cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Medical Ozone Therapy in Patients With Chronic Hepatitis B

The purpose of this study is to verify the effectiveness and safety of medical ozone therapy system in treatment of chronic hepatitis B.

Total of 189 patients with compensated chronic hepatitis B will be divided equally and randomly into three arms. Patients in arm I and II treated with medical ozone therapy with different medical ozone generators, one was made in Tianyi medical instruments limited company and the other in Germany. Sixty-three patients of arm III treated with Diammonium glycyrrhizinate Capsules, common used liver protective herb drug. The term of therapy is 12 weeks. Virology response, biochemistry response and hepatitis B viral serological response will be studied at the end of 12 weeks treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, not less than 16 years old；
2. HBsAg positive for over 6 months；
3. ALT over 2×ULN, TBIL less than 80µmol/L and serum HBV DNA over 10000copies/ml。

Exclusion Criteria:

1. Patient has a history of hemorrhagic or hemolysis disease;
2. Patient has any history of clinical signs/symptoms of hepatic decompensation or serious metabolic hepatic disease;
3. Patient is co-infected with HIV or HCV;
4. Patient is treated with anti-virus drug like interferon or nucleoside analogue in recent 6 months;
5. Patient is treated with immunosuppressive agent for long time, including patient has a history of organ transplantation;
6. Pregnancy;
7. Current alcohol or drug abuse;
8. Difficulty to draw blood through veins;
9. Patient has a history of carcinoma, or finding suggestive of possible hepatocellular carcinoma (HCC), or AFP over than 100ng/ml;
10. Patient has a history of any severe physical disease such as cardio-vascular, kidney events, hyperthyroidism or serious electrolyte disturbance;
11. Patient is enrolled in any other clinical trials.
Construction of a Prognostic and Prediction Model for Perioperative Immunotherapy in NSCLC: a Multi - Omics Perspective

This research focuses on exploring biomarkers for the application of PD - 1/PD - L1 immune checkpoint inhibitors in the perioperative immunotherapy of lung cancer. Multi - index tests are conducted on tissues prior to treatment, as well as blood samples at baseline and during the treatment course. The goal is to identify biomarkers capable of predicting the efficacy of neoadjuvant and adjuvant immunotherapies. Additionally, by integrating these multiple - index data into models, patients are to be stratified based on their potential benefits from perioperative immunotherapy, providing personalized guidance for clinical decision - making.


Eligibility Criteria:
Inclusion Criteria:

* NSCLC, clinical tumor stage II-IIIB
* Without EGFR/ALK gene mutation
* Patient 18 years or older.
* Scheduled for neoadjuvant immunotherapy.
* Eastern Cooperative Oncology Group (ECOG) performance status score 0-1
* Life expectancy ≥ 12 weeks.
* Patient able to understand and sign written informed consent.

Exclusion Criteria:

* With other cancers (excluding NSCLC or skin cancer other than melanoma, or cancers treated curatively with follow up of more than 5 years without recurrence).
* With history of chemotherapy or radiotherapy (including pre - operative and post - operative adjuvant chemotherapy and radiotherapy) or systemic anti - tumor treatment.
* with autoimmune diseases unsuitable for PD - 1 monoclonal antibody treatment, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain - Barré syndrome, or multiple sclerosis.
* Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study.
Lomustine in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well lomustine works in treating patients with stage III or stage IV non-small cell lung cancer.

OBJECTIVES:

Primary

* Evaluate the response rate to lomustine in patients with stage IIIB or IV non-small cell lung cancer with aberrant methylation of the MGMT gene.
* Determine whether the response rate in these patients is significantly greater than that of the historical control.

Secondary

* Collect preliminary data on toxicity, disease stabilization, time to disease progression, and overall survival.

Tertiary

* Evaluate the association between clinical outcome and immunohistochemical staining by grouping the patients as complete or partial loss of MGMT gene.

OUTLINE: This is a multicenter study.

Patients receive oral lomustine once on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed non-small cell bronchogenic carcinoma, including the following histologic subtypes:

  * Squamous cell
  * Adenocarcinoma
  * Adenosquamous
  * Large cell anaplastic
  * Bronchoalveolar
  * Non-small cell carcinoma not otherwise specified (NOS)
* Stage IIIB disease (with a pleural effusion) or stage IV disease

  * Stage IV patients with brain metastases are eligible provided the brain metastases are clinically stable after treatment with surgery and/or radiation therapy
* Tumors must test positive for aberrant methylation of the MGMT gene by methylation-specific polymerase chain reaction
* Bidimensionally measurable or evaluable disease

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* No other active malignancies
* WBC ≥ 4,000/mm\^3 OR absolute neutrophil count ≥ 2,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Total bilirubin normal
* AST \< 5 times upper limit of normal
* Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
* No uncontrolled serious active infection
* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* More than 3 weeks since prior chemotherapy
* No more than 2 prior chemotherapy regimens
* No prior therapy with nitrosoureas
* Recovered from prior radiation therapy
Breast Cancer: Axillary Conservation After Neoadjuvant Chemotherapy in Micro Metastatic Sentinel Lymph Nodes.

Italian multicentric non inferiority clinical study to verify whether the omission of axillary lymph node intervention in patients with SLN (Sentinel Lymph Nodes) ypN1mi after NAC (Neo Adiuvant Chemotherapy) does not lead to a significant deterioration in survival or in the risk of regional or distant recurrence, compared to patients with negative SLN (SLN ypN0) after NAC ,where the omission of axillary treatment is currently the standard treatment.

The study includes patients with cN+ positive axillary lymph nodes at initial diagnosis and who also have negative clinical and instrumental evaluation after NAC. Based on the sentinel lymph nodes definitive histological evaluation patients are allocated in one of the 2 comparison groups (Group 1 experimental or Group 2 standard) or in Group 3 internal control group. Group 3 is not used in statistical comparison with the other two groups but it's aim is to evaluate the appropriateness of the cases.

Referring to bio-pathologic characteristics after surgery patients will receive:

* no further treatment
* complementary radiotherapy
* adjuvant medical therapy (hormonal therapy and/or biological therapy)

Irradiation:

Group 1 (experimental) and Group 2 (standard): irradiation won't be performed neither in the axillary region nor in the other lymph node stations

Group 3 (internal control): after conservative or radical surgery, patients will be subjected to loco-regional irradiation according to Guidelines.

Duration:

Patients enrollment in the study protocol will last for 3 years. Patients will have to be followed for the subsequent 5 years during which they will have to undergo to periodic visits and follow-up checks provided for by the current standard guidelines:

* clinical examination every six months for the first 5 years
* mammography and breast ultrasound yearly
* axillary ultrasound yearly

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 ≤75 years
2. Breast carcinoma with infiltrating histotype
3. Tumor size: cT1 - cT2 - cT3
4. Positive axillary lymph nodes (cN +) at the initial diagnosis by clinical, ultrasound and cyto-microhistology evaluation
5. Neoadjuvant chemotherapy performed
6. Negative axillary lymph nodes (cN-) from the NAC by clinical and ultrasound assessment
7. Absence of distant metastases (M0)
8. Negative medical history for previous infiltrating breast cancer

Exclusion Criteria:

1. Current pregnancy or lactation status
2. Inflammatory breast cancer
3. In situ breast cancer
4. Synchronous contralateral breast cancer
5. Co-morbidity and/or medical disorder precluding any adjuvant therapy
6. Co-morbidity and/or medical/mental disorder making impossible making a regular follow-up
7. Other cancers in the previous 3 years (except forcarcinoma in situ of the uterine cervix, basalioma, squamous cell carcinoma or non-melanoma skin cancer)
Hematology and Clinical Picture in Pediatric COVID-19 Infection

This study is to discuss the different clinical presentations, hematological and laboratory abnormalities in pediatric COVID-19 infection.

This retrospective observational study will be conducted at Benha University Hospital, Benha, Egypt; after approval by the local ethical committee of Faculty of Medicine, Benha University, Egypt.

We will include in this retrospective study all pediatric patients who were admitted with confirmed COVID-19 infection with age range from birth to 18 years during the period from April 2020 till July 2020. The diagnosis of COVID-19 infection is based on positive SARS-CoV-2 RNA detection in throat swab specimens by PCR.

All data including demography information, contact history, previous history, clinical symptoms, clinical examination on admission, and hematology and laboratory information will be obtained from inpatient medical records.

Eligibility Criteria:
Inclusion Criteria:

-inpatient confirmed COVID-19 infection by PCR

Exclusion Criteria:

* patients with records missing hematology and/or laboratory data,
* patients transfered to other medical facilities with unknown outcomes,
* patients with age older than 18 years from the study.
Construction-LBD (Constructional Apraxia in Alzheimer's Disease (AD) and Lewy Body's Dementia (LBD))

Alzheimer's disease (AD) and Lewy body's dementia (LBD) are two frequent neurodegenerative pathologies. They differ in their expression, their evolution but share same features which make their diagnosis uneasy.

Constructional apraxia has been described in both disease.The underlying mechanisms have been less studied and could be different in AD and LBD.

The definition of the constructional apraxia is purely descriptive and few models are inconclusive.

It is admitted that drawing tasks involve visuo-perceptive and visuo-spatial abilities, executive functions and working memory as well as purely "constructive" skills.

Regarding to different studies, visuo-perceptive abilities are more severely impaired in LBD than in AD and are considered as an early onset sign of the disease.

Executive functions deficits are documented in AD and LDB and could contribute to the drawing impairment.

It is possible to compensate the planning disorders in giving patient the best strategy to use.

If drawing impairment persists, they should result of others mechanisms like visuo-perception, visuo-spatial or constructive deficits.

The investigators suggest that giving the best planning strategy will help more AD patients who are supposed to fail in raison of an executive impairment, than the LDB group who is supposed to present visuo-perceptive deficits. An MRI will be proposed to study the cerebral areas involved in constructional apraxia.


Eligibility Criteria:
Inclusion Criteria:

* Alzheimer's disease or Lewy bodies dementia
* ≥ 45 years
* the cognitive impairment is mild to moderate
* French speaker
* a caregiver is present
* An informed consent is signed by the patient and the p.i.

Exclusion Criteria:

* MRI contraindication
* Other neurological disease (FTD, brain tumor, vascular disease...)
* Psychiatric disease (Schizophrenia, major depression, psychotic disorders, melancholia...)
* Patient who doesn't want to be informed in case of the discovery of an abnormality
* View or audition deficits, or motor disability which can interfere with the cognitive testing
* Patient participating to an exclusive protocol or in the period of exclusion
* Pregnant woman
* Person under an administrative or legal measure of liberty privation
* Person under a legal measure of protection or under administrative supervision
* Person unable to give his consent
Methadone Induced Memory Retrieval-extinction Procedure in Heroin Addicts

The study assessed the efficacy of a methadone-induced memory retrieval-extinction procedure on heroin craving and relapse. Male participants aged 18-55 years old and prescribed MMT to treat heroin dependence were included in the present study, and randomly assigned to receive methadone, or receive methadone plus 10 minutes plus extinction, or receive methadone plus 6 hours plus extinction. The intervention persisted 3 times per week for 4 weeks. Then the subjects were followed up once a month for cue induced heroin craving and relapse.

In the present study, we explored the effect retrieval-extinction procedure on heroin craving and relapse in heroin addicts using the methadone (a commonly used µ-opioid receptor agonist) instead of heroin as the trigger to reactivate drug memories. The subjects were randomly divided into 3 groups, in which they received methadone alone or extinction sessions 10 min or 6 hours after methadone administration. The extinction sessions were given 3 times per week for 4 weeks, each lasted for 30 min. During the extinction procedure, the subjects were exposed to images, heroin paraphernalia and mimic heroin. Subjective craving, morphine urine test and physiological responses were recorded monthly for 4 months.

Eligibility Criteria:
Inclusion Criteria:

* met the diagnostic criteria of heroin dependence according to DSM-IV
* were prescribed methadone maintenance treatment (MMT) and took it regularly
* no change in city of residence for at least 1 year
* had normal blood pressure and heart rate
* had negative urine morphine screening test
* primary-school level education
* provide signed consent

Exclusion Criteria:

* other substance abuse(except nicotine)
* had a current or past history of Diagnostic and Statistical Manual of Mental Disorders, 4th Edition（DSM-IV) AxisⅠdisorders
* had clinically evident physical disorders
* neurological signs and/or history of neurological disease
* noncompliance with the procedure
Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery

Low thermal dissection devices have been introduced as a tool to improve surgical outcomes. PlasmaBlade, a low thermal dissection device, has shown to be associated with effective cutting, and significantly lower temperature than traditional electrosurgical dissection device. Thus, low thermal devices would improve flap perfusion by decreasing the thermal injury resulted by the dissection. Looking into the use of low thermal devices in cases of mastectomy and immediate breast reconstruction has not been documented. The aim of this study is to determine if there are clinical flap perfusion, surgical site drainage, and pain scores differences between mastectomy flaps created using low thermal dissection device and those done with the standard care of Bovie cautery in order to warrant a formal study.

This is a single-blinded, randomized, controlled clinical trial comparing postoperative flap perfusion and surgical site drainage between patients randomized to breast flap creation by PlasmaBlade (low thermal dissection intervention) on one breast and by a Bovie cautery (Control) for the contralateral breast flap. Candidates will have elected to undergo bilateral post-mastectomy immediate breast reconstruction (IBR). Participants meeting inclusion criteria will be enrolled and baseline data collection completed prior to randomization and surgery.

Patients and the plastic surgeon will be blinded in regards to intervention randomization. Only the oncology surgeon has knowledge of which device used for each breast flap. However, after the plastic surgeon makes the assessment of the flap, he/she will be unblinded in order to complete the reconstruction procedure using the same dissection device on the same side it was used for in the mastectomy procedure. Patient-specific surgical details will be recorded intraoperatively. Following the surgery, post-operative flap perfusion will be recorded using SPY imaging system. Surgical site drainage will be measured until drainage removal. Post-operative pain (Visual Analog Scale for Pain) and the occurrence of adverse events will be recorded up until discharge and 30-days postoperative follow up visit.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-75 years.
* Choose bilateral mastectomy followed by immediate breast reconstruction.
* Have no inflammatory breast cancers.
* Have not had radiotherapy before mastectomy.
* Understand the study purpose, requirements, and risks.
* Be able and willing to give informed consent.

Exclusion Criteria:

* Active connective tissue disease.
* History of, or plan to undergo irradiation of the breasts.
AZD6088 Single Ascending Dose Study

The aims of the study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD6088 following single ascending dose administration in healthy male and non-fertile females.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian male and non-fertile female healthy volunteers aged ≥18 to ≤55 years with suitable veins for cannulation or repeated venipuncture.
* Clinically normal physical findings including supine BP, pulse rate, ECG and laboratory assessments in relation to age, as judged by the investigator.
* Normal and suitable EEG, as judged by a neurologist

Exclusion Criteria:

* History of any clinically significant disease or disorder which for instance includes CNS disorder or CV disorder.
* Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator.
* Any clinically important abnormalities in the ECG.
Effect of Scapular Stabilization Exercise on Breastfeeding Women with Non-specific Neck Pain

The purpose of this study is to determine whether scapular stabilization exercises can help breastfeeding women with non-specific neck pain by reducing their neck pain, cervical range of motion, and neck disability index.

The best infant feeding practice is breastfeeding, which has both immediate and long-term advantages for mothers, babies, the environment, the economy, and society as a whole. Mothers who are nursing frequently experience neck pain. Because the scapula and neck are closely related, scapular stabilization is becoming more and more popular for patients with neck pain.

Eligibility Criteria:
Inclusion Criteria:

1. exclusive breastfeeding mothers with immediate to 6-month-old infants.
2. The bilateral cradle position is employed by patients when nursing.
3. Patients had mechanical neck pain.
4. Patients with a body mass index below 30 kg/m²
5. Patients have moderate pain intensity, ranging from 3 to 7 on the visual analogue scale
6. The patients' scores on the Neck Disability Index ranged from 10 to 40 out of 50.

Exclusion criteria:

1. Patients had preterm babies or low-birth-weight babies.
2. pregnant patients
3. Patients had postpartum complications.
4. Patients had inflammation, infection, severe degeneration, congenital deformity, and trauma.
5. Patients had sensory abnormalities or a positive motor reflex.
6. Patients had cancer, metabolic, or systemic diseases.
ADenosine Vasodilator Independent Stenosis Evaluation II - ADVISE II

To assess the clinical value of iFR to characterize, without concomitant administration of hyperemic agents and outside a specified range of iFR values, coronary stenosis severity as determined with fractional flow reserve (FFR)


Eligibility Criteria:
Inclusion Criteria:

* - Patient must be \> 18 and \< 85 years of age
* Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
* Eligible for coronary angiography and/or percutaneous coronary intervention
* Coronary artery disease with at least 1 or more visually assessed coronary stenoses (\>40% diameter stenosis) in native major epicardial vessel or its branches by coronary angiogram.
* Stable angina or acute coronary syndromes (non-culprit vessels only and outside of primary intervention during acute myocardial infarction)

Exclusion Criteria:

* - Known contraindication to adenosine administration
* Implanted temporary or permanent artificial pacemakers, Left Bundle Branch Block (LBBB), 1st and 2nd degree AV Block
* STEMI or non STEMI within 48 hours of procedure
* Any contraindications for FFR interrogation or percutaneous coronary intervention (PCI) as determined by the investigator
* Severe vessel tortuosity and/or severe calcification by angiogram
* Significant valvular pathology (moderate or severe AS/AR/MS/MR)
* Previous Coronary Artery Bypass surgery with patent grafts to the interrogated vessel
* Weight \>200kg (441 lbs.)
* Hemodynamic instability at the time of intervention (heart rate\<50 beats per minute, systolic blood pressure \<90mmHg) balloon pump
* Significant hepatic disease, renal disease, lung disease (pulmonary chronic pulmonary obstructive disease) and/or malignant disease with unfavorable prognosis or presenting with abnormal serum laboratory values that the physician believes is clinically significant
* Contraindication to antithrombotic regimen or anticoagulation therapy
* History of or known reaction or sensitivity to contrast agent and is unable to be pre-medicated
* Left main stenosis, tandem stenosis separated by more than 5 mm that require separate pressure guide wire interrogation or PCI (not to be interrogated or treated as a single stenosis), or total occlusions
* Known Left ventricular ejection fraction (LVEF) \<30%