cyrilzakka/clinical-trials huggingface dataset:
The Role of Tranexamic Acid in Reducing Blood Transfusion Requirements After Cardiopulmonary Bypass in Neonates

This is an observational, prospective study to evaluate the role of tranexamic acid in reducing blood transfusion in neonates undergoing cardiopulmonary bypass.


Eligibility Criteria:
Inclusion Criteria:

* All neonates undergoing arterial switch or aortic arch procedure utilizing cardiopulmonary bypass (CPB).

Exclusion Criteria:

* Jehovah's witness patients.
Safety and Efficacy of Bimatoprost/Timolol (Ganfort®) Ophthalmic Solution in Korea

This study is a Post-Marketing Surveillance study to evaluate the safety and efficacy of bimatoprost/timolol (Ganfort®) Ophthalmic Solution to treat open-angle glaucoma or ocular hypertension in Korea.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with Ganfort® for open-angle glaucoma or ocular hypertension in clinical practice.

Exclusion Criteria:

* None.
Prophylactic Iron and Nutrition in Preventing Infant Iron Deficiency

This study aimed to reveal the effects of prophylactic iron preparations, adequate breast milk intake, and iron-rich supplementary food intake in the prevention of IDA (iron deficiency anemia) and ID (iron deficiency) in infancy.

Iron plays an important role in oxidation and reduction reactions, which have a very important place in the continuation of life. Iron plays an essential role in these reactions because it can easily gain and lose electrons in redox reactions. Iron is mostly found in the heme molecule in organisms. However, iron has structural and functional importance for many enzymes and proteins other than heme. Iron deficiency (ID) is the most common nutritional deficiency in children worldwide. ID is more common in socio-economically developing geographies. However, it is still an important problem in developed countries. A plasma ferritin level below 12 mg/L is defined as ID, which is often used synonymously with iron deficiency anemia (IDA). However, ID develops before anemia occurs. Weakness, fatigue, tiring quickly, insomnia, and regression in neuro-cognitive functions may occur in ID that precedes the signs of anemia. With the development of anemia, the clinical diagnosis of IDA is fully revealed.

In ID that occurs in infancy, psychomotor development is adversely affected, and the development of cognitive functions slows down or even stops. Immune system functions regress. Although iron treatment can reverse these negative effects, some effects are permanent. Therefore, prevention of ID is more important than treatment. In addition, it is easier and cheaper to prevent ID and IDA than to treat them. It is a health policy to recommend iron prophylaxis to children aged 4-12 months in the Republic of Turkey.

Adding iron-rich foods to the diet, adequate breast milk intake, and prophylaxis with iron preparations can be used to prevent ID and IDA. However, there are different data in the literature on the use of prophylactic iron preparations.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 6-24 months and admitted to the general pediatrics outpatient clinic

Exclusion Criteria:

* Chronic disease
* Blood transfusion history,
* Thalassemia carrier status
* Clinical diagnosis of infection or elevated C-reactive protein (CRP)
* Patients who received iron deficiency or iron deficiency anemia treatment
* Those who were born prematurely
* Patients with low birth weight
Ovarian Tissue Cryopreservation in Females Undergoing Procedures That Will Potentially Lead To Loss of Ovarian Function

The purpose of this study is to retrieve and cryopreserve ovarian tissue from females undergoing a treatment that may lead to irreversible loss of ovarian function.

The aim of this preliminary study is to retrieve and properly cryopreserve ovarian tissue for autotransplantation in any premenopausal female whose ovarian function is threatened in a physiological, pathological or iatrogenic manner in an effort to observe the return of ovarian endocrine function and development of egg(s) appropriate for use in in vitro fertilization.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be female.
* Patient must have a disease process where the disease or its treatment adversely affects ovarian function.
* Patient must be recommended for this study by their oncologist or specialist.
* Patient (or legally authorized representative) must sign an informed consent.

Exclusion Criteria:

* Patients cannot be male.
* Patients must not be HIV positive.
* Patient cannot have a poor diagnosis such that she is not expected to survive to adulthood.
* Patient cannot have any medical condition that would contraindicate surgery.
* Patient cannot have any medical condition that would contraindicate general anesthesia.
* Patient cannot have any medical condition that would contraindicate pregnancy.
A Prescription-Event Monitoring (PEM) Study of Tiotropium

This prescription-event monitoring study was based upon 'event' monitoring and so capable of identifying signals of events that might be associated with the use of tiotropium, which none of the participating general practitioners (GPs) suspected to be an adverse drug reaction. The methodology of this study readily permits follow up of specific events and the obtaining of additional data as appropriate.


Eligibility Criteria:
Inclusion Criteria:

* patients who were prescribed tiotropium

Exclusion Criteria:

* not applicable
Multipurpose Disinfecting Solution Compatibility With a Silicone Hydrogel Contact Lens

The purpose of this study is to verify the compatibility of a silicone hydrogel lens when used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®, Solo-Care Aqua™ and MeniCareTM Soft).

The purpose of this study is to verify the compatibility of a silicone hydrogel lens when used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®, Solo-Care Aqua™ and MeniCareTM Soft) by observing changes within the cornea.

Eligibility Criteria:
Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

1. Is at least 17 years old and has full legal capacity to volunteer
2. Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers
3. Is willing and able to follow instructions and maintain the study appointment schedule
4. Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction
5. Has normal binocular vision (no strabismus, no amblyopia, and anisometropia less than or equal to 1.00 D)
6. Has clear corneas and no active ocular disease
7. Has had an ocular examination in the last two years.
8. Has a functional pair of spectacles
9. Is a current soft lens wearer replacing their lenses at least monthly
10. Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fitted with the study lens
11. Has astigmatism less than or equal to -1.00DC
12. Agrees to wear the study lenses on a daily wear basis

Exclusion Criteria:

A person will be excluded from the study if he/she:

1. Has any signs or symptoms of dry eye
2. Has any clinically significant blepharitis
3. Has undergone corneal refractive surgery
4. Is aphakic
5. Has any systemic disease affecting ocular health
6. Is using any systemic or topical medications that may affect ocular health
7. Is pregnant or lactating
8. Is participating in any other type of clinical or research study
9. Currently wears daily disposable lenses
10. Currently wears lenses on a continuous or extended wear basis
11. Is unable to successfully wear contact lenses without routinely using rewetting drops
Risk Factors Contributing to Oral Cancer in Patients at Dr. Hasan Sadikin General Hospital Bandung

Analytical research with a cross-sectional approach was carried out on patients diagnosed with oral cavity cancer who visited our outpatient clinic in Bandung between 2023 and 2024. Data were collected and analyzed using the chi-square test to determine the significance of the relationship between smoking, alcohol consumption, oral hygiene, and betel quid chewing and oral cavity cancer.

This study was conducted using a cross-sectional analytical design, allowing the assessment of the association between various risk factors and oral cavity cancer. This study was conducted at the oncology, ENT, and oral surgery outpatient clinics at our hospital from January 2023 to December 2024. The inclusion criterion was a confirmed diagnosis of oral cavity cancer undergoing surgical intervention. Patients with oral cancer resulting from metastasis from a primary tumor located in another organ were excluded. The control group consisted of individuals attending the hospital for non-cancer-related conditions matched by age and sex to the case group.

Data were collected through structured interviews using a questionnaire designed to obtain information on subject behavior, including smoking, alcohol consumption, betel quid chewing, and oral hygiene practices. Medical records were reviewed to gather additional clinical information and to confirm the diagnosis of oral cavity cancer.

Data were analyzed using SPSS version 25. Descriptive statistics were used to summarize the demographic and clinical characteristics of the study population. The chi-squared test was used to assess the significance of the association between risk factors and the presence of oral cavity cancer. Statistical significance was set at P \< 0.05. The study was approved by the Health Research Ethics Committee (registration number DP.04.03/D.XIV.6.5/191/2024).

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of oral cavity cancer undergoing surgical intervention.

Exclusion Criteria:

* Oral cancer resulting from metastasis from a primary tumor located in another organ
Carfilzomib, Cyclophosphamide, Dexamethasone in Transplant Eligible Newly Diagnosed High-risk Multiple Myeloma

Patients with high risk multiple myeloma have shorter remission periods and reduced overall survival. Prognostic significance of minimal residual disease negative remission is being highlighted in many of the newer studies.

The current phase 2 study investigates the combination of carfilzomib together with cyclophosphamide and dexamethasone in patients with high risk multiple myeloma in younger transplant-eligible patients.

Carfilzomib is administered over 30 minutes as an infusion. For cycle 1 only, Carfilzomib is administered at 20mg/m2 IV on days 1 and 2, followed by escalation to 36 mg/m2 on days 8,9,15 and 16 on a 28 day cycle. Patients who tolerate 36 mg/m2 dose are kept at this dose for the subsequent cycles on Days 1, 2, 8, 9, 15, 16 on a 28 day cycle. Dose and schedule modifications for intolerable side effects are detailed in the protocol. Additionally Cyclophosphamide is given a fixed dose of 500mg once per week orally, along with dexamethasone, given on the days of Carfilzomib administration, 30 minutes to 4 hours prior to Carfilzomib. Patients will undergo blood tests weekly and serum protein electrophoresis every 4 weeks during treatment. Within completion of 5 cycles of treatment, patients would undergo stem cell collection using chemotherapy and GCSF mobilization. After completion of 6 cycles of treatment, autologous bone marrow transplantation will be performed. Three months following bone marrow transplantation, subjects will undergo further 2 consolidation cycles. After consolidation, subjects will undergo disease assessment by blood and subjects who are in CR will undergo bone marrow investigations and MRD analysis MPFC. Patients who achieve MRD negativity by MPFC will be managed expectantly by watch and wait. Patients who are MRD positive at this stage will receive maintenance for 2 years or till disease progression. Follow up would extend till a minimum of 2 years from completion of the study. At the end of 2 years post maintenance or expectant monitoring, subjects who are in CR will undergo disease assessment by blood and bone marrow investigations and MRD analysis MPFC.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed Multiple Myeloma AND Transplant eligible AND
2. High Risk as defined by:

   * International Staging System 3 OR
   * FISH abnormality of t(4,14), t(14;16), 17p deletion or 1q amp
3. Patients must have evaluable myeloma, with at least one of the following (Assessed within 28 days of commencing the study)

   * Serum M protein \>/= 0.5g/dL or
   * Urine M protein \>200mg/24hr
   * Serum free light chains \>100mg/mL (involved light chain) and abnormal k/l ratio
   * For IgA patients who have no other means of measurement of disease, sIgA level \>0.75g/dL

Exclusion Criteria:

1. Relapsed Myeloma
2. Non transplant eligible patient.
3. IgM subtype Myeloma
4. POEMS syndrome
5. Amyloidosis
6. Waldenstroms Macroglobulinemia
7. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days of randomization (Limited site radiation allowed).
Early Luteal Progesterone Profile After hCG Triggering

This pilot-study will help characterize the serum progesterone profiles in IVF patients and correlate progesterone levels to ovarian follicles obtained after stimulation with exogenous gonadotropins.

The early luteal progesterone profile in IVF differs significantly from the progesterone profile of the natural cycle, in which the peak is reached around the time of implantation. With this non-invasive trial investigators wish to further explore the early luteal phase profiles of progesterone and hCG in order to optimize current luteal phase support policies in IVF and hopefully increase ongoing pregnancy rates.

Stimulation, monitoring, and oocyte pick-up will be performed according to the standard procedure of the clinic. On the day of trigger with 5.000 IU hCG a blood sample will be drawn prior to triggering for subsequent analysis. Moreover, all ovarian follicles on each side equal to or above 11 mm will be registered. Oocyte pick-up and timing of the trigger bolus will be performed according to the standard procedures of the unit.

A total 10 blood samples will be drawn during this trial - please see "blood sampling". Blood samples will be collected on the following days for subsequent analysis of LH, E2, hCG and progesterone.

All embryos will be cryo-preserved for transfer in subsequent frozen/thaw embryo transfer cycles.

Primary endpoint Serum concentrations of progesterone, LH, E2, and hCG during early luteal phase.

Secondary endpoints The correlation between follicles ≥ 11 mm and progesterone in early luteal phase

Data are analyzed using SPSS version 20 software. All tests are two tailed, and P\<0.05 is considered statistically significant. Continuous variables are presented as mean +/- SD and are tested by student's t-test. Categorical data are expressed as numbers and compared using the Chi-square test.

Eligibility Criteria:
Inclusion Criteria:

* IVF patients who meet the following criteria:
* Freeze all cycle after hCG trigger
* Age 18 - 38
* Body Mass Index (BMI) \< 28kg/m2
* Normal ovarian reserve, defined by Anti-Mullerian Hormone (AMH) \> 1.25 ng/ml or Antral Follicle Count (AFC) ≥ 6 measured within two months prior to stimulation start
* Receiving Gonadotropin Releasing Hormone Antagonist co-treatment during ovarian stimulation
* Agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
* Have given written informed consent with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.

Exclusion Criteria:

* Previous poor response (≤ 3 oocytes) after high dose FSH stimulation
* Hyper-response defined as \>20 follicles ≥ 14 mm
* Chronical medical conditions like Diabetes, Crohns disease, Thyroid disease, Hepatitis B and Sexually Transmitted Diseases Simultaneous participation in an interventional clinical trial.
Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease

The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with moderate to severe Crohn's disease and who have had an insufficient response to conventional therapy or have failed Anti-Tumor Necrosis Factor (anti-TNF) therapy.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed Crohn's Disease diagnosis via radiology, endoscopy or histology within prior 12 months. Diagnosed for at least 3 months
* Active Disease with Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450
* Failed conventional therapy or steroid dependent

Exclusion Criteria:

* Diagnosed/clinical findings of Ulcerative Colitis (UC), indeterminate colitis, non colonic/ileal disease
* Stricture/stenosis, Stoma, proctocolectomy, subtotal colectomy, ileorectal anastomosis
* History of diverticulitis, or evidence of Gastrointestinal (GI) perforations
Monitoring of the Mitochondrial Function of Circulating Myeloid Cells in Patients Hospitalized in the Intensive Care Unit of Dijon University Hospital

Severe infections (sepsis) are a common cause of admission to the intensive care unit. They represent a significant health risk for patients in the short and medium term. They are particularly linked to a change in the function of immune cells. In some patients, a state of pseudo-dormancy of monocyte and macrophage-type immune cells, called immunosuppression of myeloid cells, is observed. This situation leads to a worsening of the infection, so it should be avoided because it represents a danger for the patient even when they ar receiving antibiotics. At present, these events are still very poorly understood. Research is essential to understand how this state of immunosuppression of myeloid cells is established in order to adapt existing treatments or find new ones.

Laboratory studies on animal models of septicaemia have shown that this state of immunosuppression of myeloid cells is closely linked to a change in the production of energy by myeloid cells (monocytes and macrophages). The functioning of the mitochondria ("energy factory" of the cells) in these cells is impaired. Thus, restoring mitochondrial function in myeloid cells could be a therapeutic solution against the immunosuppression of myeloid cells during severe septicaemia.

The objective of this study is to verify whether alterations in mitochondrial function in myeloid cells also occur in patients with bacterial infection compared to patients without bacterial infection.


Eligibility Criteria:
Inclusion Criteria:

* Adult person who has given written consent (or consent obtained from a heath care proxy) hospitalized in an ICU with or without sepsis (with or without infection)

Exclusion Criteria:

* Person not affiliated or not benefiting from national health insurance
* Person under legal protection (curatorship, guardianship, safeguard of justice)
* Pregnant, parturient or breastfeeding woman
* Patient who was hospitalized within 3 months prior to inclusion for sepsis.
* Patients receiving known treatment for mitochondrial function modulation, mitochondrial biogenesis or mitophagy (chloroquine, hydroxychloroquine, rapamycin, carbamazepine, resveratrol, sildenafil).
The Effect of Prucalopride Succinate on Gastrointestinal Motility After Laparoscopic Gastrectomy : Prospective Double Blind Case-control Study

In order to improve postoperative ileus in patients undergoing gastrointestinal surgery, digestive medications and prokinetics have been routinely used. Among them, mosapride citrate is widely used as a representative drug, as it is a 5-hydroxytryptamine 4 receptor agonist that increases gastrointestinal motility.

Prucalopride succinate (dihydrobenzofurancarboxamide) is a type of 5-hydroxytryptamine 4 receptor agonist that has a higher affinity for the 5-HT4 receptor compared to mosapride (a benzamide derivative) which belongs to the same class of drugs. Prucalopride succinate has been demonstrated to increase both gastric and colonic motility through in vivo and in vitro studies. As mentioned earlier, it exhibits high specificity for the 5-HT4 receptor. The 5-HT4 receptor is not expressed in the gastric mucosa but is expressed at low concentrations in the small intestine, whereas it is highly expressed in the colonic mucosa. Therefore, prucalopride is widely used as a therapeutic agent for chronic constipation by increasing colonic motility. Furthermore, Prucalopride succinate stimulates the 5-HT4 receptors present in the nerve terminals of the myenteric plexus, promoting the release of acetylcholine. The released acetylcholine acts on α7nAch receptors located on the surface of enteric smooth muscle cells, inhibiting inflammatory responses and reducing postoperative ilues.

A randomized controlled trial (RCT) conducted on 110 patients who underwent gastrointestinal surgery demonstrated that prucalopride succinate showed significant improvement in gastrointestinal motility compared to the control group. Currently, mosapride citrate is widely used as a prokinetic agent in clinical practice. However, preliminary studies have shown no significant efficacy, and when comparing abdominal X-ray images taken on the third day after surgery, there is no significant difference compared to the placebo group. As a result, it can be observed that the recovery of gastrointestinal motility after surgery is not primarily due to small bowel motility but rather delayed gas passing caused by colon motility. Therefore, it can be assumed that using drugs that increase colon motility may be effective in improving gastrointestinal motility after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with gastric adenocarcinoma pathologically before surgery
2. Patients who underwent complete surgical resection (R0 resection)
3. Patients with an ASA score of 3 or less

Exclusion Criteria:

1. Patients over 80 years of age
2. Ascites or peritoneal metastasis
3. If you have intestinal obstruction before surgery
4. If chemotherapy was performed before surgery
5. If cancer other than gastric cancer is diagnosed
6. If there is a history of previous major intra-abdominal long-term surgery or abdominal radiation therapy
7. In case of liver failure or renal failure
8. Pregnant women
9. If it is judged that uncontrolled diabetes can affect intestinal function
10. If you have a stoma