cyrilzakka/clinical-trials huggingface dataset:
Exercise as Treatment of Neck Pain Among Helicopter Pilots and Crew Members

The aim of this project is to investigate, whether physical training, targeted neck and shoulder muscles, can reduce and prevent neck pain among military helicopter pilots and crewmembers.

Military helicopter pilots and crewmembers is often burdened by work-related neck and shoulder pain. Neck pain is a health challenge, that can reduce functional level, concentration and operational safety. Physical exercise has shown good efficacy in reducing neck/shoulder pain in other occupational groups in previous studies.

The Royal Danish Air Force and the University of Southern Denmark, wishes to examine whether specific physical exercise can prevent and reduce neck/shoulder pain within this occupational group.

Participants in this project will be randomly selected to either a physical exercise group or a reference group.

* The physical exercise group will follow a training program targeted neck and shoulder muscles and train 1 hour per week (3 x 20 min) for 26 weeks.
* The reference group will continue normal routines, including workout routines. They will later be offered the same training program as the Physical Exercise group provided that training has a positive effect.

Eligibility Criteria:
Inclusion Criteria:

* Employed within the Royal Danish Air Force
* Helicopter pilot
* Crewmember (Flight engineer, Rescue swimmer or Mission System Operator)
* Flown within the past 6 months

Exclusion Criteria:

* Grounded at time of inclusion
* Participated in a training intervention within the past 12 months
NBI-3001 Followed by Surgery in Treating Patients With Recurrent Glioblastoma Multiforme

RATIONALE: NBI-3001 may be able to locate cancer cells and stop them from growing. This may be an effective treatment for glioblastoma multiforme.

PURPOSE: Randomized phase II trial to compare different regimens of NBI-3001 followed by surgery to remove the tumor in treating patients who have glioblastoma multiforme.

OBJECTIVES: I. Determine the safety, tolerability, and optimal clinical dose of interleukin-4(38-37)-PE38KDEL cytotoxin (NBI-3001) followed by surgical resection in patients with recurrent glioblastoma multiforme.

OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients receive interleukin-4(38-37)-PE38KDEL cytotoxin (NBI-3001) intratumorally as a continuous infusion over 4-5 days beginning within 12-36 hours after ventricular catheter placement. Patients then undergo surgical tumor resection approximately 3 weeks after drug infusion. Cohorts of 6 patients receive escalating doses of NBI-3001 until the maximum tolerated dose is determined. Patients are followed within 1 week and then at 8, 16, and 26 weeks.

PROJECTED ACCRUAL: Approximately 30-36 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or progressive glioblastoma multiforme Previously treated with cytoreductive surgery Unilateral, unifocal tumor with a volume of 5-80 mL Not eligible for further radiotherapy due to prior external beam radiotherapy No multifocal, brain stem, or infratentorial tumor or tumor invading midline No tumor with a clinically significant mass effect (greater than 5 mm midline shift) while on stable dose of corticosteroid No clinical symptoms attributed to uncontrolled increased intracranial pressure and/or edema of the brain

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No focal or generalized seizure(s) within 30 days prior to enrollment No other prior or concurrent malignancy except carcinoma in situ of the cervix or basal cell or squamous cell skin cancer No medical instability due to non-malignant systemic disease No other prior or concurrent condition that would preclude study compliance Not pregnant Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior antineoplastic chemotherapy Endocrine therapy: See Disease Characteristics Stable dose of dexamethasone for at least 72 hours prior to catheter placement Radiotherapy: See Disease Characteristics No prior radiosurgery boost (e.g., gamma knife or stereotactic radiosurgery) At least 8 weeks since prior radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior craniotomy
Does Adding Lidocaine to Corticosteroid Injections Reduce Pain Intensity in Hand Surgery

The purpose of this study was to determine whether adding Lidocaine to Corticosteroid injections reduce pain intensity in hand surgery.

There is a lack of evidence about the use of lidocaine injection as an addition to steroids against pain during injections. Adding lidocaine adds to the volume of the injection, which might increase pain. It's possible that injecting cortisone without any lidocaine would be more comfortable than with lidocaine.

The aim of this randomized controlled trial is to assess the difference in pain intensity (during the injection and 4 hours later) between patients receiving a corticosteroid injection with or without lidocaine in patients with a hand condition. Secondarily, the aim of this study is to assess factors independently associated with pain intensity, satisfaction with the visit, and perceived empathy.

Eligibility Criteria:
Inclusion Criteria:

* All patients offered a steroid injection in a hand surgeon's office
* Aged 18-89 years
* English speaking patients
* Able to provide informed consent

Exclusion criteria:

* Non-English/Spanish speakers
The Effect Nature Sounds and Music on Hemodialysis Patients

The study was conducted as a randomized controlled experimental research to examine the effect of nature sounds and music on vital signs and anxiety levels of hemodialysis patients.

The study was conducted between September 6, 2019 and March 21, 2020 with 75 patients who received treatment in the hemodialysis units of three hospitals, one university, one education research and one state hospital in Antalya province, met the inclusion criteria and consented to participate in the study. Patients were homogenously divided into intervention (nature sound group n=25 and music group n=25) and control (n=25) groups on the basis of age, gender and hemodialysis duration. Patients in the intervention group were subjected to nature sounds/music during the hemodialysis procedure, while patients in the control group were not subjected to any intervention during the procedure. The data were collected by face-to-face interview technique using the "Descriptive Characteristics Form", "Vital Signs Monitoring Form", "State Anxiety Inventory" and "Trait Anxiety Inventory". Ethics committee approval, institutional permissions and written consent of the patients were obtained for the implementation of the study. Number, percentage, mean, standard deviation, minimum and maximum, the the Shapiro Wilk normality test, One-Way Analysis of Variance, Chi-Square tests, the Kruskal Wallis test, Dunn-Bonferroni test, Tukey HSD, Three-Way Analysis of Variance and Bonferroni Corrected Two Ratio Z test were employed in the evaluation of the data.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Age range between 18 and 79,
* Receiving HD treatment for at least six months,
* Receiving three sessions of HD treatment per week on a regular outpatient basis at the same institution.

Exclusion Criteria:

* Any problem that prevents cognitive, affective and verbal communication,
* Having any psychiatric condition,
* Use of anxiolytic medication,
* Out of the criteria for inclusion in the study,
Predictability of Part-time Wearing of Removable Clear Aligner Therapy Versus Full Time

14 Patients with mild to moderate crowding and spacing will be selected according to inclusion criteria.

Treatment planning will be done on Maestro® software. An impression will be taken and scanned by an extra-oral scanner. The models will be 3D printed and aligner trays will be fabricated to be delivered on biweekly basis to be worn 16 hours per day for one group and 22 hours for the other group. Superimposition of the achieved clinical model over the predicted model will be done. Linear and angular measurements will be calculated for each tooth.

Clear removable retainers could be related to clear aligners. Wearing time of retainers has been suggested that it could be changed from full time to part-time during the night only. A similar approach could be done to determine the effect of wearing time of clear aligners on treatment outcome. The standard duration per day for wearing the appliance is 22 hours. However, is part-time wearing (16 hours) would have the same effect? Therefore, a randomized clinical trial is needed to compare the effect of partial wearing of the aligner versus full time. Moreover, studying the predictability and accuracy of treatment using Maestro software.

Eligibility Criteria:
Inclusion Criteria:

1. Permeant dentition
2. Mild to moderate crowding and spacing in maxilla and mandible according to Little's Irregularity Index
3. Non-extraction cases

Exclusion Criteria:

1. Severe crowding and spacing
2. Systematic diseases
3. Compromised periodontal health
4. Craniofacial syndromes
Chronic Pain Dynamic Psychophysical Tests and Genetic Screening

Incidence and risk factors for persistent post surgical pain after Caesarean section are investigated. Demographic, psychophysical testing and genetic screening factors are performed in the perioperative period. Phone survey is performed to investigate the incidence of persistent post surgical pain after Caesarean section.

Persistent post surgical pain after Caesarean section may lead to functional limitation and pain during activities of daily living. Demographic factors, psychophysical factors (mechanical temporal summation, diffuse noxious inhibitory control, state trait anxiety inventory) and genetic screening are used to predict the association with persistent post surgical pain. Phone survey follow up is performed to investigate the incidence of persistent post surgical pain and functional limitations due to pain experienced.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing spinal anaesthesia for Caesarean section

Exclusion Criteria:

* Failed spinal anaesthesia, Unable to perform psychophysical testing.
The Role of Auricular Point Diagnosis and Treatment in ERAS During TKA

To further improve the surgical outcomes of patients undergoing total knee arthroplasty (TKA). This study aims to use ear acupoint therapy to address the following clinical issues: 1 The degree of postoperative inflammation and edema in the patient; 2. Patient pain; 3. Patient functional recovery. 4. Surgical scar repair for patients; 5. Patient perioperative anxiety and postoperative satisfaction. Exploring the safety and effectiveness of ear acupoint therapy in the postoperative application of TKA, leveraging the advantages of suitable traditional Chinese medicine techniques in simplicity, convenience, effectiveness, and cost-effectiveness, and further improving the ERAS Chinese and Western medicine collaborative plan for TKA.


Eligibility Criteria:
Inclusion Criteria:

1. Age 50-80 years old, no gender limit;
2. Meet the late diagnostic criteria for knee osteoarthritis and meet the surgical indications for TKA;
3. The patient's auricles of both ears are intact
4. The subject/guardian makes it clear that the patient will choose to go to a medical consortium hospital for standardized medical treatment after surgery.

   Repeat treatment.
5. Subjects/guardians can understand the purpose of the trial and show sufficient compliance with the trial protocol,and signed the informed consent form (ICF).

Exclusion Criteria:

1. Suffering from severe arrhythmia, heart failure, chronic obstructive pulmonary disease, epilepsy, mental illness sick;
2. The patient's ears are damaged, red, swollen, bleeding, infected, etc. and have contraindications that are not suitable for auricular acupoint diagnosis and treatment.
3. Patients with knee varus \>15° or valgus before surgery;
4. Other circumstances in which the researcher deems it inappropriate to participate in this clinical trial.
Antiretroviral Regime for Viral Eradication in Newborns

This is a multi-center, randomized, controlled, open clinical trial. The trial will be carried out in five provinces in China. Pregnant women with HIV infection and at high risk of mother-to-child transmission of HIV will be identified. Their newborn babies who are at high risk HIV infection will be recruited and randomized into intervention and control groups. Children in intervention groups will receive ART and intensive HIV testing after birth. Children in control group will receive routine prevention of mother-to-child transmission services. All the included children will be followed up and their development and infection status will be recorded and compared.


Eligibility Criteria:
Inclusion Criteria:

* children whose mother with HIV infection
* children whose mother received antiretroviral drugs after 36 gestational weeks or received no drugs before delivery
* live birth

Exclusion Criteria:

* birth weight is less than 2000g
* Apgar score is less than 3 at 1 minute after birth or less than 6 at 5 minute after birth .
Metabolic Pathway Analysis in Intensive Care Unit Patients With Refeeding Syndrome

The overall aim of the study is to improve understanding of refeeding syndrome (RFS) in patients admitted to the intensive care unit (ICU) using metabolomics. Patients are included as part of a prospective multicenter observational study on phosphate disorders in the ICU. Blood samples are collected day 1-7 of ICU stay. Samples from patients who develop refeeding hypophosphatemia and matched controls without hypophosphatemia are analysed for metabolomics and proteomics. Untargeted analyses will be performed to identify the affected metabolic pathways. The investigators will also perform AUROC analyses to identify potential biomarkers for early detection of RFS.

A nested case-control study situated within GUTPHOS Part B: A prospective, multicenter non-interventional cohort study investigating the incidence of abnormal phosphate levels and associated outcomes in adult patients admitted to the ICUs of participating sites. Inclusion/exclusion criteria for GUTPHOS Part B are described in the separate study protocol.

At sites participating in the nested substudy, an additional 2 ml EDTA blood sample is drawn once daily in all patients included in GUTPHOS Part B from ICU admission up to a maximum of calendar day 7 in ICU. The sampling for metabolomics analysis should be performed in close proximity with daily routine blood tests, and always before treatment of hypophosphatemia with phosphate supplementation or restricted nutritional intake. Plasma samples are obtained through centrifugation within 20 minutes and frozen to -80 degrees Celcius within 60 minutes until analysis. The timing and handling of samples according to standard operating procedures will be documented on a separate case report form.

In ICU patients diagnosed with refeeding hypophosphatemia, comprehensive metabolomic profiling is performed in the plasma sample from ICU admission and the sample drawn in conjunction to the blood phosphate measurement diagnostic of RH.

Cases with RH are matched in a 1:1 ratio to ICU patients without RH. Controls are matched according to sex, age, illness severity on admission and energy delivery (kcal/kg adjusted body weight) in the 24 hours preceding the diagnosis of RH.

Refeeding hypophosphatemia is defined as new onset hypophosphatemia (\<0.65 mmol/L) within 72 hours from the start of medical nutrition therapy, with a drop of \>0.16 mmol/L from any previous Pi value during ICU stay and where no other likely cause of hypophosphatemia is present.

Eligibility Criteria:
Inclusion Criteria:

* Admission to ICU during the study period
* Age ≥18 years

Exclusion Criteria:

* Age \<18 years
* Patients with restrictions of care such as "no intubation" or "no renal replacement therapy" on ICU admission and patients admitted for treatment as organ donors
* Continuous chronic home ventilation for neuromuscular disease;
* Declined participation or informed consent (if the local ethics committee requests the latter for this non-interventional study);
* Readmission to ICU during the study period
Multi Neuro-functional Biomarkers for Monitoring the Effects of Treatments in ADHD Children

MIMOSA study aims to characterize from behavioral, neurophysiological and neurocognitive perspectives children and adolescents with attention deficit hyperactivity disorder (ADHD), in order to identify a possible biomarker of response to medication treatments. To achieve this aim, in the study children with ADHD (drug naive) are recruited and undergo behavioral and clinical screenings, neurocognitive profile, and neurophysiological evaluation with functional near infrared spectroscopy (fNIRS). ADHD group is evaluated before the beginning of medications, at first dose of medication (only imaging evaluation fNIRS), and after a period of two/three months of continuous treatment with medication.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of ADHD according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) criteria;
* drug naive

Exclusion Criteria:

* presence of intellectual disability, neurological diseases, epilepsy, genetic syndromes
* and previous treatment with psychoactive drugs
Healthcare Provider Human Papillomavirus Education and Professional Skills Intervention

Healthcare providers (HCP) serving the El Paso U.S.-Mexico Border Region will be recruited to compare educational and professional skills interventions focused on the human papillomavirus (HPV). Our hypothesis is that improving provider knowledge and communication strategies about HPV and its vaccine will reduce hesitancy and increase uptake and completion among the populations they serve.

A sample of emerging \[in training\] and current \[in practice\] health professionals from the El Paso U.S.-Mexico Border Region will be recruited to participate in a human papillomavirus (HPV) educational and professional skills intervention. Hypothesis: improving provider knowledge and communication strategies about HPV and its vaccine will reduce hesitancy and increase uptake and completion among eligible individuals through a tailored multi-media intervention to strengthen providers' ability to discuss HPV and vaccination in an informed and culturally competent manner, and increase subsequent provider recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Current (in practice) or emerging (in training - medical student, resident, or fellow) healthcare provider
* Working/training or living in the El Paso U.S.-Mexico Border Region (i.e., El Paso County, TX-Southern New Mexico)
* Have the authorization to recommend/prescribe/administer the HPV vaccine

Exclusion Criteria:

* Unaffiliated with the El Paso U.S.-Mexico Border Region (i.e., El Paso County, TX-Southern New Mexico)
* Participation in Phases I or II of the larger research project \[cross-sectional phases\]
* Does not identify as a current or emerging healthcare provider
* Declines or is unable to participate in the full intervention and follow-up time-points
* Unable to complete participation and activities in the English language
Comparison of Postoperative Pain and Neuropathy at Cesarean Sectio With Blunt or Sharp Fascia Incision

The purpose of this study is to compare sharp and blunt fascial entry during caesarean section.

The patients will be divided into two group, The fascia will be opened with a sharp scissors in first group (group1), on the other hand in group 2 fascia distracted from the muscle tissue with a blunt maneuver. The study is planning to perform on women having cesarean section for the first time in their life and who have not previously had lower abdominal surgery before. The following parameters are evaluated for each patients

1. All patients are evaluated for postoperative pain with VAS score when they first mobilized and following postoperative1, 3 and 7 days; 1 and 3 months 2. Postoperative sensory loss on skin incision scar, lower abdomen, pelvic region, groin, inner thigh, and labia majus

Eligibility Criteria:
Inclusion Criteria:

* Woman having caesarean section for the first time
* Woman, who have had no previous lower abdominal surgery
* Woman who can give informed consent

Exclusion Criteria:

Diabetes Mellitus (This does not include gestational diabetes)

* Infection
* Regular treatment with immunosuppressives
* Alcohol or drug abuse
* Age under 18 years old
* Chronic pain disease eg. fibromyalgia, rheumatoid arthritis
* BMI over 35
Drug Use-results Survey in Patients Infected With Hepatitis C Virus Genotype 1

The main objective of this study is to evaluate the safety and effectiveness of paritaprevir/ritonavir/ombitasvir used for patients infected with HCV genotype 1 in daily practice in Japan.


Eligibility Criteria:
Inclusion Criteria:

* HCV genotype 1 patients treated with paritaprevir/ritonavir/ombitasvir in daily practice

Exclusion Criteria:

* Patients who have been previously treated with paritaprevir/ritonavir/ombitasvir
Identification of Novel Biomarkers to Aid in the Detection of Occult Cancer in Patients With Venous Thromboembolism

Venous thromboembolism is a common and serious complication in cancer, and is associated with a substantially increased morbidity and mortality. Furthermore, VTE may be the earliest sign of cancer. Recent studies, however, fail to show a clinical benefit of extended cancer screening in this patient population. Better risk prediction models are therefore warranted to identify VTE patients who would benefit from a rapid and extensive cancer screening. Inflammation and hypercoagulability are considered hallmarks of cancer, and emerging light is being shed on the potential of various markers of inflammation and coagulation in cancer diagnostics and prognostics. Among the inflammatory and thrombotic processes linked to cancer is the neutrophil release of web-like nuclear chromatin (DNA and histones), referred to as neutrophil extracellular traps (NETs). Driven by the tumor environment, NETs have recently been shown to play a central role in tumor progression, metastasis, and tumor-associated thrombosis.

The investigators hypothesize that an enhanced inflammatory state may be predictive of an underlying cancer in patients presenting with VTE. The present study is an ongoing prospective study with the primary aim to investigate the diagnostic potential of markers of inflammation, including markers of NETs, in detecting occult cancer in patients presenting with VTE. Secondary aims are to include other biomarkers of cancer, and to assess whether any or a combination of these biomarkers may be prognostic of occult cancer, recurrent thrombotic events, mortality, or cancer disease progression in VTE patients with an underlying malignancy.


Eligibility Criteria:
Inclusion Criteria:

* Venous thromboembolism (thrombosis in the deep venous system of upper or lower extremities or iliac veins and/or pulmonary embolism) as detected by ultrasonography, phlebography, computer tomography, or angiography;
* \> 18 years or older;
* Written informed consent

Exclusion Criteria:

* \> 2 days after VTE diagnosis;
* No blood withdrawal at baseline