cyrilzakka/clinical-trials huggingface dataset:
A "negative"dendritic Cell-based Vaccine for the Treatment of Multiple Sclerosis: a First-in-human Clinical Trial

A first-in-human clinical trial to treat patients with multiple sclerosis by vaccination with tolerogenic dendritic cells (tolDC), generated using Good Manufacturing Practice (GMP) will be conducted. In doing so, the feasibility and safety of administering myelin-derived peptide-pulsed tolDC in patients with MS will be assessed.

A phase I dose-escalating clinical trial will be conducted in a coordinated and comprehensive manner to determine safety and tolerability, and to enable selection of a suitable dose regimen for phase II trials. The primary objective of the phase I study will be to determine whether tolDC-based therapy is safe and well tolerated and to establish the dose-response, with clinical relapse rates, neurological disability (assessed using various scales) and MRI endpoints, measured over 12 months. Patients will serve as their own controls pre- and post-vaccination. Completion of screening assessments and confirmation of eligibility criteria should take no longer than 6 weeks. First-line treatments will be stopped 6 weeks before baseline at the latest.

Eligibility Criteria:
Inclusion Criteria:

* MS according to 2010 revised McDonald criteria (76);
* Expanded disability status scale (EDSS) of 0-6.5 inclusive;
* Disease duration of maximum 15 years and first signs or symptoms at least 6 months prior to enrolment in the study;
* Active MS (relapsing and progressive): -1 relapse in the past year and/or

  * at least 1 enhancing lesion on brain MRI in the past year
  * new or enlarging T2 lesion(s) in comparison with a reference scan from maximum 1 year before
* Neurologically stable with no evidence of relapse for at least 30 days prior to start of screening and throughout during the screening phase;
* Positive T cell reactivity response to a mix of 7 myelin-derived peptides;
* Able to sign informed consent;
* Ability to comply with the protocol assessments;
* Appropriate venous access.
* Use of adequate contraceptive measures

Exclusion Criteria:

* Previous use of immunosuppressive or cytostatic treatment, including mitoxantrone, alemtuzumab or bone marrow transplantation or stem cell transplantation at any time prior to enrolment;
* Treatment with fingolimod or natalizumab or dimethylfumarate or teriflunomide within the last 3 months prior to study enrolment;
* Pregnancy or planning pregnancy in the next 12 months and breast feeding;
* Drug or alcohol abuse;
* Inability to undergo MRI assessments;
* History of or actual signs of immunodeficiency or malignancies;
* Concurrent clinically relevant cardiac, immunological, pulmonary, neurological, renal or other major disease;
* Hepatitis B, C, HIV, Syphilis or tuberculosis
* Splenectomy;
* Dementia or severe psychiatric, cognitive or behavioral problems or other comorbidity that could interfere with the compliance to the protocol.
Immediate Functional Versus Non Functional Implant Loading in the Mandible

comparing immediate functionally loaded implants and immediate non functionally loaded implants in the posterior mandibular region on bases of bone density and bone loss evaluated by cone-beam computed tomography (CBCT).

Patients are more demanding after the revolution in immediate implant dentistry which reduces implant procedure nowadays according to literature and research. In response to patients' demands not only implants are immediately placed but also immediately loaded within 72 hours reducing the time for prosthetic loading and also improving bone formation according to some studies. The debate in modern implant dentistry is whether to immediately load the implants in functional occlusion or non-functional occlusion and which will improve the osseointegration and reduce crestal bone loss.

Implants of the BioInfinity system were placed in 16 subjects divided into two groups.

Group (A): 8 patients with missing posterior mandibular teeth whom will be rehabilitated with immediate functionally loaded implants.

Group (B): 8 patients with missing posterior mandibular teeth in whom immediate non-functionally loaded implants were used.

The two groups were evaluated at baseline, immediately after implant placement and 4 months postoperative to evaluate crestal bone level and quantitative radiographic bone density using CBCT.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged (20-40) years old.
* Missing Posterior tooth or teeth indicated for implant placement.
* Residual alveolar ridge at least 10 mm high and at least 4 mm wide.

Exclusion Criteria:

* Systemic diseases that will contraindicate the surgery.
* Poor Oral Hygiene.
* The patient refuses to undergo the surgery.
* Parafunctional habits.
Dementia and Disability Simulation for College Nursing Students' Senior Activity Facilitation Skills

This study aims to evaluate the effectiveness of a dementia and disability simulation (DDS) program on dementia knowledge, attitude, empathy, and activity design skills for seniors among college nursing students.

This two-group randomised controlled trial aims to evaluate the effectiveness of a dementia and disability simulation program on dementia knowledge, attitude, empathy, and activity design skills for seniors among college nursing students.

The interventional group will receive a 6-week dementia and disability simulation program of activity design for seniors.

The control group will receive 6 weeks of regular dementia course and group discussion of activity design for seniors with no dementia and disability simulation.

Both groups will be assessed for their dementia knowledge, attitude, empathy and activity design skills for seniors at baseline, week 12, and week 18.

Eligibility Criteria:
Inclusion Criteria:

* college nursing students with age ranged from 19 to 40 years,
* Taiwanese nationality,
* Sophomore and above
* provide informed consent to participate in the study.

Exclusion Criteria:

-college nursing students who do not meet the inclusion criteria
Effectiveness and Safety Evaluation of Aqueduct -100 Device

Evaluation of efficacy and safety of using Aqueduct -100 - Cervical Dilator Device

There are predominantly two major dilatation techniques that are employed in dilating the cervix. The first technique uses expansible dry solid material, such as laminaria (seaweed) is inserted into the cervix in its dried stiff form. In the cervix it comes into contact with body fluids that cause the laminaria to swell and enlarge the cervical cavity. The second more widespread procedure, involves the use of series of solid, rod like instruments of graduated diameter used in serial fashion by the physician (Hegar dilators). The physician first inserts a rod like dilator and replaces it with the dilator of next higher diameter. This procedure continues until adequate dilatation occurs.

The Problem is that each of the above-mentioned methods has its shortcomings: the use of the laminaria method (rarely done) requires preliminary patient visit, for insertion of the laminaria rod and is extremely slow and typically involves often as much as 10-12 hours for a significant amount of dilatation to occur.

The use of rod-like instruments (Hegar) requires general or regional anesthesia, when local anesthetics are used, the patient nevertheless frequently experiences a great amount of discomfort from the procedure. The mechanical dilatation of the cervix demands a large amount of longitudinal force that may damage or even puncture the cervix and the uterus.

Aqueduct 100 is a catheter for use in dilating various body cavities and especially the human cervix. The device will enable continuous, fast and safe dilatation of the cervix to a pre-determined diameter as a pre-procedure to intrauterine surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Subjects, females, 18 years of age or older.
* Subjects undergoing any process that requires dilation (intrauterine procedures)
* Subjects willing to sign informed consent form.

Exclusion Criteria:

* Subjects younger than 18 years of age
* Subject with sex transmitted diseases, or with infectious diseases (HIV, HCV).
* Subjects unwilling to sign the informed consent form.
The Effect of Endometrial Scratching on Patients With Endometriosis

We aimed to investigate whether endometrial scratching could improve IVF outcomes by enhancing endometrial receptivity in patients with endometriosis.


Eligibility Criteria:
Inclusion Criteria:

1.Endometriosis that surgery or pathology confirmed; 2. normal ovarian reserve; 3. at least one implantation failure history

Exclusion Criteria:

1. hydrosalpinx; 2.ademomyosis; 3.endocrine or self-immune disease; 4.serious medical condition; 5.Contraindications of intrauterine operation
Assessing Closed-loop Insulin Delivery in Children With Type 1 Diabetes.

The objective of this clinical trial is to assess the safety of our insulin dosing algorithm in children with type 1 diabetes in a free-living study.

This is a preliminary pilot study to generate data to optimize an insulin dosing algorithm to regulate glucose levels in children with type 1 diabetes. There will be up to two 40-hour test in outpatient settings, in which we will assess an insulin dosing algorithm. The two tests will allow us to compare different tunings in the same patient (this allows easier interpretation of the data). For example, if in a specific participant, the dosing algorithm reduced insulin delivery at night to avoid low blood glucose levesl but led to a rebound increase in glucose levels, then a second visit with a slightly different target range will help answer this question. The objective of this clinical trial is to assess the safety of our algorithm in children with type 1 diabetes in a free-living study.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female children between 2 and 13 years of age.
2. Clinical diagnosis of type 1 diabetes mellitus (the diagnosis of type 1 diabetes is based on the investigator's judgment).
3. Using insulin pump therapy for at least 3 months
4. For participants aged 7-13 years: Total daily insulin dose ≤ 40 units and 0.5 ≥ units/kg/day. For participants aged 2-6 years: Total daily insulin dose \[8, 40\] units and 0.3 ≥ units/kg/day.
5. Most recent (in the last 6 months) HbA1c ≤ 12%.

Exclusion Criteria:

1. Using Medtronic 670G automated insulin delivery system (since participant's basal rates and insulin-to-carbohydrate ratios may reflect the use of 670G; generally overestimated by 20%).
2. Severe hypoglycaemia or ketoacidosis episode ≤ two months before admission.
3. Medical illness or other issues likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
Impact of Photobiomodulation on Pain During Orthodontic Treatment.

The objective of this study is to determine to effect of PBM Ortho, a photobiomodulation device, in adult patients undergoing clear aligners orthodontic treatment. We hypothesize that PBM Ortho will reduced the orthodontic associated pain in the clear aligner patients. This effect will be evaluated by recording the pain on visual analog scale given to the patients before the placement of clear aligners and collecting saliva.

Pain associated with orthodontic treatment is one of the main causes of treatment discontinuation and patient non-cooperation. Several treatment modalities have been studied to alleviate orthodontic pain which includes pharmacological, mechanical, and behavioral approach. One potential treatment is the application of photobiomodulation (PBM) therapy which is a form of light therapy. The objective of this study is to determine to effect of PBM therapy in adult patients undergoing clear aligners orthodontic treatment. This effect will be evaluated by recording the pain on visual analog scale given to the patients before the placement of clear aligners and collecting saliva. The patients will be provided with active PBM Ortho device and sham PBM device (placebo, which will look similar to the active device) to use them at home for one 8 minutes application for 7 days (4 minutes per arch, upper or lower). The pain scale sheets will also be given to the patients to fill them every day for 7 days. The inflammatory protein associated with pain present in the saliva will be collected on Day 1 (24 hours after clear aligner treatment start), Day 4 (fourth day of treatment), and Day 7 (after 1 week from the treatment start). On the last visit, the device and pain scale sheets will be collected from the patients. If successful, this device therapy will reduce the orthodontic associated pain and improve patients' compliance and cooperation.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy male and female patients (age 20 to 65), i.e., do not suffer from systemic illness nor require medication during the saliva collection period.
* Permanent dentition, with Little's Irregularity Index (LII) of 2 mm or greater for the upper and lower arch.
* Orthodontic treatment using clear aligners via non-extraction therapy.
* Patient is available for follow-up visits.
* Patient is able and willing to comply with the requirements of this trial protocol.
* Non-smoker with no use of chewing tobacco.
* Good oral hygiene.
* Caries free.
* No sign of periodontal disease.

Exclusion Criteria:

* Systemic diseases
* Medication use for the past 6 months; specially use of anti-inflammatory (e.g., NSAIDs), antiviral, antibiotics.
* Smoking.
* Active dental caries.
* Any periodontal problem including bleeding, tooth mobility, bone loss, attachment loss, deep pockets.
* Sleep apnea and other airway pathologies.
Apatinib in Combination With Stereotactic Body Radiation Therapy (SBRT) Treatment for Symptomatic Metastatic Prostate Cancer

To study safety and efficacy of apatinib in combination of radiotherapy in patients with symptomatic bony disease prostate cancer (SBPC), based on the potential synergistic antitumor activity between Apatinib and Stereotactic Body Radiation Therapy (SBRT).


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of adenocarcinoma of the prostate
* Metastatic and symptomatic prostate cancer (positive bone scan or measurable disease)
* Patients must stop using any herbal product known to decrease PSA levels (eg., saw palmetto and PC-SPES) or any systemic or topical corticosteroid at least 4 weeks prior to screening. Progressive disease must be documented after discontinuation of these products.
* Progressive disease after androgen deprivation (or hormone therapy). For patients with measurable disease, progression will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. For patients with progression in, or without any measurable disease, a positive bone scan and elevated PSA will be required.
* Patients receiving bisphosphate therapy must have been on stable doses for at least 4 weeks with stable symptoms prior to enrollment.
* No prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control prostate cancer).
* Prior radiation therapy completed at least 4 weeks prior to enrollment. No prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.

Exclusion Criteria:

* History of severe hypersensitivity reactions to drugs formulated with polysorbate 80.
* Patients with active autoimmune disease or a history of autoimmune disease that required systemic steroids or immunosuppressive medications, except for patients with vitiligo.
* Prior therapy with any anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) antibody.
* Active infection requiring therapy.
* Concurrent medical condition requiring the use of systemic or topical corticosteroids; systemic or topical corticosteroids must be discontinued at least 4 weeks prior to enrollment. The use of inhaled corticosteroids is acceptable.
Injection Pressure & Adductor Canal Block

This is a prospective, randomized, single-blinded human clinical trial that will examine how injection pressure influences the spread of a given volume of injectate in the adductor canal, during adductor canal nerve block.

This is a prospective, randomized, single-blinded human clinical trial that will examine how injection pressure influences the spread of a given volume of injectate in the adductor canal, during adductor canal nerve block. The study population will be patients undergoing elective anterior cruciate ligament repair in the distal lower extremity and receiving preoperative adductor canal nerve blocks for postoperative analgesia. They will be randomized into two groups of 25 patients each. The investigators speculate that high injection pressures (\>20 psi) will lead to greater spread of local anesthetic than low injection pressures (\<15 psi) during mid-thigh adductor canal nerve blocks. The primary endpoint is the spread of injectate, defined as the distance between the uppermost and lowermost limits of spread of local anesthetic as assessed by ultrasound. The secondary endpoints are the incidence of femoral and sciatic nerve blocks 30 minutes after block placement, amount of IV opioid administered intraoperatively and postoperatively, preoperative and postoperative pain (Numeric Rating Scale, 0-10), and postoperative physical therapy milestone achievement.

Eligibility Criteria:
Inclusion criteria:

1. Planned general anesthetic.
2. American Society of Anesthesia classes I, II, or III.
3. Patients aged 18-65.
4. English-speaking patients.

Exclusion criteria:

1. ASA classes IV and V.
2. Patients younger than 18 or older than 65.
3. Contraindication to regional anesthesia (coagulopathy, patient refusal).
4. Allergy to local anesthetic or other study medications.
5. BMI \> 35 kg/m2.
6. Chronic opioid use (daily or almost daily use for \> 3 months).
7. Active illicit drug use.
8. Additional surgical site other than the limb for adductor canal block.
9. Pregnancy.
10. Preexisting neuropathy in the operative limb.
11. Inability to communicate to investigators or hospital staff.
12. Inability to speak or understand English.
Vascular Aging in Flight Attendants With Occupational Secondhand Smoke Exposure

Specific Aim 1. Characterize the long-term effects of secondhand smoke (SHS) on vascular health in pre-ban flight attendants (FAs). Investigators will measure arterial stiffness (pulse wave velocity and augmentation index) and endothelial dysfunction (reactive hyperemia index) in the pre-ban FA cases, and compare to the cardiovascular risk-factor matched Framingham controls.

It is hypothesized that pre-ban FA cases have increased arterial stiffness (higher pulse wave velocity and higher augmentation index) and increased endothelial dysfunction (lower reactive hyperemia index) compared to Framingham controls.

Specific Aim 2. Determine the extent in which remote pre-ban SHS exposure (hours) is associated with increased arterial stiffness or endothelial dysfunction.

Investigators hypothesize that pre-ban SHS exposure is positively associated with both increased arterial stiffness and increased endothelial dysfunction.

Specific Aim 3. Investigators will calculate the cardiovascular risk scores (Framingham, Reynolds, and ASCVD) by using subjects' age, blood pressure, family history, lipid panel, and highly sensitive C-reactive protein. Investigators will explore the association of the risk scores with measures of vascular aging (arterial stiffness and endothelial dysfunction). These scores do not include SHS exposure. Investigators will also test the additive value of SHS exposure in increasing arterial stiffness and endothelial dysfunction using the risk scores as an adjustment value.

It is hypothesized that the cardiovascular risk scores are associated with vascular aging (arterial stiffness and endothelial dysfunction), and that the association between SHS exposure and vascular aging remains significant after adjusting for the cardiovascular risk scores.

The significance of this proposal and impact will be (1) mechanistic insights into how remote SHS exposure leads to hypertension and vascular stiffness, (2) increased understanding of how SHS exposure can increase risk of cardiovascular disease, which is the number one cause of death in the United States.

The investigators propose a cohort study, in which investigators will assess for evidence of accelerated vascular aging in 300 pre-ban FAs with pre-ban SHS exposure, and compare their vascular measures of arterial stiffness and endothelial dysfunction to those of age and risk-factor matched Framingham controls. It is hypothesized that pre-ban FAs have increased arterial stiffness and endothelial dysfunction compared to the Framingham subjects, related to SHS exposure.

Eligibility Criteria:
Inclusion Criteria:

* 40 years of age and older;
* Flight attendant, including current or past employment with the airlines;
* Non-smoking flight attendant (current and prior, defined as smoking \<100 cigarettes in your lifetime);
* Exposed to secondhand tobacco smoke for at least one year, while working on the aircrafts

Exclusion Criteria:

* History of Raynaud's syndrome
* Had mastectomy or arm/hand abnormality in which blood pressure cannot be measured on the arm
Clinical Study New Gel for Xerostomia

At present, there is no single consensus protocol for the treatment of oral dryness, although the main objective is to improve the quality of life of patients. Current therapy for the control of xerostomia is based on the following measures:

1. General measures ; review and control of drugs,hydration and dietary advice:

   The main recommendations are found in the following scheme.
2. Saliva stimulants( Topics and sistemic )The option of using chewing stimuli by chewing gum with non-cariogenic sweeteners helps to improve symptoms. The investigators can also use gustatory stimuli, such as citric acid that is a potent stimulator of salivary secretion.

   Among the most commonly used pharmacological agents are: pilocarpine, bethanecol, civemiline
3. Saliva substitutes or artificial saliva. Saliva substitutes can provide a moisture retention layer in the oral mucosa and can be administered by liquids, spray, pills or gels. Topical treatments have few adverse effects and improve the quality of life of patients with xerostomia; In addition, they maintain oral health.

Randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and tolerability in patients with a non-commercialized gel and property of the promoter to treat xerostomia.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of both sexes 2. Over 18 years. 3. Adequate cultural level and understanding of the clinical study. 4. Agree to voluntarily participate in the study and give their informed consent in writing 5. Present xerostomia of more than three months of evolution / sialometry less than 0.2ml / 5 min.

Exclusion criteria

The presence of at least one of the following criteria will be grounds for exclusion from the clinical trial:

1. Presence of health problems that may compromise adherence to the study protocol.
2. Pregnant or breastfeeding women.
3. Present hypersensitivity to any component of the product under study.