cyrilzakka/clinical-trials huggingface dataset:
Diagnosis and Outcomes of Placental Accretism

The goal of this observational study is to evaluate the diagnostic ability of the main criteria currently adopted for the diagnosis of placenta accreta and to define the maternal outcomes in terms of complications of the different management strategies currently adoptable when placental accretism is suspected.

Currently, the management of cases of placental accretism/percretism is not standardized. This study could help in assessing maternal and fetal outcomes related to the different therapeutic strategies applied in the clinical cases under study so that their management can be standardized in the near future.

This is a retrospective and prospective, national multicenter study. Patients will be treated according to clinical practice.

The main instrumental findings of cases of suspected accretism will be collected and analyzed, and the progression of pregnancy and postpartum (by means of laboratory and instrumental tests) will be evaluated in order to define the outcomes of conservative management (cesarean section with placenta in situ) versus more radical management (cesarean section and concomitant hysterectomy).

In particular, clinical trends (by means of assessment of vital parameters, laboratory tests, ultrasound images or instrumental examinations) in pregnancy, in the immediate postoperative period and during subsequent outpatient follow-up visits will be analyzed.

In general, in the absence of complications, visits will be performed twice a week during pre-partum. Postpartum follow-up is not standardized, as it will depend strictly on the procedure performed and the occurrence or absence of complications. There are no questionnaires and/or rating scales.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 years and 44 years
* Pregnant women with suspected placental accretism
* Acquisition of informed consent form

Exclusion Criteria:

None
Plasma NGAL in APN Patients

In recent years, novel biomarkers of renal dysfunction have attracted attention for the diagnosis of UTIs. NGAL is a 25 kDa protein that belongs to the lipocalin. It acts as a transporter for small hydrophobic molecules and is involved in many physiological processes, such as modulating inflammation, innate immune response, and maintaining metabolic homeostasis


Eligibility Criteria:
Inclusion Criteria:

* above 20 years Suspected have pyelonphirtis

Exclusion Criteria:

* age below 20
The Effect of Postoperative Eustachian Milking Maneuver on Eustachian Tube Dysfunction

This study will evaluate the effectiveness of this lymphatic drainage method in eliminating otalgia interruption due to eustachian dysfunction and reducing middle ear pressure, which occurs in the postoperative period after adenoidectomy and/or adenotonsillectomy.

The eustachian tube lies between the middle ear and the nasopharyngeal cavity and provides ventilation of the middle ear. The most important function of the Eustachian tube is to balance the air pressure in the middle ear with atmospheric pressure.

Temporary eustachian dysfunction and ear fullness occur in the early postoperative period after adenoidectomy and/or adenotonsillectomy. This temporary eustachian dysfunction is considered to be caused by clots and edema in the nasopharynx after surgery. In addition, trauma to the eustachian tube during adenoidectomy performed by curettage also contributes.

Eustachian dysfunction may present at the post-operative period resulted in otalgia related to middle ear pressure in the pediatric patients undergoing adenoidectomy or adenotonsillectomy. In this case, the need for analgesic agents rises in the early postoperative operiod and beyond this stituation impairs the quality of the healing process.

Reducing middle ear pressure by ensuring the mobility of the eustachian tube with the eustachian milking maneuver, which is a lymphatic drainage method, may reduce the otalgia symptoms during the post-operative recovery period, thus reducing the use of analgesic agents and improving the quality of the healing process. The aim of this observational study is to investigate to what extent a eustachian therapy maneuver corrects the negative values in middle ear pressure in the postoperative period.

Eligibility Criteria:
Inclusion Criteria:

Patients with ASA 1 and 2 The parent will be able to perform eustachian milking manoeuvres

Exclusion Criteria:

Tympanometric examination performed in the preoperative period revealed eustachian dysfunction Craniofacial malformation
Postoperative Pain Control for Prostatectomy

The researchers propose to investigate a relatively new anesthetic procedure, in order to maximize patient comfort and minimize the use of narcotics after a radical prostatectomy.

Our current post operative analgesic strategy involves a multi-modal approach, using local injectable anesthetic around the incision and systemic medications (i.e. non-steroidal anti-inflammatories, acetaminophen and break-through doses of opiates). As the amount of opiates used can be significant, we have to be aware of their inherent risks. Opiates have an excellent pain control profile, working peripherally by decreasing the amount of neurotransmitters released from neurons involving noxious stimuli, and also in their central processing. Some of the more common adverse reactions are reparatory depression, sedation, confusion, delirium, nausea, pruritis, constipation, hypotension and bradycardia. Often it is these resulting side effects that extend the length of in hospital rehabilitation, and decrease a patient's overall satisfaction.

Thus we propose the use of a relatively new regional anesthetic technique be employed to further decrease the need for opiates in our prostatectomy patients' post-op course, while adequately controlling their pain.

Eligibility Criteria:
Inclusion Criteria:

* prostate cancer for radical prostatectomy

Exclusion Criteria:

* chronic pain or opiate use
Suprapubic Single-incision Laparoscopic Appendectomy Versus Conventional Appendectomy: a Randomized Controlled Trial

Conventional laparoscopic appendectomy(CLA) is the current standard treatment. To obtain additional benefits such as a better cosmetic outcome, the investigators developed a surgical option termed suprapubic single-incision laparoscopic appendectomy (SSILA), which creates a non-visible scar, that was preliminarily shown to be feasible and safe in our previous retrospective studies To further evaluate the feasibility, safety and cosmetic results of this innovative approach, the investigators compared the outcomes of SSILA and CLA by performing a randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* acute appendicitis or interval appendicitis
* informed consent

Exclusion Criteria:

* diagnosis of appendicitis was not clinically established (symptoms attributable to urinary or gynecological problems)
* history of cirrhosis and coagulation disorders
* suspected or proven malignancy
* contraindication to general anesthesia (severe cardiac and/or pulmonary disease)
* inability to give informed consent(severe mental disease)
* pregnancy
* BMI\>30kg/m2
* generalized peritonitis
Medial Tab Flap for Soft Tissue Defects of the Leg

Selecting the right technique for lower limb soft tissue reconstruction is a therapeutic challenge. Despite having several reconstruction options, it's important to choose a technique that is effective and with the least possible donor site morbidity for the patient.

Objective: demonstrate the therapeutic efficacy of the medial tab flap in soft tissue reconstruction on the leg, compared to conventional flaps.

Materials and methods: Cohort study matched with Propensity Score Matching (PSM) by age. 64 patients with soft tissue defects were selected and followed up to one year postoperatively. Outcome variables: surgical time in minutes, healing, healing time in days, complications.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of soft tissue defects in the leg due to grade III B open fractures, or due to bone infection
* contraindication to using conventional flaps due to the following reasons: soft tissue injuries at the flap island site, injury to the vascular bed of the flap or injury of the flap structure (fascia, skin or muscle)
* people between 18 and 70 years of age

Exclusion Criteria:

* Patients with a history of free flaps
* Whose clinical follow up couldn't be completed to assess outcomes were excluded.
Assessment of Cortical Plasticity Following Short Term Limb Immobility

The proposed project will study the consequence of short term limb immobility on the patterns of brain activity using functional imaging (fMRI)


Eligibility Criteria:
Inclusion Criteria:

* wrist fracture.
* Fit for MRI scanning.

Exclusion Criteria:

* Unwillingness to sign informed consent.
* Neurological disease
* s/p fractures
Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated

This study is designed to determine the safety and immunogenicity of an inactivated Rift Valley Fever (RVF) Vaccine in adults

The primary objectives are to assess safety of Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200) and to assess immunogenicity of Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200). The secondary objective is to assess incidence of RVF infection in vaccinated personnel

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old.
2. Females of childbearing potential must have a negative serum or urine pregnancy test within 48 hours before each vaccination. Females will be advised not to become pregnant for 3 months after the primary series and each booster dose.
3. Females must not be breast-feeding.
4. Subject must be at risk for exposure to RVF virus.
5. Subject must have an up-to-date (within 1 year) medical history, physical examination, and laboratory tests in their charts and be medically cleared for participation by an investigator. Examinations or tests to qualify for enrollment may be repeated at the discretion of the investigators.
6. Subject must sign and date the approved informed consent document.
7. For initiation of primary series, RVF PRNT80 \<1:10.
8. For RE-ENTRY into this protocol or ROLLOVER from an earlier RVF protocol to receive a booster, RVF PRNT80 \<1:40 within past 1 year

Exclusion Criteria:

1. Older than 65 years of age for the primary series vaccination (able to receive booster doses if no other contraindications).
2. Clinically significant abnormal lab results, including evidence of Hepatitis C, Hepatitis B carrier state, or elevated (2 times normal) liver function tests.
3. Personal history of immunodeficiency or current treatment with immunosuppressive medication.
4. Confirmed positive human immunodeficiency virus (HIV) titer.
5. Any medical condition that, at the discretion of the physician, may jeopardize the safety of the subject.
6. Any serious or life-threatening allergies to any component of the vaccine: formalin human serum albumin neomycin streptomycin fetal rhesus lung cells RVF virus inactivated
7. Administration of any Investigational New Drug (IND) product or any vaccine within the 28 days before RVF vaccination.
8. Any unresolved adverse event resulting from a previous immunization.
Ultraslow SWL Versus Slow SWL for Renal Stones With High Attenuation Value

Ultraslow full-power SWL versus slow power-ramping SWL in Renal stones with high attenuation value

To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL for renal stones

Eligibility Criteria:
Inclusion Criteria:

* single Renal stone less than or equal to 3 cm (2 cm for lower calyceal stones)
* radio-opaque stone
* high attenuation value (≥ 1000 HU) stone

Exclusion Criteria:

* Abnormal renal anatomy
* renal insufficiency
* solitary kidney
* coagulopathies
* uncontrolled hypertension
* renal artery or aortic aneurysm
* active urinary tract infection
* pregnancy
* severe skeletal malformations (spinal deformity) precluding proper stone localization
* skin to stone distance (SSD) \> 11 cm
* BMI \> 30 Kgm/m2
Guided Participation Discharge Program for Very Preterm Infants

This study aimed at investigating the feasibility of a new guided participation (GP) discharge program for parents of very preterm infants. A randomized controlled trial was conducted in a neonatal intensive care unit. The intervention included three structured GP sessions and one follow-up phone call. The control group received usual care. Outcomes measured included parents' efficacy and satisfaction with parenting, and perceived stress. Data collection was conducted at baseline, on day of discharge, after the follow-up phone call, and 1 month after discharge. The outcomes were analyzed on the basis of intention-to-treat principles.


Eligibility Criteria:
For Infants:

Inclusion Criteria:

- A gestational age of ≤32 weeks at birth

Exclusion Criteria:

* Have congenital malformation(s)
* Need to undergo a major surgery

For Parents:

Inclusion Criteria:

- Must be the infant's primary caregiver

Inclusion Criteria:

- Diagnosed with a mental illness
Effects of Dietary Interventions on the Brain in Mild Cognitive Impairment (MCI)

The study will investigate whether dietary modification could provide positive effects on brain functions in elderly people with mild cognitive impairment.

The age-related degradation of cognitive functions even to the point of neurodegenerative disorders such as Alzheimer's disease are a growing public-health concern with devastating effects.

Referring to animal data, empirical studies, and pilot human trials, dietary modification (caloric restriction, omega-3 fatty acids and resveratrol) should improve cognitive functions such as learning and memory. To test this hypothesis, the researchers study general brain functions in elderly subjects (50-80 years old) with mild cognitive impairment.

Eligibility Criteria:
Inclusion Criteria:

* subjects with mild cognitive impairment
* 50-80 years old
* moderate to heavy weight (BMI 25-35)

Exclusion Criteria:

* dementia
* diabetes
* severe disease
* younger than 50 years
* BMI \< 25
Evaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study

The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of barrett's esophagus in vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is a pilot study of an novel technology, a miniaturized microscope device which can be used during upper endoscopy to image the gastrointestinal epithelium. This is an exploratory, not a comparative, study designed to evaluate the feasibility of using this instrument in Barrett's esophagus.


Eligibility Criteria:
Inclusion Criteria:

* Barrett's without dysplasia
* Barrett's with dysplasia
* Esophageal Adenocarcinoma

Exclusion Criteria:

* Subjects unfit for standard upper endoscopy
* Subjects currently receiving chemo or radiation treatment
* Subject currently receiving PDT or ablation
Video Assisted System for Nasogastric Tube Placement

A live-video system (NCKU-NG system) was developed to assist in the placement of an enteral feeding tube. This system consists of a camera and light source that can be inserted into the commercial NG tube to view live video during feeding tube placement. Manual air insufflation can be used to aid feeding tube placement and improve visualization of anatomic landmarks. After the procedure, an abdominal X-ray is done to confirm the position of the feeding tube.

This study used 15 Fr feeding tubes with an outer diameter of 4.5 mm and an inner diameter of 3.5 mm (Freka®, Bad Homburg, Germany). Patients were advised to maintain nothing by mouth (NPO) for at least four hours before the placement. An insufflation device (Olympus, Tokyo, Japan) was utilized whenever necessary to facilitate feeding tube placement or confirm its position. In cases where misplacement into the trachea was detected, the feeding tube was carefully withdrawn and reinserted into stomach. After successful insertion, all feeding tubes were securely fixed with tape on the nose. The position of NG tube was reconfirmed by traditional auscultation. Chest X-ray imaging was performed for every patient after the NG tube placement to verify the positioning of the tube by the primary care physician. Time to visual confirmation of stomach position, for completing tube placement with/without air insufflation were recorded. Numbers of attempts, vocal cord/trachea visualization and air insufflation were also recorded. A study assistant monitored the patient's condition for the subsequent seven days, recording any observed complications or adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Patients (\>20 y/o) requiring enteral feeding and/or medication with an expected duration longer than 48 hours were eligible for inclusion.

Exclusion Criteria:

* Patients can't receive an X-ray after the procedure to confirm tube position (e.g. pregnancy)
* Patients with hemodynamic instability (defined as mean arterial pressure \<65 mmHg)
* Patients with a history of basal skull fracture.
Validation of Fore-Sight Cerebral & Tissue Oximeter Saturation Measurements on Neonates ≤ 5 kg

CASMED, INC. wishes to validate the next generation FORE-SIGHT-II (FS-II) NIRS tissue oximeter monitor for neonatal brain and somatic tissue oxygen saturation (StO2) measurements. This monitor was recently FDA cleared for use on adult subjects.

1. Validate FS-II abdominal StO2 measurements from the intestines, liver, and flank to umbilical venous and arterial blood oxygen saturation.
2. Validate FS-II cerebral StO2 measurements against the predicate FDA cleared FORE-SIGHT-I (FS-I) monitor.
3. Collect data from FS-II sensors on the forehead and abdomen (intestine) for 24 hours to compare dynamic changes vs the pulse oximeter. For larger neonates, add a predicate FS-I sensor to the opposite side forehead for dynamic comparison to FS-II measurements.
4. Obtain abdominal Near Infrared Spectroscopy (NIRS) data simultaneous with accepted measures of bowel motility (a. frequency and composition of stools, and b. Ultrasound assessment for the frequency and magnitude of bowel peristalsis, if available).

Eligibility Criteria:
Inclusion Criteria:

Neonatal subjects (32 to 36 and 6/7 weeks), with umbilical venous catheterization will be enrolled from the Neonatal Intensive Care Unit.

Exclusion Criteria:

Enrollment in other studies during study period. Inability to tolerate ultrasounds or NIRS sensors
Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in HCC After Liver Resection

This trial is a multi-center, double-blinded, randomized (1:1) clinical trial. The aim is to compare the postoperative infection rate between the 3 days postoperative AMP group and the placebo group in HCC patients undergoing hepatectomy.

This trial includes two phase. The first phase is the internal pilot study to explore the expulsion rate and recruited population. The second phase is the main phase III trial.

Eligibility Criteria:
Inclusion Criteria:

* Age: over 18 years;
* Diagnosed as primary HCC according to the EASL criteria and plan to receive hepatectomy;
* Child-Pugh A class;
* No history of antibiotics in 1 week before surgery, except for antimicrobial prophylaxis in the 24h before surgery.
* No evidence of infection during preoperational assessment

Exclusion Criteria:

* Underwent hepatectomy combined with resection of other organs, except for gallbladder;
* Found obvious infection during operation;
* Combination with other operations, such as biliary reconstruction or tube drainage, bile duct exploration and stone remove, etc.;
* Allergic to the antibiotics used in the 24h before surgery;
* Emergency surgery;
* Tumor rupture;
* Did not underwent hepatectomy because of any reasons;
* Admission to ICU after surgery;
* ASA grade ≥ 3;
* Denial of informed consent.
Anterior Cervical Discectomy and Fusion (ACDF) - Behavioral Intervention

This study will prospectively recruit and enroll patients undergoing primary Anterior Cervical Discectomy and Fusion (ACDF) surgeries at NYU Langone. Participants will undergo pre-operative and six-week post-operative swallowing assessment using videofluoroscopy (VFSS). Acoustic voice samples and Patient Reported Outcome Measures (PROMs) for swallowing and voice will also be collected. Beginning one-week before surgery participants will begin a behavioral health program that will be continued for six-weeks after surgery. The primary goal of this study will be to determine whether a preventative behavioral health program improves instrumental measures of swallowing and voice six-weeks after ACDF surgery. .


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to sign consent form to participate in the study.
2. Age between 21- 99 years.
3. Scheduled to undergo ACDF surgery with surgeons in the departments of Neurosurgery or Orthopedic Surgery at NYU Langone.

Exclusion Criteria:

1. Patients with non-degenerative spine conditions, such as trauma, tumors, infection, radiation, and diabetes.
2. Patients with prior posterior-approach cervical spine procedures.
3. Patients undergoing ACDF revision procedures.
4. Patients who report a pre-existing dysphagia as the result of a neurological deficit or disorder, head and neck cancer treatment, and/or muscular condition.
5. Pregnancy. Female subjects must confirm they are not pregnant before enrolling in the study.
6. Patients with chronic kidney disease, limiting their ability to consume high levels of protein.
7. Patients with known allergies to ingredients listed in Premier Protein Clear drinks.
Near to Infrared (NIR) Light Neuroprotection in Glaucomatous Optic Neuropathy

The purpose of the study is to evaluate if near-to-infrared light stimulation can improve retinal ganglion cell function in glaucomatous patients.

Ganglion cell dysfunction in glaucomatous optic neuropathy has been ascribed to ganglion cell electrophysiological inactivation and to apoptotic cell death. Near-to-infrared light stimulation has been used to induce mitochondrial activation and to prevent apoptotic death through mitochondrial cytochrome oxidase c stimulation. Near-to-infrared light stimulation might be useful to induce ganglion cell activation and inhibit apoptotic cell death.

We propose that near-to-infrared light stimulation can be used as an adjuvant treatment combined with ocular hypotensive treatment in glaucomatous patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnose of Ocular Hypertension (cup to disk ratio 0,6 or less, normal Humphrey 24-2 visual field with aplanatic IOP over 21 mmHg) or Mild Glaucoma (cup to disk ratio 0,6 to 0,8, characteristic Humphrey 24-2 visual field defect PSD between 3 and 6 dB).
* Visual acuity 20/40 or better

Exclusion Criteria:

* Diabetic retinopathy, Multiple Sclerosis, Parkinson disease
* Refractive error of 3 diopters or more