cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Ustekinumab in Patients With Plaque Psoriasis in Asia-Pacific Countries

The purpose of this study is to determine how patients use ustekinumab (label-recommended or other/missed dose interval) in Asia-Pacific countries.

This is an open-label (all people know the identity of the medication), multicenter, Phase 4, observational study (no study medication was administered during the study) designed to assess how patients will use ustekinumab (label-recommended or other/missed dose interval) in Asia-Pacific countries. The study will consist of 4 study visits which will take place over the duration of 1 year. At the first visit (ie, Week 0), eligibility for the study will be determined (it will be screening and baseline visit). At each subsequent visit (Weeks 16, 28, and 52), exposure to ustekinumab will be recorded, questionnaires for efficacy will be completed, and information about adverse events and concomitant medications will be collected. As many patient reported outcome questionnaires as possible will be administered, depending on the availability of validated translations. Safety will be assessed by monitoring of adverse events, vital signs and physical examination.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of plaque psoriasis, according to the dermatologists' clinical judgment
* Agree to initiate treatment with ustekinumab on the same day as enrollment into the study
* Have not received anti-IL12/23 therapies within 6 months prior to enrollment into the study

Exclusion Criteria:

* Has difficulty understanding questions posed by any of the questionnaires
* Are currently participating in an investigational drug clinical study
CompRest - a Comparison Between Sleep Compression and Sleep Restriction for Treating Insomnia

This study includes two consecutive sub-trials.

Cognitive Behavioral Therapy (CBT) is treatment of choice for Insomnia. One of the most important treatment Components in CBT for insomnia (CBT-i) is Sleep Restriction (SR), but lately, adverse effects related to SR have been reported. A treatment method with similarities to SR is Sleep Compression (SC). SC is not as well studied as SR, but appears to have similar effects to SR but without the adverse effects. The first sub-trial thus aims at directly comparing SR and SC. The second sub-trial aims at evaluating any additional effects of CBT-i components given as an add-on treatment to a randomized selection of half participants in each original treatment arm.


Eligibility Criteria:
Inclusion Criteria:

* Clinical level of Insomnia (more than 10 on ISI)
* Meets criteria for Insomnia Disorder according to DSM-V
* Sufficient language skills
* Having access to Internet to fill out forms and participating in treatment
* Not foresee obstacles to participating in treatment during the coming 20 weeks, or participating in measurements during the coming year.

Exclusion Criteria:

* Sleep disorders requiring other treatment
* High consumption of alcohol/drugs that affect sleep
* Somatic or psychiatric conditions counter-indicative of treatments given in the study, requiring acute care, or with symptoms and level of functioning affecting the ability to participate in the treatment programs.
* Working (night) shifts
* Ongoing psychological treatment for Insomnia with sleep restriction or sleep compression as a treatment component - also previous such treatment can be excluding
* Use of sleep medication in such a way that may hinder the implementation of the methods in this treatment
* Pre-treatment measurements not finished within the given time-frame.
Comparative Effectiveness of Prescribed Adapted Physical Activity (APA), Either Practiced Independently After Training, or Supervised by an APA Teacher, on Glycemic Regulation in People with Unbalanced Type 2 Diabetes.

Comparative effectiveness on glycemic balance of a non-pharmacological treatment, Adapted Physical Activity (APA), either supervised by a qualified APA instructor or unsupervised in autonomy, in individuals with inadequately controlled Type 2 Diabetes, under diet alone or non-insulin treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient who has given consent to participate in the study and has signed an informed consent form.
* Patient aged 18 to 67 years
* Patient diagnosed with type 2 diabetes
* Patient newly diagnosed or on non-insulin treatment (metformin +/- DPP4 inhibitor, GLP1 analogue +/- SGLT2 inhibitor) for whom it is considered to initiate or intensify antidiabetic treatment by introducing a new therapeutic class.
* Patient insufficiently controlled (\&gt; 1.30 g/L fasting blood glucose measured in the laboratory twice a few days apart in a city laboratory)
* Patient with good venous access.
* Patient capable of engaging in regular physical activity
* Patient who has undergone a coronary artery disease screening test in the year prior to inclusion according to the new recommendations of an expert consensus.
* Patient agrees to wear a FitBit Charge 6 bracelet for the entire duration of the study, including the run-in period, and agrees to recharge it and transmit the data.

Exclusion Criteria:

* Patient diagnosed with type 1 diabetes
* Patient treated with sulfonylureas
* Patient with a history of severe cardiovascular diseases (myocardial infarction, acute coronary syndrome, or stroke in the past year)
* Patient presenting a medical contraindication to performing a physical activity session (uncontrolled resting hypertension, i.e., systolic blood pressure \&gt; 160 mmHg and/or diastolic blood pressure \&gt; 100 mmHg, unstable coronary artery disease, heart failure, severe proliferative or non-proliferative evolving retinopathy (unstabilized), or having undergone recent surgical laser treatment of the eye, plantar perforating ulcer, disabling osteoarthritis of the lower limbs, respiratory failure, severe renal impairment, liver failure, severe dysautonomia, i.e., risk of chronotropic insufficiency during exercise, peripheral neuropathy)
* Patient with a history of severe hypoglycemia in the 6 months prior to entering the study and/or not feeling their hypoglycemia at all
* Patient with an IPAQ score in the high category
* Patient with a known latex allergy
* Patient with morbid obesity (BMI \&gt; 40 kg/m²)
* Other conditions that may interfere with glycemic variation: particularly the use of corticosteroids during the study
* Patient treated with beta-blockers or calcium channel blockers with negative chronotropic action (such as isoptin)
* Breastfeeding woman
* Pregnant woman\* or wishing to become pregnant
Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery

To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. vehicle for the treatment of inflammation following cataract surgery


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are candidate for routine, uncomplicated cataract surgery
2. Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.

Exclusion Criteria:

1. Subjects who will require concurrent ocular therapy with NSAIDs, mast cell stabilizers, antihistamines, decongestants, or immunosuppressants (e.g., Restasis), or with ocular or systemic corticosteroids
2. Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components
3. Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye
4. Subjects who have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to the Screening Visit
Lung Tumor Protein Synthesis Rates in Lung Cancer Patients

The current study will recruit lung cancer patients to measure tissue protein synthesis rates of non-small cell lung carcinomas and healthy lung tissue. The protein synthesis rates of healthy lung tissue will be compared to lung tumor tissue to establish the remodeling characteristics of healthy versus cancerous lung tissues. We will also examine whether tissue protein synthesis rates of non-small cell lung carcinomas are associated with various tumor- (i.e., size, subclassification) and patient-derived (i.e., inflammation, lung function, smoking status, and smoking history) parameters.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-65 years
2. Compos mentis
3. Diagnosed with lung cancer, with treatment requiring a thoracotomy or VATS lobectomy

Exclusion Criteria:

1. Neoadjuvant chemo- or radiotherapy in the past four weeks
2. Use of systemic steroids in the past four week
3. Insulin-dependent diabetes mellitus
4. Pregnancy
Retrospective Study on the Use of CEFALY® Device During Migraine Attacks

This is an Internet survey to collect data on the use of the Cefaly device to treat migraine attacks in regular Cefaly users.

About 1000 CEFALY users, having the device since more than one year and having reordered electrodes in the last year, will be invited to participate to an Internet survey. This survey contains at most 8 questions, and data will be collected completely anonymously. Questions concern the use or not of the CEFALY during migraine attacks, the number of treated attacks and the number and type of acute anti-migraine drugs that were avoided thanks to the use of the CEFALY.

Eligibility Criteria:
Inclusion Criteria:

* Subjects using Cefaly device regularly for more than a year identify by reordering of electrodes during the last year.
* History of likely episodic or chronic migraine with or without aura diagnosed by a physician

Exclusion Criteria:

* N/A
Study on Roujin Formula in the Treatment of Fibromyalgia Syndrome With Blood Deficiency and Liver Depression

To evaluate the efficacy and safety of Roujin Formula in the treatment of fibromyalgia syndrome(FMS)patients with blood deficiency and liver depression through a randomized,single-blind,placebo-parallel controlled exploratory clinical trial study,and to provide reliable clinical evidence for the treatment of fibromyalgia syndrome with Roujin Formula. 48 eligible participants with FMS of blood deficiency and liver depression syndrome were selected and randomly divided into treatment group(n=24)and control group(n=24). The treatment group was given Roujin Foumula 150mL,twice a day; The control group was given Roujin Foumula placebo 150mL,twice a day,the study period was 8 weeks. The evaluation points were 0 weeks,4 weeks,and 8 weeks of treatment,and follow-up to 12 weeks. To evaluate the effect changes before and after treatment,FIQR score、VAS score、PSQI score、BDI score and SF-36 PCS、MCS score were used as secondary efficacy evaluation indexes. SPSS23.0 was used to analyze the data.


Eligibility Criteria:
Inclusion Criteria:

* 1. Meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for filbromyalgia;
* 2. Be over 18 years of age;
* 3. Sign informed consent.

Exclusion Criteria:

* 1.patients with rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, ankylosing spondylitis and other rheumatic diseases ;
* 2.severe liver and kidney dysfunction;
* 3.severe cardiovascular and cerebrovascular diseases and other diseases ;
* 4.pregnant or lactating women ;
* 5.had taken drugs for the treatment of this disease in the last 4 weeks.
Real World Study on the Use of Cemiplimab in Adult Patients in UK

The primary objective is to describe the real-world clinical effectiveness of cemiplimab in patients with locally advanced cutaneous squamous cell carcinoma (laCSCC) or metastatic cutaneous squamous cell carcinoma (mCSCC) treated in routine clinical practice.

Patients initiating treatment with cemiplimab in the UK between 2nd July 2019 and 30th November 2020, will be followed for a minimum of 12 and a maximum of 36 months from initiation of cemiplimab.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>=18 years at initiation of cemiplimab.
* Patients treated with \>=1 dose of cemiplimab for laCSCC or mCSCC who were not suitable for curative surgery or curative radiation according to routine practice.
* Patients initiating treatment with cemiplimab in the UK between 2nd July 2019 and 30th November 2020.

Exclusion Criteria:

* Patients who are known to have opted out of participation in any research (as required for compliance with GDPR).
* Patients participating in any form of investigative study (e.g., clinical trials) during the post-index observation period.
Method Validation for New Nitrogen/Sulfur Species Analysis Techniques

Plasma redox status is well known to alter with age but previously differences have only been reported for two specific redox couples; reduced and oxidized cysteine and reduced and oxidized glutathione. (Jones DP, Rejuvenation Res. 2006) The overall aim of this project is to develop new methods to determine how other Reactive Nitrogen and Sulfur species, such as free and protein-bound thiols (organic compounds that contain a Sulfhydryl group, -SH) and Hydrogen Sulfide (H2S) change with age and gender in a medium-sized cohort of healthy individuals (n=100 of either sex; age 18-70).

Our group has recently developed a novel analytical platform to measure thiol-containing compounds in biological samples that is based on the reaction with the thiol-alkylating agent N-ethylmaleimide (NEM). We have used this chemical for years as stabilisation agent in other analyses to quantify Nitric Oxide metabolites.(Feelisch et al, FASEB 2002 and Levett et al, Sci Rep 2011) We now wish to develop a similar method to measure thiol containing compounds using a novel rapid LC-MS/MS based technology for screening large numbers of individuals.

The project will therefore have 2 stages:

1. Initial method development will require occasional use of whole blood, plasma and red blood cells to establishing optimal conditions. E.g. to compare heparin and EDTA as anticoagulants to serum; investigate effects of temperature and pH; identify optimal concentration of derivatisation/reduction agents and optimal reaction times.
2. We then aim to establish the normal distribution of these novel compounds across healthy individuals of different gender and varying ages.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or above
* Currently healthy (i.e. no inter-current illness/infection)
* Capacity and ability to give written informed consent

Exclusion Criteria:

* Current or previous smoker
* Other medical co-morbidity (e.g. hypertension, diabetes, asthma, COPD, cardiovascular disease, current or previous malignant disease etc.)
* Surgery within previous 28 days
* Excessive alcohol intake (i.e above UK's recommended intake limit of 14 units per week).
* Pregnant or currently breast-feeding
* On current medication
* Taken vitamins / minerals / herbal remedies within previous 28 days
* Difficult venous access
* Needle phobia
* Participating in another similar/conflicting research study already
Etoposide and Celecoxib in Patients With Advanced Cancer

RATIONALE: Etoposide and celecoxib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving more than 1 drug may be an effective treatment for advanced cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when given together with etoposide in treating patients with advanced cancer.

OBJECTIVES:

* To describe the toxicities of the combination of oral etoposide at 50 mg daily with escalating doses of celecoxib in patients with advanced malignancies.
* To evaluate the effects of the combination of etoposide and celecoxib on plasma levels of vascular endothelial growth factor.

OUTLINE: This is a dose-escalation study of celecoxib.

In course 1, patients receive oral etoposide once daily on days 1-35 and oral celecoxib twice daily on days 8-35. In all subsequent courses, patients receive oral etoposide once daily and oral celecoxib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline, periodically during treatment, and at time of tumor progression. Samples are analyzed for vascular endothelial growth factor levels by enzyme-linked immunosorbent assay and stored for future analysis of circulating DNA of angiogenic biomarkers by polymerase chain reaction assays.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically proven diagnosis of a malignant disease for which no satisfactory treatment exists at the time of enrollment
* Patients with brain metastases which at the time of study enrollment are controlled and do not require treatment with corticosteroids are eligible

PATIENT CHARACTERISTICS:

Inclusion criteria:

* WHO performance status 0-2
* Life expectancy ≥ 3 months
* ANC \> 1.5 x 10\^9/L
* Platelet count \> 100 x 10\^9/L
* Creatinine clearance \> 50 mL/min
* Serum bilirubin \< 1.5 mg/dL
* AST and ALT \< 2.0 times upper limit of normal (unless clearly due to the presence of tumor)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Patient must be capable of understanding the nature of the trial and must give written informed consent

Exclusion criteria:

* Unstable or severe intercurrent medical conditions or active, uncontrolled infection
* History of allergic reactions to non-steroidal anti-inflammatory drugs (NSAIDs)
* History of bleeding peptic ulcer within the past 3 months

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

* Recovered from all prior chemotherapy or radiotherapy
* Concurrent aspirin for cardiovascular indications allowed
* More than 2 weeks since prior and no other concurrent NSAIDs

Exclusion criteria:

* Had radiotherapy or chemotherapy within 3 weeks (nitrosoureas or mitomycin C within 6 weeks) prior to anticipated first day of dosing
* Undergoing concurrent therapy with other investigational agents or antineoplastic therapy
Enhanced Gait and Balance Training

The purpose of this study is twofold:

1. Establish baseline measures of gait performance in healthy young and older adults, and older adults with a history of falls.
2. Investigate the effects of gait and balance training with and without cranial nerve noninvasive neuromodulation (CN-NINM) on postural balance and gait performance in older adults.

For the second purpose, the study will incorporate a placebo-controlled design to evaluate the effects of CN-NINM augmented exercise compared to physical exercises alone. Both groups will perform gait and postural balance training (outlined in more detail below) but will differ in the stimulation level of the PoNS device. The investigators will use the results of this study as a first step toward evaluating the benefits of CN-NINM in a falls prevention program.


Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling
* Able to understand and give informed consent
* Able to stand and walk independently without an assistive device
* No contraindication to exercise

  1. Healthy young adults
* Between ages of 18 and 39
* Scores above 19 on Dynamic Gait Index 2. Healthy older adults without a history of falls
* Age 65+
* Scores above 19 on Dynamic Gait Index 3. Older adults with a history of falls
* Age 65+
* Self-reported history of 1-3 falls in previous year
* Scores of 19 and below on the Dynamic Gait Index

Exclusion Criteria:

* History of musculoskeletal disorders (lower-limb joint replacement, radiographic evidence of severe osteoarthritis, broken leg bone or ligament/tendon injury in prior 6 months)
* Use of tobacco products
* Any oral abrasions, cuts, cold sores, piercings, tissue inflammation, or have had oral surgery within the previous 3 months
* Have a pacemaker or are identified as at-risk for cardiovascular events
* Have a biomechanical prosthetic
* If female, self-report of being pregnant
* Neurological condition
* Prisoners
* Individuals clearly lacking the capacity to provide informed consent
IBD Cancer and Serious Infection in Europe

The primary objective of I-CARE is to assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.

We will stratify the risk of cancers and serious infections according to IBD phenotype and disease activity (clinical, radiologic and endoscopic).

The four main secondary objectives of the I-CARE project are:

* To investigate prospectively the impact of anti-TNF based strategies on the natural history of IBD and their potential for disease modification by collecting validated surrogate markers such as mucosal healing and disease complications such as bowel damage (strictures, fistulas, abscess), surgeries, and hospitalizations
* To assess the evolution of Patient Reported Outcome (ePRO) on a yearly basis and the impact of anti-TNF agents on ePRO in IBD
* To evaluate the benefit-risk ratio of strategies based on an earlier and wider use of anti-TNF therapy for IBD
* To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD 5-ASA and Steroids across Europe At least 5000 IBD patients treated with 5-ASA or Steroids and FU for 3 years

  * use of 5-ASA and efficacy (persistence, switch, mucosal healing etc.)
  * chemoprevention of CRC: first study that will specifically and accurately address this question
  * use of budesonide mmx and efficacy (clinical efficacy, mucosal healing and potential for disease modification)
  * safety of steroids (infections etc)

STUDY DESIGN:

22 patients per investigator. Each Investigator will recruit and enrol 20 patients with imposed treatment stratification : Group 1: 5 without previous or ongoing exposure to IS or biologics, (5 ASA and Steroids are allowed) Group 2: 5 with on-going anti-TNF monotherapy Group 3: 5 with thiopurines monotherapy Group 4: 5 with on-going combination therapy Group 5: 2 patients on vedolizumab (on vedolizumab alone and 1 on combination therapy) (optionnal) Group 6: 5 patients treated with ustekinumab with or without any concomitant medications. (optional)

Eligibility Criteria:
Inclusion Criteria:

* CD or UC
* Capable to complete eDiary on a regular basis, and have access to smartphone or internet
* Accepted to participate and provide personal information (name, phone and email) for contact
* Accepted to be contacted by study coordinators on a regular basis for follow up with missing information

Exclusion Criteria:

* Unable to sign consent
* Unable to access internet or use smartphone
* Refused to sign consent or to provide personal identification information