cyrilzakka/clinical-trials huggingface dataset:
Dose Exploring and Setting Study for Tolvaptan to Treat Hepatic Cirrhosis With Ascites

To observe the safety/efficacy of tolvaptan for treatment of patients with hepatic cirrhosis with ascites and exploring the dosage-effect relations of the drug.

Tolvaptan is able to exert hydragogue diuretic effects (water diuresis) via inhibition of water reabsorption by renal collecting ducts without corresponding increase in electrolyte excretion. It has been confirmed that tolvaptan is able to increase urine volume without any adverse effects on renal functions.

Eligibility Criteria:
Inclusion Criteria:

1. hepatic cirrhosis patients after 7days treatment of loop diuretics and aldosterone antagonist but still with ascites
2. Hospitalized patients or those who can be hospitalized in this trial between observation period and posttherapeutic observation (Visits at clinic will be allowed after day 8);
3. During the observation period (-3 day to -1 day ), subjects whose body weight difference fall within ±1.0 kg range 2 days (day-2 and day -1) prior to initiation of trial drug treatment;
4. Ages: ≥18 and ≤75 years of age;
5. Genders: men or women;
6. Signed the Informed Consent Form.

Exclusion Criteria:

1. Patients with the following diseases, complications or symptoms:

   * Hepatic encephalopathy (Coma scale Note 1) grade 2 or higher);
   * Malignant ascites;
   * Uncontrolled spontaneous bacterial peritonitis;
   * Patients are likely to experience alimentary tract hemorrhage during the trial;
   * Heart failure (NYHA cardiac function scale Note 2) stages 3 and 4);
   * Anuria (daily urine volume below 100mL);
   * Dysuria resulting from urethral stricture, calculus and tumors.
2. Patients with the following medical history:

   * Alimentary tract hemorrhage within 10 days prior to screening;
   * Cerebrovascular accident within 1 month prior to screening;
   * Gout attack within 1 month prior to screening;
   * Past allergy or hypersensitive reactions to benzodiazepines (e.g. benazepril hydrochloride)
3. Systolic pressure below 90mmHg at screening;
4. Patients with the following abnormalities in laboratory examinations at screening:

   Serum creatinine exceeds 2.5X upper limits of normal, serum Na+\>145mmol/L (or exceeds upper limits of normal), serum K+\>5.5mmol/L, uric acid\>8.0mg/dL (476μmol/L), Child-pugh scale greater than 12.
5. Patients cannot take drugs orally;
6. Pregnant or breast-feeding patients or women at child-bearing ages without taking acceptable contraceptive measures;
7. Patients received albumin or other blood preparations within 4 days prior to trial drug administration;
8. Patients participated in clinical trials of other drugs within 1 month prior to screening;
9. Patients participated in tolvaptan trials and took tolvaptan previously;
10. Patients are unsuitable to participate in this trial in investigators' opinion.
Study of TQ-B3139 Versus Crizotinib in the First Line Treatment of Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC)

To evaluate the efficacy and safety of TQ-B3139 versus crizotinib in subjects with ALK-positive NSCLC that have received one chemotherapy regimen and have not received ALK inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* 1.18 and 75 years. 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.

  3. Life expectancy ≥12 weeks. 4. Histologically or cytologically confirmed advanced or metastatic NSCLC with ALK-positive.

  5. Has not received ALK tyrosine kinase inhibitor (TKI). 6. Has received one chemotherapy regimen for stage IIIB-IV NSCLC. 7. At least one measurable lesion. 8. Adequate organ system function. 9. Understood and signed an informed consent form.

Exclusion Criteria:

* 1. Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. Exceptions include cured cancer carcinoma in situ of the cervix, intramucosal carcinoma of gastrointestinal tract, breast and melanoma skin cancers and superficial bladder tumors.

  2. Hypersensitivity to TQ-B3139 or crizotinib. 3. Has received any cancer therapy within 4 weeks or 5 times of t1/2. 4. Has received any major surgery within 4 weeks. 5. Has received any radiotherapy or minor surgery aimed to cure cancer within 2 weeks.

  6. Acute toxicity that is ≥ Grade 2 caused by previous cancer therapy. 7. Has active viral, bacterial and fungal infections within 2 weeks before the first dose.

  8. Has serious cardiovascular disease within 3 months before the first dose. 9. Has currently uncontrollable congestive heart failure. 10. Has continuous arrhythmia ≥ Grade 2, uncontrollable atrial fibrillation or QTc interval \> 480ms.

  11. Has interstitial fibrosis or interstitial lung disease ≥ Grade 3. 12. Brain metastases with symptom. 13. HBsAg positive and HBV DNA positive (≥ULN);HCV antibody and HCV-RNA positive (≥ULN); HIV positive or ≥HIV ULN.

  14. Has multiple factors affecting oral medication. 15. Has received a strong CYP3A inhibitors within 7days before the first dose. 16. Has received a strong CYP3A inducers. 17. Breastfeeding or pregnant women.; Men unwilling to use adequate contraceptive measures during the study.

  18. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Music to Decrease Pain and Anxiety During Head CTs Performed at the PEds ED

A single blinded controlled trial to determine if an intervention of listening to nursery songs with integrated heart beat sounds results in changes in anxiety level in infants and young children less than four years of age in an emergent setting.

This study is a prospective cohort with a randomized single-blinded intervention with convenience sampling design. Our pediatric emergency medicine department (PED) treats nearly 2,500 patients between 1 and 3 years of age annually in 2008-10 and is a regional referral center for specialty care for our state. All data is collected in the PED between May 2008 and July 2010.

One PED examination room is designated as the study room. The music was stored on an ipod played in a portable speaker. The music is from the Compact Disk(CD), "Baby Go to Sleep." This is a commercially available CD.23 The "Baby Go to Sleep" Compact Disk played a combination of the sound of an actual human heartbeat and children's songs. Tempo changes occurred between each song. During the study, the initial three nursery rhymes were played.

The principal investigator's research associates recruit all patients up to 3 years of age presenting to the PED during the hours they were available. Once situated in the room, children both in the control and experimental group received the usual medical care including the evaluation by attending physician to determine if head CT would be performed or not. After subjects were determined to need a head CT by the attending physicians, they were randomly assigned to either the Control(Con) or experimental(Exp) group. Children in the Con group received the usual medical care while children in the Exp group received the usual medical care in combination with the intervention. The intervention was started by the patients nurse without the knowledge of the research associate. In the intervention group, music was played until the CT scan was completed. Research associates rated children's anxiety levels using a visual analogue scale(VAS) and Modified Ramsay Sedation Scale(MRSS) before children were transferred to radiology department for head CT then after children was laid down to go through head CT. Researchers associates were blinded to group by wearing headphones that were tested to ensure that they could not hear whether or not music was playing during the intervention phase.

Eligibility Criteria:
Inclusion Criteria:

* We sampled all children up to ages 3 years who present to the PED during the hours that the research assistant was present to collect data.

Exclusion Criteria:

* All children requiring trauma room care were excluded because they were not able to move to the study's examination room after triage (their care will be completed in the trauma room). Children with hearing deficit and those who are unable to move to the designated examination room for other reasons including needing oxygen and cardiopulmonary monitoring were excluded as well. The patients were also excluded if we were unable to track their results or chart at final review of patient data.
Study of LM-108 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours

This is a phase I/II, open-Label, dose-Escalation and dose-expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-108 (an Anti-CCR8 mAb) as a Single Agent or in combination with Toripalimab in Advanced Solid Tumours.


Eligibility Criteria:
Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
2. Histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.
3. At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
4. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.

Exclusion Criteria:

1. Have received anti-CCR8 drug treatment or other clinical study drug or treatment not on the market within 28 days prior to the first dose.
2. Subjects with anti-tumor treatment within 21 days prior to 1st dosing of LM-108, including radiotherapy, chemotherapy, biotherapy, endocrine therapy and immunotherapy, etc.
3. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
4. Subjects with uncontrolled tumor-related pain.
5. Subjects with known brain metastases.
6. Uncontrollable clinical third luminal effusion.
7. Known history of autoimmune disease.
8. Use of any live attenuated vaccines within 28 days.
9. Have severe cardiovascular disease.
10. Uncontrolled or severe illness.
11. History of immunodeficiency disease.
12. Active malignancies which are likely to require the treatment.
13. Child-bearing potential female.
14. Have psychiatric illness or disorders.
A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants

The main purpose of this study is to assess the effect of multiple doses of itraconazole, fluconazole, and carbamazepine on single dose pharmacokinetic of LY4100511 (DICE-853) in healthy participants. The study will also evaluate the safety and tolerability of LY4100511 (DICE-853) with itraconazole, fluconazole, and carbamazepine.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index within the range of 18.0 to 32 kilograms per square meter (kg/m²)
* Males who agree to follow contraceptive requirements and women of not childbearing potential
* Have body weight greater than or equal to (\>=) 50 Kilograms at screening.
* Must have a negative Interferon-Gamma Release Assays (IGRA) testing at screening
* Must have been stopped all the prescribed medication at least 14 days prior to admission to the clinical site
* Ability and willingness to abstain from alcohol, caffeine, and methylxanthine-containing beverages or food 2 days prior to admission to the clinical site
* Abstain from any strenuous physical exercise from 4 days prior to admission and during confinement at the clinical site

Exclusion Criteria:

* Have a history of relevant drug and/or food allergies, or sensitivity to medications used in the current study
* Females participants who are currently breastfeeding
* Have History of alcohol abuse or drug addiction
* Unable to abstain from tobacco products within the 2 days prior to admission and during confinement at the clinical site
* Have Positive screen for hepatitis B surface antigen, hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) 1 and 2 antibodies
* Consumption of any nutrients known to modulate CYP450 enzymes activity
* Are immunocompromised
* Have received live vaccine(s) (including attenuated live vaccines) or Bacillus Calmette-Guérin within 28 days of screening or intend to receive them during the study
* Have had any malignancy within the past 5 years
Post Covid-19 Quality of Life After Hospital Discharge in Patients Treated With NIV/C-PAP

A multicenter longitudinal study with data collection at 4 and 8 months after hospital discharge.

The study population consisted of patients treated with NIV/CPAP, admitted to the COVID-19 wards of the AO SS Antonio e Biagio and Cesare Arrigo in Alessandria (the promoting center), the Azienda Sanitaria Locale Bt (Barletta, Andria, Trani) and the Azienda Socio Sanitaria Territoriale in Lecco, from November 2020 to June 2021. The study assessed at 4 and 8 months after hospital discharge in the patient's home environment, quality of life, residual disability, anxiety and insomnia.

Enrollment took place only after the approval of the Ethics Committee of each participating center.

Eligibility Criteria:
Inclusion Criteria:

All patients aged ≥18 years admitted for COVID-19 pneumonia treated with NIV/CPAP, discharged to their home with a negative molecular swab and signed informed consent were included in the study

Exclusion Criteria:

Exclusion criteria were set in; patients admitted for COVID-19 pneumonia treated with NIV/CPAP and invasive ventilation and patients with pre-existing cognitive disorders at the hospital admission date.
Phase 3 Clinical Trial of Wujia Yizhi Granules in the Treatment of Mild-to-moderate Alzheimer's Dementia (Syndrome of Deficiency of Spleen and Kidney)

This study is a randomized, double-blind, placebo-controlled phase 3 design aimed at further verifying the safety and efficacy of Wujia Yizhi granules for mild-to-moderate Alzheimer's dementia

This is a multi-center, randomized, double-blind, placebo-controlled phase 3 clinical trial targeting patients with mild-to-moderate Alzheimer's dementia (TCM differentiated as syndrome of deficiency of spleen and kidney). 570 subjects were recruited and randomly assigned to the experimental and placebo groups at a ratio of 2:1.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age range : 50 - 80 years old.
2. Informed consent signed and dated by patient or legal representative.
3. The participants are mild-to-moderate AD patients who meet the diagnostic criteria for AD proposed by the National Institute on Aging and the Alzheimer's Association (NIA-AA) in 2018 and have a disease course of more than 6 months. If participants lack previous pathological evidence or biomarkers of Alzheimer's dementia, they must have evidence of β-amyloid deposition biomarkers during screening (PET with abnormal amyloid deposition or low cerebrospinal fluid Aβ 42 and Aβ 42/Aβ 40 ratio).
4. MMSE score 11 to 26;CDR-GS score 1 to 2 。

Exclusion Criteria:

1. Participants with non AD induced memory and cognitive impairment, such as diagnosis of other types of dementia, including but not limited to mixed dementia (AD VaD), vascular dementia (VD), Parkinson's disease dementia (PDD), Lewy body dementia (DLB), Huntington's disease related dementia, frontotemporal lobe dementia (FTD), etc; Endocrine system disorders (such as thyroid diseases, parathyroid diseases) and dementia caused by folate, vitamin B12 deficiency, or any other reason; Existence of consciousness disorders, etc.
2. Participants have a history of epileptic seizures.
3. Participants are psychiatric patients, including but not limited to schizophrenia, affective schizophrenic disorder, bipolar disorder, or delirium.
4. HAMD-17 score ≥ 17 points.
5. HAMA score ≥ 14 points.
6. Participants were taking antidepressants, anxieties, and antipsychotic drugs during screening.
7. HIS score ≥ 4 points..
Nilotinib + Pegylated Interferon Alpha 2a for Untreated Chronic Phase Chronic Myelogenous Leukemia

The aim of this study is to demonstrate the safety and the efficacy of a combination of 2 treatments shown to have some efficacy in Chronic Phase Chronic Myelogenous Leukemia (CP CML) separately, but that have never been combined to date, and this combination is expected to substantially increase the molecular response rates.


Eligibility Criteria:
Inclusion Criteria:

* Performans status 0-2
* CP CML diagnosed since less than 3 months without previous Tyrosine Kinase Inhibitor (TKI) or interferon treatment
* Adequate organic functions:

  * Total Bilirubin \< 1.5xUpper Normal Range (UNR).
  * Aspartate Amino Transferase (ASAT) and Alanine Amino Transferase (ALAT) \< 2.5xUNR.
  * Alkaline phosphatase ≤ 2.5xUNR
  * Amylase and lipase ≤ 1.5xUNR.
  * Creatininemia \< 1.5xUNR.
* Biological blood standards :

  * Potassium ≥ Lower Normal Range (LNR)
  * Magnesium ≥ LNR.
  * Phosphorus ≥ LNR
  * Calcium ≥ LNR.
* Negative pregnancy test within the last 7 days for women with childbearing potential.
* Informed consent signed up
* Compliance to tretament ensured,
* Valid social insurance

Exclusion Criteria:

Prior TKI or interferon treatment for the CML

* Contra-indication to IFN
* Pregnancy, breast feeding
* Human Immunodeficiency Virus positive, chronic hepatitis B or C.
* Other BCR-ABL transcript than M-bcr
* Cardiopathy defined as:

  * Left Ventricular Ejection Fraction (LVEF) \< 45%.
  * Left bundle branch block
  * Ventricular pacemaker.
  * Congenital prolonged QT
  * Past ventricular or significant auricular tachyarrythmia
  * Clinically significant bradycardia (\<50 per minute).
  * QTc (Fredericia) \> 450 ms (average on 3 Elektrokardiogramm (EKG)).
  * Myocardial infarction in the last 12 months.
  * Unstable angina within the last 12 months.
  * Other significant cardiac diseases.
* Other uncontrolled severe disease (such as diabetes melittus etc...)
* Other ongoing malignant disease.
* Past history of congenital or acquired clinically significant bleeding disorder.
* Previous radiotherapy ≥25% of bone marrow.
* Serious surgery within the past 4 weeks
* Investigational treatment within the last 30 days prior to day 1.
* History of non compliance.
* Cytochrome P450 3A4 (CYP3A4) inhibitors that could not be withdrawn or modified (such as erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil).
* Severe gastro-intestinal disorders (such as gastric ulcer, uncontrolled nausea, malabsorption syndrome, small intestine resection, gastric shunt).
* Hepatic, renal or pancreatic chronic disorder unrelated to CML
* Recent history of acute pancreatitis within a year or history of chronic pancreatic disease .
* Any concommittant treatment inducing QT prolongation.
Surgical Management of Low Grade Glioma

To assess the morbidity and mortality in low grade glioma patients following surgical management.

lower-grade gliomas histological diagnosis has had a long history, each iteration of disease classification suffered from continued variability, with detrimental consequences on prognostic precision and treatment decision making.

In the WHO 2021 classification, there are three primary categories of adult-type diffuse gliomas: isocitrate dehydrogenase (IDH)-mutant, 1p/19q codeleted oligodendroglioma; IDH-mutant, non-codeleted astrocytoma; and IDH-wildtype glioblastoma. Diffuse low-grade glioma is classified as WHO grade 1 and 2 astrocytoma with IDH mutation or oligodendroglioma with IDH mutation and 1p/19q codeletion.

The presence of the IDH1 mutation has become a defining factor for adult diffuse low-grade glioma. Roughly 70% of grade 2-3 gliomas harbor mutations in either IDH1 or its mitochondrial counterpart IDH2.

Although lower-grade gliomas may present in various ways, the most common manifestation is seizures, and the development of seizures during the course of the disease may herald tumor progression. Among grade II tumors, the incidence of epilepsy is higher with IDH mutation. Anaplastic gliomas are somewhat less likely to manifest with seizures (57%) and are more likely than grade II gliomas to produce mental status, vision, and motor deficits.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed radiologically with low grade glioma

Exclusion Criteria:

* patients not fit for surgery
Study of the Clinical Management of Bipolar Disease

This study is to provide reliable information on the management of bipolar disorders in real every day, clinical practice, to determine the clinical outcomes of such management and use of resources in relation to the disease, and to establish the factors associated with different management patterns and clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Bipolar Disorder I or II (DSM-IV TR) in any phase of the disorder
* Patients who had at least one mood event (depression, mania, hypomania or mixed) according to DSM-IV TR definition during the 12 months prior to the beginning of the study

Exclusion Criteria:

* Patients who had the index mood event during the 3 months before the beginning of the study (Time 0).
EFFICACY OF INSPIRATORY MUSCLE TRAINING ASSOCIATED WITH MANUAL TECHNIQUES IN INDIVIDUALS WITH GERD

The objective of this clinical trial is to investigate the efficacy of inspiratory muscle training (IMT) combined with manual techniques for the lower esophageal sphincter (MTLES) and diaphragmatic release (DRT) in patients with Gastroesophageal Reflux Disease (GERD). The main questions it aims to answer are:

1. If the combination of IMT, DRT, and MTLES can improve GERD symptoms and patients' quality of life.
2. If the home-based IMT protocol, with weekly adjustments, and the manual techniques applied twice a week can have a positive impact on various clinical measures, such as pressure at the lower esophageal sphincter, reflux episodes, and quality of life.

The researchers will compare three groups: Group 1 (IMT), Group 2 (IMT + DRT + MTLES), and Group 3 (control, sham), to see if the group receiving IMT combined with DRT and MTLES shows greater improvements compared to the control group.

Participants will perform inspiratory muscle training at home, following a protocol adjusted weekly, and will receive manual techniques twice a week.

The IMT protocol will be performed at home with a load set at 50% of maximal inspiratory pressure (MIP) and adjusted weekly, while manual techniques will be applied twice a week at LACAP. Outcomes include mean pressure at the gastroesophageal junction (esophageal manometry), number of reflux episodes and acid exposure time (impedance-pH monitoring), diaphragmatic mobility and thickness (ultrasound), respiratory muscle strength (manovacuometry), heart rate variability (heart rate monitor), and reflux symptoms and quality of life (questionnaires). It is expected that the combination of IMT, DRT, and MTLES will improve GERD symptoms and positively impact patients' quality of life, providing an effective and less invasive alternative compared to conventional interventions.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with gastroesophageal reflux disease (GERD)
* using 20 mg of proton pump inhibitors (PPIs).

Exclusion Criteria:

* Individuals with a hiatal hernia \>3 cm,
* chronic lung diseases (chronic obstructive pulmonary disease and interstitial lung diseases)
* severe heart diseases,
* history of previous abdominal and/or thoracic surgeries, rib fractures within the past year,
* severe osteoporosis
* BMI \>30 kg/m²
Relationship Between Mid-luteal Serum Progesterone Levels to Pregnancy Rates in Assisted Reproductive Techniques (ART)

In Assisted Reproductive Techniques (ART) there is a need for luteal support using progesterone, estrogen and probably human chorionic gonadotropin (HCG). The optimal route of administration and dose has not yet been determined.

The aim of the study is to investigate whether high levels of mid-luteal serum progesterone are related to higher pregnancy rates in ART cycles. We also plan to investigate whether using higher doses of vaginal progesterone results in higher pregnancy rates.


Eligibility Criteria:
Inclusion Criteria:

* Mid-luteal serum progesterone levels below 15 ng/dl

Exclusion Criteria:

* Does not sign consent form