cyrilzakka/clinical-trials huggingface dataset:
Impact of a Nutrition Quality Improvement Program on Outcomes of Malnourished Patients

A nutrition-focused QIP will be implemented as standard of care at select branches of the home health division of the health care system. The QIP will be comprised of three groups of patients, Group 1 will consist of hospitalized, at-risk/malnourished patients being discharged to home health, Group 2 will consist of outpatients at-risk/malnourished patients enrolled in home health and Group 3 will consist of SNF, at-risk/malnourished patients being discharged to home health. Groups will be followed for 90 days post enrollment. The QIP groups will be compared to historical controls, concurrent controls, and matched concurrent controls across other sites within the health system.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to home health from within the healthcare system's hospitals, skilled nursing facility (SNF) or outpatient clinics
* Patient is screened positive for malnutrition during hospital stay and/or by home health nutrition screening tool upon enrollment into home health
* Patient is able to consume foods and beverages orally and the physician has not indicated otherwise

Exclusion Criteria:

* Enrollment to home health from a hospital, SNF or outpatient clinic not affiliated with the healthcare system
* Patient is pregnant
* Patient is intubated, receiving tube feeding or parenteral nutrition
* Patient has severe dementia or delirium
* History of significant psychiatric disorder
* Any other disorder that may interfere with QIP product consumption or compliance with QIP protocol procedures as per the admitting clinicians
* Subject has stated an allergy or intolerance to any of the ONS ingredients
* Patients receiving hospice care
Should a Standard Lymphadenectomy Include the No. 16 Lymph Nodes for Patients With Pancreatic Head Adenocarcinoma.

The aim of this study is to determine whether para-aortic lymph nodes(No.16) should be included in the lymphadenectomy during the pancreatoduodenectomy in order to improve the long-term survival of patients with pancreatic head ductal adenocarcinoma.

Pancreatic cancer is now raised to the 7th leading cause of death. Surgical resection seems to be the unique curative therapy for pancreatic cancer. The pancreaticoduodenectomy is widely performed for the patients with pancreatic head cancer in recent decades. The lymphadenectomy is an indispensible procedure. In 2014, the International Study Group for Pancreatic Surgery (ISGPS) recommended a standard lymphadenectomy should include lymph node stations 5, 6, 8a, 12b1, 12b2, 12c, 13a, 13b, 14a, 14b, 17a, and 17b. However, no consensus was reached on Lymph node 16 in particular 16b1. There was no stronge evidence available concerning the impact on survival.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of pancreatic ductal adenocarcinoma
* Signed the informed consents

Exclusion Criteria:

* Pathologic diagnosis of other pancreatic cancers
* Pre-operative anti-cancer treatment
* Recurrence patients
* Patients with contraindication(hepatic/ respiratory/ renal dysfunction, etc )
* Pre operative exam: Total bilirubin more than 250µmol/L
* AJCC stage IV
* Operation non radical
Phase 1 Food Effect Study for Alicaforsen Tablets

Phase 1 study to compare the effect of food on alicaforsen tablet.

A study on healthy male vounteers in a phase 1 unit. Alicaforsen tablets are gievn in a fed and fasted state

Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteer

Exclusion Criteria:

* Drugs of abuse
* Alcohol abuse
Postoperative Kidney Functions in Geriatric Major Gynecologic-Oncologic Surgery

The increasing number of patients who develop perioperative acute kidney injury (AKI) is partly related to the aging population and the increasing number of individuals with chronic comorbidities, particularly those with premorbid chronic kidney disease. Anesthesiologists and surgeons will increasingly have to deal with such patients who are elderly and have comorbidities and require major surgery.

The aim of this study was to determine the incidence of postoperative acute kidney injury (primary aim) in patients aged 65 and over who underwent elective major gynecological-oncological surgery under general anesthesia in Ankara City Hospital Gynecology-Oncology Operating Room between January 2020-2022 and were followed up in the PACU in the postoperative period. To investigate risk factors and their results in a retrospective manner in line with the KDIGO criteria (secondary purpose).


Eligibility Criteria:
Inclusion Criteria:

* patients underwent major abdominal gynecologic oncologic surgery between January 2021 and January 2022
* followed in the PACU

Exclusion Criteria:

* Patients with inaccessible data and missing data
Clinical Study of ART-123 for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis

The purpose of this study is to assess the efficacy and safety of the intravenous drip infusion of ART-123 in patients with acute exacerbation of idiopathic pulmonary fibrosis (IPF) in a multicenter, double-blind, randomized, placebo-controlled, parallel group comparison study, and to confirm its superiority over placebo with survival rate on Day 90 as the primary endpoint.


Eligibility Criteria:
Main Inclusion Criteria:

* Patients diagnosed with IPF who meet all criteria from (1) through (4) during the course of IPF
* (1)Unexplained development or worsening of dyspnea within 1 month during the course of IPF
* (2)Finding of new, bilateral ground glass opacities and/or consolidation on HRCT
* (3)No apparent Pulmonary infections, pneumothorax, malignant tumors, pulmonary embolism, or left heart failure
* (4)A decrease\* in PaO2 of ≥10 mmHg or SpO2 of ≥4% under the same conditions compared with the level at the previous measurements

  * (\*) In cases where no PaO2 or SpO2 test values under the same conditions are available, a patient with a P/F ratio ≤300 in the current episode of acute exacerbation is considered to have met criterion (4)
* Aged 40 years or older and no older than 85 years at the time of informed consent with either sex

Main Exclusion Criteria:

* Have intracranial hemorrhage, pulmonary hemorrhage, gastrointestinal bleeding (continued hematemesis, bloody discharge, gastrointestinal ulcer-induced hemorrhage)
* Have a history of cerebrovascular disorder (e.g., cerebral hemorrhage or cerebral infarction) within 52 weeks (364 days) before informed consent
* Patients for whom the completion of hemostatic treatment has not been confirmed after undergoing surgery of the central nervous system or after trauma
* Have a high risk for fatal or life-threatening hemorrhage
* Patients with malignant tumors
* Have acute exacerbation attributable to drug induced pulmonary disorder, after surgery for malignant tumors, chemotherapy, or radiation therapy
* Have acute exacerbation due to a thoracic surgical procedure (including thoracoscopic lung biopsy)
* Have a history of acute exacerbation of IPF
* Receiving mechanical ventilation through intratracheal intubation
* Patients who are pregnant or nursing, or who may be pregnant
* Patients with a platelet count less than 100,000/uL at the time of enrollment
* Patients with severe renal (serum Cr: ≥4 mg/dL) or hepatic (AST/ALT: ≥500 IU/L or T-Bil: ≥10 mg/dL) dysfunction
* Have been administered a commercially available thrombomodulin alfa (recombinant )(Recomodulin® for Intravenous Injection 12800) within 30 days before the start of investigational product administration
* Have a history of hypersensitivity for investigational product
Accuracy of Noninvasive Hemoglobin Pulse Oximeter (Rainbow Resposable Adhesive Sensors)

In this study, the concentration of hemoglobin within the subject's blood will be reduced in a controlled manner by administering fluids intravenously. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18-40 years of age
* Weight of at least 110 lbs and less than 250 lbs or a BMI under 36 for subjects taller than 6 feet.
* Physical status of ASA I of II
* Able to read and communicate in English
* Has signed written informed consent
* Female, non pregnant. Female subjects will be provided with a pregnancy test free of charge.

Exclusion Criteria:

* Age less than 18 yrs and greater than 40 years
* Weight of less than 110 lbs or more than 250 lbs. or a BMI of 36 or greater for people over 6 feet tall.
* Hemoglobin less than 11 g/dL
* ASA physical status of III. IV, V.
* Pregnant
* Subject has known drug or alcohol abuse
* Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails.
* Subject has experienced a head injury with loss of consciousness within the last year.
* Subject has known neurological and psychiatric disorder that interferes with the subjects' level of consciousness.
* Known or concurrent chronic usage of psychoactive or anticonvulsive drugs within the last 90 days, or any use in the last 7 day (i.e. tricyclic antidepressants, MAO inhibitors, Lithum, neuroleptics, anxiolytics or antipsychotics, except SSRIs).
* Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study, such as Reynauds Syndrome.
* Systolic BP \>140 mmHg or Diastolic BP \> 100 mmHg.
* Baseline heart rate \< 50 bpm.
* Inability to tolerate sitting still or minimal movement for up to 90 minutes
* Discretion of investigator
Minor Histocompatibility Vaccination After Allogeneic Stem Cell Transplantation for Advanced Hematologic Malignancies

This is a clinical research study designed to evaluate whether the administration of a vaccine to patients after transplant consisting of a minor histocompatibility antigen (mHag peptide) mixed with G-CSF (a drug intended to stimulate the immune system) can stimulate increased graft versus leukemia (GVL) responses without causing graft-versus-host disease (GVHD).


Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory acute myelogenous or lymphoid leukemia.
* Acute myeloid or lymphocytic leukemia in first remission at high-risk for recurrence.
* Chronic myelogenous leukemia in accelerated phase or blast-crisis.
* Chronic myelogenous leukemia in second or subsequent chronic phase
* Recurrent or refractory malignant lymphoma or Hodgkin's disease
* Multiple myeloma at high risk for disease recurrence.
* Chronic lymphocytic leukemia, relapsed or with poor prognostic features.
* Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor prognostic features.

Exclusion Criteria:

* Clinical progression.
* Contra-indications for vaccination.
The Safety and Effectiveness of r-HuEPO in Patients With AIDS and Anemia Caused by AIDS and Treatment With AZT

To determine the safety and efficacy of erythropoietin administered subcutaneously to AIDS patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy. Efficacy will be assessed by correction of anemia and decrease in transfusion requirements.


Eligibility Criteria:
Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* History of any primary hematologic disease.
* Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS.
* AIDS-related dementia.
* Uncontrolled hypertension (diastolic blood pressure \> 100 mmHg).
* Presence of concomitant iron deficiency.
* Anemia attributable to factors other than AIDS or zidovudine (AZT) therapy.
* Acute opportunistic infection.
* History of seizures.

Patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS are excluded.

* Patients who have previously participated in any other r-HuEPO clinical study are excluded.

Prior Medication:

Excluded within 30 days of study entry:

* Experimental drug or experimental device.
* Cytotoxic chemotherapy.
* Excluded within 2 months of study entry:
* Androgen therapy.

Clinical diagnosis of AIDS related anemia.

* Clinical diagnosis of AIDS.
* Clinically stable for 1 month preceding study entry.
* Maintenance dose of zidovudine (AZT) of at least 400 mg daily.

Substance abuse.
The Effect of Weight Loss on Serum Mannose-Binding Lectin(MBL) Levels

High levels of mannose-binding lectin (MBL), an activator of a part of the immune system called the complement system, have been associated with increased mortality and risk of early signs of kidney damage in patients with type 2 diabetes. The effect of weight loss and changes in insulin resistance on MBL levels have been poorly elucidated.

This study includes 36 nondiabetic obese subjects, who will receive a very low- calorie diet (VLCD) of 800 kcal/day for 8 weeks.

Fasting blood samples will be obtained at baseline and after 8 weeks of VLCD and concentrations of MBL, glucose and insulin will be measured. Insulin resistance is assessed using the HOMA-IR method.


Eligibility Criteria:
Inclusion Criteria:

* Obese

Exclusion Criteria:

* Diabetes
* Other severe disease
Motor Impairments in Children With Autism Spectrum Disorder: a Multimodal Approach

The general goal of the present proposal, Progetto MOSAICO, is the identification of a multimodal panel of neuropsychological, kinematic, neurophysiological, and genetic markers associated with motor abnormalities present in ASD.


Eligibility Criteria:
Inclusion Criteria:

* having a clinical diagnosis of neurodevelopmental disorders (either ASD, ADHD, or intellectual disability) according to DSM-5 criteria;
* children with typical development are also recruited from the general population by local pediatricians or from kindergartens/schools sited near our institute

Exclusion Criteria:

* using any stimulant or non-stimulant medication affecting the central nervous system
* having an identified genetic disorder
* having vision or hearing problems
* suffering from chronic or acute medical illness.
Post-marketing Study for the Evaluation of Profilm Mouth Sores

The study aims to assess the effect of Profilm Mouth Sores treatment for relieving symptoms caused by mouth sores. It will involve 35 participants and last around 14 days or until the sores heal, with three daily applications. A dermatology specialist will evaluate the results through tests and examinations of the treated area.


Eligibility Criteria:
Inclusion Criteria:

* Male / female / aged 18 years or older.
* Presence of an ulcer on the oral mucosa, regardless of the number of days since its appearance.
* At least 30 days have passed since the last episode.
* Willingness to return for all study-related visits.
* Sufficient willingness and ability, as judged by the investigator, to respond to the questionnaires included in the study.

Exclusion Criteria:

* Pregnant women or women in the breastfeeding period.
* Patients undergoing treatment with antiviral medications, hydrocortisone, or other medications.
* Patients with immunodeficiency diseases, such as acquired immunodeficiency syndrome or altered immune activity in the last 7 days.
* Patients undergoing other pharmacological therapy for oral conditions.
* Patients with other oral mucosa diseases simultaneously.
* Known allergy or hypersensitivity to any of the components.
Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.

Preterm birth is the leading cause of neonatal death and a significant cause of life long disability and health problems. It has been shown that the drug 17-hydroxyprogesterone caproate can help reduce the risk of preterm delivery in women with certain risk factors for preterm birth. We hope to learn whether this same medication can be used to prolong pregnancy in a group of patients in whom this medication has not been previously studied. Specifically, we hope to learn whether progesterone supplementation will delay delivery in women with pre-term, premature rupture of membranes (PPROM).

When women present to either the Obstetrical clinic or labor and delivery with a complaint of possible preterm, premature rupture of membranes (PPROM), they will be examined by an obstetrician to either confirm or rule out this diagnosis. If they are diagnosed with PPROM, they will then be admitted to Lucile Packard Children's Hospital and treated with the normal protocol which includes receiving antibiotics, receiving steroids, being hospitalized until delivery, and having ongoing maternal and fetal monitoring for possible complications. The patients will be identified by their treating obstetricians as possible study candidates and asked by a member of the treatment team if they are potentially interested in participating in a research study. Subsequently, a member of the study team or the treating physician will approach the patient about participating in the trial. Those who choose to participate will receive the standard care protocol in addition to receiving the study medication. The study medication will be a weekly injection of either placebo or 17-hydroxyprogesterone caproate or placebo. The placebo medication (castor oil) was chosen as it has been used in previous studies as a placebo for 17-hydroxyprogesterone caproate. The choice of which medication the patient receives will be determined by a randomization table. Only the pharmacist will be aware of the medication that has been administered. The patient, members of the treatment team, and members of the study team will be blinded to the medication that is being administered. The timing of their delivery will be managed by the treating obstetrician according to standard medical practice. After delivery, the patient's and her infant's medical outcomes will be recorded for analysis.

Eligibility Criteria:
Inclusion Criteria:

1. 18yr of age
2. Singleton pregnancy
3. PPROM confirmed on clinical exam
4. GA between 24+0 and 33+5 wk
5. Ability to understand consent in either English or Spanish

Exclusion Criteria:

1. Contraindication to ongoing pregnancy including:

   1. Evidence of active infection
   2. Evidence of significant placental abruption
   3. IUFD diagnosed at the time of P-PROM diagnosis
2. Major fetal malformation
3. Maternal allergy to progesterone or placebo drug components
4. Current use of progesterone at the time of P-PROM
5. Multiple Gestations
6. Inability to understand consent in either English or Spanish
Comparison of Loop and Primary Incision&Drainage Techniques in the Emergency Department

Skin abscesses are among the most common soft tissue infections cause emergency room visits frequently. Management of abscess drainage and prevent further complications are important entities for emergency physicians. Historically primary incision and drainage (I\&D) technique has found very effective method of abscess drainage, however a novel technique loop drainage holds promising. The purpose of our study is comparison efficacy of I\&D and loop drainage techniques in patients with cutaneous abscess.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients presenting to Kocaeli University Emergency Department with cutaneous abscess.
* Providing written informed consent.

Exclusion Criteria:

* Under 18 years of age.
* Immunosuppressive patients.
* Using medications have effects on wound healing.
* Abscess is not recognizable by bedside ultrasound.
* Lidocaine allergy
An Observational Study of Pruritus Amongst Hemodialysis Patients

The purpose of this observational study is to better understand the natural history/natural course of uremic pruritus (UP) - itching associated with chronic kidney disease(CKD). During the lifetime of a CKD dialysis patient, UP tends to be a prolonged, frequent, and an intense itch that is known to impair the patient's quality of life (QoL), including sleep and mood.

The study will follow hemodialysis (HD) patients longitudinally to characterize their pruritus over time. The study will quantify and characterize UP and assess change over time; collect data on conditions that may be affected by UP such as sleep, mood, socialization and overall quality of life; collect data on use of medications, particularly anti-pruritic treatments, sleep aids, and medications for depression and anxiety; and collect data on medical resource use, particularly hospitalizations for treatment of skin and other infections over the duration of the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years;
* Patients receiving chronic hemodialysis 3 or more times per week;
* Patients who have "mild", "moderate" or "severe" pruritus;

  * "Mild" pruritus is defined as a nighttime or daytime worst itch intensity VAS \>10 mm and \< 40 mm at Screening and a combined daytime and nighttime Kawashima Itch Severity Score of \< 2;
  * "Moderate" pruritus is defined as a nighttime or daytime worst itch intensity VAS \>10 mm and \< 40 mm at Screening and a combined daytime and nighttime Kawashima Itch Severity Score of ≥ 3;
  * "Severe" pruritus is defined as a nighttime or daytime worst itch intensity VAS of ≥ 40 mm at Screening and a combined daytime and nighttime Kawashima Itch Severity Score of ≥ 3;
* Patients who are able to understand and complete questionnaires written in English;
* Patients who are expected to continue to dialyze at the present dialysis unit for the duration of the study.

Exclusion Criteria:

* Patients who have pruritus attributed to causes other than chronic kidney disease (CKD) or the direct consequences of CKD (i.e., hyperparathyroidism, circulating "uremic toxins");
* Patients who have had significant alteration in their dialysis regimen within the 2 weeks prior to Screening (or those for whom such changes are anticipated during the study) are excluded. A "significant alteration" is defined as:

  * A change in the type of hemodialysis filter;
  * An increase or decrease in total duration of dialysis prescribed of \> 1 hour/week;
  * A change in the site or type of venous access for dialysis;
  * An increase or decrease in prescribed blood flow of \>100 mL/min;
* Patients who are unwilling to comply with the study protocol. Test Product, Dose, Mode of Administration and Duration of Treatment