cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Once Daily Low Dose and High Dose Solabegron or Placebo Given for 12 Weeks to Treat Women With Symptoms of Overactive Bladder: Sudden Urge to Urinate, Frequent Urination Associated With Wetting Episodes (VEL-2001)

This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of solabegron modified release low dose or high dose tablets, compared to matched placebo, administered once daily for 12 weeks to adult female subjects with overactive bladder symptoms (frequency, urgency, and predominantly urgency incontinence) for at least 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult female subjects 18 to 80 years of age, with a ≥ 6-month history of symptoms of overactive bladder including: frequency, urgency, urgency urinary incontinence, and mixed incontinence. Subjects must provide written informed consent and either be of non-childbearing potential or of childbearing potential meeting specific criteria (e.g., negative pregnancy test, sexual inactivity, acceptable methods of birth control, and use of hormonal contraceptives).

Exclusion Criteria:

* Subjects must have no history of pelvic or bladder disease, e.g., uterine prolapse, malignancy, prior surgery, or treatment with botulinum toxin.
* Diabetes insipidus or poorly controlled Type 1 or Type 2 diabetes mellitus
* Cardiac conditions:
* prior cardiovascular events or procedures within 6 months of screening
* congestive heart failure
* abnormal ECG findings, including ECG QT correction interval (QTc) \> 470 msec at the Screening Visit
* systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg, or heart rate \> 100 beats per minute
* Abnormal tests of liver function
* History of prior infection due to HIV or hepatitis B or hepatitis C virus
* Allergy or hypersensitivity to solabegron or mirabegron
* Women of childbearing potential: breastfeeding, pregnant, or actively trying to become pregnant
* Participation in a trial of an investigational or marketed drug ≤ 30 days prior to the Screening Visit or in any clinical trial of an investigational drug that may affect urinary function within 3 months prior to Screening Visit.
* Inability to read, understand, or complete study-related materials
mTLIP vs. ITP Blocks in Lumbar Disc Surgery

to compare ultrasonography (USG)-guided intertransverse process block and modified thoracolumbar interfascial plan (mTLIP) block in the treatment of postoperative pain in patients undergoing lumbar disc herniation surgery under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old
* ASA I-II-III risk group
* Patients whose consent was obtained with an informed consent form
* Patients who will undergo lumbar disc herniation surgery

Exclusion Criteria:

* Patients who refused to participate in the study
* Allergic to local anesthetics
* Patients with coagulopathy
* Infection at the site of intervention
* Patients under 18 years of age
* Patients with ASA score IV and above
* Chronic pain disorders
* Those with neurological or neuromuscular disease
* Patients with psychiatric problems
* Patients with a history of opioid use
* Chronic use of NSAIDs
* Those contraindicated for regional anesthesia
* Patients with a history of opioid use
* Chronic analgesic use
Effect of Genetic Polymorphisms on Response to Preoperative NSAIDs in Endodontic Postoperative Pain Management

This study aims to evaluate the influence of genetic polymorphisms on the effectiveness of preoperative non-steroidal anti-inflammatory drugs (NSAIDs) in managing postoperative pain following endodontic treatment. Participants will receive standard preoperative NSAIDs before undergoing root canal therapy, and their pain responses will be assessed. Genetic analysis will be performed to investigate possible associations between drug response and individual gene variations. The study seeks to improve personalized approaches in endodontic pain management.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged between 18 and 65 years
2. Vital mandibular molar teeth diagnosed with symptomatic apical periodontitis
3. ASA physical status classification I or II
4. Preoperative VAS pain score greater than 50
5. No known genetic disorders (e.g., Down syndrome, congenital insensitivity to pain)

Exclusion Criteria:

1. Patients classified as ASA III or higher
2. Pregnant women or those suspected of being pregnant
3. Presence of root canal curvature greater than 25° (Schilder classification)
4. Patients with generalized periodontitis
5. Presence of periodontal pockets deeper than 3 mm in the affected tooth
6. History of systemic disease or known allergies
7. Patients with diagnosed psychiatric or psychological disorders
8. Presence of swelling, sinus tract, or preoperative tenderness on palpation
9. Patients with bruxism
10. Presence of resorption in the affected tooth
11. Use of analgesic or anti-inflammatory drugs within 12 hours prior to the procedure
12. Teeth with root fractures, ankylosis, or pathological mobility
Effects of Remote Ischemic Preconditioning on Peripheral Blood Biomarkers in Healthy Adults (EMINENT)

The aim of this study is to investigate the effects of remote ischaemic preconditioning on the peripheral blood characteristics of healthy adults and to explore the possible mechanisms for improving ischaemia/reperfusion injury and its protective effects on the cardiovascular system.

This study plans to recruit 60 healthy volunteers, who will be randomly divided into a high-frequency group and a low-frequency group. The high-frequency remote ischemic preconditioning (RIPC) group will undergo RIPC training continuously for seven days, twice daily, with each session consisting of four cycles of 5 minutes of ischemia followed by 5 minutes of reperfusion. The low-frequency RIPC group will follow the same cycle and compression pattern but will train only once a day. Biological samples and physiological indicators will be collected from participants on the day just before the start of ischemic preconditioning training, as well as on the 7th and 14th days following the start of the training. These samples will be analyzed to identify the differences in blood components between groups and at different time points before and after RIPC. The study aims to investigate the effects of different training frequencies of RIPC on the characteristics of peripheral blood in healthy adults, as well as the changes in the peripheral blood characteristics of the participants before and after the training.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 45 years;
* Be in good health;
* Consent to participate in the clinical trial and sign the informed consent form.

Exclusion Criteria:

* Abnormal results in biochemical checks and physiological indicators.
* Cardiovascular and cerebrovascular diseases: hypertension, coronary heart disease, congenital heart disease, cerebrovascular alterations, etc.
* Endocrine diseases: diabetes, thyroid disorders, etc.
* Hematologic diseases: anemia, paroxysmal hemoglobinuria, primary thrombocytosis, etc.
* Infectious diseases: hepatitis B, hepatitis C, syphilis, etc.
* Cancer.
* Neurological and psychiatric disorders.
* Vascular diseases: peripheral vascular disease, Raynaud's syndrome, thromboembolic diseases.
* Major trauma or surgery within the last six months.
* Pregnant or breastfeeding women.
* Upper limbs unsuitable for compression treatment: history of upper limb surgery, presence of tissue damage and limb deformity, and concomitant hemorrhagic diseases.
* Recent circumstances that may affect results: blood donors within the last month, any medication taken within the last month, fever within the last week, women within their menstrual cycle or within 7 days before the start of menstruation.
* Patients who refuse to sign the informed consent form for participation in this study.
Goal-directed Therapy in High-risk Surgery

There is growing evidence that the risk of postoperative complications can be decreased by optimizing the amount and type of infusion fluids given during surgery, steered by goal-directed therapy based on flow-related hemodynamic parameters, particularly in high-risk patients. This study is undertaken subsequently to test the hypothesis that the intraoperative goal-directed strategy based on FloTrac/Vigileo, a minimally invasive monitor, can partially prevented postoperative complications and shorten hospital stay in the elderly high-risk patients undergoing total hip replacement with continuous spinal anaesthesia .

After sedated with IV 0.02 mg/kg midazolam, all patients will receive arterial, central venous, and L3-4 intrathecal catheterizations. A T12 sensory level block was attained with ropivacaine through the intrathecal catheter. Besides currently recommended monitoring during the intraoperative period, arterial blood pressure, stroke volume (Edwards Lifesciences, Irvine, Calif.), and central venous oxygen saturation (Edwards Lifesciences) will be measured and recorded. All Patients will receive intranasal oxygen 2 mL/min and be kept normothermic (body temperature \> 36°C). Patients in both groups receive 8 mL/kg/hour of Ringer's lactate solution from 30 minutes prior to induction of anaesthesia through the end of surgery, when the rate will be decreased to 100 mL/hour. In addition, boluses of colloid will be given to different protocol group according to the study arm to which the patient allocated.Postoperative care and discharge criteria were predefined using the hospital care map and protocol.

Eligibility Criteria:
Inclusion Criteria:

* 1. Adult patients scheduled for total hip replacement at this institution.
* 2. American Society of Anaesthesiologists (ASA) physical status of III or VI.
* 3. Two or more risk factors according to risk index of Lee .

Exclusion Criteria:

* 1. Age under 70years old
* 2. idiopathic coagulopathy: with warfarin or heparin
* 3. systemic or local infection
* 4. unable to cooperate
* 5. spinal trauma or severe low back pain history
* 6. patient refusal.
A Study to Evaluate of the Absorption, Metabolism, and Excretion of 14C-JNJ-39823277 in Healthy Male Participants

The purpose of this study is to investigate the absorption, metabolic pathways and excretion of JNJ-39823277 in healthy male adults after administration of a single oral dose of a 25 mg (0.5 mg/mL solution) of 14C-JNJ-39823277.

This is an open-label (all people know the identity of the intervention) and single-arm (group) study. The study consists of 3 phases including, the screening phase (within 3 weeks prior to the start of study medication), treatment phase (8 to 15 days), and the follow-up phase (up to 6 days after the discharge from the hospital). Approximately 6 participants will be receiving the 14C-JNJ-39823277 in the study. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, 12-lead electrocardiogram, and clinical laboratory tests which will be monitored throughout the study. The total duration of study will be up to approximately 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 20 and 30 kg/m2 (BMI will be calculated as weight \[kg\]/square of height \[square meter\])
* Had consistent bowel movement habit (approximately once per day) within 30 days before dosing
* No clinically significant laboratory and electrocardiogram abnormalities

Exclusion Criteria:

* Exposure to radiation for professional or medical reasons (exception of dental x rays and plain chest x ray) within 1 year before study medication administration
* History of or current clinically significant medical illness
* Clinically significant abnormal laboratory values, physical examination
* Positive test for drugs of abuse, such as cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines, or barbiturates at screening and on the study medication administration
Investigating ACute HeArt FailuRe Decongestion Guided by Lung UltraSonography

The goal of this clinical trial is to investigate whether a lung ultrasonography (LUS)-guided decongestion strategy in adults hospitalized for acute heart failure (AHF) can improve patient-centered outcomes.

The main questions it aims to answer are:

* Does this strategy shorten the length of stay and reduce early hospital readmissions?
* Does this strategy improve patients' symptoms and quality of life ?

Researchers will compare LUS to physical examination (PE).

Background: Despite recent medical advances, AHF remains one of the leading causes of hospital admissions and one of the most frequent reasons for readmission. As the main reason for AHF hospitalization is congestion-driven symptoms, the cornerstone of treatment is decongestive therapy. In the absence of specific quantitative measures, however, undertreatment often occurs and is associated with an increased risk of readmission. LUS is highly accurate for detecting extravascular lung water (EVLW). It has shown clinical benefits when used to guide decongestive therapy in chronic heart failure ambulatory patients. However, data for its use in AHF inpatients are currently lacking.

Aim: To investigate the effect of a bedside LUS-guided decongestive therapy in hospitalized AHF adults on patient-centered outcomes, as compared to usual care.

Methodology: This will be a Swiss multicenter, blinded, randomized controlled trial (RCT) aiming to recruit 222 adults hospitalized for congestive acute heart failure (AHF). Study participants will be included within the first 48 hours of their hospital arrival. Patients will be randomized to either a LUS-guided decongestive strategy or a decongestive strategy based on a structured physical examination. The primary outcome will be the number of days spent alive outside the hospital within a 40-day timeframe from study inclusion (DAOH-40). This outcome integrates length of stay, early readmission, emergency room visits, and mortality.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Planned or actual admission to intermediate care units, general internal medical or cardiology wards
* Diagnosis of congestive AHF on admission chart (primary or secondary diagnosis)
* Raised value of N terminal-pro-brain natriuretic peptide (≥1000 ng/l).

Key Exclusion Criteria:

* Known isolated right heart failure
* Systolic blood pressure \<90 mmHg, mean arterial pressure \<65 mmHg at the moment of inclusion
* The following conditions mimicking lung cardiogenic oedema on LUS if known at inclusion and documented: Interstitial lung disease, lung cancer or metastasis, acute respiratory distress syndrome, pulmonary contusion
* Known virologically confirmed SARS-CoV-2 pneumonia in the preceding 3 months
* Unwillingness to give consent
* Subjects who are pregnant or breastfeeding
* Hospitalisation for palliative care and probable end-life within 30 days
Drug Interaction Between Ritonavir And Sitaxsentan

The study is to assess if sitaxsentan and ritonavir will affect the blood levels of each other when coadministered.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects and/or women of non-child bearing potential.
* Subjects (because of teratogenic risk of sitaxsentan) between the ages of 21 and 55 years, inclusive.
* Signed informed consent.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* History of significant alcohol and drug use.
* Has hepatic dysfunction.
Ziprasidone in the Psychosis Prodrome

This study aims to determine whether ziprasidone is superior to placebo over 24 weeks for patients with the psychosis prodrome.


Eligibility Criteria:
Inclusion Criteria:

* Structured Interview for Psychosis-risk Syndromes criteria for Clinical High Risk for Psychosis
* clinically referred

Exclusion Criteria:

* prolonged corrected QT interval
* history of syncope
rTMS in Wilson Disease Dysarthria

Wilson disease is a hereditary hepatic and neurological disease associated with copper accumulation. Neurological symptoms are of extra-pyramidal, cerebellar and dystonic origin. Dysarthria is one of the debilitating symptoms of Wilson disease poorly responsive to pharmacological treatment. The most common form is a dystonic hyperkinetic Dysarthria.

Pathophysiology of dystonia is still not elucidated. Motor cortex hyperexcitability has been demonstrated in various forms of dystonia. Furthermore, rTMS inhibitory applied over motor cortex has been shown to transitory reduce dystonic symptoms in various forms of dystonia.

In the present study, we investigate the effect of a single 1Hz 20-minutes inhibitory rTMS session applied over the motor laryngeal cortex on dyasarthria is the main kinetic dysarthria has been shown to be associated with inhibition of laryngeal motor cortex in Parkinson disease.

A consecutive series of Wilson disease patients with dystonic hyperkinetic dysarthria will be prospectively recruited.

Patients will receive 3 days apart to two rTMS sessions.

rTMS procedures will be performed with a figure of eight coiled. A single 20-minutes 1 Hz biphasic stimulation (1200 pulses) session will be applied over the laryngeal motor cortex. A brain imaging positioning device will be used during all the procedure A second stimulation session will be performed 3 days apart.

Patients will be centrally randomized to receive first either the active stimulation (80% of the resting motor threshold) or the sham stimulation (using a visually identical coil to reproduce the click sound and the scalp sensation of the active coil).

A TMS evaluation of cortical silent period over the left motor cortex will be performed before the first rTMS session.

Before and immediately after each stimulation (active or sham) patient will received an clinical evaluation including Clinical Assessment Battery for Dysarthria intelligibility score, "A" phonation time, diadococinesia , bucco-linguo-facial motricity score and UWDRS.

A standard 20-minutes EEG will be performed before the first rTMS session and immediately after the second rTMS session.

Eligibility Criteria:
Inclusion Criteria:

* Conseting adult patients with social insurance
* Wilson disease with dystonic hyperkinetic dysarthria
* Stable pharmacological therapy n the last 6 monts
* Brain MRI in the previous 6 months, without additional brain lesion
* Patients that did not receive botulinium toxin in the previous 4 months

Exclusion Criteria:

* Incapacitated adult
* Previous mdedical history of epilepsia
* Pregnancy or breastfeeding
* Brain lesion outside basal ganglia on brain MRI
* Patient consider by the investigator not able to sustain an 30 minutes rTMS session without moving
* Vocal chord lesion
* Previous history of laryngeal surgery
* rTMS contra indication
Evaluation of Plasma Angiotensin II and Angiotensin II Receptor Levels in Patients With Sepsis and Septic Shock: a Prospective Observational Study.

Evaluation of plasma angiotensin II and angiotensin II receptor levels in patients with sepsis and septic shock: a prospective observational study.

There is an increasing number of experimental publications investigated effects of angiotensin II and receptors on the pathogenesis and treatment of sepsis and septic shock. However, its level in humans and its relationship with the severity of the disease has not been investigated. If angiotensin II plays a role in the diagnosis and prognosis of septic shock by evaluating this relationship in our study, it may be a biomarker to be used in future diagnosis, prediction of prognosis and treatment. This will enable early recognition and treatment of this disease, which causes high mortality and cost in intensive care units, thus increasing the survival rate and reducing the cost.

Eligibility Criteria:
Inclusion Criteria:

* intensive care unit patient

Exclusion Criteria:

* End-stage organ failure,
* immunodeficiency, vasospastic disease, pregnancy, other shock causes (hypovolemic, cardiogenic, neurogenic) a life expectancy of less than 48 hours
Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment

Evaluate the proportion of patients with an urticaria control test \[UCT\] score of greater than or equal to 12 at Week 12.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged between 18 and 75 years.
* Diagnosis of CSU for ≥ 6 months and an inadequate response to nsH1 antihistamines at the time of the request, as defined by the following:
* The presence of itch and hives for \> 6 consecutive weeks at any time prior to enrollment, despite current use of H1 antihistamine therapy during this time period.
* Weekly UAS7 score (range 0 to 42) 16 and UCT score (range 0 to 16) \< 8 prior to enrollment (Day 1)
* Current use of an H1 antihistamine for CSU on the day of the initial visit and Day
* Informed consent

Exclusion Criteria:

* Treatment with an investigational agent within 30 days before enrollment.
* Routine (daily or every other day during 5 or more consecutive days) doses of the following medications within 30 days prior to Day -7: systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide.
* Intravenous (i.v.) immunoglobulin G or plasmapheresis within 30 days prior to Day -7
* Regular (daily/every other day) doxepin (oral) use within 14 days prior to Day -7.
* Any H2 antihistamine use within 7 days prior to Day -7.
* Any leukotriene receptor antagonist (LTRA) (montelukast or zafirlukast) within 7 days prior to Day 7.
* Concomitant use of cyclosporine or any other immunosuppressive agent.
* Hypersensitivity to omalizumab or any component of the formulation.
* History of anaphylactic shock.
Detection of Gut Metabolites in Mother's Milk Following Juice Intake

The goal of the biological sample collection is to assess the presence of gut metabolites in human breast milk (BM) samples obtained prospectively from healthy lactating mothers and after consumption of fruit juice.


Eligibility Criteria:
Inclusion Criteria:

* 20-40 yrs. female subjects with no lactation problems
* Healthy and term delivery
* Healthy dietary intake (vegetarian or omnivore)
* Agree to donate breast milk (not colostrum)
* First 6 months of lactation
* Subjects agree to consumer 8oz. of pomegranate juice for a week prior to 2nd collection

Exclusion Criteria:

* \<20 yrs or \>40 yrs. of age
* Subjects with lactation problems
* Preterm delivery
* Colostrum samples
* Lactation\>6 months
* Subjects fail to drink juice for at least a week