cyrilzakka/clinical-trials huggingface dataset:
Shoulder and Neck Mobilization in Patients With Subacromial Impingement Syndrome

Patients who come to Tavşanlı State Hospital's Physical Therapy and Rehabilitation Department and have been diagnosed with subacromial impingement syndrome by a physician will be included. Patients will be selected by randomization method among the patients determined by the physician to receive conservative treatment, shoulder mobilization in addition to conservative treatment, and neck mobilization treatment program in addition to these. Conventional treatments such as hot packs, TENS, ultrasound, and exercise will be given to all patients by the hospital staff. Pain intensity will be evaluated with VAS. Additionally, painful arch and pain-free joint range of motion evaluation will be made using a goniometer. The DASH questionnaire will be used to evaluate shoulder functionality. Sensory evaluation will be made with pressure pain threshold and two-point discrimination tests. Measurements will be made before the intervention and repeated after 3 weeks of intervention.


Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years of age
* Diagnosed with Subacromial Impingement
* Not having received any treatment for shoulder problems in the last 6 months
* The pain has been continuing for 3 months
* Initial pain must be 4 or higher on the Visual Analog Scale (VAS)

Exclusion Criteria:

* History of surgery in the shoulder, cervical and thoracic region
* Having a shoulder problem such as a frozen shoulder or instability
* Full-thickness rotator cuff tear
* Having systemic musculoskeletal disease
* Having systemic rheumatic disease
* History of upper extremity fracture
* Diagnosed with scoliosis
* Have neurological problems
Evaluation of Preoperative Anxiety Level Based on the Day of Admission for Cardiac Surgery

Prospective, observational, non-randomized study that evaluates the impact of the admission day (J-1 vs J-0) on preoperative anxiety in cardiac surgery patients.

The goal of this study is to determine whether the admission day (J-1 or J-0) has a significant effect on preoperative anxiety using the APAIS (Amsterdam Preoperative Anxiety and Information) scale and to identify modifiable factors to improve patient care.

This study includes 400 patients divided into two groups : 200 patients admitted the day before their surgery (J-1) and 200 patients admitted on the day of surgery (J-0).

Patients admitted for cardiac surgery at the University Hospital of Rennes will be invited to participate after verification of the inclusion criteria. A nurse or surgeon will explain the objectives and procedures of the study and provide the patient with an information and non-opposition letter. If the patient agrees, they will be included in the study, and the non-opposition form will be recorded in their medical file.

Patients will complete the questionnaire in two stages : upon admission and just before leaving for the operating room. The estimated time to complete the questionnaire is approximately 15 minutes, with 10 minutes for the first part and 5 minutes for the second part.

Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 years old
* Scheduled for cardiac surgery
* Have received written and oral information about the protocol
* Admitted to the cardiac and thoracic surgery units
* Not opposed to participating in the research.

Exclusion Criteria:

* Patient undergoing emergency cardiac surgery with no time for reflection
* Legal adults under legal protection (guardianship, curators, or legal protection)
* Pregnant or breastfeeding women, minors, individuals unable to express consent
* Patient on long-term anxiolytic treatment
* Patient with psychiatric disorders, cognitive impairments, or central neurological disorders.
* Patient already participating in an ongoing study in the department of Thoracic and Cardiovascular Surgery.
Interest of Virtual Reality on Anxiety Before the Planning CT Scan in Radiotherapy

In France, according to the National Cancer Institute, it appears that treatments in radiotherapy centers for cancer will increase from 198,000 in 2015 to 239,000 in 2030: this represents 40,000 additional treatments in 15 years.

A meta-analysis on radiotherapy indicated that 10 to 20% of patients had clinically significant levels of anxiety at the beginning of radiotherapy.

Indeed, several factors generate this tension, above all the new or unfamiliar environment, the imposing and noisy scanner, the restraints that are difficult to bear or the nudity required for the examination.

This anxiety has an impact on performance of the planning CT scan examination, an essential step for the future treatment.

The radiotherapy unit of the Centre Hospitalier Departemental de Vendee has put in place resources to reduce anxiety felt during treatment sessions (music therapy, conversational hypnosis, sophrology or aromatherapy). However, nothing has been put in place to reduce the anxiety of patients in the period preceding the planning CT scan.

Virtual reality software seems to be a good alternative that requires fewer human resources.

The research hypothesis is that patients who have benefited from the virtual reality software will have a lower level of anxiety before the planning CT scan than patients who have not benefited from virtual reality.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with an indication for first radiotherapy treatment for breast or pelvic cancer (prostate, rectum, endometrium, anal canal and cervix)
2. Patient ≥ 18 years old,
3. Patient who has the capacity to understand the protocol and has given written consent to participate in the research,
4. Patient with social security coverage.

Exclusion Criteria:

1. Metastatic patients
2. Patients with previous radiotherapy
3. Patients with a diagnosis of hearing impairment
4. Patients with major cognitive disorders (such as dementia)
5. Psychiatric pathology such as schizophrenia
6. Patients with epilepsy or hypersensitivity to flashing lights
7. Patient with a pacemaker, hearing aid or defibrillator
8. Claustrophobic patients
9. Patients sensitive to motion sickness
10. Patients who are visually impaired or blind
11. Patients with migraine
12. Patients with skin defects and open wounds in the area where the helmet is applied (face or scalp) or in the eyes
13. Patients under guardianship, curators or deprived of liberty
14. Non French speaking patient
15. Illiterate patient
16. Patient participating in another clinical investigation or interventional clinical research protocol involving a drug
17. Pregnant or breastfeeding patient
Accelerating Cognitive Gains From Digital Inverventions With Noninvasive Brain Stimulation

The overall goal of this project is to collect pilot feasibility and early efficacy data showing improvements in cognition and wellbeing in adults with mild cognitive impairment (MCI) through a combination treatment of non-invasive brain stimulation (transcranial alternating current stimulation (tACS)) and a one of two digital cognitive interventions.


Eligibility Criteria:
comfortably ambulatory healthy physical condition normal or corrected to normal visual auditory acuity fluency in spoken English Between 60-85 years old No neurological or psychiatric disorders No substance abuse Not taking anti-depressants Not taking anti-anxiety medication No history of seizures No color blindness No glaucoma No macular degeneration No amblyopia (lazy eye) No strabismus (cross eyed) Aneurysm clip(s) No Cardiac pacemaker No Implanted cardioverter defibrillator (ICD) No Electronic implant or device No Magnetically-activated implant or device No Neurostimulation system No Spinal cord stimulator No Internal electrodes or wires No Bone growth/bone fusion stimulator No Cochlear, otologic, or other ear implant No Insulin or other infusion pump No Implanted drug infusion device No type of prosthesis (eye, penile, etc.) No Heart valve prosthesis No Eyelid spring or wire No Artificial or prosthetic limb No Metallic stent, filter, or coil No Shunt (spinal or intraventricular) No Vascular access port and/or catheter No Radiation seeds or implants No Swan-Ganz or thermodilution catheter No Medication patch (Nicotine, Nitroglycerine) No metallic fragment or metallic foreign body in/on the body that can not be removed No Wire mesh implant No Tissue expander (e.g., breast) No Surgical staples, clips, or metallic sutures No Joint replacement (hip, knee, etc.) No Bone/joint pin, screw, nail, wire, plate, etc. No IUD, diaphragm, or pessary No Dentures or partial plates that can not be removed No Tattoo or permanent makeup No Body piercing jewelry No Claustrophobia
Sequential Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of TB006 in Healthy Subjects

This is a single dose, dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of TB006, a monoclonal antibody that will be studied as a disease modifying treatment for Alzheimer's disease.

The TB006 nonclinical pharmacology program establishes its potential as a therapeutic agent for AD. Overall, the data suggest the potential for beneficial therapeutic effects of TB006 in addressing underlying pathology and ameliorating the course of AD. The preclinical safety profile of TB006 further supports the clinical investigation of TB006. This is a Phase 1 SAD study in healthy adult subjects. The study will evaluate the safety, tolerability, and PK of single doses of TB006, administered as an IV infusion over 1 hour.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, male or female 18-55 at the time of informed consent
* In good health as determined by the principal investigator
* Body weight of ≥ 50 kg and BMI within the range 18-30 kg/m2 (inclusive).
* Chinese subjects are eligible to be included in the study if all of the following criteria apply in addition to the above: Must have been born in China, with 2 Chinese biological parents and 4 Chinese grandparents as confirmed by interview; Must have lived no more than 10 years outside of China; Must not have changed their lifestyle or habits significantly, including diet, since leaving China.

Exclusion Criteria:

* Any current history of clinically significant disease in the opinion of the investigator or receiving maintenance medications on a daily basis.
* Any active or unstable clinically significant medical or psychiatric condition as judged by the investigator.
* Smokes cigarettes or uses other nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers), and has done so in the 3 months prior to screening.
* Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of \> 20 units for males or \> 16 units for females. One unit is equivalent to 8 glasses of alcohol: a half pint (∼240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
Utilizing Blood Volume Measurements in the Treatment of Heart Failure Patients

This will be a clinical test to determine if using blood volume measurements (BVM) to help guide fluid removal with ultrafiltration in patients hospitalized with decompensated heart failure leads to improved outcomes.

Subjects will be randomized into two groups. In the control group, the treating physician will not see the blood volume measurement results. In the experimental group, the physician will be given the blood volume measurement results. Ultrafiltration is performed based on the results of blood volume measurement in the experimental group followed by repeat blood volume analysis after 30 minutes of the completion of ultrafiltration. Clinical and laboratory assessment as per the standard of care will be used to assess overall fluid status, and blood volume measurement results will be used as the assessment of intravascular fluid. These assessments will be used to determine a goal quantity of fluid to be removed. All subjects will return for a clinical assessment at 30 and 90 days and laboratory data will be drawn at that time to evaluate renal functional indices, electrolytes and blood volume measurements.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of heart failure
* \>/= 2 criteria of volume overload

  1. JVD \> 7 cm
  2. Ascites
  3. Lower extremity edema
  4. Sacral Edema
  5. Pleural effusion by clinical or radiologic criteria
* CKD 3 or worse renal function ClCR \< 60 ml/min
* HCT \< 40%
* Serum Albumin \>/= 2.5 gm/dL
A Retrospective Study to Characterize Participants With Propionic Acidemia and Methylmalonic Acidemia

This is a non-interventional, global, multicenter, retrospective cohort study describing participant characteristics, clinical outcomes, and event rates in participants with propionic acidemia (PA) or Methylmalonic acidemia (MMA).

This study will abstract participants data from their medical records from approximately 2015-2025. All data will be abstracted retrospectively in 6-month increments.

Eligibility Criteria:
Abstraction Criteria:

Participants' medical records are eligible for abstraction only if all of the following criteria apply:

* Availability of evidence supportive of the participant having received a physician's diagnosis of PA or MMA due to MUT deficiency as indicated by documented evidence.
* Participant provided informed consent (and assent, as applicable).
* Participant has had at least one MDE in 2015 or later before eligibility assessment.

Censoring Criteria:

Participants medical records meeting the following censoring criterion will not be abstracted:

* Participation in a clinical study of mRNA-3927, mRNA-3705, or another investigational agent.
* Other reasons of censorship of data include:
* Withdrawal of consent
* Death
* Lost to follow-up
* End of study period
Quantifying Skin Oxygenation Properties in Normal vs Sun Exposed Skin

This research study aims to determine if there are differences in oxygen consumption between chronically sun exposed and less sun exposed skin. This study uses a new imaging device that can detection oxygenation properties skin in a non-invasive manner.

Sun and ultraviolet light exposure has both short term and long term effects on skin. While the short term effects, such as sunburn, are understood, chronic long-term sun exposure can cause changes to the skin that are not well characterized. One particular alteration may be how the skin consumes oxygen, a change that may be linked to biochemical alterations that have been observed in past studies. Measuring skin oxygen consumption has traditionally been difficult as the tools available have not been easy to incorporate into clinical studies. In this study, we overcome this barrier through the use of a new non-invasive oxygen-sensing device that can rapidly measure skin oxygenation properties such as oxygen consumption. This observational study will measure the oxygenation properties of both chronically sun exposed and less sun exposed skin in the predefined groups of both young and older men and women.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age groups: 20 - 30 and 55 - 65
* Fitzpatrick skin types I, II, III, and IV

Exclusion Criteria:

* Fitzpatrick skin types V and above
* Tattoo markings anywhere on the arm(s)
* Significant scarring or discoloration (e.g. birthmarks) on the arm(s)
* Any current injuries, infections or wounds on the arm(s)
* Routinely (4+ doses per week) take high dosages of anti-inflammatory drugs (e.g. aspirin, ibuprofen, corticosteroids), immunosuppressive drugs, or antihistamine medications. However steroid nose drops and/or eye drops are permitted.
* Has taken an anti-inflammatory drug (e.g. aspirin) within the prior 24 hours of the study visit.
* Have diabetes that is treated with injectable or oral insulin
* Have any other active or chronic skin problems on the arms
* Are currently participating in another skin care product study at this or any other facility
* Have participated in any type of skin product treatment study within the past 2 weeks
* Have or ever have had dermatographia
* Pregnant women
* Lactating women
Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).

The primary objective of the study is to evaluate the effect of BG00012 on lymphocyte subset counts during the first year of treatment in subjects with relapsing-remitting multiple sclerosis (RRMS). A secondary objective is to evaluate the pharmacodynamic effect on absolute lymphocyte counts (ALCs) and immunoglobulins (Igs) during the first year of treatment.


Eligibility Criteria:
Key Inclusion Criteria:

* Subjects of childbearing potential (including female subjects who are post-menopausal for less than 1 year) must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
* Must have a confirmed diagnosis of RRMS according to the revised McDonald criteria (2010) \[Polman 2011\]

Key Exclusion Criteria:

* History of or positive test result at Screening for:
* human immunodeficiency virus
* hepatitis C virus antibody
* hepatitis B infection
* Drug or alcohol abuse within 1 year prior to Screening.
* Prior treatment with any of the following:
* cladribine
* mitoxantrone
* total lymphoid irradiation
* alemtuzumab
* T-cell or T-cell receptor vaccination
* any therapeutic monoclonal antibody, with the exception of natalizumab or daclizumab
* Treatment with any of the following medications or procedures within 6 months prior to Baseline (Day 1):
* DMF (given as Fumaderm®) or BG00012; enrollment will be limited to no more than 40 subjects (out of 200) with prior DMF exposure
* cyclosporine
* azathioprine
* methotrexate
* mycophenolate mofetil
* intravenous (IV) Ig
* plasmapheresis or cytapheresis

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody

The purpose of this study is to test 89Zr-DFO-daratumumab, a new imaging agent, to demonstrate its safety and ability to take pictures of the myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Age 21 years or greater
* Histologically/Immunohistochemistry confirmed CD38-positive multiple myeloma
* At least one tumor lesion on CT, MRI, or FDG PET/CT within 60 days of protocol enrollment
* ECOG performance status 0 to 2
* For Phase II patients only: plan for initiation of standard-of-care daratumumab/lenalidomide therapy.

Exclusion Criteria:

* Life expectancy \< 3 months
* Pregnancy or lactation
* Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
* History of anaphylactic reaction to humanized or human antibodies or a Grade 3 or 4 administration reaction during a daratumumab administration.
Home Usage of Conception Kit Instructions

Patients will use the Conception Kit in their home and fill out a 22 question questionnaire in order to demonstrate their knowledge of the method of usage as described in the instructions and on the website: www.conceptionkit.com.

Patients will be given a Conception Kit and take the Kit home and read the instructions and if needed consult the website. The patient will then complete a 22 question questionnaire in order to demonstrate their knowledge of the method of use.

All Components have 510K clearance. This study is a validation of the instructions for use (IFU) only.

OPK Class I Device 21CFR 862.1485, Conception Cap K993953, Pregnancy Test Kit K974059, Semen Collection Device K902936 (21CFR 884.5300),

Conception Kit has CE Marked by GMED. (Certificate 2037)

Conceivex is an ISO 13485: 2003 company

Eligibility Criteria:
Inclusion Criteria:

* Women who are actively trying to become pregnant

Exclusion Criteria:

* Women who are contraindicated for a pregnancy
Communication Practices to Develop the Health Literacy Competencies in Nursing Students

Communication is a key health literacy educational competency in the professional training of health providers. However, students often have difficulty in applying theoretical communication models to the reality of clinical practice. Multimodal interventions based on simulation models emerge as an essential element to overcome this gap. During the simulation training, students must be aware of their communication errors and the needs that patients share in a clinical interaction.

The aim is to evaluate the effectiveness of multimodal training, which incorporates a systematic feedback guide about the student's clinical interview simulation performance, as a training complement to classical education to improve health literacy competencies and clear communication practices in health sciences students.

A randomized controlled trial will be conducted on 82 second-year nursing students recruited from the University of Cadiz. The experimental and control groups will receive the same communication multimodal training except for the inclusion of feedback on key aspects of communication for health literacy, which the experimental groups only used. Students will be assessed through clinical interview simulations by external observers. Bivariate and inferential statistical analyses will be carried out.


Eligibility Criteria:
Inclusion Criteria:

* Second-year nursing students at the University of Cadiz enrolled in the Interpersonal Communication Skills subject.

Exclusion Criteria:

* Absence in training.
* Does not consent to participate in the study.
Prevalence of BRCA1 and BRCA2 Mutations in Ovarian Cancer Patients in the Gulf Region

A prospective, multi-centre, epidemiological observational study designed to evaluate the prevalence of BRCA1 and BRCA2 (BReast CAncer gene) mutations in current and newly diagnosed ovarian cancer patients across different countries in the Gulf region. This study will also describe the epidemiological features for the disease for the enrolled patients.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects willing to sign the informed consent form (ICF)
2. Female subjects 18 years of age or older
3. Have histologically confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) ovarian epithelial, primary peritoneal cancer made by one or more of the following:

   1. Standard staging laparotomy including bilateral salpingo-oophorectomy,omentectomy, and lymph node sampling and debulking and/or
   2. Surgical resection and radiographic evidence consistent with ovarian cancer
   3. Paracentesis or biopsy with radiographic evidence consistent with ovarian cancer(normal appearing pancreas, liver, and gastrointestinal tract).
4. Have availability of paraffin-embedded archived tumor tissue block (preferred) or, if a block is not possible, a minimum of twenty 10-um sections.

Exclusion Criteria:

Patients who meet any of the following criteria are ineligible to participate in the study and hence will not be consented:

1. The diagnosis is not of a primary ovarian cancer; thus, patients will be excluded if a previous cancer has metastasized to the ovary, or if there is a secondary malignancy that is associated with the ovarian cancer.
2. Is not able or willing to provide written informed consent.
3. Have a diagnosis of other severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of the study.
4. Be a patient who, in the judgment of the Investigator, would be inappropriate for enrollment in this study.

A rationale will be documented for all patients who are screened and ultimately excluded from the study as a result of meeting any of the aforementioned exclusion criteria