cyrilzakka/clinical-trials huggingface dataset:
Autonomic Function in COPD and Risk for Atrial Fibrillation

In the presented study, autonomic function as well as risk for atrial fibrillation will be assessed to characterize the relation between risk of atrial fibrillation and autonomic function.

Atrial fibrillation (AF) has been suggested as relevant comorbidity in patients with chronic obstructive pulmonary disease (COPD). The evaluation of the total atrial conduction time via tissue Doppler imaging (PA-TDI interval) can be used to identify patients with increased risk of new onset AF. Autonomic function can be assessed by different non invasive clinical investigations.

The investigators hypothesise that PA-TDI interval is increased in acutely exacerbated COPD (AECOPD) compared within stable COPD and that increased PA-TDI is related to impairment of autonomic function. For this purpose, 25 patients with AECOPD and 25 patients with stable COPD were characterized by clinical characteristics, laboratory tests, lung function, electrocardiography, echocardiography and autonomic function.

Eligibility Criteria:
Inclusion Criteria:

* patients with chronic obstructive pulmonary disease, exacerbated or stable between the age of 40-80 years with sinus rhythm who gave informed written consent

Exclusion Criteria:

* Inability to give written consent, acute myocardial infarction with ST-segment elevations in last 30 days, severe acute or chronic renal dysfunction, severe heart failure, atrial fibrillation, severe valve disease, severe hypotension, active malignant disease, active rheumatic disease
Meta-Iodobenzylguanidine (123I-mIBG) Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease

The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to predict cardiac outcome in subjects with heart failure and in comparison to subjects without cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Study subjects must be adults with an established diagnosis of heart failure (New York Heart Association Class II or III) and reduced left ventricular ejection fraction (LVEF) (≤ 35%) or be healthy volunteers without heart disease.

Exclusion Criteria:

* Healthy volunteers were not eligible if they had a history of diabetes mellitus, signs/symptoms of neurological disease (e.g., Parkinson's Disease, multiple system atrophy, Parkinsonian syndromes), or other diseases known to affect the sympathetic nervous system.
* Subjects with New York Heart Association Class I or IV heart failure were not eligible.
* Subjects were excluded if they had previously received 123I-mIBG or 131I-mIBG or participated in a clinical study involving investigational medicinal product or devices within 30 days.
* Subjects that had a pacemaker or had received defibrillation, anti-tachycardia pacing or cardioversion to treat a previous arrhythmic event or had an ICD inserted within 30 days before study entry are not eligible.
Buccal Misoprostol and Intravenous Tranexamic Acid During Emergent Cesarean Delivery

Purpose to evaluate the effects of buccal misoprostol with or without intravenous tranexamic acid (TA) in comparison with placebo on reducing post-partum hemorrhage in pregnant women undergoing emergent cesarean section

The American Congress of Obstetricians and Gynecologists (ACOG) defines postpartum hemorrhage (PPH) as the loss of more than 1,000 mL after cesarean delivery. In the majority of cases, uterine atony is responsible for the occurrence of excessive bleeding during or following childbirth. The Millennium Development Goal of reducing the maternal mortality ratio by 75 % by 2015 will remain beyond the investigator reach unless prioritize the prevention and treatment of PPH in low-resource countries. Consequently, the administration of uterotonic drugs during cesarean section (CS) has become essential to diminish the risk of PPH and improve maternal safety. Misoprostol is a prostaglandin E1 analog proven in several randomized controlled trials to be effective in preventing PPH because of its strong uterotonic effects. In addition, misoprostol is inexpensive, stable at room temperature, and easy to administer. Misoprostol has been broadly studied in the prevention and treatment of PPH after vaginal delivery; however, its use in conjunction with CS has not been investigated as much.T he buccal route is recognized as having the greatest benefit due to its rapid uptake, long-acting effect, and greatest bioavailability compared with other routes of misoprostol administration. Anti-fibrinolytic agents, such as tranexamic acid (TA), reduce the risk of death in bleeding trauma patients. On the other hand, it has been suggested that TA administration reduces blood loss and the incidence of PPH in females after vaginal or elective CS. The investigators designed this study to evaluate and compare these two new therapeutic options in controlling PPH following emergent CS.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years, singleton pregnancy, term gestation and decision made for a cesarean section in labor

Exclusion Criteria:

* multiple gestations
* placenta praevia and placental abruption
* undergoing cesarean section with general anesthesia
* women undergoing cesarean section at less than 37 weeks of gestation--with a severe medical disorder
* allergy to tranexamic acid or misoprostol
* refuse to consent
* elective cesarean section
Gut Microbiota Stunted Children NTT

NTT Province is on the list of priority areas of high prevalence of stunting, Southwest Sumba, South Middle East, and Kupang district have a stunting prevalence of 36.2%, 34.5% and 48.1% respectively in 2020. Therefore, it is necessary to conduct a profile study. microbiota, SCFA, gastrointestinal integrity, parasites, hygiene practice, and cognition in stunting and healthy toddlers in the province of East Nusa Tenggara,

Stunting indicates a public health problem because it is associated with an increased risk of morbidity and mortality, decreased motor and mental function development, and reduced physical capacity. Stunting is a chronic nutritional deficiency condition that affects the growth and development, and intelligence of children. Lack of nutrients can cause intestinal microbiota dysbiosis where this will reduce the metabolism of short chain fatty acids (SCFA) which will affect the absorption of nutrients in the small intestine and cause impaired immunity, which in turn worsens stunting conditions. The composition of the gut microbiota is influenced by age, sex, geographic area and food intake. Therefore, the description of knowledge, attitudes and applications in society, especially mothers and child subjects, was also analyzed using a hygiene practice questionnaire. The aim of the study was to obtain an overview of the gut microbiota, gastrointestinal integrity, parasitic infections, hygiene practices and cognitive scores in stunting and healthy toddlers in several areas in the province of East Nusa Tenggara as a baseline study to be followed up by intervention study.

The research will be conducted for 3 (three) months in 2021/2022. The subjects involved represented 100 stunted children and 100 healthy children aged 36-45 months from each region. Determination of the sample with a sampling quota. The variables studied were the nutritional status of under five years children, characteristics of children under five (age, gender, birth weight (BBL), birth length, breast feeding history, immunization history, history of diarrhea, history of ARI (Upper Respiratory Tract Infection)), mother and family characteristics (age, education). , occupation, father's occupation, total family income), home environment and hygiene, vaccination history, gastrointestinal microbiota status, gastrointestinal integrity, parasites, hygiene practices, and cognitive scores.

Eligibility Criteria:
Inclusion Criteria:

* Anthropometric measurements of stunting were measured based on the parameters of length/height according to age compared to the 2005 WHO anthropometric standards and the Indonesian Ministry of Health Decree No. 1995/MENKES/SK/XII/2010.

Exclusion Criteria:

* criteria thats makes subject appropiate, like more than 5 years old, not live in sampling area, unhealthy
Healthy Volunteer Visibility Study of Micromachined Tags for the Detection of Surgical Sponges

Surgical sponges can be accidentally left inside patient's bodies. We are working on special tags (called microfabricated tags) that surgeons can put on their sponges. Then, if the surgeons forget to remove a sponge from a patient, they'll be able to detect these special tags in an x-ray.

Surgical sponges can be accidentally left inside patient's bodies. We are working on special tags (called microfabricated tags) that surgeons can put on their sponges. Then, if the surgeons forget to remove a sponge from a patient, they'll be able to detect these special tags in an x-ray. We wish to take x-rays of healthy people's abdomens with microfabricated tags lying on them. The x-rays will help us improve our system for detecting sponges left inside people's bodies.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy men and women
2. Ages 18 or older -

Exclusion Criteria:

1. Under 18 years of age
2. Pregnant female or if female has not had a negative pregnancy test prior to the research scans.

   -
Magnetic Seed Localisation for Nonpalpable Breast Lesions

Screening programs and advances in imaging have led to more breast lesions being diagnosed at an impalpable stage. Multiple localisation techniques for nonpalpable breast lesions have been developed during the past decades. Specifically, several alternatives to the golden standard hooked-wire technique have become available, of which magnetic seed localisation is one of the newest approaches. Since September 2018, Magseed® localisation is the standard of care for localising impalpable breast lesions in UZ Leuven. In this study, the oncological safety, the clinical safety and surgeon satisfaction of Magseed® localisation will be assessed and retrospectively compared to hooked-wire localisation.


Eligibility Criteria:
Inclusion Criteria:

* Breast conserving surgery with preoperative localisation
* Minimum 18 years old
Aprepitant and Ondansetron Monotherapy or Combination for Postoperative Nausea and Vomiting in Thyroid Cancer

The vast majority of patients treated prophylactically with "first-line" antiemetics in the 5-hydroxytryptamine (5-HT3) receptor antagonist class still have significant PONV. Combination therapies with different pharmacologic bases have the potential to reduce the incidence of PONV. This study is a multicenter, three-arm, prospective study to evaluate the efficacy and safety of aprepitant and ondansetron, monotherapy or in combination, in the prevention of nausea and vomiting after surgery for thyroid cancer.

Postoperative nausea and vomiting (PONV) is the most common complication after surgery, especially thyroidectomy, and the incidence of PONV can be as high as 80% without the administration of prophylactic antiemetics. Currently, available prophylactic interventions for PONV, especially monotherapy, lack universal efficacy. Combination therapy with a different pharmacologic basis has the potential to reduce the incidence of PONV. Previous studies using various 5-HT3 receptor antagonists in combination with aprepitant have shown promising results in reducing the incidence of PONV. The present study is a multicenter, three-arm, prospective study designed to evaluate the efficacy and safety of aprepitant and ondansetron, alone or in combination, in the prevention of postoperative nausea and vomiting in thyroid cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18-80 years;
2. Voluntary enrollment in the study and signing the informed consent form;
3. Diagnosed with thyroid cancer and needing surgical treatment;

Exclusion Criteria:

1. Patient has depression, history of chronic pain, insulin-dependent diabetes mellitus I or II, history of severe vomiting;
2. history of prior thyroid or neck surgery;
3. Cases in which surgery requiring sternotomy is anticipated;
4. History of long-term hormone use, period of immunosuppressive therapy;
5. pre-operative voice changes or laryngoscopic confirmation of vocal cord paralysis;
6. Pregnant or breastfeeding patients;
7. Patients who are allergic to any of the study medications;
8. Patients who have received any sedative, hypnotic, anxiolytic, opioid, steroid or other antiemetic medication within 24 hours prior to the procedure;
9. Patients taking or planning to take a combination of drugs such as rifampicin, carbamazepine, phenytoin or other drugs that strongly induce CYP3A4 activity;
10. patients with other malignant tumors;
11. Patients with hypothyroidism;
12. Participating or planning to participate in other clinical studies.
Examining the Ability of Herpes Simplex Virus Type 2 (HSV2) Therapy to Reduce HIV Target Cell Numbers in the Cervix

Herpes simplex virus type 2 (HSV2), the most common cause of genital herpes, increases a woman's risk of HIV acquisition from 3-6 fold, perhaps because HSV2-infected women have increased numbers of HIV "target cells" (CD4 T cells and dendritic cells) in the cervical mucosa. However, recent clinical trials showed no impact of HSV2 suppression on HIV acquisition rates. The reasons for this negative result are unclear. The investigators propose to examine the effect of valacyclovir (a widely used herpes medication) treatment on cervical immunology and HIV target cells in the cervix. The study will take the form of a randomized, double-blind, placebo-controlled crossover trial. Primary endpoints will be (1) the number of CD4 T cells on a cervical cytobrush and (2) the number of immature dendritic cells per cervical cytobrush.


Eligibility Criteria:
Inclusion Criteria:

* Female
* HSV2 infected

Exclusion Criteria:

* HIV infected
* Pregnant
* Taking HSV2 therapy
* Current/recent (past 3 months) genital infection
Estrogen and the Outer Eye in Women During Fertility Treatment

The purpose of this study is to determine the relation between estrogen and progesterone levels, and between dryness of the eyes, in women during their fertile years.

Women during their fertility treatments will be submitted to the research. The research will include 3 meetings with a doctor from the ophthalmology department. Each meeting will be individual for each participant of the research.

The meetings will take place during the day of regular appointment of the participant to the fertility clinic.

Meeting #1:

During first visit to the fertility clinic for the stimulation process.

During this day will be done:

1.Submission of the patient to the research and signing on letter of agreement 2.Blood tests for estrogen, progesterone, luteinizing hormone (LH) 3.Eye examination: 3a. Filling of Schein Questionnaire 3b. Examination of the external eye: 1.microscope, 2.Schirmer test (paper strips inserted into the eye for several minutes to measure the production of tears), 3. tear break up time test (checking the eye with the fluorescein light after painting the eye with fluorescein dye) 3c. Checking the Intra Ocular Pressure with Tonometer

Meeting #2:

During visit to the fertility clinic for the egg collection (about 10 days after meeting #1)

During this day will be done:

1.Blood tests for estrogen, progesterone, luteinizing hormone (LH) 2.Eye examination: 2a. Filling of Schein Questionnaire 2b. Examination of the external eye: 1.microscope, 2.Schirmer test (paper strips inserted into the eye for several minutes to measure the production of tears), 3. tear break up time test (checking the eye with the fluorescein light after painting the eye with fluorescein dye) 2c. Checking the Intra Ocular Pressure with Tonometer

Meeting #3:

During visit to the fertility clinic for the pregnancy test (about 14 days after meeting #2)

During this day will be done:

1. Blood tests for estrogen, progesterone, luteinizing hormone (LH)
2. Eye examination:

2a. Filling of Schein Questionnaire 2b. Examination of the external eye: 1.microscope, 2.Schirmer test (paper strips inserted into the eye for several minutes to measure the production of tears), 3. tear break up time test (checking the eye with the fluorescein light after painting the eye with fluorescein dye) 2c. Checking the Intra Ocular Pressure with Tonometer

Collection and summary of all the data End of the research

Eligibility Criteria:
Inclusion Criteria:

* women during fertility treatment
* without any known eye diseases
* no current or past history of treatment against dry eye

Exclusion Criteria:

* known eye disease
* current or past history of treatment against dry eye
Effects of Mulligan and Cyriax Approach in Patients With Subacute Lateral Epicondylitis.

Lateral epicondylitis (LE) is a pain causing musculoskeletal disease which mainly occurs due to the over exertion or over use of extensors of wrist mainly ECRB and pain is felt at the origin of common extensor tendon. This study was focused to assess the effectiveness of cyriax approach and mulligan approach to improve the functional status of sub acute lateral epicondylitis patients through patient related tennis elbow evaluation form.

A total of 39 athletes with knee pain were recruited and randomly divided into two groups. 30 subjects fulfilled the inclusion criteria and were part of this trial, 15 in each group.The data was collected through general demographic questionnaire, PRTEE questionnaire to determine the level of pain and functional disability and Hand grip strength chart to measure grip strength while having epicondylitis.

Eligibility Criteria:
Inclusion Criteria:

* Age group 20-50 years of both gender.
* Vas \< 7
* Positive mills test and cozens test.
* Local tenderness on palpation over lateral epicondyle of the humerus.
* From sub-acute to chronic more than 2 weeks.

Exclusion Criteria:

* Any previous pathology of bone around elbow.
* Corticosteroid injection in the preceeding 3 months.
* Absence of clinical signs of tennis elbow.
* Any other systemic illness like metabolic, metastatic, infective disorders.
* Any other neurological abnormalities.
* Allergies to Mulligan tape.
Hepatocellular Carcinoma (HCC) Transarterial Chemoembolisation (TACE) +Axitinib

The survival of subjects with unresectable hepatocellular carcinoma (HCC) receiving transarterial chemoembolization is improved with addition of axitinib.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed HCC (or fulfilling AASLD criteria for HCC diagnosis in HBsAg positive subjects with cirrhosis in case biopsy is not feasible)
2. Disease must not be amenable to potentially curative surgery
3. Without prior systemic nor transarterial treatment
4. Prior surgery or local therapy is allowed but the target lesion must have not been previously treated
5. Child-Pugh stage A liver function
6. ECOG performance 0-2
7. Life expectancy longer than 12 weeks
8. At least one measurable treatment lesion according to modified RECIST criteria
9. Adequate haematological, hepatic and renal function

Exclusion Criteria:

1. Contra-indications to TACE treatment:

   * Main portal vein thrombosis or occlusion
   * Evidence of biliary obstruction
   * Presence of extra-hepatic disease
2. Diffuse-type HCC
3. Major surgery \<4 weeks or radiation therapy \<2 weeks of starting the study treatment.
4. Any form of prior transarterial therapy or systemic therapy for HCC.
5. Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors or CYP3A4 or CYP1A2 inducers.
6. Requirement of anticoagulant therapy with oral vitamin K antagonists. Low dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.
7. Any haemorrhage or bleeding event of CTCAE Grade 3 or more within 4 week
Effect of Suctioning by Bronchoscope on Postoperative Pulmonary Complications Among Patients With SCI in the PACU

Respiratory failure and dyspnea are common in spinal cord injury (SCI), and in acute situations, any spinal cord lesion above T11 can cause abnormal respiratory function and impair the airway clearance.

Although surgical decompression is one of the key early neuroprotective therapies, surgery and general anesthesia disrupt many aspects of respiratory function and may cause a series of postoperative pulmonary complications.

Endotracheal suction is important to reduce the risk of lung consolidation and atelectasis. But for patients with respiratory insufficiency such as SCI, ordinary suction is not enough to clear secretions in the deeper airways. And repeated intratracheal suction may even cause some serious complications.

Bronchoscopy can generally penetrate into the bronchus of grade 3-4, and fully attract the secretions in it under visual conditions. Its curative effect on pneumonia and atelectasis in the ICU has been affirmed, but no one has yet explored the application in the postoperative care unit .

All patients admitted to PACU with tracheal tube after operation will be recruited, and than be randomly divided into two groups during resuscitation:

1. one group receives routine ordinary sputum suction ; the other group receives routine ordinary sputum suction with bronchoscopy
2. After entering the PACU, both groups will receive two lung ultrasound examinations and record the lung ultrasound scores: when entering PACU and when leaving PACU.

After returning to the ward, the doctor in charge will make medical decisions and treatments based on the condition.

Follow up for pulmonary complications (respiratory tract infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, pulmonary edema, pulmonary embolism, aspiration pneumonia) within 7 days after surgery.

Follow-up 30 days and 90 days after operation.

Eligibility Criteria:
Inclusion Criteria:

- Age\>=18 Spinal injury level :above T11 Stable preoperative spontaneous respiration Elective cervical/thoracic spine fixation American Spinal Injury Association (ASIA) class: A-D

Exclusion Criteria:

- Unconscious before surgery Pregnant With mental disorders Directly transfered to ICU