cyrilzakka/clinical-trials huggingface dataset:
Azygos Vein Preservation; Its Impact on Early Outcomes After Neonatal EA/TOF Repair

Azygos vein preservation revisited: impact on early outcomes after repair of Esophageal atresia/ Tracheo-Esophageal Fistula in newborns. A randomized controlled study.

Since the first successful repair of esophageal atresia/tracheoesophageal fistula was performed approximately eight decades ago, surgeons have made considerable technical advances in solving intraoperative surgical challenges and reducing postoperative complications. According to some surgeons, the advantage of maintaining the Azygos vein makes this modification attractive. This study aimed to explore the benefits of retaining the Azygos vein during surgery for Esophageal Atresia with tracheoesophageal fistula, to emphasize its advantages in terms of reducing anastomotic leak, stricture, and other postoperative outcomes.

Patients and Methods: This prospective randomized study was conducted between April 2020 and April 2023. The study included all newborns with (EA \& TEF) eligible for primary repair, patients were randomly assigned to either Group A or Group B. (Group A) patients who underwent Azygos vein preservation during TEF repair, whereas the remaining patients (Group B) had Azygos vein disconnection.

Statistical analysis: The Statistical Package for Social Sciences (SPSS) (version 23.0, IBM Corp IBM Corp., Armonk, NY, USA) was used for statistical analysis. The chi-square test (X2) was used to compare qualitative data in the groups, while an independent-sample t-test was used to compare quantitative data between groups. The degree of confidence was set at 95%. The p-value was considered significant at a level of 0.05.

Discussion: will focus on advantages of azygous vein preservation on intactness of esophageal anastomosis, retaining the venous drainage of the bronchial system, and chest wall. Points of discussion will include effects of Azygous vein preservation on incidence of postoperative pneumonitis, anastomotic leakage and stricture rate, and mortality rate. The results obtained from this study will be compared between both groups and with those reported in the literature.

Finally, the investigators will conclude the reconstructive technique that gives the better results and least morbidity.

Eligibility Criteria:
Inclusion Criteria:

* all neonates suitable for primary repair of Esophageal Atresia and tracheoesophageal fistula

Exclusion Criteria:

* long gap esophageal atresia (\> 3 cm)
* esophageal atresia without tracheoesophageal fistula
Juvenile Primary Fibromyalgia Syndrome (JPFS) in an Adolescent Psychiatric Population

The purpose of this study was to identify clinical characteristics and estimate the prevalence of Juvenile Primary Fibromyalgia in a female inpatient psychiatric population. The secondary purpose of this study was to determine the efficacy of an intervention (psychoeducational seminar and relaxation technique) on reducing the symptoms of Juvenile Primary Fibromyalgia Syndrome. We looked at the short-term and long-term effects of this intervention in comparison to the control (skin care seminar).

The specific aims of phase one of this study were to estimate the prevalence of Juvenile Primary Fibromyalgia Syndrome (JPFS) in an inpatient female psychiatric population and to identify characteristics associated with JPFS in this population. We chose to explore two primary hypotheses. Because of the common link between adult fibromyalgia and anxiety and depression, we hypothesize that those with JPFS will score higher on measures of these symptoms. Given the adult literature on the suspected link between physical and or sexual abuse and adult fibromyalgia, we also hypothesized that adolescents who meet criteria for JPFS will have higher rates of sexual and physical abuse.

The other specific aim of this study was to determine the short- and long-term impact of an intervention on reduction of JPFS symptoms. The intervention was a psychoeducational seminar on JPFS (pain management, diet, exercise and sleep hygiene) followed by a relaxation technique (audio-guided CD). The control group was involved in an educational seminar on skin care (WITHOUT relaxation technique). Study measures were obtained immediately before and after the intervention/control seminars (short-term) and 8 weeks after discharge (long-term). Each group was discharged with a CD player and CD with relaxation technique or skin care seminar. Participants recorded the use of the CD's and completed follow up questionnaires 8 weeks after discharge from the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to inpatient child psychiatric facility
* Between 12-18 years of age
* in parental or family (relative as guardian) custody

Exclusion Criteria:

* In state custody
* low intellectual functioning (i.e. IQ less than or equal to 70)
* active psychosis
A Study to Evaluate Symptomatic Remission in Schizophrenia With Long Acting Risperidone Microspheres

The purpose of this study is to evaluate symptomatic remission rate in patients with schizophrenia using long acting risperidone microspheres

Although most of Korean schizophrenic patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to daily oral regimen. Long-acting injectable formulation may eliminate this need for daily medication. This is a prospective, open-label, multicenter study to determine the long-term efficacy, especially symptomatic remission rate of long-acting risperidone microspheres administrered in the muscle at 2 week intervals in patients with schizophrenia.

The patients will receive intramuscular injections either 25, 37.5, 50 mg equivalent of risperidone at every 2 weeks for 1 year

Eligibility Criteria:
Inclusion Criteria:

* Subjects with schizophrenia or schizoaffective disorder - Subjects who have experienced relapse or re-admission previously - Subject and/or his/her relative, guardian or legal representative who has signed the informed consent form

Exclusion Criteria:

* First antipsychotic treatment ever - On clozapine during the last 3 months - Serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities - Subjects that are previously on concomitant use of Risperdal Consta within 60 days prior to entry - Previous sensitivity history to risperidone - History or current symptoms of tardive dyskinesia - History of neuroleptic malignant syndrome - Pregnant or breast-feeding female - Female patient of childbearing age without adequate contraception (adequate contraception includes: abstinence, oral contraceptive, intrauterine devices, barrier method (diaphragm or condom) plus spermicide - Norplant TM or Depo-Provera TM. A female patient of childbearing potential must have an adequate contraception and a negative urine pregnancy test at every visit)
Efficacy Study of Ilaprazole to Treat Erosive Esophgitis

This study compared Ilaprazole 20mg with lansoprazole 30mg for the healing of erosive esophagitis and resolution of heartburn.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D) within 14 days prior to baseline.
* Episodes of heartburn or regurgitation has experienced during the last 7 days prior to baseline.

Exclusion Criteria:

* Coexisting diseases affecting the esophagus (eg, eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, or esophageal stricture), history of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus. Presence of a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter) or Barrett's esophagus were not exclusionary.
* Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer.
* Known hypersensitivity to any PPI (including lansoprazole, omeprazole, rabeprazole, pantoprazole or esomeprazole), any component of ilaprazole, or Gelusil.
* Cancer (except basal cell carcinoma of the skin) within 5 years prior to screening.
Novel Therapeutics and Endothelial Dysfunction in T1DM Patients

The aim of study is impact of additional treatment with new antidiabetic drugs (semaglutide or empagliflozine) compared to control group in T1DM patients - impact on endothelial function measured by FMD and FPF, arterial stiffness - measured by PWV, inflammatory biomarkers, markers of oxidative stress and endothelial progenitor cells (CD 34+/VDRL2, CD 133+/VDRL2) and correlation with glucovariability or time in range, measured with CGM system.


Eligibility Criteria:
Inclusion Criteria:

* T1DM
* HbA1C\<=9%
* prone to CGM system
* 20 - 70 years

Exclusion Criteria:

* HbA1C \>9%,
* BMI\<22,
* pregnancy or lactation,
* known hypersensitivity to study drug,
* malignant disease ( excluded \>5 years disease free, bazocellular or planocellular ca of skin),
* liver cirrhosis child C,
* eGFR\<60 ml/min,
* chronic inflammatory disease,
* proliferative diabetic rethinopathy,
* MEN or medullary thyroid cancer in familly,
* concomitant drugs with influence on glycemia and antiinflammatory influence (corticosteroids, immunosupresive therapy),
* Major cardiovascular event last 2 months ( stroke, MI)
Beta-blockers for Prevention Of Growth Of Small Esophageal Varices In Cirrhosis: An Randomized Controlled Trial (RCT)

Background and Aims: The efficacy of portal pressure reduction by beta blockers for the management of small (≤5 mm) esophageal varices in patients of cirrhosis is not clear. The present randomized controlled trial aims to address these issues. The investigators also assessed the utility of serial HVPG measurements in these patients.

Patients and Methods: Consecutive patients with cirrhosis with small varices, with no history of variceal bleed, were randomized to receive propranolol or placebo. These patients were further randomized to undergo no HVPG, only baseline HVPG, or serial HVPG measurement. Propranolol was titrated to reduce heart-rate to 55/min.


Eligibility Criteria:
Inclusion Criteria:

* A clinical, radiological or histologic diagnosis of cirrhosis was made
* Age was between 18 and 70 years
* Esophageal varices were small (i.e. ≤5 mm or of grade 1 or 2 according to Conn et al).

Exclusion Criteria:

* Presence of previous variceal bleeding
* Previous medical, surgical or endoscopic treatment for portal hypertension
* Child-Pugh score \>13
* Neoplastic disease of any site
* Splenic or portal vein thrombosis
* Concurrent illnesses expected to decrease life expectancy to less than one year
* Pregnancy
* Contraindication to beta-blockers (atrioventricular block, sinus bradycardia with heart rate \<50 beats per minute, arterial hypotension with systolic blood pressure \<90 mm Hg, heart failure, asthma, peripheral arterial disease, or diabetes needing insulin treatment)
* Concurrent anti-viral treatment during the study period
* Inability to perform follow-up
* Failure to give consent to participate in the study.
Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant

Nestle Impact has shown efficacy in multiple surgical trials in relation to improving hospital length of stay and infection rate. 1 dose of Nestle Impact Advanced Recovery will be taken orally three times a day beginning on the morning following stem cell transplant and will continue until the day of hospital discharge.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving an autologous stem cell transplant using the preparative regimens of BEAM (Carmustine, Etoposide, Cytarabine, Melphalan), Melphalan 140mg/m2, or Melphalan 200mg/m2
* Any prior diet or supplement will be allowed.
* Age \>18 years.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Nestle Impact including fish oil.
A Clinical Study of the GO-LIF® Approach for Lumbar Spinal Fixation

The purpose of this study is to collect data regarding the safety and feasibility of the GO-LIF procedure for spinal fixation and stabilization, in conjunction with conventional approaches for interbody lumbar fusion. This is in order to allow for evidence-based comparison to pedicle-screw-based techniques as described in the literature.


Eligibility Criteria:
Inclusion Criteria

1. Men and women, 18-80 years of age.
2. The capability to comprehend the nature and rationale of the study and to consent to participating in the study.
3. Unequivocal medical indication for the fixation surgery of a single motion segment of the lumbar spine.
4. Correct coronal profile of the lumbar spine. An asymmetric collapse of the disk space in the coronal plane between the vertebral bodies envisioned for instrumentation is by itself not an exclusion criterion.

Or any of criteria below:

1. Patients with Grade II or Grade III spondylolisthesis in the sagittal plane with preserved or normal sagittal alignment requiring single-level instrumented interbody fusion from L1 to S1. (Not excluding patient with a need to decompression)
2. Patients must have normal alignment of the spine in the coronal view. 2. The interbody fusion approach may be TLIF or PLIF or ALIF or other, as clinically indicated.

   3. The procedure may be combined with a Micro-decompression and/or Micro-discectomy and/or direct or indirect decompression and/or laminectomy or laminotomy and/or other procedures, as clinically indicated - as long as such procedures do not compromise the structural integrity of the pedicles of the inferior vertebra or the vertebral body of either vertebra of the levels involved..

   4. Patient is 18 years or more 5. Patient is willing and able to comply with study requirements

   Exclusion Criteria:
   1. Lumbar hyperlordosis \> 70° between the end plate of the lumbar vertebral body 1 and the end plate of the sacral vertebral body 1.
   2. Deformities of the vertebral bodies envisioned for instrumentation or the sacrum.
   3. Spondylolisthesis \> grade 2 acc. to Meyerding.
   4. Scoliosis and other deformities in the coronal plane.
   5. Fractures of the vertebrae envisioned for instrumentation.
   6. Osteoporosis or osteopenia (see below for examination criteria).
   7. Therapy with systemic corticosteroids or immunosuppressants.
   8. Bone metabolism diseases, such as osteomalacia or Paget's disease.
   9. Post inflammatory instability of the vertebral spine.
   10. State after radiation therapy of the relevant vertebral spine region.
   11. Current Marcoumar or heparin therapy for more than 6 months at the time of operation.
   12. Malignant diseases with or without bone metastases.
   13. Immunologic-inflammatory diseases (e.g., rheumatoid arthritis).
   14. Diabetes mellitus.
   15. Infectious diseases.
   16. BMI \> 30.
[68Ga]-NeoBOMB1 Imaging in Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR)

This was a Phase II, multi-center, open label, single dose study in patients with tumor types known to overexpress Gastrin-Releasing Peptide Receptor (GRPR), including breast, prostate, colorectal, Non-Small Cell Lung Cancer (NSCLC) and Small-Cell Lung Cancer (SCLC).

A total of 50 subjects were planned for the study (10 subjects for the dosimetry group and 40 subjects for the non dosimetry group). In total, 22 subjects were screened for eligibility and 19 subjects were enrolled (2 subjects in the dosimetry group and 17 subjects in the non dosimetry group).

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be at least 18 years of age
* Subjects must have signed and dated an informed consent prior to any study-specific procedures
* Subjects with histologically-confirmed tumor for whom a recent biopsy (not older than 6-months old) has been performed.
* Dosimetry group: luminal breast cancer, adenocarcinoma of the prostate
* Non-dosimetry group: luminal breast cancer, adenocarcinoma of the prostate, small cell lung cancer, non-small cell lung cancer, colorectal carcinoma
* At least one malignant lesion detected via functional or morphological imaging (PET combined to appropriate tracer according to tumor type, CT, MRI) within 3 months prior to \[68Ga\]-NeoBOMB1 administration
* The Eastern Cooperative Oncology (ECOG) performance status 0-2.
* Subjects must agree to use highly effective methods of contraception (female partners of male participants should use highly effective methods of contraception) during the trial.

Exclusion Criteria:

* renal insufficiency or an eGFR \<50 ml/min/1.73m2
* hematological toxicity grade \> 2 (Toxicity Grading Scale in vaccine clinical trials)
* participation in any other investigational trial within 30 days of study entry
* subjects with positive pregnancy test (urine dipstick), and/or currently breast-feeding
* concurrent severe illness or clinically relevant trauma within 2 weeks before the administration of the investigational product that might preclude study completion or interfere with study results
* concurrent bladder outflow obstruction or unmanageable urinary incontinence
* known or expected hypersensitivity to \[68Ga\]-NeoBOMB1 or any excipient present in \[68Ga\]-NeoBOMB1
* any condition that precludes raised arms position
* prior administration of a radiopharmaceutical within a period corresponding to 8 half-lives of the radionuclide
* history of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
Informational Intervention in Increasing Lactation Practices by African American Women

This trial studies how well an informational intervention works in increasing lactation practices by African American women. Giving additional information about breastfeeding and breast cancer risks to African American women may help doctors understand the factors that affect the decision to breast feed and to test whether providing useful information about breastfeeding will change breastfeeding behavior.

PRIMARY OBJECTIVES:

I. Develop appropriate intervention strategies about the "breastfeeding-breast cancer connection" appropriate for use by experienced Women, Infants and Children (WIC) Peer Counselors (PCs) to disseminate to African-American mothers through a community-based participatory research (CBPR) approach including social media..

II. Assess the comparative cognitive (e.g., knowledge, utility, cost-benefit), affective association (e.g., feelings), socioeconomic, familial and intent/outcome (e.g., breastfeeding) measures pre- and post-intervention to determine effectiveness of the content to impact cognitive and feeling measures and increase breastfeeding in young African-American mothers compared to an existing counseling program.

OUTLINE: Participants are assigned to 1 of 2 groups.

GROUP I: Participants receive standard information about pregnancy and breastfeeding. Participants may also participate in a focus group with their partner/spouse or family members after the baby's birth.

GROUP II: Participants receive standard information about pregnancy and breastfeeding as well as information about breastfeeding and breast cancer. Participants may also participate in a focus group with their partner/spouse or family members after the baby's birth.

After completion of the information intervention, participants are followed for up to 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant African American women participating in the Catholic Charities WIC Program
* INCLUSION - FOCUS GROUPS: Representative mothers, spouses/partners, influential family members (e.g., grandmothers, sisters) from the families served during the study.
* INCLUSION - FOCUS GROUPS: Partners/spouses may include men or women.

Exclusion Criteria:

* Unwilling or unable to follow protocol requirements.
Cyproheptadine as an Appetite Stimulant

Cyproheptadine is currently clinically used as an appetite stimulant for children with failure to thrive without underlying organic disease. Otherwise, no randomised control trial demonstrates the efficacy of Cyproheptadine on those patients. This is precisely what the investigators intend to demonstrate on this randomised placebo control cross-over trial. Our hypothesis is that Cyproheptadine is more efficient than placebo to improve weight gain and feeding behaviour on 2 to 4 years old children with failure to thrive.


Eligibility Criteria:
Inclusion Criteria:

* 2 to 4 years of age
* failure to thrive

Exclusion Criteria:

* Medication affecting appetite
* Medication interacting with Cyproheptadine
* Prematurity under 36 weeks of gestation
* Neurologic impairment
* underlying organic disease
Comparing the Efficacy of Reverse Hybrid Therapy and Concomitant Therapy

Reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains unanswered.

A 14-day hybrid therapy invented by our study group appears very promising in H. pylori eradication, achieving excellent eradication rates of 99% and 97% according to per-protocol and intention-to-treat analyses, respectively. Recently, the investigators demonstrated that the eradication rate of reverse hybrid therapy was higher than that of standard triple therapy. However, whether reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains unanswered.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria:

* previous H pylori-eradication therapy
* ingestion of antibiotics or bismuth within the prior 4 weeks
* patients with allergic history to the medications used
* patients with previous gastric surgery
* the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
* pregnant women
Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue Versus Tack Mesh Fixation

The quality of life after hernia surgery like chronic pain and discomfort has frequently been reported with a frequency varying from 0 to 53%. As many as 10% of the patients report increased pain following surgery. Therefore, the current study aimed to assess the quality-of-life for patients with post-inguinal hernia repair by mesh fixation versus fibrin glue.

A wide variety of mesh fixation techniques are available for laparoscopic hernia repair. These can be broadly divided into mechanical and nonmechanical methods. Mechanical methods include sutures and tissue penetrating fixation devices like tackers. Nonmechanical techniques include self-gripping meshes and tissue adhesives (glues).

Mechanical methods are hypothesized to cause more postoperative pain and increased risk of seroma formation, hematoma formation, and osteitis pubis due to tissue trauma and also have increased risk of chronic pain due to nerve entrapment. On the other hand, nonmechanical methods do not have these disadvantages.

Furthermore, the quality of life after hernia surgery like chronic pain and discomfort has frequently been reported with a frequency varying from 0 to 53%. As many as 10% of the patients report increased pain following surgery. Such a chronic pain is often developed due to the use of open inguinal technique along with heavy weight mesh with mechanical fixation techniques, presence of severe pain before surgery and young age. To the best of our knowledge, there are lacking evidence assessing the impact of mesh fixation using fibrin glue upon the quality of life of patients. Therefore, the current study aimed to assess the quality-of-life for patients who had post inguinal hernia repair by mesh fixation versus fibrin glue.

Eligibility Criteria:
Inclusion Criteria:

1. Age group of 18-60 years.
2. All types of inguinal hernias.
3. Didn't undergo pervious hernia repair surgery.

Exclusion Criteria:

1. Patients who are unfit for general anesthesia or with American Society of Anesthesiologists (ASA) grade 3 and above.
2. Presence of other groin or abdominal hernias.
3. Patients with complicated hernias such as irreducibility, obstruction, and incarceration.
4. Patients with obesity or morbid obesity BMI \>= 35.