cyrilzakka/clinical-trials huggingface dataset:
Predictive Value of Prostate-specific Antigen Isoform p2psa and Its Derivates in the Diagnosis of Prostate Cancer

In Europe, prostate cancer (PCa) is the most common solid neoplasm, with an incidence rate of 214 cases per 1000 men, outnumbering lung and colorectal cancer. Early detection tests have been developed in order to identify PCa while it is still confined to the prostate gland.

The two most commonly used tests are digital rectal examination and serum prostate-specific antigen (PSA) level: however, most of cases is detected in the so called T1c stage, i.e. for PSA increasing only. As marker, PSA is organ-specific but not cancer-specific, and its levels may change as result of physical activity, sexual activity, in the presence of benign prostatic hyperplasia (BPH), acute and chronic prostatitis, as well as in the presence of PCa.

A total serum PSA of 4.0 ng/ml has traditionally been used as threshold for considering prostate biopsy and large programs for the early detection of prostate cancer have shown that almost 70% of cancer cases can be detected using a PSA cutoff of 4.0 ng/ml. However, using a PSA threshold of 4.0 ng/ml 20% to 25% of prostate cancer cases are not detected (false-negative) and the false-positive rate is 65%. To improve the usefulness of PSA for identifying patients who require biopsy, the PSA threshold has been lowered at 2 ng/ml; moreover, the levels of free and bound PSA have been assessed, together with PSA density (the rate of PSA over the prostate volume) and PSA velocity (the rate of PSA increase), which seem to have some validity for detecting prostate cancer.

Recent studies have shown that other new biomarkers could be used in the diagnosis of early prostate cancer as they showed a higher sensitivity and specificity. In the last two years, several investigators showed that PSA isoform \[-2\] proPSA (p2PSA) and its derivatives, namely, percentage of p2PSA to free PSA (%p2PSA) and the Prostate Health Index \[PHI; (p2PSA / free PSA) × √tPSA)\] improve the accuracy of total PSA (tPSA) and percentage of free PSA (%fPSA) in predicting the presence of PCa at prostate biopsy and they are also related to PCa aggressiveness at biopsy.

The aim of this study is to confirm the diagnostic and prognostic predictive value of prostate-specific antigen isoform p2psa and its derivates, %p2psa and prostate health index in the detection of prostate cancer in patients with a PSA 2-10 ng/ml and/or suspicious DRE.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 18-75
* Total serum PSA of 2.0-10 ng/ml at entry and/or suspicious digital rectal examination
* Patients suitable for prostate biopsy

Exclusion Criteria:

* History of PCa
* Previous prostate biopsy or prostatic surgery
* History of acute urinary retention within 3 months prior
* Use of any investigational or marketed 5ARI, anabolic steroids or any drug with anti-androgenic properties within 12 months prior to screening.
Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder

This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blind phase and a 52-week open-label phase.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Major Depressive Disorder, single or recurrent episode, according to DSM-IV criteria
* HAM-D17 total score \> or = 22 at Screening and Baseline
* CGI-Severity score \> or = 4 at Screening and Baseline
* Only patients who complete the core protocol are eligible to participate in the Open-Label Extension Phase

Exclusion Criteria:

* History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder
* Any current Axis I disorder other than major depressive disorder which is the focus of treatment
* Substance or alcohol abuse in the last 30 days, dependence in the last 6 months
* Concomitant psychotropic medication, including herbal preparations and melatonin
* Psychotherapy of any type
* Female patients of childbearing potential who are not using effective contraception

Other protocol-defined inclusion/exclusion criteria may apply
NK Cells Infusion for Advanced Malignancies

This study is designed to explore the safety and efficacy of natural killer (NK) cell infusion as treatment for patients with advanced malignant tumors after multiline therapy, and to evaluate the pharmacokinetics of NK cells in patients


Eligibility Criteria:
Inclusion Criteria:

1. Patients with advanced malignant tumors diagnosed by pathological histology and/or cytology who have failed multi-line therapy and have no standard treatment method are unable to undergo surgery, radiation therapy, or chemotherapy;
2. Age 18-75 years old (≥18, ≤75);
3. ECOG: 0-1;
4. Priority should be given to the inclusion of ovarian cancer, malignant leukemia, lymphoma, etc. that have been shown to respond well to NK cell therapy;
5. Expected survival period ≥ 3 months;
6. Hematology tests also meet the following requirements:

1) WBC≥3×109/L, ANC≥1.5×109/L, Hb≥90g/L, PLT≥100×109/L; 2) TBIL ≤ 1.5 × ULN (normal upper limit), ALT and AST ≤ 2 × ULN (if there is liver metastasis, then ≤ 5 × ULN); 3) Endogenous creatinine clearance ≥ 60 ml/min (calculated based on Cockcroft-Gault formula); (7) Length of solid tumors do not exceed 6 cm; (8) Signing of informed consent from each patient

Exclusion Criteria:

1. History of other malignancies with a disease-free period \<5 years (except for cured basal cell carcinoma of the skin, cured carcinoma of the cervix in situ, and gastrointestinal tumors proven to be cured by endoscopic mucosal resection);
2. Patients with brain metastases (unless the investigator believes that brain metastasis is currently stable, it is generally not recommended for enrollment);
3. Transplant recipients;
4. T-cell lymphoma patients;
5. Allergies to biologics used in this treatment;
6. Patients with HIV and syphilis;
7. HBV carriers;
8. Patients who are undergoing radiation therapy or immunotherapy within 4 weeks;
9. Patients who have undergone high-dose radiation therapy on the lung and liver within 4 months;
10. Patients with pulmonary inflammation determined by chest radiography;
11. Oxygen saturation ≤ 90% on room air;
12. Patients with cachexia caused by advanced tumors;
13. Long-term use of immunosuppressive drugs or patients who are using immunosuppressive drugs;
14. Those with serious autoimmune diseases;
15. Patients with organ failure (grade 4 of heart function; liver function with Child class C or above; brain metastasis with disturbance of consciousness; severe respiratory failure symptoms);
16. Active infections (including intra-abdominal infections).
17. Researchers consider it inappropriate to participate in the trial
Effects of a Health Belief Model-Based Fall Prevention Education Program on Health Literacy and Physical Function in Patients with Chronic Stroke

The goal of this clinical trial is to to evaluate the effects of a health belief model-based fall prevention education program on health literacy and physical function, fall rate, fall risk, fear of fall, and quality of life in patients with chronic stroke.

The main question it aim to answer is

\* Does a health belief model-based fall prevention education program have a positive effect on health literacy, physical function, fall risk, fear of falling, and quality of life in patients with chronic stroke?

Researchers will compare the intervention group, who will receive the health belief model-based fall prevention education program, to the control group, who will receive their usual intervention in the physical therapy clinic, to see if the health belief model-based fall prevention education program has an effect on health literacy and physical function, fall rate, fall risk, fear of falling, and quality of life in patients with chronic stroke.

The clinical trial will be conducted in four phases; each participant will take around 8 weeks and will receive two in-person individual educational sessions based on the health belief model (HBM).


Eligibility Criteria:
Inclusion Criteria:

* Aged 60 years and older
* Diagnosed with stroke (more than 6 months),
* No cognitive impairment (Arabic version of Mini-Mental State Examination \[MMSE-A\] score of 24 or more)
* No visual or hearing impairment
* Able to walk independently or with assistive devices for 10 meters

Exclusion Criteria:

* Severe communication deficiencies.
* Having neurological conditions other than stroke or other serious medical conditions that precluded participation in the study.
Buccal Midazolam Versus Nasal or Oral Midazolam Sedation for Minor Invasive Procedures in Children

Currently Midazolam sedation is the standard of care for minor invasive procedures in pediatric patients; its use is restricted to two routes of administration for this purpose oral and intranasal.

A third route of administration (buccal) is tested and approved for seizure management. In the investigators' study the researchers investigate the buccal route of administration versus oral or intranasal administration for sedation. The investigators' hypothesis is that buccal route of administration is more convenient than intranasal and better absorbed than oral.


Eligibility Criteria:
Inclusion Criteria:

* age 5 months to 6 years.
* need to undergo a minimal invasive procedure that requires light sedation.
* ASA (American Society of Anesthesiologists) I-II
* parent that can read, understand and sign an informed consent form

Exclusion Criteria:

* patients with life threatening conditions.
* patients with respiratory or cardiac chronic illnesses or ASA other than I-II.
* patients with traumatic injury for the nose or the oral cavity.
* patients that would not or cannot take the drug in the route picked in a randomized way.
An Open-Label, Two-Part Study Designed to Assess the Absolute Bioavailability and Mass Balance of Aramchol

A two-part open-label study to assess the absolute bioavailability of aramchol and the mass balance recovery, metabolite profile and identification of metabolite structures for \[14C\]-aramchol in healthy male subjects

A two-part open-label study to assess the absolute bioavailability of aramchol and the mass balance recovery, metabolite profile and identification of metabolite structures for \[14C\]-aramchol in healthy male subjects.

A subject was considered evaluable in Part 1 if they provided PK samples for up to a minimum of 120 h after first investigational medicinal product (IMP) administration. A subject was considered evaluable in Part 2 if they provided biological samples for up to a minimum of 144 h after IMP administration or demonstrated \>90% mass balance recovery, or \<1% of the administered dose eliminated in excreta for 2 consecutive days, whichever was sooner.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy males
2. Aged 35 to 64 years at the time of signing informed consent
3. Body mass index (BMI) of 18.0 to 35.0 kg/m2 as measured at screening
4. Must be willing and able to communicate and participate in the whole study
5. Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)
6. Must provide written informed consent
7. Must agree to adhere to the contraception requirements

Exclusion Criteria:

1. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
2. Subjects who are study site employees, or immediate family members of a study site or sponsor employee
3. History of any drug or alcohol abuse in the past 2 years
4. Regular alcohol consumption \>21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
5. A confirmed positive alcohol breath test at screening or each admission
6. Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or each admission
7. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
8. Subjects with pregnant or lactating partners
9. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study
10. Participation in any study involving administration of any \[14C\]-labelled compound within 12 months prior to dosing in Part 1 of this study
Elimination of Prostate Cancer Treatment Side Effects Using a Nutraceutical

Does nutraceutical N-111 lower the number of side effects occurring during ADT + External Beam Radiation (EBR) prostate cancer treatment?

Researchers will compare nutraceutical N-111 to a placebo (a look-alike substance that contains no active ingredients) and control group to see if N-111 works to alleviate side effects of prostate cancer treatment.

Participants will:

Take N-111 or a placebo by mouth every day for the duration of the ADT + EBR therapy. Fill out the self-evaluation reporting form weekly during EBR therapy and every three months during ADT therapy to assess their symptoms or lack of symptoms.

The patients will see a physician once a week during the EBR therapy and once every three months for the duration of the ADT therapy.

Eligibility Criteria:
Inclusion Criteria:

* Male undergoing treatment for prostate cancer with ADT + EBR.

Exclusion Criteria:

* Everyone else
Study on the Effect of Combined Estrogen and Progestogen Therapy on Endometrial Repair After Induced Abortion

Induced abortion is a common method to terminate pregnancy, but during the operation, it is necessary to dilate the cervix and aspirate the uterine cavity. Repeated induced abortions may increase the risk of uterine damage, leading to cervical stenosis or intrauterine adhesions, thinning of the endometrium, which may affect the implantation of fertilized eggs and the development of embryos, and ultimately may lead to infertility or miscarriage. This study aims to explore the effects of combined estrogen and progesterone on endometrial repair and ovarian function recovery after induced abortion.

Postoperative care after induced abortion should prioritize the issue of endometrial repair. In 2021, the Family Planning Branch of the Chinese Medical Association published the "Expert Consensus on Promoting Endometrial Repair After Induced Abortion" \[10\], emphasizing the importance of endometrial repair for high-risk populations following induced abortion. Currently, clinically, methods to promote endometrial repair include estrogen-progestin medications, compound short-acting oral contraceptives, traditional Chinese medicine, and bioelectric stimulation. However, controversies still exist regarding endometrial repair, and selecting an effective and safe treatment plan remains crucial. This study aims to prospectively evaluate the efficacy and safety of estradiol/estradiol/dydrogesterone in endometrial repair after induced abortion through clinical research, providing a basis for endometrial repair and ovarian function recovery post-abortion.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age between 18 years old (inclusive) and 40 years old (inclusive); 2. Body Mass Index (BMI) ranging from 18.5Kg/㎡ to 23.9Kg/㎡; 3. Experienced at least 2 abortions or had a missed abortion; 4. Confirmed gestational age of no more than 10 weeks, and the ultrasonic examination within three days prior to the surgery shows a gestational sac (average of three diameters) of at least 1.0cm, with an embryo length of no more than 3.0cm; 5. Normal preoperative examination results as per the "Clinical Diagnosis and Treatment Guidelines and Technical Operation Standards: Family Planning Volume (2017 Revision)"; 6. Capable of regular follow-ups and willing to sign the informed consent form.

Exclusion Criteria:

* 1. Individuals with contraindications to estrogen and progesterone therapy; 2. History of uterine adhesions confirmed by hysteroscopy, or a history of uterine cavity surgery or uterine malformation correction; 3. Subjects who require placement of an intrauterine device or administration of oral contraceptives or subcutaneous implants after the procedure; 4. Individuals with mental status or cognitive function abnormalities who are unable to cooperate with the treatment process; 5. Subjects who, in the opinion of the investigator, have potential risks or any other factors that may interfere with the study.
Efficacy and Safety of a Probiotic Formulation in Adults With Irritable Bowel Syndrome With Diarrhea (IBS-D)

The purpose of the study is to monitor safety and to evaluate the efficacy of a probiotic formulation on abdominal pain, abnormal defecation, comorbid mood disorders (anxiety and depression) as well as general quality of life in adults with IBS-D.

To monitor safety and to evaluate the efficacy of a probiotic formulation on severity of gastrointestinal symptoms (abdominal pain, abnormal defecation), anxiety, depression and quality of life in adult participants with IBS-D.

Eligibility Criteria:
Inclusion Criteria:

* Experiencing symptoms of IBS-D
* Having a diagnosis of IBS-D based on Rome IV criteria
* Participants with symptom onset at least 6 months before diagnosis
* Having a normal colonoscopy result in their medical file

Exclusion Criteria:

* A history of inflammatory or immune-mediated gastrointestinal diseases
* Diagnosed with a co-existing organic gastrointestinal disease which can affect the study
* Currently undergoing a treatment for other severe conditions such as coronary disease, neurological disorder, kidney or liver disease,
* Currently diagnosed with an eating disorder,
* Having undergone any abdominal surgery including cholecystectomy, with the exception of hernia repair or appendectomy
* Currently diagnosed with any mood- or anxiety-related disorder, major psychiatric illness, or participants with a history of suicidal ideation, or current suicidal ideation,
* Regular use of anti-diarrhea medications and laxatives however occasional use is permitted (≤ than once a month); if current use is \> once per month a one month wash out is needed,
* Unwilling to avoid the use of antidiarrheal or laxative medication on an "as-needed basis" during the full length of the study,
* Pregnant, breast-feeding or planning on becoming pregnant.
The Immunogenicity, Safety, and Effectiveness of the COVID-19 Inactivated Vaccine

To fast respond the coronavirus disease of 2019 (COVID-19) pandemic, the Indonesian government has launched "Vaksinasi Gotong Royong" (a mutual cooperation vaccination program) in which any company/legal entity/business entity may purchase vaccines to be given free of charge to their employees and families of employees (The Indonesian Ministry of Health, 2021). Vaccines provided for this program include the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) inactivated vaccines produced by Sinopharm.

The Indonesian National Agency of Drug and Food Control (NADFC) has issued an Emergency Use Authorization (EUA) for several COVID-19 vaccines, including the SARS-CoV-2 vaccine (Vero cell) inactivated produced by Sinopharm (NADFC, 2021). Following EUA, Kimia Farma Indonesia as the holder of EUA has the obligation to monitor the safety and effectiveness in Indonesian population.


Eligibility Criteria:
Inclusion Criteria:

Male or female subjects aged 18 years old and above; Will receive the SARS-CoV-2 vaccine (Vero cell) inactivated produced by Sinopharm; Obtain informed consent to participate this study

Exclusion Criteria:

Previous SARS-CoV-2 vaccination, except for drop out after the first vaccine dose of more than 6 months ago; History of SARS-CoV-2 infection within the last 3 months
Clinic Features and Outcome of BPD (SGBPD)

This study described the perinatal high-risk factors and clinical manifestations of the children, and compared the high-risk factors, clinical manifestations and prognosis of BPD among different clinical subtypes by comparison between groups. BPD grading was performed using the 2018 grading standard to compare the distribution of I/II/III BPD among different groups.


Eligibility Criteria:
Inclusion Criteria:

1. Premature infants born at \<32 weeks of gestational age;
2. hospitalization time ≥ 14 days;
3. The clinical medical records are complete

Exclusion Criteria:

* • 1) Children with congenital heart, lung malformation and definite chromosomal diseases; 2) children gave up treatment halfway; 3) corrected gestational age 36 weeks before death, the cause of death was confirmed as factors other than respiratory system.
Prediction Model for Lateral Lymph Node Metastasis

Mid to low-lying rectal cancer patient with enlarged lateral lymph node befor treatment and receiving lateral lymph node dissection would be enrolled. Radiomics parameters of lateral lymph nodes would be extracted by expert software. Then a part of the nodes would be used as the training set to build the prediction model, and the another part nodes would be used as the validation set.

After performing lateral lymph node dissection for the enrolled patients, we would find the targeted lateral node which was matched with the enlarged one in imaging from the specimen. Then the nodes would be send for pathological examination. Then we would extract the radiomics parameters of the nodes from the pretreatment CT and MRI with ITK-SNAP software. According to the pathological status, lymph nodes and corresponding radiomics parameters would be divided into positive and negative groups. Then significant parameters would be selected by R software. Then the prediction model with nomogram would be developed. 70% nodes would be used for for model development and the other 30% would be used for validation.

Eligibility Criteria:
Inclusion Criteria:

* middle to low-lying rectal adenocarcinoma patients with enlarged lateral lymph node ≥5mm for short diameter in CT and/or MRI

Exclusion Criteria:

* other kind of rectal tumor including neuroendocrine and malignant.
* high location rectal cancer.
* recurrent rectal cancer
Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease

The principal research objectives are to demonstrate cardioselective beta-blockade using bisoprolol is not inferior to placebo with regard to pulmonary function and improves quality of life in patients with heart failure and coexistent moderate or severe chronic obstructive pulmonary disease with or without significant reversibility. Patients will be followed up for 4 months during which bisoprolol will be up-titrated to the maximum clinically tolerated dose. Health status will be assessed using a generic and two disease specific questionnaires, and pulmonary function by spirometry, body box plethysmography, and cardiopulmonary exercise testing.


Eligibility Criteria:
Inclusion Criteria:

* symptomatic NYHA II or III chronic heart failure
* left ventricular systolic dysfunction
* moderate or severe chronic obstructive pulmonary disease
* with or without significant reversibility

Exclusion Criteria:

* beta-blocker contraindications
* non-dihydropyridine (diltiazem / verapamil) calcium channel blockers
* recent coronary percutaneous intervention or coronary artery bypass graft surgery
* haemodynamically significant valvular disease or hypertrophic cardiomyopathy.
* active myocarditis or pericarditis.
* recent cerebrovascular accident or transient ischaemic attack
* serious concurrent systemic disease, such as malignancy, resulting in likely reduced life expectancy
* pregnancy, childbearing potential with inadequate contraception, breast feeding