cyrilzakka/clinical-trials huggingface dataset:
Autologous Antigen-activated Dendritic Cells in the Treatment of Patients With Colorectal Cancer

The purpose of this work: to assess the tolerability and effectiveness of the autogemotherapy method on the basis of autologous antigen-activated dendritic cells in the treatment of patients with colorectal cancer.

This technology is intended for complex treatment of patients with colorectal cancer and is aimed at preventing the occurrence and treatment of secondary foci. The need for this technology is justified by the widespread occurrence of colorectal cancer, a decrease in the average age at onset of the disease, and the chemoresistantness of locally advanced forms of cancer.

Currently, technologies are being developed to improve the clinical outcomes of patients with complex treatment of colorectal cancer. Many patients are immunosuppressed after surgical, radiation and chemotherapeutic treatment, which leads to dysfunction of T cells, resulting in tumor cells avoiding immune surveillance. Restoration of antitumor immunity during immunotherapy is one of the modern approaches in the treatment of colorectal cancer, which contributes to the formation of an effective specific immune response, the destruction of tumor cells while minimizing toxicity. Dendritic cells (DC) and the lymphocytes induced by them are one of the most effective methods for the destruction of residual cancer cells, which are the leading cause of relapse and metastasis.

Eligibility Criteria:
Inclusion Criteria:

1. For the first time established morphologically confirmed diagnosis of colorectal cancer
2. Patients with II A, II B, II C, III A, III B, III C stages of colorectal cancer;
3. Patients with progressive or primary IV stage of colorectal cancer with cytologically confirmed and accessible soft tissue metastases;
4. Absence of severe somatic pathology in which medical intervention (at the stage of obtaining biological material or the stage of immunotherapy) will only worsen the patient's condition,
5. The patient's desire.

Exclusion Criteria:

1. Pregnancy at any time,
2. Impossibility of correction of therapy of concomitant diseases, if the taken preparations are proved to influence the immune status,
3. Rapid progression of the underlying disease, in which the use of immunotherapy is deontologically unjustified,
4. Individual intolerance to the components of the vaccine and / or the development of severe side effects on any of the components,
5. Refusal of the patient to participate in the study in oral or written form.
6. Patient involvement in any other clinical study (including those that the patient has not been informed by the direct oncologist who has been treated, but which has become known already after the beginning of any stage of the study).
The Immediate Effects of Kinesio-Taping on Scapular Muscle Endurance and Strength in Asymptomatic Subjects

The purpose of this study was to investigate the immediate effects of Kinesio-taping (KT) on scapular muscle endurance and strength and compared to placebo Kinesio-taping in asymptomatic subjects.

Thirty-nine asymptomatic subjects (20 females and 19 males, mean age 20.46±1.09 years, mean BMI 21.99±3.02 kg/m2) were included in this study. Subjects were randomly allocated to KT (with the muscle facilitation technique) and placebo-KT (without any technique and tension). Scapular isometric muscle endurance was measured with a scapular muscle endurance test. The strength of the upper, middle, and lower trapezius, and serratus anterior was assessed using a hand-held digital dynamometer. Data were analyzed with 2x2 \[groups (KT and Placebo-KT) x time (pre- and post-intervention)\] mixed-model ANOVA.

Eligibility Criteria:
Inclusion Criteria:

* An age range of 18 to 25 years,
* The ability to participate voluntarily.

Exclusion Criteria:

* Shoulder injuries in the last year, previous shoulder surgery, shoulder dislocation, and having performed upper-body exercises within the 24 hours before each evaluation session. - Diagnosed with cardiovascular or neurological disease
Strategic Research Program 17 (VUB Funding)

Objectives: The main objectives are to determine neural dynamics during gait using electro-encephalography as well as brain sources and to investigate the attentional demand during walking in able-bodied individuals, and individuals with an amputation.

Materials \& Methods: 6 able-bodied individuals conducted one experimental trial, and 6 unilateral transtibial and 6 unilateral transfemoral amputees performed 2 experimental trials; the first with the current and the second with a novel powered transtibial prosthesis, i.e. the Ankle Mimicking Prosthetic foot 4.0. Each experimental trial comprised 2 walking tasks; 6 and 2min treadmill walking at normal speed interspersed by 5min of rest. During 6min walking the sustained attention to response (go-no go) task, with measures reaction time and accuracy, was performed. Electro-encephalographic (EEG) data were gathered when subjects walked 2min. Motor-related cortical potentials and brain activity during gait are extracted using EEG.

Detailed description of the novel device:

The device mainly distinguishes itself from commercial prostheses thanks to its new type of actuation providing a compact and energy efficient solution to the challenge of ankle-foot actuation. This new actuation method consists of using springs, a servo motor and a locking mechanism, coupled with a sensory network providing intelligence to the robotic device. The AMPfoot 4.0 design is also based on previous research conducted on the AMP-Foot 2. However, it is important to note that in contrast with its preceding designs, the AMP-Foot 4.0 does not provide active propulsion at push-off.

During walking, the AMP-Foot 4.0 working principle is divided into two main logic sequences, i.e. the stance and the swing phase. These two phases are detected by analyzing gyroscope and acceleration measurements from an Inertial Measurement Unit chip. During the stance phase, the ankle performs a dorsi-flexing movement while a plantar-flexing torque is applied at the ankle. The person's gravitational potential energy is stored into elastic potential energy by means of the used spring. It is this spring that provides the plantar-flexing torque required at the ankle as reaction to the movement of the user. Due to the use of a locking system, the prosthesis can adapt its so-called zero torque rest point depending on the slope or stride length of the user. This provides adaptability and therefore greater comfort compared to prostheses with a fixed zero torque rest point. During the swing phase, the locking mechanism unlocks to free the ankle movement. Parallel springs external to the stance system are then activated to reset the foot to its initial position. From that moment, the device is ready for a new step.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral transfemoral amputees
* Unilateral transtibial amputees
* Able-bodied individuals

Exclusion Criteria:

* Children
* Functional k-level lower than 4 (Amputee has the ability for prosthetic ambulation that exceeds basic ambulation skills, exhibiting high impact, stress or energy levels)
Salivary Bacterial Profiles in Relation to Periodontal Treatment

The purpose of the present investigation is to record and compare bacterial compositions in subgingival plaque samples and saliva samples in subjects receiving periodontal treatment. The hypothesis is that the composition of the salivary microbiota might reflect local bacterial alterations in relation to periodontal treatment.

In this study we plan to enroll 35 subjects with manifest periodontitis, which will be treated according to national and international guidelines. Clinical registration and collection of subgingival plaque samples and saliva samples will be performed at baseline and 2, 6 and 12 weeks after treatment.

Eligibility Criteria:
Inclusion Criteria:

- Manifest chronic periodontitis according to international classification

Exclusion Criteria:

* Other treatment requiring oral conditions
* Systemic antibiotics within the latest 6 months
* Systemic diseases and medications with known associations to periodontitis
* Pregnancy and breastfeeding
Prevalence Rate, and Clinical Characteristics of Obesity Hypoventilation Syndrome Via Screening Patients Admitted to Medical Intensive Care Units

A prospective observation study to screen adult obese (BMI ≥30 kg/m2) patients who were newly admitted to the medical intensive care units and turned out to be diagnosed as Obesity hypoventilation syndrome(OHS). The investigators purpose is to look into the prevalence, predictive factors, and outcomes of OHS in these critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 30 kg/m2
* Suspected chronic hypercapnia as following Paco2 ≥ 45 mmHg, HCO3- ≥ 27mEq/L or base excess, BE ≥ 2 mEq/L

Exclusion Criteria:

* Malignancy with lung involvement
* Autoimmune disease with lung involvement
* Moderate to severe obstructive respiratory pattern via spirometry
* Uncontrolled endocrine disease
* Pregnancy
* Pneumonia confirmed by image
* Out-of-hospital cardiac arrest
* Lung edema
* Foreigner of Taiwan
A Retrospective Observational Study Comparing Two Different Treatment Options in Thyroid Cancer Patients With T4 Tumours

The study is to demonstrate non-inferior thyroid remnant first ablation success of Thyrogen and 131I compared to thyroid hormone withdrawal (THW) and 131I in patients with T4 tumour based on historical diagnostic whole body scan (DxWBS) records.


Eligibility Criteria:
Inclusion Criteria:

Historical records from patients who meet all of the following criteria will be eligible for inclusion in this retrospective evaluation:

1. Male or female patients living or deceased, aged 18 years or older at the time of first ablation for thyroid cancer.
2. Diagnosed with a well-differentiated T4 tumour (defined as a primary tumour of any size that extends beyond the thyroid capsule \[this may be referred to as TNM classification T4, N0-1, M0-1\]). This excludes unusual histological types such as oncocytic (Hurthle cell carcinoma), tall cell, sclerosing or cribriform thyroid cancers.
3. Undergone a near-total or total thyroidectomy on or after 01 January 2000
4. Undergone first ablation of thyroid remnants with high activity 131I (≥28 mCi or ≥ 1.036 GBq).
5. Undergone first 131I ablation for the T4 tumour using either Thyrogen (0.9 mg IM on 2 consecutive days) or THW stimulation. This excludes use of non-standard Thyrogen regimens (i.e., had a regimen of Thyrogen other than the standard 0.9 mg IM on 2 consecutive days or received Thyrogen in combination with THW).
6. Historical records are available confirming ablation results by:

   * DxWBS using small activity (≥2 mCi or 74 MBq) of iodine 131I (or 123I) performed at least 6 months after administration of the first ablation activity of 131I and/or
   * Stimulated Tg measured at least 6 months after administration of the first ablation activity of 131I.

Exclusion Criteria:

Historical records from patients who meet any of the following criteria will be excluded from this retrospective evaluation:

1. Received propylthiouracil, methimazole, vitamins or supplements containing kelp or iodine (taking a multivitamin that does not contain iodine or kelp is acceptable), medications that significantly affect iodine handling such as high dose corticosteroids, high dose diuretics, or lithium in the 45 days before administration of first ablative activity of 131I.
2. Received any iodine-containing contrast agents within 3 months prior to first ablative activity of 131I administered.
3. Used amiodarone within the 2 years prior to first ablative activity of 131I administered.
Mobile Health Intervention for Infants in Guatemala (18-m Intervention)

Promoting optimal development for children at risk in low- and middle-income countries (LMICs) is an important global health priority. Supporting caregivers to provide nurturing care is an evidence-based strategy, however feasibility of scaling-up this supporting is limited by competing demands on health workers' time. For infant development, mHealth technologies have the potential to solve this problem by providing tailored content directly to caregivers, involving and empowering them to promote infant development, promoting and facilitating interactions with health workers when areas of concern are identified and, therefore, expanding the reach of healthcare systems. Following a pilot feasibility study, this current study will examine the effectiveness of a caregiver-directed smartphone application to directly engage first-time caregivers in rural Guatemala and support early childhood development.

Rationale: According to recent estimates, nore than 40% of children under age 5 residing in low- and middle-income countries (LMICs)-250 million children in total-are at risk of not reaching their developmental potential due to living in environments with malnutrition, poverty, and lack of early stimulation. Mobile health (mHealth) technology represents an efficient strategy for scaling interventions to promote infant development.

Intervention: Individually-randomized controlled trial of mHealth application compared to paper caregiving materials. Length of intervention = 18 months.

Objectives and purpose: We will test the effectiveness of a smartphone application that will directly engage caregivers in providing nurturing care to at-risk infants. We will assess effectiveness of the mHealth application compared to paper caregiving materials by comparing group differences in Bayley scores after 18 months.

Study population: first-time parents of newborn infants, newborn infants.

Eligibility Criteria:
Inclusion Criteria:

* first-time caregivers with an infant in the eligible age range (0-4 weeks)
* infant from singleton birth
* infant from full-term (\> 37 weeks gestation) birth

Exclusion Criteria:

* Presence of acute malnutrition/wasting or severe medical illness (heart disease, kidney disease, congenital abnormality) in the infant
* medical need for supplementation of breastfeeding
* caregiver not literate
The Effect of Arabica Gayo Cascara Pulp Extract on Photoaging

The purpose of this study was to assess the safety of Gayo Arabica coffee pulp extract cream as an antioxidant for the skin that can increase skin moisture

This study is a phase I clinical trial aimed to assess the safety of the cream to be performed on volunteers, women, aged 20-40 years, who have healthy and normal skin. Research subjects that included in the study were determined based on inclusion and exclusion criteria. Enumerators previously provided information to the public using print media about this research to obtain research subjects that matched the inclusion and exclusion criteria. After that, the enumerators will conduct interviews and the willingness of research subjects according to the inclusion criteria by filling in the informed consent. Then before intervention, there will be an examination of skin conditions which will be carried out by two dermatologists including the condition of research subjects' skin moisture with a corneometer.

The cascara pulp cream of Gayo Arabica coffee works to improve skin structure and increase moisture in the skin. The safety test of the cream with the patch test method of cascara pulp cream of Gayo Arabica coffee was carried out by researchers and left for 48 hours. After 48 hours, the patch test unit was opened and evaluated by 2 dermatologists, the changes that occurred were recorded. Then with a corneometer examination was done to determine skin moisture. The same thing will also be done at the research subjects visit after 72 hours and 96 hours after the patch test is opened to reassess whether there are changes in the skin such as irritation/redness and skin moisture.

Data analysis in this study used univariate, bivariate and multivariate data analysis. Univariate analysis was carried out by describing the characteristics of the basic data in the form of frequency distribution, average value, standard deviation and range that occurred from the variables studied, both dependent (dependent) and independent (independent) variables. Bivariate analysis in this study was carried out by collecting data on a numerical scale first and then assessing its distribution using the Kolmogorov Smirnov test. Furthermore, if the data is normally distributed, the comparison of the mean before and after the intervention in the group will be analyzed using the Paired sample t-test. If the data is not normally distributed, a non-parametric test in the form of the Wilcoxon Rank test will be used.

Eligibility Criteria:
Inclusion Criteria:

* female, healthy and normal skin condition
* age 20-60 years old
* Willing to participate in research

Exclusion Criteria:

* history of allergy to one of the ingredient of the cream
* history of allergy to coffee
Study Evaluating the Association of Antibiotic Measures and Control of Bacterial Resistance

Assess efficacy of piperacillin/tazobactam in reducing the cases of colonization and infection of bacteria.

Primarily, this study is designed to assess the efficacy of piperacillin/tazobactam in reducing the cases of colonization and infection of extended-spectrum betalactamases (ESBLs) producing E.coli or K pneumoniae, S aureus methicillin resistant (MRSA) and Enterococcus vancomycin resistant (VRE). Secondly, this study plans to determine the acquisition rate of ESBL producing E Coli or K pneumoniae, methicillin resistant S Aureus (MRSA) and vancomycin resistant Enterococcus spp (VRE), both pre- and post-intervention.

Eligibility Criteria:
All patients admitted in ICU will be enrolled (who qualify for treatment).
Evaluating the Influence of Showing Patients Their Predicted Teeth Alignment on Their Expectations and Satisfaction

Patients who have moderate crowding will be treated in this study. The efficacy of showing the predicted alignment of patient's teeth at the end of orthodontic treatment previously to treatment on their expectations from orthodontic treatment and their satisfaction with their teeth alignment will be assessed.

It is known that most patients expect that orthodontic treatment will improve their appearance which increases their confidence and self-esteem level.

The ability to approach patient's expectations to reality is crucial to making them reasonable and to improve patient's satisfaction with treatment outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Class I malocclusion with moderate crowding (between 4-6 mm of tooth-size-arch-length-discrepancy).
* Good oral hygiene and periodontal health.
* No severe skeletal discrepancy.
* Normal proclination for the upper and lower incisors.

Exclusion Criteria:

* Bimaxillary dentoalveolar severe protrusion.
* Need for extraction.
* Previous orthodontic treatment.
* Subject with psychological abnormalities.
* congenitally missing or extracted teeth (except for the third molars).
* history of previous trauma to the maxillofacial region or surgical interventions.
Letermovir for CMV Prevention After Lung Transplantation

This is an interventional, open-label, single center, pilot study with historical controls to test the efficacy of letermovir (LET) for the prevention of CMV infection and disease in adult lung transplant recipients (LTRs) with idiopathic pulmonary fibrosis (IPF).

Approximately 30 patients with IPF listed for lung transplantation will be enrolled and 15 are expected to undergo lung transplantation during the study period and receive the intervention. Patients who are CMV seropositive will receive letermovir for 6 months, patients who are CMV seronegative and receive lungs from a CMV seropositive donor (CMV D+/R-) will receive letermovir for 12 months. All patients will be followed for 12 weeks after completion of letermovir for the occurrence of CMV infection or disease after prophylaxis.

Historical controls will be LTRs for IPF from 2010-2019 who are CMV R+ or CMV D+/R- (donor positive/recipient negative). CMV prophylaxis in the historical controls was with valganciclovir for 6 months for CMV R+ and for 12 months for CMV D+/R-. Patients will be matched for CMV serostatus, induction immunosuppression, age, and telomere length.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years on day of signing informed consent
* Listed for lung transplantation (single or double) due to a diagnosis of IPF or receipt of a lung transplant (single or double) for IPF in the 72 hours prior to enrollment
* Have a documented positive serostatus for CMV (CMV IgG seropositive, R+)
* Have a documented negative serostatus for CMV (CMV IgG seronegative, R-) and anticipate receiving or having received a lung allograft from a CMV IgG positive donor, D+). Only participants who are R+ or who are CMV D+/R- will receive intervention. Participants who are CMV D-/R- will be considered screen failures
* Able to travel to UPMC for routine post-transplant visits for a minimum of 15 months after transplantation
* Able to provide informed consent
* Be willing to use a contraceptive method while receiving LET and for at least 90 days following last dose of LET

Exclusion Criteria:

* Receipt of a previous solid organ transplant or hematopoietic stem cell transplant
* Multi-organ transplant recipient, i.e., heart-lung or lung-liver
* HIV seropositive
* HCV antibody or HCV RNA positive
* Donor HCV NAT positive
* Anticipated need for use of ganciclovir, valganciclovir, foscarnet, or cidofovir at the time of transplant
* Known or suspected hypersensitivity to LET or acyclovir
* CrCl \< 10 ml/min or dialysis on day of transplant
* Child-Pugh Class C severe hepatic insufficiency
* Pregnancy or expected to conceive while on LET and through at least 90 days following cessation of LET