cyrilzakka/clinical-trials huggingface dataset:
Copeptin in the Diagnosis of Post-operative Insipidus Diabetes After Pituitary Surgery

Endoscopic trans-sphenoidal pituitary endoscopic surgery is one of the main axes of management of tumours of the sellar region.

Central diabetes insipidus is a frequent complication of endoscopic trans-sphenoidal pituitary endoscopic surgery, with a prevalence of up to 30% of cases. It is the consequence of insufficient secretion of the anti-diuretic hormone arginine vasopressin (AVP) by the posterior pituitary (Melmed et al, 2017).

In the absence of specific treatment, diabetes insipidus can lead to severe ionic and osmotic disorders, mainly acute dehydration with the risk of severe consequences particularly neurological.

Monitoring for the appearance of diabetes insipidus is therefore necessary from the immediate post-operative period.

To date, diabetes insipidus is initially suspected before the appearance of major polyuria. Several biological assays (urinary density, natraemia, urinary osmolarity and plasma) can help to confirm the diagnosis, but the sensitivity and specificity of these biomarkers remains quite low for this indication.

The determination of MVA is difficult because this hormone is unstable ex vivo. To date, its use in current practice remains complicated.

MVA and copeptin are derived from the same precursor and are therefore co-secreted by the pituitary gland in equimolar proportions.

Copeptin has a relatively short in vivo half-life of about 25 minutes, as does MVA, but is more stable in vitro when blood has been drawn.

Its use in the early diagnosis of diabetes insipidus after pituitary surgery could therefore be of interest.

Objective is to study the interest of copeptin dosage as an early predictive marker for the diagnosis of post-operatice diabetes insipidus in trans-sphenoidal endoscopic pituitary surgery.

Eligibility Criteria:
inclusion criteria : adult patient patient undergoing pituitary surgery for tumour of the sellar region patient consenting to participate to the study patient enrolled in the national healthcare insurance program

exclusion criteria : Patient with preoperative diabetes insipidus. Patient undergoing pituitary surgery for suspicion of craniopharyngioma Patient undergoing pituitary surgery for pituitary metastases Patient under 18 years
Dietary Plant Hormone and Mental Health

The aim of this cross-sectional online study is to investigate the association between regular feeding behavior and stress, sleep as well as anxiety and depressive symptoms in healthy subjects.

The gut-microbiota-brain (GMB) axis has a multidirectional communication between the intestine, the microbiota, and the central nervous system (CNS). Over the past decade, there has been extensive research showing that the GMB axis has a profound influence not only on neurological disorders but also on neural development, activation of the neuroendocrine axis and neurotransmission, as well as modulation of complex human behaviors. Thus, the GBM-axis is involved in the regulation of stress, emotions, behaviour, and higher cognitive functions. As the GMB plays an essential role in human psychological functioning and mental health, the dietary manipulation of the microbiome may have direct effects on mental well-being, sleep, anxiety and depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 30

Exclusion Criteria:

* None
Evaluation of Verbal and Visual Information Techniques

The aim of this study is to evaluate the effects of preoperative and postoperative anxiety levels on patients using oral information, visual information with surgical photographs and visual information via audio-video. To evaluate anxiety levels, dental anxiety scale (DAS), modified dental anxiety scale (MDAS) and state anxiety scale (STAI-S, STAI-T) scales will be used.

After giving written information about the study, an informed consent form will be distributed to patients who want to participate in the study and they will be asked to sign it. Patients who have signed the consent form will be asked to complete the DAS, MDAS, STAI-T and STAI-S questionnaires in the waiting room to assess preoperative anxiety levels.

Verbal, photos and video information used to inform patients. Patients will be randomly divided into 3 groups. A total of 60 patients with 20 patients in each group will be included in the study. Patients in all groups will be operated by the same surgeon. Oral information will be given to the patients in the first group. In the second group, visual information will be given to the patients by showing the photos of the operation process. Patients in group 3 will also be shown a video of an audio implant operation showing the operation process. The operation video of a previously implanted patient will be watched by the attending physician. This video will begin with the physician informing the patient about the implant and continue with anesthesia. Afterward, the video will be terminated by giving information about the implant operation video and the complications that the patient may encounter and the points to be considered after the operation.

A 7-day pain score will be obtained using the Smiley VAS scale to measure postoperative pain levels and patients will be asked to note how many painkillers they use. In addition, blood pressure and pulse measurements will be taken before and after surgery.

A common text was prepared in all groups in order to provide preoperative information in an ideal way. In group 1, information related to this text will be given orally. In the 2nd and 3rd groups, patients will be informed about the same information as well as visuality.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the investigator's clinic for implant surgery

Exclusion Criteria:

* pregnant patients
* patients using psychiatric drugs
* patients with visual problems
Study of the Hemispheric Specialization for Language in Subjects With Neuropsychiatric Disorders Compared to Control Subjects

Recently, we have shown functional resonance imaging (fMRI) that variations in signal induced by a language task were significantly lower in a semantic region of the left hemisphere (comprised of that part pars triangularis of the inferior frontal gyrus and the temporal gyri medium and angular) in schizophrenic patients compared with controls matched for age, sex, level of education and handedness.

Investigators wish to test the hypothesis that functional modification of the hemispherical specialization is specific language and also specific for schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* patients under 65 years
* Schizophrenics, bipolar or schizoaffective (DSM IV)
* Patients who signed informed consent

Exclusion Criteria:

* Women with childbearing potential without effective contraception or positive pregnancy test.
* Contra-indications to fMRI
Phase II Study of Different Doses of Radiotherapy Combined With Sintilimab in the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma

This study is aimed to evaluate the efficacy and safety of different doses of radiotherapy combined with sintilimab in locally advanced esophageal squamous cell carcinoma.

This study was designed as a two cohorts, phase II trial. Subjects will receive different doses of radiotherapy combined with sintilimab. The primary endpoint is progression-free survival.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Histopathological examination of the primary biopsy confirmed the diagnosis of locally advanced esophageal squamous cell carcinoma
* At least one measurable lesion
* Eastern cooperative oncology group (ECOG) performance status of 0 to 1
* With adequate organs function

Exclusion Criteria:

* Patients with active malignancy within 5 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer
* Patients who have a higher risk of bleeding or perforation due to the tumor\&#39;s obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula
* Patients who have received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional Chinese medicine therapy
Third Stage of Labor a Swedish Randomized Controlled Trial

The purpose with this study was to compare blood loss and women's experience of afterpains during the third stage when handled with active or expectant management of the third stage of labour.

Hypothesis 1. To detect a 5% difference (15% vs 10%) in blood loss \>1000 mL between the two groups with 80% power (α=0.05), at least 726 subjects were required in each group.

Hypothesis 2. Afterpains are more pronounced in active compared to expectant management during the third stage of labour

Management of the third stage of labour has been focus for investigation during decades and active management of the third stage of labour (AMTSL)has been recommended in all women giving birth vaginally at hospitals. In Sweden the recommendation has been to give an injection of oxytocin immediately after birth of the neonate but not the entire AMTSL procedure.

Women in labour were asked to participate voluntarily when entering the hospital and after acceptance they were randomised to either active or expectant management of the third stage of labour(EMTSL).

AMTSL included:

* Early cord clamping
* 10 UI oxytocin i.v
* controlled cord traction
* uterine massage after placenta expulsion

EMTSL included:

* early cord clamping
* 2 mL saline solution i.v
* wait for signs of placenta detachment
* encourage the women to push out placenta by her own effort
* uterine massage after placenta expulsion

All blood was measured by weighing bed pads and sanitary towels up to two hours postpartum Assessment of afterpains was performed by a Visual Analogue Scale (VAS) and the Pain-o-meter (POM-WDS) two hours after the delivery of placenta, and the day after childbirth.

Eligibility Criteria:
Inclusion Criteria:

* healthy women with normal pregnancies
* gestational age of 34+0 - 43+0 weeks
* singleton, cephalic presentation
* expected vaginal birth

Exclusion Criteria:

* non Swedish-speaking
* previous PPH \>1000 mL
* elective Caesarean section
* pre-eclampsia
* grand multiparity (≥5)
* intrauterine fetal death
The Clinical Efficacy of Three Oral Hygiene Regimens Using a Manual Toothbrush, Toothpaste and a Mouthwash in Controlling Dental Plaque and Gingivitis

The objective of this clinical research study is to assess the efficacy of three oral hygiene multi-component regimens encompassing the use of a manual toothbrush, toothpaste and a mouthwash in controlling established dental plaque and gingivitis.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects, ages 21-70, inclusive.
2. Availability for the six-week duration of the study.
3. Good general health.
4. Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
6. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
7. Signed Informed Consent Form.

Exclusion Criteria:

1. Presence of orthodontic bands.
2. Presence of partial removable dentures.
3. Tumor(s) of the soft or hard tissues of the oral cavity.
4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
5. Five or more carious lesions requiring immediate restorative treatment.
6. Use of antibiotics any time during the one month prior to entry into the study.
7. Participation in any other clinical study or test panel within the one month prior to entry into the study.
8. Pregnant women or women who are breast feeding.
9. Dental prophylaxis received in the past two weeks prior to baseline examinations.
10. History of allergies to oral care/personal care consumer products or their ingredients.
11. On any prescription medicines that might interfere with the study outcome.
12. An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
13. History of alcohol or drug abuse
Creatine Monohydrate as Adjuvant Therapy for Bipolar Depression

The purpose of this study is to determine whether creatine monohydrate is effective as an adjuvant treatment for bipolar depression.

Bipolar Depression is associated with high rates of disability and increased mortality. Despite its major negative impact, treatment of Bipolar Depression is still controversial and only partially efficacious, with over half of patients not responding adequately to available treatment. In this context, the use of drugs that modulate energy metabolism has been proposed as promising new option as treatment strategies for bipolar depression. The aim of our proposed study is to perform a 6-week randomized, double-blind, placebo-controlled clinical trial of creatine monohydrate as an adjuvant treatment for bipolar depression.

Eligibility Criteria:
Inclusion Criteria:

* Individuals eligible for the study will be adults aged 18 to 60 years of age who met DSM-IV criteria assessed by the SCID (Structural Clinical Interview for DSM-IV) for type I bipolar disorder, current episode depressed.
* Patients who have scored \> 19 on the Montgomery-Asberg Depression Rating Scale (MADRS) will be included, although more than two weeks of treatment with lithium (serum level\> 0.8 mEq / L), valproate (serum levels\> 50 mg / L) or quetiapine (300-600mg/dia dose) or drug combination.
* Antipsychotics, anticonvulsants, benzodiazepines, and thyroid supplementation will be allowed if the dose has remained stable over the past two weeks.
* Antidepressants will be allowed if the dosage has remained stable for 4 weeks.

Exclusion Criteria:

* Subjects with substance abuse within 2 weeks before inclusion or substance dependence up to 2 months will not be included.
* Other exclusion criteria will be:

  * diagnosis of schizophrenia,
  * dementia,
  * delirium,
  * epilepsy,
  * mental retardation,
  * clinically unstable medical illnesses,
  * preexisting renal disease,
  * history of hypersensibility to creatine.
* Not included are individuals at high risk for suicidal or homicidal behavior or self-mutilation will not be included.
* Women with gestational potential can only be included if they are using reliable contraception.
The Association Between Advancing Age and Mortality at 30 Days in Patients With Bacteremia E. Coli Beta-lactamase Phenotype Extended Spectrum RC15_0421

In the US and Europe, bacteremia are ranked the 7th leading cause of death from all causes. E. coli is one of the main microorganism involved, responsible for 30% to 45% of bacteremia. In Europe, bacteremia E. coli, including BLSE phenotype, have a strong impact on public health, causing increased mortality, particularly in the elderly, and an increase in the average hospital stay. However, few studies have specifically concerned with the criteria associated with mortality of elderly patients with BLSE E. coli bacteremia. Finally, improving epidemiological knowledge of the elderly patients with bacteremia due to BLSE E. coli has importance in terms of public health and is a prerequisite to the development of preventive strategies and to improve the short-term prognosis.


Eligibility Criteria:
Inclusion Criteria:

* All patients with positive blood culture E. coli BLSE will be included in the study. Bacteremia E. coli BLSE will be defined as the identification of one or more blood cultures positive for E. coli BLSE in patients with clinical criteria of systemic inflammatory response, at least two of the following 4 criteria:

  * temperature\> 38 ° C or \< 36 ° C;
  * heart rate\> 90 beat / min;
  * respiratory rate \> 20 c / min or PaCO2 \< 32 mmHg;
  * WBC \> 12,000 / microL or \< 4000 / microL or 10% immature forms

Exclusion Criteria:

* For each patient included, only the first episode of bacteremia will be included in the study
Valsartan to Prevent Left Ventricle Remodeling in Pacemaker Patients

Dual chamber pacing is known to induce left ventricle remodeling and may eventually lead to heart failure. The investigators aim to test hypothesis that valsartan started immediately after dual chamber pacemaker implantation will prevent left ventricle remodeling in twelve months long follow up in comparison with placebo. Echocardiographic assessment of left ventricle remodeling will be correlated with plasma activity of matrix metalloproteinases and their tissue inhibitors, indices of functional capacity such as plasma level of NTproBNP and distance in meters during six minute walking test.


Eligibility Criteria:
Inclusion Criteria:

* informed written consent
* age ≥ 18 years
* first time pacemaker implantation for trifascicular block, atrioventricular second or third degree block
* left ventricle ejection fraction ≥ 40%

Exclusion Criteria:

* significant valvular heart disease
* ischaemic heart disease requiring further revascularization
* symptomatic hypotension
* orthostatic disorders
* pregnancy, breast feeding, child bearing potential
* previous use of angiotensin receptor blocking agents
* known hypersensitivity to valsartan
* significant liver disorders
* significant renal disorders, including renal artery stenosis
* hyperaldosteronism
* chronic use of nonsteroid antiinflammatory drugs
* chronic use of lithium salts
* Patient's reluctance or disability to obey protocol and/or follow the scheduled visits
* any significant disease to reduce the expected life duration \< 12 months
* participation in any other trial within the last 30 days before randomization
* any situation that would put more risk on patient
Liquid Biopsy-Based Novel Modality for Postoperative Management of Lung Cancer

The goal of this study is to develop new techniques for minimal residual disease(MRD) monitoring and to confirm the efficacy and safety of MRD-guided postoperative management for early stage non-small cell lung cancer. The main questions this study aims to answer are:

* How to develop multi-omics-based high-sensitivity detection methods to accurately capture MRD and monitor postoperative recurrence in lung cancer?
* Is adaptive treatment guided by ctDNA-MRD for lung cancer patients superior to traditional clinical management and effectively improves survival?
* Do heterogeneous patient populations (grouped by stages, histopathological subtypes, driver mutations, and treatment histories) show differences in effects under ctDNA-MRD guided postoperative management strategies?

Approximately 30% of early-stage lung cancer patients experience recurrence after curative surgery. However, the clinical utility of routine chest CT surveillance remains limited. Emerging evidence has demonstrated that liquid biopsy-based minimal residual disease (MRD) detection may serve as a more sensitive monitoring strategy. Longitudinal ctDNA dynamics analysis further enables real-time assessment of tumor progression and early detection of molecular relapse.

This study aims to develop a novel multidimensional approach for non-invasive postoperative recurrence monitoring in lung cancer and establish an MRD-guided adjuvant therapy model to optimize precision treatment and MRD-stratified follow-up protocols for lung cancer patients. This study will evaluate the sensitivity and specificity of novel monitoring methods and further compare emerging non-invasive recurrence monitoring approaches with conventional ctDNA-based techniques, driving continuous advancements in lung cancer research.

Eligibility Criteria:
Inclusion Criteria:

* Non-small cell lung cancer with stage IA-IIIA (8th edition TNM classification) planning to undergo curative surgery or to undergo neoadjuvant therapy
* Solid nodules \>1 cm or ground-glass nodules \>1.5 cm on imaging
* No history of malignancies other than non-small cell lung cancer in the past 5 years
* Specimens are well preserved and imaging documents are accessible.

Exclusion Criteria:

* Age\<18 years old
* Non-small cell lung cancer with pathologic stage IIIB-IV (8th edition TNM classification)
* Pathology results confirmed not to be non-small cell lung cancer
* History of malignancies other than non-small cell lung cancer in the past 5 years
The Influence of Coronary Chronic Total Occlusion on Myocardial Perfusion on Computed Tomography

The COPACABANA study is designed as a single-centre, open, prospective trial aimed to assess the influence of coronary chronic total occlusion (CTO) on downstream myocardial ischemia via the novel computed tomography perfusion (CTP) imaging technique. To this end, consecutive patients with CTO of a major coronary artery scheduled to undergo percutaneous recanalization of occluded coronary artery based on clinical grounds, will undergo stress CTP using state-of-the-art dual-energy CT scanner at 2 time points (before and 3 months after successful restoration of flow in the CTO vessel).


Eligibility Criteria:
Inclusion Criteria:

* delivery of an informed consent and compliance with study protocol
* persistent angina pectoris (CCS class ≥2) refractory to optimal medical therapy
* CTO of a major coronary artery (left anterior descending artery, right coronary artery, left circumflex artery) of at least 2.5 mm vessel diameter confirmed by invasive angiography
* preserved left ventricular ejection fraction (\>50%) on echocardiography or cardiac magnetic resonance with preserved contractility in the CTO territory (normokinesia and/or hypokinesia)

Exclusion Criteria:

* unstable angina and/or myocardial infarction
* prior myocardial infarction within 4 weeks before study enrolment
* occurrence of myocardial infarction and/or unplanned revascularization between the index procedure and post-procedural CTP study
* impaired renal function (eGFR ≤45 ml/min/m2)
* contraindications to antiplatelet therapy and/or heparin
* other contraindications to CTP (pregnancy, allergy to contrast media or pharmacologic stress agents, tachyarrhythmia, claustrophobia)
Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women

The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 2 years postmenopausal
* Osteoporotic subjects without vertebral fracture who meet BMD criteria, or Osteoporotic subjects with vertebral fracture

Exclusion Criteria:

* Diseases that may affect bone metabolism
* Vasomotor symptoms requiring treatment
* Known history or suspected cancer of the breast
* Active or past history of venous thromboembolic events