cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of App-based Relaxation for Patients With Chronic Neck Pain

The aim of the pragmatic randomized study is to evaluate whether additional relaxation technique is more effective in the reduction of chronic neck pain compared to usual care alone.

Objective: To evaluate whether additional relaxation technique is more effective in the reduction of chronic neck pain compared to usual care alone.

Study design: Open single-centered randomized two-armed pragmatic trial.

Participants: 220 patients aged 18-65 years with chronic (\>12 weeks) neck pain and a mean pain score ≥ 4 on a Numeric Rating scale (NRS) in the last week before randomization who will be randomly allocated to two groups (relaxation, usual care alone as waiting list)

Intervention: Participants apply either a daily 15-minute relaxation exercise guided by a smartphone application ("app"). or apply no additional intervention. The exercise should be applied daily, (minimally, five days per week) for 6 months. The app contains audios to guide autogenic training, muscle relaxation training and guided imagery. On a daily basis, participants can select one of the three exercises which they want to apply.

Main outcome measure: The primary outcome is the mean pain intensity after 3 months measured by the daily pain intensity on the NRS.

Eligibility Criteria:
Inclusion Criteria:

* female or male
* 18-65 years of age
* chronic neck pain for at least 12 weeks
* if additional back pain is reported, neck pain has to be predominant
* intensity of the average neck pain ≥ 4 on the numeric rating scale (NRS) in the last week
* presence of a smartphone (iphone, Android phone) and willingness to do data entry through a smart phone application (App)
* physical and mental ability to participate in the study
* willingness to be randomized, to apply study intervention according to the protocol, to complete the baseline questionnaire in paper form and electronic questionnaires and diaries provided by a smart phone application
* written and oral informed consent

Exclusion Criteria:

* neck pain caused by a known malignant disease
* neck pain caused by trauma
* known rheumatic disorder
* history or planned surgery of the spinal column of the neck in the next 6 months
* known neurological symptoms e.g radicular symptoms because of prolapsed vertebral disc
* regular intake of analgesics (\>1x per week) because of additional diseases
* intake of centrally acting analgesics
* known severe acute or chronic disorder, that do not allow participation in the therapy
* other known diseases, that do not allow participation in the therapy
* known alcohol or substance abuse
* no sufficient German language skills
* current application for a benefit
* participation in another clinical trial during six months before the study and parallel to the study
* conducting regular relaxation techniques, mindfulness training or meditation six weeks before the study or planned in the next 6 months
Effect of RDX-002 on Postprandial Triglycerides in Subjects Treated With Olanzapine

This Phase 1b Study RDX-002-22-09 has been planned to evaluate the effect of RDX-002 on postprandial triglycerides and ApoB48 levels in normal healthy subjects treated with the atypical antipsychotic drug, olanzapine.

This Phase 1b Study RDX-002-22-09 has been planned to evaluate the effect of RDX-002 on postprandial triglycerides and ApoB48 levels in normal healthy subjects treated with the atypical antipsychotic drug, olanzapine. It is a randomized, open-label, parallel group study that will be conducted at a single study site in the US. Normal, healthy subjects aged 18-50 years and with a body mass index (BMI) of 18-27.5 kg/m2 will be eligible for screening. Screening (Day -28) will begin approximately 28 days prior to Baseline (Day 1). Subjects will be admitted to the clinical research unit (CRU) on the morning of Day -1 and will remain in the CRU until discharge on Day 16.

Eligibility Criteria:
Inclusion Criteria:

* A glycated hemoglobin (HbA1c) level of \<5.7% at Screening
* A 12-lead electrocardiogram (ECG) at Screening which, in the opinion of the Investigator, had no abnormalities that compromised safety in this study
* Hematology, clinical chemistry and urinalysis at Screening, the results of which fall within normal parameter ranges and/or are deemed clinically acceptable by the Investigator Exclusion Criteria
* Males and nonpregnant, nonlactating females

Exclusion Criteria:

* Any prior use of or contraindication to atypical antipsychotics
* Concomitant use of drugs known to impact the PK of olanzapine
* Type 1 or Type 2 diabetes
* Recent CV event
* Uncontrolled hypertension
* Fasting triglycerides ≥400 mg/dL
* Fasting glucose ≥100 mg/dL
* Any condition that impacts the absorption of dietary fats
* Significant gastrointestinal disorders
* Gall bladder disease
* Uncontrolled hypothyroidism
* Liver disease or dysfunction
* Renal disease or dysfunction
* Gastrointestinal conditions
* Hematologic disorders
* Active malignancy
* Psychiatric disorder
* History of drug or alcohol abuse
* Pregnant, breastfeeding, or intending to become pregnant
* Use of weight loss products
* Blood donation or loss within 30 days prior to Screening
Feasibility of an Evidence-based Walking Program in Cancer Pts 60+ During Chemotherapy

The study will look at conducting a medium-intense walking program called Walk With Ease with cancer patients age 60 and above who are starting chemotherapy treatment. We will measure how many of these patients complete their participation in this program.

The primary purpose of this study is to evaluate the feasibility of implementing a moderate-intensity walking program (Walk With Ease/WWE) among cancer patients, age ≥60 years, as they undergo cytotoxic chemotherapy treatment. Feasibility will be determined based on the rate of participation in the WWE program. As secondary objectives, we will also establish the rate of completion of a number of instruments, including a Geriatric Assessment tool, and other instruments that measure self-reported quality of life (e.g., fatigue, depression, and pain), and self-reported physical activity (PA). Data from these instruments, as well as from serial measurements of a biomarker of aging (p16INK4a) will be explored and used to inform future studies designed to evaluate any relationship between these variables and participation in the WWE program.

We propose a sample (n=30) of cancer patients ≥60 years of age with potentially curable cancer and a diagnosis of Stage I-III breast cancer, Stage I-III lung cancer, or Stage II-III colon cancer, who are about to begin chemotherapy. Participation will be defined as completing the 6-week WWE program. Results from this study will be used in an RO1 application to the National Cancer Institute (NCI) pertaining to PA interventions among cancer patients and the effects of biomarkers on prognosis and survival.

Eligibility Criteria:
Inclusion Criteria:

* ≥60 years of age, male or female
* Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer diagnosis, then the most recent diagnosis); Stage I, II or III lung cancer, or Stage II or III colon cancer
* Scheduled to begin a chemotherapy (or concomitant chemoradiotherapy) regimen that will last at least 6 weeks in duration
* English speaking
* IRB approved, signed written informed consent
* Approval from their treating physician to engage in moderate-intensity physical activity
* Patient-assessed ability to walk and engage in moderate physical activity
* Willing and able to meet all study requirements.

Exclusion Criteria:

* One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention
* Cancer surgery scheduled within the study period
* Unable to walk or engage in moderate-intensity physical activity
Pharmacokinetics and Safety of HD-P023 and Co-administration of Teneligliptin and Empagliflozin High in Healthy Volunteers

The purpose of this study is to compare the pharmacokinetics and safety of HD-P023 and coadministration of Teneligliptin and Empagliflozin in healthy adult volunteers


Eligibility Criteria:
Inclusion Criteria:

* Patients who are 19 years or older on screening
* Signed informed consent
* Healthy Volunteer
* Other inclusion applies

Exclusion Criteria:

* Clinically relevant/significant findings as evaluated by the investigator
* Other exclusion applied
An Open Label pH Comparison of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients

The purpose of the study is to compare the treatment of esomeprazole 40 mg once daily and lansoprazole 30 mg once daily in controlling intragastric pH in Barrett's Esophagus patients


Eligibility Criteria:
Inclusion Criteria:

* Documented history (within 2 yrs of histologically proven BE;
* Aged 18-70 (inclusive);
* Willing and able to comply with all study procedures

Exclusion Criteria:

* Signs of clinically significant GI bleeding within 3 days prior to randomization;
* History of gastric or esophageal surgery;
* Clinically significant illness within 2 weeks prior to first dose of study drug or during study
HBA1c and Diagnosis of Type 2 Diabetes

Following the 6th Tromso study subjects with HbA1c \> 5.7 plus a subsample of subjects with lower hba1c values will be invited to an oral glucose tolerance test to see the predictive value of HBA1c in the diagnosis of type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* participated in the 6 Tromso study

Exclusion Criteria:

* type 2 diabetes
Postconditioning in ST-elevation Myocardial Infarction

Study objectives: To assess the effects of postconditioning on infarct size in patients with ST-elevation infarction referred to PCI.

Study design: Prospective, randomized, open-label study with blinded endpoint evaluation. Included patients will be randomly allocated to postconditioning or control. Patients with symptoms of acute myocardial infarction of less than 6 hours duration fulfilling ECG criteria for primary PCI are eligible. PCI follow established routines. In postconditioning patients, additional, short (1 min), intermittent balloon occlusions will be applied after initial opening of infarct related artery. After this intervention, PCI proceeds routinely with stent implantation. In the control group, stent implantation after initial opening proceeds as usual. Primary endpoint is final infarct size, determined by MRI after 4 months. 260 patients will be included. Follow-up is 1 year. Inclusion period: 18 - 24 months.

Clinical implications: Reperfusion therapy, administered as early as possible after start of symptoms, has improved the prognosis in acute ST-elevation myocardial infarction. Still, however, many patients suffer large infarctions, subsequently with an increased risk of heart failure, arrhythmias, and death. In pilot studies, mechanical postconditioning has been shown to reduce infarct size and thus potentially improve prognosis. However, the effect of postconditioning must be confirmed in larger clinical trials before implemented in routine treatment.


Eligibility Criteria:
Inclusion Criteria:

* acute symptoms consistent with an acute myocardial infarction of less than 6 hours duration
* an occluded infarct related artery must be demonstrated (TIMI-flow 0-1)

Exclusion Criteria:

* Prior myocardial infarction
* Demonstration of collaterals to the infarcted area
* TIMI-flow \>1 before intervention or TIMI-flow \<2 after initial balloon inflation
* Demonstration of a distal occlusion
* Patients given thrombolytic treatment
* Patients in cardiogenic shock
* Any contraindication to MRI (magnetic resonance imaging)
* Unwillingness to participate
GAG Replacement vs URethral DIlAtatioN

The aim of this randomised parallel trial is to compare the efficacy of Glycosaminoglycan layer replacement against cystoscopy and urethral dilatation in the treatment of recurrent urinary tract infection in pre-menopausal women.

The women will be randomised to 1 of 2 arms.Arm 1 patients will receive standard treatment from the Urologists. This will involve rigid cystoscopy and urethral dilatation, under general anaesthetic.

Arm 2 patients will receive standard treatment from the Gynaecologists.

Recurrence of a Urinary Tract Infection (UTI) is defined as infection, following complete resolution of a previous UTI.Recurrent UTI (rUTI) is defined as 3 or more microbiologically confirmed UTI within 12 months. rUTI is an economic problem for healthcare services. rUTI is also detrimental to the quality of life (QoL) of women who suffer the disease. 61% of women who suffer rUTI report symptoms of depression and an associated decrease in their reported QoL scores. QoL was found to improve significantly with successful treatment.

E-coli is the most common bacteria causing UTI and 10% are thought to be antibiotic resistant. Consequently, new treatment strategies are required.

The Glycosaminoglycans (GAG) layer is thought to be instrumental as a defence mechanism against uro-pathogens.

GAG's are polysaccharides forming a gel like substance on the apical surface of the bladder wall and act as a barrier to uro-pathogens. There is now strong evidence that a reduction in the impermeability of the GAG layer is linked to rUTI. Urethral dilatation is an alternative treatment to GAG replacement in the management of rUTI. It is a treatment option more widely adopted by Urologists, although there is a paucity of data to support its use.

Currently there is no standardised strategy for the management of women with rUTI. Treatments vary between GAG layer replacement (intravessical therapy with hyaluronic acid and chondroitin sulphate) or a cystoscopy and urethral dilatation. Evidence for each regime varies greatly and is of poor quality. This is a randomised study comparing GAG layer replacement with cystoscopy and urethral dilatation.

Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Pre-menopausal 3 - 3 episodes of cystitis in the last 12 months as defined by:

   1. 3 symptoms from dysuria, frequency, urgency, suprapubic tenderness, haematuria, polyuria
   2. Or less than 2 symptoms from the above list, but with cloudy urine 4 - Normal flow studies with bladder residual \<150ml 5 - Normal renal tract on USS

Exclusion Criteria:

1. - Anatomical anomalies of urinary tract
2. - Neurological condition
3. - Diabetes mellitus
4. - Pregnancy
5. - Use of Immunosuppressants
6. - Symptomatic of UTI at time of treatment
3D Modeling of the Cervico-facial Region and Cranial Nerve Tractography: IMAG 2 ORL Project

3D modeling associated with the tracking of nerve fibers meets the needs of preoperative planning for tumors and cervico-facial congenital malformations. Indeed, these lesions are closely related to the cranial nerves and in particular nerve V (infratemporal fossa), nerve VII (temporal bone, parotido-masseter region), nerves IX, X, XI, XII and the chain cervical sympathetic (infratemporal and cervical regions). The development of a model of this region will therefore improve the surgical management of these children.

Children aged 1 to 5 benefiting from a 3T magnetic resonance imaging (MRI) at the Necker Enfants-Malades hospital for their care, meeting the inclusion criteria and participating in the study, will benefit during their MRI from the care, a sequence "Research" tractography MRI lasting 10 minutes. This sequence is already validated and proposed for tractography but in specialties other than pediatric ENT.

Tractography techniques are mathematical algorithms based on the diffusion tensor (micro-movements of water molecules in tissues) to reconstruct the path of nerve fibers in each volume unit of the MRI image (voxel).

3D modeling associated with the tracking of nerve fibers meets the needs of preoperative planning for tumors and cervico-facial congenital malformations. Indeed, these lesions are closely related to the cranial nerves.

Eligibility Criteria:
Inclusion Criteria:

* Benefiting from social security scheme.
* Informed consent signed by holders of parental authority and the investigator.
* Patient group: children aged 1 to 5 benefiting from a 3T MRI at the Necker Enfants-Malades hospital as part of the initial assessment of a tumor or a cervico-facial malformation.
* Control group: children aged 1 to 5 benefiting from a 3T MRI at the Necker Enfants-Malades hospital as part of the initial assessment of an ENT pathology other than that of the patient group (examples: velar insufficiency, congenital deafness).

Exclusion Criteria:

Child with a contraindication to MRI: allergy to contrast product, pacemaker, Starr Edwards valves, stent placed for less than 6 weeks, vascular clips, contraindication to sedation.
Diagnostic Performance of Plasma Procalcitonin for the Detection of Blood Cultures Contaminations

In blood cultures, species considered as potentially contaminating (coagulase negative staphylococci (CNS), Bacillus spp., Corynebacterium spp., Cutibacterium acnes, Micrococcus spp., viridans group streptococci, and Clostridium perfringens) can, however, be responsable for true bacteremia.

Blood levels of the prohormone procalcitonin (PCT) markedly increase in the early stages of bacterial infections. The aim of our study is to determine the role of plasma PCT as a biomarker differentiating blood culture contaminations from true bacteremia.

Blood culture contamination is defined by the introduction into of a microorganism into blood culture bottles from either the patient's or healthcare worker's flora, or the immediate environment during specimen collection. Species considered as potentially contaminating (coagulase negative staphylococci (CNS), Bacillus spp., Corynebacterium spp., Cutibacterium acnes, Micrococcus spp., viridans group streptococci, and Clostridium perfringens) can, however, be responsible for true bacteremia. If an organism belonging to one of those species is detected in isolates, rapidly and accurately assessing its contaminant or infectious potential is hence important to ensure effective antibiotic therapy as well as to reduce financial burden caused by unnecessary treatments, and additional clinical and laboratory costs.

Blood levels of the prohormone procalcitonin (PCT) markedly increase in the early stages of bacterial infections. The aim of our study is to determine the role of plasma PCT as a biomarker differentiating blood culture contaminations from true bacteremia.

Eligibility Criteria:
Inclusion Criteria:

* At least one blood culture positive for of the following microorganisms: coagulase negative staphylococci, viridans group streptococci
* PCT levels measurement on the day of blood culture specimen collection
* Adult patients

Exclusion Criteria:

* Patients with less than 3 blood culture bottles collected
Risk Factors and Biomarkers for Diagnosis and Treatment of EoE

Purpose: To validate our previously developed model of risk factors for diagnosis of eosinophilic esophagitis (EoE), and to assess the utility of serum levels of biomarkers in diagnosis and monitoring of treatment of EoE. Participants: Up to a total of 800 participants (approximately 400 with EoE and 400 without EoE) who are referred for upper endoscopy. Procedures: This is a prospective cohort study. Patients will be compared with newly diagnosed EoE to non-EoE controls, obtain baseline measures, reassess EoE patients after treatment, and also reassess untreated controls. Data collection will include questionnaire results, blood collection, and tissue collection (esophageal biopsies performed during upper endoscopy per pre-specified protocol). Blood will be analyzed for the presence of the candidate biomarkers. Patients will be compared with newly diagnosed EoE to non-EoE controls, obtain baseline measures, reassess EoE patients after treatment, and also reassess untreated controls. Data collection will include questionnaire results, blood collection, possible saliva collection, possible urine collection, and tissue collection (esophageal biopsies performed during upper endoscopy per pre-specified protocol). Blood will be analyzed for the presence of the candidate biomarkers, including eotaxin-3 and IL-13.


Eligibility Criteria:
Inclusion Criteria:

1. Referral for upper endoscopy (esophagogastroduodenoscopy; EGD) to evaluate specific symptoms (dysphagia, heartburn, reflux, chest pain, regurgitation, abdominal pain, nausea, or vomiting).
2. Age 18 or older

Exclusion Criteria:

1. Acute GI bleeding.
2. Known cancer of the esophagus, stomach, or small bowel.
3. Prior esophageal resection.
4. Esophageal varices.
5. Active anticoagulation or bleeding diathesis.
6. Medical instability (determined by the performing endoscopist) to precludes performing EGD.
7. Pregnancy
8. Inability to read or understand the consent form and questionnaire.
Carpal Tunnel Syndrome Release Using PSU Retractor

The investigators study aims to evaluate both efficacy and safety of carpal tunnel release using limited incision with the PSU retractor compared to standard incision.

The investigators will do a randomized controlled trial in 60 patients with carpal tunnel release and evaluate for outcome regarding pain, VAS score, return to work time, CTS score and complications at 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as carpal tunnel syndrome who failed to conservative treatment 3 months

Exclusion Criteria:

* Underlying disease such as : DM, neuropathy
* Previous wrist or hand surgery in the same side
* Previous wrist and hand trauma
* Pregnancy
Clinical Study to Investigate a New Mouthwash in Reducing Plaque and Helping Prevent Gum Problems on Dental Implants Over a 6-month Period of Product Use

The objective of this six-month clinical research study is to evaluate the clinical efficacy of a new mouthwash on helping prevent gum problems (gingival index scores ) in adults as compared to a control mouthwash.


Eligibility Criteria:
Inclusion Criteria:

* Availability for the six-month duration of the clinical research study.
* Good general health.
* Minimum of two dental implants (2 different quadrants ), each implant must have a restoration.
* Initial mucositis index of at least 1 .0 as determined by the use of the Mombelli Modified Gingival Index.
* Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque Index.
* Signed Informed Consent Form.

Exclusion Criteria:

* Presence of orthodontic bands.
* Tumor (s ) of the soft or hard tissues of the oral cavity.
* Advanced periodontal disease (purulent exudate, tooth mobility, and /or extensive loss of periodontal attachment or alveolar bone ) or peri-implantitis.
* Five or more carious lesions requiring immediate restorative treatment.
* Antibiotic use any time during the one-month period prior to entry into the study.
* Participation in any other clinical study or test panel within the one month prior to entry into the study.
* Dental prophylaxis during the past two weeks prior to baseline examinations.
* History of allergies to oral care /personal care consumer products or their ingredients.
* On any prescription medicines that might interfere with the study outcome.
* An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
* History of alcohol or drug abuse.
* Self-reported pregnant or lactating subjects