cyrilzakka/clinical-trials huggingface dataset:
APACE - Feasibility of Using Accelerometers to Measure Physical Activity in Cancer Patients on Early Phase Clinical Trials

Increased physical activity has been shown to improve outcomes for cancer patients, however the measure of activity is highly variable and understudied in cancer patients on early phase clinical trials where activity is used as a criteria for eligibility. Additionally, more than half of cancer patients experience fatigue at some point in their treatment with exercise and psychosocial interventions currently recommended as interventions. Therefore, it is important to be able to more accurately measure activity and fatigue in cancer patients to ensure adequate intervention, management and appropriate access to treatment.

This proposal is a non-interventional feasibility study designed to collect activity and sleep data from patients with advanced cancer newly enrolled in early phase clinical trials. The data will be collected over a 5-6 week period using a wearable accelerometer device. This study will be conducted concurrently with the early phase trial related activities/treatment and will have no impact on a patient's clinical pathway. Data generated from the study will be used to evaluate the feasibility of collecting activity and sleep data from patients with advanced cancer on early phase clinical trials.

In this study, participants in the UK will be able to opt-in to using eNutri, a web-based graphical food frequency questionnaire (FFQ), and provide feedback on its usability. The output of eNUTRI will help us understand if there is a use for eNutri in cancer care environments for a range of purposes such as providing nutritional support for cancer patients, and exploring drug-nutrient interactions on the patient outcome.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary informed consent.
* Aged at least 16 years.
* Consented to an early phase clinical trial.
* Willingness to wear a device for the duration of the study.
* Willingness to comply with scheduled study procedures.
* ECOG PS 0 or 1.

Exclusion Criteria:

* Judgement by the investigator that the individual should not participate if they are unlikely to comply with study procedures and requirements.
* Patient deemed ineligible for enrolment onto an early phase clinical trial.
NB1011 Administered by Continuous Infusion in Cancers That Overexpress Thymidylate Synthase (TS)

The purpose of this trial is to assess the tolerability and safety of NB1011 in the treatment of patients with cancers that overexpress TS, such as ovarian, gastrointestinal, colorectal, bladder, breast, and lung cancers.


Eligibility Criteria:
Inclusion Criteria:

* Advanced, recurrent, or metastatic solid tumors
* TS overexpression (\> 4 by reverse transcription polymerase chain reaction \[RT-PCR\]) in archival and fresh samples
* Suitable for experimental monotherapy
* Measurable disease

Exclusion Criteria:

* Tumors that cannot be biopsied or with low level of TS expression
* Requirement for concomitant anticancer therapy
* Treatment with another investigational product within 30 days of study entry
* Pregnant or lactating women
* Active or uncontrolled serious bacterial, viral, fungal, or parasitic infection.
* HIV infection
* Clinically apparent meningeal or central nervous system (CNS) metastases or carcinomatous meningitis
A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease

Psychological intervention by COBMINDEX application to reduce psychological stress among CD patients, fatigue and pain and improve the patients' well being, quality-of-life and disease-coping skills, as well as improvement of the patients' immunological profile and intestinal microbiome.

200 patients will be randomly divided into two groups - 100 patients will learn and practice COBMINDEX by a human therapist-social worker and 100 patients will learn and practice COBMINDEX by a digital therapist using the COBMINDEX application.

In the first 3-months there will be an assessment of patient progress following randomization to human therapist or digital therapist using the application for learning and practicing. During this period, the group of the human social-worker will have a limited access to the application dedicated for daily exercises and assessment.

In the following 9-month period, all patients will practice using the application, each group by it's permissions.

There will be daily assessment of stress, pain, fatigue, well-being and frequent assessments of patients' medical, psychological, and immunological status.

Throughout the trial, adverse events and concomitant medications will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate and signed informed consent
* Hebrew-speaking
* Age 18-75
* Proven diagnosis of Crohn's disease, at least 3 months post-diagnosis
* Stable medical treatment for the last 3 months
* Any Harvey Bradshaw Index score
* Ability to operate a smartphone and cellular application

Exclusion Criteria:

* Diagnosis of ulcerative colitis or unclassified inflammatory bowel disease
* Planned surgery for Crohn's disease
* Surgery for Crohn's disease (excluding drainage of perianal abscess) in the last 3 months
* Psychiatric disease (schizophrenia, major depression or bipolar disorder)
* Alcohol or drug dependency (stable medical use of cannabinoids will be allowed)
* Pregnancy or planned pregnancy during study period
* Clinically significant comorbidity
* Former participation in COBMINDEX trials
Immediate Effects of Mental Practice and Therapeutic Exercise in Mild Smokers

The goal of this clinical trial is to learn about the effects who would add mental practice based on action observation to a therapeutic exercise program in young mild smokers.

The main question it aims to answer is whether the observation of actions prior to the implementation of a therapeutic exercise session improves the response to it on respiratory, strength and muscle function variables.

Participants will be assigned to one of 2 study groups:

G1) Therapeutic exercise plus action observation training (n=20) G2) Therapeutic exercise plus sham action observation training (n=20)


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Had a pack per year index of \<5 (mild smoking index).

Exclusion Criteria:

Those who presented:

* a respiratory pathology,
* cardiac, systematic, or metabolic disease,
* history of recent surgery,
* vertebral fracture,
* or osteoarticular disorders of the spine area.
Quality of Life in Patients With Congenital Afibrinogenemia

The aim of this observational study is to evaluate the quality of life in patients with congenital afibrinogenemia using the Haemo-QoL SF for kids and the Haem-A-QoL for adult patients.

In this observational study, children and adults suffering from congenital afibrinogenemia confirmed by biology will be enrolled. All patients will receive a questionnaire on quality of life in their own language during a routine visit and filled out by the patient at home. A general questionnaire will be filled out by the patient's physician.

Eligibility Criteria:
Inclusion Criteria:

* Congenital afibrinogenemia confirmed by biology (absence of circulating fibrinogen) and genotype

Exclusion Criteria:

* Lack of participant's consent
* Patient unable to understand the questionnaire
The Comparative Efficacy of an Over the Counter Light Therapy Mask vs Over the Counter Topical Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne

This is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of the Neutrogena® Light Therapy Acne Mask an Over the Counter (OTC) Blue/Red light LED mask, as compared to the combination of topical OTC benzoyl peroxide 2.5% gel and OTC adapalene 0.1% gel, for the treatment of mild-to-moderate facial acne. This will be an investigator-blinded, randomized, 12-week study to observe these over the counter treatments. The two arms will be: (1) Neutrogena® Light Therapy Acne Mask (MASK), (2) topical OTC benzoyl peroxide 2.5% gel and OTC adapalene 0.1% gel (TOP). Both treatment groups in this study will also receive and use standardized, non-medicated cleansing and moisturizing products. All products will be purchased through commercial sources.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acne vulgaris as determined by the study physician
* Mild-to-moderate acne defined as a grade 2 or 3 on the FDA Investigator Global Acne Assessment (IGA) for Acne vulgaris (Appendix 1)19
* If female,

  * Negative urine pregnancy test at the time of enrollment and negative urine pregnancy tests at follow up visits
  * Agreement to comply with medically acceptable forms of birth control with heterosexual intercourse
* Agreement to comply with the study protocol and attend all study visits

Exclusion Criteria:

* Is unwilling to participate in the survey
* Outside of specified age range
* Patients with clear, almost clear acne, or severe acne defined as grade 0-1 or 4 on the IGA Scale
* Females who are pregnant or breastfeeding
* Known allergy to any ingredients in the test products or history of photosensitivity
* Pre-existing facial dermatologic conditions including excoriations that could interfere with the outcome of this study and quantification of acne lesions
* Excessive facial hair or scarring that could interfere with quantification of acne lesions
* Does not have decision making capacity
Benefits of Pulmonary Rehabilitation to Patients Post Liver Transplant

The goal of this clinical trial was to access the benefits of a 12-week home-based pulmonary rehabilitation regimen on pulmonary function recovery in post-liver transplant patients. The main questions it aims to answer are:

Does pulmonary rehabilitation facilitate pulmonary muscle strength recovery? Does the intervention improve pulmonary function and reduce dyspnea sensation?

Participants performed:

Inspiratory muscle training twice a day for 12 weeks after discharged from the hospital Upper limb resistive training Lower limb exercise

Patients undergoing liver transplantation often face significant challenges related to pulmonary rehabilitation. Although postoperative rehabilitation has been extensively studied, the specific role of pulmonary rehabilitation programs has received limited attention. This study aims to evaluate the efficacy of a home-based pulmonary rehabilitation program in improving respiratory function recovery among post-liver transplant patients. The training group participated in a 12-week pulmonary rehabilitation program post-discharge, emphasizing respiratory muscle and exercise training, while the control group received standard care, which included traditional rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 years or older
* Scheduled to undergo living donor liver transplantation
* Stable vital signs
* Normal cognitive function
* Able to perform activities independently using their own strength and coordination
* Willing and able to participate in 12 weeks of rehabilitation training

Exclusion Criteria:

* Severe physical illness during the operation
* Acute bleeding
* Unstable vital signs
* Hepatic encephalopathy, or neurological conditions such as stroke, Parkinson\&#39;s disease, or cognitive dysfunction
* Limited mobility (e.g., unable to stand, lift upper limbs, or bedridden)
* Inability to comply with 12 weeks of pulmonary rehabilitation post-discharge
* Unstable vital signs
* Hepatoencephalopathy, such as cardiovascular accident, Parkinson disease, cognitive dysfunction
* Those with limited mobility (unable to stand, unable to lift upper limbs, or bedridden)
* Those who are unable to cooperate with the 12 weeks of pulmonary rehabilitation exercises after discharge.
Surgical Technique To Control Postpartum Hemorrhage

Placenta accreta is an obstetrical complication where the placenta becomes firmly adherent to the uterine wall. Placenta accreta can lead to considerable maternal morbidity and mortality due to hemorrhage, infection, or other surgical complications such as those resulting from hysterectomy. Retained placenta accreta is usually a rare condition, but its prevalence is increasing due to the rise in the rate of deliveries by Cesarean section.

Placenta accreta is a potentially life-threatening obstetric condition that requires a multidisciplinary approach to management. The incidence of placenta accreta has increased and seems to parallel the increasing cesarean delivery rate. Women at greatest risk of placenta accreta are those who have myometrial damage caused by a previous cesarean delivery with either an anterior or posterior placenta previa overlying the uterine scar. Diagnosis of placenta accreta before delivery allows multidisciplinary planning in an attempt to minimize potential maternal or neonatal morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

1. Estimated gestational age between 34 -40 weeks .
2. Presence of total or focal parts of placenta accreta "morbidly adherent placenta" .
3. Cases with mild vaginal bleeding or not having any vaginal bleeding

Exclusion Criteria:

1. Severe attack of bleeding require an immediate intervention.
2. Associated with placental abruption
3. Patients with known bleeding disorders or on anticoagulant therapy.
4. Preoperative decision to do peripartum hysterectomy.
Comparing Use of the Glidescope Cobalt to Direct Laryngoscopy in Infants

The investigators seek to prospectively compare intubation with the Glidescope Cobalt to Direct Laryngoscopy (DL) in infants.

We seek to study the intubation characteristics of a new video laryngoscope, the Glidescope Cobalt in children less than or equal to 1 yr of age. This evaluation would provide insight as to the efficacy of this device in facilitating intubation in infants.

Eligibility Criteria:
Inclusion Criteria:

1. Scheduled to undergo elective surgery at CHOP
2. American Society of Anesthesiologists (ASA) Physical Status I or II
3. Anesthetic plan requiring tracheal intubation with a neuromuscular relaxant
4. Parental/guardian permission (informed consent). Subjects will be too young to understand the study procedures and therefore assent will not be sought. -

Exclusion Criteria:

1. At known or anticipated high risk for aspiration pneumonia
2. Known or predicted difficult intubation as assessed by the clinical attending anesthesiologist
3. Emergency surgical procedure
4. Patients with preoperative airway pathology or stridor -
RFA to Prevent Metachronous Squamous Neoplasia Recurrence After Complete Endoscopic Submucosal Dissection

Esophageal cancer is a highly lethal disease, and its incidence is still increasing in the world. Recent advances in image-enhanced techniques such as Lugol chromoendoscopy and narrow band imaging, the number of patients with early esophageal squamous cell neoplasias (ESCNs) detected has markedly increased. Endoscopic submucosal dissection (ESD) enables en bloc resection of the neoplasia, and the resected specimen allows for a pathological assessment to evaluate the curability. However, the patients who received complete ESD for early ESCNs frequently developed metachronous recurrence. The cumulative metachronous recurrence rate at 5 years was 50%, and the mean annual incidence of newly diagnosed metachronous tumors was 10%. Among them, those with "speckled" lugol staining pattern over the esophageal background mucosa have the highest risk and should be seen as a precancerous lesion of ESCCs. This issue is gaining attention in the era of endoscopic treatment, but currently there was no appropriate strategy to prevent the tumor recurrence in these high-risk subjects.

Endoscopic radiofrequency ablation (RFA) is a rapidly evolving therapeutic modality, and recent studies have shown its efficacy and safety for eradicating for flat type early ESCNs. To search a best strategy for the prevention of ESCNs, the investigators thus propose a hypothesis that the preemptive RFA for esophageal "speckled" lugol background mucosa may prevent the metachronous neoplastic recurrence after complete endoscopic resection.


Eligibility Criteria:
Inclusion Criteria:

* Adults with early stage ESCNs (squamous high grade dysplasia, carcinoma in situ, or T1N0M0 SCC) who were treated by endoscopic submucosal dissection.
* Lugol staining showed "speckled" (\>10 small lugol-unstained lesions) pattern of background mucosa.

Exclusion Criteria:

* Having a history of incomplete endoscopic treatment, or complications during/after treatment (perforation, stricture).
* Having history of systemic chemotherapy or radiation therapy for esophagus or post esophagectomy.
* Life expectancy \<2 yr.
* Decompensated cirrhosis (Child score B, C).
* Having large esophageal varices.
* Poor performance status (ECOG\>2).
Social Experiences and Sleep Study

This study will test the effect of race-based social rejection on polysomnography derived sleep outcomes and nocturnal cardiovascular psychophysiology in a sample of 80 African Americans and 80 Caucasian Americans. The investigators will test group differences on these outcomes as well as within subjects by testing impact of rejection compared to a non-rejection control night in the sleep laboratory.

African Americans (AA) are disproportionally burdened by cardiovascular disease compared to Caucasian Americans (CA). Poor sleep, which is more common among AA, may serve as an important pathway in understanding these disparities. Race-based rejection has been cross-sectionally related to poor sleep and negative cardiovascular outcomes. To test the links between social experiences and sleep, participants will spend two nights in the sleep laboratory. One night will be a control night where participants complete low arousal tasks prior to bedtime. On a second night, the investigators will randomize 80 AA and 80 CA to either race-based social rejection (i.e., being rejected by an out-group member) or same-race social rejection prior to bedtime to test the causal influences of race-based rejection on objective sleep parameters, measured using polysomnography, and nocturnal cardiovascular functioning. The investigators will test group differences on these outcomes as well as within subjects by testing impact of rejection compared to a non-rejection control night in the sleep laboratory. The order of the control and rejection task night will be counterbalanced.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 64 years old
* Self-identified as African American/Black or Caucasian American/White
* English speaking, able to provide consent
* Self-reported bedtime between 10PM and 12AM for 5/7 nights for the past 3 months (stability to be confirmed by sleep diary and wrist actigraphy).
* Self-reported sleep duration between 6.5 and 8.5 hours for 5/7 nights for the last month (duration to be confirmed by actigraphy and sleep diary)

Exclusion Criteria:

* Body mass index of 40 or above
* Participants at high risk for obstructive sleep apnea, based on "high risk" score from the STOP-Bang.
* Medical or psychiatric condition, as assessed by self-report and clinical interview that affect sleep and/or cardiovascular functioning, including doctor diagnosed arrhythmia, hypertension, congestive heart failure, major depression, bipolar disorder, post-traumatic stress disorder.
* Medication use that is likely to affect sleep and/or cardiovascular functioning, including antidepressants, anxiolytic or soporific medication, and beta-blockers.
SABINA INTERNATIONAL

The aim of the study is to describe the prescribing pattern of the different types of medications which are used to treat asthma, across multiple countries.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients ≥12 years-old
2. Documented diagnosis with Asthma as per medical records.
3. Have had ≥3 consultations with the HCP at study start date
4. After full explanation, a patient or legal guardian must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

1. Patient with a diagnosis of chronic obstructive pulmonary disease or other chronic respiratory disease different from Asthma.
2. An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in this study
Evaluation of Arginine in Periodontal and Cardiovascular Disease

Asymmetric dimethylarginine (ADMA) plays a key role in endothelial function and may be a link for the known interaction of periodontitis and coronary heart disease (CHD). The investigators compared the impact of gingival health, periodontitis (CP), CHD or of both diseases (CP+CHD) on saliva and serum ADMA levels.

The aim of this study was to evaluate a possible association between both saliva and serum ADMA levels in patients with CP and with CHD and if the serum ADMA levels are mediated by serum CRP.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least 16 teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL) ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.