cyrilzakka/clinical-trials huggingface dataset:
Home Treatment of Acute Pancreatitis

Acute pancreatitis (AP) is considered a disease requiring in-hospital treatment. We studied the feasibility of home management in AP.The aim of study was to compare 30 day readmission rates in patients with mild non-alcoholic acute pancreatitis (NAAP) randomized to home monitoring versus hospitalization.

Between 11/11-5/12, 84 patients with mild NAAP were randomized to home or hospital groups after a short (≤24 hours) hospital stay. AP was defined as ≥2 or more of the following: characteristic abdominal pain, amylase and/or lipase ≥3X the upper limit of normal, and/or imaging findings. Patients with an Imrie's score ≤5 and a harmless acute pancreatitis score (HAPS) ≤2 were included. Patients in both groups received intravenous lactated Ringer for 3 days and pain was treated with intramuscular diclofenac. A nurse visited all patients in the home group on the 2nd, 3rd and 5th day. All patients recalled for follow-up on the 7th, 14th, and 30th days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AP based on 2 out of 3 findings: characteristic abdominal pain, amylase and/or lipase levels ≥3 times the upper limit of normal, and/or abdominal imaging demonstrating changes of acute pancreatitis
* Presentation within 48 hours of symptom onset
* Imrie's scores of ≤5 and HAP score ≤2 within 24 hours of presentation to the hospital
* Lack of hemoconcentration (hematocrit ≥44%) on presentation since hemoconcentration has been shown to be a risk factor for pancreatic necrosis.

Exclusion Criteria:

* The presence of organ failure by the Atlanta criteria on the first day of presentation
* The presence of clinical signs and/or symptoms of sepsis
* Alcoholic acute pancreatitis
* A history of abdominal imaging demonstrating a dilated pancreatic duct and/or pancreatic calcifications
* Coagulopathy (international normalized ratio \>1, and/or platelet count \<50,000/mm3
* Comorbidities requiring hospitalization regardless of the presence of AP e.g. acute myocardial infarction, malignancy, cirrhosis, chronic kidney disease, and chronic pulmonary disease)
Electromagnetic Tracking of Devices During Interventional Procedures

This prospective, randomized, controlled, parallel-design trial will compare the use of electromagnetic tracking and image guidance during biopsy/ablation procedures verses the typical standard or conventional image guided procedure alone (control). "US" ultrasound-guided biopsies/ablations with or without "CT" computed tomography- imaging will be used to complete the procedures in either the CT suite or a procedure room, at the discretion of the physician, and according to normal local practice patterns.

The study will consist of approximately 300 patients from 1 sites. Each site will have a study group, where the physician will use the electromagnetic tracking system along with "US" ultrasound or "CT" computed tomography to complete the procedure and a control group, where the electromagnetic tracking system will be used, but the physician will be blinded to it and use only the typical, standard, conventional protocol, using US or CT, to complete the procedure. The expected completion time for enrollment is 12 months, but will depend on the ability of each Clinic to enroll patients.

Data and observations will be collected at a total of 2 scheduled appointments (screening and 1 study visit) or based on the current hospital workflow, which may combine these into one patient encounter.

Eligibility Criteria:
Inclusion Criteria:

* Has had a pre-operative CT scan performed and will be undergoing a biopsy or ablation procedure of the chest, abdomen and/or pelvis;
* Is over the age of 18;
* Has the ability to understand and the willingness to sign a written informed consent form, and complies with the protocol;
* Has the ability to follow procedural instructions, including, but not limited to, holding their breath and remaining reasonably motionless during the procedure.

Exclusion Criteria:

* Was precluded from a biopsy/ablation procedure based on standard exclusions;
* Has an adhesive allergy (due to the application of active fiducials with adhesive backing);
* Has a pacemaker or automatic implantable cardiac defibrillator;
* Has a gross body weight above the procedural table limit (typically \> 170 kg);
* Is pregnant
Efficacy and Safety of Shen Que (RN8) Moxibustion in Unexpected POR

Moxibustion of Shen Que (RN8) can increase the number of embryos available for transfer, thus improving pregnancy outcomes in women of advanced reproductive age who experience unexpected poor ovarian response.

According to the traditional Chinese medicine (TCM) theory, Shen Que (RN8) is the place where the vitality converges under the navel, and is closely connected with the vitality generated by the kidney Qi. Therefore, stimulating Shen Que may stimulate the essence stored in the kidney, and improve the fertility of "五七" (≥ 35 years old) women.

Shen Que moxibustion has been shown to improve ovarian functional reserve in patients with ovarian insufficiency in previous studies. Nevertheless, studies on Shen Que moxibustion in advanced women with unexpected poor ovarian response (POR) who undergo IVF-ET are very limited. Consequently, we designed this randomized controlled trial to validate the hypothesis that Shen Que moxibustion improves reproductive outcomes in unexpected POR women.

Eligibility Criteria:
Inclusion Criteria:

* ≥35 years old with normal pre-stimulation ovarian reserve parameters (antral follicle count (AFC) ≥ 5 or anti-mullerian hormone (AMH) ≥1.2 ng/ml) and with an expected poor ovarian response (fewer than 4 oocytes) after standard ovarian stimulation.

Exclusion Criteria:

* Individuals with a Body Mass Index (BMI) ≥ 35 Kg/m2
* Those using the natural cycle or mild stimulation for IVF/intracytoplasmic sperm injection (ICSI) treatment
* Those with a history of unilateral oophorectomy or recurrent pregnancy loss, defined as two or more spontaneous abortions
* Acceptors of donated oocytes or performed either In vitro Maturation (IVM) or blastocyst biopsy for Preimplantation Genetic Diagnosis (PGD) or Preimplantation Genetic Testing for Aneuploidies (PGT-A)
* Those previously diagnosed with congenital (e.g., mediastinal uterus and double uterus) or acquired (e.g., submucosal myoma and adenomyosis) uterine abnormalities
* Patients with extremely advanced age ( ≥ 45 years old)
* Presence of a non-surgically treated hydrosalpinx or endometrial polyp and an ovarian endometriosis cyst requiring surgery, during ovarian stimulation
Effects of St. John's Wort on the Oral Contraceptive Hormone Levonorgestrel

This study will determine the effects of St. John's wort, a common herbal remedy, on metabolism of the female contraceptive hormone levonorgestrel.

In the last decade, St. John's wort has become one of the most commonly used botanicals. Levonorgestrel is a form of progesterone, a female hormone involved in conception. It can be given as both a pill and an injection and is used for contraception and for the treatment of endometriosis. However, evidence suggests that St. John's wort may reduce the effectiveness of the contraceptive hormone levonorgestrel. This study will determine whether interactions between St. John's wort and levonorgestrel reduce the effectiveness of the hormone. This study will also determine whether a higher dose of levonorgestrel will override the effects of St. John's wort.

All participants will receive a single dose of levonorgestrel between Days 9 and 12 of their first menstrual cycle after entering this study. Blood and urine collection will occur immediately after the levonorgestrel is given and every week until participants' next menstrual cycle to determine the levels of reproductive hormones in participants' bodies.

At the beginning of participants' next menstrual cycle, they will be randomly assigned to one of four groups and receive either St. John's wort or placebo for 6 weeks. Group 1 will receive a placebo; Groups 2 and 3 will receive a standard dose of St. John's wort (900 mg per day); and Group 4 will receive an increased dose of St. John's wort (1500 mg per day). After 6 weeks, Groups 1, 2, and 4 will receive 150 mcg levonorgestrel; and Group 3 will receive 225 mcg levonorgestrel. Blood and urine collection will occur immediately after levonorgestrel is given and every week until participants' next menstrual cycle.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 20 and 25
* Regular menstrual cycles for at least 3 months prior to study entry

Exclusion Criteria:

* Current use of foods, herbs, vitamins, over-the-counter supplements, or any medications that could alter pharmacokinetics of other drugs
* Medical contraindications to the use of contraceptives
Observational Study of Delayed Nausea and Vomiting

Delayed emesis following administration of carboplatin-based chemotherapy despite prophylaxis with standard antiemetic prophylaxis (5-HT3 and corticosteroid) remains a clinically significant and distressing problem for patients with cancer. The incidence of delayed emesis appears to be higher in women compared to men.

All patients will be given the Functional Living Index- Emesis (FLIE), a standardized questionnaire. This is a self-administered questionnaire to assess the impact of nausea and vomiting on the patient's functional living, including physical activities, social and emotional function, and ability to enjoy food and drink. Patients will complete the questionnaire during the 5 days following carboplatin administration (at 24 hours, 48 hours, 72 hours and 96 hours) during their first and third cycles of chemotherapy. The questionnaire should take approximately 10 minutes or less to complete.

Patients will also be interviewed by a trained CRA or research nurse over the telephone 24-48 hours following carboplatin administration in order to assess the severity of the delayed nausea and vomiting.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have newly diagnosed, histologically or cytologically proven cancer, and be scheduled to receive chemotherapy with carboplatin at AUC 5 or above.
* Patients should receive standard antiemetic prophylaxis prior to carboplatin administration, defined as 5-HT3 antagonist and dexamethasone. We will include only patients whose standard care includes treatment with a carboplatin-containing regimen and who are not being treated with aprepitant (Emend®).
* Age \>= 18.
* After being informed of the treatment involved, patients must give written consent.
* Entry to this study is open to both men and women and to all racial and ethnic subgroups.

Exclusion Criteria:

* No prior cytotoxic chemotherapy within the last 5 years.
* Should not be pregnant.
Outcomes of Critically Ill Patients Undergoing RRT- a Registry Based Study.

Rationale: Acute kidney injury (AKI) requiring renal replacement therapy (RRT) is a frequently occurring entity among critically ill patients. This study aims to determine the outcomes of patients undergoing renal replacement therapy in the ICU.

Study Objective: To find the outcomes of patients undergoing RRT in the ICU in terms of mortality and length of ICU stay.

Design: A registry based, retrospective, descriptive study. Sample size: Convenience sampling of all the patients who require RRT during the ICU stay.

Duration: Retrospective data from three years January 1, 2020 to December 30, 2023.

Place: Intensive care units (ICUs) of the Department of Critical Care Medicine, Tribhuvan University Teaching Hospital (TUTH).

Interventions: Not applicable Expected results: The study will help determine the outcomes of the critically ill patients undergoing RRT in a low middle income country ICU.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Admission to the ICU
* All patients undergoing RRT during ICU stay

Exclusion Criteria:

* None
Mass Spectrometry Based Cutoffs for Cortisol After Stimulation Tests

There are two main stimulation tests used to decide if a patient has cortisol deficiency. It is the "synacthen test", were we stimulate the patient with intramuscular or intravenous synacthen ( ACTH) to see how much cortisol the adrenals are capable of producing, and it is the "Insulin hypoglycemia test" were we give the patient insulin to provoke a hypoglycemia, and look at the adrenal response to that stimulus. The cut off values for a normal response is based on old immunological assays no longer in use. Assays with a lot of interference and cross reactivity leading to measurement of higher values for cortisol than what we measure on the highly specific LCMS/MS ( Liquid chromatography mass spectrometry methode) that we are using for cortisol today. So, there is a need for new cut off values for a normal response to such tests. The purpose of this study is to produce such new cutoff values by performing the test in 120 healthy controls. We also want to perform the test in patient groups normally going trough this tests according to the same protocol as the control persons, to evaluate the new cutoffs in different patient groups.

120 healthy controls will perform an intravenous synacthen test in our out patient clinic. We register anthropometric data, and take basal blood screening to assure they are healthy. We take basal blood and saliva samples right before start of the test ( called 0-samples). Then they get intravenous synacthen, and we take new samples at 30 minutes and 60 minutes. They are observed during the procedure. We will then calculate a new cut off value for cortisol after the test, based on the 2.5 percentile for cortisol in this population. We will also calculate the same for 17-OH-progesterone, a parameter we also look at after synacthen test in som patient groups ( patients with hirsutism, who are suspicious of having an enzyme defect in the cortisol synthesis cascade). The saliva samples will also be analyzed for cortisol and 17-OH-progesterone, to evaluate if it is possible to use saliva instead of blood samples in synacthen tests in the future. The advantage of using saliva samples is that they can be used also in patients with elevated amount of cortisol binding globulin (CBG), because it measure the free hormone that is biological active ( not both the free and the protein bound, as we measure in serum samples). This is important in patients on estrogens , and in pregnant women, that have large amount of CBG.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals not using any corticosteroids .
* Patients with clinical suspicion of primary or secondary adrenal insufficiency. -Patient suspicious of having an enzyme defect ( 21 hydroxylase deficiency) giving hirsutism.

Exclusion Criteria:

-Use of corticosteroids.
Sonographic 3D Measurement of Fetal Thymus May be Used to Predict the Small Baby in Pregnancy.

The exact etiology of intrauterine growth restriction (IUGR) remains unclear but is known to involve immunologic/infectious factors. The thymus is one of the main organs involved in the development of the fetal immune system. The aim of this study was to explore the association between 3D fetal thymus volume (VOCAL) on ultrasound and intrauterine growth restiction by adding the 3-dimensional measurement of thymus volume to the routine fetal ultrasound scan at 15-24 week of gestation.

Investigators performed a prospective clinical study in 100 pregnant women in their second trimester of pregnancy who attended the Fetal Medicine Unit of the Medicine Faculty of Karadeniz Technical University during the study period. Maternal age, gravida, para, BMI, blood pressure, gestational age, BPD, FL ,AC, EFW and fetal timus volume measured with VOCAL programme are recorded. For all patients routine clinical and ultrasound examinations were performed during pregnancy. Gestational age at birth, way of birth and newborn birthweight were recorded. The results were statistically compared in the SPSS 13.0 program. Student-t test and chi-square test were used for statistical analysis. ROC curve analysis was used for limit values. The data of patients with IUGR and without IUGR were compared. The ability of the thymus volume to predict the IUGR was tested using binary logistic regression analysis. P value \<0.05 was considered statistically significant.

A signed informed consent form for voluntary participation in the study was provided by all the women. A record was made for each patient of age, gravida, parity, body mass index (BMI), and sonographic measurements of biparietal diameter (BPD), abdominal circumference (AC), femur length (FL), and estimated fetal weight (EFW).

3D Fetal thymus volume (TV) was measured by using a VOLUSON E-10 ultrasonography device, by a single researcher experienced in the use of obstetric ultrasound with a transabdominal volumetric probe. The fetal thymus, transverse section of the fetal chest, and the 3 vessel sections were visualised, then the 3D US modality was activated and the thymus volume was obtained immediately with the same probe.

All cases were followed up in terms of pregnancy complications (IUGR development) until delivery.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-35 years,
* Who presented at the polyclinic for routine antenatal follow-up at 15-24 weeks
* Had no complaints.
* Had normal renal, hepatic, and thyroid functions test results.

Exclusion Criteria:

* Any known endocrinopathy,
* systemic disease,
* collagen disorder,
* hypercholesterolemia,
* hemoglobinopathy
* history of neoplasm,
* current or previous cardiovascular disease,
* the use of any drugs within the 3 months before the pregnancy,
* multiple pregnancy,
* current smoking,
* abnormal renal, hepatic, or thyroid function test results,
* the presence of any findings of fetal chromasomal or structural anomaly,
* refusal to participate in the study.
Pregabalin Stabilize Cardiovascular Response to Intubation

The purpose of the study is to evaluate whether Pregabalin is safe and effective in stabilizing cardiovascular response to laryngoscopy and tracheal intubation of patients under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists(ASA) grade I and II scheduled for elective surgery

Exclusion Criteria:

* patient refusal.
* patients with serious chronic kidney, liver, lungs, or cardiovascular diseases.
* allergy to any of the study medications.
* patients taking sedation or antihypertensive medications.
* suspected difficult intubation or intubation time more than 22s.
* pregnant or breastfeeding women.
* BMI\>30.
Comparing Virtual Reality (VR) to Non-VR for Decreasing Preoperative/Procedural Anxiety

The primary objective of the study is to utilize the modified Yale Preoperative Anxiety scale (mYPAS), a validated preoperative/procedural anxiety score, to measure preoperative anxiety via distraction in pediatric oncology patients undergoing port access.

The hypothesis is that using Virtual Reality (VR) will objectively decrease anxiety scores measured by mYPAS by five percent (primary outcome).

The secondary outcome will be the parents or the legally authorized representative (LAR) subjective reports of anxiety with the use of VR.

The Kind VR device is used in house at Children's Health in the Dallas and Plano campuses. The VR device used in this study qualifies as exempt from FDA IDE regulations. It is a non-significant risk, non-invasive, interactive video device the user wears like goggles. The study carries minimal risks to the subjects and is designed to minimize patient discomfort from placement or motion sickness. Furthermore, the device has disposable covers for protection against infection and can be sanitized between uses, once the disposable covers are removed. Children's Health System of Texas (CHST) and this research group are not partnering entities with the Kind VR, and the Kind VR device is not being studied. The effect of virtual reality (VR) on preprocedural anxiety as measured by questionnaires and the observations of the modified Yale Preoperative Anxiety Scale (mYPAS) is being studied

Most patients coming to the Clinic of Cancer and Blood Disorders (CCBD) are under chronic care for their ongoing disease and are likely to be coming to the CCBD at least twice in a 6-month period. The CCBD schedule will be reviewed by the researchers for patients age 5-12, requiring port access at least twice during the next six-month period. Patient families whose child meets the basic screening criteria, and have no exclusion criteria, will be approached privately as possible participants in the study. Up to 100 subjects will be enrolled over a 2-year period. Once the subject/parent or LAR agrees to participate, study staff will randomize the subjects into which standard of care distraction method for anxiety management they will receive first in this study.


Eligibility Criteria:
Inclusion Criteria:

* Any patient of the Children's Medical Center CCBD
* 5-12 years of age
* Patient requiring their port accessed twice or more within a 6 months period
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria

* Subjects younger than 5 and older than 12
* Patients requiring recovery in PICU or sites other than PACU
* If parents or subject is not willing to participate
* Subjects with severe developmental delays and subjects with developmental challenges preventing them from keeping the VR device on are also excluded
* Patients who will not be in CCBD for port access at least twice in 6 months
Long-Term Safety Study of KW-6500 in Patients With Parkinson's Disease

The purpose of this study is to evaluate the safety and efficacy of KW-6500 when administered as long-term subcutaneous self-injections in Parkinson's disease patients with motor response complications on levodopa therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have given written informed consent
* Patients who have Parkinson's disease
* Patients who have been on a stable regimen of levodopa plus at least one other antiparkinsonian agent and who have OFF state
* Patients who meet stage 4 or 5 while in the OFF state and stage 0 to 3 while in the ON state on the Modified Hoehn and Yahr Scale
* Patients who have experienced a 30% or more improvement in UPDRS partⅢ score when tested for responsiveness to levodopa during the baseline period
* Patients who have at least one OFF state per day
* Patients who can understand the expression of OFF state, ON state, and dyskinesia
* Patients or their families have a desire for self-injection of KW-6500

Exclusion Criteria:

* Patients with an illness of the cardiac, hematologic, hepatic, renal, pancreatic, metabolic, respiratory, gastrointestinal, endocrinologic, or neurologic system (excluding Parkinson's disease)
* Patients with orthostatic hypotension
* Patients with a history of intolerance to morphine or its derivatives, sulfur, sulfur-containing pharmaceutical products, or sulfite
* Patients with a history of malignant syndrome
* Patients with a diagnosis of cancer or evidence of continued disease
* Patients who do not test negative in the direct Coombs' test
* Pregnant or lactating women, women who are planning to have children, women who test positive in the pregnancy test, or women who cannot adhere to a reliable method of contraception
* Patients who have received MAO inhibitors except selegiline
* Patients with a history of mental disease (excluding psychiatric symptoms associated with Parkinson's disease)
* Patients with a Mini-Mental State Examination (MMSE) score of 23 or less
* Patients who are taking antipsychotics or central dopamine antagonists (excluding domperidone)
* Patients who are receiving methyldopa or 5-HT3 receptor antagonists
* Patients who are receiving reserpine or papaverine
* Patients who have had a neurosurgical operation for Parkinson's disease
* Patients who have had transcranial magnetic stimulation
* Patients with a history of drug or alcohol abuse or dependence