cyrilzakka/clinical-trials huggingface dataset:
The Evaluation of Pro/Antioxidative Profile and Diagnostic Parameters in the Patients With Pancreatic Disease

The study aims to assess and analyze some selected antioxidants and laboratory parameters during hospitalization of the patients with acute pancreatitis. It will allow to better understanding of the mechanisms of disease and the development of better diagnostic, treatment and monitoring.

It is an observational diagnostic study and does not involve any additional administration of medicinal substances, modification of treatment or dropping the use of routine methods of treatment of a disease. The study procedure includes detailed personal medical history as separate document like as a routine medical interview, and three times taking a small amount of venous blood (together about 15 ml), in the first, third, and seventh day of hospitalization (in the case of longer hospital treatment).


Eligibility Criteria:
Inclusion Criteria:

* The patients were classified into the group of patients with acute pancreatitis (AP) due to clinical symptoms (acute onset of a persistent, severe, epigastric pain with tenderness on palpation on physical examination), personal interview and clinical method used in the diagnosis of pancreatitis - laboratory tests (elevation in serum lipase or amylase to three times or greater than the upper limit of normal) and characteristic findings of acute pancreatitis on imaging (contrast-enhanced computed tomography (CT), magnetic resonance imaging (MRI) or transabdominal ultrasonography). In patients with characteristic abdominal pain and elevation in serum lipase or amylase to three times or greater than the upper limit of normal, no imaging was required to establish the diagnosis of acute pancreatitis. In patients with abdominal pain that was not characteristic for acute pancreatitis or serum amylase or lipase levels that were less than three times the upper limit of normal, or in whom the diagnosis was uncertain, the investigators performed abdominal imaging with a contrast-enhanced abdominal CT scan to establish the diagnosis of acute pancreatitis and to exclude other causes of acute abdominal pain. In patients with severe contrast allergy or renal failure, the investigators performed an abdominal MRI without gadolinium.
* The volunteers classified as healthy based on the research conducted by clinicians of primary medical care (control group)

Exclusion Criteria:

* other accompanied diseases than acute pancreatitis (the patients groups)
* Individuals of the control group with diagnosed disease as well as alcohol and drugs abusers
The Utility of Thromboelastography in Cirrhotic Patients Undergoing Endoscopic Procedures

Cirrhosis results in decreased synthesis of both procoagulants and anticoagulants resulting in "rebalanced homeostasis". However, conventional blood tests (platelets/ INR levels) that are performed prior to invasive procedures do not accurately reflect the coagulation changes that occur in cirrhotics, resulting in unnecessary transfusion of blood products. Thromboelastography (TEG) is a global hemostasis assessment tool that is being used in surgery (including liver transplant) to help guide blood product transfusion in the operating room. The investigators would like to compare the use of TEG vs. INR/platelets to help guide blood product transfusion in cirrhotic patients undergoing inpatient endoscopy. The investigators will evaluate to see if there is a decrease in prophylactic blood transfusions prior to endoscopy when using TEG.


Eligibility Criteria:
Inclusion Criteria:

* All 18 yo + cirrhotic patients who are being scheduled for inpatient endoscopy

Exclusion Criteria:

* Patients on blood thinners (prophylactic anticoagulation is permissible)
* Hemodynamically unstable patients requiring pressors (ie ICU level patients)
* Pregnant or lactating individuals
* Inability to provide consent for any reason
Ph+/Bcr-Abl+ ALL Imatinib and Nilotinib Rotational Study

This study is an open-label, multicentric, exploratory, single arm, phase II study of adults who are either more than 60 years old, or are unfit for intensive chemotherapy and allo SCT. The patients are treated with NILOTINIB, administered orally twice daily, for 6 weeks (Course A) followed by IMATINIB, administered orally twice daily, for other 6 weeks (Course B).The courses will be repeated (rotated) for a total of 4 times or until relapse, or until it is in the interest of the patients. Prednisone (P) will be administered to all patients for 7-14 days, before TKIs, so as to make it possible to wait for the results of cytogenetic and molecular tests, and to evaluate the response to P alone, hence for another 21 days. Intrathecal therapy (IT) with MTX/AraC/DEX is mandatory, monthly, in patients without clinical-cytologic evidence of meningeal involvement, while in patients with CNS involvement it is performed twice weekly until clearance of leukemic cells, hence once weekly. IM will be administered at the dosage of 600 mg daily (300 mg twice daily) and Nilotinib at the dosage of 800 mg daily (400 mg twice daily) in all courses.

All patients are scheduled to receive at least 4 courses of either drugs, for a total of 4 courses (4 x 6 = 24 weeks). After 4 courses, patients are either allowed to continue the treatment until relapse or progression, if it is in their interest, or to discontinue the treatment and receive other therapies.


Eligibility Criteria:
Inclusion Criteria:

* Previously untreated Ph+ ALL more than 60 years old or more than 18 years old, but unfit for program of intensive therapy and allogeneic SCT
Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules

This study is a randomized, double blind, double dummy, multicenter, parallel controlled clinical trial, the investigators objective is to evaluate the efficacy and safety of Qizhi Weitong granules in the treatment of functional dyspepsia.

This study is a randomized, double blind, double dummy, multicenter, parallel controlled clinical trial, the investigators objective is to evaluate the efficacy and safety of Qizhi Weitong granules in the treatment of functional dyspepsia. The experiment will be carried out in 8 sub centers at the same time, and the investigators estimated that there will be 384 cases of income, including the experimental group and the control group (n = 192), and the investigators choose mosapride citrate tablets for drug control.

Eligibility Criteria:
Inclusion Criteria:

1. Metting the diagnostic criteria of functional dyspepsia in Rome IV.
2. The subjects were informed, and the subjects voluntarily signed informed consent.
3. The subjects have reading ability.

Exclusion Criteria:

1. Patients suffering from gastric ulcer, gastroscopy see bleeding and mucosal erosion, pathological examination showed atrophy of gastric mucosa, intestinal metaplasia or dysplasia.
2. Patients with Hp infection positive.
3. Patients with gastroesophageal reflux disease.
4. Patients with digestive system organic lesions.
5. The patient had a history of stomach or abdominal surgery.
6. Patients had taken the relevant drugs in the past 2 weeks.
7. Patients suffering from severe illness affecting survival.
8. Pregnant or lactating women.
9. Participating in clinical trials of other drugs.
10. Long term using of sedative hypnotics.
11. Suspected or true alcohol, drug abuse history.
A Prospective, Phase IV, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice

The purpose of this registry study is to gather safety information on the current clinical use of and the safety of DEFINITY®


Eligibility Criteria:
Inclusion criteria

* Patients who, in the investigator's opinion, require DEFINITY® echocardiography due to suboptimal, unenhanced images.

Exclusion criteria

* Known hypersensitivity to perflutren, DEFINITY®, or other echo contrast agent.
* Prior SAE associated with perflutren, DEFINITY®, or administration of other echo contrast agent.
Trial to Assess Implementation of New Research in a Primary Care Setting (TRAINS)

In England and Wales, unscheduled care for school-aged children with asthma significantly increases after their return to school in September, a trend linked with decreased asthma preventer prescriptions during the summer holidays. The PLEASANT study found that a reminder letter from GPs to parents of children with asthma led to a 30% increase in prescription uptake during August and reduced unscheduled medical visits from September to December.

The TRAINS trial will now assess if informing GPs of PLEASANT findings would lead to its implementation. This pragmatic cluster randomised implementation trial will use routine data from Clinical Practice Research Datalink (CPRD).


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria of practices Practices inclusion criteria

  1- General practices who are currently contributing part of the CPRD in England.
* Inclusion criteria of children with asthma

Inclusion criteria for the data extraction from CPRD:

1- School-aged children with asthma aged between 4 to 16 years old as of 1st September 2021 with a coded diagnosis of asthma who have been prescribed asthma medication in the last 12 months.

Exclusion Criteria:

* Practice exclusion criteria:

  1. General practices that are not in England.
  2. General practices that are not included in the CPRD.
  3. Practices that cease to be part of the CPRD during the intervention time without contributing to the primary outcome.
  4. Practices that merge during the intervention (where the merging practices were in different study arms).
* Exclusion criteria of children with asthma:

  1. School-aged children with asthma under 4 and over 16 years old as of 1st September 2021.
  2. Children with no asthma diagnosis
  3. Children with asthma who have not received a prescription for asthma medication. in the last 12 months
Effect of Pertubation on Pregnancy Rates Before Intrauterine Insemination Treatment

To demonstrate a possible beneficial impact of pertubation we designed a randomized prospective study, in which uterine washing was administered prior to insemination in patients diagnosed with unexplained infertility.


Eligibility Criteria:
Inclusion Criteria:

* age of 18-44 years; presence of regular menstrual cycles and ovulation; absence of tubal occlusion on HSG; sperm concentration \>15 million spermatozoa/ml and total sperm number \>39 million/ml according to WHO criteria

Exclusion Criteria:

* the presence of endocrinologic disease; use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids; clinical findings suggestive of pelvic inflammatory disease; and the presence of undiagnosed uterine bleeding
Side Branch Predilatation Strategy in Coronary Bifurcation Lesion Stenting (SBPS)

The role of Side Branch (SB) predilatation during coronary bifurcation lesion percutaneous coronary intervention (PCI) is still not established. The predilatation could potentially damage SB ostium by vessel dissection, making subsequent wiring problematic. However, predilatation could eliminate SB ostial stenosis obviating need for further SB treatment after main vessel stent implantation. The aim of the study is to assess in random fashion the periprocedural myonecrosis, complication rates and time for SB rewiring in groups with and without SB predilatation.


Eligibility Criteria:
1. Inclusion Criteria

   * Subject at least 18 years of age.
   * Subject able to verbally confirm understandings of risks, benefits of receiving PCI for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
   * Target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) located in a native coronary artery with diameter of ≥ 2.0 mm.
   * Target lesion(s) amenable for PCI with balloon angioplasty of the side branch.
2. Exclusion Criteria

   * ST-segment elevation myocardial infarction (STEMI)
   * Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
   * Subjects who refuse to give informed consent.
   * Subjects with left ventricle ejection fraction \<30%
   * Subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy
   * Contraindications for 12 months double antiplatelet therapy
Establishment and Validation of an Early Diagnostic Model for Bladder Cancer Based on Serum and Urine Metabolomics

Metabolomics is a complementary approach for identifying perturbed metabolic pathways. The goal of this study is to establish and validate an early diagnostic model for bladder cancer by metabolomics.

Early diagnosis and life-long surveillance are clinically important to improve the long-term survival of bladder cancer patients. Currently, a noninvasive biomarker that is as sensitive and specific as cystoscopy in detecting bladder cancer is lacking. Metabolomics are small organic molecules (below 2000 mass units) that are products of complex pathways. This is a prospective study aims to create an early diagnostic model based on serum and urine metabolomics. Commonly employed metabolomics analytical platforms include nuclear magnetic resonance spectroscopy (NMR), gas chromatography mass spectrometry (GC-MS), and liquid chromatography mass spectrometry （LC-MS）. The diagnostic model will be made to distinguish bladder cancer and benign disease of the urinary system.

Eligibility Criteria:
Inclusion Criteria:

Bladder cancer group:

1. Any male or female patient aged 18 or older
2. Able to provide serum and urine specimen before treatment
3. Diagnosis with incident or recurrent bladder cancer

Control group

1. Any male or female patient aged 18 or older
2. Able to provide serum and urine specimen before treatment
3. Diagnosis with benign disease of the urinary system, such as urinary calculi and benign prostatic hyperplasia.

Exclusion Criteria:

1. Kidney and liver dysfunction.
2. Incomplete clinical information and laboratory test result
3. Tumor-related treatment was received preoperatively
4. Preoperative routine examination and medical history indicate a history of diabetes, hyperlipidemia and other metabolic diseases or other malignant tumors
Antimony Plus Pentoxifylline in Cutaneous Leishmaniasis

The purpose of this study is to determine whether pentoxifylline associated to pentavalent antimony has a higher cure rate than pentavalent antimony alone in the treatment of cutaneous leishmaniasis.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).
* Number of lesions: 1 to 3 ulcerative lesions.
* Lesion´s diameter: 1 to 5 cm.
* Disease duration: up to three months.

Exclusion Criteria:

* Safety concerns:

  * AST, ALT \>3 times upper limit of normal range
  * Serum creatinine or BUN \>1.5 times upper limit of normal range
  * Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary)
  * Immunodeficiency or antibody to HIV
  * Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases
  * Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months
* Lack of suitability for the trial:

  * Negative parasitology (aspirate/biopsy/PCR)or negative Montenegro test
  * Any history of prior anti-leishmania therapy
  * Any condition which compromises ability to comply with the study procedures
* Administrative reasons:

  * Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)
  * Anticipated non-availability for study visits/procedures
Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold

The purpose of the study is to determine the effectiveness of an acetylsalicylic acid (aspirin) pseudoephedrine combination for the treatment of pain and congestion symptoms compared to the effectiveness of the individual components of the medicine and the placebo (dummy treatment that looks like the real thing).The combination product of acetylsalicylic acid / pseudoephedrine is already marketed in several European countries as Aspirin® Complex.


Eligibility Criteria:
Inclusion Criteria:

* Patient in general good health with suspected viral upper respiratory tract infection (common cold)

Exclusion Criteria:

* \< 18 years old
A Pilot Study to Estimate the Impact of a Screening and Referral Service on Contraceptive Use

The specific aim of this pilot study is to estimate the impact of a new digital health service on the uptake of family planning among Kenyan women with an unmet need for contraception. Enrolled women will be randomized to a control arm or an encouragement arm that will receive a special invitation to try the new service.

Based on global projections, meeting the unmet demand for contraceptives would prevent more than two-thirds of unintended pregnancies and more than two-thirds of maternal deaths. Voluntary family planning has also been shown to improve newborn health outcomes, advance women's empowerment, and bring socioeconomic benefits through reductions in fertility and population growth. Yet among the populations that would benefit the most from family planning, uptake remains too low.

The specific aim of this pilot study is to estimate the impact of a new digital health service on the uptake of family planning among Kenyan women with an unmet need for contraception. This service promotes uptake by offering free screening and referral. Women text the service for free, complete a short automated screening over the phone, and receive a list of recommended methods and a referral to local family planning providers offering those methods. The main hypothesis is that the service will increase the uptake of family planning among these users.

Eligibility Criteria:
Inclusion Criteria:

1. be between the ages of 18 and 35 (inclusive);
2. have an unmet need for family planning;
3. live in the service catchment area;
4. demonstrate phone ownership;
5. opt-in to receiving calls and/or SMS messages from the study team;
6. demonstrate basic ability to operate study tablet; and
7. consent to participate in the study.

Exclusion Criteria:

1. outside of the age range;
2. no unmet need for family planning;
3. live outside the service catchment area;
4. not able to demonstrate ownership of basic phone capable of receiving/making phone calls and receiving/sending SMS messages;
5. does not agree to receive calls and/or SMS messages from the study team;
6. does not demonstrate basic ability to operate study tablet; or
7. does not consent to participate in the study
8. not pregnant or \<4 months postpartum
Improving Keloids Using Targeted Ultraviolet-B Irradiation

Treatment of keloids with targeted Ultraviolet-Beta (UVB) radiation will improve the clinical appearance and induration of lesions.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be 18 years old or over
* Participants must have a diagnosis of keloid
* No treatment with topical or intralesional steroids for 1 month prior to study

Exclusion Criteria:

* Patients who are unable to provide informed consent
* A history of photosensitivity, lupus erythematosus, porphyria or current use of a known photosensitizing drug
* Unwillingness to stop with topical or intralesional steroids for 1 month prior to study
* A history of malignant melanoma
* A history of radiation therapy to area of interest
* Subjects who self-report that they are pregnant or nursing
Bioavailability of 3 Different Formulations of BI 207127 in Healthy Male Volunteers

The primary objective of the current study is to investigate the relative bioavailability of three trial formulations of BI 207127, the trial formulation 2 (TFII), the final formulation (FF), and a FF modified formulation. All formulations are supplied as film-coated Tablets and administered as single dose treatments of BI 207127 (3 film-coated Tablets) in healthy volunteers, with the aim to compare the bioavailability of the three formulations. All treatments will be applied fed, 30 minutes after start of the intake of a standard normal breakfast.


Eligibility Criteria:
Inclusion criteria:

1. Healthy males according to a complete medical history, including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age =21and Age =50 years
3. Body mass index =18.5 and BMI = 29.9 kg/m2
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.

Exclusion criteria:

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. Surgery of the gastrointestinal tract (except appendectomy)
5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
6. History of relevant orthostatic hypotension, fainting spells or blackouts
7. Chronic or relevant acute infections
8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
9. Intake of drugs with a long half-life (\> 24 hours) within at least 10 half-lifes prior to administration of the trial drug or during the trial
10. Use of drugs which might reasonably influence the results of the trial within 10 days prior to administration or during the trial
11. Participation in another trial with an investigational drug within two months prior to administration of the trial drug or during the trial
12. Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
13. Alcohol abuse (more than 40 g/day)
14. Drug abuse
15. Blood donation (more than 100 mL within four weeks prior to first administration of the trial drug or during the trial)
16. Excessive physical activities (within one week prior to first administration of the trial drug or during the trial)
17. Any laboratory value outside the reference range that is of clinical relevance
18. Inability to comply with dietary regimen of trial site
19. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 ms)
20. A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
21. History of photosensitivity or recurrent rash
22. Subject is not willing to avoid sun exposure from the first administration of the trial drug until the end of the study.