cyrilzakka/clinical-trials huggingface dataset:
Efficacy & Safety of the Oral Neurokinin-1 Antagonist, Aprepitant, in Combo With Ondansetron & Dexamethasone in Patients Undergoing Auto Peripheral Blood Stem Cell Transplantation

The purpose of this study is to determine the efficacy of aprepitant in preventing acute and delayed chemotherapy induced nausea and vomiting when administered in combination with intravenous or oral ondansetron and intravenous or oral dexamethasone in the autologous transplant setting.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18 years of age or older
* Patients deemed eligible to undergo autologous bone marrow or peripheral stem cell transplant therapy per usual transplant inclusion and exclusion criteria
* Patients with Non-Hodgkins Lymphoma, Hodgkins Lymphoma or Multiple Myeloma or Amyloidosis
* Written informed consent

Exclusion Criteria:

* Nausea at baseline
* Chronic use of other antiemetic agent(s)
* Gastrointestinal obstruction or active peptic ulcer
* Radiation therapy to pelvis or abdomen within 1 week before or after study day 1
* Allogeneic stem cell transplant recipient
* Aspartate transaminase (AST) \> 3x upper limit of normal (ULN)
* Alanine transaminase (ALT) \> 3x ULN
* Bilirubin \> 3x ULN
* Alkaline phosphatase \> 3x ULN
* Creatinine \> 2
* Documented hypersensitivity to any component of study regimen
* Pregnant or lactating women
* Participating in a clinical trial which involves other investigational agent(s)
* Patients taking any of the following medications at time of study day 1: warfarin, oral contraceptives (except for the administration of stopping menses), tolbutamide, phenytoin, midazolam, ketoconazole, rifampin, paroxetine, and/or diltiazem.
Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy Subjects

The purpose of this study is to assess the pharmacokinetics and safety of co-administration of VX-770 and VX-809 in healthy adults.

Cystic fibrosis (CF) is an inherited disease resulting from defects to a gene known as the cystic fibrosis transmembrane conductance regulator (CFTR). CF affects approximately 70,000 children and adults worldwide (30,000 in the United States) and is the most common fatal genetic disease in persons of European descent. Despite progress in the treatment of CF with antibiotics and mucolytics, the predicted median age of survival for a person with CF is in the mid-30s. Though the disease affects multiple organs, most morbidity and mortality is caused by progressive loss of lung function.

This is a Phase 1, randomized, double-blind, placebo-controlled, multiple-dose study of orally administered VX-809 and VX-770 in healthy subjects. The study will evaluate safety and tolerability of co-administration of VX-809 and VX-770 in healthy volunteers.

Enrollment is planned for 24 subjects at 1 clinical site. Subjects will be randomized to receive study drug or placebo during three 14-day treatment periods separated by 14-day washout periods. In Treatment Period 1, subjects randomized to study drug will receive VX-809 every 24 hours. In Treatment Period 2, subjects randomized to study drug will receive VX-770 every 12 hours. In Treatment Period 3, subjects randomized to study drug will receive VX-809 every 24 hours and VX-770 every 12 hours. Subjects randomized to placebo will receive placebo during all treatment periods.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject between 18 and 55 years of age, inclusive
* Body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive
* Subjects of child-bearing potential and who are sexually active must meet contraception requirements
* Female subject must have a negative serum pregnancy test at screening, Day -1, and throughout the study

Exclusion Criteria:

* History of any illness that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject. This may include but is not limited to a significant history of cardiovascular, central nervous system, hepatobiliary or renal disease, or a history of mental illness
* Participated in a clinical study involving administration of either an investigational or a marketed drug within 60 days or 7 terminal half-lives (whichever is longer) before the Screening visit
* Subject who has received VX-770 or VX-809 in a previous clinical study
Autism ALERT Expansion

Autism Access Link for Early Referral and Treatment \[ALERT\], the intervention proposed in this application, is a novel state-wide referral and case management platform that PCPs can activate to ensure that a child with suspected ASD receives all necessary ASD diagnosis and treatment resources in a single referral, radically simplifying a complex diagnostic and treatment process. We hypothesize that Autism ALERT will have strong acceptability and high rates of use among primary care providers as well as among diverse low-income parents of children at risk for ASD, and that we will see increased rate of child ASD educational evaluations within six months, and shortened time between referral and ASD treatment.

Though significant research effort has focused on autism spectrum disorder (ASD) screening, less attention has been devoted to optimizing follow-up of children who are subsequently identified as at-risk. Despite increases in ASD screening rates, many children with ASD wait years between when autism is suspected in the primary care setting and when definitive diagnosis and treatment begin. Delayed and missed diagnoses are particularly problematic for low-income and racial/ethnic minority children in the US, who experience higher rates of these adverse outcomes.

The Autism Access Link to Early Referral and Treatment (Autism ALERT) program is a statewide monitoring and case management program to accelerate access to ASD diagnosis and treatment among children with suspected ASD the primary care setting. The system will reduce the time between identification of suspected ASD in the primary care setting and establishment of ASD diagnosis and treatment services, by reducing family barriers to care, decreasing primary care provider burdens, and simplifying referral processes. Following an initial pilot trial, we propose implementing the intervention to families in the Portland metropolitan area before expanding the program elsewhere in the state. The program will be available to any Oregon child age 12-54 months, regardless of health system or payor type. Autism ALERT will become part of the Help Me Grow national network, which gives it potential for statewide and national spread.

In this proposed research, we will undertake a single arm implementation/effectiveness trial in which the program will be tested throughout the state of Oregon, beginning in the Portland metropolitan area. In the long term, this research will result in a sustainable, evidence-based statewide and ultimately national monitoring system children with suspected ASD.

Eligibility Criteria:
Inclusion Criteria:

* child's primary care provider suspects the child has ASD
* child is a patient at one of the study clinics
* child age 12 to 54 months
* family speaks English or Spanish
* no prior ASD medical diagnosis or ASD diagnostic evaluation

Exclusion Criteria:

- Previous diagnosis of ASD or prior diagnostic evaluation for ASD.
Subcutaneous Aspart Insulin to Treat Diabetic Ketoacidosis (DKA) and Beta-Hydroxybutyrate Testing in DKA

The purpose of this study is to determine whether insulin administered by a subcutaneous injection is effective in the treatment of a diabetic crisis and to determine if beta-hydroxybutyrate is useful to monitor during treatment of a diabetic crisis.


Eligibility Criteria:
Inclusion Criteria: age 18 or older

* venous pH \< 7.3 or arterial \< 7.35
* at least 2 of the following 3:

  1. serum HCO3 \< 18/anion gap \> 16
  2. serum glucose \> 300 mg/dl
  3. serum acetone positive

Exclusion Criteria:

* pregnant
* less than age 18
Fall Prevention in Elderly: Mechanisms and Strategies

In communities with over 100,000 residents, to investigate the incidence and mechanisms of fall in elderly, and strategies of fall prevention.


Eligibility Criteria:
Inclusion Criteria:

* community dwelling adults without medical conditions to impair walking ability

Exclusion Criteria:

* cognitively or physically unable to cooperate with the examiner to finish the test
Early Warning and Classification Model for Acute Non-traumatic Chest Pain

Acute non-traumatic chest pain is one of the common causes of presentation in emergency patients, but the causes of acute non-traumatic chest pain are complex, the severity of the condition varies greatly, and the specificity of symptoms is not high. Machine learning and intelligent auxiliary models can greatly shorten the time of clinical decision-making, and improve the accuracy of etiological diagnosis in patients with chest pain, reduce the rate of misdiagnosis and missed diagnosis, and provide a clear direction for further treatment.

Prospective observational studies used outpatient and follow-up information to construct an auxiliary early warning model of acute non-traumatic chest pain based on federated learning, and optimized the accuracy of early warning models through retrospective and prospective studies of large cohort data, and established an efficient and stable early warning and classification model for acute non-traumatic chest pain.

Eligibility Criteria:
Inclusion Criteria:

1. older than 18 years old;
2. provided written informed consent;
3. Outpatient visits in the pilot hospitals from June 2022 to December 2022

Exclusion Criteria:

1. did not provide written informed consent and were unwilling to be followed up;
2. traumatic chest pain;
3. systemic pain caused by malignant tumors or rheumatic diseases involving the chest;
4. transferred patients;
5. sudden death or death during hospital treatment;
6. women who are known to be pregnant or lactating;
7. have participated in other clinical trials within 3 months before enrolling in this trial or are currently participating in other clinical trials The lender;
8. According to the investigator's judgment, the patient was unable to complete the study or comply with the requirements of the study;
9. Patients were lost to follow-up.
Endoscopic Placement of Metal Stent in Patients With Cancer-Related Bowel Obstruction

RATIONALE: The use of endoscopy to place a metal stent in the large intestine is less invasive than surgery for treating cancer-related bowel obstruction and may have fewer side effects and improve recovery.

PURPOSE: Phase I/II trial to study the effectiveness of endoscopic placement of a metal stent in treating patients who have cancer-related bowel obstruction.

OBJECTIVES:

* Determine the objective response and clinical outcome in patients with colonic obstruction secondary to malignancy treated with enteral Wallstents.
* Evaluate the efficacy and safety of this treatment in these patients.
* Evaluate the quality of life of these patients after enteral Wallstent placement.

OUTLINE: All patient undergo a colonoscopy, followed by placement of an enteral Wallstent through an endoscope under fluoroscopic guidance into the large intestine.

Quality of life is assessed at 48 hours and 6 months after the procedure.

Patients are followed at 48 hours, 30 days, 6 months, and then yearly thereafter until death.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Endoscopically confirmed localized tumor as the cause of colonic obstruction

  * All primary tumor types are eligible
* No prior colonic Wallstents
* Must have symptoms of gastrointestinal obstruction, including:

  * Inability to move bowels, absence of flatus, nausea/vomiting, abdominal pain, or diarrhea

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-3

Life expectancy:

* Not specified

Hematopoietic:

* Platelet count greater than 50,000/mm\^3

Hepatic:

* INR no greater than 1.5 times upper limit of normal

Renal:

* Not specified

Cardiovascular:

* No cardiac condition

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No significant active infection (e.g., pneumonia, peritonitis, wound abscess) that would preclude endoscopy
* No other serious concurrent illness
* No uncontrolled metabolic disease (e.g., diabetes or hypothyroidism)
* No dementia, psychiatric disorder, or altered mental status that would preclude compliance
* History of other neoplastic disease allowed
* Veterans Administration patients are not eligible

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Prior or concurrent chemotherapy allowed

Endocrine therapy:

* Not specified

Radiotherapy:

* Prior or concurrent radiotherapy allowed

Surgery:

* At least 3 weeks since prior surgery and recovered
Comprehensive Laparoscopic Curriculum for Medical Students

Laparoscopic surgery has become the standard approach to a vast variety of surgical procedures. Due factors such as 2D- to 3D conversion, reduced tactile sensation, amplification of tremor and fulcrum effect of the abdominal wall, surgeons require a different set of skills than in open access surgery. Acknowledging this, several comprehensive curricula have been developed to teach basic skills as well as advanced laparoscopic procedures. Despite a recent emphasis on early exposure of medical students to surgery no designated curricula have been developed to introduce medical students to the technique of laparoscopic surgery.

Participation in an introductory curriculum in laparoscopic surgery results in improved cognitive and technical performance compared to self-directed learning. The greater homogeneity and fewer dropouts amongst those in the curriculum group suggest that a structured curriculum is essential in ensuring standardization of clinically relevant training. An introductory curriculum for medical students should be delivered in a structured and standardized fashion prior to clinical exposure in order to maintain motivation and enhance learning.


Eligibility Criteria:
Inclusion Criteria:

* first and second year medical students

Exclusion Criteria:

* previous exposure to laparoscopy or laparoscopic simulation
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma

This study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called "study drugs". The study is focused on patients with a type of skin cancer known as melanoma. The aim of the study is to see how safe and effective the combination of fianlimab and cemiplimab is in treating melanoma, in comparison with the combination of two medications, relatlimab and nivolumab, commercialized under the brand name Opdualag™ and approved for the treatment of melanoma in adults and children.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drugs.
* How much study drug is in the blood at different times.
* Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)


Eligibility Criteria:
Key Inclusion Criteria:

1. Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition.
2. Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.
3. Measurable disease per RECIST version 1.1.
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
5. Adequate bone marrow, hepatic, and kidney function.

Key Exclusion Criteria:

Medical Conditions:

1. Uveal, acral or mucosal melanoma.
2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol.
3. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection. Mild cancer-related immunodeficiency (such as immunodeficiency treated with gamma globulin and without chronic or recurrent infection) is allowed.
4. Unknown v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status as described in the protocol.

   Prior/Concomitant Therapy:
5. Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol
6. Systemic immune suppression as described in the protocol.

   Other Comorbidities:
7. Participants with a history of myocarditis.
8. Troponin T (TnT) or troponin I (TnI) \>2x institutional upper limit of normal (ULN).
9. Active or untreated brain metastases or spinal cord compression as described in the protocol.

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.
Non Invasive Measurement of Coagulation in Term and Preterm Neonates

The purpose of this study is to assess the reliability of a new non-invasive device to assess the blood coagulation status among term and preterm babies.

Coagulation abnormalities among neonates aren't common - but can be life threatening. Testing the coagulation system in small babies involves drawing significant amounts of blood (especially in premature babies). Non-invasive testing can help assess and treat term and preterm neonates at risk. Recently, a non-invasive device to assess the blood coagulation status was developed - The Thrombo-Monitor (ThM). The objective of this study is to assess the reliability of this new non-invasive device among term and preterm babies by comparing the result of the ThM reading to coagulation analysis from blood.

Eligibility Criteria:
Inclusion Criteria:

* Newborn babies - term and preterm
* Written parental informed consent

Exclusion Criteria:

* Congenital anomalies / chromosomal abnormalities
Remote Ischemic Preconditioning Before Abdominal Surgery

Major abdominal surgeries are associated with perioperative cardiac morbidity of up to 10%.

Ischemic preconditioning may have a protective effect. The purpose of this study is to find out remote ischemic conditioning by inflating a blood pressure cuff on the arm will have a protective effect.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing abdominal surgery:large bowel, pancreatic and hepatic surgery

Exclusion Criteria:

* Chronic inflammatory disease.
* Glyburide use before surgery.
Df-Life : Quality of Life in Patients With Fibrous Dysplasia

Fibrous dysplasia (FD) is a congenital skeletal disorder with multiple complications such as bone pain, fractures, deformities and nerve compression. Few quantitative studies have demonstrated its physical, mental and social negative impacts on patients but none have qualitatively evaluated their global quality of life. Our hypothesis is that a better knowledge of the quality of life of FD patients should allow to target the actions to be implemented to improve patients'care.

The main objective of this qualitative research is therefore to investigate the quality of life of FD patients through 2 approaches: a qualitative study with focus groups interviews addressing several themes: self-image, psychological and emotional well-being, difficulties and adaptative strategies; and a quantitative study to measure the impact of FD on quality of life and on olfaction (sometimes affected by nerve compression due to the disease) using standardized questionnaires Short Form 36 (SF36) and Self-reported Mini Olfactory Questionnaire (SELF-MOQ).


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* 18 years and more
* with Fibrous dysplasia
* Being followed in the rheumatology Department of the E. Herriot Hospital in Lyon.
* Non-opposition to take part in the study
* written consent to the audio recording of the discussions.

Exclusion Criteria:

* Legal incapacity or limited legal capacity
* Psychiatric or neurological condition that severely impairs comprehension
* Difficulty understanding spoken French
* Patients with another pathology with a major impact on quality of life
Transplant-Related Mortality in Patients Undergoing a Peripheral Blood Stem Cell Transplantation or an Umbilical Cord Blood Transplantation

Study CR-AIR-006 is a part of the ATIR clinical development plan and will provide control data for patients treated with ATIR in clinical studies (e.g. study CR-AIR-007).


Eligibility Criteria:
Inclusion Criteria:

* Any of the following hematologic malignancies:

  * Acute myeloid leukemia (AML) in remission at the time of the transplantation
  * Acute lymphoblastic leukemia (ALL) in remission at the time of the transplantation
  * Myelodysplastic syndrome (MDS)
* Patient received any of the following transplantations:

  * Allogeneic T-cell depleted HSCT without ATIR administration from a haploidentical donor between 1 January 2006 and 30 June 2013 (HAPLO group)
  * Allogeneic HSCT from a fully matched or 1-locus mismatched unrelated donor between 1 January 2010 and 31 December 2012 (MUD/MMUD groups)
  * Double umbilical cord blood transplantation between 1 January 2010 and 31 December 2012 with no more than 2 human leukocyte antigen (HLA)-mismatches at HLA-A, B, and/or -DR between each of the units and the recipient (UCB group)
* Male or female, age ≥ 18, ≤ 65 years.

Exclusion Criteria:

* Allogeneic stem cell transplantation prior to the transplantation qualifying for the study.
Left Renal Vein Division for Juxtarenal Aortic Exposure

Retrospective study on the outcome of the renal function in patients operated because of juxtarenal aortic aneurysms.


Eligibility Criteria:
Inclusion Criteria:

Only patients who went for a planned operation because of a juxtarenal aortic aneurysm were included in this retrospective analysis.

Exclusion Criteria:

Emergency surgery Rupture Pending rupture
Comparison of the Effectiveness of Classical Perineal Massage Therapy Versus the Use of an Intravaginal Device to Reduce Postpartum Perineal Pain

GA34.01 postpartum, a randomized design with a parallel group structure will be applied, randomly assigning participants into two groups. The first group will receive the traditional perineal massage therapy, while the second group will use the intravaginal device "Crescendo 2." In this study, a pre- and post-intervention evaluation will be conducted, using the Visual Analog Scale (VAS) as the primary outcome measure and the Clinical Global Impression Scale as the secondary outcome measure.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years or older.
* Residing in the Region of Murcia.
* Having had a vaginal delivery between 6 weeks and 12 months prior to enrollment.
* Presenting postpartum perineal pain, coded in ICD-11 as GA34.01.
* Have not received any prior treatment for this condition.

Exclusion Criteria:

* Presence of severe conditions such as:
* Excessive postpartum hemorrhage
* Serious infections
* Respiratory or circulatory complications
* Neurological disorders requiring intensive medical intervention
* Currently under pharmacological treatment for pelvic pain.
* Active vaginal infections.
* Expressed refusal to participate or inability to comply with study procedures.
* Women with episiotomy may participate only if there were no complications such as severe infection or hemorrhage following the procedure.

Willingness to participate and to follow the study protocol.

Exclusion Criteria:

-