cyrilzakka/clinical-trials huggingface dataset:
Prospective Study of Palonosetron in Radiation Induced Nausea and Vomiting (RINV)

This phase II study will investigate the use of palonosetron in the efficacy of prophylaxis or rescue of single or multiple fraction radiation induced nausea and vomiting. This prospective study employs a parallel arm design, allowing for inclusion of patients with pre-existing nausea and vomiting versus no current nausea or vomiting. Eligible patients receiving radiotherapy known to have a low or moderate emetogenic risk will receive every other day dosing of 0.5 mg palonosetron for the length of treatment. Nausea, vomiting, use of rescue medication, and impact on quality of life will be monitored during and after radiation treatment completion.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Patient will receive radiation therapy to considered moderate risk (upper abdomen, upper and half body irradiation) or low risk (lower thorax and pelvis) emetogenic palliative radiotherapy.
* Patients will be grouped according to nausea and vomiting status at baseline as follows:

  * Group 1: Patient is experiencing no nausea and vomiting at baseline
  * Group 2: Patient is experiencing at least mild nausea and/or at least mild vomiting at baseline

Exclusion Criteria:

* Patient is scheduled to receive cranial radiation therapy during or within 10 days following completion of protocol RT.
* Patient received cranial RT within 7 days prior to commencement of protocol RT.
* Patient is scheduled to receive chemotherapy during or within 10 days following completion of protocol RT.
* Patient received moderately or highly emetogenic chemotherapy within 7 days prior to commencement of protocol RT.
* Patient is scheduled to change regimen/dose or start the use of low dose corticosteroids (inhaled or topical permitted), or other medications considered to have antiemetic properties within 48 hours prior to protocol RT.
* Patient is scheduled to change regimen/dose or start the use of low dose corticosteroids (inhaled or topical permitted), or other medications considered to have antiemetic properties during or within 10 days following completion of protocol RT.
* Concurrent use of corticosteroids during protocol RT is not permitted, unless low dose corticosteroids (hydrocortisone) are used for cancer treatment
* Patient is allergic to protocol medication.
* Patient has a Karnofsky Performance Status score \<40.
* Patient is a woman who is pregnant or of childbearing potential and is not using contraceptive measures.
Pilot Study of Exposure Therapy for Posttraumatic Stress Disorder

The purpose of this project is to examine the feasibility of a culturally adapted, manual based Prolonged Exposure therapy intervention for the treatment of Spanish-speaking Puerto Ricans with posttraumatic stress disorder

This project seeks to lay the foundation for an effectiveness trial that will lead to the advancement of treatments for PTSD among Spanish-speaking Latinos, particularly Puerto Ricans. This area of research is important in light of the limited treatment options currently available for Spanish-speakers with PTSD and the long-term negative consequences of this condition. Participants in this study are recruited by referral from mental health providers in a general health setting. Patients meeting criteria for enrollment will be randomly assigned to receive either Prolonged Exposure therapy or treatment as usual. Assessments for all participants will be collected at baseline, week 8, and week 16 after randomization.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of PTSD
* CAPS score of at least 45
* 18 to 65 years old
* Spanish speaker
* competent to provide informed consent

Exclusion Criteria:

* history of bipolar disease, schizophrenia or psychotic disorder
* alcohol or drug abuse in the past three months
* moderate to severe traumatic brain injury
* applying for or receiving disability benefits
* clinically judged to have a high acute suicide risk
* life-threatening medical condition
* currently receiving psychotherapy for PTSD or changed psychotropic medication within 2 months of randomization
A Phase I Study of TS-142 in Healthy Participants (Repeated Doses)

The purpose of this study is to investigate the safety, pharmacokinetics, and pharmacodynamics of repeated dosing of TS-142 when administered once daily to healthy Japanese non-elderly participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥18.5 and \<25.0 kg/m\^2 at screening inspection

Exclusion Criteria:

* History of clinically relevant disease of some organ systems that may be considerd inappropriately for this study
* History of drug and food allergy
A Proof-of-Concept Trial to Study the Safety and Activity of Linvoseltamab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma

This study is researching an investigational drug called linvoseltamab ("study drug") in participants at high risk of developing multiple myeloma (MM), a group commonly labeled as high-risk smoldering multiple myeloma (HR-SMM).

The aim of the study is to understand the safety and tolerability (how your body reacts to linvoseltamab) as well as the effectiveness (how well linvoseltamab eliminates plasma cells and prevents the development of MM) of the study drug. There are 2 parts to the study.

* In Part 1, linvoseltamab will be given to a small number of participants to study the early side effects (safety) of the study drug and make sure the treatment is acceptable.
* In Part 2, linvoseltamab will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of linvoseltamab to treat HR-SMM and prevent progression to MM.

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

* How many participants treated with linvoseltamab (study drug) have improvement of their HR-SMM?
* What side effects may happen from taking the study drug?
* How much study drug is in your blood at different times?
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)


Eligibility Criteria:
KEY Inclusion Criteria:

1. High-risk SMM diagnosis within 5 years of study enrollment
2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
3. Adequate hematologic and hepatic function, as described in the protocol
4. Estimated glomerular filtration rate ≥30 mL/min/1.73 m\^2

KEY Exclusion Criteria:

1. Evidence of myeloma defining events \*SLiM CRAB, as described in the protocol

   \*SLiM (greater than or equal to Sixty percent clonal plasma cells in the bone marrow, involved/uninvolved free Light chain ratio of ≥100 with the involved free light chain (FLC) being ≥100 mg/L, MRI with \>1 focal lesion) CRAB (hyperCalcemia, Renal insufficiency, Anemia, or lytic Bone lesions)
2. Diagnosis of systemic light chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), soft tissue plasmacytoma, or symptomatic multiple myeloma
3. Clinically significant cardiac or vascular disease within 3 months of study enrollment, as described in the protocol
4. Any infection requiring hospitalization or treatment with IV anti-infectives within 28 days of first dose of study drug
5. Uncontrolled human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection; or other uncontrolled infection or unexplained signs of infection
6. History of severe allergic reaction attributed to compounds with a similar chemical or biologic composition as the study drug or excipient

NOTE: Other protocol defined inclusion/exclusion criteria apply
Screening CEDM in Intermediate and High-Risk Patient Populations

This research study is being done to determine if Contrast Enhanced Digital Mammography (CEDM) can improve breast cancer detection and can be used as an additional screening method to the standard mammographic screening.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 35 and had a negative routine mammogram within 6 months.
* Qualifies as intermediate or high-risk (\>15% lifetime risk of breast cancer as defined by IBIS version 8).

Exclusion Criteria:

* Known breast cancer
* Previously had negative MBI or MRI within 12 months of study
* Pregnant or lactating
* Contraindication to intravenous iodinated contrast
* Unable to understand or sign informed consent
* Self-reported signs or symptoms of breast cancer
Growth-Health and Development in Children Exposed to Drugs During Pregnancy

"Children exposed to alcohol or drugs during pregnancy: Growth, health and development" Background Children exposed to drugs during pregnancy are at risk of developmental disorders. The scope and size of this problem is poorly known in Norway.

Alcohol has a known teratogenic effect on the fetus. How other drugs affect the fetus, is associated with more uncertainty. Withdrawal in the neonatal period has been perceived as the main problem. There is less knowledge about long-term outcome of exposure to drugs during pregnancy.

Aim The aim of the study is to investigate the physical and mental health of children exposed to drugs during pregnancy. Identify the children's need for measures in the home and school, and how many of the children who are taken care of in fostercare.

A sample of the children will be offered radiological examination of the brain (f-MRI). The purpose is to study the relationship between exposure to drugs, child development, environment and organic brain dysfunction.

Design The project is a quantitative study. The relationship between exposure to drugs and development will be measured by questionnaires, clinical examination, neuropsychological tests and radiological examination (f-MRI).

Children aged 2-15years who were referred, examined or treated for drug related problems at the Department of Pediatrics, Haukeland University Hospital will be invited to participate in the study.

Information retrieval and examination of the children are expected to be completed during 2011. Data analysis and further processing of data are expected to be completed during 2013.


Eligibility Criteria:
Inclusion Criteria:

* Foetal exposure of drugs during pregnancy.

Exclusion Criteria:

* Non exposed children
3D Reconstructed Image Processin by Computer Proram From MRI Data

We use the three-dimensional image software reconstruct MRI. The propose of this research purposes as follows: 1. 3D reconstructed image processing from MRI to realize the short term nervous system response after dynamic acupuncture stimulation.2. Realizing the corresponding area in the brain caused by electroacupuncture. 3. Realizing the connection between electroacupuncture stimulation and brain physics, chemistry, and physiology. The implement the two-dimentional image into three-dimensional image by Amira software, in order to find out the difference of the pre-and post- response of the nervous system. In addition, we will use "describe statistics" and "Paired t-test" statistical analysis, compare the statistical difference of blood oxygen concentration.

We use the three-dimensional image software reconstruct MRI. The propose of this research purposes as follows: 1. 3D reconstructed image processing from MRI to realize the short term nervous system response after dynamic acupuncture stimulation.2. Realizing the corresponding area in the brain caused by electroacupuncture. 3. Realizing the connection between electroacupuncture stimulation and brain physics, chemistry, and physiology. The implement the two-dimentional image into three-dimensional image by Amira software, in order to find out the difference of the pre-and post- response of the nervous system. In addition, we will use "describe statistics" and "Paired t-test" statistical analysis, compare the statistical difference of blood oxygen concentration.

Anticipate of results: Using the three-dimensional software reconstruct magnetic resonance imaging to realize the immediate response of nervous system after acupoint acupuncture stimulation, and find out the meridian, nerve or physiological corresponding relationship. It will be a tremendous finding to the world if we can deliver a brain mapping concerning the localization of the response on the central nervous system after various acupoints stimulation.

Eligibility Criteria:
Inclusion Criteria:

* The outpatient service or the in-patient, diagnoses after pediatric nerve doctor, must carry on the central nervous system MRI.

Exclusion Criteria:

* Not symbol cooperation brain MRI condition
Equivalence of A Stable Liquid Glucagon Formulation With Freshly Reconstituted Lyophilized Glucagon

This study will test the hypothesis that micro-doses of Xerisol Glucagon (Xeris Pharmaceuticals) will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs. micro-doses of Glucagon for Injection (Eli Lilly).

This study will test the hypothesis that micro-doses of a new formulation of stable glucagon, Xerisol Glucagon (Xeris Pharmaceuticals), will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs. micro-doses of a freshly reconstituted formulation of glucagon that has poor stability in solution, Glucagon for Injection (Eli Lilly).

Eligibility Criteria:
Inclusion Criteria:

* Age 21 to 80 years old with type 1 diabetes for at least one year.
* Diabetes managed using an insulin infusion pump using rapid-acting insulin such as insulin aspart (NovoLog), insulin lispro (Humalog), and insulin glulisine (Apidra) for at least one week prior to enrollment.

Exclusion Criteria:

* Unable to provide informed consent.
* Unable to comply with study procedures.
* Current participation in another diabetes-related clinical trial that, in the judgment of the principle investigator, will compromise the results of the clamp study or the safety of the subject.
* Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception.
* End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).
* Hemoglobin \< 11.5 gm/dl.
* History of pheochromocytoma. Fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor (paroxysms of tachycardia, pallor, or headache; personal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease; episodic or treatment of refractory hypertension, defined as requiring 4 or more medications to achieve normotension).
* History of adverse reaction to glucagon (including allergy) besides nausea, vomiting, or headache.
* Inadequate venous access as determined by study nurse or physician at time of screening.
* Liver failure or cirrhosis.
* Any other factors that, in the judgment of the principal investigator, would interfere with the safe completion of the study procedures.
Craneofacial Injuries in Rink Hockey Athletes

To collect the number of injuries that affect the face and head in rink hockey athletes prospectively during a regular season.

To collect the number of injuries that affect the face and head in rink hockey athletes prospectively during a regular season, while collecting athlete´s exposure and specifical injury characteristics (Burden, mechanism, situation, etc)

Eligibility Criteria:
Inclusion Criteria:

* Compete in a spanish rink hockey league
* play at least in one game during ther regular season

Exclusion Criteria:

* do not accept the participation in the study
Development and Assessment of The Polycystic Liver Disease Questionnaire (PLD-Q).

This Pilot study will enable development \& assessment of a Polycystic Liver Disease-specific patient reported outcomes questionnaire (PLD-Q). Polycystic liver disease (PLD) is characterized by the formation of numerous cysts in the liver, and can lead to severe symptomatic hepatomegaly. It is common in patients with autosomal dominant polycystic liver disease (ADPLD) and autosomal dominant polycystic kidney disease (ADPKD).

As liver function is preserved, quality of life is the main outcome in PLD. Patient reported outcomes are increasingly utilized to assess treatment efficacy \& can include any endpoint derived from patient reports \& are usually assessed by questionnaire. Several existing generic questionnaires assess gastrointestinal symptoms, but include irrelevant items for polycystic liver disease (PLD) \& do not examine relevant extra-abdominal symptoms. Also, a questionnaire that assesses the full range of PLD related problems is more likely to be responsive to changes after treatment initiation. Therefore, a tool that accurately detects changes in PLD symptoms is required.

The development and first steps of validation of this questionnaire are already completed in Netherlands. We will further develop this questionnaire for English speaking patients and validate it in Mayo Clinic cohorts.

The study contains three phases. Phase 1: pilot testing of the directly translated questionnaire (from dutch into english) in a small group of polycystic liver disease (PLD) patients. We will include both symptomatic \& asymptomatic patients (i.e. from mild to severe PLD). Phase 2: further refinement of the questionnaire using the results of the pilot test and input of Mayo patient and clinician focus groups. Phase 3: Further validation in a large cohort of 200 PLD patients with (1) comparison with 200 controls without PLD, (2) cross-sectional correlation with total liver (TLV) \& kidney volumes (TKV), (3) comparing ADPKD patients with \& without PLD (5) against other validated questionnaires (e.g. SF36) \& (5) development of a custom "Worry Questionnaire" examining disease-related worries \& concerns. Finally, longitudinal analyses will be performed to assess PLD-Q sensitivity to change in symptoms. Statistical \& psychometric analyses will be provided by Mayo Clinic quality of life Research group, \& developed in accordance with Food and Drug Administration (FDA) guidance on patient-reported outcome measures in consultation with their Study Endpoints \& Labeling Development Division.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 year
* Polycystic liver, defined by \> 20 liver cysts on imaging

Exclusion Criteria:

* Patients unable to speak or read the English properly
* History of kidney or liver transplantation
* Dialysis
* Current use of experimental drugs (e.g. lanreotide, octreotide)
* Recent liver resection or major surgery
* Other comorbidities that can affect the outcome of the questionnaire, as deemed by the investigators
A Machine Learning Approach to Connect Multiple Myeloma Complexity to Early Disease Recurrence

This is a non-interventional, national, multicenter prospective non-profit observational study aiming at improving the accuracy of risk prediction in multiple myeloma (MM) by applying machine-learning tools for data processing to develop model(s) predicting response to therapy and the probability of early relapse for MM patients.

Improvements in the therapy of MM have prompted the achievement of very deep clinical responses, with significantly improved outcomes and survival \[2\]. However, despite significant therapeutic progress, MM remains a challenge, due to the composite pathogenesis and intricate networks of different interacting factors. As a result, a relatively high proportion of NDMM patients across the different therapeutic strategies have a higher risk of disease progression and worse outcomes, independently of the anti-MM regimen received. These patients currently represent un unmet clinical need, with consequent challenges in the management of the disease and identify these patients upfront is an important goal in MM.

At present, risk stratification scores rely on a limited set of clinical and biological variables, not always sufficient to identify patients at a high risk of early disease progression or relapse (i.e., within 12 months from start of first-line therapy). Recently, AI tools have been explored to improve the accuracy of risk prediction, showing that high-risk diseases might be upfront recognized, based on tumor and immune biomarkers \[3-4\].

By applying Machine Learning (ML) tools for data processing, clinical, genomic, and imaging data from MM patients will be integrated and employed in models aimed at improving the accuracy of MM risk prediction. In this way, ML models will aggregate all tumor- and microenvironment-related information obtained by high-throughput technologies and omics approaches to identify and describe clusters of MM patients that best correlate with the achievement of early progression.

Overall, this study will identify new knowledge to support clinical research and decision-making in MM: precise up-front stratification of patients, based on the whole landscape of MM-related features, could improve understanding of MM individual risk. Results from this study will have an impact on the possibility to access personalized treatment, with predictable overall repercussion on the effective management of MM patients and savings for the National Health System.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Signed Informed Consent form for study participation and personal data processing
* Diagnosis of active multiple myeloma

Exclusion Criteria:

* None
Evaluation of the Extraction-site, - Midline Incision vs Off-midline Incision-

The purpose of this study is to evaluate the midline extraction incision in patients with colon cancer. A prospective randomized controlled trial is conducted to compare midline extraction incision with off-midline extraction incision.

Laparoscopic colon surgery is less invasive and more cosmetic than open surgery. But the extraction-site incision is 4 to 5 cm, and it is the largest and most painful incision in laparoscopic colon surgery. The purpose of this study is to evaluate the midline extraction incision in patients with colon cancer. A prospective randomized controlled trial is conducted to compare midline extraction incision with off-midline extraction incision. The investigators hypothesize that the use of the midline extraction incision in laparoscopic colon surgery will result in more cosmetic effect and better quality of life compared to the off-midline extraction incision.

Eligibility Criteria:
Inclusion Criteria:

* Tumor size is less than 5cm
* No history of laparotomy
* No bowel obstruction by tumor

Exclusion Criteria:

* Patients who can't respond to medical question
* Patients who receive steroids or insulin therapy
* Uncontrolled DM
* Severe respiratory failure(HOT)