cyrilzakka/clinical-trials huggingface dataset:
Phase II Study of Alendronate Sodium in Children With High-Turnover Idiopathic Juvenile Osteoporosis

OBJECTIVES:

I. Determine the effects of alendronate sodium on skeletal remodeling and bone mineral density of the hip and spine in children with high-turnover idiopathic juvenile osteoporosis.

PROTOCOL OUTLINE:

Patients receive oral alendronate sodium weekly for 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Eligibility Criteria:

* 5-14 years of age
* Weight 20 kg or greater
* History of one or more atraumatic fracture
* Sexual development no greater than Tanner II
* Osteoporosis by DXA (Diagnosis of high-turnover osteoporosis with no underlying cause (e.g., malignancy, hyperthyroidism, hyperparathyroidism, or vitamin D intoxication)

Inclusion Criteria:

* Male and female children with a history of one or more atraumatic fractures, or evidence of one or more compression fractures on radiographs of the spine (reduction of \>20%).
* Bone mineral density by DXA at 2 standard deviations (SD) below normal mean for age (Z-score at least 2 SD below normal mean at the lumbar spine or hip)
* Parental consent (and patient assent after age 12 years) to participate in the study.
* Sexual development at Tanner stage II or less (Prepubertal stage)
* Weight 20kg and more

Exclusion Criteria:

* History of severe gastritis or reflux
* Marked kyphoscoliosis or inability to sit or stand for at least 30 minutes.
* Abnormalities of the esophagus that delay emptying (e.g., strictures or achalasia)
* Hypersensitivity to bisphosphonates
* Uncorrected hypocalcemia
* History of gastric or duodenal ulcers
* Renal dysfunction as indicated by serum Creatinine greater than 1.5 mg/dL
* Liver dysfunction as indicated by serum SGPT greater than 2 times upper limit of normal for age or serum total bilirubin greater than 2.0 mg/dL
* Diagnosis of osteogenesis imperfecta (including family history) or blue sclerae or deafness
* Diagnosis of active rickets, osteomalacia, or bone alkaline phosphatase \> 2 times normal for age
* Severe gastritis or reflux
* Pregnancy
* Anorexia Nervosa

  * Prior/Concurrent Therapy-
* Prior course of prednisone allowed
* No concurrent prednisone except inhaled steroids
* No concurrent high-dose glucocorticoids
* No concurrent salmon calcitonin
* No other concurrent bisphosphonates
* No concurrent long-term anti-seizure medication
Assessment of the Predictors and Moderators of Behavior Change

The current study aims to investigate two potential interventions (i.e., cognitive dissonance and action planning) for inducing behavior change for behaviors important to college students-studying and exercise. In addition, this study will investigate factors that may impact behavior change, such as psychological and neuropsychological variables, to better understand how to bridge the intention-behavior gap.


Eligibility Criteria:
Inclusion Criteria:

* Boston University Psychology 101 students at least 18 years of age
* Able to provide informed consent for the study
* Sufficient command of the English language
* Have experience using a computer and mouse

Exclusion Criteria:

* None
Validity of the Turkish Version of the Profile Fitness Mapping Neck Questionnaire for Patients With Neck Pain

As patients improve on one parametric result, the results on the other parametric may worsen, but the total score may not be affected. For this reason, it would be useful to make measurements that evaluate all the parameters of the patients. Thus, it would be more advantageous to score both pain and symptoms separately, as well as activity limitations. Therefore, neck specific surveys are needed to meet this need.

For this reason, this study was planned to determine the validity of the questionnaire named "Profile Fitness Mapping Neck Questionnaire" in patients with neck pain.

The translation of the original version of "Profile Fitness Mapping Neck Questionnaire" to Turkish will be translated by two independent professional translators. Afterwards, a person without a medical history and a native English speaker will be translated into English again. Once the translation stages are complete, the translators will be brought together to discuss the two versions of the questionnaire. Then the final state will be translated into the main language of the questionnaire and the compliance will be checked.

First of all, people who have been suffering from low back pain for at least six months will complete the "Profile Fitness Mapping NeckQuestionnaire", "Neck Disability Index", "SF-36 health related quality of life questionnaire" and "Visual Analog Scale".

Seven days after the questionnaire, the "Profile Fitness Mapping Neck Questionnaire" will be completed again.

Eligibility Criteria:
Inclusion Criteria:

* Neck pain for more than six months during activity or rest
* Having a problem with the neck based on clinical examination and story

Exclusion Criteria:

* Having neurological problems
* Having vestibular or cerebellar problems
Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases

To investigate, whether multi-fraction stereotactic body radiation therapy (SBRT) within 3 treatment fractions is non-inferior to the current standard of care of 5 fraction SBRT regarding pain response at 3 months after radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Personally signed and dated written informed consent,
* Histological diagnosis of malignancy,
* Histologically or radiologically diagnosed bone metastasis,
* Age ≥ 18 years
* Pain or under pain control medication

Exclusion Criteria:

* Pregnant or lactating women,
* Women of childbearing potential or sexually active males not willing to use effective contraception while on treatment and 3 months after the end of treatment,
* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc.,
* Prior radiotherapy to the intended treatment site,
* Lesions \> 5cm in maximum diameter,
* Prior treatment with radioactive isotopes within 30 days of randomisation,
* Spinal column, hands, feet, or head as intended treatment site,- Fracture at the intended treatment site,
* Surgery required or previous surgery at the intended treatment site
* Instability of the intended treatment site.
A Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Technique Plus Sylys® Surgical Sealant

The Cohera Sylys® Surgical Sealant study is a pivotal, prospective, randomized, controlled, multicenter superiority clinical study comparing standard anastomosis closure technique (Control) to standard closure technique plus Sylys® Surgical Sealant (Test) during stapled colorectal and ileorectal anastomosis procedures.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 22 years of age
* Be scheduled for a stapled colorectal or ileorectal anastomosis procedure with or without diverting stoma
* Agree to return for all follow-up evaluations and procedures specified in the protocol
* Understand and give informed consent

Exclusion Criteria:

* Albumin \< 3
* ASA ≥ 4
* Neutropenia ≤ 800
* Pregnancy
* The following conditions involving compromised immune system: AIDS (HIV positive not excluded), neutropenia
* Known blood clotting disorder requiring treatment
* Any condition known to effect wound healing, such as collagen vascular disease
* Have known or suspected allergy or sensitivity to any test materials or reagents
* Concurrent use of fibrin sealants or other anastomosis care devices
* Surgery for emergency abdominal indications
* Has undergone a colorectal anastomosis procedure in the previous two months
* Has an emergent infection related to a previous colorectal anastomosis procedure
* Is scheduled to undergo a Hartmann's procedure
* Is scheduled to undergo trans-anal endoscopic microsurgery (TEM) Is participating in another medical device trial related to colorectal anastomosis
QuantiFERON Change During Anti-tuberculosis Medication

The aim of this study is to evaluate the change of QuantiFERON-TB gold in tube assay (QFT) during the treatment of active tuberculosis.

Patients with active pulmonary tuberculosis are enrolled and, QFTs are performed for each subjects before treatment and 1, 3, 6 months after treatment. Investigators check the level of interferon-gamma, and reversion and conversion of this test.

Eligibility Criteria:
Inclusion Criteria:

* All subjects with active tuberculosis

Exclusion Criteria:

* Subjects who cannot complete study
* Subjects who have taken anti-tuberculosis medication for more than a month before visit of our hospital
Enhanced Quality in Primary Care for Elders With Diabetes and Dementia

The purpose of this study is to develop and test a care quality improvement intervention featuring use of consensus decisional guidance for the medical management of diabetes (DM) in patients with Alzheimer's disease and related dementia (ADRD) in primary care, provider (PCP) workflow enhancements supported by a panel manager(PM) for workflow support, electronic health record (EHR) decision support and feedback, and PCP collaborative learning.


Eligibility Criteria:
Inclusion Criteria:

* Patient must receive care at participating NYU FGP clinics.
* Patient must be English or Spanish speaking.
* Patient must have DM diagnosis.
* Patient must have documented cognitive impairment or an ADRD diagnosis.
* Patient must have someone who is identified as a family or friend who provides caregiving assistance.

Caregiver:

* Caregiver must have adequate knowledge of identified patient and/or participate in that member's healthcare decisions.
* Caregiver must be English or Spanish speaking.
* Caregiver must demonstrate capacity to consent to research participation.
* Caregiver must be at least 21 years old.

Exclusion Criteria:

Patient:

* Patient does not receive care at participating NYU FGP clinics.
* Patient is not 65 years and older.
* Patient is not English or Spanish speaking.
* Patient does not have DM diagnosis.
* Patient does not have documented Cognitive impairment or an ADRD diagnosis.
* Patient has severe dementia, other terminal illness with \<6 months to live, and/or is hospice eligible.
* Patient does not have a caregiver.

Caregiver:

* Caregiver does not have adequate knowledge of identified patient and/or does not participate in that member's healthcare decisions.
* Caregiver is not English or Spanish speaking.
* Caregiver lacks capacity to consent to research.
* Caregiver is under 21 years old.
Barriers and Faciliators for Physical Activity in People With RMDs

The aim of this project is to systematically survey and explore barriers and facilitators for the implementation of physical activity according to the physical activity recommendations of the European Alliance of Associations for Rheumatology on country specific (e.g., environmental, cultural, organization and system) level. A questionnaire to explore/identify these barriers and facilitators in the survey, will be developed through literature search, interviews with multiple stakeholders (i.e., patients with inflammatory arthritis or osteoarthritis and physical therapists) and experts in the field in four different European countries (i.e., Turkey, Switzerland, the Netherlands and France).

Additionally, in Switzerland only, the Inflammatory Arthritis Facilitators and Barriers to Physical Activity (IFAB) Questionnaire which was developed to determine the factors on personal level, will be translated into the German language. Aim is to evaluate the validity and reliability of the IFAB Questionnaire in the German-speaking population with axial Spondyloarthrits, and to perform a cultural adaptation if necessary at the same time.


Eligibility Criteria:
Inclusion Criteria:

* adults being 18years or older
* diagnosis of osteoarthritis, rheumatoid arthritis or axial Spondyloarthritis
* the cognitive and linguistic competencies to answer the survey

Exclusion Criteria:

* having a rheumatological or musculoskeletal disease other than described
* any communication problems
Sympatholytic Effects of High Thoracic Erector Spinae Plane Block: Changes in Optic Nerve Sheath Diameter

The thoracic erector spinae plane (ESP) block is suggested to potentially affect the stellate ganglion, a key component of the sympathetic nervous system, thereby influencing autonomic functions. Changes in optic nerve sheath diameter (ONSD) are used as indicators of intracranial pressure changes. This study aims to investigate the effects of the ESP block on ONSD, providing insights into its impact on the stellate ganglion and enhancing the understanding of the ESP block's safety and efficacy.

The thoracic erector spinae plane (ESP) block is a regional anesthesia technique. This technique involves the injection of local anesthetics into the deep layers of the erector spinae muscles, blocking both somatic and visceral pain pathways. Although various studies have been conducted on the effectiveness of this technique in different clinical situations over the years, further research is needed to understand the precise mechanisms behind its neuroanatomical effects.

The stellate ganglion, an important component of the sympathetic nervous system, plays a crucial role in the regulation of several autonomic functions. It has been suggested that the ESP block may affect the stellate ganglion through its injection at the upper thoracic levels. Changes in the optic nerve sheath diameter (ONSD) have been used as an important indicator of intracranial pressure changes. Any potential changes in ONSD following stellate ganglion blockade could help elucidate the effects of the ESP block, thus aiding in the understanding of its safety and potential benefits for analgesia.

The aim of this study is to investigate the changes in optic nerve sheath diameter in patients undergoing the thoracic ESP block, which could provide more information on the impact of the ESP block on the stellate ganglion. By doing so, we aim to gain further insights into the potential analgesic effects and safety of the ESP block.

Eligibility Criteria:
Inclusion Criteria:

* Adults with neck, shoulder, and arm pain
* Those with complex regional pain syndrome

The study will include 15 adult patients who are planned to receive T2-ESP block treatment.

* Age between 18-65 years
* Both genders
* ASA physical status I-II

Exclusion Criteria:

* Those who refuse procedures and tests
* Individuals with conditions that can increase intracranial pressure
* Those with severe heart failure
* Individuals with second or third-degree atrioventricular block
* Those with a history of unstable angina
* Individuals with COPD or chronic asthma
* Those who have experienced a myocardial infarction (MI) within the last 6 weeks
* Individuals with a heart rate below 50 beats per minute
* Those with systolic blood pressure below 90 mmHg
* Individuals with liver failure
* Those with kidney failure
* Individuals for whom a supraclavicular block is anatomically impossible
* Those with neurological or psychological conditions that complicate test evaluation
* Individuals allergic to any of the study medications
* Pregnant individuals
A Study of 1018 Immunostimulatory Sequence (ISS) Administered With Irinotecan and Cetuximab to Treat Patients With Previously Treated Metastatic Colorectal Cancer

The main objectives of this study are to establish a safe, tolerable and active dose of 1018 ISS administered in combination with irinotecan and cetuximab in patients with metastatic colorectal cancer. Other objectives also include determining tumor response, time to disease progression, and overall survival in treated patients.

This is a Phase I, open-label study of escalating dose levels of 1018 ISS in combination with irinotecan and cetuximab in patients with previously treated metastatic colorectal cancer. Approximately 15 patients will be treated. The objectives of this study are to establish a safe, tolerable, and active dose of 1018 ISS, determine tumor response, time to disease progression, and overall survival in treated patients.

The safety and tolerability of 1018 ISS will be evaluated by periodic laboratory assessments, physical examinations, and compilation of adverse events.

Once study patients have been consented, screened, and assigned to one of the dose levels of 1018 ISS, patients will receive two 4 week cycles of 1018 ISS therapy plus irinotecan every other week and cetuximab weekly. Irinotecan and cetuximab will continue thereafter until disease progression, unacceptable toxicity, or until the patient refuses treatment.

Eligibility Criteria:
Inclusion Criteria:

* Signed, written, informed consent must be obtained from the patient or their legal representative before any study-specific procedures are performed
* Confirmed diagnosis of adenocarcinoma of the colon or rectum not amenable to curative surgery
* One or more prior systemic therapy regimens for metastatic cancer which must have included a fluoropyrimidine (5-fluorouracil (FU) by infusion or capecitabine), oxaliplatin or irinotecan with or without bevacizumab

Exclusion Criteria:

* Clinically significant obstructive symptoms, intestinal bleeding, or chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom
* History of unstable or deteriorating cardiovascular or cerebrovascular disease within 3 months before the first dose of protocol therapy
* Clinical evidence of brain metastases or central nervous system disease
* Pregnant or lactating women
* Serious medical or psychiatric illness
* Malignancy other than colorectal carcinoma within the past 2 years, except curatively treated, superficial skin cancer or carcinoma in situ of the cervix
* Patients who have been on any experimental study or anti-tumor therapy, received radiotherapy, or had prior surgery (except venous access device placement) within 28 days before the first dose of protocol therapy
Pilot Study - Patient Education and Pelvic Strength Exercises in Elderly Women With Incontinence.

It will be investigate if women with a diaper grant in Aalborg Municipality can reduce diaper size and thus costs for diapers in the municipality through meetings with a incontinence nurse and pelvic floor exercises.

Incontinence is a world wide challenge especially in elderly women. The participation in pelvic floor exercises can to some extent help women with urinary incontinency. In the Municipality of Aalborg in Denmark, the citizens can get a diaper grant, if they are incontinence. The project will be recruiting women with diaper grants and randomly allocate the women to 3 different groups 1) Group training (usual care), 2) Individual training and 3) Individual training with biofeedback in the form of ultrasound. All groups will receive the same incontinence education from the incontinence nurses and physiotherapists. The Women will be offered 6 individual or 10 group base trainings, with increased time between trainings, to increase the participants independency and rely more on home based exercises.

Eligibility Criteria:
Inclusion Criteria:

Diaper grant

* Urinary incontinency Living in own home in Aalborg Municipality

Exclusion Criteria:

* Dementia Inability to transport herself to the training facility neurological diseases inability to understand Danish or bring a translator
Mitochondrial Remodeling After Exercise

Regulation of mitochondrial health in overweight and obese individuals may be impaired. The purpose of this study is to identify impairments in regulation of mitochondrial health within skeletal muscle and to determine if short-term exercise training (2-weeks) can reverse such impairments. The investigator's hypothesis is that pathways that serve to degrade poorly functioning mitochondria in overweight and obese individuals are down-regulated, but that short-term exercise training can restore these pathways to improve skeletal muscle mitochondrial function.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-45 years
* Body mass index (BMI) 18-45 kg/m2
* Sedentary (\<1 hour of planned exercise per week)

Exclusion Criteria:

* Regular exercise (\>1 hour of planned exercise per week)
* Smoking, tobacco or nicotine use within the last 1-year
* Fasting glucose \>126mg/dL
* Hypertension (systolic pressure \>140 mmHg or diastolic pressure \>90 mmHg)
* Chronic metabolic or cardiovascular health conditions
* Pregnant, nursing, irregular menses or post-menopausal
* Lidocaine allergy
* Certain medications
* Physical limitations that prevent safe or successful exercise completion
* Diminished capacity for consent
Analysis of the Pathophysiological and Functional State of the Knee Joint

Osteoarthritis is the most common degenerative condition affecting the knee joint globally, with an incidence of about 7% of the population. In Italy, it affects approximately 3.9 million people, with a direct treatment cost of around €2.5 billion. At the joint level, osteoarthritis manifests with pain and reduced functionality, worsening as the disease progresses and severely limiting knee movement. Compounding this, osteoarthritis can impact both elderly and younger individuals due to traumatic factors.

Despite its significant impact, effective treatments for osteoarthritis that address its underlying causes are still lacking, focusing mainly on symptom management. Therefore, improving diagnostic and prognostic approaches is crucial to better understand its onset and progression.

MRI is a primary diagnostic tool for assessing the knee joint's pathophysiological state. It uses tissue-specific sequences to investigate joint homeostasis in detail, although it primarily provides insights into morphology, structure, and tissue composition rather than functional changes within the joint. This limitation is noteworthy because joint homeostasis involves complex interactions among biomechanical, structural, and biological processes, which are directly influenced by osteoarthritis.

Gait analysis provides valuable diagnostic information on joint function. By integrating sensor measurements and electronic systems with patient-specific musculoskeletal models derived from MRI morphometric data, it is possible to assess the forces and moments within the joint during specific movements.

Given that osteoarthritis affects the entire joint, employing multidisciplinary approaches can enhance diagnostic precision and provide insights into the progressive impact of degenerative conditions like osteoarthritis on joint health.


Eligibility Criteria:
Inclusion Criteria:

* Knee pain and/or loss of functionality
* Kellgren-Lawrence grade less than or equal to 2
* Arthroscopic evidence of cartilage tissue lesions
* Evidence of cartilage and/or meniscal tissue degeneration and/or subchondral bone marrow lesions

Exclusion Criteria:

* History/evidence of previous partial or total knee prosthesis interventions
* Inability to provide informed consent
* Conditions or physical disorders incompatible with the use of MRI and electrical stimulation (implanted active and passive biomedical devices, epilepsy, severe venous insufficiency in the lower limbs)