* MoCA score is less than 26 points
* No disability, no communication barrier, and can complete the cognitive function test of human-computer interaction
* Agree to participate in the project and sign the informed consent form

Exclusion Criteria:

* Alzheimer's patients
* Cognitive impairment caused by depression, cerebrovascular accident and other specific reasons
* Those who are unwilling or unable to take part in the Yizhi Baduanjin exercise
Acute Effect of Foot Reflexology Massage on Heart Rate Variability and Arterial Pulse Waveform

Foot reflexology treatment provides acute and chronic effects on cardiovascular and hemodynamic functions. However, no information is available to us in regarding the treatment effect of foot reflexology after exercise. This study investigated the acute effect of foot reflexology treatment on heart rate variability after anaerobic-based and aerobic-based intermittent exercises.

The sympathetic activation and sympathy-vagal balance after repeat sprint performance can be immediately modulated by foot reflexology massage. The acute benefits of foot reflexology intervention on cardiac sympathovagal balance can be considered as exercise recovery strategies in sports.

Eligibility Criteria:
Inclusion Criteria:

* Undertake football/futsal training at least 3 times a week
* Age between 18 and 30 years old

Exclusion Criteria:

* History of severe neuromuscular injury
* Current lower extremity injury
* Current neurological diseases
Safety and Efficacy of Arterial Delivery of Autologous Bone Marrow Cells in the Treatment of Insulin-Dependent Diabetes

Diabetes mellitus is a long-term multi-organ disease with severe implications that constitute a major health problem worldwide. Type 1 diabetes is an autoimmune disorder in which the body's own immune system attacks and destroys the cells that make insulin. Exogenous administration of insulin is the primary method of controlling type 1 diabetes by regulating blood glucose levels, but this treatment does not reverse nor prevent disease progression.

Our hypothesis is that when implanting stimulated total bone marrow by arterial injection directly into the pancreas, we will achieve functional recovery of insulin-producing cells. This study will include patients with chronic type 1 diabetes and absence of lesions in target organs. We will follow the evolution of patients receiving autologous total bone marrow implantation by selective catheterization and compare to a non-treatment control group. All subjects will continue to use insulin therapy as needed to maintain the best possible glucose control.

The objective is to achieve a significant increase in C-peptide levels indicating a regeneration of the beta islet cells with a decrease in exogenous insulin usage in at least 70% of the patients.

This study is a follow-up to our initial study in which 22 patients received autologous total bone marrow. The initial study was 100% safe but additional studies like the one described above are needed to show efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Between 18-30 years of age, diagnosed with diabetes mellitus Type 1 (insulin-dependent).
* Negative antibody titers for GAD and anti-islet.
* Measurements of serum C-peptide below normal values.
* BMI 20-25, men, 19-24, women

Exclusion Criteria:

* Diabetes type 2, gestational diabetes, and other types of secondary diabetes.
* Patients with acute metabolic complications of diabetes such as ketoacidosis at least within the last 6 months.
* Abdominal perimeter \>102 cm in men; \>88cm in women
* Fasting glycemia \>100 mg/dl, triglycerides \>150 mg/dl, HDL \< 40 mg/dl.
* Blood pressure: SBP \>135 mmHg and DBP \>85 mmHg at the time of randomization
* Patients with BMI \> 25 for men and \>24 for women.
* Patients weighing \< 40 kg.
* Patients with abnormal ECG indicative of acute or chronic ischemia or acute/chronic necrosis.
* Patients with anemias of any origin.
* Patients undergoing antibiotic treatment for acute infection.
* Patients with any blood abnormality.
* Patients with history of moderate to severe pancreatitis.
* A female subject who is breast-feeding, pregnant, intends to become pregnant or refuses to use a contraceptive method during the course of the study.
* Patients allergic to iodine or filgrastim.
* Patients using medications that could affect this study.
* Patients with serious mental conditions.
* Patients who have undergone a previous stem cell treatment.
* Patients who do not accept and sign the informed consent.
A Preliminary Study on the Intervention Effect of Virtual Reality Exposure Therapy on Fear of Flying

The goal of this clinical trial is to explore the efficacy of VR exposure intervention in alleviating fear of flying through a randomized controlled study.


Eligibility Criteria:
Inclusion Criteria:

* The flight anxiety situations questionnaire (FAS) score is no less than 56 points (the critical value is set as two or more standard deviations higher than the average of the normal population);
* Aged between 18 and 65 years old;
* Have normal intelligence and good or corrected vision;
* No family history of any mental illness or other mental disorders other than anxiety disorder;
* Currently not receiving any treatment for phobia, including but not limited to taking psychotropic drugs (unless the dose is stable for more than 3 months, and the subject agrees to continue taking the dose throughout the study);
* Have at least 1 flight experience;

Exclusion Criteria:

* The participant cannot tolerate or adapt to VR stimulation;
* The participant was unable to immerse themselves well in the VR environment;
* Severe physical diseases and physical diseases induced by stimulation, including cardiovascular and respiratory diseases, etc.;
* Have a history of neurological diseases (such as epilepsy, cerebrovascular accident, etc.) or brain trauma or brain surgery;
* The subject suffers from a physical disease and is not in a stable treatment period (such as hyperthyroidism, visual impairment, etc.), resulting in the inability to fully participate in the experimental process;
* Pregnant women.
First Trimester Screening for Preeclampsia and Intrauterine Growth RestrIction Using Three Dimensional Doppler Angiography

Introduction: Preeclampsia (PE) and intrauterine growth restriction (IUGR) are two major pregnancy complications, related to a chronic utero-placental hypoperfusion. Nowadays, there isn't a screening or diagnostic test in clinic for utero-placental vascularization deficiency. Since 2004, 3D Power Doppler angiography has been used for the evaluation of utero-placental vascularisation and three vascular indices have been calculated: the vascularisation index (VI), flow index (FI) and vascularisation-FI (VFI). A high intra and inter-observer reproducibility and its potential interest for placental function study were reported. The investigator's main hypothesis is that these 3DPD indices could provide predictive values for PE and/or IUGR occurrence much higher than those observed with the currents other markers.

Objectives: The main objective of this study is to determine differences in 3DPD indices at first trimester between pregnancies defined at their outcome as uncomplicated pregnancy, PE (mild and severe) and IUGR in nulliparous women.

Methods and analysis: This is a prospective study. The investigators expect to include 2200 women in 4 French centers: Centre Hospitalier Universitaire de Nancy, Paris-Port-Royal (Assistance Publique - Hôpitaux de Paris), Strasbourg and Belfort (Hôpital Nord Franche-Comté).

The nulliparous pregnant women will be recruited during their 1st trimester consultation for routine Down syndrome screening (11-13+6 gestation weeks). Especially for the study, the 3DPD and Uterine Artery Doppler (UAD) acquisition, which last less than 10 min, will be included in the current routine 11-13+6 gestation weeks ultrasound screening. Also, additional blood samples will be taken for biomarker analysis (PAPP-A and P1GF) and biological collection. Utero-placental vascularization indices (VI, FI, VFI) will be quantified using VOCAL® software. For each subgroup (uncomplicated pregnancy, PE and IUGR) mean values in 3DPD indices will be computed and compared using a pairwise t test with a Bonferroni correction p value adjustment.


Eligibility Criteria:
Inclusion Criteria:

* Singleton nulliparous pregnant women between 11 and 13+6 gestation weeks.
* Mandatory enrolment in a social security plan,
* Patient (or a third person, independent from the investigator and the sponsor, in case of inability to read or write) having signed an informed consent.

Exclusion Criteria:

* Patients under a measure of legal protection.
* Patient under 18,
* Absence of social insurance,
* Patient participating simultaneously to other interventional research trial to test a pharmaceutical treatment and protocols are not compatible,
* Inability to understand and accept the protocol.
Brain Activity Changes After Cognitive Behavioral Therapy for Anxiety in Autistic Youth From High-Need Communities

The goal of this clinical trial is to investigate neural constructs related to anxiety symptoms in response to Facing Your Fears (FYF) treatment in autistic participants with co-occurring anxiety.

Researchers will compare participants receiving immediate FYF intervention to those in the waitlist control group (receiving treatment as usual) to see if there are differences in neural constructs and anxiety symptom changes over the study period.

Participants will:

* Complete the Facing Your Fears (FYF) intervention if assigned to the immediate treatment group
* Continue their usual treatment during a waitlist period if assigned to the control group, followed by the opportunity to participate in FYF intervention after the waiting period ends
* Complete assessments of neural constructs, anxiety symptoms, and other measures

Aims of the study:

* How do brain activity patterns (measured by EEG) relate to anxiety symptoms in autistic youth, as reported by both the youth and their parents?
* Will brain activity changes line up with improvements in anxiety after FYF treatment in autistic youth from underserved communities?
* Will brain activity relate to other factors related to anxiety (e.g., a person's ability to handle uncertainty and manage emotions)?

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 8 and 14
* Have significant deficits in reciprocal social behavior as defined by a score of 11 or above on the parent-report SCQ questionnaire
* Are verbally fluent in English, enabling them to participate in the appropriate modules (3 or 4) of the researcher-administered ADOS-2
* Have an estimated verbal IQ of 70 or above as determined by the researcher-administered KBIT-2
* Have clinically significant anxiety symptoms as defined by significant elevations on either the parent-report SCARED questionnaire or the parent-report PRAS-ASD questionnaire
* Have a legal guardian who can provide consent for their child's participation as well as their own participation in the intervention alongside their child. If the legal guardian is unable to participate in the intervention themselves but would like for their child to receive the intervention with another caregiver who lives with the child, the legal guardian will still be the one to sign the consent form, but will provide permission for another caregiver (logged on the consent form) to participate in the intervention alongside the child

Exclusion Criteria:

* Fail to meet any of the above inclusion criteria
* If it is determined by the research team via parent report or direct observation that the child has a severe medical or psychiatric impairment (e.g., psychosis, severe aggressive behavior, or other severe clinical symptoms) that require more intensive treatment such as day treatment or hospitalization
People-Powered Medicine (PPM): Rheumatoid Arthritis Non-responders to Biologic Therapies (RANT)

The investigators are interested in enrolling patients with rheumatoid arthritis (RA) who had a difficult time getting their disease under control even after trying multiple RA therapies. The investigators believe that there may be common patterns in the genes of this group of RA patients compared to those with more "textbook RA." Understanding genetic factors can help doctors to know in advance who may not respond to conventional therapies and start with treatments that work. Learning about underlying genes that influence treatment may help the investigators to identify new targets for therapy, to ultimately improve the lives of patients with RA and inflammatory arthritis.

The investigators are looking for patients with rheumatoid arthritis (RA) with an inadequate response to tumor necrosis factor inhibitor (TNFi) and another biologic disease modifying anti-rheumatic drug (bDMARD) or small molecule approved for treating RA. The investigators are conducting this research to learn more about RA and the genetic patterns associated with patients whose RA cannot be well controlled with most RA treatments. Investigators anticipate that these patients will differ from "classic" RA patients in their biomarker and genetic composition and that they represent a mixed group of individuals who may be similar in ways that are not currently being measured.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* RA diagnosed by a rheumatologist
* Poor control of RA disease activity with tumor necrosis factor inhibitor (TNFi) and another biologic therapy or small molecule approved for RA

Exclusion Criteria:

* If the reason for failed TNFi therapy was due to a contraindication or adverse reaction
* Unable to provide blood sample