cyrilzakka/clinical-trials huggingface dataset:
Assess Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects With Rheumatoid Arthritis

This is a Phase 1b, randomized, multi-dose, placebo-controlled, dose-escalation, multi-center study of AMP-110 in adult subjects with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Must be able to provide written informed consent
* Body mass index 18.5 to 35.0 kg/m2
* Diagnosis of Rheumatoid Arthritis according to 1987 revised American College of Rheumatology (ACR) criteria
* Global Functional Class I, II, or III according to ACR 1991 revised criteria
* Must have at least 4 tender joints and 4 swollen joints (28-joint assesssment)
* Use of \>/= 1 non-steroidal anti-inflammatory drugs is allowed, subject must be on a stable dose for \>/= 2 weeks prior to randomization
* Use of \>/= 1 Disease Modifying Anti-rheumatic Drugs (DMARD) for \>/= 3 months and a stable dose for \>/= 6 weeks prior to randomization
* Stable use of low dose oral corticosteroids (\</= 10 mg prednisone per day or equivalent) is allowed; subjects must be on a stable dose for \>/= 4 weeks prior to randomization

Exclusion Criteria:

* Prior to Day 0, use of:

  1. Rituximab within 6 months
  2. Abatacept within 3 months
  3. Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, Azathioprine or Mycophenolate mofetil within 2 months
  4. Etanercept, Anakinra, immunoglobulin or blood products within 28 days
  5. Prior immunotherapy, including high dose oral corticosteroids or systemic corticosteroids such as prednisone, biologics, Janus kinase (JAK) inhibitors, such as tofacitinib or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer
  6. Prior exposure to T cell depleting agents such as Campath (alemtuzumab)
* Evidence of any active or recent infection
* History of systemic autoimmune disease other than Rheumatoid Arthritis; secondary Sjogren's syndrome, rheumatoid vasculitis and orther extra-articular manifestations of RA allowed
* History of allergic reactions
* History of anaphylaxis or allergic diathesis
* Clinically significant cardiac disease, including: unstable angina; myocardial infarction within 6 months; congestive heart failure; arrhythmia requiring active therapy, with the exception of clinically insignificant extrasystoles, or minor conduction abnormalities; and history of clinically significant abnormality on electrocardiogram
* Evidence of active or latent tuberculosis
* Vaccination with live attenuated viruses within the 2 weeks prior to Day 0
* Pregnant or breastfeeding women
Clinical Evaluation of the Serum Free Light Chain Analysis

Background: in patients with multiple myeloma there is a raised level of a protein, named M-protein. This M-protein is normally used to monitor disease status and evaluate response to treatment, as a decrease in M-protein is taken as evidence of therapeutic efficacy. However, the M-protein has a long half life in serum, approximately three weeks, which tend to be a practical problem, since the investigators can first determine hereafter if the treatment is effective.

A new assay has the possibility only to measure part of this protein, namely "the light chains", which also is measured in a blood sample. The half life of these light chains is much shorter, namely 2-6 hours. In theory, this means a more rapid measure of the effect of a given treatment, thereby being able to determine earlier if the treatment should continue or changed to another strategy.

Purpose: the purpose of this study is to evaluate the clinical value of the use of the serum free light chain (sFLC) assay in comparison to the M-protein in monitoring patients under treatment for multiple myeloma.

Method: the investigators measure sFLC in patients receiving there 1st treatment, either at the time of diagnosis or in the relapse setting. sFLC is measured on a regular basis, and the results are compared to the M-protein.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of multiple myeloma
* abnormal serum free light chains
* medical needs of anti-myeloma therapy
* receiving standard anti-myeloma therapy

Exclusion Criteria:

* dialysis
* normal serum free light chains
* dementia
A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People

This study is to learn about flu and COVID vaccines, either alone or when mixed together. Healthy people aged 18 or older can join. Participants will get one shot in each arm, either a flu or COVID vaccine, alone or mixed. The study lasts about 6 months, and participants need to visit the research site at least 3 times.


Eligibility Criteria:
Inclusion Criteria:

* Participants 18 years of age or older
* Healthy participants who are determined by medical history, physical examination (if clinically required), and clinical judgment of the investigator to be eligible for inclusion in the study.

Exclusion Criteria:

* Vaccination with any investigational or licensed 2024-2025 season formulation influenza or COVID-19 vaccine.
* Treated with antiviral therapies for influenza (eg, Tamiflu) within 180 days prior to Day 1

Please refer to the study contact for further eligibility details.
Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )

A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and placebo administered once daily at bed time.


Eligibility Criteria:
Inclusion Criteria:

* Patient has history of physician diagnosed asthma
* Patient is in otherwise good stable health
* Patient is able to chew a tablet

Exclusion Criteria:

* Patient is hospitalized
* Patient and/or parent of guardian intends to move or vacation away from home during the course of the study
* Patient had any major surgical procedure within 4 weeks before the study
* Patient had active sinus disease within 3 weeks before the study
* Patient had required intubation for asthma in the past
* Patient required a visit to the emergency room due to an asthma exacerbation, or has been hospitalized for asthma with in 1 month prior to the study
* Patient had used inhaled, nebulized, intramuscular, or intravenous steroids with in 1 month before study
The Role of Pilates, Plyometrics, and Their Combination for Children With Unilateral Cerebral Palsy

This study was conducted to compare the effect of Pilates-based core strengthening (PsCS) and plyometric-based muscle loading (PlyoML) and their combination on postural control, balance, and mobility in children with unilateral cerebral palsy (ULCP). Eighty-one children with ULCP were randomly allocated to the PsCS (n = 27), PlyoML (n = 27), or combined intervention (n = 27) group. Participants in the three groups were assessed for postural control, balance, and mobility on the pre and post-treatment occasions.

Eighty-one children with ULCP were recruited from the Physical Therapy Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, King Khalid Hospital, and a tertiary referral hospital, Al-Kharj, Saudi Arabia. Their age ranged between 12 and 18 years, were functioning at levels I or II according to the Gross Motor Function Classification System, and had spasticity levels 1 or 1+ per the Modified Ashworth Scale. Children were excluded if they had fixed deformities, underwent neuromuscular or orthopedic surgery in the last 12 months, submitted to BOTOX injection in the past 6 months, had attentional neglect, and if they had cardiopulmonary problems preventing them from performing high-intense exercise training.

Outcome measures

* Postural control: The directional dynamic limit of stability (forward, backward, paretic, and non-paretic) and overall limit of stability were assessed using the Biodex balance system.
* Balance and mobility: The Community Balance and Mobility Scale (CB\&M), Functional Walking Test (FWT), and Timed Up and Down Stair test (TUDS) were used to quantify balance and mobility capacity.

Interventions

All groups were trained for 45 minutes, twice per week, for 12 successive weeks. The PsCS group performed eight Pilates exercises geared predominantly toward the core muscles. The PlyoML group performed 10 plyometric exercises primarily focused predominantly on the lower body. The combined group combined the same exercises as the PsCS and PlyoML groups, although with half the number of sets/repetitions.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral cerebral palsy
* Age 12-18 years
* Motor function level I or II according to the Gross Motor Function Classification System.
* Spasticity level 1 or 1+ according to the Modified Ashworth Scale

Exclusion Criteria:

* Structural deformities/contractures
* Musculoskeletal or neural surgery in the last year
* BOTOX injection in the last 6 months.
* Cardiopulmonary disorders interfere with the ability to engage in exercise training.
* Perceptual and/or behavioral disorders.
Clinical Validation of Boneview for FDA Submission

The goal of this clinical validation is to assess comparative performances of physicians with and without the assistance of BoneView for the diagnosis of fractures on radiographs.

The performances are evaluated in terms of accuracy (primary endpoint with the pair specificity/sensitivity and the secondary endpoint PPV/NPV) and in terms of time needed for diagnosis (secondary endpoint with the measurement of time on each case).


Eligibility Criteria:
Inclusion Criteria:

* Anonymized standard X-ray exams of extremity/pelvis/rib cage/dorsolumbar spine not containing or containing fracture(s).
* Adult patient, with minimum age of 21 years old.

Exclusion Criteria:

* Exams with one or more images including a body part not concerned by the intended use of BoneView (skull and cervical spine)
* Cases with one or more images being used for model design and development.
* Exams with one or more images being of poor quality (lossy), which prevent a proper interpretation by the readers.
* Cases not containing a medically relevant number of views for correct diagnosis.
Evaluation of the Therapeutic Benefit of an Initial Intensified Dosing Regimen of Mycophenolate Sodium Versus a Standard Regimen in Renal Transplant Patients

The purpose of this study is to determine if an initial intensified enteric-coated mycophenolate sodium (Myfortic) dosing regimen administered during the first six weeks post renal transplantation provides improved efficacy, with a similar safety profile, compared to a standard regimen of Myfortic.


Eligibility Criteria:
Inclusion Criteria:

* Males or females, 18 to 65 years old
* First or second time kidney transplant patients
* For females capable of becoming pregnant, negative pregnancy test prior to entry into trial and effective birth control during trial and 3 months after stopping trial medication

Exclusion Criteria:

* Previous graft loss due to immunological reasons in the 1st year after the 1st transplant
* Multi-organ recipients or previous transplant of another organ, different from the kidney
* Recipients from a non-heart-beating donor
* Known hypersensitivity to mycophenolic acid or cyclosporine
* HIV positive or Hepatitis B surface antigen positive
* History of malignancy (past 5 years)
* Pregnancy or planned pregnancy, lactating, or unwillingness to use effective contraception.
* Evidence of severe liver disease

Other protocol-defined inclusion/exclusion criteria may apply.
Can a Relaxometer Improve Cognitive Impairment of Fibromyalgia Patients

The aim of the study is to evaluate the differences in cognitive performance and quality of life, after a cycle of treatment with the relaxometer, between a group of patients affected by fibromyalgia and a control group.

The relaxometer is a device designed for the physical rehabilitation of patients with functional problems of upper limbs. It works by moving passively the patient's fingers in a gradual way (with different speeds) in all directions of space, which is innovative compared to similar machines already on the market.

The device consists of an electrical supply unit and two handling units made of 10 silicone tips of different sizes for the placement of fingers and it works with a six-minute pre-set program. It has obtained patent and certification mark and it has been used in the rehabilitation of patients with joint stiffness induced by specific working activities, as musicians.

After the treatment these patients reported a remarkable improvement of motor skills and articulation of fingers, in addition to a parallel improvement of cognitive abilities such as concentration, visual acuity and mnemonic learning.

In sight of this, the aim of the study is to establish whether the application of this treatment in a small group patients affected by fibromyalgia and cognitive impairment is able to improve some aspects of the cognitive dysfunction measured with appropriate functional tests and comparing the results with a control group of patients not affected by this condition.

Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgic Syndrome diagnosed according to the criteria of American College of Rheumatology 2016 (ACR 2016)
* moderate-severe cognitive impairment according to the Symptoms Severity Score (SS)
* informed consent gathered

Exclusion Criteria:

* contraindication to passive handling of fingers (severe arthritis, fractures or unconsolidated traumatic outcomes, not healed wounds, finger amputations, contact allergies to substances contained in the relaxometer)
* informed consent not gathered
* drug addiction
* brain stroke

Withdrawal from study

* withdrawal of informed consent
* treatment non completed
Two Doses of Conjugated Estrogen (Premarin) in Patients With Androgen-Independent Prostate Cancer

The purpose of this study is to see if Premarin is useful against androgen-independent prostate cancer and to help understand how drugs such as Premarin may work.

Patients will be randomly assigned to one of two study groups (arm A or Arm B). Arm A will receive 1.25mg of Premarin once daily and arm B will receive 1.25mg of Premarin three times a day. Patients will also receive coumadin daily to help prevent thromboembolic disease.

After reviewing the first 30 patients on Arm A, it was determined that arm A (low dose Premarin) was not effective. Arm A was then closed and patients on Arm A were given the choice to switch to Arm B.

Treatment will continue until there is evidence of disease progression or unacceptable side effects.

Every 4 weeks while receiving Premarin, a physical exam and blood work will be performed. Every 12 weeks a CT scan of the abdomen and pelvis and a bone scan will be performed.

Patients will also be encouraged to undergo standard preventative breast irradiation prior to starting Premarin or up to 4 weeks after starting treatment.

Eligibility Criteria:
Inclusion Criteria:

* Documented histologic evidence of prostate cancer.
* Progressive androgen-independent prostate cancer as defined by the Prostate-Specific Antigen (PSA) Working Group after conventional androgen deprivation and antiandrogen withdrawal.
* PSA \> 2ng/ml and serum testosterone of \< 50ng/ml
* No history of thromboembolic disease within the prior year
* ECOG performance status of 0-2
* Creatinine \< 2 x upper limit of normal
* Bilirubin \< 2 x upper limit of normal
* AST \< 2 x upper limit of normal

Exclusion Criteria:

* Unstable angina or change in anginal symptoms within the past 6 months.
* Prior therapy with estrogens or PC-SPECS.
* Concurrent megestrol acetate or steroid hormones
* Major surgery or radiation therapy within 4 weeks
* Strontium-89 or samarium-153 therapy within 8 weeks
Multisensor Technology for Beat to Beat Fetal Heart Rate Measurement

The CIC-IT 1403 laboratory of the University Hospital of Lille has developed a technological solution for acquiring and synchronizing abdominal ECG, acoustic and Doppler signals.

The purpose of this clinical trial is to build a database of signals issued from this device to develop signal processing algorithms to allow optimization of the fetal heart rate calculation.

This study will be carried out in the maternity ward of the Jeanne de Flandre Hospital in the maternal-fetal pathology department Doppler, ECG and acoustic sensors will be placed on the mother's abdomen to capture the heart rate of the fetus and mother as well as uterine contractions.

For each of the participants, we will make two 15-minute recordings: one with conventional ECG electrodes and one with ECG textile electrodes.

This procedure will not affect the usual care of the patient


Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman
* Age\>18 years

Exclusion Criteria:

* Multiple pregnancy
* Medical termination of pregnancy
"Elastography" and "Tissue Harmonic Imaging" for Characterisation of Hilar and Mediastinal Lymph Nodes

Several benign and malignant diseases are associated with hilar and mediastinal lymphadenopathy. Endobronchial elastography that is an imaging procedure used for the visualization of tissue elasticity and "Tissue Harmonic Imaging (THI)" might be useful for the differentiation of benign and malignant lymph nodes.

Patient enrolment and data acquisition is to be carried out on a prospective basis. Patients with hilar and/or mediastinal lymphadenopathy and indication for EBUS-TBNA are enroled. It is planned to evaluate 100 lymph nodes by elastography and THI. All patients will undergo diagnostic bronchoscopy at one study centre in Heidelberg.

Eligibility Criteria:
Inclusion Criteria:

* Indication for EBUS-TBNA
* Patient has provided written informed consent
Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia

The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the colon can assist clinicians in detecting dysplastic (precancerous) and neoplastic areas. This is a pilot study of a novel technology, a miniaturized microscope device which can be used during standard endoscopy to image the gastrointestinal epithelium. Theoretically, by visualizing superficial mucosal changes at a high-resolution and magnification, the investigators will be able to obtain optical images that can be used to guide endoscopic biopsy and polypectomy. This may foster the selective targeting of dysplasia/neoplasia, thereby improving diagnostic accuracy.


Eligibility Criteria:
Inclusion Criteria:

* surveillance of polyps or disease of the colon
* screening colonoscopy
* anoscopy for suspected or known anal dysplasia or neoplasia

Exclusion Criteria:

* unfit for standard colonoscopy or anoscopy
* unable to provide informed consent
Effects of Social Media Use on Young Adults' E-Cigarette Use

The goal of this clinical trial is to test the effects of social media use on e-cigarette use in young adults who use e-cigarettes. The main questions it aims to answer are:

* Does reducing social media use change young adults' e-cigarette use?
* Does reducing social media use change things such as young adults' mental health and what they see on social media?

Participants will complete surveys and submit screenshots showing how much time they spend on social media.

Researchers will compare young adults who reduce their social media use to young adults who use social media as usual, to see if their e-cigarette use differs.

The overall goals of this project are to understand how young adults' social media use affects their nicotine vaping and to identify intervention targets that mitigate social media's impact on vaping. Prevalence of vaping and social media use among young adults have increased in tandem. Exposure to vaping-related social media content is common and is associated with vaping. Intense social media use appears to contribute to young adults' increased mental health symptoms, which are linked to tobacco product use. This project aims to contribute to scientific understanding of the causal links between social media use and vaping in young adulthood. Young adults with past-month vaping will report time spent on social media, vaping-related social media content exposure, social comparison on social media, mental health, and vaping behavior. After a 1-month baseline measurement period, they will be randomized to reduce their social media use (incentivized) or use social media as usual for a 3-month experimental period. Longitudinal within- and between-subjects analyses will test relationships between time spent on social media, risk factors for vaping, and vaping behavior. Specific research aims are to: (1) investigate the relationships between a reduction in social media use and: a) vaping content exposure, b) social comparison, and c) mental health, and (2) examine whether reducing social media use reduces past-month vaping days, vaping episodes per vaping day, and puffs per vaping episode.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-25
* Daily social media use
* Ownership of a smartphone
* Vaping (i.e., use of a nicotine e-cigarette) on 1-19 days of the past 30 days
* Residing in the United States

Exclusion Criteria:

-Lack of capacity to provide informed consent
Exercise Therapy During Radiotherapy

The main purpose of our study is to investigate the effects of exercise therapy on upper extremity functions in patients receiving radiotherapy to the axillary region after breast cancer surgery.

Our study will take in place in radiation oncology clinic. In routine the patients which will receive axillary area radiotherapy will randomized into 2 groups will explained in study arms section later. There are papers explained about radiotherapy side effects to upper extremity functions. But there is lack of evidence about exercise therapy during radiotherapy protocol to cope with its side effects to upper extremity functions. In this study we will compare two groups upper extremity function related outcomes at the end of the radiotherapy sessions and also before and after results for two groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients İn the age range of 18-65
* Receiving radiotherapy to the axillary region after surgery with breast cancer diagnosis

Exclusion Criteria:

* Radiotherapy area to contain only the chest wall
* Any orthopedic injury or trauma involving the upper extremity prior to or during the cancer diagnosis
* The presence of metastases in any area other than breast tissue
Moxibustion for Mild and Moderate Ulcerative Colitis

The purpose of this study is to determine whether moxibustion is effective to mild and moderate ulcerative colitis and the effect of moxibustion on metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnosis of UC
* Mayo ≤10
* Patients should have never received any pharmacological therapy or if they are receiving aminosalicylates and/or prednisolone (the dosage has been taken at least 4 weeks, and should be kept the same as before throughout the trial)
* Patients should have never received antibiotic, biologicals, probiotics, acetaminophen, acetamide and contraceptive.
* A written informed consent

Exclusion Criteria:

* Patients with cardiac, encephalic, hepatic, nephric, hematopoietic system, psychotic or any other serious diseases
* Pregnancy or lactation
Relationship Between the Gut Microbiota and Stress

The relationship between the gut microbiota and stress is poorly studied in humans. In this study we aim to look for if stressed persons have different levels of key bacterial groups compared to the levels in non-stressed persons.

The gut microbial flora will be analyzed with molecular genetic methods. Stress will be measured with cortisol levels in saliva and with questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Healthy man between 19-35 years old

Exclusion Criteria:

* Antibiotic intake
* Gastrointestinal diseases
* Diabetes
* Phsycological diseases
* Tyroid related diseases
* Cardiovascular diseases
* Celiaki
* Cortisone drugs