cyrilzakka/clinical-trials huggingface dataset:
Evaluation of One Day Discharge After Laparoscopic Appendectomy for Uncomplicated Appendicitis in Children.

The aim of this study was to evaluate the value and safety of discharge of a child to home care within 24 hours after laparoscopic appendectomy for uncomplicated appendicitis to reduce the impact on the child's psyche and need for hospitalisation. Baseline demographic data and intraoperative finding will be recorded. Parents are given a two-page questionnaire that is completed in three cycles (immediately after discharge, daily until the first control and immediately before the first control). All data will be statistically processed using descriptive statistics.

The research would include children who underwent laparoscopic surgery due to uncomplicated acute appendicitis in the period from October 2021 to October 2023 at the Clinic for Pediatric Surgery of the University Hospital Center Split. After the suspicion of acute inflammation of the appendix is established, the pediatric surgeon decides on surgical treatment. Recently, laparoscopic appendectomy has been performed in a standardized manner at the Clinic for Pediatric Surgery of the Clinical Hospital Center Split. After the operation, and in the current practice, the children would stay in hospital for 2 to 4 days. As the generally known psychological aspects of changes in children's behaviour in involuntary hospital stays, and now even more pronounced due to the SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) COVID19 virus pandemic and reduced opportunities for parents to stay with children, the main goal of this study is to evaluate and possibly reduce hospital stay to a minimum and proof that there are no complications in treatment outcomes due to shortening the length of hospital treatment. To conduct this research, parents are given a two-page questionnaire that is completed in three cycles (immediately after discharge, daily until the first control and immediately before the first control). Baseline demographic data and intraoperative findings will be recorded. All data will be statistically processed using descriptive statistics.

Eligibility Criteria:
Inclusion Criteria:

* children 6 to 18 years
* uncomplicated acute appendicitis treated with laparoscopic approach
* children released within 24 hours

Exclusion Criteria:

* children under 6 years
* complicated acute appendicitis
* intraoperative complication
* operated by classical approach
* children needing longer hospital care and parental therapy
* children with significant comorbidities that could affect treatment outcomes
Consistency Lots Vaccine Study (V260-009)

This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants

Exclusion Criteria:

* History of abdominal disorders from a birth defect, intussusception, or abdominal surgery
* Known or suspected problems with the immune system
* Fever at time of immunization
* Prior administration of a rotavirus vaccine
* History of known prior rotavirus disease, chronic diarrhea, or failure to thrive.
The Platinum Study Comparison Group

The patients enrolled on this new study will serve as an appropriate comparison group consisting of patients with the diagnosis of germ cell testicular cancer who were cured with surgical resection and did not receive cisplatin-based chemotherapy with a group of patients from another study who did receive cisplatin-based chemotherapy.

Primary Objective

To compare the prevalence of ototoxicity and neurotoxicity in GCT cancer survivors who only had surgery to a similar population from The Platinum Study (RSRB45410/1305011509) who received cisplatin-based combination chemotherapy.

Secondary Objective

To compare the prevalence of obesity, hypertension, and use of antidepressants/anxiolytics in GCT cancer survivors who only had surgery to a similar population from The Platinum Study who received cisplatin-based combination chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis or confirmation of diagnosis of a histologically or serologically confirmed testicular germ cell tumor (GCT) or GCT at another anatomic location
* Age at GCT diagnosis: 55 years of age or younger
* Males, 18 years of age or older at time of study consent
* Subject is able to provide consent
* Subject is able to speak and read English
* Treatment consisted of surgery only (i.e., orchiectomy and/or retroperitoneal lymph node dissection \[RPLND\]) for either initial testicular germ cell tumor (GCT) or subsequent testicular cancer
* Subject completed surgery \> 1 year ago
* Subject is currently undergoing active follow-up at IU
* Subject did not require any subsequent chemotherapy, salvage chemotherapy treatment or bone marrow transplant.
* Subject had no prior chemotherapy of any kind

Exclusion Criteria:

* Patients with prior chemotherapy (whether for GCT or any other cancer)
Sponge Application of MMC Versus Suntenon Injection in Trabeculectomy

Glaucoma is a leading cause of irreversible blindness worldwide, with intraocular pressure (IOP) reduction being the primary therapeutic goal. Trabeculectomy, augmented with mitomycin C (MMC), remains the gold standard surgical intervention but is limited by postoperative fibrosis. MMC delivery methods, including sponge application and sub-Tenon injection, vary in drug distribution and may influence surgical outcomes. This study aimed to compare the efficacy and safety of trabeculectomy using sponge-applied MMC versus sub-Tenon MMC injection, focusing on IOP reduction, bleb morphology, and postoperative medication requirements.

In this retrospective, randomized controlled trial, 50 patients with primary or secondary glaucoma were assigned to trabeculectomy with either MMC sponge application (Group A, n=25) or sub-Tenon MMC injection (Group B, n=25). All surgeries were performed by the same surgeon using standardized techniques. Patients were followed for one year, with primary outcomes including IOP reduction and secondary outcomes encompassing bleb morphology (Indiana Bleb Appearance Grading Scale), bleb integrity (Seidel test), and postoperative glaucoma medication use.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older,
* diagnosed with primary open-angle glaucoma (POAG) or secondary glaucoma,
* uncontrolled IOP (IOP \> 21 mmHg) despite maximally tolerated medical therapy,
* progressive visual field deterioration,
* or intolerance to anti-glaucoma medications.

Exclusion Criteria:

* age under 18 years,
* absence of light perception,
* previous incisional glaucoma surgery,
* need for combined ocular procedures,
* intraoperative use of 5-fluorouracil (5-FU),
* or follow-up duration of less than one month
Single Incision Laparoscopy

Laparoscopic surgery being performed with only one small incision via the umbilicus (belly button).


Eligibility Criteria:
Inclusion Criteria:

1. Ages 18-75
2. Patient has consented for a laparoscopic operation (independent of study participation)
3. Attending surgeon decides operation can be completed via a single incision laparoscopic approach

Exclusion Criteria:

1. Patients with BMI greater than 40
2. Minors and cognitively impaired individuals
3. Patients who are ASA class IV - Illness that is a constant threat to life
4. Patients with ascites or Child's class C of liver failure
5. Patients with known common bile duct stones
6. Patients with coagulopathy, abnormal coagulation studies, or who take heparin, coumadin, Plavix (clopidogrel), aspirin, or other medication for the purpose of anti-coagulation and cannot be removed from the medication prior to the operation.
7. Patients who present with incarcerated (irreducible) or strangulated hernias
8. Patients with preoperative hematocrits less than 25.
9. Preoperative hematocrit less than 25.
10. Patients who have evidence of hemodynamic instability including systolic blood pressure greater than 200 or less than 80.
11. Heart rate greater than 130 or less than 50. Respiratory rate greater than 35 or less than 6. Patients who are on continuous pressor drip for blood pressure support.
12. Patients who present for emergency adrenalectomy.
13. Patients with CT scan evidence of an abdominal abscess.
14. Patients who present 48 hours after the onset of abdominal pain (appendectomy patients)
Study of Tumor and Blood Samples From Women With Breast Cancer

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at tumor and blood samples from women with breast cancer.

OBJECTIVES:

Primary

* Assess relapse locally or remotely using biomarkers collected from primary tumor and blood samples from women with breast cancer during the first 2 years after diagnosis.

Secondary

* Evaluate all relapses.
* Assess survival without relapse.
* Determine correlation between biomarkers and relapse.

OUTLINE: Primary tumor and blood samples collected during usual care of patients during the first 2 years after diagnosis are analyzed for biomarkers useful in monitoring and diagnosing breast cancer.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of infiltrating unilateral breast cancer

  * No in situ disease (ductal or lobular)
  * No invasive bilateral synchronous disease
* Breast cancer at high risk, defined by at least 2 of the following factors:

  * Hormone receptor negative (HR-)
  * Axillary node positive
  * Histopathologic grade III
  * High mitotic index (as defined by the Curie Institute as \> 20 mitoses per 10 high-power fields \[HPF\])
  * Tumor size ≥ 2 cm
  * HER2-positive (3 + IHC or FISH/ICHS positive)
  * Triple-negative tumors (HR- and HER2-negative)
* Initial thoracic-abdomino-pelvic and bone scans must be negative
* Underwent initial surgery

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* Serum calcium normal (15.3 mg/dL) or normalized within 8 weeks after surgery
* No other invasive cancer within the past 5 years
* Not pregnant or nursing
* No psychological, familial, social, or geographical reasons that make monitoring impossible

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Testing the Effectiveness of a Safety-promoting Intervention in Antenatal Care

Domestic violence during pregnancy can directly or indirectly cause maternal and fetal morbidity and even mortality. The investigators have validated the Abuse Assessment Screen to the Nepali context for use with a color-coded audio computer assisted self-interview method among pregnant women. This instrument will be used to identify women experiencing domestic violence during or shortly prior to their current pregnancy. In addition, an intervention video was developed. The aim of the video is to encourage women to take safety actions, in particular telling someone about the violence experienced. Women in the control group will watch a video on a healthy pregnancy and sign and symptoms of complications and what to to if these occur.The control video was chosen to increase blinding. This study aims to investigate the effect of the video compared to an intervention video.

This randomized controlled study is a two armed study, which will take place at two locations in Nepal. Eligible women will be invited to the study when attending routine antenatal care. Women agreeing to participate will be invited to first complete a questionnaire. Upon completion of this first questionnaire women will view either the intervention or control video, irrespective of their Domestic Violence (DV) Status. In the intervention arm all women will be shown the intervention video, irrespective of their DV status. In the control arm women view an intervention video. All women are asked to return to the study during the last two months of their pregnancy. All women will be asked to complete the second questionnaire. Upon completions all women will be offered to see the intervention video. For the intervention group this will be their second viewing, for the control group this will be the first viewing of the intervention video. All women will be followed up til birth. Data about their birth will be collected from their hospital records.

Eligibility Criteria:
Inclusion Criteria:

* between 12 to 20 weeks gestational age of pregnancy

Exclusion Criteria:

* prior 12 weeks gestation
* after 20 weeks of pregnancy
* mentally unable to participate
Effect of rHDL on Atherosclerosis - Safety and Efficacy: THE ERASE TRIAL

Currently available therapies to treat Acute Coronary Syndromes(ACS) have several limitations including; the relatively long treatment duration required before apparent significant benefit; the inability to achieve reversal of the atherosclerotic process; and poor patient compliance due to chronicity of therapy. This study will assess the effects of rHDL compared with placebo on indices of atherosclerosis progression and regression as assessed with intravascular ultrasound (IVUS) in patients after acute coronary syndromes (ACS).


Eligibility Criteria:
Inclusion Criteria:

* Male or female 30 - 75 years of age
* Recent acute coronary syndrome, defined as unstable angina, non-Q wave myocardial infarction, or ST elevation indicative of myocardial infarction, within the last 14 days

Exclusion Criteria:

* \>50% stenosis by visual angiographic estimation in the left main artery
* Renal insufficiency
* Severe liver disease
* Congestive heart failure as defined by the NYHA classification as functional Class III or Class IV
* Previous or planned coronary artery bypass surgery
Safety and Efficacy of Low-dose Sirolimus to Kaposiform Hemangioendothelioma

to evaluate the safety and efficacy of Low-dose sirolimus in Kaposiform Hemangioendothelioma in Chinese children by a prospective, randomized open trial.

The clinically commonly used dose of sirolimus for Kaposiform Hemangioendothelioma is 0.8 mg/m2 administered twice daily, and the blood concentration can be maintained at 10-15 ng/ml according to the pharmacokinetic formula.Related research reports that maintaining low blood concentration of sirolimus is effective in the treatment of certain vascular malformations and hemangioma, and complications are less. In the clinical practice, we found that the blood concentration was maintained at 7-10 ng/ml, and the patients still achieved good results and the chance of infections decreased. Therefore, this clinical trial was designed.In this trial, two different dosing regimens with corresponding blood concentration were designed to compare the safety and efficacy.In the high concentration group, the sirolimus dosage was adjusted monthly to achieve trough levels between 10 and 15 ng/mL(excluding 10 ng/ml), and it is still used at 0.8 mg/m2 administered twice daily.The low concentration group is 7-10 ng/ml (including 10 ng/ml), and the initial use of sirolimus is 0.7mg/m2 administered twice daily.The dose was adjusted according to the formula after two weeks.The follow-up and evaluation were performed according to a strictly established follow-up schedule after taking the drug.

Eligibility Criteria:
Inclusion Criteria:

* Kaposiform Hemangioendotheliomas with or without Kasabach-Merritt Phenomenon.
* 0 - 12 years of age at the time of study entry.
* Male or female.
* Consent of parents (or the person having parental authority in families): Signed and dated written informed consent.

Exclusion Criteria:

* with hematological diseases.
* with other solid tumors.
* with hypertension, diabetes, adrenal insufficiency, neurological diseases, liver and kidney dysfunction, and cardiopulmonary insufficiency.
* with tuberculosis,cytomegalovirus and Epstein-Barr virus infection before the treatment.
The Effect of Time Intervals for Rescue Treatment on Eradication Effect of Helicobacter Pylori Infection

The researchers collect patients who accepted eradication program of the helicobacter pylori but failed to eradicate helicobacter pylor from the outpatient clinic. After rescue therapy, evaluating the effect of retreatment interval on eradication effect of Helicobacter pylori infection.

The researchers collect patients who accepted eradication program of the helicobacter pylori but failed to eradicate helicobacter pylor from the outpatient clinic. Record the interval between the last eradication therapy and this time，6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculating the eradication rates, adverse reaction rates, patient compliance of each group. Evaluating the effect of retreatment interval on eradication effect of Helicobacter pylori infection.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-70. Patients with H.pylori infection (Positive for any of the following: 13C/14C-urea breath test, histopathology test, rapid urease test, stool H.pylori antigen test).

Patients who have previously received helicobacter pylori eradication therapy and failed.

Exclusion Criteria:

* Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 1.5 times the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate \<50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.

Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.

Patients with active gastrointestinal bleeding. Patients with a history of upper gastrointestinal surgery. Patients allergic to treatment drugs. Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse Patients who are unwilling or incapable to provide informed consents.
A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Myeloid Tumor

This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in Myeloid tumor patients.

Phase 1a/1b study will be conducted to evaluate the tolerability, safety, PK, PD, immunogenicity and preliminary antitumor activity of IBI322 in patients with myeloid tumor. Phase 1a is the dose escalation part of the study and Phase 1b is the dose expansion part. Combination therapy with HMA(Azacitidine or Decitabine) will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who met the diagnostic criteria of recurrent / refractory AML (WHO 2016)(primordial cells in bone marrow ≥ 5%) (excluding APL and bcr-abl positive AML ) and underwent treatment.
2. Patients who meet the diagnostic criteria of recurrent / refractory MDS (WHO 2016)and underwent treatment.
3. Patients with recurrent / refractory Essential thrombocythemia (WHO2016) after treatment (for Phase Ia)
4. Male or female subject above 18 years old
5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 \~ 2.
6. Must have adequate organ function

Exclusion Criteria:

1. Previous history with myeloproliferative Neoplasms(MPN) or MDS/MPN
2. Transformation or treatment related AML/MDS.
3. PV/MF/AML/MDS evolved from Essential thrombocythemia
4. Relapse after allogeneic hematopoietic stem cell transplantation, or autologous hematopoietic stem cell transplantation within 1 year
5. Central nervous system leukemia infiltration
6. Previous history of chronic hemolytic anemia or screening Coombe test positive
7. Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
8. Previous exposure to chimeric antigen receptor T cell immunotherapy (CAR-T)
9. Patients who received immunotherapy, targeted therapy, biological therapy or any clinical research treatment within 14 days before receiving the first dose
10. Uncontrolled concurrent diseases
11. Subjects who are allergic to the ingredients of the study drug
12. Subjects who have used immunosuppressive drugs within 7 days before the first dose of study treatment
The Value of Preoperative Dynamic Lymphscintigraphy and Ultrasoundscanning, Eventually With FNA, for Identification of Malignant Sentinel Node(s) in Patients With Melanoma

The goal with this study is to evaluate the value of dynamic lymphscintigraphy and ultrasoundscanning preoperative in patients with melanomas.


Eligibility Criteria:
Inclusion Criteria:

Histologically verified melanomas, at least 1 mm thickness, or thinner melanomas with ulceration and/or Clarks level IV-V and/or mitoserate at least 1/mm2.

Exclusion Criteria:

Other malignant illness Known local, regional or non-regional metastasis on the time of diagnonsis Comorbidity which contraindicate lymphnoderemoval Age less than 18 yrs
Rate Ventricular Control Therapy in Patients With Permanent Atrial Fibrillation

The investigators hypothesized that very lenient rate control is not inferior to strict or lenient rate control assessed by implantable continuous ECG monitor for preventing cardiovascular hospitalization and mortality in patients with long-standing persistent or permanent atrial fibrillation


Eligibility Criteria:
Inclusion Criteria:

* Long-standing persistent or permanent atrial fibrillation
* Mean resting heart rate \> 80 beats per minute with or without rate control medication
* Age \< 70 years old
* Constant use of anticoagulation therapy

Exclusion Criteria:

* Paroxysmal or persistent atrial fibrillation
* Non-stable heart failure or \> III NYHA FC
* Indications for IPG/CRT/ICD
* Thyroid dysfunction
* Inability to walk or bike.
Parathyroid Hormone Kinetics During CRRT

The objective of this study is to assess the parathyroid hormone serum concentrations and kinetics in critically ill patients admitted to the intensive care unit due to multi-organ failure and undergoing citrate anticoagulation continuous renal replacement therapy.


Eligibility Criteria:
Inclusion Criteria:

* Acute respiratory failure
* Acute circulatory failure
* acute kidney injury treated with regional citrate anticoagulation continuous renal replacement therapy by means of continuous veno-venous hemodiafiltration (CVVHDF
* continuous renal replacement therapy started no later than 48 hours after admission
* SOFA score 5 or more

Exclusion Criteria:

* age less than 18 years
* acute liver failure
* hypercalcemia at admission (total calcium plasma level \> 10.6 mg/dL; total ionized calcium plasma level \> 1.35 mmol/L
* parathyroid glands disease
* end stage renal disease
* therapeutic plasma exchange
* extracorporeal membrane oxygenation
* unfavorable outcome (death) predicted within 72 hours (as assessed by investigator)
* lack of relatives consent