cyrilzakka/clinical-trials huggingface dataset:
Shifting Away From Pain: Neurocognitive Approach to Explain and Predict Recovery Following Whiplash Injury

Around half of the patients with neck pain after trauma (whiplash) will develop chronic pain. Understanding the transition from acute to chronic pain after whiplash is a priority since will help to identify those which patients are likely to fully recover and who do not. In the last years, there have been a call for an investigation of new biomarkers; particularly in brain structure and function. Alterations in the structure of the brain (gray matter, white matter and cortical thickness) as well as the brain function have been found in people with chronic WAD; which are also correlated with pain, disability and symptoms of central sensitization such as hyperalgesia. Previous research has found structural and functional brain differences between people who develop chronic low back pain compared to those who recovered; but research in this vein is still lacking in people with whiplash. Consequently, this study aims to examine the neural correlates of recovery following whiplash injury.

This study aims to investigate whether or not there are differences in brain structure and function between people who recover after whiplash and those who do not. Thus, patients with acute neck pain after whiplash will be recruited. Also, a pain-free age- and sex-matched control group will be recruited for comparison.

A longitudinal prospective study will be conducted with two follow-up measurements (3 and 6 months). All measurements will take place at University Hospital of Ghent (UZ Gent), Ghent (Belgium). MRI measures will be taken at baseline (\<4 weeks after the accident) and 6-months follow-up. The 3-months follow-up will only consist of the assessment of the online questionnaires; so, patients will not be required to come to UZ Gent.

Eligibility Criteria:
Whiplash patients

Inclusion Criteria:

* Neck pain within 4 weeks after the trauma
* Native Dutch speaker
* Refraining from consuming caffeine, alcohol and nicotine in the hour before the MRI scans in both measurement times

Exclusion Criteria:

* Neuropathic pain
* Being pregnant
* A history of a chronic pain syndrome
* Chronic fatigue syndrome
* Fibromyalgia
* Cardiovascular disorders
* Epilepsy
* Endocrinological disorders
* Rheumatic disorders
* Psychiatric disorders
* History of neck surgery
* Loss of consciousness during/after the whiplash trauma
* MRI incompatible health condition (e.g., pacemaker, metal prosthetic devices)
* Claustrophobia.

Healthy volunteers: (matched for age and gender). Additional exclusion criteria include for healthy volunteers

* a history of a chronic pain syndrome
* a pain condition in the last six months for which treatment was sought
CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily Practice Through Educational Approach)

This observational study is restricted to postmenopausal women with hormone-sensitive early breast cancer, who have decided to take prescribed adjuvant use of AIs, anastrozole or letrozole, according to the current product SmPCs. There is no Investigational Medicinal Product (IMP) to be taken in this observational study. The adjuvant AI medication must not have exceeded thirteen weeks. In CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily practicE through Educational approach), impact of educational material on women's compliance and persistence rates will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal woman with hormone sensitive early breast cancer
* Documented decision of treatment with upfront adjuvant AI (either anastrozole or letrozole) according to current SmPC OR current treatment with AI (either anastrozole or letrozole) according to current SmPC, that has not exceeded thirteen weeks

Exclusion Criteria:

* Upfront adjuvant AI medication which has exceeded thirteen weeks at randomisation
* Concomitant adjuvant treatment with tamoxifen or exemestane
* Previous use of adjuvant tamoxifen or exemestane exceeding thirteen weeks
COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study

The performance of the ColonRing™ will be comparable to or better than the reported performance of staplers.

The proposed study is a post marketing study intended to gather and record additional data to further evaluate the performance of the ColonRing™ device in regards to the creation of a colorectal anastomosis.

The study objective is to evaluate the performance of the ColonRing™ in the creation of a circular anastomosis in colorectal procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥ 18 years old.
2. BMI \< 34.
3. Subject is planned to undergo a non-emergency (i.e., elective) operation with the creation of an anastomosis using the ColonRing™.
4. Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.

Exclusion Criteria:

1. Subject has a known allergy to nickel.
2. Subject is planned to undergo an emergency procedure or has a diagnosis of bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel,carcinomatosis.
3. Subject has participated in another clinical study which may affect this study's outcomes within the last 30 days.
4. Subject's ASA (American Society of Anesthesiology) score 4 or 5.
5. Subject has a concurrent or previous invasive pelvic malignancy.
6. Subject has a systemic or incapacitating disease.
7. Subject has extensive local disease in the pelvis.
8. Subject requires more than one anastomosis during the surgery.
9. Women who are known to be pregnant.
Collection of Pleural Effusion Fluid

At the Laboratory for Molecular and Cellular Therapy (LMCT) of the Vrije Universiteit Brussel, Belgium, we study resistance mechanisms that hamper effective immunotherapy for solid cancer patients. To perform clinically relevant research, we apply autologous human material for functional assessment. The latter requires viable tumor and immune cells.

Solid cancer patients with pleural metastasis often develop pleural effusion. Notably, upon pleural drainage, residual material is obtained that consists of histocompatible tumor and immune cells. Hence with this study, we want to obtain blood and pleural effusion fluid drawn from solid cancer patients with pleural metastases to:

1. Collect, enrich and store primary cells derived from residual pleural effusion fluid and blood at the LMCT (VUB, Belgium)
2. Evaluate characteristics of the cells (phenotype, function,...) and compare content of pleural effusate with blood and clinicopathologic features of the patients.

Malignant pleural effusion (MPE) is characterized by the presence of malignant cells in the pleural cavity and develops in about 15% of patients with malignant disease. Two-thirds of all cases have a pleural effusion as one or sole initial manifestation of malignant disease. Primary tumors that most frequently develop MPE as metastatic disease are lung, breast cancer, and lymphoma accounting for 75% of all cases. Discomforting symptoms of MPE can include chest pain, cough, wheezing, hemoptysis, general discomfort, uneasiness, or ill feeling (malaise), shortness of breath and weight loss. To relief these discomforting symptoms, pleural drainage (evacuation) is routinely performed.

A significant number of solid cancer patients are currently being treated with immunotherapeutic drugs in first or second line or in the framework of a clinical trial. Aside from tumor cell intrinsic mechanisms, we and others previously found that non-malignant tumor infiltrated cells can also install immunotherapy resistance. Hence it remains of utmost importance to study the functional interactions between tumor cells and their non-malignant (solid) micro-environment to increase our current understanding of molecular profiles that predict responsiveness to immunotherapy. By exploiting patient-derived material, we aspire to perform more clinically relevant fundamental and translation research. The primary objective is to collect and compare blood, tumor and MPE-derived cell fractions. The secondary objective is to correlate cellular profiles with clinico-pathologic data.

Eligibility Criteria:
Inclusion Criteria:

* All solid cancer patients with pleural metastases undergoing pleural drainage with available tumor biopsy (upon informed consent)
* \>18 years of age

Exclusion Criteria:

* pregnancy

Healthy volunteers will be included for collection of control blood samples (upon informed consent).
Information With or Without Numbers For Optimizing Reasoning About Medical Decisions

Experts believe that increasing the low uptake of screening for colorectal cancer (CRC) requires educating patients about all approved tests and helping them choose one that fits their preferences. As one motto puts it: "The best test is the one that gets done." Screening tests range from more invasive and very sensitive for polyps and cancer (colonoscopy) to less invasive and less sensitive (e.g., fecal immunochemical testing (FIT)). But it is unclear how best to educate patients about the options and the tradeoffs involved. Some guidelines recommend that decision aids, a promising tool in this area, provide patients with detailed quantitative information, including baseline risk, risk reduction, and chance of negative outcomes. But this sort of "comparative effectiveness" data can confuse patients, especially those with limited mathematical ability. Previous studies have not measured the effect of providing quantitative information to patients with varying levels of ability or interest or asked them whether such data is essential for their decision-making.

The investigators will conduct a clinical trial to determine the impact on patients who view a decision aid (DA) that includes quantitative information versus a DA without such data. The investigators will also seek to determine whether numeracy moderates the effect of quantitative information.


Eligibility Criteria:
Inclusion Criteria:

1. Have not had colonoscopy performed in last 10 years, sigmoidoscopy in last 5 years, or fecal occult blood testing (including FIT) in last 1 year and
2. have a scheduled appointment or due to schedule an appointment with a healthcare practitioner at our performance sites.

Exclusion Criteria:

1. undergoing workup for symptoms consistent with colon cancer, such as weight loss or rectal bleeding
2. have a diagnosis or medical history conferring elevated risk for CRC including polypectomy or colon cancer, inflammatory bowel disease, certain inherited syndromes, or a significant family history of CRC
3. are unable to speak and read English.
Pediatric Locking Nail for the Treatment of Femoral Fractures in Children

The purpose of this multi-center prospective clinical outcomes study is to determine validity and safety of the pediatric locking nail for femoral fracture management in children with open physes.


Eligibility Criteria:
Inclusion Criteria:

1. Subject, representative willing to sign informed consent.
2. Ability and willingness of the subject to follow postoperative care instructions until healing is complete
3. Subject age must be between 8-16 inclusive.
4. Subjects with a minimal canal diameter of 9mm or greater

And any of the following fracture types

1. Non-comminuted and comminuted mid-shaft fractures
2. Distal third fractures 4 cm above the distal physis
3. Fractures that are open or closed
4. Subtrochanteric fractures

Exclusion Criteria:

1. A subject has a bone or soft tissue infection.
2. Subject has a systemic infection.
3. Subject has a distal (supracondylar) fracture.
4. Subject with pathological bone (osteogenesis imperfecta and other conditions resulting in abnormal bone quality).
5. Subjects with mental or neurological condition who are unwilling or incapable of following postoperative care instructions.
6. Subject with conditions including blood supply limitation, and insufficient quantity or quality of bone.
7. Foreign body sensitivity, where material sensitivity is suspected, testing is to be completed prior to implantation of device if at all practical or the subject should be excluded.
A Study to Evaluate the Safety, Tolerability, and Efficacy of Escalating Doses of BMS-986463 in Participants With Select Advanced Malignant Tumors.

The purpose of this study is to evaluate the safety, tolerability, and efficacy of escalating doses of BMS-986463 in participants with select advanced malignant tumors.


Eligibility Criteria:
Inclusion Criteria

* Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
* Participants must have at least 1 lesion accessible for biopsy in addition to the target lesion, from which a fresh pre treatment biopsy must be obtained.
* Participants must have an unresectable/metastatic carcinoma.

Exclusion Criteria

* Participants must not have Leptomeningeal metastases.
* Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.
* Participants must not have had any prior radiation therapy within 2 weeks prior to start of study treatment.
* Other protocol-defined Inclusion/Exclusion criteria apply.
LNG-IUS at 2 Weeks Postpartum

This is a study of 50 postpartum women interested in having the Mirena® LNG-IUS placed for contraception. The Mirena® is an FDA approved intrauterine contraceptive device that provides contraception for 5 years with excellent effectiveness. Women enrolled in this study will only have the Mirena® placed at two-weeks postpartum (day 14-20 postpartum). The participants will be followed at 6-weeks and 6-months postpartum for study visits to evaluate for satisfaction, symptoms, expulsion, and perforation. The study will be completed at six-months postpartum, and participants will be able to keep their LNG-IUS following study completion.


Eligibility Criteria:
Inclusion Criteria:

1. Desiring a LNG-IUS
2. Postpartum, ages 18-45 who deliver at a gestational age \> 32 weeks, delivery can be via cesarean or vaginal delivery
3. Following a viable, singleton pregnancy
4. Willing to return to UNC for their LNG-IUS insertion and study follow-up
5. Who plan to stay in the UNC area for 6 months and willing to return to UNC for 3 visits
6. Fluent in English or Spanish
7. At risk of repeat pregnancy (i.e. excluding those who had tubal sterilization)

Exclusion Criteria:

1. No genital bleeding of unknown etiology
2. No personal history of known or suspected breast carcinoma
3. No 4th degree vaginal laceration at time of delivery
4. No documented uterine rupture during delivery
5. No active liver disease (resolved pre-eclampsia may enroll)
6. No evidence of vaginal, cervical or uterine infection at time of LNG-IUS insertion
7. No history of postpartum endometritis treated with antibiotics or a postpartum readmission for a dilation and curettage
8. No pre-existing contraindication to a LNG-IUS as determined by the CDC's Medical Eligibility Criteria (MEC) category 3 or 4
9. Not currently incarcerated
10. No known congenital or acquired uterine anomaly, including fibroids that distort the uterine cavity
11. No suspected hypersensitivity or contraindication to the LNG-IUS
12. With any other condition or circumstance that the PI determines could cause an adverse event or interfere with completing the study.
Special Investigation in Patients With Rheumatoid Arthritis (Working Productivity Activity Impairment)

This is a single-arm, multi-center, prospective cohort study (post-marketing observational study). The observation period for each participant is 48 weeks.

This study is designed to provide additional data on treatment effects of adalimumab during 48 weeks of treatment in patients with RA under conditions of routine rheumatology care. Course of work productivity and work ability, the course of health-related quality of life, and changes in functionality during 48 weeks treatment with adalimumab are to be documented.

This study was designed as a non-interventional observational study. Adalimumab was prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines.

Eligibility Criteria:
Inclusion Criteria:

RA patients treated with adalimumab who satisfied the following conditions:

1. Paid worker (PW) RA patients who are engaged in paid work for more than 35 hours per week
2. Home worker (HW)

   * Category 1 unpaid workers; RA patients who are engaged in paid work for less than 35 hours per week
   * Category 2 unpaid workers; RA patients who perform basic activities of daily life (household duties, shopping, child caring, exercise, study, etc.) other than PW

Exclusion Criteria:

1. RA patients showing lowered basic activities of daily life, such as hospitalization and being bedridden
2. RA patients with a history of previous treatment with adalimumab
Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male Participants

This is an ADME study. Human radiolabeled mass balance studies are performed as part of drug development to obtain information about the absorption, distribution, metabolism, and excretion (ADME) of a study treatment. The goals of human ADME studies include the assessment of absorption, distribution, routes and rates of excretion, mass balance, and metabolite profile and identification.


Eligibility Criteria:
Inclusion Criteria:

* Signed ICF
* Healthy Male
* Body mass index of 18.0 to 32.0 kg/m2, inclusive.
* Agreement to use approved contraception for 94 days post treatment
* Agreement to not donate sperm for 94 days post treatment

Exclusion Criteria:

* Acute or chronic illness
* GI disease current or recent
* History of dizziness or recurring headaches
* Head injury within last 2 years
* GI surgery
* History or evidence of abnormal bleeding
Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease

The purpose of this study is to assess the efficacy and safety of Dexlansoprazole modified release (MR) (30 mg once daily \[QD\] or 60 mg QD) compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in subjects with symptomatic, nonerosive gastroesophageal reflux disease (GERD).

This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled, 3-arm study with a 4 week treatment period. This study will compare the efficacy of Dexlansoprazole MR (30 mg QD and 60 mg QD) with that of placebo when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate symptom relief in subjects with symptomatic nonerosive GERD. Approximately 900 subjects will be enrolled at approximately 200 United States (US) and potentially ex-US sites. The study consists of two periods: a screening period, which will last a minimum of 7 days and a maximum of 21 days, and a treatment period, which will last 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Subjects identifying their main symptom as a burning feeling in the mid epigastric area and/or chest area (ie, heartburn).
* Subject has a history of episodes of heartburn for 6 months or longer prior to Screening.
* Subject must have a history of episodes of heartburn for 4 or more days during the 7 days prior to Day -1.

Exclusion Criteria:

* Endoscopic Barrett's esophagus and/or definite dysplastic changes. History of dilatation of esophageal strictures.
* Subjects with erosive esophagitis (EE) as shown by endoscopy.
* Evidence of uncontrolled systemic disease. Co-existing diseases affecting the esophagus. Current or history of Zollinger-Ellison syndrome.
* Subject has abnormal laboratory values.
* Subjects with active gastric or duodenal ulcers within 4 weeks of the first dose.
* Subject known to have acquired immunodeficiency syndrome (AIDS).
* Known hypersensitivity to any proton pump inhibitor (PPI), any component of Dexlansoprazole MR, or antacid.
* Use of prescription or non-prescription PPIs, histamine (H2) receptor antagonists, or sucralfate.
* Chronic (\>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors.
* Use of antacids (except for study-supplied Gelusil® ).
* Use of drugs with significant anticholinergic effects.
* Subjects who cannot discontinue the use of misoprostol or prokinetics
* Need for continuous anticoagulant therapy.
* Females who are pregnant or lactating.
* History of gastrointestinal surgery except for simple oversew of ulcer.
* History of cancer within 3 years prior to screening.
* Subject has participated in a previous Dexlansoprazole study.
* Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.
Effects of Light and Sound Modification on Sleep Quality and Circadian Rhythm in the MICU Patients

This study will investigate the effectiveness of light and sound modification in improving sleep qualit , and circadian rhythms in MICU patients with Mechanical Ventilation in Taiwan.

Hypothesis:

1. The sleep quality in intervention group is significant improving than usual-care group at Day 1 (after the first intervention), Day 2 (after the second intervention), and Day 3 (after the third intervention).
2. The circadian rhythm in intervention group is significant improving than usual-care group at Day 1 (after the first intervention), Day 2 (after the second intervention), Day 3 (after the third intervention).

The subjects were divided into experimental and control groups. And the improving quality of sleep intervention was provided only in experimental group. In the experimental group，the patients used earplugs and eye masks during nighttime sleep. In the control group, the received routine intensive care.

Eligibility Criteria:
Inclusion Criteria:

1. ICU stay for 7 days
2. Endotracheal or Tracheostomy patients

Exclusion Criteria:

1. Patients with ear injury
2. Hearing impairment
3. Eye disease or injuries
Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis

This is a Phase 3, long term extension study to evaluate the safety and efficacy of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).

This study will also evaluate the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP

Eligibility Criteria:
Inclusion Criteria:

* Subject participated in the preceding placebo-controlled Phase 3 study ANB019-301 and completed at least the Week 1 visit of the ANB019-301 study without the use of rescue/prohibited medication for GPP
* Subject must be a candidate for prolonged GPP treatment according to the Investigator's judgment

Exclusion Criteria:

* Use of prohibited medications between the last visit of the ANB019-301 study and the Day 1 visit of the ANB019-302 study.
Safety and Efficacy of Sitagliptin Added to Insulin Therapy for Type 2 Diabetes

There is paucity of information about the combination therapy with dipeptidyl peptidase-4 inhibitor sitagliptin and insulin. This study aimed to retrospectively investigate the safety and efficacy of this therapeutic modality in Japanese patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* outpatients with type 2 diabetes
* addition of sitagliptin to insulin therapy
* aged 20 years or older
* HbA1c of 6.9% or higher (NGSP) at the time of adding sitagliptin

Exclusion Criteria:

* history of hypersensitivity to sitagliptin
* severe ketosis, diabetic coma, and/or precoma within 6 months before sitagliptin administration
* sever infection and/or severe trauma, and/or patients who are scheduled to undergo / have recently underwent surgery
* severe renal dysfunction (serum creatinine \[mg/dL\]: 2.5 or higher for men; 2.0 or higher for women)
* ongoing treatment with glinide(s)
* judgment as ineligible for the study by the attending physician