cyrilzakka/clinical-trials huggingface dataset:
Low Nicotine Content Cigarettes in Vulnerable Populations: Affective Disorders

While the prevalence of smoking in the United States general population has declined over the past 50 years, there has been little to no decline among people with mental health conditions. Affective Disorders (ADs) are the most common mental health conditions in the US, and over 40% of people with ADs are current smokers. A national policy of reducing the nicotine content of cigarettes has the potential to reduce tobacco use, dependence, and related adverse health outcomes. Controlled trials in psychiatrically-stable smokers have shown that reducing the nicotine content in cigarettes can reduce cigarettes per day (CPD), dependence and tobacco toxicant exposure, with few adverse consequences.

The goal of the proposed trial is to experimentally model whether increasing the availability and appeal of an alternative, non-combusted source of nicotine (e-cigarettes) moderates the effect of altering the nicotine in cigarettes in smokers with ADs. Additionally, investigators will test whether allowing participants to personalize the flavor of the e-liquid alters any moderating effects their availability may have on tobacco cigarette smoking.

Daily smokers with current ADs will be recruited at Brown University and the University of Vermont.

Investigators will study two research cigarettes referred to here as Research Cigarette 1 (RC1) and Research Cigarette 2 (RC2). One of these cigarettes will be a normal nicotine content cigarette and the other will be a reduced nicotine content cigarette. Investigators will study two e-cigarette conditions referred to here as E-Cigarette Condition 1 (EC1) and E-Cigarette Condition 2 (EC2). Both e-cigarette conditions will involve the same commercially available devices and same nicotine-containing e-liquid, but in one condition that e-liquid will be available only in tobacco flavor while in the other condition that e-liquid will be available in multiple flavors from which participants can choose based on personal taste preference. Participants will be assigned to one of the following four study conditions: (1) RC1 only; (2) RC2 only; (3) RC2 + EC1; (4) RC2 + EC2.

Participants will be asked to use only their assigned study products for 16 weeks. Outcome measures include total CPD, cigarette demand assessed by behavioral economics-based purchase tasks, craving, withdrawal, psychiatric symptoms, breath carbon monoxide (CO), biomarkers of tobacco toxicant exposure, brain function and structure, and airway inflammation (fractional nitric oxide concentration in exhaled breath \[FeNO\]).


Eligibility Criteria:
Inclusion Criteria

* Between 21 years and 70 years old
* Must have current diagnosis of an Affective Disorder.

Exclusion Criteria

* Being without an Affective Disorder
* Younger than 21 years old
* Older than 70 years old
Therapy Optimisation for the Treatment of Hairy Cell Leukemia

The trial will test the effectiveness and toxicity of subcutaneous treatment with one cycle of cladribine in patients with hairy cell leukemia requiring treatment.

They have to be untreated so far or may be pretreated with alpha-interferon.

Evaluation of remission status will take place 4 months after treatment. In addition, it will be tested whether patients with non-optimal response will have a benefit from a second cycle of cladribine.

Non-optimal response is: patients with detectable residual disease; achievement of partial remission or detectable residual infiltration in the bone marrow.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically verified hairy cell leukemia
* Presence of hairy cells in the bone marrow and peripheral blood detected by positive TRAP staining and / or co expression if cell surface antigens cluster of differentiation (CD) 19/CD25 or CD19/CD103 (b-ly7)
* No previous cytostatic treatment (splenectomy or interferon treatment are allowed)
* Need for treatment
* Age at least 18 years old
* General state of health according to WHO 0-2
* Current histology, not older than 6 months
* Written consent by patient

Exclusion Criteria:

* Patients not fulfilling inclusion criteria above
* Hairy cell leukemia variants (HCL-V): presence of lymphoid cells in bone marrow and / or peripheral blood, which have an intermediate morphology between hairy cells and prolymphocytes (negative TRAP staining and co- expression of CD19/CD103 without CD25
* Pretreatment with purine analogues or other chemotherapeutics
* Concomitant corticosteroid therapy
* Severe dysfunction of the heart (NYHA III or IV), the lung (WHO-Grade III or IV), the liver, except due to lymphoma (bilirubin \> 2 mg/dl, alkaline phosphatase, glutamate-oxalacetate transaminase and glutamate-pyruvate transaminase \> 2 x upper limit of normal), the kidneys (creatinin \> 2 mg/dl or creatinine clearance \< 50 ml/min), central nervous system diseases including psychoses.
* Proven HIV infection
* Active Hepatitis
* Other florid infections
* Anamnesis / diagnosis of other malignant disease (other than non-melanoma associated skin tumours or stage 0 in situ carcinoma of the cervix)
* Pregnant or lactating women
The Effects of Using Flexi-bar for Balance and Strength Training on the Balance and Muscle in Community-Dwelling Older Adults

Aging of the neuromuscular system may lead to an increased risk of falls in older adults. There are external and internal factors for falls, and lower limb muscle strength and balance are important internal factors for falls in the elderly. And can be improved through exercise. Therefore, an important interventional goal in interventional exercises to prevent falls in the elderly is to promote balance and increase lower extremity muscle strength.

Flexi-bar is a device that provides vibration stimulation. Studies have shown that a 5Hz frequency can be generated when shaken and transmitted to the whole body. Flexi bar is now widely used in fitness centers or rehabilitation therapy to improve muscle strength and balance. Vibration activates the tonic reflex, enhances the excitability of alpha and gamma motor neurons and enhances motor unit synchronization, and this active vibration training helps increase muscle coordination as it induces the tonic reflex and stimulates the proprioception of the joint Feelings, these physiological changes can lead to more effective proprioceptive feedback that improves balance. And because the vibration causes the agonist and antagonist muscles to contract alternately to regulate the instability during the movement. In recreational athletes, the use of a flexi bar in a single-legged position can effectively induce lower extremity muscle activation.

A 12-week combination of balance and strength training in older adults has been shown to be effective in reducing the risk of falls in older adults in previous studies.

Since the effect of adding Flexi bar on the basis of balance and strength training is unknown, the purpose of this study was to investigate the experimental group and the control group with the same exercise posture and training time, Flexi bar + BST Is it better for the balance and muscle strength of the elderly than simple BST?


Eligibility Criteria:
Inclusion Criteria:

•Elderly people aged 65 to 85 in the community who can move on their own without the need for support from others.

Exclusion Criteria:

* Vulnerable groups: those who lack sufficient decision-making ability due to age, intellectual or physical (physiological) status, or who are vulnerable to undue influence, coercion, or inability to make decisions of free will due to their environment, identity, or socioeconomic status, People living in nursing homes and racially disadvantaged groups, etc.
* Have been diagnosed with mental illness and cognitive impairment
* Those who have had severe cardiovascular-related diseases such as unstable angina pectoris, acute myocardial infarction and are not suitable for vigorous exercise
* Those with a history of epilepsy
* Those with severe pain in the lower extremity joints during the pre-test and unable to complete the above-mentioned lower extremity muscle strength or balance test.
Fulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma.

The purpose of this study is to determine the efficacy of a monthly administration of Fulvestrant in patients with recurrent or metastatic endometrial carcinoma by assessment of the clinical tumour response after 3 injections.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, recurrent or metastatic endometrial carcinoma
* Postmenopausal
* Hormonreceptor positive

Exclusion Criteria:

* Pre-treatment with Fulvestrant
* Previous endocrine therapy of the endometrial carcinoma
* Previous malignancy less than 3 years ago other than in situ carcinoma of the cervix, basal cell carcinoma or squamous carcinoma of the skin
Preventing Youth Substance Use With Family Talk

Family Talk, an evidence-based parent-youth dyadic intervention, is a promising approach to improving substance use outcomes for high-risk families, and its structure lends itself to delivery by existing personnel within an Office-Based Addiction Treatment (OBAT) model of care. The investigators propose a single-arm pilot study with 25 parent-youth dyads through which a rapid cycle performance improvement approach will be employed to adapt and optimize the content and delivery of the embedded Family Talk prevention strategy. The investigators will field-test relevant baseline and outcome measures and will use qualitative methodology to identify key modifications to the intervention and generate hypotheses for how the prevention strategy may impact youth and family outcomes and prevent youth substance use. Information from this study will inform a subsequent pilot randomized controlled trial of the intervention to prevent substance use for youth whose parents are in recovery from SUD (substance use disorder).


Eligibility Criteria:
Inclusion Criteria:

* Participating parent is receiving treatment for substance use disorder
* Participating youth is between the ages of 12-25
* Participating youth has no diagnosis of substance use disorder
* Parent and youth are both comfortable communicating in English or Spanish

Exclusion Criteria:

* Acute family crisis, such as recent or current incarceration, divorce, adult return to substance use, or traumatic event
* Adult or youth with cognitive limitation or intellectual disability
Study for Rural Innovations in the Delivery of Exercise

: Falls are the primary cause of injury and a leading cause of disability and mortality among older adults. Risk factors for falling are common among older adults with knee osteoarthritis (OA) - a highly prevalent condition. Physical exercise is consistently the most efficacious intervention for preventing falls in older adults. However, access to these programs is severely limited in rural settings. Considering that rural communities have a higher disease burden and higher proportion of older adults than non-rural areas, there is a critical need to (1) adapt evidence-based exercise programs for remote delivery to increase access for rural older adults and (2) develop pathways to implement exercise programs in rural health care systems that consistently reach and engage patients with knee OA. Accordingly, the proposed project aims to refine a protocol for remote delivery of Enhance Fitness (EF). EF is an evidence-based, group exercise program involving strength, endurance, and balance training that is recommended for falls prevention and OA management


Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling
* English-speaking
* Physician diagnosed knee osteoarthritis
* Knee pain that occurs almost daily for at least the past 3 months and is moderate to severe in intensity
* Knee pain-related difficulty with walking or climbing stairs
* resident of a rural county

Exclusion Criteria:

* cognitive impairment determined by a Mini Montreal Cognitive Assessment score of \<11
* any of the following in the past 6 months: cancer requiring treatment (except for non- melanoma skin cancer), heart attack, stroke, hip fracture, hip/knee replacement, spinal surgery, heart surgery, deep vein thrombosis, or pulmonary embolus; and temporary exclusions
* hospitalization within the last month
* ≥3 falls within the past month
Ultra-Widefield Fluorescein Angiography-Based Targeted Retinal Photocoagulation Versus Conventional Panretinal Photocoagulation in the Preservation of Visual Function and Regression of Proliferative Diabetic Retinopathy

Proliferative diabetic retinopathy is a vision-threatening disease that can lead to irreversible visual loss. The treatment options for proliferative diabetic retinopathy are anti-VEGF injection and retinal photocoagulation. The study aims to compare ultra-widefield fluorescein angiography-based targeted retinal photocoagulation and panretinal photocoagulation in the treatment of proliferative diabetic retinopathy.


Eligibility Criteria:
Inclusion Criteria:

* proliferative diabetic retinopathy (PDR) with neovascularization on the disc or elsewhere in the retina

Exclusion Criteria:

* Participants with a history of previous history of:
* retinal photocoagulation
* vitreoretinal surgery
* tractional retinal detachment
* epiretinal membrane
* vitreomacular traction
* glaucoma
* uveitis
* media opacities like cataract, corneal opacity, vitreous hemorrhage
* anti-VEGF injections in last 3 months
A Study of the Incidence of Intraocular Inflammation and Suspected Endophthalmitis Among Patients Treated With Aflibercept, Vial and Pre-filled Syringe, 2014-2022

Specific study objectives include:

* To describe patient and provider characteristics for aflibercept patients and aflibercept user injections by aflibercept dispensing device, overall, and stratified by time (quarterly, annually).
* To estimate the annual and quarterly incidence of intraocular inflammation (IOI) and suspected endophthalmitis for aflibercept user injections by aflibercept dispensing device.

Secondary objectives

• To estimate the annual incidence of IOI and suspected endophthalmitis for aflibercept user injections by dispensing device, stratified by indication for use, history of IOI, and provider characteristics.

This study is entirely descriptive using secondary data from the Vestrum Health Retina Treatment and Outcomes database.

Eligibility Criteria:
Inclusion Criteria for a Treatment Episode:

1. Must have received one or more injections of aflibercept, regardless of indication, between 01Jan2014 to 30Apr2022
2. Patients must have at least one eligible treatment episode a. Specification of laterality of aflibercept injection (left or right eye or both) for treatment episode

Exclusion Criteria for a Treatment Episode:

1. A post-operative follow-up visit for any ocular surgery (excluding vitrectomy), within +/-28 days of aflibercept injection, as defined in the protocol
2. Active steroid treatment, defined as steroid treatment (topical or intravitreal) on the date of aflibercept injection. This criterion is limited to date of aflibercept injection since steroids may be used to treat IOIs.
3. Any treatment episode where a patient eye receives \>1 (or an unknown) anti-VEGF injection on the index date (date of aflibercept injection).
MRI and PET Imaging in Predicting Treatment Response in Patients With Stage IB-IVA Cervical Cancer

This trial studies magnetic resonance imaging (MRI) and positron emission tomography (PET) imaging in predictive treatment response in patients with stage IB-IVA cervical cancer. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. PET is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Comparing results of diagnostic procedures, such as MRI and PET, done before, during and after radiation and chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

OUTLINE:

Patients undergo radiation therapy and receive chemotherapy per standard of care. Patients undergo dynamic contrast-enhanced (DCE) MRI, diffusion-weighted (DW) MRI, and magnetic resonance (MR) spectroscopy at baseline, 2-2.5 weeks, 4-5 weeks, and 1 month following radiation therapy completion, and fludeoxyglucose F 18 (FDG) PET/computed tomography (CT) at baseline, 2-2.5 weeks, and 4-5 weeks.

After completion of study, patients are followed up at least every 3-6 months for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically confirmed stage IB2-IVA epithelial carcinoma of the cervix, including squamous cell, adeno-, and undifferentiated carcinoma, and excluding small cell/neuroendocrine carcinoma, who will undergo radiation therapy for cervical cancer with curative intent
* Surgical staging with retroperitoneal staging and lymphadenectomy is permitted
* Patients who will undergo standard radiation therapy with concurrent cisplatin-based chemotherapy for cervical cancer
* Patients with no prior radiation therapy to the pelvis
* Patients with no contra-indications to magnetic resonance (MR) imaging
* Patients must have adequate renal function: glomerular filtration rate (GFR) \> 30 mL/min/1.73 m\^2; for the test-retest sub-study MRI, patients must have a GFR of \> 60 mL/min/1.73m\^2
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients with small cell/neuroendocrine cervical carcinoma
* Patients who have received any prior pelvic radiation therapy in the area of the tumor that precludes the delivery of a curative dose of pelvic radiation
* Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds, GFR \< 30)
* Major medical or psychiatric illness that, in the investigator's opinion, would prevent completion of treatment, completion of the study protocol, or interfere with follow-up
* Life expectancy of less than 6 months
Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke

The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.

In this study, cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times within 6 hours to 24 hours from thrombolysis. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times within 6 hours to 24 hours from thrombolysis . Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

* 1) Age≥18 years, \< 80 years, regardless of sex;
* 2) Patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis;
* 3) Baseline NIHSS \>= 5, and \<= 25;
* 4) Baseline GCS ≥8;
* 5) Signed and dated informed consent is obtained

Exclusion Criteria:

* 1) Patients who undergo endovascular treatment;
* 2) mRS ≥ 2 before the onset of the disease;
* 3) Double upper limbs or lower limbs paralysis was found in this case;
* 4) Active bleeding of organs within 6 months of admission or current, including cerebral hemorrhage, subarachnoid hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage and so on;
* 5) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumor and other diseases involving the brain;
* 6) Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban;
* 7) Severe organ dysfunction or failure;
* 8) Patients suffering from severe hematological diseases or severe coagulation disorder dysfunction
* 9) Those who have a history of severe trauma or had major surgery within 6 months prior to admission;
* 10) Those who have a history of atrial fibrillation;
* 11) The patients who have the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb#Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;
* 12) Pregnant or lactating women;
* 13) Previous remote ischemic conditioning therapy or similar treatment;
* 14) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons;
* 15) Severe hepatic and renal dysfunction;
* 16) Unwilling to be followed up or treated for poor compliance;
* 17) He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission;
* 18) Other conditions that the researchers think are not suitable for the group.
Financial Distress in Patients With Advanced Cancer

Advanced cancer has an adverse effect in virtually all dimensions of patients' lives (physical, psychosocial, spiritual, familial, role function). One of the less frequently explored effects of cancer is its impact on personal finances and the contribution of financial-related distress to overall suffering and quality of life. Financial issues have been recently found to be the second most frequent source of distress identified by cancer patients in a community cancer center context (22%).

In the context of continuous increased health care costs, it is likely that the frequency of health care related financial problems will keep rising. The relative contribution of these adverse financial events in advanced cancer patients to overall patient distress is not well assessed and this is particularly true in France. The main objective of this work is to determine the association between financial distress and quality of life of patients with advanced cancer in a Public General Hospital and in a Comprehensive Cancer Center. A secondary objective is to characterize the frequency and intensity of financial distress reported by French cancer patients and their impact on their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least 18 years old and have a diagnosis of advanced cancer which is defined as one of the following: recurrent disease, received \>2 lines of chemotherapy, locally-advanced disease, metastatic disease, or refractory disease.
* Patients must have a cancer diagnosis of: breast, colon, lung or prostate.
* Patients must be able to understand, read, write, and speak French.

Exclusion Criteria:

* Clinical evidence of cognitive impairment, as determined by the palliative care physician.