cyrilzakka/clinical-trials huggingface dataset:
Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 9-1067

The purpose of this study is to assess the tolerability of BIA 9-1067 after multiple rising dose regimens of BIA 9-1067.

Single centre, double-blind, randomised, placebo-controlled study of four dosage regimens of BIA 9-1067 in four groups of healthy male volunteers. In each group, the study will consist of an once-daily (o.d.) 8-day multiple-dose period. Progression to the next dose level will only occur if the previous dose level was considered to be safe and well tolerated. An appropriate interval (will separate the investigation of doses to permit a timely review and evaluation of safety data prior to proceeding to a higher dose level.

Eligibility Criteria:
Inclusion Criteria:

1. A signed and dated informed consent form before any study-specific screening procedure is performed.
2. Aged between 18 and 45 years, inclusive.
3. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead electrocardiogram (ECG).
4. Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Exclusion Criteria:

1. Any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, haematological, neurologic, or psychiatric disease.
2. Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study day 1.
3. History of drug abuse within 1 year before study day 1.
4. History of alcoholism within 1 year before day 1. Consumption of more than 50 g of ethanol per day (12.5 cL glass of 10° \[10%\] wine = 12 g; 4 cL of aperitif, 42° \[42%\] whiskey = 17 g; 25 cL glass of 3° \[3%\] beer = 7.5 g; 25 cL glass of 6° \[6%\] beer = 15 g
5. Have previously received BIA 9-1067.
6. Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
7. Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA \[3,4-methylenedioxy-methamphetamine; ecstasy\]).
8. History of any clinically important drug allergy.
9. Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (IMP) administration.
10. Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 before study day 1.
11. Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen \[paracetamol\], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before IMP administration.
12. Donation of blood (ie 450 ml) within 90 days before study day 1.
VExUS in Patients With Acute Heart Failure

The importance of assessing venous congestion in heart failure patients is widely acknowledged, but its study is hampered by the lack of a practical evaluation tool. Venous excess ultrasound score (VExUS) is a promising noninvasive ultrasound-guided modality that can detect and objectify clinically significant organ congestion. VExUS congestion grading score was still not formally validated in patients with AHF, as there is limited data on its clinical application in this group of patients.

It is currently unknown whether changes in systemic venous congestion, assessed by venous excess ultrasound score (VExUS), are associated with worsening renal function, reduced diuretic and natriuretic response, and poor prognosis in patients with acute decompensation of heart failure (AHF).

This prospective, observational, single-center study included patients admitted to the intensive care unit with AHF. At admission all patients undergo bedside Doppler ultrasound of inferior vena cava, hepatic, portal and renal veins to determine blood flow patterns. Congestion was graded with the VExUS score (grade 0, grade 1, grade 2, grade 3). Sodium concentration in a spot urine sample was assessed in 1 hour after first standard intravenous loop diuretic administration. The primary endpoint was the development of acute kidney injury (AKI), defined as oligoanuria (diuresis rate \<0.5 ml/kg/hour for 6 hours) and an increase of serum creatinine \>26 µmol/l within a 48-hour period or 50% from baseline creatinine within a week. The secondary endpoints were in-hospital mortality, change in spot urine sodium content \<50 mmol/l and development of diuretics resistance (defined as the need to double starting dose of intravenous furosemide in 6 hours without adding a different class of diuretic agents).

Eligibility Criteria:
Inclusion Criteria:

* Acute decompensation of heart failure (diagnosis was based on the European Society of Cardiology (ESC) heart failure guidelines, with patients presenting with dyspnoea at rest or with minimal exertion and signs and symptoms of congestion (rales on chest auscultation, peripheral oedema, swelling of the cervical veins, hepatomegaly, ascites, hepatojugular reflux) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) \> 1000 pg/ml

Exclusion Criteria:

* Chronic renal replacement therapy or glomerular filtration rate \< 15 ml/min/1.73m 2 (chronic kidney disease Epidemiology Collaboration (CKD)-EPI)
* Cirrhosis with portal hypertension
* Acute myocardial infarction according to The Fourth Universal Definition of Myocardial infarction
* Pulmonary embolism
* Sepsis (according to The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3))
* Endotracheal intubation at the time of admission
* Pregnancy or breastfeeding
* Aortic dissection
* Active cancer
* Neurological or mental disease during exacerbation
* Refusal to sign an informed consent form, inadequate acoustic window
Effects of GCP on Prostate Cancer.

Genistein Combined Polysaccharide (GCP) is derived from adding soy powder to shiitake mushrooms. This concentrated mixture is currently being sold in Japan and the United States and is thought to possibly contain properties that may be useful in treating certain types of cancer.


Eligibility Criteria:
Inclusion Criteria:

Participants must be male and have a pathological diagnosis of prostate cancer.

No treatment (surgery \[RRP\], radiation, or hormones) prior to study entry.

The patient has decided, after consultation with his own doctor, to have no treatment intervention (surgery \[RRP\], radiation, or hormones) for the next six months.

PSA between 2.0 and 10.0 ng/ml.

If PSA is \>10.0, patient must have been on Active Surveillance for 12 months prior to study initiation.

No known allergy to soy or soy products.

The patient is not currently taking more than 2 grams of genistein a day in nutritional or diet enhancing supplements (OTC supplements).

-

Exclusion Criteria:

No pathological documentation of prostate cancer.

Allergy to soy or soy products

Prior history of treatment for prostate cancer.

-
Plyometric Training, in the Improvement of Explosive Strength and Speed in Soccer Players

Football requires a high number of actions at high speed and intensity. The application of plyometrics can improve explosive strength and speed levels in soccer players.

The main objective of the study is to assess the effectiveness of a program based on plyometric exercises for the improvement of the explosive force in vertical jump and the speed in running with and without the ball in soccer players of youth category.

Randomized clinical study, simple blind, with follow-up period. 30 players will be randomized to the study groups: experimental and control. The intervention will last 4 weeks, with 2 weekly sessions lasting 20 minutes. The study variables will be: Vertical Countermovement Jump Test with Arms and Twenty-Centimeter Drop Jump Reactive Strength Index (Explosive Force), running speed without ball and ball (20 meter speed test), hitting speed of ball (Maximal Kicking Velocity Test), hamstring extensibility (Sit and Reach Test) and sural triceps extensibility (Leg Motion Basic). Normality will be calculated using an analysis of Kolmogorov Smirnov. With the t-student test the differences between assessments will be calculated and with an ANOVA of repeated measures, the effect between intersubject will be calculated. The effect size will be obtained with Cohen's formula.

It is expected to obtain an improvement in the explosive force in the vertical jump, as well as in the running speed with and without the ball.


Eligibility Criteria:
Inclusion Criteria:

* Youth soccer players federated in Castilla y León
* Over 18 years
* Male
* That they train at least twice a week.

Exclusion Criteria:

* subjects who: present a medical diagnosis of musculoskeletal lesion in the lower limb at the time of starting the study
* Who have been out of the competition for more than 6 months as a result of an injury in the last year
* That are part of the experimental phase of another study during our intervention and follow-up period
* That they do not attend at least 80% of the intervention sessions
* Not sign the informed consent document.
Breast Reconstruction

Complications following postmastectomy breast reconstruction can compromise surgical outcomes and lead to significant morbidity. The aim of this study was to determine factors associated with complication following two-stage implant-based reconstruction


Eligibility Criteria:
Inclusion Criteria:

* Patients who received implant-based breast reconstruction following mastectomy between 2015 and 2020 in Seoul National University Hospital

Exclusion Criteria:

* Patients who received flap surgery simultaneously with implant insertion
An Phase 1 Study to Evaluate the Pharmacokinetic (PK) Profile of FDL169 New Formulations in Healthy Subjects

Two parts, two periods, crossover study with part 2 is optional. In both parts, subjects will be randomized to sequentially receive both sublingual and oral formulations of FDL169.

This is a single center, open label study on healthy volunteers. The study will consist of up to 2 parts; the decision to proceed to the optional second part will be made following review of Part 1 data. Part 1 and optional Part 2 have randomized, 2 period crossover designs. Subjects will randomized to 1 of 2 treatment sequences in order to receive 2 single doses of FDL169 on separate occasions, one as a sublingual administration and one as an oral administration. There will be a minimum washout period of 10 days between FDL169 administrations. The duration of each part is approximately 7 weeks from screening to follow up.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy males or non-pregnant, non-lactating healthy females
2. Body mass index of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
3. Must agree to follow the study's contraception requirement Subject has normal healthy oral mucosa with no clinically significant findings

Exclusion Criteria:

1. Subjects who have received any IMP in a clinical research study within the previous 3 months
2. Subjects who have previously received FDL169
3. History of any drug or alcohol abuse in the past 2 years
4. Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
5. Current smokers and those who have smoked within the last 12 months
6. Females of childbearing potential who are pregnant or lactating (all female subjects must have a negative urine pregnancy test at screening and each admission). A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) or is postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle-stimulating hormone \[FSH\] concentration \>40 mIU/mL)
7. Alkaline phosphatase, aspartate aminotransferase and/or alanine aminotransferase level \>1.5 x upper limit of normal at screening
8. Abnormal renal function at screening, defined as estimated glomerular filtration rate \<60 mL/min using the Modification of Diet in Renal Disease (MDRD) equation
9. Clinically significant abnormal biochemistry, haematology, coagulation or urinalysis as judged by the investigator (laboratory parameters are listed in)
10. Positive drugs of abuse test result
11. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
12. History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
13. Subjects with a history of abdominal surgery eg cholecystectomy (appendectomy is allowed unless procedure was within 12 months)
Clinical Study of ASN-3186 in Patients with Advanced Solid Tumors

This is a Phase I/IIa, open-label, multi-center, dose-escalation, and expansion study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of ASN-3186 when given orally in subjects with advanced solid tumors


Eligibility Criteria:
Key Inclusion Criteria:

1. Males or females aged ≥ 18 years at time of signing informed consent form (ICF). Signed ICF must be obtained before the performance of any protocol-specified procedures.
2. Life expectancy ≥12 weeks evaluated by investigator.
3. ECOG Performance Score 0 to 2.
4. Histologically or cytologically confirmed advanced solid tumors defined as unresectable locally advanced or metastatic and do not have standard treatment available, or have disease progression on/after standard treatment, or cannot tolerate standard treatment.
5. For Phase Ia subjects: Subjects who have confirmed deleterious or suspected deleterious germline or somatic BRCAm, or HRRm, or HRD positive or other alterations are preferred, but gene alteration state is not mandatory as an inclusion criterion and no need to wait for biomarker detection results before enrollment.
6. For Phase Ib subjects: Subjects must have confirmed deleterious or suspected deleterious germline or somatic BRCAm, or HRRm, or HRD positive or other alterations.
7. For Phase IIa subjects: Subjects must have confirmed deleterious or suspected deleterious germline or somatic BRCAm, or HRRm, or HRD positive or other alterations.

Key Exclusion Criteria:

1． Treatment with any of the following:

1. . Prior treatment with any USP1 inhibitors.
2. . Prior treatment with radiotherapy, chemotherapy, targeted therapy or endocrine therapy within 4 weeks prior to the first dose of ASN-3186.
3. . Participated and received investigational therapy or used an investigational device or participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks or 5 × t1/2, whichever is longer, prior to the first dose of ASN-3186.

2．Subjects who expect to require any other form of anti-tumor therapy during the treatment period. 3． Subjects who have unresolved toxicity greater than common terminology CTCAE V5.0 Grade 1 from prior anti-tumor therapy prior to the first dose of ASN-3186, except for alopecia and chemotherapy-induced peripheral neurotoxicity ≤ CTCAE V5.0 Grade 2. 4． Subjects who have undergone surgery on vital organs (other than aspiration biopsy) or suffered major trauma within 4 weeks prior to the first dose, or subjects who have not recovered from any surgical effect at screening, or subjects who are scheduled for major surgery during the study period. 5． Subjects who have gastrointestinal disorders that will affect oral administration or affect the absorption of ASN-3186 as judged by the investigator. Or subjects who have severe or clinically significant gastrointestinal disease (e.g., refractory diarrhea, intractable vomiting, colitis, etc.) within 4 weeks prior to the first dose of ASN-3186 and did not recover to CTCAE V5.0 Grade 1.
N-Acetylcysteine Augmentation in Treatment-Refractory Obsessive-Compulsive Disorder

Obsessive-compulsive disorder (OCD) affects 2-3% of the population and leads to a great deal of suffering. Many patients benefit from established treatments, the mainstay of which are cognitive behavioral therapy and a group of antidepressant medications known as serotonin reuptake inhibitors. However, 20-30% of patients get minimal benefit from these established therapeutic strategies. New avenues of treatment are urgently needed.

Existing medications for obsessive-compulsive disorder affect the neurotransmitters serotonin or dopamine; but increasing evidence suggests that functional disruptions of a different neurotransmitter, glutamate, may contribute to some cases of OCD. The researchers are therefore interested in using medications that target glutamate as novel treatment options for those OCD patients who do not benefit from established treatments.

One such medication is the drug N-Acetylcysteine, whose glutamatergic antagonistic properties may be effective in reducing the glutamatergic hyperactivity that is thought to contribute to the pathophysiology of OCD and major depressive disorder (MDD).

Riluzole, which is FDA approved for amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease) is also a glutamatergic agent. There is evidence that riluzole possesses anti-depressant, anti-obsessional, and anti-anxiety properties.

The modulation of glutamatergic activity is a promising new approach to the treatment of mood disorders. The researchers are therefore now recruiting patients to participate in a double-blind, placebo-controlled trial of N-Acetylcysteine, added to whatever other OCD medications they are taking.

Due to limited participation, this study has closed.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of OCD, confirmed by SCID-IV; symptoms of at least 1 year duration
* moderate to severe OCD symptoms (Y-BOCS \> 16)
* documented failure of an adequate trial of an SSRI
* agreement to engage in a reliable form of birth control (women only)

Exclusion Criteria:

* primary diagnosis of a psychotic disorder
* active substance abuse or dependence
* unstable medical condition
* prior exposure to N-Acetylcysteine
* prior psychosurgery
* pregnancy, breastfeeding, or intent to become pregnant during study
* liver function tests (LFTs) elevated to more than 2x the upper limit of normal
* evidence of active liver disease
* seizure disorder
* active suicidal ideation
Effects of Pelvic Floor Health Education Program in Women With Stress Urinary Incontinence

The aim of this study is to investigate the effects of pelvic floor health education program on urinary incontinence symptoms, knowledge level and quality of life in women with stress urinary incontinence.

Stress urinary incontinence (SUI) is the involuntary urinary incontinence that develops in parallel with the increase in intra-abdominal pressure and is seen in the absence of detrusor contraction. Studies have shown that SUI, leading to a decrease in the quality of life and worsening of social and health conditions, is more common in women than men.

Knowledge of pelvic floor health or urinary incontinence is generally low. Low level of knowledge or wrong information limits patients' access to treatment. Pelvic floor muscle exercise and lifestyle recommendations are also the first treatment options for SUI.

The information and awareness related to the pelvic floor and SUI can be increase and unhealthy behavioral strategies can be modifiable through education programs. Therefore the education programs related to the pelvic floor health would have positive effects on urinary incontinence symptoms, knowledge level and quality of life. Studies about this issue are needed.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* Women with stress urinary incontinence
* Those who volunteered to participate in the study
* Being literate

Exclusion Criteria:

* Having advanced pelvic organ prolapse
* Having a malignancy
* Having a urinary tract infection
* Those who have a problem that interferes with cooperation and understanding
Direct Comparison of Ga-68-DOTATATE and Ga-68-DOTATOC

The goal of this study is to propose the first direct comparison of Ga-68-DOTATATE PET/CT or PET/MR and Ga-68-DOTATOC PET/CT in patients with meningioma.

The investigator is proposing a direct comparison of Ga-68-DOTATATE and -DOTATOC in a pilot cohort of patients with meningioma, and hypothesize non-inferiority of DOTATOC. This pilot study will form the basis for a subsequent prospective clinical trial and will allow us to optimize our existing imaging protocols, while developing a more cost-effective protocol.

Primary Objectives:

* Optimize the Ga-68-DOTATOC PET/CT protocol.
* Compare Ga-68-DOTATATE PET and -DOTATOC PET/CT in patients with meningioma.

Secondary Objectives

• Correlate Ga-68-DOTATATE PET and -DOTATOC PET/CT with clinical and pathological characteristics

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with clinically suspected meningioma
* Patients planned for surgery - undergoing preoperative workup
* No contraindications to either radiotracer

Exclusion Criteria:

* Age less than 18 years
* Inability to lay on the scanner table for the required period of time, e.g., due to bone pain or claustrophobia.
Narrow-Band Imaging (NBI) Versus Lugol Chromoendoscopy in the Detection of Oesophagus Squamous Cell Carcinoma in High Risk Population

Narrow-Band Imaging (NBI) is as sensitive as Lugol chromoendoscopy to detect oesophageal squamous cell carcinoma (SCC) and appears more specific than Lugol chromoendoscopy in expert centres but its specificity in current practice is not known. This study aimed to prove the superiority of NBI specificity over Lugol chromoendoscopy to detect oesophageal SCC and high-grade dysplasia (HGD) in current practice (including tertiary care centres, local hospitals and private clinics).


Eligibility Criteria:
Inclusion Criteria:

* Patients had a history or current SCC

Exclusion Criteria:

* NONE