cyrilzakka/clinical-trials huggingface dataset:
Combined Behavioral/Pharmacological Therapy for Insomnia

This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.

Long-term insomnia is a common and significant health problem. Two main treatments, pharmacotherapy and behavioral therapy, have been used to help people with insomnia. Because both treatments have advantages and disadvantages, a combination of these treatments may be a good way to treat insomnia.

During the first 2 weeks of the study, participants keep a sleep log, wear an actigraph (a device that resembles a wristwatch and records activity to help determine when participants are asleep or awake), and complete questionnaires.

Participants are then randomly assigned to receive 6 weeks of behavioral therapy plus zolpidem tartrate (Ambien), behavioral therapy plus placebo, or behavioral therapy alone. During treatment, participants return to the clinic once a week to turn in their sleep logs, download their actigraph, and complete questionnaires.

After 6 weeks, participants enter the post-treatment phase of the study, which lasts 2 weeks and is identical to the 2-week assessment at the beginning of the study.

After the post-treatment phase, participants enter the follow-up period and are contacted at 3 months, 6 months, and 1 year to complete another 2-week assessment with sleep logs, actigraphy, and questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* be between 21 and 75 years of age
* have a mean total nocturnal wake time of \> 60 min./night
* have a history of insomnia \> 6 months
* have a history of one or more poor sleep hygiene practices such as taking 3 or more naps/week, varying bed times or wake times by \> 2 hrs. from day to day, or routinely lying in bed awake for periods \> 30 min

Exclusion Criteria:

* pregnant women
* the terminally ill
* individuals with other medical conditions (e.g. chronic pain disorders, etc.) that compromise sleep
* individuals with major psychiatric diagnoses
* persons with hypnotic-dependent insomnia
* subjects on antidepressants or anxiolytics
* subjects with evidence of sleep apnea
A Study of JNJ-80038114 in Participants With Advanced Stage Prostate Cancer

The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-80038114 in Part 1 (dose escalation) and to determine the safety at the RP2D(s) in Part 2 (dose expansion).


Eligibility Criteria:
Inclusion Criteria:

* Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by Prostate Cancer Working Group 3 (PCWG3)
* Measurable or evaluable disease
* At least 1 prior treatment for mCRPC
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ functions as defined by certain laboratory values
* Must sign an informed consent form (ICF)
* Participants must agree to use a highly effective form of birth control as guided by the study doctor

Exclusion Criteria:

* Concurrent anticancer therapy
* Severe or long-lasting side effects related to prior anticancer therapy
* Known allergies to JNJ-80038114 or its excipients
* Brain metastasis or known seizure history
* Significant infections or lung, heart or other medical conditions
Optical Frequency Domain Imaging for Non-melanoma Skin Cancers

The purpose of this research study is to find out if a non-invasive imaging device called Optical Frequency Domain Imaging (OFDI) can help doctors to see the tissue and blood vessels that are related to non-melanoma skin cancers. OFDI was designed to see microscopic details of your skin without needing to use any invasive techniques such as surgery or biopsy.

Non-melanoma skin cancer (NMSC) is the most common cancer in the United States, with more than 750,000 diagnosed patients treated every year. Its prevalence and incidence have significantly increased over the past two decades and it has been estimated that 20% of all Americans will develop this type of cancer during their lifetime (Neville et al., 2007). Biopsy and surgical resection of NMSC can result in tissue mutilation and scaring. Therefore, there is a need for new imaging technologies that can be used to non-invasively guide biopsy and surgery.

Optical Frequency Domain Imaging (OFDI) is a second-generation imaging implementation of optical coherence tomography (OCT) developed at the Wellman Center. OFDI provides high-resolution three-dimensional imaging in tissue. It uses an interferometric depth-sectioning technique and employs a near-infrared light source. Through analysis of phase information in the recorded signal. OFDI can detect blood vessels within tissues and tumors. Importantly, OFDI-based vascular imaging can be performed without the need for exogenous contrast agents, making it relatively easy to deploy in clinical settings.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects with Fitzpatrick skin type I-VI
2. Subjects with ages between 18 and 80 years of age
3. Presence of at least one NMSC lesion

Exclusion Criteria:

1. Subjects with active localized or systemic infections
2. Subjects participating in potentially confounding clinical studies of investigational therapies, either drug or device.
3. Subjects taking any topical/systemic chemotherapy or immunosuppressants
4. Subjects who are pregnant and/or breastfeeding
5. Subjects with tape adhesive allergies
Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema)

The study is being conducted to evaluate the efficacy, safety and tolerability of 2% tofacitinib ointment (20 mg/g) BID (twice daily) in subjects with mild to moderate atopic dermatitis compared to placebo (vehicle) BID for 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have a clinical diagnosis of atopic dermatitis (also known as atopic eczema) for at least 6 months prior to Day 1 that has been clinically stable for at least 1 month prior to Day 1 and is confirmed to be atopic dermatitis according to the criteria of Hanifin and Rajka.
* Have a PGA score of 2 (mild) or 3 (moderate) at Day 1.
* Have atopic dermatitis on the head (including face, but excluding hair bearing scalp), neck, trunk (excluding groin and genitals), or limbs including palms and soles covering at least 2% of total body surface area (BSA) and up to and including 20% of total BSA at Day 1. At least 2% of the total BSA will need to be on the head (including face, but excluding hair bearing scalp), neck, trunk (excluding groin and genitals), or limbs (excluding palms and soles).

Exclusion Criteria:

* Evidence of certain skin conditions/infections at baseline
* Currently have atopic dermatitis on groin, genitals, palm or soles
* Have certain laboratory abnormalities at baseline
* Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception
Soluble Cluster of Differentiation 160 (sCD160) in Sera and Intra-ocular Fluids: Association With Ischaemic Retinopathies

CD160 represents a new angiogenic factor as its specific engagement by an agonist monoclonal antibody directed against human CD160 reduced angiogenesis of endothelial cells with a distinct mechanism from current angiogenic therapies that target the VEGF/VEGF-R pathway. A soluble form of CD160, sCD160, has been found to be highly expressed in the vitreous and the sera of patients with severe diabetic retinopathies, and can now be dosed with help of an ELISA test.

The investigators aim to evaluate the association between ischaemic retinopathies (patients with or without) and sCD160 concentrations in the vitreous, the aqueous humour and the serum.

120 patients enrolled for ophthalmic surgery (cataract or posterior segment surgery (epiretinal membrane, macular hole, vitrectomy)) will be recruited in the Department of Ophthalmology, Robert Debré Hospital, Reims, France.

Each patient will benefit a complete ophthalmologic examination, and either an aqueous sampling (cataract) or a vitreous sampling (posterior segment) along with a serum sampling at the beginning of the surgery. ELISA test will be performed on vitreous or aqueous samples in triplicates. Luminex will be performed on vitreous samples in order to determine the concentrations of several ischemia biomarkers (VEGF, PlGF, Platelet-derived growth factor (PDGF-B), SDF-1, Angpt2, InterIeukin IL-6, IL-8, CD105, Monocyte chemoattractant protein 1 (MCP-1), IL-10, interferon-inducible protein-10 ( IP-10), IL-1B and CD106, RAGE).

Primary objective is:

- Evaluation of the association between ischaemic retinopathies (patients with or without) and sCD160 concentrations of the vitreous or the aqueous humours.

Secondary objectives are:

* Evaluation of the association between diabetic retinopathies (patients with or without) and sCD160 concentrations of the vitreous, the aqueous humours and the sera.
* Evaluation of the association between several vitreous biomarkers of ischaemia and sCD160 concentrations of the vitreous and the sera.
* Evaluation of the association between sCD160 concentrations in the vitreous and the sera.
* Evaluation of the association between sCD160 concentration in the aqueous humours and the sera.

Eligibility Criteria:
inclusion criteria :

* over 18 years old
* with social security affiliation
* willing to participate this study non-inclusion criteria :
* any prior (3 months) or concomitant treatment with anti-VEGF therapy, corticosteroids, or immunosuppressive agents
* any history of previous vitreoretinal surgery, ocular tumor, severe ocular trauma, severe intraocular, periocular infection, inflammation, or radiation
* any serious allergy to the fluorescein sodium for injection in angiography
* any history of previous systemic anti-VEGF treatment
* any history of inflammatory or auto-immune disease
* any active extraocular inflammation or infection in the last 4 weeks before surgery exclusion criteria :
* Patients with C-reactive protein CRP \> 10mg/mL (serum sampling during surgery)
A Prospective, Randomized Trial Comparing Same Day Discharge and Overnight Hospital Stay Among Total Hip Arthroplasties Done by the Direct Anterior Approach

The purpose of this study is to identify differences in satisfaction, pain and length of stay between patients undergoing hip replacement who are discharged from the hospital on the day of surgery compared to patients who stay one night in the hospital.


Eligibility Criteria:
Inclusion Criteria:

* Primary THA without acute hip fracture or prior hardware that would need to be removed at the time of surgery
* Unilateral THA
* Pre-operative Body Mass Index (BMI) \< 40 kg/m2
* Age \< 75 years at time of surgery
* Pre-operative hemoglobin \> 10 g/dL if pre-operative hemoglobin data is available
* No history of cardiopulmonary disease that would necessitate inpatient monitoring after surgery
* Pre-operative ambulatory status does not require the use of a walker or wheelchair
* No chronic pre-operative opioid medication use or opioid addiction
* Assistance available at home after discharge from hospital
* No other condition or circumstance that would preclude rapid discharge from the hospital after surgery
* Subject's English proficiency allows understanding of study and Informed Consent
* Subject consented to participate in this study

Exclusion Criteria:

* Revision THA
* Bilateral THA
* Pre-operative BMI ≥ 40 kg/m2
* Age ≥ 75 at time of surgery
* Pre-operative hemoglobin ≤ 10 g/dL if pre-operative hemoglobin data is available
* History of cardiopulmonary disease requiring acute inpatient monitoring
* Pre-operative ambulatory status requiring the use of a walker or wheelchair
* Chronic pre-operative opioid medication use or opioid addiction
* Limited or no assistance available at home after discharge from hospital
* Any other condition or circumstance that would preclude rapid discharge from the hospital
* Subject not proficient in English
* Subject did not consent to participate in this study
LOW-PV Continuation

This multicenter longitudinal observational study focuses on Italian patients with Polycythemia Vera (PV) who were enrolled in the Low-PV RCT and continued receiving Ropeginterferon alfa-2b until the study's conclusion on March 31, 2023. It includes patients who were responders to Ropeginterferon alfa-2b after two years in the phase II randomized trial "LOW-PV." Data will be collected retrospectively every 6 months from March 31, 2023 to November 30, 2024 and prospectively from December 1, 2024 to March 31, 2026.

Multicentre longitudinal observational Italian study of patients with Polycythemia Vera (PV) enrolled in Low-PV RCT and still receiving the experimental drug (i.e., Ropeginterferon alfa-2b) at study end (31-03-2023). Thirty-six patients who completed the Low-PV RCT and were responders to Interferon, continued treatment with the drug and are followed at their respective centers in Italy. The "LOW-PV Continuation" study aims to collect after 1,2,3 years the data on these patients, regardless of the treatment they were undergoing at the time of enrollment in the current study, after their informed consent. In details, data will be collected retrospectively from March 31, 2023 to November 2024 and prospectively from December 1, 2024 to March 31, 2026.

Given the descriptive nature of the study, no formal statistical hypothesis will be made.

Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled in the LOW-PV RCT study who continued to receive Ropeginterferon alfa-2b until the conclusion of the study on March 31, 2023. These patients will be included regardless of the treatment they are undergoing at the time of enrollment in the current study.
* Patients who have signed the written informed consent for study participation.

Exclusion Criteria:

* None
Does Watching Video Increase the Perioperative Anxiety in Patients Undergoing Third Molar Surgery

Third molar extraction is the most common surgical procedure in the field of oral and maxillofacial surgery and usually cause anxiety. Although different informed consent methods have been used previously, the most effective information method that provide the optimum anxiety management is still not clear. Therefore, investigators planned a clinical study to explore the effect of different information formats (verbal information with written document and verbal information with written document subsequent to watching video from internet) on peri-operative anxiety of the participants who scheduled to undergo impacted lower third molar surgery. Also, investigators aimed to explore the effect internet usage before the third molar surgery on the level of anxiety.

The participants were randomly divided into two groups. The control group consisted of participants who informed verbally about the surgical procedure and the potential postoperative complications,. Also, a written informed consent document was given. Participants in the study group were asked to watch a video which was previously uploaded to the internet and was showed procedural details of an impacted right lower third molar extraction (with permission and written consent). Participants in the study group were also informed verbally about the surgical procedure-possible postoperative complications and was given with a written informed consent document. In both groups questions of the participants were answered by the same surgeon. To evaluate anxiety; participants were asked to complete 3 questionnaires one week before the procedure when taking appointment for surgery, just after watching video or informed verbally, immediately after the procedure and one week after the procedure.

Eligibility Criteria:
Inclusion Criteria:

patients;

* without systemic disease,
* have indication for third molar extraction,
* radiographic degree of impaction according to the classification of Winter (vertical and mesio-angular) and the classification of Pell and Gregory 2, or 3 and B

Exclusion Criteria:

patients who;

* has psychiatric illness and systemic disease,
* refused to watch the video,
* failed to fill out the forms for any reason,
* had incomplete data and wanted to withdraw from the study,
* had underwent a previous third molar surgery,
* had history of anxiety attacks and/or anxiolytic treatment,
* had unpleasant dental treatment experience could not cooperated,
Etoricoxib vs Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis

Comparison of lower dosage etoricoxib (60 mg daily) with aceclofenac (100 mg bid) for their efficacy and safety in the treatment of rheumatoid arthritis (RA).

This was a single medical center, parallel-group, randomized controlled trial, which conducted for eight weeks. In this study, 40 patients of RA were randomly assigned to two different treatment groups (etoricoxib and aceclofenac), and 20 patients were enrolled for each group. In addition to baseline data collection, objective assessment tools were used to evaluate for efficacy and safety. The primary endpoint was American College of Rheumatology 20% improvement criteria (ACR20) , secondary endpoints were the ACR 50,70, disease activity score 28 (DAS 28), European League Against Rheumatism (EULAR) response criteria, the number of tender and swollen joints, physician's global assessment, patient's global assessment, pain scores, the short form health survey (SF-36) health Questionnaire and etc. In addition, all adverse reactions were recorded and all the results were analyzed in the intention to treat (ITT) manner.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis as Rheumatoid Arthritis

Exclusion Criteria:

* 1. Pregnant or breast-feeding women. 2. Chemotherapy or radiation therapy in cancer patients
Efficacy and Safety Study of ISIS 301012 (Mipomersen) as Add-on in Familial Hypercholesterolemic Patients With Coronary Artery Disease

The purpose of this study is to determine whether mipomersen safely and effectively lowers low-density lipoprotein cholesterol (LDL-C) in patients with Heterozygous Familial Hypercholesterolemia (HeFH) and coronary artery disease (CAD) who are already on a stable dose of other lipid-lowering agents (including maximally tolerated statin therapy).

Familial hypercholesterolemia (FH) is an autosomal dominant genetic disorder of lipoprotein metabolism characterized by markedly elevated LDL-C, premature onset of atherosclerosis and development of xanthomata. Patients with heterozygous familial hypercholesterolemia typically have total plasma cholesterol between 350 to 550 mg/dL and disease onset in their third and fourth decade.

Mipomersen (ISIS 301012) is an antisense drug that reduces a protein in the liver cells called apolipoprotein B (apo-B). Apo-B plays a role in producing low density lipoprotein cholesterol (the "bad" cholesterol) and moving it from the liver to one's bloodstream. High LDL-C is an independent risk factor for the development of coronary heart disease (CHD) or other diseases of blood vessels. It has been shown that lowering LDL-C reduces the risk of heart attacks and other major adverse cardiovascular events.

This study consisted of a 26-week treatment period and a 24-week post-treatment follow-up period (with the exception of patients who enrolled in the open-label extension study \[Study 301012-CS6; NCT00694109\]). The treatment period spanned the time during which the study treatment was administered until the later of the primary efficacy time point (PET) or 14 days beyond the last day of study drug administration. The post-treatment follow-up period began the day after completion of the treatment period and ended on the day of the patient's last contact date within the study.

Following treatment and Week 28 evaluations, eligible patients who tolerated study drug could elect to enroll in an open-label extension study (301012-CS6). Patients who were not eligible for or who elected not to enroll in the open-label extension study and patients who discontinued during the 26-week treatment period were followed in this study for an additional 24 weeks from administration of the last dose of study drug.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Heterozygous Familial Hypercholesterolemia (HeFH)
* Diagnosis of Coronary Artery Disease (CAD)
* Stable lipid-lowering therapy for 12 weeks
* On maximally tolerated statin therapy with at least 1 statin at a dose greater than zero, per Investigator judgment
* Stable low-fat diet for 8 weeks
* Stable weight for 6 weeks

Exclusion Criteria:

* Significant health problems in recent past including heart attack, stroke, coronary syndrome, unstable angina, heart failure, significant arrhythmia, orthostatic hypotension, uncontrolled hypertension, blood disorders, liver disease, cancer, or digestive problems
* Receiving apheresis treatment or last apheresis treatment within 8 weeks
A Mobile SMART Exercise Support Program to Improve Fatigue in Lung Cancer Patients - A RCT

Lung cancer (LC) is a common cancer in the world. Among all symptoms, Fatigue is considered as the most distressing medical condition of LC. Prior studies revealed that physical activity effectively relieve fatigue and related problems. The current study attempt to explore the effectiveness of SMART Exercise Support Program (SES) with the use of mobile instant messaging application, on reducing symptoms such as fatigue, and improving physical activity level, physical fitness performance, sleep quality and habits, and quality of life in advanced lung cancer (ALC) patients.

Lung cancer (LC) is the most and second most common cancer globally and locally, respectively. Nearly half of LC patients are diagnosed in the advanced stage. Fatigue is perceived to be the most distressing symptom. Physical activity has been proposed as an alternative treatment to relieve fatigue and related problems.

Mobile instant messaging applications (e.g. WhatsApp/WeChat) are popular and inexpensive for interactive messaging. A systematic review showed a majority of messaging interventions were effective in diabetes self-management, weight loss, physical activity (PA), smoking cessation, and medication adherence.

The proposed randomized controlled trial (RCT) aims to examine the effectiveness of SES on relieving fatigue, pain, dyspnea, happiness, anxiety and depression symptoms, physical activity level, physical fitness performance, sleep quality and habits, and quality of life in ALC patients (SES group), compared to the General Hygiene Information (GHI, control) group.

Questionnaires and simple fitness tests will be used at baseline, 6-week, and 24-week assessments. Qualitative feedback will be obtained at the completion of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and above;
* Diagnosis of Stage III or IV non-small cell lung cancer;
* Edmonton Symptom Assessment System Scale fatigue symptom score ≥4 out of 10
* Self-reported engagement of \<150 minutes of moderate intensity PA each week,
* Ambulatory and capable of all self-care activities (European Co-operative Oncology Group (ECOG) Performance Status of ≤2)
* Either undergoing or finished oncology therapy, biological agents and/or support care;
* Mentally, cognitively and physically fit to join the trial as determined by the doctor in-charge and responsible clinical investigators;
* Able to speak and read Chinese;
* Willing to complete the patient-reported outcome questionnaire;
* Completion of the Physical Activity Readiness Questionnaire; and
* Possession of a smartphone with instant messaging functions such as WhatsApp or WeChat.

Exclusion Criteria:

* Those preparing for lung operation;
* Skeletal fragility;
* Serious active infection;
* Inability to walk;
* Previously untreated symptomatic brain metastases;
* Severe respiratory insufficiency;
* Uncontrolled pain; or
* Diagnosed psychiatric illness with or without medication such as major depressive disorder.