cyrilzakka/clinical-trials huggingface dataset:
A Study of JNJ-66525433 in Healthy Participants and Participants With Ulcerative Colitis

The purpose of this study is to evaluate safety and tolerability of JNJ 66525433 compared with placebo after administration of: 1) single ascending oral doses of JNJ 66525433 administered to healthy participants (Part 1), 2) multiple, ascending oral doses of JNJ 66525433, administered to healthy participants once daily over 14 consecutive days (Part 2), and 3) multiple oral doses of JNJ 66525433, administered once daily over 14 consecutive and once daily over 42 consecutive days in participants with ulcerative colitis (UC) (Part 3).


Eligibility Criteria:
Inclusion Criteria:

For Part 1 and Part 2, healthy volunteers

* Have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m\^2) (BMI = weight/height), inclusive, and a body weight of no less than 50 kilogram (kg) and maximum weight of 100 kg
* Have normal bowel movements, ranging from 1 to 3 times daily to every other day and have normal consistencies according to the Bristol Stool Scale, ranging from 3 to 5 at admission

For Part 3, participants with ulcerative colitis (UC)

* Have a clinical diagnosis of UC at least 3 months before screening
* Have moderately to severely active UC, defined as a Week 0 mayo score of 6 to 12, inclusive, based on central read of the video endoscopy performed during the screening
* Have a greater than or equal to (\>=) 2 endoscopy subscore of the Week 0 mayo score based on central read of the video endoscopy performed during the screening

Exclusion Criteria:

For Part 1 and Part 2, healthy volunteers

* History of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Known allergies, hypersensitivity, or intolerance to antisense oligonucleotides, JNJ-66525433 or its excipients

For Part 3, participants with UC

* Has UC limited to the rectum only or to \<20 centimeter (cm) of the colon evaluated by endoscopy at screening
* Presence of a stoma
* Presence or history of a fistula at any time

COVID-related

* If a participant is excluded due to recent Coronavirus disease (COVID-19) related features, the reason for screen failure should be documented in the case report form under the exclusion criterion of having a condition for which participation would not be in the participant's interest or could confound study assessments
* The field of COVID-related testing (for presence of, and immunity to, the severe acute respiratory syndrome coronavirus 2 \[SARS-CoV-2\] virus) is rapidly evolving. Additional testing may be performed as part of screening and/or during the study if deemed necessary by the investigator and in accordance with current regulations / guidance from authorities / standards of care
Impact of Preoperative Counseling and Education in Reducing Anxiety Levels in Patients With Gynecologic Tumors

The surgical procedure can be considered a transition in the patient's life. The transition can generate instability and produce negative effects, which may be temporary or permanent. Failure to prepare people to deal with the unexpected, such as diagnosing a disease, such as cancer, and surgical necessity can be a frightening and frustrating experience, developing painful and distressing feelings, involving their family members as well.

A preoperative orientation process with potential benefits to the patient has been adopted for some surgical procedures. However, recently some surgical specialties such as orthopedics have been implemented in their routine a potentially modifiable conduct of the emotional trauma of a surgery, is the use of the preoperative advice and orientation, in order to attain an ability to increase the client's satisfaction, to facilitate the recovery, decrease the rate of complications without increasing reintegration, decrease hospitalization time and health costs without additional patient risk. There is a belief among surgeons that preoperative counseling and counseling is vitally important for a post-operative outcome. Despite this, there is a paucity of well-conducted studies that examine the importance of the need for preoperative counseling with detailed information to analyze the yearnings and needs as well as the emotional impact. In addition, there are few studies evaluating the emotional impact and impact in the postoperative period in general of detailed preoperative counseling in patients with gynecological tumors submitted to laparotomy and minimally invasive surgery. For these reasons, this study aims to evaluate whether the application of detailed and clear preoperative counseling and education about the surgical procedure to be performed, as well as all the perioperative guidelines that involve the procedure versus the usual preoperative orientation and preoperative, can have an impact on the level of anxiety of the patient and the companion, as well as assess the degree of satisfaction of the companion.

Eligibility Criteria:
Inclusion Criteria:

* Patients submitted to accessory treatment for tumors of the cervix, vulva, ovary or endometrium.
* Primary therapy, which may be radiotherapy or chemotherapy.
* Patients between the ages of 20 and 80 years.
* Patients submitted to a laparotomic or minimally invasive method (robotic and laparoscopic).
* Patients should be treated at the Oncology Gynecology Service of the Barretos Cancer Hospital.

Exclusion Criteria:

* Patients treated at another oncology service previously.
* Patients who have already been treated for some other cancer in the past.
* Patients without a complete primary level and / or who can not read or write.
* Patients and / or family members who refuse to participate in the study.
* Patients who will be admitted to the ICU.
Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.

The purpose of this study is to see if treatment with sodium bicarbonate will lower urine levels of proteins that are indicators of kidney damage in people with diabetes who also have chronic kidney disease.

Diabetic chronic kidney disease (CKD) is a common problem in Veterans and progresses to end-stage renal disease in many people. It is important to identify treatment strategies that will help prevent the progression of CKD to overt kidney failure. The purpose of this study is to see if sodium bicarbonate reduces urinary markers of kidney damage in Veterans with diabetic CKD and normal serum bicarbonate levels.

Eligibility Criteria:
Inclusion Criteria:

* Veteran
* Age older than 18 years
* Diabetes mellitus
* Serum bicarbonate 22 - 28 mmol/L on the most recent measurement within the past six months
* Stage 2, 3, or 4 CKD (defined as estimated glomerular filtration rate (eGFR) 15 - 89 ml/min/1.73m2 using the CKD-Epidemiology equation)
* Urinary albumin:creatinine ratio \> 30 mg/gm on the most recent sample within the past 12 months.

Exclusion Criteria:

* Lean body weight \> 100 kg
* Use of oral medications typically prescribed to raise low serum bicarbonate levels (i.e. sodium bicarbonate, sodium citrate, potassium citrate).
* Serum potassium \< 3.5 meq/L at enrollment visit
* Use of 5 or more antihypertensive agents, regardless of the indications of each agent
* Systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg at the enrollment or baseline visit
* Diagnosis of congestive heart failure with current, active Class III or IV New York Heart Association symptoms.
* Significant fluid overload such that it is unsafe in the opinion of the PI for the patient to participate in the trial
* chronic gastrointestinal disorder or any other factors judged to be likely to limit adherence to interventions (i.e. alcoholism, a history of missing clinic visits)
* Chronic immunosuppressive therapy for transplanted organs or other indications
* Individuals who are currently a member of a vulnerable population (I.e. incarcerated, pregnant).

  11.Currently participating in another interventional research study
Development of In Vitro Functional Assays From Primary Cells of Patients With Monogenic Diseases

The objective of this project is to build a collection of biological samples consisting of fibroblasts and primary keratinocytes from patients with orphan monogenic diseases and to use these cells in the customization of functional tests. The miniaturized tests we are setting up make it possible to distinguish patient cells from control cells. They can be used to test molecules or for the development of diagnostic tests.

As part of the research protocol, the investigating physicians will be able to perform a skin biopsy on their patient included in the study. APTEEUS will isolate fibroblasts and keratinocytes and ensure their preservation. As part of the project, it is planned to preserve the biological samples collected and to preserve the collection after the end of the study. Skin fibroblasts and keratinocytes that are isolated from the biopsy are cells that can be preserved and amplified. They are a material of choice for the functional study of many monogenic diseases.

This study will allow the adaptation of tools dedicated to the functional study of monogenic diseases in order to help in the research and development of new treatments for these diseases, but also to highlight and explain the inter-individual variability of symptoms and responses to treatments, and finally, to help in the development of diagnostic methods.

Patients with orphan monogenic diseases whose genetic defect has been confirmed and for whom the study of the disease can be performed on fibroblasts, keratinocytes or cells derived from them, may be included in the study. Subjects, after information and consent, will undergo a skin biopsy. The sample will be sent directly to the promoter company APTEEUS, which will carry out all in vitro developments. The fibroblasts and keratinocytes will be preserved and will constitute a collection of cells "orphan monogenic diseases". The samples can be reused for new research in the same field.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an orphan monogenic disease (without any satisfactory therapeutic option).
* Patients with a pathology whose functional cause can be demonstrated by APTEEUS technologies in skin cells or cells derived from them.

Exclusion Criteria:

* Patients whose molecular cause is not clearly identified.
* Patients contraindicated for skin biopsy.
Elastography and Thermography Plantar Fasciopathy Assessment After Radiofrequency Stimulation in a Sporty Population

448kilohertz capacitive resistive monopolar radiofrequency is a novel technique in physiotherapy and its usefulness and clinical relevance is still to be investigated at both clinical practice and also in performance. Current studies show promising results in different musculoskeletal disorders, however there no studies in the assessment of quality soft tissue in sporty population after the used of this technique.

Plantar Fasciopathy pain is is one of the most common musculoskeletal disorders, presenting a high prevalence in primary care centers and sport populations. Many factors have been proposed as the cause of pain, however there are no studies analysing possibilities of preventing foot injuries by using a radiofrequency stimulus.

The use of 448kilohertz capacitive resistive monopolar radiofrequency as the focus of the treatment looking for improve the quality of the tissue is still to be explored.

The hypothesis of the present project is that focus treatments on 448kilohertz capacitive resistive monopolar radiofrequency on the shoulder will produce better outcomes in terms of ultrasound assessment measured by quantified elastography, and this will decreased the possibilities of get injured.

All interventions will be developed by the same examiner, who is a physiotherapist with 6 years of clinical experience.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-50 years --Sporty people with at least 3 days of training per week and presenting an upper limb dominance

Exclusion Criteria:

* Suffer from any painful shoulder condition.
* History of significant shoulder trauma, such as fracture or ultrasonography
* Clinically suspected partial thickness cuff tear, following the classification of Wiener and Seitz.
* Recent shoulder dislocation in the past two years
Eye-Tracking FP "A Pilot Study of the Quantitative Evaluation of the Attention Paid to Faces With Facial Palsy by the Eye-tracking Technology.

The facial palsy concerns between 15 and 40 people per 100000 inhabitants. They are of various etiologies such as infectious, tumoral, traumatic or idiopathic.

It has variable severities with sometimes heavy functional repercussions and different recovery potentials. The proposed palliative treatments are based on surgery, physiotherapy and botulinum toxin injections. However, when recovery is incomplete, acceptance is more difficult, with an impacted quality of life. In this context, patients' expectations and feelings about their care may become difficult for clinicians to apprehend.

The eye-tracking is widely used in the marketing field, but it also finds medical applications including head and neck lesions and facial palsy in particular. Published studies focus on the gaze of photographs, excluding any notion of dynamics and by the analysis of the gaze of outside observers, ignoring the patient's gaze.The main objective is to evaluate the attention paid to the facial side with abnormal facial movement by patients with facial paralysis compared to healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* for patient with facial paralysis:
* Patient with peripheral facial palsy, irrespective of grade, whether or not previously treated
* Patient providing written informed consent
* Patient aged ≥ 18 years
* Patient affiliated to a social security system
* for Healthy voluntary subject :
* Subject without major facial sequelae
* Subject who provided written informed consent
* Major subject ≥ 18 years old
* Subject affiliated to a social security system

Exclusion Criteria:

* for Patient with facial paralysis:
* Patient with recent peripheral facial palsy whose total recovery is possible
* Patient unable to provide written informed consent
* Patient with difficulties to follow instructions and especially to stand in front of a computer screen
* Minor patient \<18 years
* Patient under guardianship or curators or judicial safeguard
* for Healthy voluntary subject :
* Subject with major facial sequelae
* Subject not able to provide written informed consent
* Subject presenting difficulties in following instructions and in particular in standing still in front of a computer screen
* Minor subject \< 18 years old
* Subject under guardianship or curators or judicial safeguard
Taurolock for Preventing Bacterial Peritonitis During Renal Insufficiency

Dialysis catheters are sites of bacterial proliferation. The purpose of this study is to determine whether or not the use of Taurolock (a catheter lock solution) can prevent bacterial peritonitis in patients undergoing peritoneal dialysis.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Renal insufficiency, stage V (HAS 2007 classification)
* Requires incident peritoneal dialysis
* No signs of peritoneal infection on inclusion
* signed consent
* affiliated with a social security system

Exclusion Criteria:

* Patient will have a renal transplant in the upcoming year following dialysis
* Survival prognosis for one year is weak
* allergy to citrate, (cyclo)-taurolidine, or heparin
* patient is taking medication with a known contra-indication with citrate or (cyclo)-taurolidine
* patient has a thrombopenia caused by heparin
* impossible to inform the patient correctly
* patient under guardianship
* patient already included in another biomedical research protocol
* no signed consent
* no social security system
A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood

SRD-Part: To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising doses (SRD) of BI 1569912 BA/FE-Part: To investigate (a) the relative bioavailability (BA) of BI 1569912 and (b) the influence of food (FE) on the relative bioavailability of BI 1569912


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), temperature (T)), 12-lead ECG, and clinical laboratory tests
* Age of 18 to 45 years (inclusive)
* BMI of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
* Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:

  * Use of adequate contraception, e.g. any of the following methods (of female partners) plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device
  * Sexually abstinent
  * Surgically sterilised (including hysterectomy of female partner)
  * Postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the upper limit of normal (ULN) after repeated measurements
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* History of relevant orthostatic hypotension, fainting spells, or any unexplained blackouts
* Chronic or relevant acute infections
* A positive polymerase chain reaction (PCR) test for SARS-CoV-2/COVID-19 and/ or any clinical symptom suggestive for this disease at screening and on Day -3.

Further exclusion criteria apply.
Genetic Biomarker Discovery for Metastatic Prostate Cancer

Biomarkers from circulating cell-free tumor DNA in peripheral blood will identify patients with metastatic prostate cancer diagnosed with C11 choline PET/CT who will benefit from metastasis-directed radiation, ablative therapies, and/or surgery. Tissue and blood will be collected before treatment. If patients receive androgen deprivation, then blood will be collected after neoadjuvant androgen deprivation but before radiation, ablative therapies, or surgery. Subsequent samples will be obtained at 3 months and 6 months following treatment, after which no further patient contact will occur.


Eligibility Criteria:
Inclusion Criteria:

* Men age 18 years old and older.
* Histologically proven diagnosis of prostate cancer.
* Radiographic evidence of non-regional lymph node involvement, pelvic lymph node recurrence, and/or bone metastases.
* Requiring a clinically directed biopsy or resection of tumor at Mayo Clinic Rochester.
* Receiving local therapy for metastatic disease with radiation, ablative therapies, and/or surgery at Mayo Clinic Rochester.
* Willingness to provide blood sample prior to receipt of treatment, as well as after neoadjuvant androgen deprivation therapy and at 3 months and 6 months after radiation, ablation, or surgery.
* Absence of a second active malignancy.
* An understanding of the protocol and its requirements, risks, and discomforts.
* The ability and willingness to sign an informed consent.

Exclusion Criteria:

* Inability on the part of the patient to understand the informed consent or be compliant with the protocol.
* History of a serious or life-threatening allergic reaction to local anesthetics (i.e., lidocaine, xylocaine).
Group Therapy Versus Individual Therapy for Tourette Syndrome and Chronic Tic Disorder

Chronic tic disorder (CTD) may have a huge impact on life quality. Habit Reversal Training (HRT) and Exposure Response Prevention (ERP) are effective therapeutic modalities. This study examined the effect of a combined treatment using both HRT and ERP in children and adolescents with CTD. The treatment outcome was examined as an individual treatment compared to a group setting. There was no control group. The study examined both acute outcome and outcome at one year of follow-up. Predictive factors for treatment outcome were evaluated.

Chronic tic disorder (CTD) may have a huge impact on life quality. Habit Reversal Training (HRT) and Exposure Response Prevention (ERP) are known to be effective therapeutic modalities. Little is known about the effect of group therapy, the effect of combining HRT and ERP training, and of the long-term effect of treatment. This study therefore wanted to examine the effect of a combined treatment using both HRT and ERP in children and adolescents with CTD. The participants were randomized to treatment either in groups or in an individual setting. The parents were included in the training programme. The participants were asked to fulfill questionnaires concerning anxiety, mood, life quality, their thoughts about tics and the experienced premonitory urge. Furthermore, they were interviewed with the semistructured interview Yale Global Tic Severity Scale (YGTSS).

Data was obtained from patient files as to examine possible predictors of both acute and long-term treatment effects. The evaluators were a specialized psychologist and a child and adolescent psychiatrist with several years of experience in diagnosing, evaluating and treating tic disorders. A random sample of 10% were audiotaped and evaluated by another rater with extensive experience and expertise in the use of the YGTSS. The evaluator was not blinded to the treatment allocation, yet not involved in the treatment of the patient, and blinded to any previous evaluations

Eligibility Criteria:
Inclusion Criteria:

* A primary diagnosis of either Tourette syndrome or a chronic motor/vocal tics disorder
* Moderate or greater severity corresponding to a total score on the Yale Global Tic Severity Scale (YGTSS) higher than 13 (higher than nine if only motor or vocal tics were described)

Exclusion Criteria:

1. Disorders that required immediate treatment

   * psychotic disorder
   * primary severe depression
   * suicidal ideation or attempts
   * primary severe anorexia nervosa
2. Disorders that makes participation difficult

   * IQ below 70
   * a life-time diagnosis of pervasive developmental disorder
3. Treatment with HRT or ERP during the last six months.
Pilot Study of a Nerve Block Simulator for the Training in Axillary Blocks

The purpose of this study is to determine whether an ultrasound-guided nerve block simulator is effective for the training of the axillary block technique.

Ultrasound-guided nerve blocks are becoming the standard of care in patients requiring regional anesthesia. Cost-effective training is needed for the implementation of these techniques in the global anesthesia practice. Existing simulators are expensive and not available in low income countries. The investigators aimed to test an inexpensive simulator for the training in this technique.

Eligibility Criteria:
Inclusion Criteria:

* Anesthesia residents

Exclusion Criteria:

* Previous training in regional anesthesia techniques