cyrilzakka/clinical-trials huggingface dataset:
A Comparison Study of Persistence of UPadacitinib vs. TNF-inhibitoRs In a German Real-world SettING

This study will compare the retention rates for UPA vs. TNFi treatment in adult participants with moderate to severe active RA per local label and according to local standard of care

This is a mono-country, prospective, multi-center observational study in patients with moderate to severe active RA receiving UPA or TNFi therapy. Around 678 participants will be enrolled in approximately 80 sites in Germany.

Study recruitment will last approximately 24 months, and the study participation time will be up to 24 months, for a total study duration of approximately 48 months.


Eligibility Criteria:
Inclusion Criteria:

* Current or Past participants with a confirmed diagnosis of moderate to severe active RA upon judgement of the treating physician.
* Physician decision on participant treatment with Upadacitinib (UPA) or tumor necrosis factor inhibitor (TNFi) must have been reached prior to and independently of recruitment in the study
* UPA or TNFi prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies

Exclusion Criteria:

* Participation in a clinical trial with an investigational drug (within a minimum of 30 days or 5 half-lives of the investigational drug \[whichever is longer\] prior to baseline)
* Prior treatment with Upadacitinib
* Prior treatment with the same tumor necrosis factor inhibitor as the one prescribed for this study
Strategic Intervention on Preserving Language Function During Awake Craniotomy

This study is designed to compare the language function after traditional or a new surgical plan during awake craniotomy for glioma resection.

This study concentrates on patient who has type II language area glioma occupation. The investigators designed new surgical plan which is using monopolar stimulator to determine and retain the tumor margin within 5 mm from the posterior superior longitudinal fasciculus or posterior arcuate fasciculus. For the tradiitional surgical plan, the investigators use bipolar stimulator according to the current standard surgery plan. After they positive points are identified by stimulator, the positive points are retained to preserve the motor function while all the negative points of the tumor are resected. This study is to determine whether the new surgical plan is more suitable for type II language area glioma occupation.

Eligibility Criteria:
Inclusion Criteria:

1, patients with glioma near or on the language function area that have the necessity to undergo awake craniotomy and language function identification during tumor resection

Exclusion Criteria:

1. patients with incompleted monitoring procedures;
2. paitents without data of the pre-and postoperative resting state MRI, diffuison tensor image and functional MRI.
Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin

The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during long-term concomitant low-dose aspirin therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of low-dose aspirin.


Eligibility Criteria:
Inclusion Criteria:

1. Participants who require continuous low-dose aspirin therapy during the treatment period with the study drug
2. Participants who have completed the preceding study
3. Outpatient (including inpatient for examinations)

Exclusion Criteria:

1. Participants deemed to be ineligible to participate in the study by the principal investigator or investigator due to the occurrence of adverse events in the preceding study
2. Participants who are scheduled to change the type and dosage regimen of low-dose aspirin
3. Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed during the preceding study
4. Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology
5. Participants who have a history of surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy) or who are scheduled to undergo such surgery
6. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
7. Participants with a previous or current history of aspirin-induced asthma
Study of Undertreatment of Patients With Dyslipidemia in Bulgaria

The purpose of this study is to establish the proportion of Bulgarian patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Fourth Joint European Task Force guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks
* Signed Informed Consent

Exclusion Criteria:

* Informed Consent not provided
Diagnostic Performance of Exercise Stress Tests for the Detection of Epicardial and Microvascular Coronary Artery Disease

Prospective, single-arm, multicenter study of patients with an intermediate pre-test probability of CAD and positive exercise stress tests referred for invasive angiography. Patients underwent an invasive diagnostic procedure (IDP) with measurement of fractional flow reserve (FFR) and index of microvascular resistance (IMR) in at least one coronary vessel. The objective was to determine the false discovery rate (FDR) of cardiac exercise stress tests with both FFR and IMR as references.

The Redefining the Diagnostic Performance of Non-invasive Tests for the Detection of Coronary Artery Disease: UZ Clear is an investigator-initiated, single-arm, multicenter, prospective study of patients presenting with chest pain with an intermediate probability of CAD. The intermediate pre-test probability of CAD was defined based on the European Society of Cardiology Guidelines as a score between 15% and 85% based on age, sex, and the nature of symptoms. All patients had a positive exercise stress test and were referred for an invasive evaluation. Patients underwent a study protocol with an invasive diagnostic procedure (IDP) consisting of measurements of FFR and IMR in at least one coronary vessel. Exclusion criteria are acute coronary syndromes, known coronary artery disease, previous myocardial infarction, previous revascularization, and abnormal baseline electrocardiogram (ECG). All data were centrally collected and analyzed by the core laboratory.

The primary objective was to determine the false discovery rate of exercise stress tests using an interventional diagnostic procedure (IDP) with indexes of epicardial (FFR) and microvascular resistance (IMR) as clinical references. The secondary objective was to assess the impact of an IDP accounting for the presence of CMD on the accuracy of exercise stress tests.

Eligibility Criteria:
Inclusion Criteria:

- 1. Stable angina-like chest pain (typical or atypical) with intermediate (15-85%) pre-test probability of coronary artery disease using the ESC criteria.

2. Positive non-invasive exercise test, or inconclusive stress with additional positive imaging.

Exclusion Criteria:

1. Age \<30 or \>80-year old
2. Acute coronary syndromes.
3. Known coronary artery disease
4. Inability to perform exercise tests.
5. Previous myocardial infarction.
6. Previous CABG/PCI
7. Left ventricular dysfunction EF \<35% or NYHA class III-IV
8. Uncontrolled or recurrent ventricular tachycardia
9. Atrial fibrillation
10. Severe renal dysfunction, defined as an eGFR \<30 ml/min/1.73m2
11. Contra-indication to adenosine (e.g. asthma bronchial, severe COPD)
12. Active cancer
13. Recent stroke
14. Cardiomyopathy (dilated, hypertrophic, amyloidosis, arrhythmogenic right ventricular dysplasia)
15. Left Bundle Branch Block or baseline ST-segment depression \>1mm.
16. Congenital heart disease
17. More than moderate valve disease
The Effect of Oral Hyaluronic Acid (UltraHA®) on the Knee Function

This clinical trial aims to clarify the effect of UltraHA® on knee joint conditions.

In this study, the investigators will evaluate the knee condition before and after the intervention. The groups to be compared are two different doses of UltraHA® and a placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Japanese
2. Men or women
3. Adults
4. Healthy subjects
5. Subjects whose skin viscoelasticity is relatively low at screening (before consumption)
6. Subjects whose BMI are 23 kg/m\^2 or more and less than 30 kg/m\^2
7. Subjects who are judged in the Kellgren-Lawrence grade (KL grade) as either 0 or 1 in X-ray
8. Subjects whose WOMAC score is relatively high

Exclusion Criteria:

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
5. Subjects who consciously consume foods that contribute to knee joint improvements, such as collagen and chondroitin sulfate
6. Subjects who are currently taking medications (including herbal medicines) and supplements
7. Subjects who are allergic to medications and/or the test-food-related products (particularly alcohol)
8. Subjects who are pregnant, lactating, or planning to become pregnant during this trial
9. Subjects who suffer from COVID-19
10. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
11. Subjects who are judged as ineligible to participate in this study by the physician
CArdiac Desynchronization In Obstructive HCM, CARDIO-HCM

The purpose of this study is to evaluate the benefit of the optimal pacing configuration, including the possibility of biventricular or left ventricular pacing, in hypertrophic obstructive cardiomyopathy patients.

In this study, subjects will be randomized to Cardiac Resynchronization Therapy-Defibrillation (CRT-D) or Cardiac Resynchronization Therapy-Pacing (CRT-P) vs Pacing Therapy AAI. Randomization will be stratified by indication. Optimal pharmacological therapy in both treatment arms. Length of follow-up for each subject will be 2y, since all subjects will be followed to a common study termination date.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hypertrophic Obstructive Cardiomyopathy with significant left ventricular obstruction (baseline LVOT gradient more 50mmHg and severe symptoms

Exclusion Criteria:

* HOCM intraventricular gradient \< 50mmHg
* LV ejection fraction \< 50%
* mild symptoms
The Effect of Bariatric Surgery on Spermatogenesis

Little is known about the effects of weight loss surgery on male reproductive health. This study will investigate the effect of bariatric surgery on male infertility by evaluating sexual health, blood hormone levels, and semen parameters before and after roux-en-y bariatric surgery.

Obesity is a worldwide epidemic that has numerous health consequences including male infertility. Prior studies have shown a variety of health benefits with bariatric surgery, including an improvement/resolution in diabetes and a significant improvement in serum testosterone levels. Based upon preliminary data from the literature, the investigators hypothesize that bariatric surgery is associated with a transient decrease followed by a robust long-term improvement in semen parameters including DNA fragmentation and oxidative stress. To test this hypothesis, the investigators propose a prospective observational study examining changes in hormone and semen parameters over the 12 months following Roux-en-Y gastric bypass surgery. The investigators will correlate these changes to weight loss, changes in subjective sexual function, and advanced semen parameters including DNA fragmentation. If successful, this study will conclusively identify a new modifiable cause for male infertility and suggest an additional medical indication for bariatric surgery in obese infertile men.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 18-55
* Undergoing Roux-en-Y bariatric surgery

Exclusion Criteria:

* History of undescended testes
* Prior scrotal surgery
* Known karyotypic abnormalities
Stepping Stones and Creating Futures Plus Pilot

The goal of this randomised controlled clinical trial is to test the Stepping Stones and Creating Futures Plus (SSCF+) intervention, in young (18-25 years) people living in urban informal settlements in Durban and rural communities in KwaZulu-Natal, South Africa. The main questions it aims to answer are:

* Is the intervention acceptable and feasible
* What is the potential effect size on key outcomes of intimate partner violence

Participants will be randomised (1:1) to compare SSCF+ and a control arm to see if there are differences between the two on intimate partner violence.

Intimate partner violence is very common in South Africa, particularly urban informal settlements. We have co-developed an intervention, called Stepping Stones and Creating Futures Plus (SSCF+), which will be evaluated in women and men aged 18-25 years living in KwaZulu-Natal, South Africa.

This is a pilot randomised controlled trial and as such there is focus on understanding whether the intervention is acceptable (to participants), feasible to deliver, and the potential effect sizes we may see in a full trial.

Eligibility Criteria:
Inclusion Criteria:

* Normally resident in the community where recruiting
* Aged 18-30 years old
* Not in formal employment, or full-time education
* Able to communicate in the main languages of the study (English, isiXhosa or isiZulu)
* Able to provide informed consent

Exclusion Criteria:

* Only in the community temporarily
* Unable to provide informed consent
* Under 18 years of age, or over 31 years old at point of recruitment
* Unable to communicate in main study languages
An Open-Label Pilot Study of Sublocade as Treatment for Opiate Use Disorder

The proposed study is a 12-week, open-label pilot study of sublocade (extended-release burprenorphine, BXR) as treatment for opiate use disorder (OUD) testing positive for Highly Potent Synthetic Opioids (HPSO). The investigators plan to enroll 10 participants into the study.

This is an open-label, uncontrolled pilot study. Outpatients seeking treatment for Opiate Use Disorder (OUD) will be screened, and those eligible who are positive for fentanyl analogues at screening will be consented and inducted onto sublingual buprenorphine (target dose 16mg to 24mg). On the fourth day after starting the buprenorphine induction, participants will receive sublocade (BXR) 300mg by subcutaneious injection. Participants will be seen twice per week for urine collection for toxicology and research assessments and will have Medication Management counseling weekly during one of these visits. BXR will be administered monthly and dosing will be according to the FDA prescribing instructions of 300mg for the second dose and 100mg for the third.

Eligibility Criteria:
Inclusion Criteria:

* Individuals between the ages of 18-65
* Voluntarily seeking treatment for opioid use
* Meets current DSM-5 (Diagnostic and Statistical Manual) criteria for Opioid Use Disorder (OUD) as a primary diagnosis, with at least moderate severity
* Test positive for Highly Potent Synthetic Opioids (HPSO) use
* Able to provide informed consent and comply with study procedures

Exclusion Criteria:

* Meets DSM-5 criteria for substance use disorder other than opioid as the primary diagnosis
* Having a comorbid psychiatric diagnosis that might interfere with participation or make participation hazardous, such as an active psychotic disorder or current suicide risk
* Methadone maintenance treatment
* Buprenorphine maintenance treatment
* Known history of allergy, intolerance, or hypersensitivity to candidate medication (buprenorphine)
* Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients, male participants are required to use adequate forms of birth control as the exposure to Sublocade on sperm and subsequent fetal development are not known.
* Unstable medical conditions, which might make participation hazardous such as uncontrolled hypertension (blood pressure \>150/100), acute hepatitis, uncontrolled diabetes, or elevated liver function tests (AST (aspartate transaminase) and ALT (alanine aminotransferase) \>3 times the upper limit of normal
* Legally mandated to substance use disorder treatment
* Current physiological dependence on alcohol or sedative-hypnotics that would require a medically supervised detoxification-other substance use diagnoses are not exclusionary
* Individuals, who in the clinicians judgment, have a history of failed trial of buprenorphine or sublocade (e.g. history of severe opioid intoxication or overdoses despite adequate adherence to buprenorphine or sublocade), or other features of the history that strongly suggest the patient is not a good candidate for outpatient treatment with buprenorphine.
Pharmacokinetics Study of NI-071

The purpose of this study is to assess equivalence of pharmacokinetics between NI-071 and infliximab(the comparator) in Japanese healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, clinical laboratory tests, etc.)
2. Body Mass Index (BMI) of 18.5 to 25.0 kg/m2, and a total body weight of 50 to 80 kg

Exclusion Criteria:

1. Subjects with a following past History or concomitant diseases

   * Chronic or recurrent infectious disease
   * Demyelinating disease
   * Congestive heart failure
   * lymphoproliferative disorder or myelodysplastic syndrome
   * Malignancy
   * Interstitial lung disease
2. Subjects with active or latent tuberculosis or history of tuberculosis
Yoga for a Healthy Heart

The Yoga for a Healthy Heart study will address various barriers to both medication management and blood pressure regulation for African American patients with hypertension.

The program will take place in person at South Pointe's hospital community outreach center. The program will be an 8-week program, once per week, 60 minutes in length, consisting of meditation, or relaxation, pranayama which are breathing techniques and asana, or physical postures. Yoga, is defined as the fluctuations or roaming tendencies of the mind according the Patanjali's Yoga Sutras. In addition to therapeutic yoga techniques, lifestyle management will be discussed or self-reflections written in journals. Lifestyle management skills include learning how to take blood pressure and manage a pillbox, as well as develop prosocial communication skills through lessons on mindful communication. The classes will be taught in person. The instructor facilitating the program will be a skilled healthcare professional certified in both Occupational Therapy and Yoga teaching at the 500-hour level. The Occupational Therapist will provide both skilled assessments and interventions in the group setting of the community health class. Assessments include: 1. Perceived Stress Scale 2. Canadian Occupational Performance Measurement 3. Mini and Medi-Cog 4. Blood pressure assessments pre and post class.

.

Eligibility Criteria:
Inclusion Criteria:

* Over 18
* has transportation to South Pointe Hospital
* Has the ability to walk, or use a wheelchair from the entrance of the building
* Able to attend all 8 sessions
* Diagnosis of hypertension
* African American
* Prescribed antihypertensive medication
* Able to stand up from the chair independently
* Able to walk to the bathroom independently with or without a device
* Approved by cardiologist to participate

Exclusion Criteria:

* Unable to tolerate sitting for 1 hour
* BP over 200/100
* Unable to independently walk or use a wheelchair to the bathroom
Comparison of Two Daily Disposable Lenses

The purpose of this study was to compare the clinical performance of the new DAILIES® AquaComfort PLUS® FreshTech (DACP FreshTech) contact lenses to an already marketed daily disposable contact lens, DAILIES® AquaComfort PLUS® (DACP).

Subjects attended 4 scheduled visits for an expected duration of participation of 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

* At least 3 months of soft contact lens wearing experience;
* Wears habitual lenses at least 5 days per week and at least 8 hours per day;
* Uses digital devices (computer, tablet, and/or smart phone) for an average of 4 hours per day;
* Experiences eye fatigue at least once per week attributable to digital device use with habitual lenses;
* Is willing to NOT use rewetting/lubricating drops during the period of study product exposure;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Routinely sleeps in contact lenses;
* Known pregnancy at time of enrollment;
* Binocular vision issues or issues of eye alignment;
* Any eye infection, inflammation, disease or abnormality that contraindicates contact lens wear;
* Use of medications as specified in the protocol;
* Ocular surgery within the past 12 months;
* Other protocol-specified exclusion criteria may apply.
Slow and Deep Breathing to Lower Blood Pressure in Women With Pregnancy-induced Hypertension

This study evaluates the effect of slow and deep breathing on lowering blood pressure in women with pregnancy-induced hypertension. Slow and deep breathing will be practised daily for 10 minutes from enrolment until the woman gives birth. This feasibility study aims to investigate the practicality of conducting a proposed future randomised controlled trial.

In addition to the slow and deep breathing intervention the women will undertake a short protocol investigating the physiological responses to slow and deep breathing during their initial meeting. The women will undertake 4 separate 5-min breathing exercises with a 5 minute rest period between each exercise. The breathing exercises are normal breathing, and fixed breathing frequencies of 4, 6 and 8 breaths per minute. Blood pressure, heart rate and breathing rate will be monitored continuously, and non-invasively, throughout each breathing protocol.

The women will also have the opportunity to provide feedback on the intervention and their experiences in an online survey at 36 weeks gestation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with pregnancy-induced hypertension (PIH). Defined as "new hypertension presenting after 20 weeks of pregnancy without significant proteinuria (urinary protein:creatinine ratio greater than 30mg/mmol" by NICE guidelines (2010) OR diagnosed as having one-off high blood pressure but at risk of developing PIH;
* Single pregnancy;
* Capable of giving informed consent;
* Age over 18.

Exclusion Criteria:

* Under 18 years old;
* Referred immediately to obstetric-care after PIH diagnosis for an immediate intervention, with systolic blood pressure over 160 mmHg or diastolic blood pressure over 100 mmHg;
* Multiple pregnancy (twins, triplets, etc.);
* Current smoker;
* Current diagnosis of respiratory diseases; asthma, COPD (Chronic Obstructive Pulmonary disease), bronchitis. (A previous occurrence or diagnosis that has not been present for longer than 1 year ago does not exclude participants, i.e. childhood asthma);
* Allergy/reaction to gel used on ECG tabs;
* Vulnerable participants who are unable to give informed consent.