cyrilzakka/clinical-trials huggingface dataset:
A Study Comparing Two Formulations of Selpercatinib (LY3527723) in Healthy Participants

The main purpose of this study is to compare the amount of selpercatinib that gets into the blood stream and how long it takes the body to get rid of it, when given as different formulations. The information about any adverse effects experienced will be collected and the tolerability of selpercatinib will also be evaluated. The study may last up to 56 days including the 28 days of screening period.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and vital signs.
* Participants who have clinical laboratory test results within the normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.

Exclusion Criteria:

* Have a history of allergic reactions to medications or food products
* Have a clinically significant abnormality of blood pressure and/or pulse rate as determined by the investigator
* Clinically significant abnormalities on ECG as determined by the investigator or prolongation of the QTcB or QTcF \>450 msec at screening
* Have clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to the planned start of selpercatinib
* Have a history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data. Appendectomy, splenectomy, and cholecystectomy are considered as acceptable
* Use of H2 blockers, proton pump inhibitors, and other drugs that affect selpercatinib exposure within 7 days of screening
* Are intending to use over-the-counter or prescription medication, including dietary supplements, within 14 days prior to dosing and until study discharge (apart from occasional acetaminophen (≤2 g/24 hours), hormonal contraception, or hormone replacement therapy)
CD147 Targeting Peptide Probe for PET Imaging in Solid Tumors

The objective of the study is to construct a noninvasive approach using 68Ga-DOTA-AP9 PET/CT to detect the CD147 expression of tumor lesions in patients with solid tumors and to identify patients benefiting from CD147 targeting treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Malignant melanoma, liver cancer, colon cancer, pancreatic cancer, breast cancer, gastric cancer, lung cancer, etc., confirmed by histopathology or cytology;
2. age ≥18 and ≤75 years old, male or female;
3. ECOG score 0 or 1;
4. expected survival time ≥6 months;
5. There was at least one measurable target lesion according to RECIST1.1 criteria, and biopsy could be performed within one month before and after PET scan, and the patient could provide 2-3 lesion tissue slides;
6. Women of childbearing age (15-49 years) must have had a negative pregnancy test within 7 days before starting testing; Women and men of childbearing potential must agree to use effective contraception to avoid pregnancy during the study and for 3 months after the examination;
7. patients recommended by clinicians to undergo PET/CT examination for tumor staging;
8. The subjects could fully understand and voluntarily participate in this experiment, and signed an informed consent.

Exclusion Criteria:

1. Pregnant or breastfeeding women, or women planning to become pregnant during the study or within three months after administration, as well as individuals donating sperm or oocytes.
2. Individuals known or suspected to be allergic to the investigational drug or any of its components.
3. Individuals with significantly abnormal liver or kidney function: serum total bilirubin (TBIL) \> 1.5 × 20 µmol/L, or aspartate aminotransferase (AST) \> 2.5 × 45 µmol/L, or alanine aminotransferase (ALT) \> 2.5 × 40 µmol/L, or serum creatinine \> 1.5 × 130 µmol/L.
4. Unable to cooperate in completing the PET scan, or suffering from claustrophobia or other conditions that prevent cooperation during the PET scan.
5. Other situations deemed inappropriate for participation in the trial by the investigator. Female patients who are pregnant or breastfeeding.
Effect of Extracorporeal Shock Therapy for Dysmenorrhea

This study was carried out upon forty women diagnosed as primary dysmenorrhea. They were selected from outpatient clinics of gynecology of Ain Shams University Hospital, Cairo University. Their age ranged from 25-35 years, BMI\<30kg/ m².

Patients with primary dysmenorrhea diagnosed by a physician, spondylolisthesis and chronic low back pain were excluded from the study. They were randomly assigned into two equal groups (A\& B). Group (A) consisted of twenty subjects, with an average age 29.2±1.9Yrs, and BMI 27.28±2.1kg/m2 who received Extracorporeal shock waves. Group (B) consisted of twenty patients, with an average age 28.58±2.2Yrs, and BMI 28.92±0.7kg/m2 who received sham technique. A hot pack was used for 15 minutes for both groups (A\&B) before the treatment.

Eligibility Criteria:
Criteria:

Inclusion Criteria:

* forty virgin females.
* their age ranged between 25 to 35 years old.
* Body mass index (BMI) \<30kg/ m².

Exclusion Criteria:

* females with pelvic pathology as endometriosis.
* females have irregular menstrual cycles.
* females have secondary dysmenorrhea.
Assessment of L-PRF, Nanohydroxyapatite Combined With L-PRF Using Pulpotomy in Mature Mandibular First Molars

Clinical and Radiographic Assessment of L-PRF, Nanohydroxyapatite material combined with L-PRF scaffold in Vital pulp Therapy. Treatments in Mandibular First Molars with Closed Apices, Randomized Controlled Trial.

pulpotomy by using 3 materials. The first group(control group ) uses hydroxyapatite material as a pulpotomy agent, and the second group uses L-PRF as a pulpotomy agent. the third group uses combined material (L-PRF = Nano hydroxyapatite )as a pulpotomy agent .. then assesses the clinical and radiographic result of the 2 interventions group with control group

Eligibility Criteria:
Inclusion criteria:

Patients should be free from any systemic disease. Patients of either gender aged from 15-30. Patients will agree to the consent and will commit to a follow-up period. Soft tissues around the tooth are normal with no swelling or sinus tract. The tooth is restorable tooth has signs and symptoms of irreversible pulpitis of the mature root The tooth doesn\&#39;t contain any internal or external resorption or periapical lesions.

The tooth should give a positive response to the cold test.

Exclusion criteria:

Pregnant and lactating females. Patients with Mental disturbance. Patients who could/would not participate in a 6-month follow-up. A tooth with immature roots. Patients with necrotic pulp.• tooth with periapical lesions or infections. Soft tissue having fistula or swelling Homoeostasis after 10 minutes can not be controlled after total pulpotomy
Assessment of Emotion-regulation Skills in Game-based Situations

The aim of the study is to investigate the validity of in-game scores as indicators for emotional regulation abilities in children and adolescence.


Eligibility Criteria:
Inclusion Criteria:

* children and adolescents between 10 and 14 years
* provided written parental consent

Exclusion Criteria:

* Intellectual disability or physical limitations precluded the use of the computer program
* Had a major mental health disorder
Detection of Group A Streptococcus (GAS) in Oral Cavity

The investigators intend to screen children who are suspected of having GAS tonsillitis. From each child we will take a throat culture and saliva sample to screen for molecular evidence of GAS.


Eligibility Criteria:
Inclusion Criteria:

* clinical evidence of GAS tonsillitis
* healthy, no chronic illness
* not a GAS carrier

Exclusion Criteria:

* GAS carrier
* Active background disease
Effect of Hydroxyurea as Treatment for Primary Desmoid Tumors

The purpose of this study is to examine the response rate of desmoid tumors to hydroxyurea. The investigators hypothesize that hydroxyurea will be a safe, non-toxic alternative to aggressive surgery or chemotherapy for this difficult to treat tumor.

The treatment of desmoid tumors is complicated by benign histology and potentially aggressive and recurrent behavior. Invasive or intensive treatments with surgery or radiation therapy can lead to good tumor control, but at the expense of significant side effects along with a high risk of local recurrence after surgical excision. Low dose regimens of standard chemotherapy drugs have been favored as a conservative first-line treatment; however, refractory and recurrent tumors are not uncommon. The purpose of this study is to investigate the efficacy and safety of using hydroxyurea, an anti-neoplastic agent with relatively few side-effects, as a novel treatment for primary, unresectable desmoid tumors, desmoid tumors that have had an incomplete primary resection, or desmoid tumors that have recurred after other therapy.

Patients presenting to our oncology center with a new diagnosis of desmoid tumor, or a recurrent desmoid tumor, will be eligible for this study. After informed consent, physical examination, and baseline imaging studies (CT/MRI), patients will receive oral hydroxyurea at a starting dose of 20 mg/kg daily. Laboratory tests will be performed at set intervals to maintain the appropriate dose and monitor for cytopenias. Clinical evaluations, physical examinations, and/or imaging studies will be conducted every three months to assess for changes in tumor size. Patients will remain on hydroxyurea as long as there is a response or stability in tumor size and associated toxicities are manageable. Data will be collected regarding the response to the drug, the duration of the response, and the occurrence of adverse events. The goal of the analysis will be to determine the efficacy of hydroxyurea as a treatment modality for desmoid tumors.

Eligibility Criteria:
Inclusion Criteria:

* Patients \</= 21 years of age will be eligible
* Histologically-confirmed diagnosis of desmoid tumor
* Measurable disease
* Stable hematologic, renal and hepatic parameters
* Negative pregnancy test for women of childbearing potential

Exclusion Criteria:

* Presence of a second neoplastic process
* Pregnant or breastfeeding women, fetuses, and prisoners will not be included in this study
* Patients receiving additional treatment for tumor other than pain control
* Patients having taken an investigational drug within the past 30 days
Study of Admission Versus Discharge After Transient Ischemic Attack (TIA)

Evaluate for difference in outcome between hospital admission versus discharge after recent TIA, and evaluate feasibility of a larger study.

20 patients will be randomized within 24 hours of a TIA to be admitted to the hospital or discharged to home, and the investigator will compare outcomes, cost, and evaluate the feasibility of a larger study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older.
* Clinical diagnosis of TIA within 24 hours of consent.

Exclusion Criteria:

* Crescendo TIAs, defined as multiple within 24 hours of presentation.
* Posterior circulation TIAs diagnosed clinically by a member of the Stroke Team.
* High grade carotid stenosis.
* Any compelling medical reason they should or should not be admitted or discharged (for example decompensated congestive heart failure, unstable angina, new EKG changes, pneumonia, sepsis). Patients will only be enrolled if the only consideration for admission is the TIA, and they otherwise meet appropriate standard of care criteria for discharge to home.
* Patients will be excluded if no one can be with them for the next 12 hours to ensure a rapid call to 911 should problems arise, specifically stroke.
Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia

This is a study where there are no interventions planned. Investigators will only collect data already in the patient's history and analyze it. Particularly, we are interested in molecular data from AML patients.

This means that patients will follow their regular diagnostic and clinical practice. The analyses will be conducted according to the routine diagnostic and clinical practice as well and no additional blood withdrawal will be performed.

The study will be conducted as follows:

1. Retrospective phase clinical and molecular data of patients analyzed for IDH1/2 mutations will be retrospectively collected in the centers that have already introduced IDH1/2 mutational screening in their practice from cases collected according to standard procedure (Ficoll and lysis in RLT buffer).
2. Prospective phase: each participating center already performing IDH1/2 mutational status on samples of their AML patients at diagnosis or relapse - on freshly isolate mononuclear cells from bone marrow and/or peripheral blood using Ficoll density gradient preparation - will prospectively collect the clinical and molecular data.

Eligibility Criteria:
Inclusion criteria:

* Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable);
* AML patients;
* Age ≥18;
* IDH mutation test performed at diagnosis or relapse until January 31st, 2019.

Exclusion criteria:

* AML M3 subtype according to the FAB classification;
Small Bowel Obstruction and Surgery

Postoperative management after small bowel obstruction (SBO) surgery is not consensual and better knowledge of risk factors for postoperative morbidity could help to add evidence of the feasibility of enhanced recovery programs (ERPs).

In elective surgery, ERPs have shown a significant benefit for the patient but this is not performed routinely in emergency surgery due to the difficulty to avoid postoperative nasogastric tube.

The aim was to identify risk factors for postoperative morbidity and for nasogastric tube (NGT) replacement after SBO surgery.


Eligibility Criteria:
Inclusion Criteria:

* Surgical management of Small bowel obstruction due to adhesions

Exclusion Criteria:

* obstruction not caused by single band adhesion
* matted adhesions, or if they were less than 18 years old
Does the Hematopoietic Stem Cell Govern Residual Inflammatory Cardiovascular Risk in Type 2 Diabetes

To study the effect of type 2 diabetes (T2D) on vascular wall inflammation and hematopoietic stem cell composition in vivo, and whether these changes can be reversed with glucagon like peptide 1 receptor (GLP1R)-agonism.

We will use 68Ga-Dotatate PET/CT scans, bone marrow aspirations and peripheral blood analyses to determine the effect of type 2 diabetes on vascular wall inflammation, and hematopoietic stem cell composition, and whether these changes can be reversed using high dose semaglutide treatment, up to 2.0mg subcutaneously per week, for a period of six months.

Eligibility Criteria:
Inclusion Criteria:

* Age \>50 years old
* Diagnosed with type 2 diabetes
* HbA1c \>64mmol/mol

Exclusion Criteria:

1. (History of) malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.
2. Chronic or recent infections and/or clinical signs of infection and/or a plasma C-reactive protein above 10ng/ml
3. Auto-immune diseases (including type 1 diabetes)
4. Recent or chronic immunosuppressant or antibiotic usage
5. Use of any GLP1R-agonist at baseline or prior intolerance to use of GLP1R-agonists.
6. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
7. Uncontrolled hypertension (systolic blood pressure \> 180mmHg, diastolic blood pressure \> 100mmHg)
8. Uncontrolled chronic inflammatory conditions, including gout.
9. Women of childbearing age who are not using effective contraceptives.
10. Heart failure New York Heart Association (NYHA) class IV at screening visit.
11. Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) ≥ 2 times the upper limit of normal (ULN) at screening visit.
12. Pancreatitis in medical history.
Mastiha or Mastiha Water in Functional Dyspepsia

The main aim of this study is to establish whether Mastiha products ameliorate functional dyspepsia symptoms.

Functional dyspepsia has an approximate prevalence of 20% and is one of the main causes of upper abdominal discomfort. Its pathogenesis remain unclear and therapeutic options remain limited with patients seeking alternative therapies in herbal remedies. Mastiha has been proven to significantly improve symptoms in patients with functional dyspepsia compared to placebo. In the present study, the investigators aim to determine whether Mastiha capsules or Mastiha water have a better effect on the improvement of functional dyspepsia symptoms. Therefore, the investigators designed a randomized, three-way cross-over clinical trial. Fifty patients with functional dyspepsia, will be randomized over three treatment sequences of 30 days each, separated by 14-day washout periods. The three treatments will be: Mastiha capsules, Mastiha water or Mastiha free treatment. The primary outcome, which will be assessed by intention to treat, will be the Leuven Postprandial Distress Scale, a validated instrument for the assessment of symptoms in functional dyspepsia, supported by the European Medicines Agency.

Eligibility Criteria:
Inclusion Criteria:

functional dyspepsia diagnosis according to

* Rome criteria
* negative urea breath test for Helicobacter pylori
* upper gastrointestinal tract endoscopy with biopsy

Exclusion Criteria:

* organic diseases, such as peptic ulcer, gastrointestinal neoplasms, gastroesophageal reflux, irritable bowel syndrome
* pregnancy or lactation
* history of abdominal surgery or actinotherapy
* mental illness
* Severe impairment of heart, liver, or kidney function or respiratory function
* Alcohol overuse
Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2)

Multicenter, phase III, randomized, blinded, controlled, parallel group.

This is a 24-week, multicenter, phase III, randomized, blinded, controlled, parallel group with a 24-week treatment period to evaluate the efficacy and safety of LYR-210 compared with sham control for treatment in adults with CRS.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Diagnosed as having CRS
* Bilateral ethmoid disease confirmed on CT
* Mean 3 cardinal symptom (3CS) score
* Undergone at least 2 trials of medical treatments in the past
* Has been informed of the nature of the study and provided written informed consent
* Agrees to comply with all study requirements
* If currently on a waiting list for sinonasal surgery, willing to be removed from the waiting list or have preplanned surgery date cancelled for the duration of the study. \[Note: this does not preclude a participant from receiving or being recommended for sinonasal surgery as rescue treatment during the study\].

Exclusion Criteria:

* Inability to tolerate topical anesthesia
* Previous nasal surgery
* Presence of nasal polyp grade 2 or higher
* Seasonal allergic rhinitis
* Perennial rhinitis with symptoms that are well controlled by regular use of intranasal corticosteroids
* Severe asthma
* History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, atrophic rhinitis, or odontogenic sinusitis
* Obstruction preventing proper placement and retention of LYR-210 as seen on endoscopy
* Anatomic variation that, in the opinion of the investigator, would adversely impact placement of LYR-210 as seen on CT
* Known history of hypersensitivity or intolerance to corticosteroids
* Known history of hypothalamic pituitary adrenal axial dysfunction
* Previous pituitary or adrenal surgery
* Dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
* Past or present acute or chronic intracranial or orbital complications of CRS
* History or diagnosis (in either eye) of glaucoma or ocular hypertension
* Past or present functional vision in only 1 eye
* Past, present, or planned organ transplant or chemotherapy with immunosuppression
* Currently positive for COVID-19 or residual sinonasal symptoms from a previous COVID-19 infection
* Pregnant or breast feeding. Females of child-bearing potential must test negative for pregnancy at the time of screening
* Evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments
* Currently participating in an investigational drug or device study
* Determined by the investigator as not suitable to be enrolled
Comparing Wound Area Reduction of Non-healing DFUs Using MolecuLight i:X Versus Standard of Care

This is a 12 week, randomized controlled trial. There are 2 arms and 20 patients with non healing diabetic foot ulcer allocated in each arm. One arm receives i:X guided treatment and the other arm receives standard of care treatment. Our primary objective is to compare the wound area reduction in both arms.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients presenting with chronic DFU
* The chronic DFU has a surface area that has reduced \<25% in the previous 4 weeks1 prior to first study visit
* Patient has been receiving treatment for their DFU for less than 12 weeks.
* The chronic DFU is \> 1 cm2 in area and less than 15 cm in length (max. diameter)
* 18 years or older
* Willing and able to make all required study visits

Exclusion Criteria:

* • Patients categorized as having a maintenance wound

  * Use of skin substitutes or hyperbaric oxygen therapy or surgical intervention
  * Treatment with an investigational drug within 1 month of enrolment
  * Presents with chronic (\>10 mg/kg for \>30 days) systemic corticoids before enrolment
  * Has ABI \<0.5 (measured within 3 months of randomisation)
  * Undergoing chemotherapy or is immunocompromised
  * Diagnosed with Charcot disease or ulcers from electrical, chemical or radiation burns, or presents with collagen vascular disease, ulcer malignancy, untreated osteomyelitis or cellulitis
  * Recombinant or autologous growth factors or skin/dermal substitutes within 30 days of enrollment
  * Inability or unwillingness to consent
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of SHR-2173 in Patients With Systemic Lupus Erythematosus

To investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple subcutaneous injections of SHR-2173 in patients with systemic lupus erythematosus (SLE).


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years, regardless of gender;
2. Weight ≥45.0 kg at screening;
3. Confirmed SLE diagnosis for ≥12 weeks at screening.

Exclusion Criteria:

1. Pregnant or breastfeeding women, or those with a positive human chorionic gonadotropin (HCG) test.
2. History of alcohol abuse or illegal drug use within one year prior to screening.
3. Blood donation ≥450 mL within 8 weeks prior to screening or plans to donate blood during the study.
4. Current active infection or a history of active tuberculosis
5. Other inflammatory or autoimmune diseases beyond SLE and LN that may interfere with the interpretation of trial results or clinical assessment.