cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis

The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in biologic-experienced participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have been previously treated with 1 biologic agent for psoriatic arthritis (PsA) or psoriasis and the reason for discontinuation must be documented
* Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study intervention and meet classification criteria for Psoriatic Arthritis (CASPAR) at screening
* Have active PsA as defined by: (a) At least 3 swollen joints and at least 3 tender joints at screening and at baseline (b) C-reactive protein (CRP) greater than or equal to (\>=) 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory.
* Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
* Have active plaque psoriasis with at least one psoriatic plaque of \>= 2 cm diameter or nail changes consistent with psoriasis
* A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (Beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention

Exclusion Criteria:

* Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances
* Currently has a malignancy or has a history of malignancy within 5 years prior to screening
* Has known allergies, hypersensitivity, or intolerance to icotrokinra or its excipients
* Has other inflammatory diseases that might confound the evaluations of benefit of icotrokinra therapy, including but not limited to rheumatoid arthritis (RA), systemic lupus erythematosus, or Lyme disease
* Participants with fibromyalgia or osteoarthritis symptoms that, in the investigator's opinion, would have potential to interfere with efficacy assessments
Safety & Efficacy of BCT197 in Patients Undergoing Cardiac Surgery

This study will assess the safety and efficacy of BCT197 on acute kidney injury in patients undergoing cardiac surgery with cardiopulmonary bypass.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective cardiac surgery with CPB. Allowable procedures are CABG alone, aortic valve replacement or repair alone, mitral valve replacement or repair alone, CABG with aortic valve replacement or repair, and CABG with mitral valve replacement or repair. Patients with repeat surgery for any of the procedures can be included.
* Patients must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) 18 kg/m2
* Have an eGFR ≥ 30 and ≤ 60 mL/min/1.73 m2 to participate in Part A, or an eGFR \> 60 mL/min/1.73 m2 to participate in Part B. Upon completion of Part A, patients with eGFR ≥ 30 mL/min/1.73 m2 may participate in Part B, with dose administered as per the dosing table

Exclusion Criteria:

* left ventricular ejection fraction, in the last 6 months, ≥30%
* Active systemic infection or uncontrolled diabetes mellitus with a glucose ≥250 mg% at the screening assessment
* Pregnant or nursing (lactating) women,
* Female subjects must either:

have been surgically sterilized or hysterectomized at least 6 months prior to study participation, or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to study participation. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow- up hormone level assessment is she considered not of child bearing potential, Surgical sterilization procedures or hysterectomy must be supported with clinical documentation made available to the sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF, OR be postmenopausal. Female subjects are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms). Female subjects 60 years of age or younger must confirm menopause by the demonstration of a plasma FSH level in the postmenopausal range according to the lab normal range. Documentation of a prior plasma FSH level is acceptable

* History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of drug abuse as indicated by the laboratory assays conducted during screening or baseline
* New cancer diagnosis with planned chemotherapy and/or radiation therapy, or cancer requiring ongoing chemotherapy and/or radiation therapy at the time of screening

Other protocol-defined inclusion/exclusion criteria may apply
Piezo-surgical Implant With Laser

Evaluation of the effect of laser with piezo-surgical device in dental implants


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects having good oral hygiene
* History of bilateral extractions in the lower molar area not less than 6 months ago.

Exclusion Criteria:

* Patients with debilitating diseases or bad oral hygiene,
* Patients with parafunctional habits and patients who are taking analgesics or with alcohol abuse.
Eating Behaviours in Female Patients With Fibromyalgia

The Relationship Between Eating Behaviours and Health Status of Female Patients with Fibromyalgia

The purpose of this study is to evaluate the nutritional behaviours of female patients with fibromyalgia according to the healthy population and the relationship of these behaviours with the current health status of the patient.

In the investigatgor's clinical practice, eating-related problems (increased or decreased appetite, uncontrolled eating, etc.) are observed in fibromyalgia patients. In this study, it will be investigated whether this situation is different from healthy population and whether it is related with the healt status.

Patients diagnosed with fibromyalgia according to 2013 American College of Rheumatology criteria and healthy volunteers are planned to be included in the study.

Demographic data (sex, age, level of education, job, socio-economic situation) will be questioned and their body mass indexes (BMI) will be calculated from all participitants All participants' eating behaviour will be questioned with Three Factor Eating Questionnaire.

In fibromyalgia patients, effect of fibromyalgia on the daily life of the patients will be questioned with Fibromyalgia Impact Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Female patients between the ages of 18-40
* Patients diagnosing fibromyalgia for the first time according by 2013 American College of Rheumatology (ACR) criteria

Exclusion Criteria:

* History of eating disorders such as anorexia nervosa, bulimia nevroza
* History of hypothyroidism or hyperthyroidism
* Pregnant or breast feeding
* History of central or peripheral nervous system disorders
* History of infectious, chronic inflammatory disease, malignant tumors
* Subjects with active psychiatric illness or who use psychiatric medication
* Uncooperative subject
* History of cardiac pathology such as heart failure, coronary artery disease
* History of diabetes, chronic renal insufficiency, chronic liver failure
Cognitive Behavioral Interventions for Motivation, Psychological Distress and Quality of Life Among Individuals With Smoking Cessation: A Randomized Control Trial

The main purpose of this research is to find out how brief cognitive behavior intervention influences the motivation level, psychological distress, and quality of life among people with smoking cessation. Another objective of this research is to examine the effectiveness of cognitive behavioral therapy (CBT) among smoking people, another objective of this study is to investigate how Cognitive behavioral therapy helps to enhance the motivation level and quality of life and minimize psychological distress among people with smoking cessation

Participants:

This was basically pre and post study, initially 60 sixty research participants were recruited for pre-assessment, while 4 participants left due to some reasons (2 persons went out of the city for a job, 1 person met a severe road accident, and 1 person simply refused to participate in this study furthermore. Finally, 55 research participants were recruited for post-assessment. These research participants belong to different residential areas (rural/urban) have varied family systems (nuclear/joint) have different birth order, education, socioeconomic status, education, occupation, marital status, and distant smoking duration. The data were analyzed with the help of SPSS-23 (Statistical Package for Social Sciences - 23) descriptive statistics, correlation analysis, and repeated measure ANOVA were used to understand the association and differences among pre and post-assessment of smoking personals.

Eligibility Criteria:
Inclusion Criteria:

* If we talk about inclusion criteria, the individuals who were ready to change their lives were part of this study, furthermore, persons above 18 years and below 60 years old were recruited for this study, minimum duration for smoking personnel was not less than 6 months and not more than 5 years were part of this study. The individuals who have signed a written informed consent form were part of this study. Moreover, only males who were easily comprehended and understood the instructions of the researcher were recruited in this study. On the other hand, if we talk about the exclusion criteria of the study

Exclusion Criteria:

* the individuals who were reluctant to participate, or had any kind of psychophysiological illness prior to the study were excluded from this research. Further, the people below 18 and above 60 years were excluded. Furthermore, the research participants who had any kind of trauma during this study were excluded and those who refused to become further part of this study were excluded from this research study.
The Effect of Anakinra on Insulin Secretion

Rationale: Once diabetes develops, β-cell function progressively deteriorates and therapeutic approaches that prevent of delay loss of β-cell function are needed in the treatment of type 2 diabetes mellitus. Recent findings suggest that interleukin-1 (IL-1) may be involved in the progressive β-cell dysfunction in type 2 diabetes mellitus.

Objective: to determine whether blocking IL-1β by recombinant human IL-1ra (anakinra) improves beta-cell function in subjects with β-cell dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Impaired glucose tolerance assessed by oral glucose tolerance test and/or impaired fasting glucose ( ≥ 5.6 mmol/L) and/or HbA1c levels of 5.7-6.4%
* BMI \>25 kg/m2
* Age 40-70 years

Exclusion Criteria:

* Known diabetes mellitus
* Fasting plasma glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5%
* Immunodeficiency or immunosuppressive treatment (including TNFα blocking agents and corticosteroids)
* Use of anti-inflammatory drugs ( including corticosteroids and non steroidal anti-inflammatory drugs, 100 mg or less of aspirin is allowed)
* Signs of current infection (fever, C-reactive protein \>30 mmol/L, treatment with antibiotics, previous or current diagnosis of tuberculosis)
* A history of recurrent infections
* Pregnancy or breastfeeding (contraception of at least 3 months before inclusion is required)
* Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range
* Renal disease defined as MDRD \< 60 ml/min/1.73m2
* Neutropenia \< 2x 109/L
* Inability to understand the nature and extent of the trial and the procedures required.
* Any medical condition that might interfere with the current study protocol
* Participation in a drug trial within 60 days prior to the first dose
Pneumococcal Conjugate Vaccine 13 (Prevnar13®) in Children Who Are Solid Organ Transplant Recipients (SOT)

The purpose of this study is to determine the safety and long-term immunogenicity of the 13-Valent Pneumococcal Conjugate vaccine in children who are solid organ transplant recipients.

The purpose of this study is to determine if a booster dose of 13-valent pneumococcal conjugate vaccine (PCV13) is safe and results in a measurable and durable immunologic response against pneumococcal subtypes present in the vaccine in solid organ transplant recipient (SOT) children.

Pneumococcal infections are amongst the most common infections seen in immunocompromised children. Infection by Streptococcus pneumoniae is one of the most frequently observed infection in immunocompromised children.

Pneumococcal polysaccharide vaccines (PPV) have been licensed in the U.S. for over 40 years. In contrast, pneumococcal conjugate vaccines are immunogenic and efficacious in normal infants and children, and offer hope of reducing pneumococcal infections in immunocompromised children. However, conjugate pneumococcal vaccine can only protect against a limited number of the 90 pneumococcal serotypes.

It is reasonable to anticipate that the introduction of PCV13 may help reduce the chances of severely immunocompromised children getting pneumococcal infections. Many of these children have been previously immunized with a full series of a 7-valent pneumococcal conjugate vaccine. These children will benefit from an additional dose of the new 13-valent vaccine. The degree to which SOT-recipient children are protected by prior immunizations and are responsive to new immunizations is still largely undefined. This study aims to expand the knowledge regarding the safety and immunogenicity of PCV13 immunization in this growing and vulnerable population.

Eligibility Criteria:
Inclusion Criteria:

* Are 12 to 59 months of age.
* Have received a solid organ transplantation requiring ongoing immunosuppression.
* Have been receiving immunosuppressive agents for at least 3 months. Non-steroidal anti-inflammatory agents, G-CSF, erythropoietin and inhaled corticosteroids are not considered immunosuppressive agents for the purposes of this study.
* Expect to be able to complete the study injection and follow-up.
* Have parent or guardian's consent.
* Have received at least 3 doses of an approved PCV7 and/or PCV13 vaccine series.

Exclusion Criteria:

* Have received any inactivated vaccine within 4 weeks, or any live vaccine within 6 weeks of entering the study.
* Have had an allergic reaction or a serious side effect after receipt of any previous immunization to pneumococcal vaccines, or to other routine childhood immunizations.
* Have any other condition that would make receiving study vaccine inadvisable.
* Have other diseases of the immune system.
* Have any other disease or previous surgery that would interfere with study treatment.
* Are likely to have bleeding disorders.
Use of Passive, Adaptive, and Active Prosthetic Knees in Persons With Unilateral, Transfemoral Amputation

The goals of this study are to assess measured, observed, and self-reported outcomes achieved through the use of passive (mechanical), active(motorized) and adaptive (magnetorheological) prosthetic knee control systems in individuals with unilateral, transfemoral amputation.

An interrupted time-series trial with pre/post baseline assessments, randomized crossover of interventions, and within-phase repeated measures is used to evaluate and compare the effectiveness of the Össur Power Knee II and the Össur Rheo Knee in individuals with unilateral, transfemoral amputation. A rigorous and clinically-meaningful experimental protocol is applied to verify study participants receive appropriate training, experience, and assessment in each knee condition. A suite of standardized and ad-hoc physical performance tests, patient-reported questionnaires, and monitoring technologies were carefully selected to assess important, clinically-relevant participant outcomes. Comparative effectiveness of three prosthetic knee interventions are evaluated using direct measurement (i.e., timed tests), observed clinical ratings (i.e., subjective assessments of gait quality) and self-report instruments (i.e., health status surveys). Analyses will focus on identifying differences between control system technologies inherent to each type of prosthetic knee (i.e., passive \[mechanical\], adaptive \[magnetorheological\], and active \[power\]). Outcomes will be used to establish recommendations for which activities and patients knees are most appropriate or likely to produce a desired effect.

Eligibility Criteria:
Inclusion Criteria:

* age 45 - 75
* body weight less than 275lbs
* unilateral amputation between the hip and knee
* amputation due to non-vascular causes
* no other major limb amputations
* amputation occurred at least 2 years prior
* stable limb volume (i.e., at least 6 months on an unmodified prosthetic socket)
* intact skin tissue without open wounds or sores for at least 2 months
* physiologically stable medical condition (i.e., non-degenerative)
* possession and regular (i.e., daily) use of a prosthesis with a prosthetic knee with non-microprocessor (i.e., mechanical or fluid) stance control
* Medicare functional classification level (MFCL or "K-level") 3

Exclusion Criteria:

* expect to receive or are expected to require a replacement prosthetic socket within 15 months
* complete reliance on an assistive device (i.e., cane or walker) for ambulation
Histopathological Analysis of Temporal Artery Biopsy Following Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings in Patients With Suspected Giant Cell Arteritis (DOCTA)

Giant cell arteritis (GCA) is a type of large vessel granulomatous vasculitis responsible for the inflammation of the aorta and the branches of the external carotid, notably temporal arteries. The diagnosis of GCA relies upon the identification of vasculitis following histopathological analysis of temporal artery biopsy (TAB) showing mononuclear cells infiltration, fragmentation of the internal elastic lamina as well as significant intimal hyperplasia. Apart from its lack of sensitivity, one of the weaknesses of TAB is the delay in obtaining the result due to the time required to prepare the sample for histological analysis. Pursuing the idea to improve TAB performances, our group recently demonstrated the use of full-field optical coherence tomography (FF-OCT) to visualize structural changes associated with the inflammatory processes of GCA. The present work suggests a further use of dynamic FF-OCT on TAB for a direct visualization of the mononuclear cells infiltration to ensure rapid on-site diagnosis of GCA.


Eligibility Criteria:
Inclusion Criteria:

* patient \> 50 years of age with suspected giant cell arteritis who received temporal artery biopsy between start study date and primary completion date

Exclusion Criteria:

* inability to perform dynamic full-field optical coherence tomography observation at the moment of temporal artery biopsy
A Multi Center Study to Validate a Condition-specific Measure of Sexual Health in Women With Pelvic Floor Disorders

Study Aims:

1. To validate a new measure of sexual function and activity in women with PFDs;
2. To establish the responsiveness to change of the new measure.

The investigators hypothesis is that the investigators can create a new questionnaire that accurately measures sexual health in women with pelvic floor disorders that improves on the already published questionnaires.

600 women presenting for care to urogynecology clinics in the United States and England will be recruited to participate. They will give data regarding their physical exam, including measurements by the Pelvic Organ Prolapse Quantification exam and medical and surgical history. In addition, they will complete validated questionnaires including the Incontinence Severity Index, the Pelvic Floor Distress Inventory (short form) and question # 35 from the Epidemiology of Prolapse and Incontinence Questionnaire. All women will also complete two sexual health questionnaires; the Female Sexual Function Index and the Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire (Revised). Women will receive standard care for their pelvic floor disorders. They will then be recontacted to repeat the same set of questionnaires to determine the responsiveness of the new measure. Reliability of the questionnaire will be measured by having a subset of women complete the questionnaire twice; a factor analysis will be performed to determine the underlying factor structure. Responses to the other QOL measures will be compared to those to the new instrument to establish validity.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for patients include age over 18 years.
* Not pregnant.
* Able to read/write and understand English.
* And, because this is a project to validate a measure of female sexual function, all subjects will be women.
* All women will be seeking care for PFD including urinary and anal incontinence and POP. Since data collection will primarily be by mail
* Women must have a stable and current address.

Exclusion Criteria:

* Women under the age of 18.
* Are pregnant or who are unable to read/write or understand English will not be eligible for participation.
* In addition, women with a diagnosis of vulvodynia, painful bladder syndrome, or chronic pelvic pain (defined as pelvic pain for greater than 6 months) as determined by the consenting physician will be excluded.
* Since this is a study to evaluate both sexual activity status as well as sexual function, women need not be sexually active to participate.
Changes in Digital Phenotype During PE Therapy

PTSD is characterized by physiological changes, some of which are thought to be chronic, while others are observed in response to stressogenic stimuli. Prolonged Exposure (PE) therapy is a widely used protocol considered highly affective among individuals diagnosed with PTSD.

The current study is a non-interventional observational study, aimed at measuring changes in the digital phenotype of participants with PTSD during and following PE therapy. Physiological data will be collected using wearable sensors during the sessions, and participants will be assessed using questionnaires and psychiatric assessments before and after the completion of their imaginal or writing based PE therapy (10-15 sessions).


Eligibility Criteria:
Inclusion Criteria:

* PTSD diagnosis
* Proper ability to give informed consent

Exclusion Criteria:

* Active psychotic or suicidal symptoms
* Severe dissociative symptoms
* A traumatic brain injury (TBI) diagnosis
* Pregnancy