cyrilzakka/clinical-trials huggingface dataset:
Phase 1 Weekly Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04629AM6)

The study will evaluate the safety, tolerability, maximum administered dose, and dose limiting toxicity of SCH 727965 administered as an intravenous infusion on Days 1, 8 and 15 of each 28 day cycle in participants with solid tumors, non Hodgkins lymphoma, multiple myeloma or chronic lymphocytic leukemia.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years, either sex, any race.
* Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
* There must be no known standard therapy, or disease must be refractory to standard therapy
* Adequate hematologic, renal, and hepatic organ function and laboratory parameters
* For advanced solid tumors, non-Hodgkin's lymphoma, or multiple myeloma:

  * Participants must have histologically proven solid tumors, non-Hodgkin's lymphoma, or multiple myeloma.
  * Evaluable malignancy must be present by computed tomography or magnetic resonance imaging, obtained within 4 weeks prior to the start of treatment with SCH 727965.
* Subjects with multiple myeloma must have measurable disease defined as:

  * Serum monoclonal protein greater than 0.5 g/dL or urine light chain excretion of greater than 0.2 g/24-hour obtained within 4 weeks prior to the start of treatment.
  * Participants with lower M protein values or nonsecretory myeloma are eligible if measurable disease can be established within 4 weeks prior to start of treatment, such as:

    * serum free light chain ratio greater than 5 times the normal ratio limit; and/or
    * measurable soft tissue plasmacytoma greater than 2 cm, by either physical examination and/or applicable radiographs; and/or
    * bone marrow involvement greater than 30%.
* For B-cell chronic lymphocytic leukemia (B-CLL):

  * Diagnosis of B-CLL according to the National Cancer Institute Working Group (NCI-WG) criteria or a histological diagnosis of small lymphocytic lymphoma.
  * Disease must be evaluable according to NCI-WG response criteria.

Exclusion Criteria:

* Symptomatic brain metastases or primary central nervous system malignancy.
* Previous radiation therapy to \>25% of the total bone marrow.
* Previous treatment with SCH 727965.
* Known HIV infection.
Role of Nanoemulsified Sesame Oil in Post-operative Care After Endoscopic Sinus Surgery

The goal of our thesis is to design, develop and characterize a novel thermodynamically stable NE by spontaneous method intended for topical use. Subsequently, appraisal of nanoemulsified sesame oil formulation has been performed on the post-operative symptoms in CRS patients who have undergone ESS (endoscopic sinus surgery) combined with different types of nasal irrigation which may affect formulation efficacy.


Eligibility Criteria:
Inclusion Criteria:

1. Patient age between 18 and 60 years old.
2. chronic rhinosinusitis patients who have undergone endoscopic sinus surgery.

Exclusion Criteria:

1. Patients with history of allergy for sesame seed derivatives.
2. Patients with chronic diseases which affecting the process of healing (uncontrolled DM, renal failure and hepatic failure).
3. Patients with nasal granulomas.
4. Patients with invasive fungal rhinosinusitis.
5. Smokers.
6. Patients with history of radio and/or chemotherapy exposure.
7. Patients with systemic diseases affecting integrity of nasal mucosa (e.g. CF, scleroderma, Sjogren syndrome ...).
Japanese OMI Treatment With Kit-positive Cells for Enhanced Regeneration

The purpose of this study is to determine the safety and effectiveness of intracoronary infusion of autologous cardiac stem cells in patients with ischemic cardiomyopathy.

This phase I trial will involve 6 patients suffering from chronic ischemic cardiomyopathy and congestive heart failure, to be compared with historical control subjects. This study will be conducted as a collaborative project between the Sakakibara Heart Institute and the CellBank of Japan. The trial is designed to assess the safety and effectiveness of autologous administration of 1,000,000 c-kit-positive cardiac stem cells (CSCs) via intracoronary route following cultivation. The preliminary eligibility criteria will utilize a left ventricular ejection fraction (LVEF) less than 40% measured by echocardiography. During the coronary artery bypass grafting (CABG) surgery, a part (less than 1 gram) of the right atrial appendage (RAA) will be harvested and frozen. When the LVEF is less than 40% after the CABG surgery, the subject will be enrolled as a candidate for the delivery of CSCs, which will be selected from the RAA tissue and cultured for a few months for expansion. The outcome will be evaluated by adverse events as well as cardiac functions.

Eligibility Criteria:
Inclusion Criteria:

* Adult with ability to provide informed consent.
* Left ventricular ejection fraction less than 40% as evidenced by echocardiogram.
* Scheduled for elective surgical revascularization within 2 months.

Exclusion Criteria:

* Positive for HBs-Ag, HCV-Ab, HIV-Ab, or tests for syphilis.
* Diabetic HbA1c greater than 8.5%.
* Pregnant women.
* Scheduled for additional interventions including ventriculoplasty.
The Effect of Cold Steam Application on Nausea and Vomiting

The aim of this study was to determine the effect of cold vapour applied to patients undergoing laparoscopic abdominal surgery primarily on nausea and vomiting and secondarily on antiemetic requirement, patient satisfaction and thirst.

H1: Cold steam application after surgical intervention has a decreasing effect on postoperative nausea.

H2: Cold steam application after surgical intervention has a decreasing effect on postoperative vomiting.

H3: Cold steam application after surgical intervention reduces the need for antiemetic drugs.

H4: Cold steam application after surgical intervention has a satisfactory effect on reducing nausea and vomiting.

The research will be conducted with the participation of surgical patients who underwent laporoscopic abdominal surgery between December 2024 and March 2025 in the General Surgery Department of Trakya University Hospital.

Effect size of 0.2 was predicted, the smallest possible significant correlation coefficient between repeated measurements was accepted as 0.3, and the minimum number of people to be included in the sample was calculated as 80, consisting of 40 patients from each group with a 95% confidence level, 5% margin of error and 80% power value. In case of possible data loss, drop out rate was accepted as 10% and 44 patients were included in each group.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing abdominal surgery under general anaesthesia,
* Admitted to the general surgery ward after surgery,
* Who volunteered to participate in the research,
* No mental disability,
* 18 years of age,
* Literate,
* Accepting random selection,
* without Turkish communication problems,
* No preoperative oncological treatment,
* undergoing elective surgery,
* Postoperatively without a nasogastric catheter,
* with an operation time \<4 hours,
* Laparoscopic surgery performed,
* No postoperative nausea and vomiting or mild/moderate nausea,
* Patients with ASA score 1, 2 or 3 were determined as inclusion criteria.

Exclusion Criteria:

* Severe nausea or active vomiting prior to administration,
* Migraine, vertigo, etc. who may experience nausea and vomiting due to vestibular disease, pregnancy,
* COPD, asthma, etc. with respiratory problems,
* Not accepting the application of cold steam,
* Not accepting random selection,
* Those with a history of chemotherapy or radiotherapy before surgery,
* Patients who underwent sudden movement changes (bed change, patient transfer, etc.) during the data collection period (0 to 2nd hour),
Endurance Training in Patients Undergoing Lung Transplantation

Lung Transplantation is usually the last option for patients with chronic respiratory conditions in the late stages of the disease. Pulmonary rehabilitation and, particularly, endurance training, is a cornerstone in the management of these patients both during the pre-operative as well as the post-operative period as it improves cardiopulmonary fitness, muscle mass, muscle strength, health-related quality of life and potentially, survival. However, very few studies have been published addressing which modality of training, intensity, frequency or duration of training provides the best possible results in these patients. Therefore, the objective of this study was to compare two training modalities (treadmill walking versus cycle-ergometry) on functional capacity, muscle strength and lung function.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing lung transplantation at the Thoracic Surgery Unit of the Hospital Clínico Universitario de A Coruña.
* Adults \> 18 years.
* Ability to attend post-surgery exercise training for a minimum period of one month.
* Sign informed consent.

Exclusion Criteria:

* Torpid post-operative recovery with a prolonged stay at the Post-Anaesthesia Care Unit \> 12 days.
* Diagnosed with intensive care unit acquired muscle weakness.
Physiological and Psychological Effects of Music Therapy in the Pregnant Woman and Fetus

To evaluate the effects of music therapy in the care of antepartum mothers admitted for long-term hospitalization due to the high-risk status of their pregnancy. The investigators speculate that mothers who receive music therapy will be more successful in forming positive coping habits, bonding with their infant, and increasing the length of incubation during their pregnancy.

Furthermore, there is no research that correlates music therapy applied to stress reduction, increased coping, and increased caregiver-infant bonding prior to birth within one protocol. However, there is a significant amount of research supporting music therapy efficacy with neonatal intensive care unit infants and caregiver bonding post-partum as well as improved physiological signs of stress in infants in the post-partum period.

The investigators will identify and screen patients who are admitted to the Texas Children's Pavilion for Women and Houston Methodist Willowbrook with a clinical diagnosis of threatened preterm birth caused by preterm premature rupture of membranes (PPROM), between a gestational age of 24 and 36 weeks. The investigators will approach the patients to discuss this study and if they are interested in participating, the investigators will provide the informed consent form for their signature. After that, the investigators will start collecting data, such as basic demographic information and the Edinburgh Postnatal Depression Scoring scale (EDPS) scores that are clinically taken before and after the PPROM diagnosis.

Inclusion Criteria:

1. Pregnant women between 18 and 64 years of age.
2. Singleton pregnancy.
3. Hospital admission due to a high risk of premature delivery.
4. Confirmed diagnosis of preterm premature rupture of membranes.
5. Length of stay in the hospital for 48 hours or more and stable for 48 hours or more.
6. Patients willing to listen to music.
7. Patients willing to participate throughout all the music therapy sessions and the postpartum follow-up visit.

Exclusion Criteria:

1. Hospital length of stay of less than 48 hours.
2. Non-singleton pregnancy.
3. Gravidae with severe medical and or surgical complications during their hospital admission that prevents them from participating in Music Therapy sessions.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women between 18 and 64 years of age.
2. Singleton pregnancy.
3. Hospital admission due to a high risk of premature delivery.
4. Confirmed diagnosis of preterm premature rupture of membranes.
5. Length of stay in the hospital for 48 hours or more and stable for 48 hours or more.
6. Patients willing to listen to music.
7. Patients willing to participate throughout all the music therapy sessions and the postpartum follow-up visit.

Exclusion Criteria:

1. Hospital length of stay of less than 48 hours.
2. Non-singleton pregnancy Gravidae with severe medical and or surgical complications during their hospital admission that prevents them from participating in Music Therapy sessions.
Postoperative Pain After Total Laparoscopic Hysterectomy: a Comparison of Single-port and Three-port Laparoscopy

The objective of this study is to compare postoperative pain between single-port access total laparoscopic hysterectomy (SPA-TLH) using a transumbilical single-port system and conventional multi (three)-port access total laparoscopic hysterectomy (MPA-TLH). A prospective study was conducted on women who underwent SPA-TLH and MPA-TLH for benign gynecologic diseases from March 2014 through January 2015. The study enrolled 60 patients and postoperative pain and operative outcomes were examined.

The randomization code was inserted into numbered and sealed envelopes. A single envelope was opened when the patient was arrived in operating room. All patients gave their informed consent for the study and underwent hysterectomy for benign diseases. After surgery, in all patients, three sticking plasters were applied by the same manner with three port surgery group therefore not only patients but also anesthesiology staff who measure the pain score could not know the type of surgery until data collection was finished. Pain was assessed according to the visual analog scale (VAS) (0 = no pain; 10 = worst pain imaginable). Patients were asked to evaluate the maximal degree of pain. Pain scores were recorded at least at 30 minutes, 1, 12, 24 and 48 hours after surgery. Postoperative pain was measured by two independent anesthesiology staff members for cross-checking. In order to compare the intensity of postoperative pain accurately, all the participants had anesthesia in the same way and postoperative pain was managed by fentanyl-based intravenous patient-controlled analgesia pump (IV-PCA, Baxter healthcare Corporation, U.S.A: bolus dose 0.12mg/kg of fentanyl, lockout interval of 5 min, basal infusion 0.02ml/kg) with the same regimen on both groups. A patient was instructed to press the IV-PCA bolus button when the VAS was 3 or higher. A patient under IV-PCA whose VAS was over 5 received 50mg of Tridol injection intravenously. IV-PCA was removed 48 hours after surgery unless a patient specially asked it. Then, using log data downloaded by a program, we analyzed the number of IV-PCA bolus requests by time interval, total amount of fentanyl consumption, and the number of additional Tridol administration and injection time.

Eligibility Criteria:
Incluson Criteria

1. Subject has benign uterine disease
2. Subject needs total hysterectomy.
3. Subject has appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification system 1-3).

Exclusion Criteria:

1. suspicion of malignancy
2. the need for simultaneous interventions such as prolapse repair
3. uterine size greater than 18 weeks of gestation
4. ongoing peritoneal dialysis
5. diseases associated with abdominal pain such as pancreatitis
A Real World Study of Ensartinib in Advanced ALK-positive NSCLC

The primary objective of this study is to evaluate the efficacy and safety of Ensartinib in advanced ALK-positive non-small cell lung cancer, and the mechanisms of population pharmacokinetics and resistance to Ensartinib.

Participants will receive Ensartinib at 225 mg orally once a day (QD). Treatments will continue until disease progression, meeting one of treatment discontinuation criteria (eg, patient decision, adverse event, pregnancy). At the time of disease progression, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier. Collection of venous blood sample from participants included 3 times: before treatment, 8 weeks of treatment, and disease progression. Blood specimens of 8 ml were collected each time for ctDNA NGS testing, and evaluation of Ensartinib population pharmacokinetics with blood sampling after 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed stage III b or IV NSCLC, according to the International Association for the Study of Lung Cancer staging manual in Thoracic Oncology, 8th edition.
2. Documented ALK-positive disease according to FISH , Ventana IHC ,RT-PCR or NGS;
3. Patients must have demonstrated progression during or after ALK-TKI treatment;
4. Eastern cooperative oncology group performance status (ECOG PS) of 0-2, overall survival\>3 months;
5. Patients need radiotherapy or can receive radiotherapy, such as bone metastatic lesions, intrapulmonary lesions, adrenal lesions, etc.
6. Initially general blood tests including complete blood count, biochemistry, electrolytes, and urine biochemistry were performed as a routine screening in order to identify any abnormalities.
7. Male and female patients must agree to abstain or to use two highly effective forms of contraception during the treatment period and for 90 days after the last dose of study medication.

Exclusion Criteria:

-
European Drug Utilization Study

The purpose of this retrospective observational study is to evaluate the characteristics of patients receiving Seroquel XR as treatment for their Major Depressive Disorder. The study will also investigate how the medication is used for these patients and if there are any differences in drug utilisation between the included countries. The study is observing patients initiating Seroquel XR during a 9 month period corresponding to 3 to 12 months following the launch of the product in each country for the MDD indication. A drug utilisation questionnaire will be used to collect study data from patients' medical records.

A Multinational, Multicenter, Retrospective, Observational Drug Utilisation Study of Seroquel Extended Release (XR) Prescribed by Psychiatrists as Treatment for Major Depressive Disorder (MDD) in Selected Countries in the European Union (EU)

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent before initiation of any collection of questionnaire data.
* Documented clinical diagnosis of Major Depressive Disorder, Single Episode, or Recurrent.
* Initiation of Seroquel XR for treatment of MDD during the period defining the inception cohort, i.e. from 3 months after launch until the index date (12 months after launch).

Exclusion Criteria:

* If participating in any clinical trial during the time from 3 months after launch until the index date, the patient cannot take part in this study.
Design of Optimally-diagnostic Skin Test Solutions for Diagnosis of Sensitisation to a Pollen and Dust Mite Mixture.

Multicenter Skin Prick Test


Eligibility Criteria:
Inclusion Criteria:

* anamnesis referring to suspicion of an IgE-mediated allergy
* positive Skin Prick Test in the medical history to at least one of the investigational allergens with an existing anamnesis

Exclusion Criteria:

* serious chronic diseases
* Other perennial allergies
Quantitative Pulmonary Imaging Registry & Biorepository

The goal of this project is to establish a registry and biorepository of images and biological samples from subjects undergoing novel pulmonary imaging methods to be used for future research aimed toward identifying clinical applications of imaging methods and toward understanding the physiological significance of imaging biomarkers. This registry and biorepository will accelerate the development of these imaging techniques and may lead toward future clinical adoption of quantitative pulmonary imaging.

Imaging is increasingly used for the non-invasive assessment of pulmonary health. Alongside this increased usage, there is enhanced interest in quantitative imaging methods that provide robust, repeatable, and objective measures of lung structure and function. At the forefront of this effort is quantitative computed tomography (qCT). CT imaging is the gold standard for high-resolution imaging of pulmonary structure, and the underlying physics of CT imaging is highly amenable to quantitative analysis.

In addition to qCT, MRI is garnering increased interest as a modality for pulmonary imaging. Like CT, MRI is non-invasive, and it has the additional advantage of being ionizing radiation-free, making it more suitable for repeat imaging and for use in pediatric patients. Traditionally, MRI was not often used for lung imaging due to several difficulties regarding the acquisition of quality images in the lungs. However, recent advances to pulmonary MRI methods have enabled the acquisition of high-quality images of pulmonary structure and function. These advances include the use of ultra-short and zero echo time (UTE and ZTE, respectively) MRI methods, as well as the use of gaseous contrast agents such as hyperpolarized 129Xe.

Despite these advances in qCT and MRI methods, the clinical applications for these imaging techniques are often unclear. Moreover, as new techniques, many of the imaging biomarkers in use have been independently developed by multiple sites and thus require standardization. As such, there is an urgent need both to standardize imaging/analysis techniques and to determine optimal clinical applications for these novel quantitative imaging methods.

Eligibility Criteria:
Inclusion Criteria:

* The participant is enrolling/has enrolled in a research study at the University of Kansas Medical Center that involves Pulmonary MRI and/or Pulmonary CT.

Exclusion Criteria:

* The participant declines to participate.