cyrilzakka/clinical-trials huggingface dataset:
Additional Effect of Intrapulmonary Percussive Ventilation (IPV) on Respiration in People With Multiple Sclerosis (MS).

This study aims to investigate whether intrapulmonary percussive ventilation (IPV) in combination with active breathing exercises using the flow-based incentive spirometer (Inspirix) has a positive effect on the respiratory values in people with multiple sclerosis (MS).

The primary research question includes "what is the additional effect of intensive IPV treatment in combination with active breathing exercises on respiratory power (Peak Expiratory Flow, PEF) in people with MS?".

In a single-center randomized clinical trial, 96 people with MS-related respiratory problems will be allocated to either the intervention group (IPV + active breathing training) or the control group (active breathing training only). Interventions will be provided by trained speech- and language therapists, in combination with a multidisciplinary rehabilitation programme of 3 weeks. Pre- en posttraining assessment includes measures of respiration, speech and fatigue.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis MS
* inpatient in the National Multiple Sclerosis Center Melsbroek for at least 3 weeks in the period Jan-Dec 2020
* adequate lip closure
* adequate cognitive functioning (MMSE\>26/30 \& clinical observation)
* Peak Expiratory Flow (PEF) with a cut off score of 80% or lower

Exclusion Criteria:

* IPV or other breathing treatment of more than 1x/week within 3 months prior to study participation
* MS relapse within 3 months prior to study participation
* asthma or Chronic Obstructive Pulmonary Disease (COPD)
* infection of lower respiratory tract within 6 weeks prior to study participation
* infection of upper respiratory tract within 2 weeks prior to study participation
Effects of Oxytocin on Negative Symptoms and Social Cognition in Schizophrenia and Its Possible Mechanisms

The purpose of this study was to investigate the effects of oxytocin on negative symptoms and social cognitive task performance in schizophrenia. The investigators conducted a randomized, placebo-controlled trial testing the effects of twice daily intranasal oxytocin treatment for 14 days on psychotic symptoms and social cognition in patients with schizophrenia. The investigators hypothesize that PANSS scores will decline significantly and several social cognition measures will improved significantly or nearly significantly in oxytocin but not placebo recipients.

Social impairment is a primary cause of disability in schizophrenia, responds poorly to current antipsychotic medications and is related to deficits in social cognitive abilities, which include Theory of Mind, emotion recognition and attributional style. Oxytocin (OT) has many pro-social effects in animals and antipsychotic-like efficacy in preclinical tests. In this study, the investigators conducted a randomized, placebo-controlled trial testing the effects of twice daily intranasal oxytocin treatment for 14 days on psychotic symptoms and social cognition in patients with schizophrenia. The investigators will recruit patients with schizophrenia, screening of subjects included a review of psychiatric and medical history, physical examination, baseline social cognition measures were obtained followed by psychiatric ratings. Daily intranasal treatments were initiated after baseline assessments. Social cognition measures and psychiatric ratings were repeated beginning 50 min after the morning dose of study medication on treatment day 14. psychiatric ratings include The Positive and Negative Syndrome Scale (PANSS) and The Clinical Assessment Interview for Negative Symptoms (CAINS). The social cognition instruments are some social scales such as Toronto Alexithymia Scale, the Interpersonal Reactivity Index(IRI), and some computer tests such as reinforcement learning task and facial emotion identification test.

Eligibility Criteria:
Inclusion criteria were:

1. aged between 18 and 55 years;
2. DSM-IV diagnosis of schizophrenia, acute schizophreniform disorder, or schizoaffective disorder.

Exclusion criteria were:

1. presence of other psychiatric diagnoses (e.g., depression);
2. active misuse of substance or alcohol;
3. intellectual disability (IQ \< 70);
4. a history of neurological disorder.
Preoperative Anesthesia Automatic System:a Retrospective Cohort Study

To evaluate of PACMAN triage system is able to discern patient who may be safely screened by phone

PACMAN triage system consists of a health questionnaire and an algorithm. Patient were called up by registered nurses and asked to answer the questionnaire. Patients answers were applied to PACMAN algorithm to determine what kind of screening patient should receive: in person or by phone.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old, scheduled for elective clinical interventions under procedural sedation and all types of elective medium or low risk surgery with anaesthetic guidance, as defined by the European Society of Anaesthesia (ESA) guidelines.

Exclusion Criteria:

* \<18 years. Patients scheduled for emergency and high-risk surgery were excluded as the policy of our department dictates that these patients must always be seen in person, according to ESA guidelines.
Comparing Acular LS and Pred Forte in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells

The Investigators will compare, in a randomized, prospective, masked and controlled fashion the effect of a non-steroidal anti-inflammatory agent (Acular LS), a corticosteroid (Pred Forte) and a placebo (Refresh Tears) on patient discomfort, degree of intraocular pressure (IOP) lowering and degree of ocular inflammation following selective laser trabeculoplasty treatment for open angle glaucoma.

Currently, many ophthalmologists use anti-inflammatory agents like corticosteroids and nonsteroidal anti-inflammatory agents (NSAIDs) as a preventative measure to control the post-selective laser trabeculoplasty (SLT) anterior chamber inflammation. Both classes of compounds reduce inflammation through the inhibition of the cyclooxygenase pathway, whereas the corticosteroid class also inhibits the lipoxygenase pathway of the arachidonic acid cascade. Although effective, topical corticosteroids are associated with increase in intraocular pressure (IOP), posterior subcapsular cataract formation, and reduced response to infection. These adverse side effects have not been reported to occur with topical NSAIDs, which are effective in controlling the pain after SLT along with the prevention and suppression of the ocular inflammation. There are ophthalmologists who forgo using the anti-inflammatory agents post SLT and prescribe Refresh Tears to their patients to comfort the treated eye.

The significance of the study lies in assessing the efficacy of Acular LS, compared to Pred Forte and to Refresh Tears in reducing discomfort, inflammation and maximizing IOP lowering following SLT procedure for open angle glaucoma with the hope of resolving the dispute over the effective post-operative care in SLT patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with open angle glaucoma patients at the Rocky Mountain Lions Eye Institute Glaucoma Clinic.
* Able to provide written informed consent to participate.
* Must be the age of 18 years of age or older.
* Patients in which further intraocular pressure lowering by selective laser trabeculoplasty is necessary in the opinion of the treating physician.

Exclusion Criteria:

* Patients with eye surgery in the prior six months.
* Patients with prior or current use of topical or systemic corticosteroids or NSAIDs.
* Patients with pre-existing anterior chamber inflammation.
* Patients with known sensitivity to any of the study medications.
* Due to the age range and the disease entity, special patient populations such as children or pregnant women will not be enrolled in this study
Change of Renal Function and Bone Mineral Density in CHB Patients Switch from TDF to TAF Vs. Maintaining TDF

In Chronic hepatitis B (CHB) patients receiving long-term sequential Neucleos(t)ides(NAs), majority of these CHB patients experienced drug resistance and switched to Tenofovir disoproxil fumaratate(TDF). However, some of patients on long term TDF experienced impairment of renal function and bone mineral density. After Tenofovir alafenamide(TAF) was in clinical practice, these group of patients got an clinical option to switch from TDF to TAF. The investigators designed a prospective cohort study to evaluate the real life effectiveness and safety in participants with chronic HBV infection switch from TDF to TAF vs. maintaining on TDF.

Tenofovir disoproxil fumarate(TDF) have been associated with renal toxicity and reduced bone mineral density. Tenofovir alafenamide(TAF) is a novel tenofovir prodrug that reduces tenofovir plasma concentrations by 90%, thereby decreasing off-target side-effects. The investigators aimed to assess whether efficacy, safety, and tolerability were non-inferior in participants switched to TAF versus in those remaining on TDF. This is a prospective clinical study.

Eligibility Criteria:
Inclusion Criteria:

1. Chronic hepatitis B,
2. Antiviral experienced,
3. Currently on long term TDF anti-HBV treatment,
4. HBV DNA \< 6 log IU/ml (LLOD)
5. Able to sign the consent form of anticipating in the study

Exclusion Criteria:

1. Co-infected with HCV, HIV or other viral hepatitis,
2. Diagnosis of HCC
Misoprostol for Cervical Priming Before Office Hysteroscopy

The objective of the present study is to evaluate the appropriate route of administration of misoprostol, either oral or vaginal, for cervical priming to facilitate the procedure of office hysteroscopy and reduce patient discomfort to minimum

Sample size calculation was done using the comparison of pain sensation represented through VAS between oral and vaginal misoprostol for cervical ripening before office hysteroscopy. As reported in previous publication (Sordia-Herna'ndez et al., 2011), the mean ±SD of VAS in oral misoprostol group was approximately 6.04 ± 1.5, while in vaginal misoprostol group was approximately 2.8 ± 1.2. Accordingly, we calculated that the minimum proper sample size was 23 women in each arm to be able to detect a real difference of 1 unit with 80% power at α = 0.05 level using Student's t test for independent samples. Sample size calculation was done using Stats Direct statistical software version 2.7.2 for MS Windows, StatsDirect Ltd., Cheshire, UK

However, the study population consists of 100 patients in reproductive age that requires diagnostic hysteroscopy for investigation of infertility or AUB.

The patients will be recruited from Office hysteroscopy clinic of the Obstetrics and Gynecology Department, Faculty of Medicine, Cairo University from October 2017 to march 2018.

The Patients will be allocated equally into 2 groups ( each group contain 50 patients)

Groups will be as follows:

1. Group A: 50 patients receive 200 mg oral misoprostol (Misotac; Sigma Pharm) 3h before the procedure.
2. Group B: 50 patients receive 200 mg misoprostol (Misotac; Sigma Pharm) 3h before the procedure moistened with saline solution will be inserted in posterior fornix of vagina.

Eligibility Criteria:
Inclusion criteria:

1. Patients indicated for diagnostic hysteroscopy for infertility or AUB.
2. Reproductive age \>19 - 45yrs.
3. Postmenstrual between days 7 and 11 of the cycle ( except in irregular bleeding)

Exclusion criteria:

Contraindicating the use of prostaglandins such as:-

1. Cardiovascular disease
2. Severe bronchial asthma.
3. Hypertension.
4. Renal failure.
5. Known sensitivity to Prostaglandins

Contraindication to office hysteroscopy such as:-

1. Pelvic inflammatory disease.
2. Marked cervical stenosis.
3. Known cervical malignancy.
4. pregnancy
5. profuse uterine bleeding
6. Recent uterine perforation.

Neurological disorders affecting the evaluation of pain.

Previous cervical surgery.
Apatinib Plus Radiotherapy for Patients With Brain Metastases From Non-small-cell Lung Cancer

To observe the effectiveness and safety of apatinib combined with radiotherapy for brain metastasis from non-small cell lung cancer patients


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 75 years old, males or females;.
2. According to pathological and histological，the subjects were diagnosed with wild-type non-small-cell lung cancer patients from brain metastasis examinations;
3. Subjects failed first-line standard chemotherapy ;
4. Subjects expected survival of more than 3 months;
5. Eastern Cooperative Oncology Group performance status :0-2 points;
6. The main organ function is normal, that is to meet the following standards:(1) Blood routine examination meets the following standards

   a. Hemoglobin ≥90 g/L；b. Absolute Neutrophil Count≥1.5×10\^9/L； c. Platelet ≥80×10\^9/L； (2)Blood biochemistry examination meets the following standards

   a.Total Bilirubin \<1.5 times the upper normal limit；b.Glutamic transaminase \<2.5 times the upper normal limit, glutamic-oxalacetic transaminase \<2.5 times the upper normal limit， For patients with liver metastasis ,the Glutamic transaminase and glutamic-oxalacetic transaminase index is less than 5 times the upper normal limit c.Serum Cr was less than 1.25 times the upper normal limit
7. Women of reproductive age must undergo urine tests to eliminate the possibility of pregnancy.During the period of treatment and within 8 weeks after the treatment, the subjects voluntarily adopted appropriate methods of contraception .
8. Subjects volunteered to participate in this study and signed informed consent

Exclusion Criteria:

1. Patients with meningeal metastasis;
2. Patients with intracranial stroke;
3. Previous toxicity associated with chemotherapy and / or radiotherapy persisted;
4. Radiological evidence indicates the presence of an empty or necrotic tumor;
5. Radiological evidence indicates the presence of a central tumor invading large blood vessels;
6. Patients need to be treated with anticoagulants or antiplatelet drugs;
7. The subjects with abnormal coagulation function and bleeding tendency (INR\>1.5×ULN、APTT\>1.5×ULN);during the past 6 months, the subjects experienced severe thrombosis or clinically related severe bleeding events;In the past 3 months, clinically significant hemoptysis occurred;the subjects had inherited bleeding or thrombosis tendency;
8. Subjects with high blood pressure and whose blood pressure can not be reduced to normal range by antihypertensive drugs;
9. Other investigators believe that patients are not eligible for inclusion
Spiritual Well-being, Self-compassion, Physical Symptoms Distress and Demoralization Among HD Patients

To explore the associations between spiritual well-being, self-compassion, physical symptoms distress and demoralization among hemodialysis patients

The aims of this study is to explore the associations between spiritual well-being, self-compassion, physical symptom distress and demoralization in hemodialysis patients.

A cross-sectional correlation design will be used. We use convenient sample to recruit hemodialysis patients in a regional teaching hospital in the southern Taiwan. The research data is collected with a pact of self-administrated questionnaire including Chinese version of the Demoralization Scale , FACITsp-12 Scale, Self-Compassion Scale, and Physical Symptom Distress Scale. SPSS statistical software will be used to data analysis. Analysis methods included descriptive and inferential statistics. Finally, multiple linear regression will be used to test the predictors of demoralization. The research results will offer health providers to identify symptoms related to demoralization earlier and provide appropriate care to patients to adapt the long treatment process and improve their quality of life

Eligibility Criteria:
Inclusion Criteria:

* hemodialysis patient who agrees to join this study.
* The participant is over 20 years old.
* The participant has a clear consciousness and can communicate in Mandarin and Taiwanese to answer the questionnaire.

Exclusion Criteria:

* The hearing impaired cannot communicate.
* Intensive care unit or inpatients.
* Mental disorders or dementia such as depression, schizophrenia, and anxiety diagnosed by a physician.
* Those who are seriously unwell or have unstable vital signs.
Patient Satisfaction and Safety Outcomes After Enrollment in a Same-Day (SD) Percutaneous Coronary Intervention Program

Subjects in this study have recently had or are scheduled for a (percutaneous coronary intervention) PCI as part of their normal, routine medical care. This procedure should restore the blood flow in the vessels of the heart.

Recent studies have shown that stable patients who undergo PCI and are discharged home after 4 hours of observation do not suffer any more complications compared to patients who stay in the hospital overnight. In addition, studies suggest that patients express increased satisfaction at being discharged after 4 hours.

The University of Chicago is one of the first US medical centers to institute a formal program of same-day discharge after PCI. This study will seek, through a analysis of medical information and satisfaction questionnaires, to assess whether this particular same-day discharge program can improve patient satisfaction and preserve patient safety.


Eligibility Criteria:
Inclusion Criteria:

* age 18 and up
* undergoes coronary angiography in the Cardiac Catheterization Laboratory

Exclusion Criteria:

* if the subject declines participation
Lesinurad and Febuxostat Combination Extension Study in Gout

This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat over a long-term timeframe.

This is a Phase 3 extension study to assess the long-term efficacy and safety of lesinurad in combination with febuxostat in subjects who completed the double-blind treatment period in Study RDEA594-304.

Eligibility Criteria:
Inclusion Criteria:

* Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity.
* Subject completed the double-blind treatment period in Study RDEA594-304 and was actively receiving and tolerating study medication (lesinurad or placebo) and febuxostat 80 mg at the Month 12 visit.
* Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth control during the study and for at least 14 days after the last dose of study medication.

Exclusion Criteria:

* Subject has any medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.
Feasibility of a Postpartum Lifestyle Intervention on the Cardiometabolic Risk Profile of GDM Women

The goal of the study is to investigate the effect of a lifestyle intervention program (adoption of exclusive breastfeeding, healthy diet and regular physical activity) on minimizing postpartum weight retention among women with recent GDM.

Women with a history of gestational diabetes (GDM) are characterized by increased risk for subsequent type 2 diabetes (T2D) and cardiovascular disease (CVD). These women are also characterized by higher body mass index (BMI) and waist circumference compared to women without prior GDM. Failure to lose the weight gained during pregnancy can lead to increased BMI for subsequent pregnancies. As such, the childbearing-age period has been described as a potential period of weight gain and represents a critical window for the development of obesity, T2D and CVD. Therefore, strategies aiming at preventing postpartum weight retention (WR) and early cardiometabolic alterations in women with a history of GDM are of paramount importance. Principal investigator have shown that a low diet quality score was associated with greater adiposity and lower insulin sensitivity in women with prior GDM. Furthermore, less than 10% of women with prior GDM met the recommendations for breastfeeding, nutrition, and physical activity. Investigators have shown that attitude and perceived behavioral control were significant predictors of the intention to adopt healthy eating. For those who did engage in healthy behaviors, lower prevalence of cardiometabolic alterations was observed, providing supportive evidence that the adoption of healthy behaviors may be key to prevent the progression to an altered cardiometabolic profile.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women diagnosed with GDM
* Fluent in French
* Had a singleton pregnancy
* At least 18 yrs old
* With a reported pre-pregnancy BMI ≥18.5 kg/m2

Exclusion Criteria:

* Women who had bariatric surgery
* Women who plan another pregnancy in the following year
* Women with a history of type 1 or type 2 diabetes
* Women with a multiple pregnancy
Study on the Antiviral Therapy and Immune Reconstitution of Chinese HIV/AIDS Patients

This study will recruit 520 treatment-naive and 150 treatment-experienced patients to take the first line or second line of antiviral therapy. This study aims to set up a well-trained clinical and laboratory team in China, to explore the effects and side-effects of the first-line and the second line of ARV treatment in Chinese HIV/AIDS adult patients, to investigate the side-effects of ARV drugs, such as hepatotoxicity, lipoatrophy, cardiovascular influence, to explore the pharmacokinetics/pharmacodynamics (PK/PD) of Chinese generic ARV regiments and effective drug concentrations and to explore primary and secondary drug resistance in China and the immune reconstitution characters of long term ARV in Chinese adult AIDS patients. This study might provide more practical and optimizing prove for the treatment guideline for resource limited areas.

Three arms will be studied in this research, 520 naive-treatment patients would be randomized to two groups, taking the generic drugs 3TC+D4T+NVP or AZT+3TC+NVP, 6 months later half of the 3TC+D4T+NVP group will switch to AZT+3TC+NVP, in order to observe the efficiency and safety of the first line drugs. Arm 2 will recruit 100 patients who are taking ARV for about three years already. Arm 3 will recruit 150 patients who have a Viral load of more than 1000 copies/ml, i.e., drug resistance. The second line drug 3TC+TDF+LPV/RTV will given to them and the safety and efficiency will be observed. All patients should be explored in terms of the clinical features, drugs side-effects, and immunological and viral response. The drug concentration and the metabolism changes would be explored also. Also the immune reconstitution will be studied for all patients. This study will be the first large-scale, multicentered, randomised, prospective ARV therapy study in China for HIV/AIDs patients. The result would provide proves for further practical antiviral therapy for China or other resource limited countries.

Eligibility Criteria:
Inclusion Criteria:

* age between 18-65 years
* HIV seropositive and confirmed by western blot
* antiretroviral therapy naive for arm 1
* CD4 cell count \< 350/mm3
* good adherence and follow up in the same place

Exclusion Criteria:

* pregnancy and breastfeeding
* AIDS defining illness or any infectious disease occured in one month but still unstable within 14 days
* with WBC \< 2000/ul, neutrophil count \< 1000/ul, hemoglobin \< 9 g/dl, platelet count \< 75000/ul, amylase \> 2 ULN, transaminase or alkaline phosphatase or total bilirubin \> 2 ULN, creatinine \> 2 ULT.
* present acute or chronic pancreatitis
* intravenous drug user
* peripheral nephropathy
* severe nephropathy or mental disorder
* severe gastral ulcer
* heart or brain arthrosclerosis