cyrilzakka/clinical-trials huggingface dataset:
Cognition, Age, and RaPamycin Effectiveness - DownregulatIon of thE mTor Pathway

Evaluation of central nervous system penetration of orally administered Rapamune (RAPA) in older adults with Mild Cognitive Impairment (MCI) or early Alzheimer's disease (AD) and investigate associated safety, tolerability, target engagement, cognition, and functional status as initial proof-of-concept study

This study is an open-label pilot study of orally administered RAPA to measure its target engagement in Cerebrospinal Fluid (CSF) and blood, and to establish the feasibility and safety of RAPA treatment in older adults with MCI and early stage AD as initial proof-of-concept for a larger Phase 2 clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's disease, Global Clinical Dementia Rating Scale (CDR)=0.5-1
* Normal blood cell counts without clinically significant excursions; ; normal liver and renal function; and glucose control (HbA1c \< 6.5%). Lipid panel and PT/PTT/INR within normal limits
* A Legally Authorized Representative (LAR) if necessary for consent
* An LAR or study partner to accompany participant to all visits
* Availability for all study visits
* Stable dose of AD medications) Donepezil, rivastigmine, memantine, galantamine) for at least 3 months prior to the baseline visit

Exclusion Criteria:

* Diabetes (HbA1c≥6.5% or anti-diabetic medications)
* History of skin ulcers or poor wound healing
* Current tobacco or illicit drug use or alcohol abuse
* Use of anti-platelet or anti-coagulant medications other than aspirin
* Current medications that affect cytochrome P450 3A4; current or recent medications for hypertriglyceridemia (eg, Gemfibrozil)
* Hypersensitivity or history of allergy to Rapamycin
* Immunosuppressant therapy within the last year; current treatment with hydroxychloroquine and chloroquine (requires "washout period" of 14 days)
* Chemotherapy or radiation treatment within the last year
* Current or chronic history of liver disease or known hepatic or biliary abnormalities
* History of primary hypertriglyceridemia. Abnormal triglycerides \>200 or LDL cholesterol \>193, or other abnormal labs deemed clinically significant upon investigator review
* Current or chronic history of pulmonary disease or abnormal pulse oximetry (\<90%)
* Chronic heart failure
* Pregnancy
* Recent history (past 6 months) of myocardial infarction, active coronary artery disease, intestinal disorders, stroke, or transient ischemic attack
* significant neurological conditions other than AD
* Poorly controlled blood pressure (systolic BP\>160, diastolic BP\>90mmHg)
* Active inflammatory, COVID-19, autoimmune, infectious, hepatic, gastrointestinal, malignant, and/or psychiatric disease
* History of, or Magnetic Resonance Imaging (MRI) positive for any space occupying lesion, including mass effect and/or abnormal intracranial pressure, which would indicate contraindication to lumbar puncture
* Organ transplant recipients
Biogeography of the Oral Microbiome

A cross-sectional study to metatranscriptomically analyze and compare the oral microbiome in different environmental niches within the oral cavity.

This study will collect samples from participants meeting the eligibility criteria over the span of 3 months. Samples will be collected from multiple locations within the oral cavity and metatranscriptomically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older

Exclusion Criteria:

* Positive SARS-CoV-2 test result, if performed
* Antibiotic use in the previous 30 days
* Mouthwash use in the previous 6 months
Thromboelastography in Non-elective Cesarean Delivery

The purpose of the study is to assess the coagulation changes that occur in laboring patients undergoing non-elective (intrapartum)Cesarean delivery using thromboelastography (TEG). We will compare coagulation data to assess potential coagulation changes associated with hemoglobin changes before and after surgery, and related to estimated blood loss.

The purpose of the study is to assess the coagulation changes that occur in laboring patients undergoing non-elective (intrapartum)Cesarean delivery using thromboelastography (TEG). TEG is a point- of-care device which measures the viscoelastic properties of clot formation. This device can provide rapid and detailed information about coagulation changes in the perioperative period. We will compare coagulation data collected from the study to assess potential coagulation changes associated with Hemoglobin changes before and after surgery, and related to estimated blood loss.

Eligibility Criteria:
Inclusion Criteria:

* Obstetric in-patients
* Laboring patients with Epidurals for Labor Analgesia going for non-elective Cesarean
* Patients of all ethnic backgrounds will be included
* Singleton pregnancy
* ASA 1 or 2

Exclusion Criteria:

* Patients with underlying coagulation disorders.
* Patients with thrombocytopenia (platelet count \<100).
* Patients with pregnancy-induced hypertension, pre-eclampsia.
* Patients requiring the following medications prior to surgery: NSAIDS, aspirin, anticoagulants.
* Patients requiring elective Cesarean delivery.
* Patients with significant obstetric or medical disease.
* No patients \<18 years of age will be recruited.
Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain

This is a trial to evaluate if single port laparoscopic cholecystectomy causes less pain than conventional laparoscopic cholecystectomy.

This study is a randomized, two-arm, double-blinded three-center trial to compare single-port transumbilical laparoscopic cholecystectomy with conventional 4-port laparoscopic cholecystectomy. 120 patients are included with a 1:1 randomization. Three centers participate in the trial.

Inclusion criteria: Female patients, ASA I-III, age between 18 and 75 years, elective laparoscopic cholecystectomy because of biliary pain or recent uncomplicated biliary pancreatitis.

Exclusion criteria: Expected poor compliance, history of cholecystitis or severe pancreatitis, previous open upper abdominal surgery, pregnancy or lactation, preoperative chronic pain or conversion from laparoscopic to open surgery.

Pain and nausea is measured on VAS before the operation and 3 hrs, 1 day, 2 days and 3 days after the operation.

Cosmesis is evaluated after 28 days.

Patients are telephone-interviewed after 12 months and asked about port hernia formation. If hernia is suspected patients are called in for an abdominal ultrasonography.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* Planned elective laparoscopic cholecystectomy because of biliary pain or uncomplicated biliary pancreatitis

Exclusion Criteria:

* Expected poor compliance
* History of cholecystitis or severe pancreatitis
* Earlier open upper abdominal surgery, pregnancy or lactation, chronic pain or conversion to open surgery
Safety and Efficacy of Encapsulated Allogeneic MPS-1 Therapy

SIG-005-121 is a FIH, Phase 1/2, multi-centre, open-label, sequential dose-escalating study to assess the safety, tolerability, and preliminary efficacy of SIG-005 in adults with MPS-1. The study will evaluate up to three ascending dose levels of SIG-005 in male and female patients with attenuated MPS-1 (Scheie or Hurler-Scheie), 18 years of age or greater, who received Enzyme Replacement Therapy (ERT) for a minimum of 12 months prior to the study entry. Each cohort will include 3 patients.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to provide informed consent
* Male or female aged 18 or older
* Diagnosis of attenuated MPS-1 (Hurler-Scheie or Scheie)
* Alpha-L-iduronidase enzyme activity level of less than 10% of the lower limit of the normal range
* Prior treatment with ERT
* Willing to transition from ERT to SIG-005
* Female patients of childbearing potential with negative pregnancy test
* Use of highly effective method of contraception if applicable

Exclusion Criteria:

* A diagnosis of severe MPS-1
* Previous haematopoietic stem cell transplantation (HSCT)
* History of elevated total (IgG) anti-IDUA antibody
* Use of assistive respiratory devices
* Unable to walk independently
* History of allergic reaction or anaphylaxis to recombinant hIDUA
* Body mass index (BMI) ≥35
* History of abdominal adhesions, medical history of Crohn's disease, inflammatory bowel disease or any disease that increases the risk of post-operative abdominal adhesions
* Significant underlying disease or comorbidities that are a contraindication for general anaesthesia or laparoscopic procedure
* Pregnant or lactating patients
* Prior administration of a gene therapy product
* Participation in another investigational medicine or device study
* Abnormal laboratory values as defined in the protocol
* Active alcoholism or drug addiction during the 12 months before the screening visit
* Active malignancy or history of malignancy in the 5 years prior to study entry
* Recent COVID-19 infection: within 60 days of recovery from infection
* Vaccination(s) within the last 60 days (including vaccines for SARS-CoV-2/COVID- 19)
Feasibility of Elder Mistreatment VOICES-CI Screening Tool

The aim of this study is to assess the feasibility of the VOICES Elder Abuse Intervention among older adults with cognitive impairment.

The VOICES Elder Abuse Intervention was developed and refined to promote self-identification and self-disclosure to increase reporting of elder abuse and elder mistreatment at the point-of-care in the Emergency Department (ED) setting. A study (N= 1000) examining the use of VOICES in a busy ED with cognitively intact older adults was completed.

The purpose of this study is to to assess the feasibility (N= 80) of the VOICES screening tool among older adults with cognitive impairment.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Age 60 or above
4. Montreal Cognitive Assessment (MoCA) score between 14-25
5. Not in police custody
6. Non-full trauma track upon arrival
7. Able to consent and communicate in English
8. Agrees and able to use the iPad

Exclusion Criteria:

1. Subjects who live in nursing homes or other long-term care settings
2. At the discretion of the clinician, patient will be excluded if they cannot safely undergo the studies required for participation
3. Subject refusal to participate
4. Subjects with clear signs of elder mistreatment
5. Severe hearing and vision impairment
6. Presenting with acute intoxication
7. Presenting with active psychotic symptoms
8. Presenting with COVID-19 diagnosis and/or severe COVID-19 symptoms
Radiographic Comparison of Obturation Performed by Conventional Method and Obtura II.

Root canal therapy plays an importanmt role in dental health care.An importanat parameter necessary to achieve a proper endodontic treatment is quality of root canal filling.This study compare the radiographic quality of obturation with cold lateral condensation and thermoplasticiszed gutta percha technique and obtura II system.

The aim of this study is to assess and compare the radiogrphic quality of obturation with thermoplasticized injectable gutta percha technique obtura II system and cold lateral compaction technique in permanent teeth.For this study selected patients will be divided into two groups in a manner that the odd numbers will be alotted to Group A and Group B .Local anesthesia at 2% lidocaineHCl with 1:100000 epinephrine as buccal infiltration in upper teeth and inferior alveolar nerve block in the lower teeth. Access cavity preparation will be done. Canals will be located and negotiated with a DG-16 endodontic explorer . Initial filing will be done from Number 8 to 10 K- files (ISO standardized 0.02 taper) under 5.25% sodium hypochlorite) irrigation and Ethylenediamine Tetra-Acetic Acid as chelating agents.. Working Length will be confirmed with Electronic Apex Locator , and then with working length radiograph will be taken. Rotary preparation will be done with Protaper using S1, S2, F1, F2, F3 files. Master gutta-percha radiograph will be taken at the commencement of the first visit with Protaper F3 gutta-percha point placed in the canals. Intervention will be provided to both groups by the principal investigator. On the second visit, both the canals will be dried with F-3 paper points.Root canal fillings will be then performed using cold lateral condensation in Group A, and thermoplasticized injected gutta-percha in Group B.

Postoperative periapical radiographs will be obtained immediately after the obturation. These radiographs will be examined under illumination in a darkened room at ×2 magnification to assess for voids and termination of obturation. Our study will be based on the radiographic assessment of the buccolingual view of the canals, as it will be the only possible view to visualize on the radiograph in a clinical setting for assessing the quality of endodontic treatment.

Root canal fillings will be assessed

* Presence or absence of voids.
* Acceptable/flush: Root canal filling is within the root canal system and within 2 mm of radiographic apex.
* Under-filled: Root canal filling is \>2 mm short of radiographic apex.
* Over-filled: Root canal filling is extruded beyond the radiographic apex

Eligibility Criteria:
Inclusion Criteria:

* Single rooted teeth in which endodontic treatment was clinically indicated.
* Single rooted teeeth in which root canal treatment was recommended for elective reasons.

Exclusion Criteria:

* • Teeth with severely curved roots.

  * Sclerosed canals on periapical radiographs.
  * Periodontally compromised teeth.
  * Endodontic retreatment cases.
  * Teeth with apical resorption.
  * Teeth not salvageable by conventional root canal treatment.
Safety and Tolerability Study With Multiple Ascending Doses of ORM-12741

The purpose of this study is to evaluate the safety and tolerability of escalating multiple doses of ORM-12741 in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Good general health ascertained by detailed medical history and physical examinations
* Males between 18 and 45 years
* Body mass index (BMI) between 18-30 kg/m2
* Weight 55-90 kg

Exclusion Criteria:

* Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease
* Any condition requiring regular concomitant treatment including herbal products or likely to need any concomitant treatment during the study
* Susceptibility to severe allergic reactions
* Regular consumption of more than 14 units of alcohol per week
* Current use of nicotine-containing products more than 5 cigarettes or equivalent/day
* Inability to refrain from using nicotine-containing products during the stay in the study centre
* Inability to refrain from consuming caffeine-containing beverages during the stay in the study centre
* Blood donation or loss of significant amount of blood within 3 months prior to the screening visit
* Abnormal finding in ECG, vital signs, laboratory tests or physical examination
* Participation in a drug study within 3 months prior to the start of this study
Argus® II Retinal Prosthesis System Post-Market Surveillance Study

This post-market surveillance study is conducted in the European Economic Area where Argus II has been CE certified for use in outer retinal degeneration patients.

This study is being conducted to monitor the use of Argus II in a larger population than available within pre-market approval studies. Safety data will be monitored to ensure continued acceptability of risks to study participants, and an attempt will be made to include all eligible and willing participants implanted with Argus II. Measures of visual function that may contribute to device improvements will also be gathered and evaluated.

Eligibility Criteria:
Inclusion Criteria:

Adults, age 25 year or older

* with severe to profound outer retinal degeneration (not including Age-related Macular Degeneration)
* Have some residual light perception. If no residual light perception remains, the retina must be able to respond to electrical stimulation;
* Have previous history of useful form vision
* Have consented to participate in the study
* Had an Argus II Retinal Prosthesis surgically implanted 14 days (± 7 days) prior to enrollment (at Baseline Visit) in the study
* At the time of the Baseline Visit, do not suffer from non-ophthalmic serious adverse events (e.g. coma, myocardial infarction, etc.).

Exclusion Criteria:

* Ocular diseases or conditions that could prevent Argus II from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus, etc.)
* Ocular structures or conditions that could prevent the successful implantation of the Argus II Implant or adequate healing from surgery (e.g. extremely thin conjunctiva; axial length \<20.5 mm or \> 26 mm; corneal ulcers; choroidal neovascularization in the area of the intended tack location, etc.)
* Ocular diseases or conditions (other than cataracts) that prevent adequate visualization of the inner structures of the eye (e.g. corneal opacity)
* Pre-disposition to eye rubbing
* Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including:

  * cognitive decline including diagnosed forms of dementia and/or progressive neurologic disease,
  * psychiatric disease including diagnosed forms of depression;
  * does not speak a principal language associated with the region, and
  * deafness or selective frequency hearing loss that prevents hearing device alarms and alerts
* Participants who are pregnant or wish to become pregnant during the course of the study
* Participation in another investigational drug or device study that may conflict with the objectives, follow-up or testing of this study;
* Conditions likely to limit life to less than 1 year from the time of inclusion.
Acceptable Hemodynamic Changes in Dexmedetomidine for Single Intravenous Bolus Injection

Dexmedetomidine（DEX）is a potent and highly selective α 2 adrenergic receptor agonist. It has the pharmacological effects of sedation, hypnosis, analgesia, anti-sympathetic and neuroprotective. Its sedative effect is similar to normal sleep, and easy to wake up. DEX is widely used clinically because of its advantages and acceptable side effects. The best clinical use of DEX is uncertain, including intravenous, intramuscular, oral, intralnasal and sublingual administration. Its clinical recommended use is intravenous load infusion for more than 10 minutes, followed by continuous infusion. However, the clinical recommended usage is inconvenient, time-consuming and other shortcomings, for the growing popularity of daytime surgery, will inevitably affect the operation process and turnover. If a suitable dose range of DEX can be found for a single intravenous injection to achieve clinical efficacy quickly without significant hemodynamic effects, this will improve the patient's postoperative recovery. We will speed up the utilization and turnover of medical resources. The aim of this study was to investigate the optimal dosage of DEX for single intravenous injection.

Patients undergoing thyroidectomy under general anesthesia were treated with routine anesthesia induction and maintenance, and DEX was injected intravenously 30 minutes before the end of operation. Single bolus is for more than 1 minute. In the first case, the dosage of DEX was 0.1 ug/kg. If the cardiovascular reaction was positive (MAP or heart rate was more than 20% before intravenous injection), the dosage of DEX in the next patient decreased by a gradient (0.05ug/kg). If the cardiovascular response was negative, the next patient increased the dose of DEX by a gradient (0.1ug/kg); if a patient withdrew from the study, the next patient received the same dose as the patient who withdrew. There were 8 turning points of cardiovascular reaction and the test was completed. The changes of blood pressure and heart rate per minute in 10min were recorded after single bolus. The dosimetric map of patients with DEX was drawn, and the ED50 and ED95 were calculated by probit probabilistic unit regression (Bills method).

Eligibility Criteria:
Inclusion Criteria:

1. volunteer to participate in the study and sign the informed consent;
2. selective operation of thyroid gland whose anesthesia time is less than 2 hours ;
3. aged 18-55 years;
4. ASA I - II;
5. BMI 18\~28kg/m2.

Exclusion Criteria:

1. Mallampati grade Ⅲ or Ⅳ;
2. opening degree \< 2.5 cm;
3. taking analgesic or sedative drugs for a long time before operation;
4. a history of arrhythmia, bronchial and cardiovascular diseases, abnormal liver function and so on;
5. allergic to dexmedetomidine, similar active ingredients or excipients;
6. G-6-PD deficiency;
7. a history of use of alpha 2 receptor agonists or antagonists.
Effect of Antioxydant-enriched Media on Blastocyst Euploidy Rates.

One of the most sensible factors in IVF culture conditions is the susceptibility of gametes and embryos to an induced increase in reactive oxidative species (ROS) caused by the artificial environment. This study aims to evaluate the impact of using antioxidant-supplemented media during culture to evaluate embryo ploidy rates in a prospective randomized trial using sibling oocytes.

Improvements in culture conditions is an ongoing process in IVF due to, on one hand, the still lack of knowledge on human embryonic development, and, on the other hand, the frequent need for repeated IVF cycles to achieve an 'implantable' embryo. The main factor for optimizing conditions of an embryo to develop is its microenvironment, mainly the culture media used. One of the most sensible factors in IVF culture conditions is the susceptibility of gametes and embryos to an induced increase in reactive oxidative species (ROS) caused by the artificial environment, as it has been extensively shown in animal models and to a certain extent in humans.

A primordial step for improvement is to alleviate an increase in ROS during embryo development. This can be manipulated by means of utilizing a culture media with supplements that can serve as scavengers, leading to an equilibrium between oxidation and reduction of ROS during the culture period. So far, the produced culture media contain low concentrations of limited additives involved in anti-oxidative stress. Recently, a culture medium containing an implementation in higher doses of distinctive elements known to clearly serve as cellular scavengers has been formulated. However, very few human IVF studies have been performed up to date. Our research intends to investigate the incorporation of antioxidant-rich culture media into IVF practices with the primary objective of analyzing its impact on embryo euploidy, as well as the previous culture steps including fertilization and blastocyst developmental rates. This study aims to evaluate the impact of using antioxidant-supplemented media during culture to evaluate embryo ploidy rates in a prospective randomized trial using sibling oocytes.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing assisted reproductive technology cycles when ICSI is indicated.
* Patients when Iin vitto fertilization (IVF) is also performed will be included as far as there are enough oocytes for ICSI randomization. However, IVF oocytes will not be used for the study.
* Maternal age 18-43 years old.
* PGT-A cycles with only trophectoderm biopsies on day 5/6/7.
* Patients with more than 6 COCs expected for ICSI.
* Body mass index \<35.
* Fresh and frozen ejaculated sperm.

Exclusion Criteria:

* PGT-M cycles
* Fresh and frozen testicular sperm.