cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic and Tolerance Study of TQ-A3326 in Healthy Participants.

To study the single dose and multi-doses pharmacokinetic characteristics and tolerance of TQ-A3326 in the human body；To study the transformation of TQ-A3326；To study the effect of the food on the pharmacokinetic characteristics of TQ-A3326.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female, age 18 to 60 years, inclusive.
* The body weight of male is not less than 50kg, and female is not less than 45kg. All participants' body mass index (BMI) is between 19\~26.
* Adequate blood cell counts, kidney function and liver function.
* Healthy participants should participate in the study voluntarily and sign informed consent.

Exclusion Criteria:

* Subjects with known allergy to the similar products tested.
* Subject is on a special diet (for example subject is vegetarian).
* Medical demographics with evidence of clinically significant deviation from normal medical condition.
* Female subjects who were pregnant or nursing.
* Results of laboratory tests which are clinically significant.
* Acute infection within one week preceding first study drug administration.
* History of drug or alcohol abuse.
* Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
* Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
* ale subjects (or their partner) or female subjects have the unprotective sex behavior or have a planned pregnancy during the trial.
Virtual Reality Cognitive Therapy for Alzheimer's Disease

To evaluate the usability, feasibility, and acceptability of VRCT iteratively on 36 AD/ADRD individuals with mild to moderate CI.

Alzheimer's disease (AD) and Alzheimer's disease-related Dementias (ADRD) resulting in cognitive decline affects more than 5.8 million Americans. Given the impact on quality of life, there is a great need for therapies focused on cognition. In this study, we will test the feasibility, usability, and acceptability of a novel Virtual Reality Cognitive Therapy (VRCT) for AD developed by ClarityTek, Inc. The VRCT will focus primarily on skills that impact instrumental activities of daily living (e.g., taking medications, shopping). Thirty-six individuals with mild to moderate AD/ADRD will be enrolled and will utilize the VRCT over seven weeks within their home. Enrollment will occur in cohorts of 12 individuals, so that the VRCT can be revised and optimized based on the results, prior to the next cohort. We will also hold Expert Focus Groups with clinician specialists to obtain feedback for improvement.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild cognitive impairment (MCI), probable Alzheimer's disease (AD) or Alzheimer's disease Related Dementias (ADRD)
* Montreal Cognitive Assessment (MoCA) score of 11-25
* Age 30-89

Exclusion Criteria:

* Non-English speaking
* History of seizure disorder, vertigo disorder, or severe motion sickness that would impact their ability to participate in the intervention
* History of any other serious condition that may limit their ability to participate in the intervention, as determined by the investigators.
* Inability to use the VR device (e.g., severe visual/hearing impairment, aphasia, facial injuries)
Evaluation of the Role of Local Steroid Injection in Treatment of Idiopathic Spasmodic Flat Foot in Adolescent Patients

* Population: adolescent patients aged from 10 to 16 years
* Interventions:

  1. Examination under general anaesthesia if the deformity corrected spontaneously
  2. local injection of steroid in sinus tarsi
  3. cast in varus for 6 weeks
* Outcomes: primary outcome : Evaluate the clinical and functional outcomes according AOFAS.
* Time: follow up within one and half month, 3 months, 6 months, one year.

• Does local steroid injection have a role in treatment of spasmodic flat foot in adolescent patients? One of the most common foot complaints in the juvenile and adolescent age group is the "flatfoot" deformity. (1) Clinical evaluation of flatfeet primarily focuses on differentiation between the two main types: flexible and rigid. (2) The flexible type is a common diagnosis and is one which is usually not problematic and rarely needs treatment. (3) Rigid flatfoot deformity is less common (occurring one-third as often as the flexible type) but often is symptomatic and requires treatment. (4) Spasmodic valgus foot is usually associated with resistant pain and deformity. It shows controversy regarding its incidence, etiology, and treatment. (5) Spasmodic flatfoot is a rare condition characterized by a rigid and usually painful valgus deformity in the hind foot with peroneal muscles spasms (6,7) It is often caused by inter-tarsal bars or bone anomalies that restrict tarsal joint motion . (8) Our study aims to evaluate the functional and clinical outcome after local long-acting steroid injection in the sinus tarsi followed by cast in adolescent patients with spasmodic flatfeet without coalition.

Eligibility Criteria:
Inclusion Criteria:

* Age of the patients from 10 to 16 years
* Flat foot with peroneal muscle spasm

Exclusion Criteria:

* Flatfoot uncorrected by manipulation under general anaesthesia

  * neuromuscular disorders
  * evidence of coalition in CT or MRI
Management of Patients With Suspected of Sleep Apnea-hypopnea Syndrome From Primary Care

Obstructive sleep apnea syndrome (OSA) is characterized by the manifestation of excessive sleepiness secondary to repeated obstruction of the upper airway during sleep and cognitive-behavioral, respiratory, cardiac, metabolic or inflammatory disorders. Epidemiological studies in our country have shown that OSA is a highly prevalent disease in the general population, affecting 2-4% of the adult population. The most important clinical manifestations of OSAS is a deterioration in the quality of life and an increase in cardiovascular disease. OSA is also associated with traffic accidents. Therefore, and considering the medical complications of OSA, as well as the sociolaboral impact and its negative impact on quality of life and survival; is stated that this disease is a public health problem that requires the physician to identify patients eligible to treatment. Moreover, it has been shown that undiagnosed patients, duplicate the consumption of health resources, comparing when the diagnosis and treatment has been established. Finally, we have a highly effective treatment using positive pressure in the upper airway (CPAP) that has been shown to be effective and cost-effective. The current situation in which all patients diagnosed with OSA and receiving different treatments are monitored and controlled by the Sleep Units (SU) is an oversized medicine specialist at the expense of primary care (PC). Our working hypothesis is: "By the coordination of actions at various levels including interactive training equipment AP, use the bilateral (SU-AP) of electronic medical records and the use of new technologies can be achieved in AP satisfactory management of the diagnostic and therapeutic process of patients with suspected OSA. Patients assisted in both areas have a level of clinical response, satisfaction, compliance and avoidance of complications, similar to that obtained with monitoring by SU. In addition, management by AP will be more cost-effective than in the SU."


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years old
* Suspected OSA patients (chronic snoring, apneas, excessive daytime sleepiness) or resistant hypertension
* Written informed consent signed

Exclusion Criteria:

* Patients with impaired lung function (sd. overlap, obesity hypoventilation, and restrictive disorders)
* Severe heart failure
* Severe chronic pathology associated
* Psychiatric disorder
* Periodic leg movements
* Pregnancy
* Other dyssomnias or parasomnias
* Patients already treated with CPAP
Study of Paliperidone ER in Adolescents and Young Adults With Autism

This 8-week, prospective open-label study will investigate the effectiveness and tolerability of paliperidone ER in adolescents and young adults with autism. Hypothesis:Paliperidone Er will be well tolerated and efficacious for reducing aggression, self-injury, and irritability in adolescents and young adults.


Eligibility Criteria:
Inclusion Criteria:

* Males and females between ages of 12 and 21 years
* Tanner Sage III or IV (post-pubertal)
* Diagnostic and Statistical Manual Fourth Edition Text-Revised (DSM-IV-TR) diagnosis of autism
* Outpatient
* Ability to swallow pills
* Antipsychotic medication-free for at least 2 weeks
* Score of 4 or more on the Clinical Global Impressions Severity Scale
* Score of 18 or higher on the Aberrant Behavior Checklist Irritability Scale
* Mental age of 18 months or greater based on testing
* Subjects must be in good physical health

Exclusion Criteria:

* Asperger's Disorder, Pervasive Developmental Disorder Not Otherwise Specified (PDD NOS), Rett's Disorder, childhood disintegrative disorder, schizophrenia, bipolar disorder, Fragile X Syndrome, Tuberous Sclerosis
* A significant medical condition
* An active seizure disorder
* Females who are pregnant
* Evidence of a prior adequate trial of paliperidone ER
* History of neuroleptic malignant syndrome
* Hypersensitivity to paliperidone ER
Use of Peppermint Oil During Screening Colonoscopy to Improve Visibility

The investigators hypothesize that spraying peppermint oil containing L-menthol onto the colonic mucosa during colonoscopy will relax smooth muscle allowing better colonic visualization.


Eligibility Criteria:
Inclusion Criteria:

* Screening colonoscopy
* Age 50 years and older
* Able to give consent

Exclusion Criteria:

* No consent obtained or adult lacking capacity to consent
* Do not reach cecum on colonoscopy
* Renal impairment (defined as CrCl \<30 ml/min)
* Allergy to study peppermint oil solution
* History of colon resection
* Inflammatory bowel disease
* Known colorectal neoplasia
* Non-correctable coagulopathy
* Pregnancy or lactating
* Prisoners
Clinical and Histological Features of Head and Neck Melanoma

The worldwide incidence of cutaneous melanoma has been increasing for the last 30 years in western populations. Among all melanomas, those located on the head and neck are more frequent than expected regarding the surface of this anatomical area, occur in older subjects than melanomas at other sites and have a worse prognosis than melanomas at other sites. The question whether head and neck melanomas could be a distinct entity has been debated.

Aim of the study was to compare clinical and histological characteristics between head and neck melanomas and melanomas at other sites.

Eligibility Criteria:
Inclusion Criteria:

* patients with melanoma
* melanoma diagnosed between January 2004 and December 2011
* patients living in Champagne-Ardenne
Studying Electromyographic Activity in Patients With Upper Limb Amputations

The primary purpose of this study is to determine the extent to which the Regenerative Peripheral Nerve Interface ( i.e. reinnervation of partial muscle grafts by residual peripheral nerves) enables both the generation of high-performance motor control signals for prosthetic limbs, and the input of sensory percepts by electrical stimulation.


Eligibility Criteria:
Inclusion criteria:

* For the prosthetic control graft arm:

  * Must have previously undergone upper limb amputation
  * Must be otherwise healthy (e.g. no severe pain syndromes or untreated mental health disorders)
  * Must be American Society of Anesthesiologists (ASA) Class I (low surgical risk)
  * Must have sufficient soft tissue quality to support performance of the operative procedures
  * Must have NOT previously received the partial muscle graft surgery
* For the neuroma graft arm:

  * Must have previously undergone upper limb amputation
  * Must be otherwise healthy (e.g. no severe pain syndromes or untreated mental health disorders)
  * Must have previously received the partial muscle graft surgery
* For the able-bodied arm:

  * Must have NOT undergone upper limb amputation
  * Must be in good health

Exclusion criteria:

* For the prosthetic control graft arm:

  * Participants sustaining severe crushing or avulsion injuries with substantial superficial and deep scarring, may not be appropriate candidates for inclusion in the study
* For the able-bodied arm:

  * Participants with a history of nerve pain may not be appropriate candidates for inclusion in the study
Comparison of IL-8, FGF-1 and VEGF Levels in Pulpal Tissue, GCF and Dentinal Fluid Samples of Healthy, Reversible and Irreversible Pulpitis Diagnosed Teeth

This study will include 50 patients diagnosed with healthy, reversible and irreversible pulpitis. IL-8, FGF-1 and VEGF levels will be compared using pulpal tissue, gingival crevicular fluid, dentinal fluid samples collected from the teeth of these patients. First, the DOS sample will be collected non-invasively using periopaper strips without local anesthesia. Then, the caries will be cleaned by applying local anesthesia and rubber dam to the patient and a dentinal fluid sample will be collected noninvasively using PVDF membranes. In teeth with pulp exposure due to caries, the pulp tissue that needs to be removed will not be disposed of but collected as a sample. Routine root canal treatment procedures will then continue and treatment of the teeth will be completed. The collected samples will be analyzed for IL-8, FGF-1 and VEGF levels by ELISA test.


Eligibility Criteria:
Inclusion Criteria:

Control group:

* Unrestored, caries-free vital teeth with healthy pulp
* Orthodontically indicated teeth for extraction
* wisdom teeth indicated for extraction in terms of oral hygiene
* teeth that require root canal treatment for prosthetic purposes

Reversible pulpitis group:

* Teeth that react mildly to cold, hot, sour or sweet stimuli
* Teeth with no history of spontaneous pain
* Teeth that respond to cold test and electric pulp test within normal limits
* Teeth that are not sensitive to chewing or percussion

Irreversible pulpitis group:

* Teeth with a history of continuous moderate or severe spontaneous pain
* Teeth sensitive to percussion
* Teeth without periapical pathology

Exclusion Criteria:

* Patients requiring antibiotic prophylaxis.
* Patients with diabetes or haematological diseases.
* Patients who have used antibiotics or anti-inflammatory drugs in the last three weeks.
* Patients who are pregnant during treatment.
* Patients with intense plaque and tartar on their teeth, redness and bleeding in the gums.
* Patients with severe gingivitis, generalised periodontitis or periodontal pocket depth of more than 3 mm.
* Patients with no response to pulp sensitivity tests, presence of sinus tract, presence of periapical pathology on radiography.
* Teeth without pulp exposure after caries removal
Akershus Cardiac Examination (ACE) 1950 Study

Akershus Cardiac Examination (ACE) 1950 Study is a large, observational, prospective, longitudinal, population-based cohort study. The overall aim is to establish an extensive cardio- and cerebrovascular age cohort of elderly subjects for various longitudinal long-term follow-up studies of cardiovascular and cerebrovascular disease.

Design: The Akershus Cardiac Examination (ACE) 1950 Study is a population-based, prospective, cerebro- and cardiovascular age-cohort study of all men and women born in 1950 in Akershus County, Norway.

Time schedule: Study inclusion and baseline examinations took place in the period September 2012 - May 2015.

Current status: 10-year follow-up examinations of all participants are undertaken in 2023-2025, and sub-studies are ongoing.

Eligibility Criteria:
Inclusion Criteria:

* Resident in Akershus County (as per October 2011, prior to study invitation)
* Born in the year of 1950
* Ability to consent to participation
The Effect of Laser Combined With Pulp-capping Agents on Direct Pulp Capping

The purpose of this randomized clinical study was to evaluate the efficiency of Er,Cr:YSGG laser irradiation combined with a resin based tricalcium silicate material and calcium hydroxide (CH) in direct pulp capping for 3 months follow-up period.Sixty permanent vital teeth without symptoms and radiographic changes were randomly assigned to 4 groups (n=15): Gr 1: The exposed area was sealed with CH paste, Gr 2: The treated area was sealed with CH paste following Er,Cr:YSGG laser irradiation at an energy level of 0,5 W without water and 45% air, Gr 3: Resin based tricalcium silicate material (TheraCal LC) was applied directly to the exposed pulp, Gr 4: TheraCal LC was applied following irradiation with Er,Cr:YSGG laser.

CH is used as gold standard in pulp capping procedures due to its beneficial properties such as induction of mineralization and inhibition of bacterial growth; however tunnel defects and cell inclusions in dentin bridges formed by CH may lead to leakage and bacteria penetration resulting in loss of vitality.

TheraCal LC is a new light-cured, resin-modified, tricalcium silicate based material designed to use for direct and indirect pulp-capping aiming to achieve a bond to composite resins thus reducing micro-leakage.The formulation of TheraCal LC containing tricalcium silicate particles in a hydrophilic monomer provides significant calcium release that stimulates hydroxyapatite and secondary dentin bridge formation The use of laser for direct pulp capping has been suggested for the considerable advantages of lasers including decontamination effect, biostimulation effect, hemostatic and coagulant effect.The erbium, chromium-doped:yttrium, scandium, gallium and garnet (Er,Cr:YSGG) laser which is a relatively new device has been reported to ablate dental hard tissues thanks to its high absorption in water and also strong absorption by the hydroxyl radicals present in the hydroxyapatite structure

Eligibility Criteria:
Inclusion Criteria:

* Permanent teeth with deep caries without symptoms
* Vital teeth
* No periapical radiographic changes
* The diameter of the exposed area is between 0,5 mm to 1,5 mm

Exclusion Criteria:

* Spontaneous pain,
* Tenderness to percussion and palpation,
* Bleeding lasting over 3 minute after exposure,
* Periapical radiographic changes such as periradicular or furcal radiolucency, a widened periodontal ligament space and resorption.
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors

Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.

A Phase 1, First in Human Study of Adenovirally Transduced Autologous Macrophages Engineered to Contain an Anti-HER2 Chimeric Antigen Receptor in Subjects with HER2 Overexpressing Solid Tumors

Main Study - Group 1 and Group 2 all HER2 overexpressing solid tumors

Intraperitoneal Substudy - HER2 overexpressing peritoneal disease

89\[Zr\] radiolabeled CT-0508 Substudy - All HER2 overexpressing solid tumors (Univ of Penn, Abramson Cancer Center only)

CT-0508 Combination with Pembrolizumab Substudy - All HER2 overexpressing solid tumors

Eligibility Criteria:
Inclusion Criteria:

* HER2-positive recurrent or metastatic solid tumors for which there are no available curative treatment options.

  * Breast cancer and gastric/gastroesophageal junction cancers must have failed approved HER2-targeted agents.
  * Other HER2-positive tumor types must have failed standard of care therapies, while prior therapy with anti-HER2 drugs is not required.
* Subject must be willing and able to undergo tumor tissue biopsy procedures
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Subject has adequate bone marrow and organ function

Exclusion Criteria:

* HIV, active hepatitis B or hepatitis C infection.
* Diagnosis of immunodeficiency or chronic exposure to systemic corticosteroid therapy or any other form of immunosuppressive therapy
* Untreated or symptomatic central nervous system (CNS) metastases or cytology proven carcinomatous meningitis.

  o Subjects with small, asymptomatic CNS metastases that do not require treatment are permitted to enroll.
* Left ventricular ejection fraction (LVEF) \<50% as determined by ECHO or multiple gated acquisition scan (MUGA)

Other protocol-defined Inclusion/Exclusion may apply.

CT-0508 in Combination with Pembrolizumab Substudy Only:

Exclusion Criteria:

* Subjects with severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
* Subjects with an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
* Subjects who have a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Subjects who have had an allogeneic tissue/solid organ transplant
Effects of Different Support Surfaces on the Properties Skin After Loading

Pressure ulcers are severe injuries and wounds causing a substantial burden on patients, caregivers, and on healthcare systems worldwide. There is common agreement, that effective pressure ulcer prevention is of crucial importance to maintain skin and tissue integrity in individuals at risk. Besides risk assessment and repositioning the use of special pressure ulcer preventive support surfaces are the key interventions in pressure ulcer prevention. Pressure ulcer preventive support surface modify the degree of skin and tissue deformation and/or skin temperature and moisture. Therefore, an association between the type and working mechanism of a pressure ulcer support surface and skin function after loading is highly likely. Furthermore, such a relationship may be used to characterize and/or to quantify the performance pressure ulcer support surfaces in terms of skin protection. The overall aim of this explorative study is to measure skin responses of the two most common pressure ulcer predilection sites (heel, sacral skin) after two hours loading on three different support surfaces and the sternal skin (control area).


Eligibility Criteria:
Inclusion Criteria:

* Healthy, female volunteers
* 60 to 80 years
* Body Mass Index between 18.5 and 29.9 kg/m2
* Non-Smoker of at least one year
* Absence of skin diseases or scars in the skin areas of interest
* Ability to move independently and to maintain supine and prone positions
* Able to give written informed consent
* No use of cosmetic products or topical applied drugs on the study areas at least 12 hours before measurement
* Skin phototype I to III according to Fitzpatrick classification
* Willing and able to fulfil the study requirements

Exclusion Criteria:

* Disability to maintain in supine or prone position
* Acute diseases
* Acute or chronic diseases with increased or decreased body temperature (≤ 35°C or ≥ 38,5°C, measured in the ear)
* History or establishment of Diabetes or pre-diabetes, cardiac or renal insufficiency, atopic dermatitis, psoriasis, chronic obstructive pulmonary disease (COPD)
* Acute or chronic wounds in the skin areas of interest
* Any skin affection which may interfere with the study assessment, e.g. tattoo, psoriasis or scar on the investigational sites
* Participation in another clinical study 4 weeks before inclusion visit
* Current participation in any other clinical study