cyrilzakka/clinical-trials huggingface dataset:
Mental Health and Vigorous-intensity Physical Activity

Twenty-five percent of the population worldwide will experience a severe mental illness during their lifetime (World Health Organization, 2017). These people present strong barriers to adhering to moderate and vigorous-intensity continuous training. It is fundamental to overcome these barriers for practicing moderate-to-vigorous physical activity by adding behavioural change techniques into physical activity interventions (Maurus et al., 2023), in order to design and implement sustainable interventions that empower people to engage in it.

The main objective of this protocol is to evaluate the impact of a moderate-to-vigorous physical activity program on improving clinical, functional and personal recovery outcomes in order to seek for a diverse array of improvements in mental, physical health, quality of life and functioning in people who have severe mental illness

Multi-centric, controlled clinical trial. Data will be collected from recuperation services from Central Catalonia. A sample size of 80 people will be allocated into a control group (n=40) or intervention group (n=40), with post-intervention follow-up at 7 and 10 months. Professionals from recuperation services will explain the physical activity program to everyone included, and they will invite them to participate through a specific interview guide. The control group will receive usual healthcare from their recuperation service. The intervention group will participate in a 7-month vigorous-intensity physical activity program which pretends to increase the number of physical activity daily bouts.

Eligibility Criteria:
Inclusion Criteria:

* Severe mental illness diagnosis, according to the 5th edition of the diagnostic and statistical manual of mental disorders (DSM-5)
* Volunteers to engage in a physical activity program.

Exclusion Criteria:

* Decompensation of the underlying disorder
* Have absolute contraindications due to the practice of physical exercise
* Have lack of understanding of the Catalan or Spanish language.
Pharmacogenetics of Propofol and Depth of Anesthesia

Propofol, (2,6-diisopropylphenol) is a short-acting anesthetic drug used for induction and maintenance of anesthesia.

The aim of this study is to evaluate plasma concentrations of propofol in relation to depth of anesthesia, measured by continuous EEG and to correlate plasma concentrations with genetic analyses of liver enzymes responsible for drug elimination.

Our hypothesis is that there is an individual requirement of Propofol plasma concentration depending on genetic differences in drug elimination.

200 patients, ASA classification 1, planned for elective surgery of a duration of at least 30 minutes will be included in this study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy caucasian patents,
* (ASAclassification 1) planned for elective surgery,
* with body mass index 20-30,
* free from analgetic drug \> 12 hours prior to anesthesia

Exclusion Criteria:

* Pregnancy,
* Smoking,
* allergy to propofol or peanuts,
* alcohol abuse,
* non-caucasian
Local Treatment of Metastatic Melanoma With Autologous Lymphocytes and the Bispecific Antibody rM28

Phase I/II clinical trial to analyze safety and efficiency of intralesional application of the bispecific single chain antibody rM28 and autologous PBMCs in patients with metastatic melanoma stage III/IV and unresectable metastasis.

Phase I/II clinical trial to analyze safety and efficiency of intralesional application of the bispecific single chain antibody rM28 and autologous PBMCs in patients with metastatic melanoma stage III/IV and unresectable metastasis. The antibody is directed against epitops of human CD28 and the melanoma associated surface antigen HMV-MAA. Treatment over 5 days with dose escalation.

Eligibility Criteria:
Inclusion Criteria:

* malignant melanoma stage III/IV
* injectable soft tissue metastasis
* informed consent given
* Karnofsky \>= 70%

Exclusion Criteria:

* additional chemotherapeutical treatment
* systemic glucocorticoids
* brain metestasis
* other malignancies
Lymphocyte and Cytokine Disturbances in Polymyalgia Rheumatica

Pathophysiology of polymyalgia rheumatica (PMR) is ill defined. This study aims at characterizing immunological abnormalities in PMR patients, and to assess the effects of tocilizumab therapy on this abnormalities.

Comparison of PMR patients and matched control subjects.

Eligibility Criteria:
Inclusion Criteria:

* PMR patient included in the TENOR study with samples available

Exclusion Criteria:

* Patient not included in the TENOR study
Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector (Aim 2)

The overall objective of this study is to evaluate the public health impact of targeted antimalarials subsidies through scale-up by determining the community-wide effects of targeting an antimalarial subsidy through a partnership between Community Health Volunteers (CHVs) and the private retail sector. The primary hypothesis to be tested is that offering a fixed-price voucher that reduces the cost for artemisinin combination therapy (ACT) purchase in the retail sector conditional on a positive malaria test (targeted subsidy) can improve uptake of testing for malaria and will increase the proportion of fevers tested for malaria before treatment. The study will be carried out in two sub-counties in Kenya with similar malaria burden but different access to health services; the investigators will use a cluster-randomized design to assign community units (CUs) in each sub-county to either an intervention or control arm. CHVs will be trained to use malaria rapid diagnostic tests (RDTs) to diagnose malaria in household members with documented or reported fever; households in intervention CUs will be informed of the intervention and encouraged to contact the CHV for any febrile illness in the home. There are minimal risks associated with receiving an RDT. Households with a positive RDT will be given a serialized voucher that will entitle the holder to purchase a quality assured ACT in the retail sector at a reduced, fixed price. The primary and secondary outcome measures will be compared at baseline and 12 months post-baseline through population-based surveying. The primary aim is to determine whether there is significant difference between the 2 study arms in the proportion of clients with fever who are tested prior to any treatment after adjusting for relevant covariates.


Eligibility Criteria:
INCLUSION CRITERIA

Intervention participation criteria:

* Client is older than 1 year
* Client has fever or history of fever or feeling unwell with a malaria-like illness within the last 2 days
* Client or their parent/legal guardian (if under 18) consents to participate

Cross sectional survey participation criteria:

* Household representative in the intervention or control arm
* At least one member in the respondent's household with a history of fever or feeling unwell with a malaria like illness within the last four weeks
* Respondent is older than 18 years

EXCLUSION CRITERIA

Intervention exclusion criteria:

* Client has signs of severe disease or other problem requiring immediate referral to a health facility
* Client has already visited a health facility, taken or purchased antimalarials for the current illness.

Cross sectional survey exclusion criteria:

• Households not in the intervention or control arms
Influence of Chrono-nutrition Factors and Temporal Dietary Patterns on Glycemic Parameters During Pregnancy.

This study aims to establish a new cohort study to investigate the relationship between chrono-nutrition factors during pregnancy and maternal GDM (Gestational diabetes mellitus), glycemic parameters, and gestational weight gain.

Gestational diabetes mellitus (GDM), characterized by hyperglycemia first diagnosed during pregnancy, is associated with an increased risk of full-fledged type 2 diabetes (T2D) in mothers and adverse metabolic health in their offspring. In Taiwan, the prevalence of GDM has risen from 7.6% in 2004 to 13.4% in 2015, affecting approximately 1 in 7 pregnancies. Even at levels below the diagnostic threshold for GDM, studies such as the Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) have shown a clear graded relationship between higher maternal glycemia and an elevated risk of adverse birth outcomes and childhood insulin resistance.

Metabolic health and glycemic profile of mothers are in turn heavily influenced by diet and nutrition. While dietary content is crucial, multiple lines of evidence now suggests that not only what one eats but also when one eats impacts health. The master circadian clock in the human brain orchestrates circadian rhythms in response to the light-dark cycle. However, it is now recognized that most organs possess peripheral circadian clocks that are strongly influenced by behavioral rhythms, including feeding/fasting, activity/rest, and wake/sleep cycles. Chrono-nutrition is an emerging field of study concerning the interplay between the endogenous circadian rhythm, dietary intake, metabolism, and health. There are various dimensions of chrono-nutrition including meal timing, frequency, and regularity, and daily fasting duration. These individual dimensions have been linked to health outcomes, but few studies have examined the intricate interconnectedness across these different dimensions. Another research gap is that there is a dearth of studies investigating chrono-nutrition factors in pregnant populations.

Thus, to address these research gaps, the investigators aim to establish a new cohort study to investigate the relationship between chrono-nutrition factors during pregnancy and maternal GDM, glycemic parameters, and gestational weight gain.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged 20 years or older.
2. Pregnancy duration between 10 and 15 weeks.

Exclusion Criteria:

1. Diagnosis of type 1 diabetes, type 2 diabetes, or gestational diabetes.
2. Currently taking medications that may affect glucose metabolism (e.g., metformin).
3. Irregular working schedule, such as shift work.
4. Presence of a multiple pregnancy.
Identification of Biomarkers for Early Detection of Pancreatic Cancer

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is examining blood samples from patients with cancer to identify biomarkers that may help in the early detection of pancreatic cancer.

OBJECTIVES:

* Identify specific proteins of interest to evaluate for their potential role as markers for pancreatic cancer.
* Analyze serum proteins directly by mass spectrometry to identify new biomarkers of pancreatic cancer that can be used for early diagnosis.

OUTLINE: Blood from patients is collected prior to treatment. Plasma proteins are analyzed by matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF/MS) and/or electrospray mass spectrometry (ESI/MS).

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of pancreatic cancer

  * Newly diagnosed disease
* Planning to undergo surgery or other treatment for pancreatic cancer at Karmanos Cancer Institute or its affiliates

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Chinese Validation of the Simplified Evaluation of CONsciousness Disorders（SECONDs）

The aim of this study was to translate the SECONDs from French into Chinese and assess the validity and reliability of the Chinese version of the SECONDs .

To promote accurate assessments of DoC patients and the development of clinical research on DoC in China, we here propose and validate a version of the SECONDs translated into Mandarin Chinese. Hence, this study aims to assess the concurrent validity (compared with the CRS-R which has already been translated and validated in Mandarin), intra-rater reliability, and inter-rater reliability of the Chinese version of the SECONDs

Eligibility Criteria:
Inclusion Criteria:

* Acute (longer than 14 days, less than 28 days) or prolonged DoC (following severe acquired brain injury, longer than 28 days);
* Age: 18-85 years old;
* No history of other neurological or psychiatric deficits;
* Ability to speak Chinese fluently;
* Medical stability (e.g., absence of mechanical ventilation, sedation, infection)

Exclusion Criteria:

* None
A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients

This is a Phase 3, open-label, extension trial designed to evaluate the long term safety and efficacy over 3 months of TNX-102 SL tablets taken daily at bedtime for the treatment of Fibromyalgia (FM). Patients recruits into this trial are those who have successfully completed the double-blind studies; TNX-CY-F301 and TNX-CY-F302.

Patients will not be made aware of the therapy they received during the double-blind study.

The study consist of 4 study visits, including Screening/Baseline Visit 1 (Day 1, which is anticipated to be the same date as Visit 6 in F301 or F302) and visits after 1, 2 and 3 months of treatment (Visits 2-4).

Primary:

The primary objective of the study is to evaluate the safety of TNX-102 SL tablets taken daily at bedtime over an additional 3 months in patients with FM who have completed the double-blinded lead-in study

Secondary:

The secondary objective is to evaluate the efficacy of TNX-102 SL tablets taken daily at bedtime to control symptoms of FM

Eligibility Criteria:
Inclusion Criteria:

* The patient met all prior inclusion and exclusion requirements for study F301 or F302 originally, and has had no intervening medical conditions, increased suicidal ideation, or requirements for concomitant medications that preclude exposure to TNX-102 SL or enrollment in the extension study.
* The patient completed expected dosing in F301 or F302 defined as taking study medication up to Week 12, with at least 70% compliance with medication usage (based on overall drug accountability reconciliation at the end of the F301 or F302 lead-in study) and no major protocol deviations.
* The patient has provided written informed consent to participate in this extension protocol.

Exclusion Criteria:

* None
User Satisfaction of Customised 3D Printed Ankle-Foot Orthosis in Comparison to Thermoformed Ankle-Foot Orthosis for Patients With Neurological Conditions: A Preliminary Study

Study Design and Subject Recruitment: This was a cross-sectional study in a single centre outpatient setting at the Foot Care and Limb Design Centre, Tan Tock Seng Hospital. As this was a proof-of-concept clinical trial for the introduction of 3D printed AFOs as a patient service, only 5 subjects were recruited based on consecutive sampling.

Interventions: Thermoformed AFOs moulded over the subject's lower limb plaster model served as the control intervention. The plaster models were rectified by an orthotist with over 20 years of experience and the AFO design was determined according to the subject's clinical presentation and needs. The AFOs were manufactured from 4 - 5mm thick homopolymer polypropylene. 3D printed AFOs served as the treatment intervention. It was fabricated through 3D scanning with an Artec Eva 3D scanner (Artec 3D, Luxembourg, Luxembourg) and an adjustable Perspex glass foot plate, CAD modelling with the OrtenShape software (Proteor, Saint-Apollinaire, France), and printed using fused deposition modelling with the Fortus 450mc (Stratasys, Minnesota, United States). The 3D printed AFO is printed of Polyamide Nylon-12 material in the same thickness as the thermoformed AFO. There were no blinding procedures as both interventions were distinctly different and it is not possible to blind subjects with daily use of the AFOs.

Trial Schedule: A thermoformed and a 3D printed AFO were fitted to each subject in a single session. The QUEST survey was administered post-fitting. Subjects brought home both AFOs and were instructed to wear them during ambulation, alternating between the AFOs daily. Subjects returned for follow-up at 3 weeks and 6 weeks post-fitting for necessary adjustments and the administration of the QUEST surveys was repeated for each AFO.


Eligibility Criteria:
Inclusion Criteria:

* Existing patients of the centre,
* Clinical need for an AFO due to neurological disorders.

Exclusion Criteria:

* Cognitive impairment
* Lower limb volume fluctuations
* Severe foot/ ankle varus or valgus deformities
* Lower limb contractures of over 10°
* Non-community ambulators
Low Cost Socket for Lower Limb Amputees

The purpose of this research is to test an investigational fabrication system for transtibial prostheses. This fabrication method will be tested for comfort and function to determine feasibility of use for amputees in developing countries.

To address the need for high quality and affordable prosthetic technology in developing countries, the investigators have developed a simplified socket fitting protocol using expandable rigid foam. The foam is formed by mixing small amounts of two liquid components, which typically expands to several times its original volume.

Millions of amputees in low-income nations lack access to prosthetic care. Conventional socket fabrication is complex, and the need for prosthetists is far greater than the throughput of existing clinician training programs. The first step in fitting a prosthetic limb is to fabricate the socket, which fits over the residual limb and acts as the interface between the residual limb and the prosthesis. The socket is the most custom component of the prosthetic system and must be comfortable to wear, easy to clean, and durable enough to withstand years of day-to-day use.

Simple and low-cost methods for socket fabrication and fitting would improve access to prosthetic care and could give many people in need their first opportunity to use a prosthesis. We have developed an easy-to-follow method that allows us to cast the limb in less than 30 minutes and finish the socket in 90 minutes, making it a practical choice for socket fitting in busy clinical settings, and where users are unable to return for multiple fittings. We have submitted a provisional US patent for our socket fabrication method.

We hypothesize that our novel method of fabrication for a low cost prosthesis can produce a device that has appropriate suspension, a comfortable interface, and requires little long term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral transtibial amputees having had their amputation at least 6 months prior, so that they have a relatively stable conical residual limb shape and can ambulate independently
* Currently has a well-fitting prosthesis- as defined by a self-reported Socket Comfort Score of at least a 6 out of 10
* K2, K3, K4 level ambulators
* Understands the English language

Exclusion Criteria:

* Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate usable, reliable data. The ability to obtain relevant user feedback and informal discussion adds significant value to this study.
* Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study (e.g stroke, pacemaker placement, etc), or that would otherwise prevent acquisition of usable data by researchers.
* Bulbous residual limb shape causing inability to fit within system restrictions
* Open wounds on the residual limb
* Inability to understand the English language
17% Salicylate Versus 17% Salicylate-Ethyl Pyruvate for Plantar Foot Warts

Plantar warts on the sole of the foot are among the most common warts seen in podiatry clinics. Some patients are readily cured by simple standard of care treatments that include wart debridement (trimming or excision) and application of 17% salicylate (commercially known as Compound W)or by other treatments that may be painful and affect mobility. No treatment is consistently effective and most patients fail treatment multiple times.

Ethyl pyruvate (EP)is a common food additive noted to be 'generally regarded as safe' that may improve the activity of salicylate in wart treatment by improving the ability to penetrate and/or persist in the skin. The use of 17% salicylate with the addition of EP may improve cures of common foot plantar warts in subjects who also be receiving other standard-of-care treatment.


Eligibility Criteria:
Inclusion Criteria:

* evidence of skin plantar wart(s)

Exclusion Criteria:

* iodine allergy
Digital Mammography for the Detection and Preoperative Staging of Breast Cancer

Breast tumors are normally seen with mammography or ultrasound without the use of a dye but the size and extent of the tumor may be hard to see. Currently, after initial mammography, many patients undergo bilateral breast MR to further stage the local tumor. It is able to not only detect anatomic abnormalities but can also evaluate changes such as the development of new blood vessels, which occurs with the development of cancers. MRI is extremely sensitive and detects unsuspected disease in up to 25% of patients, which affects their treatment. It also detects unsuspected cancer in the other breast in some patients.

However, MRI is expensive, not always available, and some patients are unable to undergo MRI due to the presence of pacemakers, clips, or claustrophobia. Dual Energy Contrast Enhanced Digital Mammography (DE CEDM) is an investigational procedure that uses a non-standard contrast in a regular digital mammography exam that has been changed to give the needed dual energy and image. DE CEDM is not FDA approved. It is our hope that DE CEDM will also be able to detect unknown tumors because it will also detect new blood vessels. It is less expensive than MRI, could be more available to patients, and can be done on patients with pacemakers and clips. Claustrophobia will not be a problem. We plan to see if (DE CEDM) will help us better see the breast tumor and size of the breast tumor. We will also want to see if DE CEDM can detect additional unsuspected disease in the breast with the known tumor and in the other breast without a known tumor.


Eligibility Criteria:
Inclusion Criteria:

* Women with newly diagnosed unilateral breast cancer proven through core biopsy or FNA who are planned to have (preoperative) MRI within 30 days of DE CEDM to assess extent of disease/multifocality. (All women will have bilateral digital mammography as per standard of care.) The preoperative MRI will be based on the surgeon's recommendation.
* Both breasts are present.
* Women consenting to a bilateral DE CEDM examination.

Exclusion Criteria:

* Women under 21.
* Women who have already had a lumpectomy. (Index lesion has been removed and therefore, not evaluable for the purpose of this study.)
* Women undergoing neoadjuvant chemotherapy, hormone treatment, or radiation therapy.
* Known pregnancy.
* Women who have a contraindication to the intravenous use of iodinated or gadolinium-chelated contrast agent.
* Women with breast implants.
* Women with pacemakers.
* Women with aneurysm clips that don't allow for MRI.
* Women too claustrophobic to undergo MRI.