cyrilzakka/clinical-trials huggingface dataset:
Interstitial Lung Diseases in Primary Sjogren's Syndrome

Patients with pSS seen in the Division of Rheumatology, the second affiliated hospital of Zhejiang University, School of Medicine (SAHZU) during January 2016 to July 2018, were retrospectively reviewed. Characteristics were analyzed.

Patients with pSS were retrospectively reviewed, and pSS-ILD and pSS non-ILD were identified. Clinical data, laboratory parameters, pulmonary high-resolution CT (HRCT), and pulmonary function tests (PFTs) were collected. pSS-ILD patients were further categorized into subgroups according to HRCT patterns or PFTs.

Eligibility Criteria:
Inclusion Criteria:

* All patients with pSS fulfilled the 2002 revised version of the European criteria proposed by the American-European Consensus Group
* Patient with pSS evaluated with pulmonary HRCT and/or PFTs were included in the pSS-ILD group

Exclusion Criteria:

* patients with hepatitis C infection, past head and neck radiation treatment, sarcoidosis, acquired immunodeficiency syndrome, pre-existing lymphoma, graft-versushost disease, and use of anticholinergic drugs, IgG4-related disease
* Patients with other connective tissue diseases (CTD) or other pulmonary diseases were further excluded, including those with pulmonary arterial hypertension, pulmonary infections, tuberculosis, chronic bronchitis, emphysema, asthma, chronic obstructive pulmonary disease, malignancies, pulmonary lesions related with environmental, occupational or medication exposures, or history of smoking
Venetoclax+Azacytidine+Modified BUCY Conditioning Regimen for Acute Myeloid Leukemia and Myelodysplastic Syndromes Undergoing Allo-HSCT

The purpose of this prospective, open-label, single-center study is to evaluate the efficacy and safety of VEN-AZA (venetoclax and azacytidine) followed by modified BUCY (busulfan and cyclophosphamide) as conditioning regimen for high-risk myelodysplastic syndrome (MDS) and high-risk or relapsed/refractory acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is the only potentially curative therapy for patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). However, relapse remains a leading cause for treatment failure after hematopoietic cell transplantation (HCT) in patients, optimization of conditioning regimen can improve prognosis and decrease relapse. Abnormal gene methylation is common in AML and MDS patients. Azacytidine is a DNA methylation transferase inhibitor that can re-express tumor suppressor genes in leukemia cells. Venetoclax is a selective BCL-2 inhibitor, which has antitumor activity against a variety of hematological malignancies. The combination of the two drugs show a synergistic anti-tumor effect. The objective of this study is to evaluate the safety and efficacy of VEN-AZA regimen followed by Allo-HSCT in the treatment of high-risk MDS and high-risk or relapsed/refractory AML.

Eligibility Criteria:
Inclusion Criteria:

1. Age 8 to 65 years;
2. Diseases must be MDS and AML; high-risk MDS: int-2 risk, high risk by the IPSS; IPSS-R int-risk (\> 3.5 points), high risk, very high risk; high risk,very high risk by the WPSS; high-risk or relapsed/refractory AML: (1) age≥60 years; (2) High white blood cell count at first diagnosis (WBC≥100\*10\^9/L); (3) secondary AML (previous history of MDS, myeloproliferative disease, or treatment-related AML, etc.); (4) Complicated with extramedullary leukemia, such as central nervous system leukemia, granulocytic sarcoma, hepatosenomegaly; （5）high risk factors and relapsed/refractory AML（reference 2022-AML-ELN guideline）（6）not in remission or ≥CR2 before transplantation;
3. Must need a bone marrow transplant;
4. Must have the ability to observe the efficacy and events;
5. Patient must have ability to understand and willingness to provide written informed consent prior to participation in the study and any related procedures being performed.

Exclusion Criteria:

1. Age \<8 or \>65 years;
2. Uncontrolled bacterial, viral, fungal, or other infection before conditioning regimen;
3. Pregnant or lactating females;
4. Current participation in another clinical trial;
5. Contra-indication to one of the drug of the regimen;
6. Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo the agents included in the conditioning regimen.
International Ovarian Tumour Analysis (IOTA) Phase 5

The purpose of this study is to learn more about the appearance and behavior of benign-looking adnexal masses.

* Benign-looking means that when viewed here by ultrasound it has the appearance of looking not harmful or not malignant.
* Adnexal refers to the 'adnexa', the space in the female pelvis on either side of the uterus (or where the uterus used to be if you previously had a hysterectomy). The adnexa includes, but is not limited to, the ovaries and the fallopian tubes.
* Masses refers to a variety of structures, including but not limited to:

  * ovarian cysts that are fluid filled sacs within or attached to an ovary
  * ovarian tumors that can be solid tissue or a combination of cysts and solid tissue
  * hydrosalpinges that are fluid collections in the fallopian tube

Many women have what appear to be benign adnexal masses. Many times, removal of the masses with surgery is not necessary. Often surgery is performed unnecessarily, for fear that these masses could be cancer. There is not much information available for doctors to know how and when to follow these masses, or which ones will become cancer.

This study will combine information from centers all around the world regarding the behavior of all types of benign adnexal masses. The aim of this study is to develop decision tools for doctors to know the best way to treat these masses in order to improve the detection of ovarian cancer while at the same time reduce the number of unnecessary operations.


Eligibility Criteria:
Inclusion Criteria:

* Any woman at least 18 years old with an adnexal mass.
* Any mass with benign ultrasound morphology may be suitable for conservative management.
* Pregnant patients can be included, but their data will be analysed separately.

Exclusion Criteria:

* Cysts that are deemed to be clearly physiological and less than 3 cm in maximum diameter are not eligible for inclusion.
* Any cyst with features of malignancy is excluded from the conservative management
* The denial or withdrawal of oral informed consent
Polyphenols, Prebiotics, the Gut Microbiome and Stress

The aim of this study is to evaluate how different combinations of prebiotics and polyphenols affect the gut microbiota and perceived cognitive state. 40 volunteers will take part in this study who will be randomised into 4 different groups. One group will consume a placebo, whereas the other groups will consume prebiotics, polyphenols, or a combination of the two.

* All participants will be asked to fill out a health screening questionnaire and inclusion/exclusion criteria will be reviewed for volunteer eligibility
* Valid informed consent will be obtained from the volunteer.
* Once the study begins, participants will be randomly allocated into 1 of 4 groups each assigned a different polyphenol or prebiotic product. the prebiotic content is dosed as follows: Inulin at 5g/d, GOS at 5g/d and Resistant Starch at 20g/d.
* Participants will be asked to consume their assigned product once per day. The length of the intervention is 14 days
* Participants will provide two stool samples: one on day 0 and one on day 14 of the study to identify changes in gut microbiota composition
* Urine samples will also be provided at day 0 and at day 14 looking for changes in urinary metabolites
* Participants will also be asked to fill out various mood related questionnaires on days 0 and 14 of the study.
* You will take your own blood pressure and heart rate on day 0 and day 14 and at least 3 times per week to try and link changes in gut microbiota composition with vascular health.
* Volunteers will be given containers and specimen pots to take home for initial and final faecal and urine collections. No treatment will be issued until initial stool and urine sample has been provided
* Maintenance of normal dietary patterns throughout the study is essential and participants will be required to complete food and drink logs throughout the study via a web-based app - on three consecutive days with one of the days being a weekend

Eligibility Criteria:
Inclusion Criteria:

* Volunteer is healthy at the time of pre-examination
* Volunteer has high perceived stress levels (own self-assessment)
* Volunteer is aged ≥ 18 to ≤ 65 years at the time of pre-examination
* Volunteer is able and willing to comply with the study instructions
* Volunteer is suitable for participation in the study according to the investigator/study personnel
* Written informed consent is given by volunteer

Exclusion Criteria:

* No command of any local language
* Gastrointestinal disorders including IBS, IBD or other conditions that might affect the gut environment
* Food allergies or intolerances
* Using drugs (e.g. antibiotics) influencing gastrointestinal function (8 weeks before intervention)
* Use of laxatives
* Participants with any form of diagnosed diabetes (types I and II)
* Volunteers currently involved or will be involved in another clinical or food study
* History of drug (pharmaceutical or recreational) or alcohol abuse.
* participants are pregnant or are lactating
* Regular intake of probiotic or prebiotic supplements
* Smoking
Comparison of Cardiopulmonary Fitness Level With Normal Values After COVID-19

COVID-19 (Coronavirus disease 2019) is a new infectious disease caused by a virus named as SARS-CoV2 (Severe Acute Respiratory Syndrome Coronavirus-2). Although it can have a devastating effect on many organs, the respiratory tract is particularly affected. In the course of the disease, a wide clinical spectrum is observed, from flu-like illness to lung failure. Some of the patients who survived the disease continue to have problems such as shortness of breath, fatigue, decrease in walking distance, decrease in participation in daily life activities. These problems suggest that the effects on respiratory and cardiac functions continue even after the disease ends. This study was designed to demonstrate the effects and extent of COVID-19 on cardiopulmonary capacity.

Aims of the research are that demonstrate change in cardiopulmonary fitness level in patients with COVID-19 according to normal values and reveal the relationship of this change with age, gender, physical activity level, disease severity and accompanying medical conditions.

Patients older than 18 years old who are diagnosed with COVID-19 according to clinical symptoms and rt-PCR test positivity and at least 30 days past the end of their symptoms are accepted for the study.

According to World Health Organization's (WHO) classification, COVID-19 disease severity is determined. Physical activity level of the patients before COVID-19 is evaluated with International Physical Activity Questionnaire. Risk of anxiety and depression of the patients is identified with Hospital Anxiety and Depression Scale (HADS), which has 14 questions. To evaluate cardiopulmonary fitness level, cardiopulmonary exercise test (CPET) and 6-minute walk test are applied. Cardiopulmonary exercise test is gold standard to determine cardiac and respiratory functions. Pulmonary function test is performed to identify the conditions that affect the results of cardiopulmonary exercise test.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SARS-Cov2 with a positive result of reverse polymerase-transcriptase chain reaction test
* It must have been at least 30 days after symptoms of COVID-19 improved.

Exclusion Criteria:

* 5 days after acute myocardial infarction
* Unstable angina
* Active endocarditis, myocarditis or pericarditis
* Symptomatic severe aortic stenosis
* Uncontrolled heart failure
* Acute pulmonary embolus, pulmonary infarction or thrombosis of lower extremities
* Suspected dissecting aneurysm
* Uncontrolled asthma
* Room air desaturation at rest (O2 ⩽85%)
* Respiratory failure
* Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
* Mental impairment
* Severe untreated arterial hypertension at rest (\>200 mm Hg systolic, \>120 mm Hg diastolic)
* High-degree atrioventricular block
* Orthopaedic, neurological or systemic impairments that leading to inability to perform test
Physical Performance Levels and Social Participation in Elderly Living In Urban and Rural Areas

Purpose: This study aims to investigate the effect of physical performance levels of elderly living in rural and urban areas on social participation, social functioning, and quality of life.

Method: A total of 418 volunteer elderly aged 65 and over living in rural (42.3%) and urban (57.7%) areas participated in this study. The Mini-Mental State Examination, Short Physical Performance Battery, the World Health Organization Quality of Life Scale for Older Adults, Leisure Time subscale of the Social Functioning Scale and the Community Integration Questionnaire were applied to participants.


Eligibility Criteria:
Inclusion Criteria:

* individuals over the age of 65 years who received a score of ≥24 from the Mini-Mental State Examination were included in the study

Exclusion Criteria:

* elderly who were unable to communicate verbally, were unable to move independently, had undergone any operations in the last 6 months, had been diagnosed with cancer, or had severe vision loss, stroke, Parkinson's disease, multiple sclerosis, or other neurological diseases were excluded from the study
Efficacy, Safety, and Tolerability Study of ACT-129968 in Patients With Seasonal Allergic Rhinitis

This study will assess the efficacy and safety of ACT-129968 in adolescent, adult and elderly patients with seasonal allergic rhinitis, due to mountain cedar pollen.


Eligibility Criteria:
Inclusion Criteria

* Males and females aged 12-76 years with documented clinical history of symptomatic seasonal allergic rhinitis associated with mountain cedar pollen for the last 2 years.
* Evening reflective Total Nasal Symptom Score (p.m.rTNSS) at least 42 out of a maximum potential score of 84 over the 7-day run-in period, or \> or = 6 out of a maximum score of 12 on each of the last 4 consecutive days during the run-in period.

Exclusion Criteria

* Non-allergic rhinitis.
* Severe physical nasal obstruction.
* Acute or significant chronic sinusitis.
* Bacterial or viral infection of the upper or lower respiratory tract, nasal sinuses, or middle ear.
* Ongoing chronic respiratory disorders.
* Asthma requiring use of short-acting beta2-agonists \> 2 times a week or any asthma treatment other than inhaled short-acting beta2-agonists.
* Diagnosis of aspirin or non-steroidal anti-inflammatory drug (NSAID)-induced asthma.
* Nasal biopsy or surgery, sinus surgery, or perforation within the 8 weeks prior to the Screening Visit.
* Ocular surgery within the 8 weeks prior to the Screening Visit.
* Ocular infections (bacterial or viral) within the 4 weeks before screening.
* Use of forbidden medications (prescribed or over-the-counter \[OTC\])
* Congenital or acquired severe immunodeficiency or known Human immunodeficiency virus (HIV)infection.
Endoscopic Treatment of Benign Biliary Strictures and Cystic Duct Leakages With a Novel Biodegradable Biliary Stent

Patients with either post-cholecystectomy bile leak or benign biliary stricture are recruited for endoscopic insertion of a biodegradable biliary stent. A follow-up of 12 months with repeated serum samples and magnetic resonance imaging is scheduled. The primary end points are feasibility of endoscopic insertion with the novel implantation device and stricture or leak resolution as well as clinical treatment success.

Benign biliary strictures (BBS) and post-cholecystectomy bile leaks have traditionally been treated endoscopically with plastic stents. In BBS, promising results of covered self-expanding metal stent use have been recently published. However, in both BBS and post-cholecystectomy bile leak the need of stent therapy is temporary and endoscopic stent exchange or removal is unavoidable. These two groups of patients may be the ones that would most obviously benefit from biodegradable (BD) biliary stents. Studies of BD stents on animal models have shown excellent long term patency and safety both in biliary and pancreatic duct as well better outcome compared to plastic stents after post-cholecystectomy bile leak in an animal study. Until recently, non-operative insertion of BD polydioxanone stent in human biliary tract has been possible only via percutaneous route.

With the novel implantation device, the BD stents (braided, self-expanding polydioxanone stent, 8 x 40-60mm, Ella, Czech republic) may be used endoscopically during endoscopic retrograde cholangio-pancreatography (ERCP).

The hypothesis is that larger diameter and radial expansion strength provide at least similar treatment success as the current method of endoscopic insertion of plastic or covered self-expanding metal stents in bile leak and BBS, respectively. However, later stent exchange or removal is not necessary with BD stents.

Eligibility Criteria:
Inclusion Criteria:

* informed-consent patients with diagnosed or suspected post-cholecystectomy biliary leak or benign biliary stricture.

Exclusion Criteria:

* Patients with contra-indications for magnetic resonance imaging (MRI) or surgically altered gastro-duodenal anatomy (e.g. roux-y-loop) are excluded from the study.
Brain Blood Flow and Lactate in Non-obese and Obese Subjects

Cerebral blood flow (CBF) is essential for maintaining brain health and function, as it ensures delivery oxygen and nutrients necessary to support neuronal activity. Reduced CBF can impair the brain's ability to meet its metabolic demands, leading to deficits in cognitive ability. Impairments in CBF are associated with cognitive decline and neurodegenerative disease such as Alzheimer's and dementia. Many factors influence CBF, but recently lactate has emerged as a key player. Blood glucose has long been considered the primary fuel for the brain, but emerging evidence indicates that lactate may be the preferred fuel for neurons, and lactate may become even more important under stressful conditions.

Individuals with obesity often have impaired lactate metabolism resulting in higher resting blood lactate concentrations and reduced ability to clear lactate after a physiological stress. At the same time, it is known that exercise is a powerful intervention for improving lactate metabolism.

Thus, this project seeks to investigate the role of lactate in brain blood flow in individuals with and without obesity as well as establish if short term exercise training (individuals with obesity only) will alter circulating lactate concentrations at rest and in response to exercise.

Blood lactate is often considered a waste product from aerobic metabolism. Many people assume it causes fatigue and muscle. Lactate is a signaling molecule in the body. In addition lactate is also a fuel. Evidence supports that lactate may be more important when the brain is stressed. We also know that individuals with obesity and/or type 2 diabetes may have impaired lactate metabolism.

The investigators will compare brain blood flow and lactate response to an exercise stress test and submaximal exercise in obese and non-obese individuals.

Eligibility Criteria:
Inclusion Criteria:

healthy adult men and women 18-45 years of age BMI 18-40 kg/m2 not pregnant, premenopausal with regular menstrual cycles not breastfeeding non-nicotine users

Exclusion Criteria:

medications known to affect sleep, autonomic control, blood lactate levels or metabolic, or cardiovascular function (PI discretion) self-reported history of hepatic, renal, pulmonary, cardiovascular, or neurological disease, stroke or neurovascular disease, bleeding/clotting disorders, sleep apnea or other sleep disorders, diabetes, history of alcoholism or substance abuse major cardiovascular event or surgical procedure within the past three months hypertension (\>140/90 mmHg or at PIs discretion).

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U/S Guided SAB VS U/S Guided SAB With Modified Pectoral Nerve Block in Modified Radical Mastectomy

We hypothesize that ultrasound guided serratus anterior plane block Combined With Modified Pectoral Nerve Block is going to be more effective than Ultrasound guided Serratus anterior plane block alone in patients undergoing MRM as modified Pecs block involves the block of medial and lateral pectoral nerves which are spared in case of serratus block alone, resulting in reducing myofascial pain and opioid consumption.

Ultrasound guided Serratus anterior plane block was introduced in 2013 for analgesia of breast and lateral thoracic wall surgery. At the axillary fossa, the intercostobrachialis nerve, lateral cutaneous branches of the intercostal nerves (T3-T9), long thoracic nerve, and thoracodorsal nerve are located in a compartment between the serratus anterior and the latissimus dorsi muscles, between the posterior and midaxillary lines at this plane local anesthetic will be injected . Complications of serratus anterior plane block include local anesthetic toxicity and pneumothorax , unfortunately medial and lateral pectoral nerves are preserved which are responsible for the myofacial pain .

The pectoral nerves (Pecs) block types I and II (Modified Pectoral block) , is less invasive technique described by Blanco et al where local anesthetic is deposited into the plane between the pectoralis major muscle(PMm) and the pectoralis minor muscle (Pmm) (Pecs I block)and above the serratus anterior muscle at the third rib (Pecs IIblock).,Blocking intercostobrachial, third to sixth intercostals the long thoracic nerves in addition to medial and lateral pectoral nerves.

Addition of Modified Pecs block to Serratus anterior plane block will enhance the control of pain as it block the medial and lateral pectoral nerves which are responsible for the myofacial pain and which are spared in case of Serratus block alone .

Eligibility Criteria:
Inclusion Criteria:

* Female patients
* Type of surgery; Modified Radical Mastectomy (MRM)
* Physical status ASA I, II, III.
* Age ≥ 18 and ≤ 65 Years.
* Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2.

Exclusion Criteria:

* Age \<18 years or \>65 years
* BMI \<20 kg/m2 and \>35 kg/m2
* Known sensitivity or contraindication to drug used in the study (local anaesthetics, opioids).
* History of psychological disorders and/or chronic pain.
* Contraindication to regional anaesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
* Patient refusal.
* Severe respiratory or cardiac disorders.
* Advanced liver or kidney disease.
* Pregnancy.
* Physical status ASA IV and Male patients.
Establish a Non-invasive Prenatal Genotyping and Extraction Technology to Diagnose and Treat the HDN.

To establish a genotyping and extraction technology of non invasive prenatal diagnosis for fetal blood group genotype from cell-free fetal DNA in peripheral blood of pregnant women.

To achieve prenatal accurate identification of fetal blood group genotypes，and provide credible theoretical evidence for the prenatal diagnosis and treatment of hemolytic disease of newborn (HDN).

Establish a Non-invasive Prenatal Genotyping and Extraction Technology to Diagnose and Treat the HDN.

Eligibility Criteria:
Inclusion Criteria:

blood samples of pregnant couples,gender/nation/region is unlimited.

Exclusion Criteria:

adipose or hemolytic samples,overdue samples,unidentified samples