cyrilzakka/clinical-trials huggingface dataset:
Lippia Alba for Migraine Prophylaxis and Treatment

Abstract Background: There is no universally accepted and effective prophylaxis of migraine headache episodes. Thus the investigators aimed to investigate the effects of Lippia alba (Mill.) N. E. Brown, an herb with many effects on central nervous system, on pain frequency and intensity of migraine patients.

Methods: Patients were enrolled in a prospective, phase 2, non-controlled cohort study to orally receive ethanolic extract of L. alba leaves (1-2 drips/kg/day). Headache intensity and frequency of episodes were recorded before and after 30-60 days of treatment. The investigators also studied the chemical composition of its essential oil by gas chromatography-mass spectrometry.

Results: The investigators described for the first time a particular L. alba chemotype with geranial and carvenone as major compounds. With treatment, both frequency and intensity of pain episodes significantly decreased from baseline to first reassessment date. More than 80% of patients experienced a minimum 50% reduction on pain intensity and frequency. No side effects were reported.

Conclusions: Treatment with a geranial plus carvenone chemotype of L. alba ethanolic extract is a cheap, widely available, highly effective therapy to reduce both the intensity and the frequency of headache episodes of migraine patients with no side effects.

Keywords: headache, migraine, medicinal plant, essential oil, phytotherapy


Eligibility Criteria:
Inclusion Criteria:

* Migraine diagnostic

Exclusion Criteria:

* Patient's request
Two-dimensional Shear-Wave Elastography Evaluate Esophageal Varices Bleeding Risk of Liver Cirrhosis

The purpose of this retrospective study was to investigate the diagnostic performance of 2D-SWE for predicting the presence of esophageal varices and high-risk varices in patients with liver cirrhosis.

Variceal bleeding is a fatal complication in patients with liver cirrhosis. A screening esophagogastroduodenoscopy (EGD) is recommended in all patients with cirrhosis to identify those patients at risk of variceal bleeding. However, this technique is invasive, uncomfortable and costly. Moreover, with the development of noninvasive technology for early diagnosis of liver cirrhosis, half of these patients will not develop varices within 10 years and therefore will undergo unnecessary EGD screening. Thus, the need for noninvasive screening methods for varices in patients with cirrhosis is urgent.

2D-SWE is a promising new type of shear wave-based ultrasound technique for measuring LS. The shear waves are generated directly within the tissue by acoustic radiation force impulse, allowing the measurement of stiffness in patients with ascites. In addition, the LS values can be obtained on the basis of anatomic information to avoid major vessels and control major measurement bias. 2D-SWE has been reported to have high reliability and reproducibility in assessing liver stiffness. Several studies compared TE with 2D-SWE in predicting fibrosis stages and portal hypertension, which suggested that 2D-SWE has a higher technical success rate and a better diagnostic value for portal hypertension than TE.The purpose of this retrospective study was to investigate the diagnostic performance of 2D-SWE for predicting the presence of esophageal varices and high-risk varices in patients with liver cirrhosis.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis were diagnosed by liver biopsy, CT and ultrasound before enrolled
* Age was 16-80

Exclusion Criteria:

* With bleeding history
* With EVL history, BRTO or TIPS history
* With NSBB history
* With ascites
* With splenectomy or splenic embolism, history
* With liver cancer
Granisetron Versus Ondansetron for Nausea and Vomiting in Pediatric Age Group

The current clinical trial will include 160 children who will be presented with vomiting to the Outpatient Department of the Children's Hospital, Faculty of Medicine, Ain Shams University. Participants will be assigned randomly to receive either a dispersible film Ondansetron or oral Granisetron. After initial assessment, both groups will be followed up after 6 and 48 hours to check the frequency of vomiting, diarrhea, fever, headache as well as the return of appetite and the need for further treatment. The impact of nausea and vomiting on patients' daily lives will be assessed using a modified version of the Functional Living Index-Emesis (FLIE).


Eligibility Criteria:
Inclusion Criteria:

• Patients presenting with vomiting within the past 24 hours, including patients without dehydration and those who have mild to moderate dehydration.

Exclusion Criteria:

* Patients who are severely dehydrated.
* Patients who have bloody vomiting.
* Children with chronic diseases like type 1 diabetes mellitus, end stage renal disease and who are receiving chemotherapy.
* Patients who have vomiting due to surgical causes like intestinal obstruction.
Treatment of Infected Pulp in Primary Teeth With a Mixture of Calcium Hydroxide and Gingerols

This study was conducted to evaluate Calcium Hydroxide mixed with Gingerols versus Metapex in treatment of primary teeth with infected necrotic pulp

Study compare Calcium Hydroxide mixed with Gingerols versus Metapex in treatment of primary teeth with infected necrotic pulp clinically and radiographically

Eligibility Criteria:
Inclusion Criteria:

1. The cooperation of the child and parents, during the treatment plan, and the commitment to attend the follow-up appointments.
2. Parents signed the consent to participate in the study.
3. Absence of any systemic disease, which would contraindicate pulp therapy.
4. Child didn't have any history of a sensitive reaction to any component of used materials.
5. Present half to two third of tooth root or more
6. Root with signs or symptoms of infected necrotic pulp or chronic abscess, with or without sinus tract, soft tissue swelling, mobility or tenderness to percussion, and internal or external root resorption or unsuccessful past pulp treatment.

Exclusion Criteria:

All that does not correspond to inclusion criteria.
Efficacy and Safety of Tenalisib (RP6530), in Patients With Locally Advanced or Metastatic Breast Cancer

Phase II, randomized, open-label study, designed to evaluate the preliminary efficacy and safety of tenalisib at two dose levels in 40 patients with locally advanced or metastatic breast cancer.

The study will have two groups, Group 1 with a treatment option of 800mg RP6530 BID and Group 2 with a treatment option of 1200mg RP6530 BID, where the subjects will be randomly assigned to each group in 1:1 and continued on each group of treatment till disease progressed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be ≥18 years of age, at the time of signing informed consent.
2. Female patients who have histologically and/or cytologically confirmed locally advanced or metastatic breast cancer that has progressed following at least one line of therapy.
3. Patients with at least one measurable lesion per RECIST version 1.1 at baseline that can be accurately assessed by CT scan or MRI and is suitable for repeated assessment at follow up-visits.
4. ECOG performance status 0 to 2.
5. Life expectancy of at least 3 months.
6. Adequate bone marrow, liver, and renal functions
7. Female patients of childbearing potential should be willing to use a medically acceptable method of contraception

Exclusion Criteria:

1. Patients with HER-2 positive breast cancer.
2. Patients receiving anticancer therapy within 4 weeks or 5 half-lives of the drug prior to C1D1, whichever is shorter.
3. Patient who has not recovered from acute toxicities (defined as NCI-CTCAE grade \> 1) of previous therapy except treatment-related alopecia.
4. Patients who have had disease progression within 8 weeks of platinum chemotherapy.
5. Prior exposure to investigational or marketed PI3K inhibitors given for the treatment of breast cancer.
6. Major surgery within 4 weeks of starting study treatment OR any patient who has not recovered from the effects of major surgery.
7. Patient with symptomatic uncontrolled brain metastasis.
8. HIV-positive patients who are on antiretroviral therapy OR active hepatitis C OR active hepatitis B virus infections.
9. Ongoing immunosuppressive therapy including systemic corticosteroids except as allowed per concomitant medication.
10. Known history of severe liver injury as judged by the investigator.
11. History of severe cutaneous reactions in the past.
12. Active gastrointestinal tract disease with malabsorption syndrome or uncontrolled inflammatory gastrointestinal disease such as Crohn's disease or ulcerative colitis.
13. Pregnancy or lactation.
14. Patient with other active malignancies at the time of screening.
Hyzaar Asia HEAALTH (0954A-950)

The objective of the study is to estimate the percentage of patients who reach blood pressure goal after 8 weeks of treatment with losartan/HCTZ combination.


Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female and = 18 years of age
* Patients with essential hypertension previously treated with antihypertensive medications for at least 4 weeks but did not reach the blood pressure goal

Exclusion Criteria:

* History of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient/subject to participate
* Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study
* Previous history of severe essential hypertension
* History of stroke or myocardial infarction (heart attack)
* Evidence of renal or liver disease
* Uncontrolled diabetes mellitus
* Any known bleeding disorder
* Known sensitivity or intolerance to the study medication (losartan or hydrochlorothiazide)
* Other antihypertensive medications or medications that may affect blood pressure
Immunodeficiency in Cartilage-hair Hypoplasia: Sub-project on Safety of Vaccination Against Chickenpox

The investigatoris will carefully select cartilage-hair hypoplasia patients unexposed to varicella (VZV) and immunize patients in a controlled manner with VZV vaccine. Patients will be selected on the basis of disease severity and the degree of immunodeficiency (including CD4+ T-cell counts). Any potential complication of VZV immunization, such as rash, will be discussed with the patients/caregivers beforehand and acyclovir will be used to treat any VZV related symptoms, consistent with the current practices. The investigators will verify the development of immune response to vaccination by testing for VZV antibodies and cell-mediated immunity.


Eligibility Criteria:
Inclusion Criteria:

* genetically confirmed cartilage-hair hypoplasia diagnosis
* age \>12 months
* no history of chickenpox
* informed concent of the patient/caregiver.

Exclusion Criteria:

* positive serum IgG for varicella zoster virus
* low CD4+ cell counts (\<15% or \<200 cells/mm3)
* clinical or laboratory signs of severe immunodeficiency
* ongoing intravenous or subcutaneous immunoglobulin treatment
A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses and Multiple Doses of NNC0165-1562 in Overweight to Obese But Otherwise Healthy Subjects

This trial is conducted in the United States of America. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) for single doses and multiple doses of NNC0165-1562 in overweight to obese but otherwise healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Part I (SD):
* Male, aged 18-55 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 25.0 and 34.9 kg/m\^2 (both inclusive). Overweight should be due to excess of adipose tissue, as judged by the investigator
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator
* Part II (MD):
* Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 27.0 and 39.9 kg/m\^2 (both inclusive). Overweight should be due to excess of adipose tissue, as judged by the investigator
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

* Any clinically significant weight change (at least 5% self-reported change during the previous 3 months), dieting attempts (e.g. participation in an organised weight reduction programme within the last 3 months), prior obesity surgery, or medications affecting body weight within 3 months prior to screening
* Male subjects who are not surgically sterilised (vasectomy) and are sexually active with female partner(s) who are not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product
* Female subjects who are of child bearing potential (pre-menopausal and not surgically sterilised) and are sexually active with male partner(s) who are not surgically sterilised (vasectomy) and are not using highly effective contraceptive methods (Pearl Index 1%,such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide) combined with a highly effective method of contraception for their male partner(s) (e.g. condom with spermicide), and/or are pregnant, breast-feeding or intend to become pregnant) (applicable to Part II (MD) only)
HEPSERA Post Marketing Surveillance

An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of adefovir dipivoxil administered in Korean CHB patients according to the prescribing information

This study is a post-marketing surveillance to monitor safety and efficacy of adefovir dipivoxil and identify SAEs, adverse drug reactions (ADRs), and unexpected AEs not described as precautions or warnings and to identify possible factors that have an effect on the AEs and to assess effectiveness of adefovir dipivoxil in real clinical practices after marketing. The subjects are patients prescribed for adefovir dipivoxil by the investigators at the sites based on prescription information in normal clinical practices.

Eligibility Criteria:
Inclusion Criteria:

* Patients administrated adefovir dipivoxil at the site

Exclusion Criteria:

* Patients administrated adefovir dipivoxil before center initiated date
A Clinical Trial to Assess the Clinical Benefit of SSR411298 as Adjunctive Treatment for Persistent Cancer Pain

The primary objective of this study is to evaluate the efficacy of SSR411298 200 mg daily compared to placebo as adjunctive treatment for persistent cancer pain based on Numeric Rating Scale (NRS).

Secondary Objectives are:

* To evaluate the effect of SSR411298 200 mg daily on pain, breakthrough pain frequency, background therapy utilization, mood, patient satisfaction of pain relief, nausea, constipation, healthcare utilization and quality of life;
* To evaluate the tolerability and safety of SSR411298 as adjunctive treatment for persistent cancer pain;
* To characterize patient disease, in terms of cancer, cancer treatment, cancer pain and cancer pain treatment;
* To evaluate the pharmacokinetic (PK) exposure of SSR411298 as adjunctive treatment for persistent cancer pain;
* To assess endocannabinoid plasma concentrations.

The total study duration for a participant is 6 weeks (1-week screening, 4-week treatment and 1-week post-treatment follow-up).

Participants continue to receive WHO Step 2 or 3 cancer pain treatment as background therapy.

Eligibility Criteria:
Inclusion criteria:

Patient with moderate or severe, persistent cancer pain who is receiving the World Health Organization (WHO) Step 2 or 3 cancer pain treatment:

* Pain generator (source of pain) must be primarily due to underlying cancer or cancer treatment;
* Pain generator (source of pain) must be classified as either primarily nociceptive or primarily neuropathic;
* Pain severity must be moderate or severe with an average NRS score ≥4 during the screening week.

Exclusion criteria:

* Instability of pain during the screening week;
* Use of prohibited adjuvant pain treatment in the week prior to study entry or plan to use these medications during the study;
* Current use of medication containing tetrahydrocannabinol (THC);
* Chemotherapy within 4 weeks before study entry or chemotherapy planned during the study (a stable regiment of hormonal therapy is permitted);
* Radiotherapy within 4 weeks before study entry or radiotherapy planned during the study (hemostatic palliative radiotherapy is permitted);
* Cancer related surgery within 4 weeks before study entry or cancer-related surgery planned during the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exhaled Nitric Oxide as a Biomarker of Disease Activity in Eosinophilic Esophagitis

There is currently no reliable, noninvasive biomarker for eosinophilic esophagitis (EoE), a chronic allergic diseases characterized by significant infiltration of eosinophils in the esophagus. Because eosinophils release nitric oxide, levels of exhaled nitric oxide (FeNO) are used routinely for guiding treatment in subsets of patients with asthma. FeNO levels are also elevated in immunological diseases that do not involve the airways. The investigators hypothesize that patients with EoE have elevated nitric oxide concentration in their exhaled breath and that changes in FeNO levels could be used to measure disease activity. The objective of this study is to determine the feasibility of using FeNO as a noninvasive surrogate marker for EoE disease activity. The investigators propose to measure serial exhaled nitric oxide (FeNO) levels on a group of patients with confirmed EoE, before, during and after the course of topical corticosteroid therapy to determine whether the level declines from pre-treatment level in individual patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 7-65.
* Confirmed diagnosis of EoE. The diagnosis of eosinophilic esophagitis is based upon the presence of characteristic clinical features and large numbers of eosinophils in the esophagus on pathologic examination (≥15 eosinophils per high powered \[400x\] field in at least one specimen) despite acid suppression with a PPI for one to two months. The criteria also include normal gastric and duodenal mucosal biopsies and the exclusion of other causes. Clinical features in adults include dysphagia, pain and/or history of food impaction. Symptoms in children vary depending in part upon their age: feeding disorders (median age 2.0), vomiting (median age 8.1), abdominal pain (median age 12.0), dysphagia (median age 13.4), and food impaction (median age 16.8).

Exclusion Criteria:

* Use of systemic or inhaled corticosteroids in the preceding 3 months.
* History of doctor-diagnosed asthma, acute or chronic rhinosinusitis.
* History of cirrhosis.
* History of kidney, heart or lung disease.
* Pregnancy
Safety and Feasibility of Argatroban As Anticoagulant in Adults with ECMO

This prospective, randomized, controlled pilot trial aims to assess the safety and feasibility of Argatroban as an alternative anticoagulant to unfractionated heparin in patients receiving extracorporeal membrane oxygenation.


Eligibility Criteria:
Inclusion Criteria:

* Minimum Age 18 years
* VV- or VA-ECMO therapy
* Minimum of 24h planned ECMO-therapy

Exclusion Criteria:

* History of Heparin-induced thrombocytopenia (HIT)
* High risk of bleeding, contraindication for anticoagulation (eg. active GI-bleeding, Intracerebral bleeding; Platelet count \<50G/l, congenital bleeding disorder)
* Pregnancy
* Severe Liver disease (SOFA score liver domain 4 points = Bilirubin \>12mg/dl)
* Postoperative admission
* Strong lupus anticoagulant or acquired intrinsic clotting factor deficiency at admission (APTT \>50 sec without anticoagulation).
Diagnostic Performance of PET/CT-PSMA in Patients With Non-prostatic PSMA-expressing Neoplasms

Study to collect data from PET/CT-PSMA performed in patients with neoplasms expressing PSMA, other than prostate cancer.

Objectives The primary objective is to evaluate the diagnostic performance of PET/CT-PSMA in the staging and management of patients with non-prostatic neoplasms expressing PSMA.

The secondary objective is to analyze the prognostic value of PET-PSMA in such neoplasms and the possible use in the selection of patients eligible for target therapies against neovascularization (i.e. monoclonal anti-VEGF antibodies) and radiopharmaceutical treatments (i.e. 177Lu-PSMA).

Purpose of the register: This single-centre observational register is intended to collect data from PET/CT-PSMA performed in patients with neoplasms expressing PSMA, other than prostate cancer.

Design of the register: observational, pharmacological, non-profit, prospective, monocentric.

Duration of the record: The expected duration for the collection of PET/CT-PSMA examinations is 10 years.

Objectives The primary objective of the following registry is to evaluate the diagnostic performance of PET/CT-PSMA in the staging and management of patients with non-prostatic neoplasms expressing PSMA.

The secondary objective is to analyze the prognostic value of PET-PSMA in such neoplasms and the possible use in the selection of patients eligible for target therapies against neovascularization (i.e. monoclonal anti-VEGF antibodies) and radiopharmaceutical treatments (i.e. 177Lu-PSMA).

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with a neoplasm other than prostate carcinoma who are referred to our unit as part of the standard care pathway to undergo a PSMA PET/CT scan for staging, restaging, and pre- and post-treatment evaluation
* Signed informed consent for the collection and processing of data
* Minimum age 18 years old."

Exclusion Criteria:

* pregnancy
Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C

This Phase 2 study was intended to demonstrate superiority of sotagliflozin versus placebo on Hemoglobin A1C (A1C) reduction at Week 12 in young adult participants with type 1 diabetes mellitus (T1DM) who have poor glycemic control on their current insulin regimen.


Eligibility Criteria:
Inclusion Criteria:

* Participant had given written informed consent.
* Young adult participants \>=18 to \<=30 years old at Screening, with a confirmed diagnosis of T1DM made at least 1 year prior to informed consent.
* Participants were being treated with insulin or insulin analogue delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).
* At Screening, must had A1C \>= 9.0%.
* Must be willing and able to perform self-monitored blood glucose (SMBG) and complete the study diary.
* Females of childbearing potential must use an adequate method of contraception and had a negative pregnancy test.

Exclusion Criteria:

* Any prior use of LX4211/sotagliflozin.
* Use of antidiabetic agent other than insulin or insulin analogue at the time of screening.
* Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to start of the placebo Run-in Period.
* Chronic systemic corticosteroid use.
* Type 2 diabetes, or severely uncontrolled diabetes mellitus as determined by the Investigator.
* History of diabetic ketoacidosis (DKA) or nonketotic hyperosmolar state within 6 months prior to the Screening Visit.
* History of severe hypoglycemic event within 1 month prior to the Screening Visit.