cyrilzakka/clinical-trials huggingface dataset:
Comparison of Contrast Agents for MRI Perfusion Analysis in Brain Tumor Patients

This study will compare the use of two contrast agents to analyze blood flow characteristics of brain tumors.

This study will compare contrast agents, gadobenate dimeglumine and gadobutrol, for MRI perfusion analysis in brain tumor patients.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with brain tumors will be enrolled. These subjects may be newly diagnosed, undergoing treatment or undergoing follow-up. If a subject has undergone surgery or treatment they should have what appears to be residual tumor.

Exclusion Criteria:

* Renal failure (GFR \<45). Subjects will be screened utilizing UNMC gadolinium contrast guidelines.
* Allergic reactions to MRI contrast agents.
* Subjects who do not fit the criteria for the population we are evaluating.
* Subjects should not participate in this study if they have any of the following conditions:

  * Anxiety attacks
  * Panic disorder
  * Claustrophobia
  * Pregnant, or trying to become pregnant
  * Breast feeding
* Subjects should not participate in this study if they have certain kinds of metal in their body, for example: a heart pacemaker, defibrillator, neurostimulator, a metal plate, certain otologic implants, certain types of heart valves, metal slivers in eye, brain aneurysm clips or metal slivers and bullet fragments in or near certain structures in their body. Our standard MRI safety screening will be performed on all subjects.
* If a subject has metal in their body that requires an additional x-ray beyond what is needed for the clinical MRI examination to safely perform the research MRI examination that subject would be excluded.Subjects not being able to return for a follow-up examination
Human Ovarian Autotransplantation

Chemotherapy can cause permanent damage to a woman's ovaries. Women who are cancer survivors may find that they are not able to produce female hormones, and they may not be able to have a child. Scientists are trying to find ways to help cancer survivors regain their hormonal function and possibly get pregnant, if they desire. Scientists have developed a method where ovarian tissue is removed and frozen before chemotherapy; then it is thawed and put back into the woman's body after she is cancer-free. Putting a woman's previously-frozen tissue back into her body is called ovarian autotransplantation.

Ovarian autotransplantation is a very new technique, and there have only been a small number of women who have had this procedure. So far, only five babies in the world have been born using this technique.

The purpose of this study is to learn more about ovarian autotransplantation. Scientists hope to find better ways to use this method to help a woman's ovaries start working again after chemotherapy. If the ovaries start working again, it might be possible to have a baby.


Eligibility Criteria:
Inclusion criteria:

* Adult women (age between 18 and 40) who stored the ovary before cancer therapy.
* Adult women who completed cancer therapy and are in remission.
* Adult women who desire to conceive and are ready to have a baby.

Exclusion criteria:

* Age under 18 or over 40 years old
* Women with a disease at high risk for ovarian metastasis (such as leukemia)
* Women with contraindication for surgery
* Women with contraindication for pregnancy
* Psychological instability to sustain pregnancy (diagnosed by a psychiatrist)
* Women who are HIV Positive
A Safety Study to Evaluate the Antiviral Activity of Darunavir in Combination With Ritonavir in HIV 1 Infected Children

The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication), safety and antiviral activity to support dose recommendations by body weight of darunavir with low-dose ritonavir (DRV/rtv), in combination with other antiretroviral drugs (ARVs), in treatment-experienced Human immunodeficiency virus 1 (HIV 1) infected children.

This is an open-label (all people know the identity of the intervention), study to evaluate the pharmacokinetics, safety and antiviral activity. Approximately 24 HIV-1 infected children will be enrolled in this study. The study consists of a 4-week screening period, a 48-week treatment period, and a 4-week follow-up period. Participants will receive DRV/rtv according to their body weight. Safety evaluations will include assessment of adverse events, laboratory tests, physical Examination, neurologic examination, vital signs, and electrocardiogram. The total duration of the study will be 56 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Participants with a documented HIV 1 infection (by any of the local standard diagnostic methods, such as HIV PCR-DNA, ELISA or western blot (WB) test for HIV antibodies, etc.)
* Body weight from 10 kg to less than 20 kg at screening
* Participants currently on stable ART (anti retroviral therapy) for at least 12 weeks, who need to change their ARV regimen because it is currently failing, with a viral load of greater than 1000 copies/mL
* Screening genotype resistance test results showing less than 3 DRV resistance-associated mutations
* Parents or legal representative willing and able to give consent

Exclusion Criteria:

* Participants with presence of any currently active conditions included in the listing of WHO ( World Health Organisation) Clinical Stage 4 and participants with presence of a non-HIV encephalopathy
* Administration of any ARV (antiretroviral) or non-ARV investigational medication or investigational vaccine within 30 days prior to screening, except for those medications where dose recommendations for children are available
* Life expectancy less than 6 months, according to the judgment of the investigator
* Co-enrollment in other clinical and/or cohort trials without written permission of the Sponsor
* Participants with any active clinically significant disease (eg, tuberculosis \[TB\], cardiac dysfunction, pancreatitis, acute viral infections) or findings during screening of medical history or physical examination that, in the investigator's opinion, would compromise the subject's safety or outcome of the study
Assessing the Efficacy of IV Ibuprofen for Treatment of Pain in Orthopedic Trauma Patients

STUDY OBJECTIVES:

1. To evaluate the effectiveness of around the clock (OTC) IV ibuprofen (8 doses) in decreasing pain in orthopedic trauma patients with fractures of the extremities, face, pelvis and/or ribs compared to patients not receiving the medication.
2. To evaluate the effectiveness of around the clock (OTC) IV ibuprofen (8 doses) in decreasing the use of opioid analgesics among orthopedic trauma patients with fractures of the extremities, face, pelvis, and/or ribs compared to compared to patients not receiving the medication.

Eligible patients were trauma patients between the ages of 18 and 75 years old with adequate IV access who were able to self-report and communicate pain severity and who were consecutively admitted to the trauma intensive care unit (ICU) or trauma step-down units with a fracture of the ribs, face, extremities and/or pelvis.

Eligible patients who signed the informed consent were randomized to either IV Ibuprofen (Caldolor®) or Placebo via a computer-generated randomization list.

Patients had pain measured using a Numerical Rating Scale (NRS) that ranged from 0 (no pain) to 10 (worst possible pain)

Eligibility Criteria:
Inclusion Criteria:

1. Trauma patient admitted to Trauma ICU or Trauma Step-Down Units.
2. Fracture of ribs, face, extremities and/or pelvis
3. Age between 18 and 75 years old
4. Adequate IV access
5. Able to self report and communicate pain severity

Exclusion Criteria:

1. History of allergy or hypersensitivity to any component of IV Ibuprofen, aspirin (or aspirin related products) NSAIDs, or COX-2 inhibitors
2. Any intracranial or spinal cord trauma
3. History of clinically significant bleeding disorders including ITP, DIC or platelet dysfunction
4. Recent history of intracranial surgery or stroke (within past 30 days)
5. History of ulcers, gastritis or previous GI bleeding
6. Renal Impairment (Creatinine \> 3.0 mg/dL)
7. Pregnant or breastfeeding
8. Otherwise unsuitable in the opinion of the treating physician at time of randomization.
Measuring Single-Serving Grain Intake

The primary objective of this study is to identify markers of a single meal of whole grain oat and whole grain wheat intake in humans.

The aim of this study is to identify compounds that are found in blood and urine and are derived from a single meal of whole grain oat or whole grain wheat intake so that epidemiological studies can be conducted to provide more accurate associations between whole grain intake and health.

Eligibility Criteria:
Inclusion Criteria:

* 21 to 75 years of age
* Voluntarily agree to participate and sign an informed consent form

Exclusion Criteria:

* Body weight less than 110 lbs.
* Have a body mass index below 19 or above 38 kg/m2
* Known (self-reported) allergy or adverse reaction to study foods
* Women who have given birth during the previous 12 months or who are pregnant/lactating or who plan to become pregnant during the study
* History of bariatric surgery or nutrient malabsorption disease (such as celiac disease), Crohn's disease, diabetes, or metabolic disorders that may interfere with the study
* History of certain cancer diagnosis or treatment in the last 3 years
* Smoking or use of tobacco products in the past 6 months
* Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
* Use of certain medications or supplements (prescription or over-the-counter) that may interfere with the study objectives, including blood thinning medications
* Unable or unwilling to give informed consent or communicate with study staff
* Self-report of alcohol or substance abuse within the past 12 months and/or current treatment for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Biopsy Versus Resection in Elderly Glioblastoma Patients. A Prospective Cohort Study.

This trial is set up as a prospective observational cohort study to identify if either biopsy or resection should be the surgical modality of choice in elderly glioblastoma patients with a newly diagnosed tumor. Patients who are considered eligible for GBM resection or biopsy will be included. Through shared-decision making patients and their treating physicians will decide upon resection or biopsy. Written informed consent will be obtained. Participants will be followed for 1 year postoperative to assess potential differences in health-related quality of life and overall survival.

Follow-up will consist of health-related quality of life questionaires and neurological assessment at 6 weeks, 3 months, 6 months and 12 months postoperative. Additionally Cognitive and neuro-linguistic tests will be done at 3 months postoperative. These will be compared to results pre-operative.

After surgery, patients will receive standard adjuvant treatment with concomitant Temozolomide and radiation therapy, and standard follow-up. Patients in whom the diagnosis GBM is not confirmed in histological analyses will be excluded from the study. Total study duration will be 4 years, of which 3 years will comprise patient inclusion, with a follow-up duration of 1 year.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥70 years
2. Tumor diagnosed as glioblastoma on MRI with distinct ring-like pattern of contrast enhancement with thick irregular walls and a core area reduced signal suggestive of tumor necrosis as assessed by the surgeon.
3. Karnofsky Performance Score (KPS) ≥70
4. Written Informed consent

Exclusion Criteria:

1. Tumors of the cerebellum, brain stem or midline
2. Multifocal contrast enhancing lesions
3. Substantial non-contrast enhancing tumor areas suggesting low grade gliomas with malignant transformation
4. Medical reasons precluding MRI (e.g. pacemaker)
5. Inability to give consent as assessed by neurosurgeon (e.g. language barrier)
6. Severe aphasia prohibiting neurolinguistic testing and comprehension of informed consent
7. Previous brain tumor surgery
8. Previous low-grade glioma
9. Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin.
Comparison Study of the McGrath MAC Video Laryngoscope With the King Vision

In this study, the investigators compare the effectiveness of two relatively new video laryngoscopes, McGrath MAC (Covidien, Dublin Ireland) and the King Vision (King Systems, Noblesville, IN), by practitioners experienced in airway management but with limited exposure to these two devices. Our hypothesis was that, the McGrath MAC device would require fewer intubation attempts and shorter intubation times than the King Vision when performed by novice users.


Eligibility Criteria:
Inclusion Criteria:

* All interested airway providers (Residents, Attendings, Certified Nurse Anesthetist and
* Student Registered Nurse Anesthetist) will be eligible to be included. -

Exclusion Criteria:

* All patients with difficult airways as determined by history or physical exam (limited oral opening, limited cervical extension, receding chin, Mallampati class III or IV).
Phase I Study of SHR-2002 + SHR-1316 in Patients With Advanced Malignant Tumors

This is Phase 1 study FIH to check "Dose Escalation, Dose expansion and Indication expansion". This study is AUSTRALIA only study.


Eligibility Criteria:
Subjects must meet all the following criteria to be eligible for enrollment into the study:

1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
2. Male or female aged ≥18 years at the time of signing the ICF;
3. Histopathologically or cytologically documented advanced or metastatic malignancies and failed or intolerable to previous standard therapy, has no available standard of care therapy or refused standard therapy;
4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1 (Appendix 2);
5. Female and male patients of reproductive potential must agree to use highly effective contraception during the study treatment period and within 6 months after the last investigational drug administration.

Subjects who meet any of the following criteria will be excluded from the study:

1. Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
2. Patients with tumor-related pain that cannot be controlled as determined by the investigator.
3. Systemic anti-tumor therapy within 28 days prior to the first dose of the study treatment
4. History of autoimmune diseases, except for Type 1 diabetes (blood glucose can be controlled by insulin therapy)
5. History of clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study treatment.
6. Known history of serious allergic reactions to the investigational product or its main ingredients;
7. History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
Bone Marrow Transplantation Plus Biological Therapy in Treating Patients With Chronic Myeloid Leukemia

RATIONALE: Biological therapy may increase the number of immune cells found in bone marrow and may help a person's immune system recover from the side effects of the chemotherapy used in treating chronic myeloid leukemia. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation, chemotherapy, and biological therapy in treating patients who have chronic myeloid leukemia.

OBJECTIVES: I. Determine the one year event-free survival in patients with chronic phase chronic myeloid leukemia receiving sargramostim (GM-CSF)-treated autologous bone marrow transplantation followed by GM-CSF and interferon alfa. II. Determine the toxicity of this regimen in these patients.

OUTLINE: Patients undergo harvesting of autologous bone marrow. A portion of the cells are treated ex vivo with sargramostim (GM-CSF) for 3 days. Patients then receive myeloablative chemotherapy with busulfan and cyclophosphamide on days -9 to -2 according to the preparative regimen protocol. Patients undergo sargramostim (GM-CSF)-treated autologous bone marrow transplantation on day 0. Patients receive GM-CSF subcutaneously daily on days 5-180, and interferon alfa daily on days 90-180. Patients are followed monthly for 1 year, every 6 months for 2 years, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 9-19 patients will be accrued for this study within 2-3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Diagnosis of chronic phase chronic myeloid leukemia (CML) by cytogenetic and/or molecular analyses No more than 10% blasts on blood and bone marrow morphology Philadelphia (Ph) chromosome positive Ph chromosome-negative CML allowed if evidence of the BCR-ABL rearrangement by molecular or FISH analyses or evidence of the P120 protein Duration of CML less than 3 years, unless cytogenetic remission to interferon has been achieved Failed to obtain and maintain a complete cytogenetic remission on a prior trial of interferon therapy Absence of detectable PH-negative cells in bone marrow or blood after 6 months of therapy Lack of a progressive increase in Ph-negative cells between 6 and 12 months of therapy Less than 50% Ph-negative cells after 12 months of therapy Absence of complete cytogenetic remission after 24 months of therapy Inability to tolerate prior interferon therapy No accelerated phase or blast crisis CML, chronic myelomonocytic leukemia, or juvenile CML Concurrent enrollment on the busulfan and cyclophosphamide preparative regimen protocol

PATIENT CHARACTERISTICS: Age: 12 to 70 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No history of intolerance to sargramostim (GM-CSF)

PRIOR CONCURRENT THERAPY: See Disease Characteristics
Nasal Septum Deviation May Affect Facial Morphologic Parameters.

The aim of the study is to evaluate the relationship between the direction and degree of nasal septal deviation with nasal bone morphology , along with factors such as age and gender.

The nasal septum is located in the middle of the nasal cavity and it forms the major part of the nose structure. It is divided into a posterior part by the vomer and perpendicular plate of the ethmoid bone and an anterior part by the quadrangular cartilage .

In the growth period, the nasal septum acts as a growth plate that affects surrounding bones and facial skeletal tissues .Thus, nasal septum deviation affects facial morphologic parameters such as interalveolar distance and maxillary rotation distance, causing compensatory changes in the lateral nasal wall and septal deviation,which are associated with nasal floor and palatal region asymmetries .

Nasal septum deviation is the most common anatomic variation in up to 80% of healthy adults .

From the initial growth stages, the maxillary bone and nasal structure have significant anatomic connections because of their close embryologic development.

The severity of septal deviation also affects the ipsilateral lateral lamina of the cribriform plate width and ipsilateral middle turbinate length . Nasal septal deviation may affect nasal bone growth and facial morphology .Knowledge of nasal morphologic parameters plays an important role in planning successful rhinoplasty and septoplasty operations.

Some morphological characteristics of the nose such as bone length and thickness may present different forms according to factors correlated with age, gender, climate and race.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old who attending to Ear,Nose and throat department out patients complaining of nasal septum deviation causing nasal symptoms are exposed to maxillofacial CT.

Exclusion Criteria:

1. Patients with a history of rhinoplasty,
2. Patients with cranial and facial trauma or bone deformity (e.g. S-shaped septum deviation).
3. Patients with a mass or polyp in the nasal cavity.
4. Patients with adenoid .
5. Patients with nasopharyngeal lesions.
6. Patients with craniofacial anomalies.
The Effect of Laughter Yoga on Premenstrual Symptoms and Quality of Life in Midwifery Students

The research was planned as a prospective, randomized controlled experimental study to determine the effect of laughter yoga applied to midwifery students on premenstrual symptoms (PMS) and quality of life.

Research Hypotheses H0: Online laughter yoga has no effect on premenstrual symptoms. H1: Online laughter yoga has an effect on premenstrual symptoms. H0: Online laughter yoga has no effect on quality of life. H1: Online laughter yoga has an impact on quality of life.

59 midwifery students will participate in the research. In this study, the number of laughter yoga sessions was determined in line with the studies in the literature. Each laughter yoga session is planned to last approximately 40-45 minutes. Each session of laughter yoga consists of clapping and warm-up exercises, deep breathing exercises, childlike play and laughter.

Eligibility Criteria:
Inclusion Criteria:

* To agree to participate in the research,
* To be over 18 years old,
* Not having taken vocational courses
* Not having a chronic disease,
* Having a regular menstrual period,
* Having at least 110 points on the PMS scale
* Not receiving medical treatment for PMS.

Exclusion Criteria:

* Refusing to participate in the research,
* To have taken vocational courses,
* Having a chronic illness
* Getting a score lower than 110 on the PMS scale,
* Having any condition where laughter yoga should be avoided (having had abdominal surgery in the last three months, taking regular medications, epilepsy, uncontrollable hypertension, glaucoma, hernia, etc.)
* Receiving medical treatment for PMS.