cyrilzakka/clinical-trials huggingface dataset:
Modeling Post-traumatic Pain and Recovery: The SYMBIOME Longitudinal Cohort Study

This study will explore the contribution of stress-system activity to pain and functional disability in the acute stage of traumatic musculoskeletal injury, and to the maintenance of symptoms after 3, 6 and 12 months post-injury.

Purpose: The purpose of this protocol is to establish a longitudinal database of data collected from people having experienced an acute traumatic injury to their musculoskeletal system. This includes injuries commonly considered 'non-catastrophic' or 'minor' soft tissue injuries such as whiplash, low back injuries, sports or slip and fall-type injuries that result in sprain/strain of muscle, tendon, ligament or other such soft tissues. Uncomplicated bony fractures (those that are managed through casting only, non-surgical) will also comprise this cohort. The data will include biological specimens, psychological and cognitive profiles, and social/environmental indicators. This protocol represents the start of the SYStematic Merging of Biology, Mental health and Environment (SYMBIOME) project from the emerging Solving Traumatic pain and disability through Advanced Research Translation (START) research group centred at Western. Over time, this database will allow rich exploration of complex interactions between biology, psychology and environment as they relate to the resolution of traumatic pain and disability, or similarly the persistence thereof. Additional research ethics board (REB) applications will be submitted as those projects are ready to be formally conducted.

Eligibility Criteria:
Inclusion Criteria:

Eligible participants:

1. Will be aged 18 years or older
2. Will be able to speak and understand conversational (grade 6) English
3. Will be free of cognitive impairments that would interfere with ability to follow directions (e.g. diagnosed Alzheimer's Dementia, Down's Syndrome)
4. Will be free of neuromuscular disorder that impairs mobility (e.g. stroke, multiple sclerosis, cerebral palsy, ALS)
5. Will be free of active malignancies for the past 5 years
6. Will be free of systemic inflammatory conditions, including rheumatoid or psoriatic arthritis, scleroderma, or systemic lupus erythematosus
7. Will not have been diagnosed with a concussion over the previous 6 months (including the current injury)
8. Will not have been hospitalized overnight over the previous 6 months (including the current injury)
9. Will not have taken steroid-based medications (either prescribed or self-administered) over the previous 6 months
10. Will not have required surgical correction/relocation as a result of the trauma (e.g. open reduction/internal fixation of a fracture). -

Exclusion Criteria:

* Those who are under the influence of drugs or alcohol, or are otherwise not able to provide appropriate informed consent at the time of contact and those with no fixed address will be excluded.
Maternal-Fetal Monitoring by Connected Abdominal Patch - MOMA

During a previous clinical trial (RCF-abdo: 2018-A01194-51), trans-abdominal signals were collected in 90 patients at the maternity Jeanne de Flandre. This database allowed us to develop a new medical device able to measure in real time and continuously the fetal heart rate and the uterine contractions.

The goal here is to assess the performance of the device in real situation during labour.

This study will be carried out in the maternity labor ward in CHU Lille, France.

The TOCONAUTE will be placed on the mother's abdomen to capture fetal and maternal heart rate as well as the uterine contractions in parallel of the cardiotocograph.

For each of the participants, the TOCONAUTE will remain on the mother's abdomen till childbirth. This procedure will not affect the usual care of the patient.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman in labor
* Singleton
* Cephalic presentation

Exclusion Criteria:

* Hospitalisation for a medical termination of pregnancy
* Death in utero
* Multiple pregnancy
New Prognostic and Predictive Biomarkers for HPV-associated Oropharyngeal Cancer

The study involves the coexistence of a retrospective part, in which a group of patients with HPV-associated OPC for whom follow-up data of at least 2 years after diagnosis are available, designed in order to evaluate the expression of HPV16-specific E5 transcript as well as that of pEGFR and HLA, and a multicenter prospective part, involving the enrollment of a control group, enrolled at the ENT outpatient clinic of the IRE and the outpatient clinics of the relevant LILT provincial committees, to better elucidate the role of HPV16-E5 in identifying potentially transforming infections due to the presence of HPV.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects
* age \> 18 years
* current and/or former smokers
* reporting at least 5 (Souza 2017) lifetime oral sex partners
* Written informed consent

Exclusion Criteria:

* Oral pathology
* inability to understand and sign an informed consent form
Intelligent Diagnosis and Treatment System for Pelvic Floor Dysfunction in Elderly Women

The aim of this study is to propose an intelligent diagnosis and treatment system for for pelvic floor dysfunction in elderly women. The main question it aims to answer: 1) How can the investigators find out early if older women have different pelvic floor muscle functions? 2）How can the investigators give personalized treatment plans based on differences in pelvic floor function? Participants will be assigned different training programs by the system. The investigators will compare the treatment effects and costs of older women with pelvic floor dysfunction using and not using the system. All the participants will be offered examinations for pelvic floor function and different treatments. All examinations and treatments are non-invasive.


Eligibility Criteria:
Inclusion Criteria:

- Women over 60 years old.

Exclusion Criteria:

* Severe pelvic organ prolapse (POP-Q stage\>III)
* History of pelvic floor surgery
* Malignant tumor in pelvic
* Allergic to nickel
* Acute inflammation of pelvic or genital tract
* Subjects who has cognitive impairment and cannot sign an informed consent
Lovastatin as a Potential Modulator of Apoptosis in Chronic Obstructive Pulmonary Disease (COPD)

This study will test whether lovastatin helps to modify lung inflammation in patients with COPD (Chronic Obstructive Pulmonary Disease).

The impact of lovastatin, 40mg by mouth once daily on biological and clinical outcomes will be evaluated in an exploratory 16-week comparative treatment efficacy trial in 44 adult former smokers with established COPD of moderate severity. This trial employs a longitudinal randomized, parallel-arm, double-blind, placebo-controlled design using biomarkers of airway inflammation as the primary outcomes of interest.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (≥45 years) former smokers with ≥ 10 pack-years of cigarette smoking
2. FEV1/FVC ratio \< 70%
3. Post-bronchodilator FEV1 between 50% and 80% of predicted if undergoing bronchoscopy, or between 30% and 80% of predicted if undergoing induced sputum only
4. DLco/VA \< 80% predicted
5. Ability to perform and adhere to study protocol
6. ability to provide informed consent.

Exclusion Criteria:

1. Asthma or other comorbid lung disease,
2. Hypoxemia (PaO2 \< 55 mmHg or SpO2 \< 88% on room air), if undergoing bronchoscopy
3. Exacerbation of COPD within the last 6 weeks
4. Upper or lower respiratory tract infection within the last 6 weeks
5. Current smoking
6. Significant coronary artery disease as reflected by unstable angina, myocardial infarction or angioplasty/stenting/bypass surgery within 6 months
7. Current use of HMG-coA-reductase inhibitors
8. Current use of inhaled corticosteroid
9. Concurrent use of other Cyp3A4 (isoform of cytochrome P450) inhibitors
10. History of adverse reaction to HMG-coA-reductase inhibitors (rhabdomyolysis, hepatitis)
11. For patients undergoing bronchoscopy, any contraindication to fiberoptic bronchoscopy or conscious sedation, including abnormalities of the platelet count, prothrombin time or partial thromboplastin time.
Basic Documentation of Adalimumab (Humira) in Patients With Ankylosing Spondylitis (AS)

The research question explored in this study was whether the effectiveness and safety of adalimumab in participants with ankylosing spondylitis was maintained during long-term therapy in routine clinical practice in Germany.

This was a postmarketing observational study (PMOS) for participants with insufficiently controlled, moderate to severe, active AS who were eligible for adalimumab therapy. Participants started treatment with adalimumab under normal clinical settings in Germany. Enrolled participants were followed during adalimumab therapy . Participants were assessed during regular clinic visits for up to 24 months and 359 clinicians (rheumatologists/orthopedists/general practitioners/internist) participated in the study. Since this was an observational trial, not all doctors followed the stated age limitations and some participants under the age of 18 were enrolled.

Eligibility Criteria:
Inclusion Criteria:

1. Participants with active, AS for at least 4 weeks (BASDAI greater than or equal to 4).
2. Participants who failed treatment with two non-steroidal anti-inflammatory drugs (NSAIDs).
3. No contraindications for anti-tumor necrosis factors (TNF) therapy.

Exclusion Criteria:

1. Participants who do not meet the above listed inclusion criteria.
Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and Immunotherapy (ASCENT-GYN-01/GOG-3104/ENGOT-en26)

The goal of this clinical study is to find out how the study drug, sacituzumab govitecan (SG) works in participants with endometrial cancer who have received prior treatment with platinum-based chemotherapy and immunotherapy, versus the treatment of physician's choice (TPC).

The primary objectives of this study are to evaluate the effect of SG compared to TPC on progression-free survival (PFS) as assessed by blinded independent central review (BICR) and overall survival (OS).


Eligibility Criteria:
Key Inclusion Criteria:

* Documented evidence of recurrent/persistent endometrial cancer (endometrial carcinoma or carcinosarcoma).
* Up to 3 prior lines of systemic therapy for endometrial cancer, including systemic platinum-based chemotherapy and anti-PD-1/PD-L1 therapy, either in combination or separately.
* Eligible for treatment with either doxorubicin or paclitaxel as determined by the investigator.
* Radiologically evaluable disease (either measurable or nonmeasurable) by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1.
* Eastern Cooperative Oncology Group performance status score of 0 or 1.
* Adequate organ function

Key Exclusion Criteria:

* Uterine leiomyosarcoma and endometrial stromal sarcomas are excluded.
* Participants who are candidates for curative-intent therapy at the time of study enrollment.
* Participants eligible for rechallenge with platinum-based chemotherapy as determined by the investigator.
* Received any prior treatment with a Trop-2-directed antibody-drug conjugate (ADC).
* Have an active second malignancy.
* Have an active serious infection requiring systemic antimicrobial therapy.
* Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months prior to randomization.
* Have a positive serum pregnancy test or are breastfeeding for participants who are assigned female at birth.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Integrated Treatment and Prevention for People Who Inject Drugs

The purpose of this study is to determine the feasibility of a future trial that will assess whether an integrated intervention combining psychosocial counseling and supported referrals for antiretroviral therapy (ART) at any CD4 cell count and substance use treatment for HIV-infected people who inject drugs (PWID) will reduce HIV transmission to HIV-uninfected injection partners, as compared to routine care dictated by national guidelines for HIV-infected PWID.

This is a multi-site, two-arm, randomized, vanguard study. Network units will consist of an HIV-infected index participant and his/her HIV-uninfected network injection partner(s). Network units will be randomized to the intervention or standard of care arms in a 1:3 ratio, stratified by site. To assess feasibility of the intervention, additional interviews will be conducted with study staff (systems navigators and counselors) and clinic-based stakeholders at each study site.

Approximately 500 Index participants and their partners will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

Index participants:

* Age 18-45 years at the Screening visit (age verification procedures will be defined in the Study Specific Procedures \[SSP\] Manual)
* Able to provide informed consent
* Active injection drug user, defined as self-report of: a) injecting drugs approximately two or more times per week for the past three months, and b) ability to identify the anatomical location of the most recent injection site, as determined by study staff
* Reports sharing needles/syringes or drug solutions at least once in the last month
* HIV-infected based on a study-defined testing algorithm (defined in the SSP Manual)
* Viral load ≥1,000 copies/mL at Screening
* Willing and able to identify, recruit, and have enrolled at least one HIV-uninfected network injection partner who is eligible for study participation according to the criteria below
* Have no plans to move outside the study area for at least one year after study enrollment
* Willing to participate in intervention activities, including regular phone contact

HIV uninfected injection partners:

* Age 18-45 years at the Screening visit (age verification procedures will be defined in the SSP Manual)
* Able to provide informed consent
* Active injection drug user, defined as: a) self-report of injecting drugs approximately two times per week for the past three months, and b) ability to identify the anatomical location of the most recent injection site, as determined by study staff
* Confirmed injection partner, using referral identification cards, of index participant within the past 1 month
* HIV-uninfected based on the study-defined testing algorithm\* (defined in the Study SSP Manual)
* Have no plans to move outside the study area for at least one year after study enrollment

Exclusion Criteria:

-
Programme Evaluation on Effectiveness of The Use of Movement-based x 'Elderspirituality - Fu Le Mun Sum' Intervention to Support Elderly People With Depressive Symptoms

Depression is one of the most common mood disorders in old age, and yet it is frequently under-detected and under-treated. Adopting a train-the-trainer approach, this project intends to utilize the dance movement therapy (DMT), as intervention, to support elderly people with depressive symptoms.

In the present project, two evaluation studies will be conducted. The first study will evaluate the effectiveness of a train-the-trainer approach provided to frontline art development officers who will subsequently conduct interventions for the elderly. A participatory train-the-trainer approach will be adopted to develop a new intervention protocol by integrating body-movement therapeutic elements and a spiritual well-being enhancement group. In the second study, a quasi-experimental design will be adopted to examine the effectiveness of the Movement-based x 'Elderspirituality - Fu Le Mun Sum' intervention to support elderly people with depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

* aged 60 or above
* physical mobility of at least the limbs and body
* sufficient visual and auditory abilities to complete assessments
* with a clinical diagnosis of depression or with depressive symptoms (measured as the sum of 4 dichotomous items of the Geriatric Depression Scale)

Exclusion Criteria:

- a clinical diagnosis of severe illness that led to neurological deficits which limits the participation during the intervention
Pupil Dilation and Analgesia Nociception Index

Pain assessment is crucial in clinical practice. Currently, subjective self-report is considered the most appropriate method to evaluate pain. Although several methods to assess pain objectively exist, the lack of a golden standard still remains. This pilot study assesses the changes in pupil dilation (PD) and the analgesia nociception index (ANI) as a measure of pain in healthy, conscious, male volunteers in a highly standardized and individualized environment. Nineteen subjects received three blocks of 4 individualized electrical stimulus intensities, ranging from no to severe pain. Subjects reported their perceived severity of each individual stimulus, enabling the comparison of changes in PD and ANI in relation to both administered stimulus intensities and perceived pain severities. PD and ANI were measured before and after each administration of a stimulus.


Eligibility Criteria:
Inclusion Criteria:

* good health
* no acute or chronic pain conditions
* well rested

Exclusion Criteria:

* chronic treatment
* bad health
* daily use of analgetics or other medication
* weekly tobacco use
* weekly use of recreational drugs
* more than 10 alcohol consumptions a week
Dose Ranging Study to Assess the Safety and Efficacy of SCV-07 for the Delay to Onset of Severe Oral Mucositis in Patients Receiving Chemoradiation Therapy for Head and Neck Cancer

Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug or radiation regiments used to treat cancer. This study examines the investigational drug SCV-07 and it's possible application in treating Oral Mucositis. Studies have shown that SCV-07 can possibly increase a broad immune system response, thus lowering the painful side effects experienced when treated for head and neck cancer.

The purpose of this study is to assess the safety and tolerability of SCV-07 and it's ability to delay the onset of Oral Mucositis for patients receiving chemoradiation for head and neck cancer.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have a body weight less than 150 kg at screening
* Have recently-diagnosed, pathologically-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx that will be treated with chemoradiation therapy as first line treatment(postoperative patients are eligible, if surgery is \< 6 weeks prior to initiation of radiotherapy.
* Plan to receive a continuous course of conventional external beam irradiation
* Plan to receive a standard cisplatin chemotherapy regimen

Exclusion Criteria:

* Pregnant or breastfeeding
* Have head and neck tumors of the lips, sinuses, salivary glands or unknown primary tumor
* Prior radiation to the head and neck
* Have a plan to receive cetuximab (Erbitux) in conjunction with chemotherapy
* Had curative surgery more than 6 weeks prior to the initiation of radiotherapy
* Have current oral mucositis
* Presence of active infectious disease excluding oral candidiasis
* Chronic immunosuppression
* Seropositive for HIV or hepatitis B surface antigen or C antibody
* Used an investigational agent within 30 days of randomization
* Have a known sensitivity to any investigational agent
Effect of Physiotherapy in Patients Presenting to the Emergency Department With Nonspecific Lower Back Pain

Physiotherapy is a long established therapy in lower back pain. It is unknown if physiotherapeutic interventions in patients presenting to the Emergency Department (ED) with nonspecific lower back pain are beneficial. The aim of this study is to assess whether patients presenting to the emergency department with non-specific low risk low back pain would benefit from a physiotherapy intervention, as compared to patients without physiotherapy intervention at time of ED presentation.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Experiencing nonspecific lower back pain
* Presentation to the Emergency Department (ED) of the University Hospital Basel

Exclusion Criteria:

* Inpatient disposition after ED work-up
* "Red Flags" at time of ED-presentation:

  1. Major trauma in all patients
  2. Fractures leading to immobilization
  3. Severe or progressive sensory alteration or weakness
  4. Bladder or bowel dysfunction
  5. Evidence of neurological deficit on physical examination
  6. Severe chronic disease, such as metastasized cancer, palliative care
* Epidural steroid injections in the last 3 months
* Inability or contraindications to undergo the investigated intervention or to follow the study procedures, e.g. due to certain neurological disorders, language problems, psychological disorders, cognitive impairment, physical inability etc.
* Prior enrolment in this trial
Fetuin-A Phosphorylation Status in Insulin Resistance and Metabolic Syndrome

Fetuin-A has been identified as a novel physiological regulator of insulin action in vitro, in intact cells and in vivo in animals. Previous research has shown that circulating levels of fetuin-A were increased in animal models of insulin resistance and diabetes. Additionally, several human investigation studies demonstrate a correlation of fetuin-A levels with body mass index, insulin resistance, and a fatty liver. Recently, the investigators have elucidated the role of fetuin-A phosphorylation in the regulation of insulin action, demonstrating that phosphorylation is critical for the inhibitory activity of fetuin-A. The objectives of this study are twofold: (1) Quantitate phosphorylated fetuin-A levels in individuals with insulin resistance and metabolic syndrome, and (2) Investigate the effects of lifestyle modifications (acute or chronic exercise and dietary modifications) on fetuin-A phosphorylation and insulin sensitivity.

There are several objectives of this study: (1) Quantitate phosphorylated fetuin-A levels and the daily variation in these levels in individuals with insulin resistance and metabolic syndrome; (2) Investigate the short-term responses of fetuin-A phosphorylation and changes in insulin resistance that occur with a single session of aerobic exercise; (3) Characterize and compare the total and temporal changes in fetuin-A phosphorylation and insulin resistance that occur with an 8 to 10% weight loss induced by chronic exercise training and dietary modification, and; (4) Investigate the influence of weight loss on the short-term responses of fetuin-A phosphorylation and changes in insulin resistance that occur with a single session of aerobic exercise. Our hypothesis is that phosphofetuin-A levels are tightly correlated with insulin resistance and that lifestyle modifications will improve insulin sensitivity and decrease phosphorylated fetuin-A levels.

Eligibility Criteria:
Inclusion Criteria:

* 30 to 65 years of age
* obese (BMI \> 30 kg⋅m2 or % fat \> 30, and waist girth \> 88 cm)
* weight stable over the previous 6 months

Exclusion Criteria:

* smoker
* documented cardiovascular or metabolic disease
* currently taking medication to alter lipid or glucose metabolism
* practicing regular leisure physical activity over the previous 6 months
* engaged in strenuous vocational activity over the previous 6 months
* signs or symptoms of latent heart disease
* conditions that would preclude treadmill walking