cyrilzakka/clinical-trials huggingface dataset:
Open-label Study of Safety and Tolerability of Memantine in Children With Autism

The purpose of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of autism in pediatric patients.

This is a 48-week multicenter extension study comprised of a 6-week double-blind dose-titration period followed by a 42-week open-label maintenance period.

In the Forest autism trials conducted in children ages 6-12, dosing with an extended release formulation of memantine was weight-based. These weight based dose limits were selected to ensure exposure in terms of area under the curve (AUC) was less than the predefined limit of 2100 ng∙h/mL that represented a 10-fold lower exposure than observed at the NOAEL (No observed adverse effect level) of 15 mg/kg/day in juvenile rats.

The weight-based dose limits in these studies were as follows:

* Group A: ≥ 60 kg; max 15 mg/day
* Group B: 40-59 kg; max 9 mg/day
* Group C: 20-39 kg; max 6 mg/day
* Group D: \< 20 kg; max 3 mg/day

Eligibility Criteria:
Inclusion Criteria:

* Completed lead-in study MEM-MD-57A (NCT00872898)
* A knowledgeable caregiver capable of providing reliable information about the patient's condition, able to attend all clinic visits with the patient

Exclusion Criteria:

* Patients with a concurrent medical condition that might interfere with the conduct of the study
Effect of "Autogenous Leukocyte Platelet Rich Fibrin- Tooth Graft" Combination Around Immediately Placed Implants

Immediate implant placement into fresh extraction sockets is gaining popularity because of fewer clinical procedures and maintenance of bone architecture compared to conventional methods, thus reducing the treatment time and increasing patient satisfaction. In addition, the survival rate of the immediate implantation is comparable to that of the healed implantation sites. Recently, ATBG made from compromised teeth was applied in bone defects and resulted in a good clinical efficacy. Moreover, it is more accepted by patients to use extracted teeth as a bone graft material, especially in the case of immediate implant placement. In 2020, Kizildağ and coworkers studied the outcome of PRF as an adjunct with ATBG on bone healing in rabbit peri-implant osseous defects. They reported that combination of ATBG with PRF contributed to significantly higher new bone formation and better bone/implant contact in rabbits with peri-implant bone defects. The main hypothesis behind this study is that using L-PRF with ATBG following immediate implant placement could promote stabilization of graft particles and enhance new bone formation with a shorter time. Therefore, the purpose of this study was to compare the clinical and radiographic outcomes of ATBG on bone formation with or without L-PRF around immediately placed dental implants in periodontally compromised teeth.


Eligibility Criteria:
Inclusion Criteria:

* Teeth need to be extracted for periodontal reasons with a defect of labial bone (horizontal or vertical bone defect).
* the teeth without acute inflammation.
* no uncontrolled systemic disease which is not suitable for implantation.
* Good systemic and oral health.

Exclusion Criteria:

* patients with systemic diseases or medications known to alter healing processes
* Psychiatric disorders.
* Root canal treated teeth.
* patients undergoing or who had undergone radiation therapy and chemotherapy to the head and neck region during 12 months.
* patients with para-functional habits.
* alcoholics.
* drug abusers.
* heavy smokers
Systematic Screening for Risk-factors for Ulcer Bleeding Before Anti-thrombotic Treatment

In a prospective randomised study design to investigate, if a systematic risk factor screening for bleeding ulcer in patients, who following percutaneous coronary intervention (PCI) commence a one year combination treatment with low dose aspirin and clopidogrel, followed by prophylactic treatment with a proton pump inhibitor (PPI) in case of increased risk, can reduce the risk of bleeding ulcer. Based on the recently raised suspicion that PPI's, possibly except pantoprazole, reduce the effect of ADP-receptor inhibitors, pantoprazole has been chosen as prophylaxis in the screening group, and analyses will be done to ascertain whether PPI treatment increases the risk of coronary events. Further analyses will be made to see whether PPI prophylaxis in high risk patients can increase compliance with the antithrombotic treatment through a reduction of side effects, thereby reducing the risk of myocardial infarction in particular stent thrombosis. The study population will be analyzed further to identify the patients, who will benefit the most from PPI prophylaxis Hypothesis: screening heart patients for risk factors for bleeding ulcer and subsequently treating high risk patients with PPI can reduce the incidence of bleeding ulcer and increase compliance with the antithrombotic treatment; thereby possibly reducing the risk of coronary events and improving survival. Initial a description of the prevalence of risk factors will be done.


Eligibility Criteria:
Inclusion Criteria:

* Patients who has had a PCI with stenting or balloon dilatation in the cardiology department at Odense University Hospital, Århus University Hospital and Ålborg Sygehus, where subsequent treatment with low-dose aspiring and clopidogrel or another thienopyridine is planned for one year.

Exclusion Criteria:

* previous PCI with stenting or balloon dilatation
* treatment with clopidogrel prior to PCI
* lack of informed consent
CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies

The study participant has one of the following blood cancers: acute myelogenous leukemia (AML)/myelodysplastic syndrome (MDS), acute lymphoblastic leukemia (B-ALL, T-ALL) or Lymphoma. Your cancer has been difficult to treat (refractory) or has come back after treatment (relapse).

Primary Objective

To determine the safety and maximum tolerated dose of intravenous infusions of escalating doses of CD70-CAR T cells in patients (≤21 years) with recurrent/refractory CD70+ hematological malignancies after lymphodepleting chemotherapy.

Secondary Objectives

To evaluate the antileukemic activity of CD70-CAR T cells. We will determine the anti- leukemic activity of the CD70-CAR T cells in the bone marrow and in the treatment of extramedullary disease.

The primary interventions are a lymphodepleting chemotherapy regimen (fludarabine and cyclophosphamide), followed by a single autologous infusion of CD70-CAR T cells.

Phase I study evaluating three (3) dose levels of CD70-CAR T cells.

Eligibility Criteria:
Inclusion Criteria

Age ≤21 years old

Relapsed/refractory CD70+ hematological malignancy

Relapsed disease: Patients developing recurrent disease after a prior complete remission (CR)

Refractory disease: Patients with persistent disease despite 3 cycles of induction chemotherapy.

* Relapsed/refractory CD70+ AML or MDS:

  * Relapsed disease that is CD70 positive
  * Refractory disease that is persistent despite 3 cycles of chemotherapy
* Relapsed/refractory CD70+ B-cell ALL:

  * Relapsed disease that is CD70 positive and CD19 negative/dim or patients otherwise ineligible for CD19-directed therapies including:
  * Patients in 2nd or greater relapse
  * Patients with relapse after allogeneic HSCT
* Relapsed/refractory CD70+ T-cell ALL:

  * Relapsed /refractory disease that is CD70 positive
* Mixed Phenotype Acute Leukemia (MPAL):

  * Relapsed/refractory that is CD70 positive
* Relapsed/refractory CD70+ lymphoma:

  * Relapsed disease that is CD70 positive and CD19 negative/dim or patients otherwise ineligible for CD19-directed therapies including:
  * Patients in 2nd or greater relapse
  * Patients with relapse after allogeneic HSCT

Estimated life expectancy of \>12 weeks

Karnofsky or Lansky (age- dependent) performance score ≥50

Patients with a history of prior allogeneic HCT must be clinically recovered from prior HCT therapy, have no evidence of active GVHD and have not received a donor lymphocyte infusion (DLI) within the 28 days prior to apheresis

Patient must have an identified HCT donor

For females of childbearing age:

i. Not lactating with intent to breastfeed

ii. Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment

Exclusion Criteria

* Known primary immunodeficiency
* Known history of HIV positivity
* Severe intercurrent bacterial, viral or fungal infection
* History of hypersensitivity to cornstarch or hydroxyethyl starch
* Patients with acute promyelocytic leukemia (APL)
* Known contraindication to protocol defined lymphodepleting
* chemotherapy regimen of Fludarabine/cyclophosphamide
Robotic Natural Orifice Specimen Extraction Surgery Versus Robotic Transabdominal Specimen Extraction Surgery for Early-Stage Rectal Cancer

A retrospective cohort study, conducted nationwide（China） and across multiple centers, aimed to compare the surgical quality and short-term outcomes of R-NOSES （robotic natural orifice specimen extraction surgery）with R-TSES （robotic transabdominal specimen extraction surgery） for early-stage rectal cancer.

In this retrospective cohort study, data from 1086 patients who underwent R-NOSES or R-TSES for early-stage rectal cancer between October 2015 and November 2023 were collected from a prospectively maintained database of 8 experienced surgeons from 8 high-volume centers in china. The study was aimed to compare the surgical quality and short-term outcomes of R-NOSES with R-TSES for early-stage rectal cancer.

Eligibility Criteria:
Inclusion Criteria:

1. histologically confirmed rectal adenocarcinoma
2. robotic TME for rectal adenocarcinoma
3. postoperative pathological staging of T1-2N0M0
4. complete surgical and postoperative follow-up information

Exclusion Criteria:

1. body mass index (BMI) ≥ 35 kg/m2
2. history of abdominal surgery
3. history of pelvic surgery
4. presence of another primary cancer
5. previous endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR)
6. anal or vaginal disease
7. ileostomy or transverse colostomy
8. conversion to open operation
9. tumor distant metastasis
Ultrasonographic Evaluation of Abdominal Muscle Thickness Symmetry and Correlation With Pulmonary Function

We aimed in this study:

1. To compare the ultrasonographic measurements of the abdominal muscles thickness symmetry in patients with adolescent idiopathic scoliosis (AIS) and adolescent healthy individuals
2. To investigate the effect of measured thickness and symmetry on pulmonary function test.

This cross-sectional,case-control clinical study included 40 patients diagnosed with AIS and 40 age and gender -matched healthy individuals. AIS group was evaluated for localization of curvature and degree of curvature. Ultrasonographic measurements and were performed of bilaterally abdominal muscle thickness in both groups. Spirometry evaluation was performed in both groups. Intragroup and intergroup data were compared.

Eligibility Criteria:
Inclusion Criteria:

* Cobb angle over 10 degrees in radiological evaluation
* Between the ages of 10-18 and diagnosed with AIS by a specialist physiatrist

Exclusion Criteria:

* History of previous spinal surgery
* Patients using brace
* Those with any diagnosis of scoliosis other than AIS
* Those with a history of neuromuscular disease
* Previous spinal surgery
* Patients with neurological deficits on examination
* Patients with acute or chronic lung pathology
* Patients with abdominal surgery or injury
* Double curve or multiple curve
* Patients with concomitant chronic diseases
* The child's legal guardian does not allow it to take the tests

The control group:

* 10-18 volunteer adolescents without any health problems,
* In clinical evaluation: Healthy adolescents (without any asymmetric findings on three-way inspection, Adam's forward bend test and scoliometer) were included.
Covid-19 Vaccination in Adolescents and Children

Objectives To assess the reactogenicity, measure the adaptive immune responses and track the long-term immune memory in healthy children and adults as well as pediatric patients receiving the COVID-19 vaccines-BNT162b2, CoronaVac-chosen by the Hong Kong Government; to compare the reactogenicity and immunogenicity across the vaccines used for these children and adults.

Hypothesis to be tested The safety profile and the magnitude and durability of immune responses to the COVID-19 vaccines in children are non-inferior to those in adults.

Design and subjects A single-site, comparative nonrandomised clinical trial for 450 healthy individuals or patients under 18 years old and one or both healthy parents and unrelated adults to receive one of COVID-19 vaccines by intramuscular injection (and intradermal injection)

Instruments Mobile app for subjects to record adverse effects, enzyme-linked immunosorbent assay, plaque reduction neutralization assay, luciferase immunoprecipitation system assay and flow cytometry.

Interventions BNT162b2 and CoronaVac, by intramuscular or intradermal route

Main outcome measures Types and frequencies of adverse effects within 7 days, and changes and peaks of antibody levels and antigen-specific memory T cell responses for 3 years.


Eligibility Criteria:
Inclusion Criteria:

1. informed consent from the parents or a legally acceptable representative for an underage participant
2. biological parents of students enrolled in the trial or unrelated healthy adults
3. ability to adhere to the follow-up schedules
4. willingness to report reactogenicity daily for 7 days post dose 1, 2 and 3 (and 4) proactively
5. willingness to receive that vaccine available for that particular recruitment period (as student-parent pair, if applicable)
6. good past health, including pre-existing clinically stable disease, such as paediatric or immune disorders
7. prior COVID-19 (for COVID-19 survivor subgroup)

Exclusion Criteria:

1. reported pregnancy or breastfeeding
The Effect of Melatonin Supplementation on Fatigue Symptoms During Chemotherapy Treatment of Breast Cancer Patients

The aim of the present 3-month randomized, placebo-controlled trial was to evaluate whether adherence to Mediterranean Diet (MD) together with melatonin oral treatment or plaebo, would ameliorate Cancer Related Fatigue in Breast Cancer patients receiving chemotherapy treatment.

Cancer related fatigue (CRF) is a common distressing complaint in breast cancer (BC) patients treated with chemotherapy. Nutrition quality plays a pivotal role in CRF, while an increased interest towards new pharmacological agents has been observed.

Melatonin, an endogenous hormone that regulates the human sleep-wake cycle, could alleviate CRF.

In the present randomized, placebo-controlled 3-month trial, we investigated the effects of melatonin intake (i.e., 1 mg/day) vs. placebo on CRF of BC patients. Melatonin and placebo tablets were of similar physical and sensory properties. In both arms, Mediterranean diet (MD) was implemented. Medical history, anthropometry and blood withdrawal were performed. CRF was evaluated by the Functional Assessment of Chronic Illness Therapy - Fatigue questionnaire and MD adherence by the MedDiet Score.

Eligibility Criteria:
Inclusion criteria:

1. adult women (≥ 18 years of age) with BC diagnosis who underwent chemotherapy at the time of invitation,
2. women receiving pharmacological treatment that did not interact with melatonin,
3. women receiving standard pharmacological treatment for at least last two months prior to study initiation,
4. patients with good performance status, as indicated by scoring "0 or 1" of the Eastern Cooperative Oncology Performance Status (ECOG PS) questionnaire \[26\],
5. patients not needing a transfusion, as indicated by hemoglobin ≥ 9 g/dL,
6. patients having the ability to understand and give a written statement of consent.

   Patients were excluded from the study when:
7. fatigue was attributed to conditions other than cancer e.g., uncontrolled hypothyroidism, hypercalcemia, congestive heart failure, chronic obstructive pulmonary disease,
8. using pharmacological agents for CRF or sleeping disorders prior to the study,
9. pharmacological treatment that was modified during the study or that could interact with melatonin,
10. diagnosed with gastrointestinal diseases that could affect absorption of nutrients such as inflammatory bowel diseases infections.
11. diagnosed with psychiatric disorders such as depression, psychosis, bipolar disorder, and receiving equivalent medication.
12. excessive alcohol consumption.
13. a lifestyle that can affect sleep patterns (e.g., night shifts).
14. patients with a poor clinical state as indicated by laboratory markers: creatinine clearance \< 30 mL/min; aspartate aminotransferase (AST) \> 3 x upper limit of normal (ULN); alanine aminotransferase (ALT) \> 3 x ULN; bilirubin \> 1 x ULN.
The Effect of Vitamin C on Quality of Life of Terminal Cancer Patients

This study determines whether high dose vitamin C is effective for quality of life in terminal cancer patients.

The investigator's project is a single medical center, randomized double- blinded trial. The target group is terminal cancer patients at Palliative care clinics. The experimental group will receive intravenous high-dose vitamin C 30 g in 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment. The control group will receive 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment. The primary outcome is the improvement of quality of life, measured by European Organization for Research and Treatment of cancer (EORTC). The secondary outcome is the survival analysis.The participants will be followed up weekly for 2 weeks, then bi-weekly for 6 months.

Eligibility Criteria:
Inclusion Criteria:

-Terminal colon cancer patients without pleural effusions, who will not receive any curative radiotherapy or chemotherapy.

Exclusion Criteria:

* Renal metastasis or obstructive uropathy by radiology
* Nephrotic syndrome
* Creatinine over 1.5mg/dl
* Urolithasis
* Under other folk therapy or vitamin infusion therapy
* Those who can't exercise the right of consent
* Those who can't answer the questionaires
* Glucose-6-Phosphate Dehydrogenase Deficiency
* Severe lower leg edema or general edema
Evaluation of the Precision of the Microperimetry Function of the Spectral OCT/SLO

To conduct a precision study to assess the microperimetry function of the Spectral OCT/SLO. The study will assess variability across measurements taken by three different operator-device configuration across clinical sites, variability between subjects within a given operator-device configuration, and variability within a subject for a single operator-device configuration.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be 21 years of age or older.
* Subjects recruited to Cohort 1 will have no known retinal disease except for refractive errors (-7.5 D to +7.5 diopters).Subjects who are recruited to Cohort 2 will have one or more of the following retinal pathologies: early and intermediate Age-Related Macular Degeneration, Geographic Atrophy, Diabetic Retinopathy (mild, moderate, severe), Macular Edema secondary to Diabetes, Retinal Vein Occlusion, Central Serous Retinopathy, Pattern Dystrophy, Epiretinal Membrane or Macular Hole.
* Subjects who have signed an informed consent form.
* Subjects who can comply with the protocol.

Exclusion Criteria:

* Subjects younger than 21 years of age.
* Subjects who cannot comply with the protocol.
* Subjects who cannot complete the Simple Test procedures
* Subjects who are not available to be testing 3 times during the day (Morning, Mid - Day, and Afternoon).
* Subjects with visual acuity worse than 20/100 (Best Corrected).
* Subjects with dense media opacities.
* Ocular surgery anticipated on the day of the study visit.
Neonatal Mask Seal; a Two-handed Versus One-handed Approach: The NeoSeal Study

When babies can't breathe effectively, we can use a facemask to give them breaths and oxygen. The mask can be held with one or two hands, depending on the preference of the doctor. Both types of mask holds are recommended in international guidelines, but it is unclear which one is better for the baby. If a lot of air is leaking around the mask, it means that the baby is not getting the full breathing support that the healthcare providers are trying to give. There currently is not enough evidence to say which type of hold is better to reduce this potential leaking of air.

In this study, the investigators will compare two different ways of holding a mask on a baby's face to help them breathe. Each baby will be randomly allocated to either a one-handed or a two-handed mask hold, and the investigators will measure how much air leaks out around the mask during each breath. Any baby in the neonatal unit may be included in this study.

This study will compare the measured leak in mask ventilation delivered by a healthcare professional in the neonatal team, using a one-handed versus a two-handed hold with a standardised mask size and shape. This is to assess the two-handed technique as a potential first-line approach in neonatal bag-mask ventilation.

The handholds will be assessed by a randomised controlled trial, with the two-handed hold as the intervention and the one-handed hold as the control.

The population that will be studied is neonates in the neonatal intensive care unit (NICU), at any gestation, who the clinical team have decided to intubate.

A member of the research team, who will provide an out-of-hours on call service, will attend the event. The relevant outcomes will be measured by the Monivent Neo100, which will be set up by the research team. Standardised masks, as used per local protocol, will be used, with the sensor module placed between that and the T-piece with an adaptor.

The outcomes will assess the effectiveness of both the intervention and control, including ventilation parameters recorded by the Monivent Neo100 and the clinical stability of the patient. The primary outcome of this study is the percentage mask leak.

A research team member will record data for primary and secondary outcome. The event will be filmed for post-hoc video analysis.

The outcome assessor will be blinded to the group allocation.

This research project will take place over 24 months, with an interim analysis to ensure recruitment is projected to achieve sample size.

Eligibility Criteria:
Inclusion Criteria:

* All term and preterm neonates in the neonatal unit who the clinical team have decided to intubate, with or without pre-medication and who require mask ventilation prior to intubation attempt.

Exclusion Criteria:

* Neonates with a congenital malformation that would impact mask seal will not be included.