cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles

The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM compared with placebo when administered to bilateral nasolabial fold wrinkles.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age
* Level of severity of bilateral nasolabial fold wrinkles meeting severity criteria as per protocol
* Level of subject dissatisfaction with both nasolabial fold wrinkles as per protocol
* Ability to comply with the study requirements
* Negative pregnancy test (Females)
* Healthy post-auricular skin for biopsy

Exclusion Criteria:

* Excessive dermatochalasis of the treatment area
* Inability to lessen the nasolabial fold wrinkles by physically spreading the area apart
* Total area to be treated exceeds 20 cm in length
* Physical attributes which may prevent assessment or treatment as judged by the evaluator
* Use of an investigational product/procedure within 30 days prior to enrollment or plans for use during the study
* Previous treatment with the sponsor's product
* History of active autoimmune disease or organ transplantation
* Diagnosis of cancer, unless successfully treated or in remission (basal cell carcinoma is excluded)
* Active or chronic skin disease
* Known genetic disorders affecting fibroblasts or collagen
* Active systemic infection
* Requires chronic antibiotic or steroidal therapy
* Use of certain commercial products/procedures to the treatment area prior to study enrollment or plans for use during the study
* Use of systemic agents that increase bleeding or clotting, or disorders equated with these effects
* Known allergic reactions to agents used in preparation of treatment
* Excessive exposure to sun without adequate sun protection
Evaluation of a Novel Horizontal Ridge Augmentation Technique in Dentistry

This case series aimed to assess the efficacy of a novel horizontal ridge augmentation modality using histomorphometry and Raman spectroscopy. Combinations of "sticky bone" and tenting screws without autologous bone were used as augmentative materials.

This case series aimed to evaluate the efficacy of the horizontal augmentation technique using the tenting screw technique with "sticky bone." The main aim was to determine whether this method provides similar results to the gold standard GBR or autologous onlay block grafts. In addition, the validity of neglecting autologous graft and its possible substitution with growth factor concentrate were examined. The novelty of this study is that no human histological examination of the described procedure has been conducted previously. It is hypothesized that the "stick bone" containing autologous platelet concentrate can substitute the use of particulate autologous bone graft in these type of procedures. In this prospective case series study five patients were enrolled and treated with the same type of bone augmentation in order to increase the alveolar ridge in the horizontal dimension with the previously mentioned technique. After 5 months of healing a second reentry surgery was performed in order to harvest the bone core for biopsy, to asses the chemical compound composition by Raman spectroscopy in vivo and to place the dental implants at the same time. Newly formed tissues were evaluated clinically during reentry, radiologically by CBCT acquisition, qualitatively and quantitatively by histological processing and physicochemically by means of Raman spectroscopy.

Eligibility Criteria:
Inclusion Criteria:

* one or more missing teeth in the jaw's posterior area, where horizontal bone width is ≤5 mm.
* no deficiency in the vertical dimension.
* The tooth must have been removed ≥4 months before augmentation.
* The patient should understand the nature of the research and be compliant in study-related activities

Exclusion Criteria:

* pregnancy
* smoking
* uncontrolled diabetes
* systemic diseases or drug consumption affecting bone metabolism, and clinically relevant osteoporosis
Evaluation of Pulse Oximetry Sensors in Neonates

The purpose of this study is to evaluate sensor longevity and skin integrity with two different models of neonatal pulse oximetry sensors currently used for monitoring oxygen levels in small infants.

A common method for assessing the respiratory status of hospitalized children is the use of pulse oximetry. This noninvasive device typically is placed on a finger, foot/palm of a child. Red and infrared light is shined through the tissue under the sensor and the information is sent back to a monitor for calculation of oxygen saturation. Use of this noninvasive method provides continuous information on the oxygenation status of patients and has greatly reduced the number of arterial blood samples required for patient care.

While the advantages of noninvasive pulse oximetry are significant, there are a number of factors which can negatively impact the performance of the device. Patient movement and sensor adherence to the skin have been some of the challenges to optimal device performance. While much of the clinical research on pulse oximetry sensors over the years has evaluated device accuracy and reliability, limited data is available on sensor longevity under conditions typical of clinical use. A particular challenge with neonatal pulse oximetry monitoring is insuring proper sensor adherence within the warm, moist environment of incubators used in neonatal care. Furthermore, limited data are available on the impact of sensor adherence on skin integrity in premature infants who are at high risk for skin breakdown.

Objectives. The purpose of this study is to evaluate sensor longevity and impact on skin integrity in neonatal patients with two different models of pulse oximetry sensors.

Research Method. A sample of 32 premature infants will be recruited to participate in this study in which an adhesive sensor and a nonadhesive sensor are compared. Both sensors will be simultaneously tested in each subject, for a period of 14 days, with one sensor on the right foot and the other sensor on the left foot. Data will be collected on sensor longevity, skin integrity at the sensor site, reason for sensor replacement and ease of use rating by the clinician. Data will be summarized using descriptive statistics.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age \< 34 weeks
* Weight \< 3.0 kg
* Postnatal age \< 2 weeks
* Anticipated pulse oximetry monitoring for at least 14 days

Exclusion Criteria:

* Presence of any skin irritation or breakdown on either foot
* Foot impediments which would preclude proper placement of the test sensors
* Known allergies to adhesive materials
PRostate Cancer Enhanced Diagnosis by Calibration Technology

The CARE® Phantom system is a medical device system that is being developed has been designed to enable the quantitative measurement of the apparent diffusion coefficient (ADC) in the prostate of patients undergoing a multi-parametric MRI (mpMRI) scan to detect prostate cancer. The final device system will comprise three elements: a calibration mat containing phantoms and embedded monitoring software, a docking station to transfer data from the phantoms, and software as a medical device (SaMD) for calibrating the resulting mpMRI images.

In this clinical trial, patients will undergo MRI scanning in different scanners using the GSP Phantoms to provide mpMRI images and phantom data for subsequent in silico analysis. The captured images and data will be used to further develop and calibrate the GSP prototype SaMD part of the medical device system, and to establish the degree of optimised reproducibility that can be achieved.


Eligibility Criteria:
Inclusion Criteria:

* Men with clinically suspected prostate cancer and referred for prostate MRI
* Men willing and able to provide a written informed consent
* MRI Likert/PIRADS 3 or above
* Prior decision made to perform targeted biopsy

Exclusion Criteria:

* Prostate specific antigen (PSA) level \&amp;gt; 20ng/ml within 6 months
* Previous diagnosis of prostate cancer
* Ongoing hormone treatment within 3 months prior to MRI, excluding antiandrogens or 5-alpha reductase inhibitors
* Contraindication to MRI scan
Functional and Performance Determinants in Climbers: Examining the Role of Mobility, Stability, and Fatigue Across Proficiency Levels

The primary objective is to understand how motor skills and fatigue affect climbing performance in indoor and outdoor climbers, also comparing elite and amateur climbers.

Aims:

* Assess differences in selected joint range of motion, isometric strength, and dynamic stability between elite and intermediate climbers.
* Evaluate the impact of the fatigue protocol on functional performance and cognitive outcomes across climbers of varying skill levels (intermediate vs. advanced).
* Examine the impact of general joint hypermobility, as indicated by Beighton Scores, on functional climbing performance.
* Association between cognitive factors (e.g., attention, memory) and motor skills.

Research questions:

* Do elite climbers have better joint mobility and balance than amateur climbers?
* How does fatigue affect performance and reaction time and cognitive function?
* Does having flexible joints (joint hypermobility) make climbers better athletes
* What are the performance differences between indoor and outdoor climbers?

This study will help identify key skills and physical traits that improve climbing performance. It will also explore how fatigue and flexibility impact safety and performance in different climbing environments.

Detailed Description

This study investigates the functional and performance determinants in indoor and outdoor climbers, focusing on mobility, stability, fatigue, and skill level. The protocol will compare elite and intermediate climbers through various physical and cognitive assessments conducted before and after a climbing-specific fatigue protocol. The goal is to identify key biomechanical, physiological, and cognitive factors that influence climbing performance and fatigue resistance in both climbing environments.

Eligibility Criteria:
Inclusion Criteria:

* primary sport discipline - climbing (bouldering/lead rock or other)
* Healthy (without injury, pain, or symptoms) at the time of the study
* Participation in climbing training (minimum 3 months)

Exclusion Criteria:

* pain or other symptoms related during study
* rheumatological disease
* neurological disease or balance disorders
* orthopaedic disease
* genetic disease
* cardiovascular system disease
* surgeries of upper and lower limb in the last year
* surgeries of spine in the last year
* a primary sport other than climbing.
* taking medications that may affect balance.
* use of orthopedic supplies during the study
"Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age."

The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of infants undergoing Lumbar Puncture (spinal tap).

Pain of infants will be measured using the Neonatal Facial Coding System by videotaping the infant's face while they undergo the procedure. A comparison between the group that received active drug and the group that received placebo will allow a measurement of the difference, if any, of the pain experienced during the procedure of the infants.

Eligibility Criteria:
Inclusion Criteria:

* Full term (\>=37 weeks gestation)
* Age 0-60 Days
* Undergoing Lumbar Puncture

Exclusion Criteria:

* Unstable
* Premature (\<37 weeks gestation)
* Allergy to study medicine
* Parent refusal of consent
Assesment of Physical Activity Level of Patients With Multiple Sclerosis: From Laboratory to Real Life

This study aims to assess the feasibility of a protocol determining individual moderate-to-vigorous physical activity (MVPA) thresholds, among multiple sclerosis patients, in routine medical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 80 years old
* Multiple sclerosis according to McDonald criteria ;
* Expanded Disability Status Scale (EDSS) between 0 and 6.5 ;
* Patient able to move with or without mechanical assistance.

Exclusion Criteria:

* Deterioration of neurological symptomatology within 60 day before enrollment ;
* Changes brought to the multiple sclerosis treatment within 6 months before enrollment ;
* Introduction of a treatment acting on spasticity or fatigue within 30 day before enrollment
* Changes brought to reeducation protocol throughout the duration of the study
* Patient unable to provide an effort equivalent to 3 times the resting metabolic value = 3 Metabolic Equivalent of Task (METs).
Pericapsular Nerve Group (PENG) Block on Pain During Participant Positioning for Spinal Anesthesia in Hip Fracture Surgery

Hip fracture surgery is a common orthopedic procedure, especially in elderly patients. These fractures are quite common in adults over the age of 65, and the one-year mortality rate ranges from 12% to 37%. Recent studies have suggested that general anesthesia and spinal anesthesia are not superior to each other in patients undergoing hip fracture surgery. Untreated/poorly managed perioperative pain is directly linked to delirium, poor prognosis, and secondary chronic pain in hip fracture patients. Therefore, considering the associated mortality, morbidity, and early recovery, control of perioperative pain should be one of the highest priorities of the anesthesiologist, regardless of the anesthesia method used.

Ultrasonography (USG)-guided regional anesthesia techniques are often used as part of multimodal analgesia in the management of perioperative pain in patients with hip fractures. One of the most recently described blocks used in hip fracture surgery, the USG-guided pericapsular nerve group (PENG) block, aims to directly block the articular branch of the femoral nerve, the articular branch of the obturator nerve, and the accessory obturator nerve, which selectively innervates the anterior aspect of the hip capsule. Case reports and a limited number of clinical studies have reported that PENG block is effective in managing acute fracture-related pain, neuraxial anesthesia positioning pain, and postoperative pain in hip fracture patients.

In this study, investigators aimed to investigate the effect of USG-guided PENG block on positional pain before spinal anesthesia in patients undergoing surgery for hip fractures and to compare this effect with intravenous ketamine.

In addition, investigators aimed to investigate the effect of PENG block on pain scores, perioperative opioid consumption, time to first analgesic requirement in the postoperative period, and quality of recovery in the first 24 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

hip fracture aged between 35 and 90 years old

Exclusion Criteria:

contraindications for spinal anesthesia and PENG block impaired cognition or dementia multiple fractures any previous analgesic administration during the last 12 hours
Multiple Ascending Dose Study of TD-1439 in Healthy Adult and Elderly Subjects

Multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-1439 in healthy adult and elderly subjects


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) 18 to 32 kg/m2 inclusive
* Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use highly effective methods of birth control
* Women of non-childbearing potential are at least 2 years postmenopausal or are surgically sterile
* Males must abstain from sex or use highly effective methods of birth control
* Negative for HIV, and Hepatitis A, B, and C

Exclusion Criteria:

* Female subjects who are pregnant, lactating, breastfeeding or planning to become pregnant during the study.
* Subjects with a history of angioedema.
* Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
* Subject has acute illness (gastrointestinal, infection \[e.g., influenza\] or known inflammatory process)
* Subject has bradycardia
* Subject has hypertension
* Subjects has orthostatic hypotension
* Subjects has orthostatic tachycardia
* Subject has a known personal or family history of congenital long QT syndrome or known family history of sudden death.
* Subject has donated blood or blood components or has had blood loss exceeding 400 mL within the 90 days prior to Screening.
* Additional exclusion criteria apply
Mineralocorticoid Receptor Antagonist and Pulmonary Fibrosis in COVID-19.

In December 2019 SARS-CoV-2 virus appeared in the world, mainly appearing as an acute infection of the lower respiratory tract. In March 2020, the World Health Organization (WHO) announced a pandemic in relation to the disease caused by the SARS-CoV-2 virus, known as COronaVIrus Disease 2019 (COVID-19). Since then, the efforts of scientists from around the world have focused on finding the right treatment and vaccine for the new disease. COVID-19 has spread rapidly in a few months, affecting patients in all ages. The disease has a varied course, patients can be 80% asymptomatic, but many develop respiratory failure, complicated by sepsis and ultimately death. One of the possible complications associated with COVID-19 lung involvement is pulmonary fibrosis, leading to chronic breathing difficulties and prolonged disability. No specific mechanisms leading to this phenomenon have been identified in COVID-19, but some information is derived from previous studies on the SARS and MERS epidemic. There have been several reports that the use of spironolactone may be important in preventing pulmonary fibrosis.

The aim of the study is to evaluate the effectiveness of intravenous form of mineralocorticoid receptor antagonist canrenoate potassium (an aldosterone antagonist of the spirolactone group) in the treatment of COVID-19-associated pulmonary fibrosis based on the mechanisms of the immune response.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of both sexes, 18-90 years of age.
2. Patient requiring oxygen therapy, SpO2 \<94%.
3. Confirmed COVID-19 infection.
4. At least one risk factor for increased mortality in the course of COVID-19: currently published in the literature e.g. smoking, hypertension, diabetes, cardiovascular disease.
5. Documented informed consent according to ICH-GCP and national regulations.

Exclusion Criteria:

1. Chronic bronchitis, emphysema, interstitial lung disease, or other history of lung disease.
2. Contraindications to the use of spironolactone.
3. Hypersensitivity to spironolactone or any of the excipients.
4. Pregnant patients (pregnancy test will be performed in every patient of reproductive age) and during lactation.
5. Patients with mental illness or dementia who are unable to give informed consent to the examination.
6. ARDS caused by another viral infection (SARS-CoV-2 negative).
7. ARDS from other causes/trauma.
8. Ionic disorders: hyperkalemia, hyponatraemia.
9. Adrenal crisis.
10. Acute and chronic renal failure, creatinine clearance less than 30 ml/min.
11. Anuria.
12. Porphyria.
Feasibility of a Yoga Intervention in Sedentary African-American Women

This study aims to test the feasibility, acceptability, safety of a 3-month hatha and restorative yoga intervention to decrease sedentary behavior, stress and blood pressure in sedentary African-American women.

This study aims to assess feasibility of a hatha and restorative yoga intervention compared to a control group. Investigators will examine feasibility of participant recruitment, retention and adherence; fidelity of intervention delivery; and intervention materials. Investigators also aim to evaluate the acceptability and safety of a hatha and restorative yoga intervention compared to a control group. Investigators will examine the acceptability of intervention location and strategies, class format, enjoyment of sessions, and safety of the intervention. Finally, investigators aim to test feasibility and appropriateness of the targeted outcomes for subsequent trials. Expected outcomes will be properly measured, but no comparisons between intervention and control groups will be made.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified as an African-American woman at least 18 years old
* Engaging in less than 30 minutes/week of moderate-to-vigorous physical activity
* If employed, working in a sedentary occupation that requires primarily seated work; • If unemployed, typical day involves sedentary, primarily seated activities
* Able to exercise for 20 minutes continuously
* No pre-existing condition that limits physical activity
* Access to a computer (or mobile device) and internet service

Exclusion Criteria:

* Diagnosed with heart disease, diabetes, cancer, kidney, liver disease, major depression or bipolar disease
* Take more than two daily medications for lipids or blood pressure
* Current smoker
A Clinical Controlled Trial on the Effect of Physical Activity After Cancer Treatment (PACT)

The PACT Study (Physical Activity after Cancer Treatment) is a unique study within the field of cancer rehabilitation in Denmark. It differs from other studies mainly due to the intervention itself. A combination of physiological, health educational and therapeutic elements will be tested. These components are incorporated into a one-year training program for mixed groups (i.e. men + women, with varying cancer diagnoses) to encourage them to enhance their well.-being and quality of life. The overall aim of this approach is to place increased focus on the treated cancer patient's introduction to and exploitation of both physiological and psychosocial yields through physical exercise. Whether or not the study results bear a positive effect, they are expected to support new knowledge in rehabilitation for cancer survivors.

The PACT ('Physical Activity after Cancer Treatment') Study is a multidisciplinary collaborative study carried out by the University Hospitals Centre for Nursing and Care Research (UCSF) and the Finsen Center (Oncology and Hematology Clinics) of the Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark. The project draws in cancer patients who have undergone chemotherapy and who are now disease-free or at a stable phase in their illness and have good prognoses.

The aim of the study is to investigate the effect of a 12-month rehabilitation program comprising supervised and structured physical exercise training (body conditioning; strength-building; relaxation; massage), patient education and coaching combined with a home-based physical exercise group component and will include a control group. Groups of 12-15 patients will be formed (mixed genders; different oncological and hematological diagnoses) who will train together once weekly during the intervention period. Participation in a training program with peers is seen as a positive motivational factor that stimulates and challenges the patient through physical activity, to use his/her own resources to establish sustainable coping strategies.

Eligibility Criteria:
Inclusion Criteria:

* Cancer diagnosis
* Completed cytostatic treatment \<6 months
* Affiliated with either the Oncology or Hematology Clinic at the Copenhagen University Hospital, Copenhagen
* Between the ages of 15-70 years
* No evidence of disease or life expectancy \>2 years.

Exclusion Criteria:

* Contraindications for physical activity
* Bone and brain metastases
* Multiple myeloma (in the case of hematological patients)
* Symptomatic cardiac illness, including clinical congestive heart disease, treatment caused arrhythmia or myocardial infarction experienced within the previous three months
* Dementia and/or psychosis
* Patients who cannot read or write Danish.