cyrilzakka/clinical-trials huggingface dataset:
An InnovaTive Approach to Ventilator-Induced Diaphragmatic Dysfunction

'Ventilator-Induced Diaphragmatic Dysfunction (VIDD) was originally described by Vassilakopoulos and Petrof in 1998, where it is used to cover the effects of mechanical ventilation and respiratory muscle unloading on the diaphragm. A recent article by Grosu and colleagues has demonstrated that the thickness of the diaphragm decreases with about 6% a day in a small cohort of mechanically ventilated patients. This is a longitudinal, single-centre, observational cohort study to examine the long-term effects of invasive mechanical ventilation on the diaphragm, and to study the risk factors associated with VIDD.


Eligibility Criteria:
Inclusion Criteria:

* The patient must suffer from respiratory insufficiency requiring mechanical ventilation

Exclusion Criteria:

* The patient has been hospitalized and mechanically ventilated (invasive or non- invasive) in the period up to 1 year before start of the study.
* The patient is known or suspected to have an anatomical malformation of the diaphragm.
* The patient suffers from a disease that may impair diaphragmatic function:

  * Central neural disease at the level of the brain (Multiple sclerosis, stroke, Arnold-Chiari malformation) and spinal cord (quadriplegia, amyotrophic lateral sclerosis, poliomyelitis, spinal muscular atrophy, syringomyelia).
  * Neural disease of the phrenic nerve (Guillain-Barré syndrome, tumor compression, neuralgic neuropathy, chronic inflammatory demyelinating polyneuropathy, Charcot-Marie-Tooth disease).
  * Disorders of the neuromuscular junction (Myasthenia gravis, Lambert- Eaton syndrome, botulism, organophosphate poisoning).
  * Muscular diseases (muscular dystrophies, myositis (infectious, inflammatory, metabolic).
* The patient is known or suspected to have a psychiatric illness inhibiting his/her cooperation with the study protocol or possibly obscuring the obtained results.
* The patient has been mechanically ventilated for over 24 hours before the first ultrasonographic measurement can be performed.
Asthma During Pregnancy; Impact of Severity

bronchial asthma (BA) may affect pregnancy and this affection may increase with increasing asthma severity. This study was designed to detect the effect of asthma severity on the course of asthma during pregnancy and its effect on the pregnancy and perinatal outcome

This was prospective study conducted in sohag university hospital ( obstetric outpatient clinic, chest outpatient clinic and emergency department ).This study aimed to detect the effect of baseline asthma severity on the course of asthma during pregnancy and its effect on the pregnancy and perinatal outcome in the setting of advancements in the management and pharmacotherapy of asthma compared with that previously

Eligibility Criteria:
Inclusion Criteria:

* pregnant women in ages 18y or more with confirmed diagnosis of bronchial asthma presenting in1st trimester to inpatient or outpatients clinic of chest department.

Exclusion Criteria:

* Patients with Chest diseases other than bronchial asthma and patients with cardiac disease.
HPV-based Screening Among Women 23-29 Years of Age

The aim of the trial is to determine whether organized screening with primary HPV analysis provide higher cancer protection in the age group 23-29 years compared to primary cytology.

The aim is to investigate whether primary HPV analysis in the organized cell sampling program for women in the age group 23-29 provides higher cancer protection compared to the current method where cell samples are primarily analyzed with cytology. In this study, all women in the age group 23-29 in the Stockholm and Skåne Region of Sweden will participate. Age is defined by year of birth. For 2020, women born 1991-1997 are included. Sampling and collection of samples is the same as for cytology.

Eligibility Criteria:
Inclusion Criteria:

* Women ages 23-29 invited to screening.

Exclusion Criteria:

* Women who do not show up for screening or do not consent.
Activation of Biobank Registry for Bilio-pancreatic Diseases

The purpose of establishing the biobank is to create a collection of biological material and clinical data, with a prospective and retrospective mold, in order to investigate the role of genetic predisposition in multifactorial bilio-pancreatic diseases, so that an evaluation of the possible association in the pathogenesis of exogenous factors with endogenous factors can be allowed.

Multifactorial diseases are in fact an expression of genetic predisposition upon which one or more environmental stimuli act. Usually the aforementioned factors are not capable individually of triggering disease but, when simultaneously present, can cause the pathological phenotype. Therefore, it becomes important in the description of disease pathogenesis to identify as many risk factors for disease prevention and early diagnosis.

Samples collected depending on the disease:

* Peripheral blood;
* Portal blood;
* Saliva;
* Urine;
* Stool;
* Cystic fluid;
* Pancreatic juice;
* Biopsy tissue specimens;

Eligibility Criteria:
Inclusion Criteria:

* age \>= 18 years
* signed informed consent

Exclusion Criteria:

* age \< 18 years
* unwilling to sign informed consent
Analysis of CMV Infections in Patients With Brain Tumors or Brain Metastases During and After Radio(Chemo)Therapy

Radio(chemo)therapy is the standard therapy for both, brain tumors and brain metastases. Neurological decline is observed in these patients and tumor progression or radiotherapy side effects have been made responsible for this. However CMV encephalitis may also be a reason. Therefore the investigators aim to analyze the CMV status in patients during and after radio(chemo)therapy. It will be checked by CMV-DNA (PCR analysis) and CMV antibodies (IgG and IgM ELISA) in the blood of the patients. These findings will be correlated with changes in the brain, visualized by MRI. In addition a detailed immunophenotyping in the peripheral blood will be performed.


Eligibility Criteria:
Inclusion Criteria:

* brain tumours (glioblastoma or anaplastic astrocytoma)
* brain metastases from diagnosed primary tumours
* legal age
* planned chemoradiation and adjuvant chemotherapy \[metastases\]
* planned chemoradiation and adjuvant chemotherapy with temodal (according to Stupp et. al.) \[brain tumors\]

Exclusion Criteria:

* fertile patients who refuse effective contraception during study treatment
* persistent drug and/or alcohol abuse
* patients not able or willing to behave according to study protocol
* patients in care
* patients that are not able to speak German
* patients with claustrophobia
* patients with artificial joint or any metal parts in the body
* patients with pacemakers
Health Education and Counseling in Smoking Cessation Behavior, Smoking Decisional Balance, and Self-efficacy

Most male smokers with coronary heart disease resume smoking after hospital discharge. The main reason for failure to quit smoking is lack of motivation. However, few studies have used individual health education models to explore the effectiveness of smoking cessation according to the stage of change in smoking cessation behavior of patients. The purpose of this study was to examine the effectiveness of health education and counseling on the stages of change, smoking decisional balance, and self-efficacy of smoking cessation in smokers with no intention of quitting.

Patients diagnosed with coronary heart disease by a medical center and smoked habitually were recruited as participants through convenience sampling. The research period was divided into a control stage (first to fourth week: standard of care) and the experimental stage (fifth to eighth week: health education and counseling). In the control stage, participants only received standard nursing care. In the experimental stage, intervention measures (health education and counseling) were implemented. The baseline data were the pretest data collected in the control stage. Four weeks later, a posttest was performed, namely the pretest of the experimental stage. Subsequently, 4 weeks of health education and counseling were introduced to smokers according to different stages. After 4 weeks of intervention, participants were asked to fill out the posttest questionnaire again to measure the stages of change for smoking cessation, smoking decisional balance, and self-efficacy of smoking cessation.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with coronary heart disease by a medical center and smoked habitually

Exclusion Criteria:

-
Third Ventricle Echographic Study for Neuro-intensive Care Unit Patients

Transcranial Doppler ultrasonography is usually used in the evaluation and management of patients with brain injury. This noninvasive method measures local blood flow velocity and direction in the proximal portions of large intracranial arteries. The operator requires a short training and experience to perform. The third ventricle diameter measurement by transcranial duplex flow sonography was performed in healthy volunteers . This studies show similar results in those obtained with the MRI or Computer Tomography (CT). Currently the third ventricle diameter measurements by transcranial Doppler ultrasonography was not validated for neuro-intensive care unit patients. The investigators propose to used recent ultrasound system to validate the third ventricle diameter measurements in comparison with the standard method (CT).

Transcranial Doppler ultrasonography is usually used in the evaluation and management of patients with brain injury. This noninvasive method measures local blood flow velocity and direction in the proximal portions of large intracranial arteries. The operator requires a short training and experience to perform. The third ventricle diameter measurement by transcranial duplex flow sonography was performed in healthy volunteers . This studies show similar results in those obtained with the MRI or Computer Tomography (CT). Currently the third ventricle diameter measurements by transcranial Doppler

Eligibility Criteria:
Inclusion Criteria:

* Adult, \> or equal to 18-yr
* Admission to neuro-intensive care unit with brain injury
* Evaluation by Computer Tomography
* Indication for Transcranial Doppler ultrasonography

Exclusion Criteria:

* Opposition to participate by the patient or a next of kin
PK/PD Clinical Trial of YYD601 in Healthy Adult Male

A dose block-randomized, open-label, parallel clinical trial

This study to evaluate comparatively a characteristics and safety of the PK/PD of single/repeated oral administration YYD601 and Nexium tab and the effects of food influence the PK/PD of YYD601 in healthy adult male.

Eligibility Criteria:
Inclusion criteria:

* Healthy adult male above 19 years old when getting a screening test.
* Subjects who have over 50kg weight, included in the IBW± 20% range. \[IBW(kg)={height(cm)-100}x0.9
* Subjects who haven't any congenital or chronic disease, and any other disease following the medical examination.
* Subjects who are confirmed as a participant by the serum test, hematologital test, blood chemistry tests, urine tests, and clinical laboratory test, 12-lead EKG etc following the characteristics aboht the IP within the 3 weeks before investogator products are administrated.
* Subjects who voluntarily decide to participated in this trial after comletely understand about this clinical trial.

Exclusion criteria

* Subjects who are judged not suitable to participated in this trial.
* Other specific exlusion criteria is identified in the protocol.
Critical State of "Remission-Recurrence" of Ulcerative Colitis

This study will recruit 100 patients with ulcerative colitis in remission for a 6-month non intervention follow-up observation. During the study, their conditions will be recorded truthfully, including general information, disease-related symptoms and signs, inflammatory bowel disease questionnaire, anxiety self-assessment scale, depression self-assessment scale, etc., every month. Collect blood, urine, and stool samples from patients every month for examination. Follow up for each subject until their condition recurs.


Eligibility Criteria:
Inclusion Criteria:

* Patients who meet the criteria based on the clinical characteristics of ulcerative colitis patients in the "remission recurrence" critical state, combined with clinical symptoms, are diagnosed with ulcerative colitis through imaging, endoscopy, laboratory, and histopathological examinations;
* Patients with comprehensive laboratory testing indicators.

Exclusion Criteria:

* Patients with incomplete case information records;
* Patients who have not completed serological tests;
* Complications including intestinal obstruction, intestinal perforation, toxic megacolon, and severe local stenosis;
* Diagnosed or suspected patients with coexisting uncertain colitis, infectious or ischemic colitis;
* Patients with coexisting local or systemic infections, any malignant diseases, or autoimmune diseases;
* Merge primary diseases such as respiratory, circulatory, neurological, endocrine, and hematological disorders;
* Individuals at risk of developing cancer;
* regnant or lactating women.
Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis

Preeclampsia is a disease which occurs in about 6-8% of all pregnancies and is the main cause of maternal and fetal morbidity and mortality. The cause of preeclampsia is still not clear and the only therapy is preterm caesarean section. In severe preeclampsia an accumulation of triglyceride-rich lipoproteins occurs. Therefore, lipid apheresis is performed as lipid-removing therapy for treatment of preeclampsia in order to prolong pregnancy and provide the fetus more time for maturation. In this individual treatment patients with early preeclampsia (\<= 32 weeks of gestation) will be offered a H.E.L.P.-apheresis to postpone caesarean section and therefore prolong pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* early preeclampsia (\< 32 week of pregnancy)
* arterial hypertension during pregnancy
* proteinuria (=\> 1 + dipstick or 0\> 300 mg/24h)
* and/or intrauterine growth retardation (IUGR)
* informed consent

Exclusion Criteria:

* every acute indication for immediate delivery
* no informed consent
Efficacy, Tolerance and Satisfaction With CLOBEX® Spray When Used as Monotherapy or Add-on Therapy in Plaque Psoriasis

Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents.

Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents, as determined by the change in the target plaque severity (TPS) rating between Weeks 0 and 4.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe plaque psoriasis between 3% and 20% of Body Surface Area (BSA) with a target plaque severity (TPS) of moderate to severe
* At least 1 target site (not on the palms or soles of the feet) with a TPS rating of moderate to severe and with 1 or more elevated, easily palpable, plaques having well-circumscribed margins, and at least 1 cm in diameter
* History of stable plaque psoriasis of greater than or equal to 3 months

Exclusion Criteria:

* Diagnosis of guttate, generalized pustular, erythrodermic, psoriatic arthritis, or nail psoriasis as the sole or predominant form of psoriasis
* Psoriatic arthritis that was not stable or might have required a change in medication during the 4-week study period
* Plaque psoriasis requiring treatment on the face, scalp, neck, groin, and armpits
A Single-arm Pilot Study of Tislelizumab Combined With Anlotinib in Patients With Advanced NSCLC With Driver-negative After Progression to Immunotherapy

Immune resistance after treatment, there is no standard treatment, one of the most important and the most effective measures is immune to combination therapy。Targeted angiogenesis therapy has always been the focus of research on the treatment of NSCLC patients with progressive disease after immunotherapy. From the mechanism of action, angiogenesis and immunosuppression are interrelated processes.


Eligibility Criteria:
Inclusion Criteria:

1. voluntary participation in clinical research; Fully understand and Informed the study and sign the Informed Consent Form (ICF); Be willing to follow and be able to complete all trial procedures;
2. age of 18-75 years old (including boundary value), regardless of gender;
3. Pathologically confirmed locally advanced, metastatic non-small cell lung cancer (NSCLC), including squamous non-small cell lung cancer and non-squamous non-small cell lung cancer. Patients with non-squamous non-small cell lung cancer should exclude known EGFR mutation or ALK gene rearrangement.
4. patients with resistance to first-line PD-(L)1 inhibitors combined with chemotherapy;
5. patients with tumor response of CR/PR/SD after at least one first-line immunotherapy;
6. Subjects' ECOG PS score was 0-1 (including boundary value);
7. Patients had to have ≥1 measurable lesion (according to RECIST1.1 criteria).
8. predicted survival time ≥6 months;

Exclusion Criteria:

1. Frontline treatment with anlotinib, anti-angiogenic macromolecular monoclonal antibody or other small molecule TKI drugs;
2. central lung cancer with large blood vessel invasion;
3. patients with any signs or history of bleeding that may affect treatment according to the investigator's judgment; Patients with bleeding events ≥CTCAE grade 3, unhealed wounds, ulcers, or fractures within 4 weeks before the first dose of study drug;
4. hemoptysis \> 50ml/d;
5. inability to swallow capsules or diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, gastric or small bowel resection, bariatric surgery, inflammatory bowel disease, partial or complete intestinal obstruction;
6. Poorly controlled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg)
7. other known malignant tumors that are developing or require active treatment;
8. Currently participating or has participated in the clinical research of other drugs;
9. interstitial lung disease or (non-infectious) pneumonia requiring steroid therapy
Levitra® - Real Life Safety and Efficacy of Levitra

Collect data on safety, efficacy, and subject acceptance of vardenafil treatment under daily life conditions in a large number of subjects with erectile dysfunction (ED)


Eligibility Criteria:
Inclusion Criteria:

* Male outpatients \>/= 18 years of age with a diagnosis of ED according to the 1992 US National Institutes of Health (NIH) Consensus Statement (the inability to achieve and maintain penile erection sufficient to complete satisfactory intercourse), and independent of any previous ED treatment

Exclusion Criteria:

* Exclusion according to US PI
A Trial of Two Mask Systems in Preventing SARS CoV-2 in Healthcare Workers (HCW)

A cluster randomized trial will be conducted to evaluate the difference between an Acteev™ system (Acteev™ N95 masks YQD8008 during shifts+ Acteev™ fabric masks in community) and a standard system (standard N95 masks during shifts+ fabric masks in community) in preventing Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2)in healthcare workers(HCWs).

This is a maximum 10-week (8-week intervention+2-week follow up) two-armed controlled study to investigate efficacy of Acteev™ system (Acteev™ N95 masks YQD8008 during shifts+ Acteev™ fabric masks in community) compared with standard system (standard N95 masks during shifts+ fabric masks in community) in HCWs working in high-risk hospital wards (ICU, emergency), against the prevention of SARS CoV-2 infection. Prospective HCWs will be identified for the study by the study investigator/study team and be invited for participation in the study. All study procedures will begin only after obtaining written informed consent from the subjects. Subjects will be randomized in one of the two arms mentioned below after meeting all the study eligibility criteria: Arm 1:Acteev™ system (Acteev™ N95 masks YQD8008 during shifts+ Acteev™ fabric masks in community) Arm 2: Standard system (standard N95 masks during shifts+ fabric masks in community).

Eligibility Criteria:
Inclusion Criteria:

* Health care workers and allied health care staff working in COVID wards, COVID ICU, Non COVID ICU (This will include all specialty ICUs in the hospital), Casualty/Emergency, Operation Theatre and Pathology lab of the hospital
* Health care workers and allied health care staff involved in performing high risk procedures like suctioning, intubation, nebulized medications, chest physiotherapy, other aerosol generating procedures and handling pathology samples
* Negative COVID 19 RT-PCR test within last 3 days of screening
* COVID 19 vaccinated or non-vaccinated

Exclusion Criteria:

* Unable or refused to consent
* Current respiratory illness, rhinitis and/or allergy
* Currently participating in any other clinical trial
* Beard or facial hair
Topical Analgesia Post-Haemorrhoidectomy

Symptomatic haemorrhoids, or piles, have significant effects on quality of life. The treatment for advanced disease is surgical excision (haemorrhoidectomy) which is extremely effective. However, pain following haemorrhoidectomy is known by all to be a miserable experience and current treatment is not very effective. We have formulated a new cream treatment which targets three theorised mechanisms of pain after haemorrhoidectomy. We will test the effectiveness of the treatments with a multi-centred randomised controlled factorial trial with four parallel double-blinded arms containing different combinations of the active agents. The outcomes include pain scores, amount of analgesia required and time to return to work. The results of our study could provide evidence of an effective treatment for post haemorrhoidectomy pain. The treatment may provide considerable benefit to patients undergoing this surgical procedure.

Study Design: This will be a patient-and-investigator blinded factorial randomised trial with four parallel groups. Participants in all four groups will be instructed to apply cream 3 times a day for 7 days after surgery. A standard analgesia prescription will be provided with laxatives as per routine care. Patients will be provided a questionnaire to complete and return on day 14.

Random Sequence Generation: Computer generated sequence allocating patients to a 1:1:1:1 ratio using permuted block randomisation in blocks of 12.

Allocation Concealment: This randomisation code will be seeded to the pharmacist to who will package and label the cream according to a code. The creams will be indistinguishable to which active ingredient they contain.

Assignment of intervention: Patients will be assigned in order according to the numbering of the cream tubes by the blinded investigator.

Data recording: Data will be recorded on Redcap database.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥16
* All patients undergoing excisional haemorrhoidectomy

Exclusion Criteria:

* Age \<16,
* history of chronic pain,
* drug allergy or idiosyncracies to any actives or excipients in
* cream,
* breastfeeding,
* any medical history which is a contraindication to any of metronidazole, lidocaine, or diltiazem including including:
* sick sinus syndrome,
* atrioventricular block,
* hypotension,
* heart failure and bradycardia.
* concomitant medications which are contraindicated to metronidazole, lidocaine or diltiazem.
* patients already taking diltiazem.