cyrilzakka/clinical-trials huggingface dataset:
Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor

The study aims to evaluate and assess the effectiveness and safety of vaginal administration of isosorbide mono nitrate (IMN) to induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor.

Research Hypothesis:

In women undergoing induction of labor, vaginal administration of isosorbide mono nitrate (IMN) is effective to induce cervical ripening and shorten the interval time between induction and delivery.

Research Questions:

Does vaginal administration of isosorbide mono nitrate (IMN) induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor?

* Type of Study : Prospective double blind randomized controlled clinical trial.
* Study Setting : This study will be conducted in Kafr Elsheikh University maternity hospital.
* Study Period : Expected 6 months from December 2023 to June 2024.
* Study Population : Patients will be recruited in this study those attending labor ward at Kafr Elsheikh hospital for induction of labor at term or post-term with unripe cervix (Bishop Score ˂ 6).

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy.
* Cephalic presentation.
* Bishop score \< 6.
* Average size of the fetus.
* Adequate pelvic dimensions.
* Term or post-term pregnancies with an indication for labor induction either maternal or fetal.

Exclusion Criteria:

* • Previous uterine scar.

  * Patients with regular uterine contractions.
  * Malpresentation.
  * Multifetal gestation.
  * Prelabour rupture of membranes.
  * Established fetal distress.
  * Indication for CS, e.g. Major degree of cephalopelvic disproportion and fetal macrosomia.
  * Antepartum hemorrhage.
  * Active genital herpes infection.
  * Severe maternal illness (e.g. severe preeclampsia).
A Study to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia

This purpose of this study is to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 or more years of age
* Lung Infection of Individual not Recently Hospitalized meeting the following criteria: Radiographically-confirmed pneumonia (new or progressive infection site of the lungs) consistent with bacterial pneumonia), AND Acute illness (≤ 7 days duration) with at least three of the following clinical signs or symptoms consistent with lung infection: New or increased cough, Purulent sputum or change in sputum character, Auscultatory findings consistent with pneumonia, Difficulty in breathing, short breath, or decreased partial pressure of oxygen in blood, Fever greater than 38ºC oral or body temperature lower than that required for normal body function(\< 35ºC), White blood cell count greater than or less than the normal, Greater than 15% immature neutrophils (bands) irrespective of white blood cell count, AND Moderate lung infection
* The subject must require initial hospitalization, or treatment in an emergency room or urgent care setting, by the standard of care
* The subject's infection would require initial treatment with intravenous antimicrobials
* Female subjects of child-bearing potential, and those who are fewer than 2 years post-menopausal, must agree to, and comply with, using highly effective methods of birth control while participating in this study

Exclusion Criteria:

* Lung Infection of Individual not Recently Hospitalized suitable for outpatient therapy with an oral antimicrobial agent
* Confirmed or suspected respiratory tract infections attributable to sources other than bacteria from the individuals not recently hospitalized(e.g., ventilator-associated pneumonia, hospital-acquired pneumonia, visible/gross aspiration pneumonia, suspected viral, fungal, or mycobacterial infection of the lung)
* Non-infectious causes of lung lesion (e.g., pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure)
* Accumulation of pus in the pleural cavity
* Microbiologically-documented infection with a pathogen known to be resistant to ceftriaxone, or epidemiological or clinical context suggesting high likelihood of a ceftriaxone-resistant "typical" bacterial pathogen.
Safety and Efficacy of C21 in Subjects With COVID-19

This is a randomised, double-blind, placebo-controlled phase 2 trial investigating the safety and efficacy of C21 in subjects who are hospitalised with COVID-19 infection, but not in need of mechanical invasive or non-invasive ventilation.

In total, approximately 100 subjects will be enrolled and randomised to receive twice daily oral administration of either standard of care (SoC) + placebo (N=50) or SoC + C21 (N=50). Subjects will be treated for 7 days.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent, consistent with ICH-GCP R2 and local laws, obtained before the initiation of any trial related procedure
2. Diagnosis of coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test \< 4 days before Visit 1 with signs of an acute respiratory infection
3. Age \> 18 and \< 70 years
4. CRP \> 50 and \< 150 mg/l
5. Admitted to a hospital or controlled facility (home quarantine is not sufficient)
6. In the opinion of the Investigator, the subject will be able to comply with the requirements of the protocol

Exclusion Criteria:

1. Any previous experimental treatment for COVID-19
2. Need for mechanical invasive or non-invasive ventilation
3. Concurrent respiratory disease such as COPD (chronic obstructive pulmonary disease), IPF and/or intermittent, persistent or more severe asthma requiring daily therapy or any subjects that have had an asthma flare requiring corticosteroids in the 4 weeks (28 days) prior to COVID-19 diagnosis
4. Participation in any other interventional trial within 3 months prior to Visit 1
5. Any of the following findings at Visit 1:

   * Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus 1+2 antigen/antibody (HIV 1+2 Ag/Ab
   * Positive pregnancy test (see Section 8.2.3)
6. Clinically significant abnormal laboratory value at Visit 1 indicating a potential risk for the subject if enrolled in the trial as evaluated by the Investigator
7. Concurrent serious medical condition with special attention to cardiac or ophthalmic conditions (e.g. contraindications to cataract surgery), which in the opinion of the Investigator makes the subject inappropriate for this trial
8. Malignancy within the past 3 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I
9. Treatment with any of the medications listed below within 1 week prior to Visit 1:

   1. Strong Cytochrome p450 (CYP) 3A4 inducers (e.g. rifampicin, phenytoin, St. John's Wort, phenobarbital, rifabutin, carbamazepine, anti HIV drugs, barbiturates)
   2. Warfarin
10. Pregnant or breast-feeding female subjects
11. Female subjects of childbearing potential not willing to use contraceptive methods as described in Section 5.3.1
12. Male subjects not willing to use contraceptive methods as described in Section 5.3.1
13. Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
Study on Heart Rate Variability in Cardiac Transplant Recipients With Exercise and After Exercise Training

The purpose of the study was to investigate the changes on heart rate variability, exercise capacity, activities of daily living, and quality of life after aerobic exercise training in cardiac transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* Heart transplant recipients with stable post operation condition
* Age between 20-70 years
* No acute or severe chronic rejection

Exclusion Criteria:

* Any condition that might affect exercise performance
Pre-therapeutic Analysis of the Individual Radiosensitivity of Cancer Patients in Luxembourg (APRI-Lux): Prospective National Interventional Study With Minimal Risk

Pre-therapeutic analysis of the individual radiosensitivity of cancer patients in Luxembourg


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Patient with an indication for curative radiotherapy
* Patient having given his signed written informed consent before any specific procedure of the protocol.

Exclusion Criteria:

* Patient with a contraindication to radiotherapy
* Patient with an indication for palliative radiotherapy
* Patient with a history of radiotherapy in the area where the cancer is located
* Patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons.
Urinary Kidney Injury Molecule-1 (KIM-1) Excretion As Biomarker for Injury in Kidney Transplant Recipients

The purpose of this study is to determine if measuring the level of a protein called Kidney Injury Molecule-1 (KIM-1) in the urine will help healthcare providers detect any problems with the transplanted kidney before the laboratory investigations that are used on a routine basis do. This approach may allow the doctor to intervene at an earlier point of a rejection episode and may thereby prolong survival of the transplant kidney.

SPECIFIC AIMS:

1. To investigate the role of urinary Kim-1 excretion as a marker of delayed graft function, acute kidney allograft rejection and/or virus-induced allograft nephropathy and/or calcineurin-inhibitor nephrotoxicity.
2. To determine the role of urinary Kim-1 excretion in predicting long term outcome after kidney transplantation compared to standard diagnostic tests.
3. To determine the role of reduction in urinary Kim-1 excretion after a rejection episode and/or viral infection as a marker of repair of renal tubules.

HYPOTHESIS:

Monitoring of urinary KIM-1 in kidney transplant recipients will facilitate the detection of delayed graft function, acute allograft rejection or infectious causes of proximal tubular injury, allowing earlier intervention with better long-term graft survival. Detection of urinary KIM-1 will precede increases in serum creatinine to detect acute graft injury and urinary KIM-1 will decrease faster than serum creatinine and will predict responsiveness (or lack thereof) to intervention more accurately.

Eligibility Criteria:
Inclusion Criteria:

Children and adults from the age of 3 years who are eligible transplant candidates listed for deceased donor kidney or who are scheduled for a living related or unrelated donor kidney transplant at Mount Sinai Hospital will be eligible for inclusion in this project. Patients will be recruited from the population awaiting kidney transplant treated at the Schneider Children's Hospital and Mount Sinai Hospital.
Efficacy Study of Atorvastatin in Pelvic Pain Relief in Women With Endometriosis

The purpose of this study is to determine whether atorvastatin (alone or in combination with oral contraceptive) is effective in treatment of pelvic pain and inflammatory response in women with endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* informed written consent
* premenopausal women aged 18-45
* clinical signs and symptoms of endometriosis for minimum 3 months with endometriosis confirmed at laparoscopy or laparotomy within last 4 months - 5 years (preferably with histological confirmation)
* pain symptoms of moderate intensity (dysmenorrhoea + dyspareunia + nonmenstrual pelvic pain \> 6 points on Biberoglu \& Behrman scale \[1981\])
* no clinical signs of sexually transmitted disease

Exclusion Criteria:

* cancer of the ovary, adrenals, endometrium, uterine cervix, breasts
* pregnancy or lactation
* unexplained uterine/cervical bleeding
* hormonal therapy within last 3 months (for GnRH analogs 6 months)
* irregular menses (\> 35 days) or secondary amenorrhoea (\>3 months)
* other chronic disease affecting pelvic or abdominal cavity (including PID, ulcerating colitis , Crohn's disease, recurrent interstitial cystitis)
* sexually transmitted disease (gonorrhoea, Chlamydia)
* uncontrolled diabetes mellitus type I or II, VTE or other contraindications to medicine used in the study
* chronic therapy with CYP3A4 inhibitors (including ketoconazole, erythromycin and others)
Efficacy and Safety of TACE in Combination With ICIs for HCC: a Real-world Study

The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) in patients with hepatocellular carcinoma (HCC) .

Transarterial chemoembolization (TACE) can induce immunogenic cell death and tumor-specific immune response which results in the release of tumor antigens and transform "cold" tumors with lacking immune effector cells into "hot" tumors with immune effector cells infiltration. This provides a theoretical basis for TACE combined with immune checkpoint inhibitors (ICIs) in hepatocellular carcinoma (HCC) patients. The purpose of this study is to evaluate the safety and efficacy of TACE in combination with ICIs in patients with HCC. This real-world study also explores the optimal combined treatment and outcome of HCC patients for providing further information for clinical practice and trials.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed with HCC by radiology, histology, or cytology;
2. patients who underwent TACE combined with ICIs therapies ( with or without molecular targeted therapies) were included in the study group. For patients in the study group, ICIs therapies were received before the TACE or within 2 months after TACE and at least one cycle of immunotherapy has been received;
3. during the same period, patients who underwent TACE without the combination of ICIs therapies ( with or without molecular targeted therapies) were included into the control group;
4. patients who underwent TACE combined with ICIs therapies and molecular targeted therapies, molecular targeted therapies must be performed simultaneously with TACE or immunotherapy.

Exclusion Criteria:

1. exceeding the time interval of the combination therapy defined above;
2. missing follow-up data;
Cognitive Changes in Childs After Anesthesia / Surgery

The role of surgical stress and anesthesia is unknown in the early childhood. In vitro and animal studies showed a risk for treatment with anesthesia in the developmental brain. Furthermore, stress is also an important risk factor for cognitive impairment. Therefore, the investigators want to investigate in a clinical prospective cohort study the role anesthesia and surgery on different cognitive parameters and self-controling mechanisms in children under 3 years.

In order to investigate the role of anesthesia and / or surgery on cognitive abilities the investigators want to perform a prospective cohort study in children under 3 years. Three groups should be compared: i) control without anesthesia / surgery, ii) children with only anesthesia, and iii) children with both surgery and anesthesia. All children will be investigate before and after intervention. Different behavioral scales will be used for detailed cognitive abilities and self-regulatory skills.

Eligibility Criteria:
Inclusion Criteria:

* Age 9 month to 3 years with or without anesthesia / surgery

Exclusion Criteria:

* Psychiatrical, neurological, oncological diseases
Measuring Response to Depression Treatment

The primary goal of this study is to compare a new symptoms rating questionnaire, called the Vancouver Semi-Structured Interview for Depression (V-SID), to the traditionally used questionnaires. The investigators predict that the V-SID will be more sensitive to patients' improvement than are traditional questionnaires.

Depression is sometimes associated with difficulties in thinking skills. Recent evidence suggests that in those people who have thinking difficulties, effective treatment and improvement of depression can also result in improved thinking skills. Therefore, a test of thinking skills is included in this study.

This study will also evaluate three other potential indicators of treatment response: cortisol, cytokines, and grip strength.

Eligibility Criteria:
Inclusion Criteria:

* Major depressive episode, diagnosed using the Mini-International Neuropsychiatric Interview (MINI)
* Depression not currently effectively treated
* Age 19 to 65 years

Exclusion Criteria:

* Co-morbid Axis I disorders (co-morbid anxiety symptoms, including generalized anxiety or panic attacks, are not exclusionary if they are present in the context of a primary mood disorder)
Adjuvant Radiotherapy After Cystectomy for Muscle Invasive Bladder Cancer

A radical cystectomy + extended pelvic lymph node dissection is considered to be the treatment of choice for patients with muscle invasive bladder cancer (MIBC). Despite this aggressive treatment the outcome is poor and ultimately, 30% of the patients with ≥pT3 tumors develop a pelvic recurrence. One- and 2-years survival for patients developing a local recurrence after cystectomy is only 8% and 3% respectively, with a median survival of \<4 months. For patients with lymph node recurrence prognosis is somewhat better, but nevertheless still disappointing with reported 1- and 2 years survival of 42% and 11% respectively. The investigators hypothesize that an earlier implementation of external beam radiotherapy (EBRT) i.e. in the adjuvant setting, will prevent local and lymph node recurrence and improve disease free- and overall survival as local recurrence is linked to the development of distant metastasis. Adjuvant EBRT was tested in a prospective randomized trial and resulted in a 20% increase in 5-year disease free survival. Despite those impressive results, severe intestinal toxicity rates hampered the enthusiasm to use adjuvant EBRT, till now. In the last decade, great technological advancements in EBRT planning, such as intensity modulated arc therapy (IMAT), and positioning have been realised. This has resulted in a better coverage of the target volume while sparing normal tissue (mainly small bowel) and in a more precise delivery of the EBRT. Therefore, it is desirable to reconsider the use of adjuvant EBRT in selected MIBC patients.

The investigators plan to perform a prospective phase 2 study including 76 patients.

Radiation up to a median dose of 50 Gy in 25 fractions will be delivered with IMAT to the pelvic lymph node regions. If there is a positive surgical margin, the operative bladder bed will be included in the radiation field. A simultaneous integrated boost to 64 Gy to the positive lymph nodes will be delivered. Pathological evaluation on cystectomy specimen includes: tumor stage and grade, area of necrosis (absolute and relative), micro vessel density, epidermal growth factor receptor.

Eligibility Criteria:
Inclusion Criteria: muscle invasive bladder cancer with:

* ≥ pathological tumor stage (p)T3 stage + presence of lymphovascular invasion on pathological examination
* pT4
* \<10 lymph nodes removed
* positive lymph nodes
* positive surgical margins

Exclusion Criteria:

-
Dual Therapy With High Doses of Ilaprazole and Amoxicillin for Helicobacter Pylori Infection

This study assessed eradication rate of dual therapy with high doses of Ilaprazole 40mg BID and Amoxicillin 750mg QID for 14 days on Helicobacter pylori infection.

The study performed to assess the eradication rate of H.pylori after 14 days treatment. The treatment is defined as those participants who confirmed on gastric or duodenal ulcer (including scar stage) or gastritis by endoscopy or the participants who received endoscopic treamtment for gastric polyp, gastric adenocarcinoma, confirmed to be H.pylori positive patients by the Biopsy or CLO test or Serological Diagnosis.

Patients administered Ilaprazole 40mg BID and Amoxicillin 750mg QID for 14days. The eradication rate on High dose dual therapy assessed by UBT test at Day 49±7.

Eligibility Criteria:
Inclusion Criteria:

* Subject who is confirmed on gastric or duodenal ulcer (including scar stage) by endoscopy or among the participants who received endoscopic treamtment for gastric polyp, gastric adenocarcinoma, confirmed to be H.pylori positive patients by the Biopsy, CLO test and Serological Diagnosis.
* Subject who fully understands conditions of clinical trial.
* Subject who agrees to participate and spontaneously sign the ICF

Exclusion Criteria:

* Known hypersensitivity to any component of Ilaprazole, Amoxicillin(Penicillin Antibiotics).
* Subjects who are taking contraindicated medications for experimental and concomitant drug.
* Administrated of PPI, antibiotic medication within 4 weeks prior to commencement of the study.
* Pregnant and/or lactating women
* Reproductive aged women not using contraception
* Uncontrolled diabetics
* Uncontrolled hypertension
* Uncontrolled liver dysfunction
* Uncontrolled kidney dysfunction
* Alcoholics
* Subjects with a history or possibility of digestive malignancy within 5 years
* Subjects with a history of gastrectomy or esophagectomy
* Subjects with hereditary diseases such as Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption.
* Infectious mononucleosis patients
* Subjects participating in a clinical trial before another trial wihin 30 days
* Inconsistence judged subject by researcher
Accuracy Testing of Validated and Non-validated Home BP Devices Sold on the Online Market.

This study aims to assess whether validated and non-validated blood pressure measuring devices sold on the online market are accurate in regards to the mean awake BP from ambulatory blood pressure monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged \> 18 years scheduled to undergo an ABPM

Exclusion Criteria:

* Upper arm size outside of cuff range of selected devices (\<22 cm or \>42 cm)
* Night shift workers
* Permanent atrial fibrillation
* Known severe aortic stenosis
* Contraindication to measure BP on the non-dominant arm
* Ongoing pregnancy
* Inability or unwillingness to provide consent
A Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic

The primary objective of this study is to assess the effectiveness of a digital intervention in reducing suicide attempts.

This double blind, randomized controlled trial will evaluate effectiveness of two digital interventions among 391 participants. Study participation will start when participants sign consent. Participants and research assessors will be blinded to treatment assignment.

Eligibility Criteria:
Inclusion Criteria:

1. Ages ≥18 years old
2. Patients recently hospitalized.
3. Owns a smartphone.
4. Willing and able to complete enrollment procedures.
5. Able to understand the nature of the study.
6. Able and willing to provide at least two verifiable contacts.

Exclusion Criteria:

1. Patients who have untreated psychosis or active psychosis
2. Patients who appear to be impaired by the use of alcohol or other substance(s)
3. Patients who sign, or have signed, an informed consent form to participate in any clinical research
4. Patients who upon clinical examination are cognitively impaired
5. Patients with a medical condition that may compromise, interfere, limit, effect or reduce the subject's ability to complete