cyrilzakka/clinical-trials huggingface dataset:
Physical and Cognitive Effects of Fluoroscopy

Background and objectives:

The researchers will perform this study to reveal the clinical meaning of fatigue, headache, diarrhea, and impaired cognitive functions that are often expressed verbally in healthcare professionals who are exposed to fluoroscopy.

Methods:

After obtaining written informed consent, 84 samples will be included in the study. For operating room employees who meet the criteria determined before and after the operation; mini-mental state examination, weight, heart rate, non-invasive blood pressure value, VAS score for headache, radiation exposure time on fluoroscopy device, Rad measurement with the help of personal dosimeter before and after surgery, and total time in the operating room will be recorded.

Background and objectives:

Nowadays, operations under fluoroscopy are performed at increasing rates with the aim of increasing case management and surgical success. Due to this increasing exposure to radiation, it is important to show that fluoroscopy has an impact on employees not only annually but also daily. The researchers will perform this study to reveal the clinical meaning of fatigue, headache, diarrhea, and impaired cognitive functions that are often expressed verbally in healthcare workers who are exposed to fluoroscopy.

Methods:

After obtaining written informed consent; 84 samples consisting of orthopedic surgery and anesthesia residents and orthopedic operating room nurses between the ages of 18-60 who do not have cardiological, neurological and psychiatric diseases, have had fluoroscopic operations lasting more than 2 hours, wear protective scopy gowns and collar during surgery, will be included in the study. The total number of samples required for the study will be reached by taking repeated measurements on consecutive days from the same sample group, but not on the same day. For operating room employees who meet the criteria determined before and after the operation; mini-mental state examination, weight, heart rate, non-invasive blood pressure value, VAS score for headache, radiation exposure time on fluoroscopy device, Rad measurement with the help of personal dosimeter before and after surgery, and total time in the operating room will be recorded. This prospective study will be executed between December 2020 and June 2021.

Eligibility Criteria:
Inclusion Criteria:

1. Volunteering to participate in the study
2. ASA classification 1 or 2
3. Not leaving the operating room during the operation
4. To be carrying a fluoroscopy gown, protective collar, and dosimeter.

Exclusion Criteria:

1. Having a psychiatric illness
2. Having a neurological disease
3. Being under the age of 18
4. Presence of cardiac pathology
5. Being pregnant or suspected of pregnancy
A Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium Given With a Fixed Dose of Docetaxel and Prednisone in Patients With Metastatic Prostate Cancer

This aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose) when combined with a fixed dose of docetaxel and concomitant prednisone. This study will also characterize the pharmacokinetics of elesclomol and docetaxel.

This aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose) when combined with a fixed dose of docetaxel and concomitant prednisone. This study will also characterize the pharmacokinetics of elesclomol and docetaxel.

Eligibility Criteria:
Inclusion Criteria

* Confirmed metastatic prostate cancer
* No more than one prior chemotherapy on which the disease progressed
* ECOG performance status of less than or equal to 2
* Adequate bone marrow, renal and hepatic functions as defined in the protocol
* Neuropathy less than or equal to 2
* Reliable venous access for frequent study drug infusions

Exclusion Criteria

* Significant cardiovascular disease
* Known active brain metastases
* Subjects that have received treatment for other malignancies with in the past 5 years
* Other clinically significant uncontrolled conditions
Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)

The purpose of this study is evaluate the efficacy of pemigatinib in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation who have failed at least 1 previous treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed cholangiocarcinoma.
* Radiographically measurable or evaluable disease per RECIST v1.1.
* Tumor assessment for FGF/FGFR gene alteration status.
* Documented disease progression after at least 1 line of prior systemic therapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Life expectancy ≥ 12 weeks.

Exclusion Criteria:

* Prior receipt of a selective FGFR inhibitor.
* History of and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.
* Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination.
* Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug. Topical ketoconazole will be allowed.
Efficacy, Safety, and Pharmacokinetic Profile of Etokimab (ANB020) in Adult Participants With Moderate-to-Severe Atopic Dermatitis

This study is designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profiles of multiple doses of etokimab in adult participants with atopic dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants must be 18 to 75 years of age, at the time of signing the informed consent.
2. Body mass index (BMI) of 18 to ≤ 35 kilogram per square meter (kg/m\^2) at screening.
3. Clinically confirmed diagnosis of AD.
4. Eczema Area and Severity Index (EASI) score ≥ 16, body surface area (BSA) involvement ≥ 10%, and an Investigator's Global Assessment (IGA) score (5-point scale) ≥ 3 at baseline.
5. Participants with a history of inadequate response to topical treatment, use of systemic treatments to treat AD, and/or for whom topical treatments are otherwise medically inadvisable.
6. Daily use of non-medicated emollient for at least 7 days prior to baseline.

Exclusion Criteria:

1. Treatment with topical corticosteroids, topical calcineurin inhibitors, or crisaborole within 2 weeks before dosing.
2. Prior exposure to an anti-interleukin (IL)-33 antibody.
3. Exposure to an investigational or licensed or other anti T-helper 2 (Th2) type cytokine or cytokine receptor antagonist within 16 weeks or 5 half-lives, whichever is longer.
4. History of prior exposure to any investigational or biologic systemic treatment within 5 half lives of the screening or is currently enrolled in another clinical study.
5. Have received systemic treatment for AD (including systemic corticosteroids, immunosuppressants or immunomodulating drugs, or phototherapy or use of a tanning booth) within 4 weeks before screening.
6. History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Cevimeline 30 mg under fed conditions


Eligibility Criteria:
Inclusion Criteria:

- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to cevimeline or any comparable or similar product.
Computer Presented and Physical Exercises to Maintain Cognitive Function and Emotional Health in Older Adults

The aim of this study is to investigate and compare how 18-weeks of computer-based brain training and physical exercise together can improve physical performance, cognitive function and mood in older adults in a cross-over design with participants randomized to receive the intervention first and then be assessed before and after an 18 week period without intervention, or the reverse sequence.

The aim of this study is to investigate and compare how 18-weeks of computer-based brain training and physical exercise together can improve physical performance, cognitive function and mood in older adults in a cross-over design with participants randomized to receive the intervention first and then be assessed before and after an 18 week period without intervention, or the reverse sequence. 80 adults between the ages of 65 and 105 years old will be invited to participate. After providing informed consent, in the case of subjects who are living on units for individuals with memory or other cognitive compromise, after assent from the individual and approval from facility staff, subjects will be randomly assigned to either receive the intervention for 18 weeks and then be followed for an additional 18 weeks, or to be followed for 18 weeks without intervention and then do the intervention for 18 weeks. The intervention will consist of 18 weeks of 60-minute PE sessions 3-4 times/week and 25-minute CBB training sessions 3-4 times a week.

There will be 3 assessments of participants: before and after the first 18-week period and then again after the second 18-week period. Assessments will be done in 2 sessions over a total of 90 minutes and will include demographic, health, physical activity and social activity questionnaires as well as the self-report measures of cognitive function, emotional state and weekly activities; quantitative assessments of physical balance, strength, flexibility blood pressure and heart rate; and tests of cognitive function. Subject medications will be recorded at each assessment. The wait-list control group will receive the same assessments at the same time points.

Eligibility Criteria:
Inclusion Criteria:

* Associated with Whitney center as residents or participants in non-resident programs.
* Able to understand and read English.

Exclusion Criteria:

* Not able to sit in a chair independently.
* Not able to move both arms in simple movement sequence.
* Hearing and vision insufficient to do the computer exercises or follow the PE instructions.
* Not able to remember 3 movements in succession.
Quality of Life of Patients With Psoriasis Treated With Methotrexate: Prospective, Randomized, Double-blind, Parallel Group Study.

Methotrexate (MTX) is considered the 'gold-standard' drug for the treatment of severe psoriasis. Health-related quality of life (HRQOL) is impaired in patients with psoriasis, more so if disease is severe.


Eligibility Criteria:
Inclusion Criteria:

Age range 18 to 65 years Both sexes Severe plaque-type psoriasis (BSA \>10% or PASI \>12) -

Exclusion Criteria:

Pregnancy Lactation Malignancy or immunosuppression including HIV Liver disease Renal disease Non compliant Psychiatric illness Hypersensitivity to methotrexate in the past

-
Kinesiological Taping in Individuals with Meniscus Injury

This study aims to explore how kinesiology taping affects people with mild to moderate meniscus injuries (grades I/II), focusing on pain, movement fears, muscle strength, balance, joint movement, and quality of life.

Two groups will be involved: one will receive kinesiology taping on the thigh muscle with some tension, while the other will receive a placebo tape with no tension. Researchers will measure various factors, including pain and muscle strength, both before and 48-72 hours after taping.

This study aims to understand the short-term (acute) effects of kinesiology taping on people with mild to moderate meniscus injuries (grade I/II). These injuries, affecting the cartilage in the knee, can cause pain, reduced mobility, and fear of movement. Kinesiology taping, a popular therapy, involves applying elastic tape to support muscles and joints. This research looked at whether taping could improve pain, muscle strength, movement, balance, and quality of life in patients with these knee injuries.

Study Design The study will use a randomized, placebo-controlled, and double-blinded design, meaning that patients were randomly assigned to two groups, and neither the patients nor the researchers knew which group each person was in during the treatment.

Experimental Group: will receive kinesiology taping on the quadriceps muscle (the large muscle at the front of the thigh) using a 'Y-shaped' technique with moderate tension (25-50% stretch).

Control Group: will receive a placebo tape applied without tension and placed in a different direction.

Measurements

To evaluate the effects of taping, several aspects will be measured both before the tape was applied and 48-72 hours later:

Pain levels Fear of movement (kinesiophobia) Muscle strength (ability to extend the knee) Proprioception (awareness of limb position and force applied) Joint range of motion (how much the knee can bend and straighten) Joint position sense (accuracy in detecting knee position with eyes closed) Quality of life, using a questionnaire (SF-36) that assesses various aspects like physical function and energy levels.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with meniscus grade I/II,
* Who agreed to participate in the study
* Signed the voluntary consent form

Exclusion Criteria:

* Pregnant individuals
* Individuals with additional knee injuries (e.g., ligament tears) or chronic conditions affecting the knee (e.g., arthritis).
* Patients with grade III meniscus tears or more severe injuries.
* Who had knee surgery in the last 6 months.
* Patients with skin conditions or allergies to adhesive materials or kinesiology tape.
* Individuals with neurological conditions such as multiple sclerosis
Effect of Mobile Phone Addiction With Forward Head Posture on Pain and Cervical Functions

to investigate the effect of mobile phone addiction with forward head posture on the endurance of deep neck flexor muscles, respiratory functions, pain pressure threshold , and neck functional disability level.

Nowadays, the mobile phone has become an important requirement. The number of mobile phone users and the duration of mobile phone use are increasing rapidly, and the side effects can be detrimental one of them is forward head posture.

Prolonged use of the mobile phone has also affected posture, resulting in many musculoskeletal disorders or improper posture. Neck posture, particularly in a sitting position, is regarded an essential contributing factor to the development and long-term maintenance of cervical pain and headache. Neck flexed posture increased due to the frequent use of the relatively small screen of a mobile phone compared to that of a desktop computer. Constant use may also have unexpected consequences: increased stress on the cervical spine.

Forward head posture (FHP) is the most common side effect of prolonged, sustained mobile and tablet use. This leads to extension at atlantooccipital (C1 to C2) joints with flexion of lower cervical spine (C4 to C7) and flattening of mid cervical lordosis which cause joint dysfunction associated with negative affection of lung function, abnormal afferent information affecting the tonic neck reflex and encourages the gradual adaptation of FHP.

Eligibility Criteria:
Inclusion Criteria:

1. Forward head with craniovertebral angle less than 50 degree.
2. Both sexes will participate in this study.
3. Their age will be ranging from 18-40years (Molaeifar et al., 2021).
4. Body mass index is ranged from 18-25 kg /m2 (Molaeifar et al., 2021).
5. Area of mobile phone is 17 × 8cm.
6. Participants will be randomly allocated into 2 groups, group (A) should not have addicted to mobile phone and group (B) should have addicted to mobile phone.

Exclusion Criteria:

1. Previous cervical operation.
2. Musculoskeletal disorders such as cervical spine fracture, myelopathy, spinal cord tumor.
3. Neurological conditions that affected head, neck, and upper limbs.
4. Cervical disc or spondylosis.
5. Respiratory diseases such as Restrictions in lung function.
Asses the Impact of Early Starting Erythropoetin in the Reduction of Transfusions Blood in Childrens

Anemia is a frequent complication among cancer patients, both as a result of the malignancy of the disease and the aggressiveness of the treatment. Regardless of the degree of anemia, cancer patients produce less erythropoietin (EPO) and, consequently, cannot compensate for the deficit in the production of red blood cells, a situation that can worsen in presence of inflammation or infection. In the pediatric oncology population, studies vary in relation to anemia treatment protocols, indications for starting treatment and even there is no robust evidence that treatment with erythropoiesis stimulators results in increased hemoglobin levels, even in mild and moderate anemia, with improvement in quality of life scores and fatigue. Therefore, the proposed study aims to test the efficacy and safety of erythropoietin therapy in the treatment of cancer-related anemia in children and adolescents aged 2 to 17 years. As a secondary objective, to evaluate the benefit of early initiation of EPO (Hb\<12g/dL) in children undergoing chemotherapy in improving quality of life and reducing fatigue.

For the evaluation of secondary outcomes, the Student's t test can be applied and analyzes of variance or covariance (ANOVA or ANCOVA) (with treatment group as a factor, and baseline hemoglobin level as a covariate) will be used to compare the outcomes of efficacy defined by variation (change) time point post versus baseline between 2 groups. Adjusted means ("least square means") with 95% CI will be reported. When applicable, secondary outcomes defined by continuous variables evaluated over time (3 or more instants) will be analyzed using mixed model analysis of variance for repeated measures


Eligibility Criteria:
Inclusion Criteria:

* Children between 2-17 years old
* Hemoglobin \<12g/dL
* Solid tumors without bone metastasis
* Being on current chemotherapy treatment
* Adequate serum levels of iron, folic acid and Vitamin B12
* Signature of the Free and Informed Consent Form by the person responsible and Term of Assent by the patient

Exclusion Criteria:

* Refusal to sign the Free and Informed Consent Form and/or Term of assent
* Estimated survival less than 12 weeks
* Previous adverse reactions associated with EPO
* Estar em uso de EPO e inibidores do fator de indução de hipóxia.
Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors

The purpose of this study is to evaluate the safety and pharmacokinetics of two dose schedules of panitumumab in subjects with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of advanced solid tumors that are refractory to at least 1 standard therapy or for which no standard therapy is available and have not received more than 3 prior treatment regimens (not inclusive of hormonal therapies for breast and prostate cancer subjects) for the advanced solid tumor (tumor must be diagnosed by standard criteria for the specific tumor type)
* Measurable disease or evaluable (non-measurable) disease per RECIST guidelines (all sites of disease must be evaluated within 28 days before enrollment)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy of \> 3 months as documented by the investigator
* If history of other primary cancer, subject will be eligible only if she or he has:

  * Non-melanomatous skin cancer, not requiring treatment
  * Curatively treated cervical carcinoma in situ
  * Other primary solid tumor curatively treated with no known active disease present for the last 5 years and no treatment administered for the last 3 years
* Man or woman 18 years of age or older
* Paraffin-embedded tumor tissue (from primary or metastatic tumor tissue) available for immunohistochemistry studies of EGFr expression (biopsy or archived tissue are acceptable). The immunohistochemical EGFr staining and evaluation must be conducted at the designated central laboratory using the DakoCytomation EGFR pharmDXTM kit. Local laboratory EGFr expression is not permitted for the purpose of eligibility in this study
* Hematologic function, as follows:

  * Absolute neutrophil count (ANC) \> 1.5 x 109/L
  * Platelet count \> 100 x 109/L
  * Hemoglobin \> 8 g/dL
* Renal function, as follows:

  o Creatinine \< 2.0 mg/dL
* Hepatic function, as follows:

  * Aspartate aminotransferase (AST) \< 3 x ULN (if liver metastases ≤ 5 x ULN)
  * Alanine aminotransferase (ALT) \< 3 x ULN (if liver metastases ≤ 5 x ULN)
  * Bilirubin \< 2 x ULN
* Competent to comprehend, sign, and date an IEC/IRB-approved informed consent form
PET Respiratory Gating to Detect Hepatic Metastasis in Patients With Colon Cancer

This study is to examine if there is improved sensitivity in detecting hepatic lesions using respiratory gating and if there is an improvement in confidence defining lesions as benign or malignant.


Eligibility Criteria:
Inclusion Criteria:

* Patients with colon cancer
* 18 years or older
* Signed Informed Consent Form
* Blood Glucose of 200 or less prior to scan

Exclusion Criteria:

* Patients with known hepatic metastasis
Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Laparoscopic Hand-assisted Nephrectomy and Robot Assisted Partiel Nephrectomy

Patients with kidney cancer often undergo hand-assisted laparoscopic nephrectomy or Robot assisted partiel nephrectomy. The investigators performed a one-year retrospective study. the sudy revealed that 67% of the patients needed substantial amounts of opioids for postoperative pain management (PPM) in recovery despite a multimodal analgesic regime. In a prospective pilot study including ten laparoscopic hand-assisted nephrectomy, with severe postoperative pain the investigators found that bilateral Ultrasound-guided (USG) transmuscular quadratus lumborum (TQL) block substantially reduced pain and opioid consumption. This study aims to evaluate the effect on PPM of a bilateral USG TQL block compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years
* Kidney cancer
* Have received thorough information, orally and in written
* Signed the "Informed Consent" form on participation in the trial

Exclusion Criteria:

* Inability to cooperate
* Inability to speak and understand Danish both orally and written
* Allergy to local anaesthetics or opioids
* Daily intake of opioids
* Local infection at the site of injection or systemic infection
* Difficulty visualisation of muscular and fascial structures in ultrasound visualisation necessary to the block administration
* Known abuse of alcohol or medicine
* Pregnancy