cyrilzakka/clinical-trials huggingface dataset:
Guided and Unguided Internet Treatment for Problematic Alcohol Use

The purpose of this study was to determine whether a 10-week internet-based program based on cognitive behavioral therapy (CBT) is effective in the treatment of alcohol problems, and if having therapist guidance leads to greater effects.

Objectives: An 10 week Internet-based self-help program based on cognitive behavioral therapy (CBT) was tested among Internet help seekers.The design was a three-armed randomized controlled design, and outcomes were measured in terms of changes in problematic alcohol use, as well as depression, anxiety and quality of life. 80 participants were recruited entirely online from an open access website and randomized into three different groups. All participants had access to the same self-help program. However, one group was given a choice between two forms of therapist guidance (messages or weekly chat sessions), one group received therapist guidance in the form of secure messages, and one group received no therapist guidance.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* access to the Internet
* problematic alcohol use defined as ≥ 8 p or more for men and ≥ 6 p or more for women in the Alcohol Use Identification Scale

Exclusion Criteria:

• not adequately fluent in Swedish
Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B Virus (HBV) Infection

This is an open label, randomized, parallel-group study to evaluate the safety and efficacy of combination treatment BRII-835 (VIR-2218) and BRII-179 (VBI-2601) in adult participants with chronic HBV infection


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 - 60
* Body mass index ≥ 18 kg/m\^2 and ≤ 32 kg/m\^2
* Chronic HBV infection as defined by a positive serum HBsAg for ≥ 6 months

Exclusion Criteria:

* Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
* Significant fibrosis or cirrhosis
* History or evidence of drug or alcohol abuse
* History of intolerance to SC or IM injection
* History of chronic liver disease from any cause other than chronic HBV infection
* History of hepatic decompensation
Vasoconstrictors as Alternatives to Albumin After Large-Volume Paracentesis (LVP) in Cirrhosis

This clinical trial compares a combination of two drugs that constrict blood vessels (Octreotide LAR and Midodrine) to albumin after large volume paracentesis. Subjects have cirrhosis and ascites.

This prospective, placebo-controlled, randomized, clinical trial compares the effect of a combination of vasoconstrictors (octreotide plus midodrine) to albumin on the time to recurrence of ascites in patients with refractory ascites treated with large volume paracentesis. The treatment allocation ratio for the two treatment arms is 1:1 using a stratified random permuted block design. Subjects are patients 18-80 years old with cirrhosis and ascites who are stratified according to the presence or absence of renal dysfunction at the time of randomization. Measurements include blood pressure, weight, girth, abdominal ultrasound, forearm blood flow, plasma renin activity, angiotensin, and aldosterone, repeated during a 6 month period.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis of any etiology
* Age 18-80 years
* Moderate to severe ascites

Exclusion Criteria:

* No or small ascites
* Severe hepatic hydrothorax
* Recent GI (gastrointestinal) hemorrhage
* Active bacterial infection
* Cardiac failure
* Organic renal disease
* Hepatocellular carcinoma
* Severe comorbidity (advanced neoplasia)
* Serum creatinine \> 3 mg/dl
* Pregnancy
Chemotherapy Induced Peripheral Neuropathy (CIPN) and Lymphoma Longitudinal Follow-up and Prognostic Factors

Vincristine-induced peripheral neuropathy, which is commonly a sensorimotor neuropathy, remains a major complication of lymphoma patients treated with R-CHOP. The investigators propose a clinical, electrophysiological and biological follow up of patients treated by vincristine for lymphoma to determine the factors implied in VIPN occurrence.

Patients with lymphoma will be evaluated before chemotherapy (T1), after 4 cycles (T2), at the end of the chemotherapy treatment (If more than 4 cycles) (T3) and 6 month after the end of chemotherapy (T4).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of indolent or aggressive B/T NHL confirmed by biopsy and requiring chemotherapy after PCR decision including vincristine, RCHOP/CHOP protocol or CHOEP
* Accept to participate in the study
* Age \> 18 year
* Able and willing to provide informed consent
* Affiliated to a social security system

Exclusion Criteria:

* Life-threatening emergency requiring chemotherapy in extreme urgency
* Neuro-meningeal damage at diagnosis
* Protected person (under guardianship or curators)
* Person under court protection
* Pregnant or breastfeeding woman
* Persons deprived of liberty by judicial or administrative decision
* Persons under forced psychiatric care
* Persons admitted to a health or social institution for purposes other than research
* Persons unable to express their consent
Prospective Multicenter Study on Clinical Application of Sonazoid in Breast Tumor

Sonazoid as a new generation of ultrasound contrast agent.This study based on the features of Sonazoid specific angiography and high mechanical index,the role of Sonazoid in the differential diagnosis of breast benign and malignant tumors was explored.

This trial is a prospective, multi-center study.With pathology as the gold standard, based on quantitative and qualitative analysis, Sonazoid-CEUS was compared with MRI to explore the diagnostic efficacy (accuracy, sensitivity and specificity) of Sonazoid-CEUS for breast tumor in different pathological types.

Investigators will also record the parameter information of imaging examination, pathological type of pathological examination and immunohistochemical index.Contrast-enhanced ultrasound includes lesion location, initial peak tumor volume, 1-minute tumor volume, 2-minute tumor volume, and 5-minute tumor volume, as well as the time for contrast enhancement, contrast agent clearance, and contrast agent clearance.Whether there is no enhancement area in the lesion after contrast enhancement, shape after contrast enhancement, edge after contrast enhancement, order of enhancement, uniformity of enhancement, intensity enhancement, pattern of enhancement, clear boundary after contrast enhancement, aspect ratio after contrast enhancement, etc.The magnetic field strength of the equipment is planned to be recorded in the enhanced MRI information, the name of the MRI contrast agent, the lesion location, the size of the LESION, and the scanning performance are enhanced (lump-like enhancement, non-lump-like enhancement, point-like enhancement), time-signal intensity enhancement curve, DWI signal, ADC value, etc.

Eligibility Criteria:
Inclusion Criteria:

1. Conventional ultrasonography suggested definite lesions in the breast;
2. In addition to conventional ultrasound, there is also enhanced MRI examination;
3. There are no contraindications for puncture biopsy, and pathological examination (cytology, histology) is planned to examine the patients with target lesions
4. Patients volunteered to participate in the study and signed informed consent.-

Exclusion Criteria:

1. Those who are known to be allergic to ultrasound contrast agents;
2. The subject has a history of allergy to eggs or egg products (i.e. skin rash, dyspnea, swelling of the mouth or throat, hypotension or shock, etc.)
3. Arteriovenous (left and right) shunt patients in the heart and lungs
4. Patients with serious heart disease or serious lung disease
5. Patients who are pregnant, possibly pregnant or lactating
6. Patients who cannot receive contrast agent MRI
7. In addition, the investigator or the patient that the investigator considers not suitable to participate in this study
Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid Cells

The idea of the project is to develop a method of treatment of postoperative hypoparathyroidism using cultured allogenic parathyroid cells.

The cells will be isolated and cultured from the parathyroid gland of brain-dead organ donors. Cells will be tested for the immunophenotype, viability, sterility and the production of parathyroid hormone. Cells will be co-cultured with the patients T-cells and the expression of perforin and granzyme B proteins will be assayed as well as the apoptosis/viability of parathyroid cells. Prepared cells will be used to treat the patients with postoperative hypoparathyroidism. The safety, tolerability and clinical efficacy will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of postoperative hypoparathyroidism
* Decreased PTH concentrations in blood serum
* The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
* Written informed consent

Exclusion Criteria:

* The presence of any malignant tumor within the last 5 years
* Acute or chronic diseases in the stage of decompensation
* Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis
* Patients who are pregnant, breastfeeding, or fertile patients who are not using adequate contraceptive methods
* Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol
* Patients are unable or unwilling to give written informed consent and / or follow research procedures
* Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study
Detection of COVID-19 in Saliva Collection

Since December 2019, the world has faced a pandemic of COVID-19, an infectious disease caused by SARS-CoV-2, a virus that emerged in China. The reference diagnosis is based on the search for the SARS-COV-2 genome in the nasopharyngeal sample.

Carrying out this sample requires the competence of a healthcare professional and presents some inconveniences for the tested patient. Because saliva collection is simple, non-invasive, painless and inexpensive, and can be performed by poorly trained personnel, it could be an alternative to the reference nasopharyngeal sample. SARS-CoV2 detection in human saliva could be a potential diagnosis of COVID infection.


Eligibility Criteria:
Inclusion Criteria:

* patient hospitalized at the Amiens CHU in a COVID-19 unit
* patient seen as outpatient in the area of infectious pathologies for COVID-19 infection

Exclusion Criteria:

* Patients under 18
* patients under guardianship or curators
Azopt (Brinzolamide 1.0%) Plus Travatan (Travoprost 0.004%) in Treating Patients With Chronic Angle-Closure Glaucoma (CACG)

To evaluate the IOP (Intraocular Pressure) lowering efficacy and safety of Brinzolamide 1.0% (Azopt), dosed twice daily as adjunctive therapy in patients treated with Travoprost 0.004% (Travatan) once daily. The study is double masked. The patients will receive either treatment for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years;
* CACG (Chronic Angle Closure Glaucoma) ≥ 1eye
* have been treated with PGA (prostaglandin analogues) once daily ≥ 2 weeks prior to the screening visit and IOP=19-32 mmHg (millimeters mercury) in at least one eye and ≤ 32 mmHg in both eyes
* clinical stability of VA (Visual Acuity) and optic nerve throughout the study

Exclusion Criteria:

* Abnormality restricts exam of the fundus or anderior chamber
* conjunctivitis, keratitis or uveitis
* unable to be discontinued from using all ocular hypotensive medication(s) except Travatan (Travoprost 0.004%) and/or Azopt (Brinzolamide 1.0%) for 12days-4weeks
* ocular surgery prior to the study
Bobath Approach On Hemiplegic Shoulder Pain

In this study, it is investigated that whether Bobath approach is superior to conventional physiotherapy in terms of improving hemiplegic shoulder pain, spasticity and upper extremity functionality in stroke patients.

Objective: This study aims to determine the effect of Bobath approach on hemiplegic shoulder pain, spasticity and upper extremity functionality in stroke patients.

Patients and Methods: For this prospective, randomized, controlled and single-blind trial, 30 stroke patients aged 40-65 years with hemiplegic shoulder pain were included. Patients were divided into two groups and randomized into these groups. Only conventional physiotherapy was applied to the control group, whereas both conventional physiotherapy and Bobath exercises were also applied to the experimental group. Visual analog scale (horizontal) for shoulder pain, modified Ashworth scale for spasticity and Fugl-Meyer assessment of the upper extremity for functionality were used for both pre-test and post-test.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 40 and 65
* Patients who had a stroke for the first time and had a disease duration of at least four weeks
* Patients who were diagnosed with ischemic or hemorrhagic stroke
* Patients who had Brunnstrom stage 3, 4 or 5 and had hemiplegic shoulder pain were included in the study.

Exclusion Criteria:

* Patients with severe cognitive impairment who could not understand simple verbal commands
* Those who had severe dysarthria to prevent verbal communication
* Those with unilateral neglect syndrome
* Those with loss of sensation in the upper extremity of the hemiplegic side
* Those with botulinum toxin-A injected to the hemiplegic upper extremity muscles
* Those with previous shoulder-related trauma or pain history
* Those with other accompanying neurological disease were excluded from the study.
Specialized Clozapine Clinic for Bipolar and Schizoaffective Disorder

Bipolar Disorder (BD) and Schizoaffective Disorder (SA) clients.

* determine if after 12 months of treatment with clozapine, the BMI changes with clients who are councelled as usual regarding weight gain while on Clozapine.
* determine if after 12 months of treatment with clozapine, the BMI changes with intense, structured councelling about diet and exercise.

To determine whether the changes in BMI produced in subjects with Bipolar Disorder (BD) and Schizoaffective Disorder (SA) by 12 months of treatment with clozapine, can be diminished after an intense and highly structured intervention focused on diet and exercise, compared with the usual brief counseling regarding weight gain on this drug.

Eligibility Criteria:
Inclusion Criteria:

* Clients diagnosed with bipolar disorder or schizoaffective disorder
* Clients who respond poorly to treatment
* Males and females ages 18 years or older
* Clients who have had a trial of antipsychotics, incl. at least one atypical antipsychotic plus at least 2 mood stabilizers
* Clients who are capable of providing informed consent

Exclusion Criteria:

* Clients who take carbamazepine
* Clients with a history of extremely low white blood counts
* Clients with severe kidney, liver or heart disease, or heart operation
* Clients are hypersensitive to clozapine
* Clients who have a history of serious side effects after previous treatment with clozapine
* Clients with alcohol or drugs abuse within the last 3 months
* Clients who have a seizure disorder
* Clients who have metal in the head, neck or eyes, shrapnel, bullets, or body piercing, a pacemaker, brain aneurism clips, cochlear implant, hearing aid, tens unit, spinal implant, or pregnancy. These safety measures are necessary because of the magnetic fields of the MRI scan.
Different Anesthetic Managements of Esophageal Resection and Reconstruction

Anesthetic management and fluid therapy is crucial in esophageal resection and reconstruction, which is associated with high incidence of postoperative morbidity and mortality. This study aims to investigate the effect of goal directed fluid management on the postoperative outcome of esophageal resection and reconstruction.

Anesthetic management and fluid therapy is crucial in esophageal resection and reconstruction, which is associated with high incidence of postoperative morbidity and mortality. Excessive fluid administration may result in pulmonary complication, while extremely hypovolemia may lead to shock, circulatory dysfunction, and renal damage. Little is known about fluid status will have impact on anastomotic leakage. Goal-directed fluid therapy has shown to benefit perioperative outcome in major abdominal surgery. This study aims to investigate the effect of goal directed fluid management on the postoperative outcome of esophageal resection and reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as esophageal cancer
* Scheduled for minimally invasive esophageal resection and reconstruction

Exclusion Criteria:

* End-stage organ dysfunction, including heart failure, hepatic failure, renal failure
* Arrhythmia
* Pregnancy
A Comparison of Three Nutritional Assessment Methods Predicting Prognosis in COPD With Respiratory Failure

This is a retrospective study of patients diagnosed with chronic obstructive pulmonary disease (COPD) with respiratory failure and admitted in West China Hospital during January 2014 to March 2016 by review of medical records. The following variables will be retrospectively studied: age, sex, marriage, height, weight, respiratory rate, PaO2, PaCO2, nutritional risk screening 2002 (NRS 2002) score, ALB, short-term and long-term prognostic outcomes, and so on. The purpose of this study is to compare the predictive power of three widely used nutritional assessment methods (BMI, NRS 2002 and ALB) predicting the prognostic outcomes in a cohort of COPD patients with respiratory failure.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosis of COPD at West China Hospital during January 2014 to March 2016
* Partial pressure of O2 (PaO2) \< 60 mmHg and/or partial pressure of CO2 (PaCO2) \>50 mmHg
* Age ≥ 18 years
* Respiratory rates \> 23 bpm

Exclusion Criteria:

* Pregnancy or during lactation
* Ventilatory dysfunction due to neuromuscular disorders, acute and chronic thromboembolic disease, severe illness in other systems
* Incomplete medical profiles
Developing a Digital Handover Application for Paramedics to Provide a Personalized Approach to Pre-hospital Stratification for Out of Hospital Cardiac Arrest

A prospective study validating the role of the MIRACLE2 score in patients with resuscitated out of hospital cardiac arrest in a pre-hospital setting.

Design: Prospective observational cohort study enrolling OOHCA patients across London in a pre-hospital setting

Study Protocol: Patients with OOHCA and ROSC will be recruited from the community into the study by London Ambulance Service NHS Trust (LAS). LAS has -40 Advanced Paramedic Practitioners in Critical Care (APP-CC) who have a range of specialist skills including airway management and focused ultrasound and attend to over 1500 OOHCAs/year.

Point of Care pH test: The recruited participants will have point of care pH testing performed using the CG4+ iStat system (Abbott Vascular, Illinois, U.S.A.). The test requires 2ml of venous blood and can provide blood results within minutes. The device and blood taking system have received CE marking and are already in routine use across the NHS. Once the blood results are received, the blood sample and testing system are discarded in a routine manner.

Standard Care: Participants will then be conveyed to either the local emergency department or to a HAC based on current routine protocols. Patients will be treated in a routine manner after reaching secondary care in accordance with local and national guidance with no change in care based on this study.

Power calculation: In 2019, APP-CCs from LAS attended to -700 OOHCA patients with ROSC. Assuming 60% recruitment, we could comfortably envisage -500 patients to be recruited in a 15 month period. From previous data, we can expect approximately 60% of the patients (n=300) to have a CPC score of 3-5 on hospital discharge. This would be of a similar size to the dataset used to derive the original score, which gave good levels of accuracy in model performance measures.

Eligibility Criteria:
Inclusion Criteria:

* Patients with out of hospital cardiac arrest with sustained ROSC (defined as \>20 minutes or sufficient stability to consider conveyance)

Exclusion Criteria:

* Any clear non-cardiac cause of arrest (trauma, drowning Overdose, asphyxia, asthma, anaphylaxis).
* Suspected or confirmed intra-cerebral bleeding
* Known CPC score 3 or 4 pre-cardiac arrest
* Known disease limiting survival to 6 months
* Suspected or known pregnancy
Pharmacokinetic Interactions and Safety Between Exforge Tab. and Crestor Tab. in Healthy Male Subjects

This study is designated to evaluate the pharmacokinetic interactions of amlodipine besylate, valsartan and rosuvastatin in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Male volunteers in the age between 20 and 55 years old
2. The weight range is not exceed ±20% of ideal weight Ideal weight = \[height -100\]\*0.9
3. Subjects with no history of any significant chronic disease
4. Judged to be in good health on the basis of their electrocardiography (ECG) and routine laboratory data obtained within 3 weeks prior to study drug administration
5. Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

1. History of clinically significant allergies including drug allergies
2. History of clinically significant hepatic, renal, gastrointestinal, pulmonary, ,musculoskeletal, endocrine, psychiatric, hematologic, oncologic, neurologic or cardiovascular disease
3. History of genetic muscular disease and family history
4. hypotension (Systolic Blood Pressure(SBP) ≤ 105 or Diastolic Blood Pressure(DBP) ≤ 65) or hypertension(SBP ≥ 150 or DBP ≥ 100)
5. AST(Aspartate Transaminase), ALT(ALanine Transaminase), total bilirubin( \> 1.5 times to normal range
6. Creatinine clearance \< 80mL/min
7. Subjects with a history of gastrointestinal diseases which might significantly change ADME(Absorption, Distribution, Metabolism and Excretion) of medicines
8. Serious injury, surgery and acute illness within 4 weeks prior to drug administration
9. History of alcohol, smoking abuse

   * alcohol \> 21 units/week, 1 unit=10g=12.5mL of pure alcohol
   * smoking \> 10 cigarettes/day
10. Use of any other medication, including herbal products, within the 2 weeks before dosing
11. Participated in a previous clinical trial within 3 months prior to drug administration
12. Subjects with whole blood donation within 2 months, component blood donation within months prior to drug administration
13. Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
14. Clinical laboratory test values are positive (HBsAg, HCV Ab, HIV Ag/Ab, VDRL)
15. Subjects considered as unsuitable based on medical judgement by investigators