cyrilzakka/clinical-trials huggingface dataset:
The Effects of Environmental Factors on the Macro-genome and Metabolism of Obese Patients.

The present study was designed to include obese patients diagnosed with obesity in the First Affiliated Hospital of Chongqing Medical University and a healthy control population. By analysing the relationship between metabolic parameters and macrogenomes in obesity, identifying key metabolic and macrogenomic differences between obese patients and healthy populations, and establishing the association between environmental factors and obesity-related metabolic disorders, the investigators will be able to provide new biomarkers and intervention targets for obesity prevention and treatment.

Obese patients who attended the First Hospital of Chongqing Medical University and intended to undergo bariatric surgery were screened according to the inclusion and exclusion criteria. Patients' basic personal information and biological specimens including blood, faeces and urine were collected for metabolic and macro-genomic analyses. Air pollution exposure of the study subjects was collected by telephone follow-up. Metabolite profiles in blood and urine were analysed using liquid chromatography-mass spectrometry (LC-MS). Microbial community composition in faecal samples was analysed using 16S rRNA gene sequencing. Metabolic and macrogenomic differences between obese and control groups were compared using t-test or Mann-Whitney U-test. Logistic regression analyses were used to assess the independent effects of different environmental factors on metabolism and macrogenome. Identify key metabolites and microorganisms associated with obesity using Random Forest and Principal Component Analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Obese patients with BMI ≥30kg/m2;
* Patients did not undergo surgical treatment before enrolment;
* Willing to participate in this study and sign the informed consent form;
* Complete clinical data.

Exclusion Criteria:

* Patients with systemic diseases such as severe cardiorespiratory insufficiency that affect the choice of treatment regimen;
* Pregnant or lactating women;
* Patients who are not suitable for enrolment as assessed by the investigator;
* Patients with incomplete clinical data.
Prevalence of Thyroid Function Abnormalities in HIV-infected Patients

Review the evolution of thyroid function in HIV-infected patients, with sufficient follow-up.

Since the appearance of high-efficiency anti-retrovirals (HAARTs) in the treatment of Human Immunodeficiency Virus (HIV), several studies have shown an increase in the prevalence of hypothyroidism (frank, rough or low hypothyroidism T4) in cohorts of HIV-infected adults and children. More specifically, rough hypothyroidism (increased TSH and normal thyroid peripheral hormones) have a prevalence of about 3-12% in HIV-treated patients, which is higher than the general population of about 4.3%. The etiology of frustrated hypothyroidism remains debated in the literature; Effects of antiretroviral therapy (ARV) such as Stavudine®, the effect of dyslipidemia, the effect of HIV infection itself, in proportion to severity (expressed as low CD4 cell count) and AIDS stage. Thyroid dysfunction does not appear to be of autoimmune origin, as anti-peroxidase antibodies are rarely present in HIV-infected patients, unlike the general population.

With the increased life expectancy of HIV-infected patients and the indications of different experts to be treated earlier, the duration of exposure to ARVs is also increasing. Therefore, their chronic toxicity deserves particular attention, in particular on thyroid function and / or thyroid hormone metabolism, since iatrogenicity has not been completely ruled out. In addition, clinical evidence suggests that dysthyroids may be corrected or worsened over time in HIV patients (unpublished personal data).

Today, the natural history of frustrated hypothyroidism and its consequences are not reported in patients infected with HIV. However, it is recognized in the elderly, fructified hypothyroidism evolves over time towards frank hypothyroidism; The latter is associated with an increased prevalence of dyslipidemia, atherosclerosis, diastolic hypertension and therefore an increased risk of myocardial infarction.

It therefore seems interesting to review the evolution of thyroid function in HIV-infected patients, with sufficient follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Major Patients.
* Infected with HIV, regardless of stage of disease and treatment, diagnosed between January 2001 and December 2012
* Follow-up at the University Hospital of Amiens.

Exclusion Criteria:

* Patients in the THIVY1 study lost to follow-up since 2001, having moved or undergoing therapeutic break-up
* Deceased Patients
* Major protected persons (under guardianship or guardianship)
* Pregnant women
* Refusal of participation
BIBX 1382 in Treating Patients With Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of BIBX 1382 in treating patients who have solid tumors.

OBJECTIVES: I. Determine the maximum tolerated dose of oral BIBX 1382 in patients with solid tumors. II. Determine qualitative and quantitative toxicities of oral BIBX 1382 in these patients. III. Determine predictability, duration, intensity, onset, reversibility, and dose relationship of the toxicities of oral BIBX 1382 in these patients. IV. Determine safe and optimal doses of oral BIBX 1382 for a Phase II study. V. Assess the pharmacokinetics of oral BIBX 1382 in these patients. VI. Document any antitumor activity in these patients treated with oral BIBX 1382.

OUTLINE: This is a dose escalation study. Patients receive BIBX 1382 IV over 1 hour followed 7 days later by oral BIBX 1382. Beginning 3 days later, patients receive oral BIBX 1382 daily for 28 days. Courses of daily oral BIBX 1382 repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of oral BIBX 1382. The maximum tolerated dose (MTD) is defined as the dose at which dose limiting toxicity occurs in at least 2 of 6 patients. Patients are followed for up to 4 weeks.

PROJECTED ACCRUAL: A total of 40-80 patients will be accrued for this study over 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically proven solid tumor not amenable to standard treatment No symptomatic brain involvement or leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Other liver function tests no greater than 2 times upper limit of normal (unless related to liver metastases) Renal: Creatinine no greater than 1.4 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No active bacterial infections No nonmalignant disease that would be incompatible with study No prior alcoholism, drug addiction, or psychotic disorders

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy (6 weeks for extensive radiotherapy) No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational or antitumor drugs
Apotransferrin in Atransferrinemia

Atransferrinemia is a very rare disorder, which is caused by a deficiency of the protein transferrin. No regular treatment is available for these patients. The objective of this study is to investigate the pharmacokinetics, efficacy and safety of Apotransferrin replacement therapy in atransferrinemia patients.


Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of atransferrinemia, defined as serum levels of transferrin below 40 mg/dl
* Informed consent

Exclusion Criteria:

* Known with allergic reactions against human plasma or plasma products
* Having detectable anti-immunoglobulin A antibodies
Near-infrared Autofluorescence (NIRAF)-Guided Total Thyroidectomy: Impact in Low-volume, Non-parathyroid Institutions

Hypoparathyroidism is the most frequent complication in total thyroidectomy. The use of near-infrared autofluorescence (NIRAF) intraoperatively, seems to reduce the rate of transient hypoparathyroidism. Unfortunately, no effect on permanent hypoparathyroidism has been shown.

In order to cover every aspect of the impact of NIRAF in thyroid surgery, an evaluation in low-volume, non-parathyroid institutions is needed. This is the overall aim of our current studies. The objective of this specific study is to evaluate the impact of NIRAF on immediate, transient and permanent hypoparathyroidism following total thyroidectomy in low-volume, non-parathyroid institutions.

Patients referred for total thyroidectomy will undergo NIRAF-assisted surgery (Fluobeam LX) at two low-volume ENT-departments with no experience in parathyroid surgery.

PTH and ionized calcium will be assessed preoperatively, on postoperative day 1 (POD1) and minimum two months following surgery. Patients who still fulfill the criteria for hypoparathyroidism at that point will be followed until one year following surgery. The rates of immediate, transient and permanent hypoparathyroidism will be assessed and compared to a historic cohort.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for total thyroidectomy
* Age \> 18
* Able to understand patient information
* Able to give informed consent

Exclusion Criteria:

* Previous thyroid surgery
* Need for accelerated surgery
* Insufficient biochemical profile
Regent China Post-Market Clinical Follow-up Study

Regent China Post-Market Clinical Follow-Up (RC-PMCF): this clinical study is to confirm the safety and performance of Abbott's Regent MHV for replacement of native or prosthetic aortic valves in a Chinese population.

The purpose of the RC-PMCF study is to meet the post-market clinical followup (PMCF) requirements of the National Medical Products Administration (NMPA). The primary objective of this clinical study is to confirm the safety and performance of Abbott's Regent MHV for replacement of native or prosthetic aortic valves in a Chinese population. This is a prospective, observational, multi-center study of subjects clinically indicated for implantation of an Abbott Medical's Regent Valve.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is eligible to be implanted with Regent to replace a native or prosthetic aortic valve per Regent's IFU.
2. Subject will be \>18 years of age at time of being consented.
3. Subject, provides written informed consent prior to any clinical investigation-specific procedure.

Exclusion Criteria:

1. Subject is unable to tolerate anticoagulation therapy.
2. Subject has active endocarditis.
3. Subject is currently participating in another clinical investigation which may interfere with the effectiveness of anticoagulation therapy.
4. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. Women of child-bearing potential must have a documented negative pregnancy test within one week prior to enrollment.
5. Subject has anomalous anatomy or medical, surgical, psychological or social history or conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.
6. Subject is unable to read or write or has a mental illness or disability that impairs their ability to provide written informed consent.
7. Subject's life expectancy is less than 1 year in the opinion of the Investigator.
Off-script Diagnosis & Differential Diagnosis (D&D) Training and Residents' Stroke Knowledge

This study is a single-center, randomized, open-label, controlled, endpoint-blinded study to assess the effect of off-script diagnosis \& differential diagnosis (D\&D) training in improving the residents' knowledge of acute ischemic stroke in China. The investigators will enroll 22 residents and assess the score of mASMaQ 30 days after randomization.

Ischemic stroke is characterized by high incidence and disability rates, with a critical time window for reperfusion therapy, necessitating prompt recognition, diagnosis, and treatment by frontline physicians. In clinical practice, residents across all specialties may encounter acute ischemic stroke (AIS) patients in emergency departments, outpatient clinics, or inpatient wards. However, many residents face challenges in managing AIS cases, often leading to missed diagnoses, treatment delays, and non-adherence to clinical guidelines. A primary contributing factor is their insufficient mastery of key AIS management principles and inability to effectively apply stroke knowledge in clinical contexts.

Enhancing residents' AIS management competence represents a significant challenge in stroke education. Traditional "Initial Progress Note" training overemphasizes comprehensive differential diagnoses, with most residents relying on scripted presentations. The actual clinical application of stroke knowledge remains uncertain. This study aims to evaluate whether off-script diagnosis \& differential diagnosis (D\&D) training (i.e., "Structured off-script D\&D") can significantly improve residents' AIS management knowledge.

The investigators will enroll 22 neurology residents and randomly assign them to two groups: the off-script diagnosis \& differential diagnosis (D\&D) training group (n=11) and a blank control group (n=11). The modified Acute Stroke Management Questionnaire (mASMaQ) will be used to assess residents' AIS knowledge 30 days after randomization.

Eligibility Criteria:
Inclusion Criteria:

1. Residents (physicians in postgraduate training).
2. Currently in neurology wards
3. Managing acute ischemic stroke (AIS) patients, defined as: 1)Time from onset to randomization ≤ 2 weeks; 2) If onset time is unknown, the last known well time is considered the onset time.
4. Signed informed consent

Exclusion Criteria:

1. Managing asymptomatic ischemic stroke patients.
2. Residents who are currently participating or have participated in another interventional ischemic stroke training program within the past 3 months.
Effectiveness of Spa Treatment, Outpatient Physiotherapy and no Physiotherapy in Spine Osteoarthritis

In the first study group will participate patients with spine osteoarthritis who will be treated in polish spas in Subcarpathian Region. Complex physiotherapy including balneotherapy will be applied in study group participants. In the second study group will participate patients with spine osteoarthritis who will be treated in outpatient treatment. Complex physiotherapy without balneotherapy will be applied in second study group participants. In the control group will participate patients with spine osteoarthritis who will not have applied physiotherapy nor balneotherapy during observation. In all patients will be evaluated quality of life, level of pain intensity and health assessment.

The following questionnaires will be used: original socio-demographic data questionnaire, the VAS (visual analogue scale) pain severity rating scale, the modified Laitinen pain questionnaire, the Life Satisfaction Questionnaire LISAT-9 and the HAQ: Health Assesment Questionnaire.

Questionnaires will be completed: before the beginning of therapy, one month and six months after the end of therapy.

Questionnaires in control group will be completed: in the beginning of observation and in the same time intervals as in study groups.

Eligibility Criteria:
Inclusion Criteria:

* Spine osteoarthritis

Exclusion Criteria:

* no consent to participate in the study
Evaluation of Correlations Between Radiologic Features and Pathologic Subtypes of GGO LUAD Via WMS (ECTOP-1011)

This study is one of the Eastern Cooperative Thoracic Oncology Projects (ECTOP-1011). It aims to evaluate the correlations between radiologic features and pathologic subtypes of ground glass opacity featured lung adenocarcinoma via whole-mount section.

The pathological lepidic growth pattern was believed to relate to the ground-glass component, whereas invasive adenocarcinoma patterns relate to the solid component. However, the solid components might be fibrosis rather tumor; and previous studies demonstrated the ground-glass components might be invasive lesions. Therefore, it is of considerable significance to establish the correlations between radiologic features and pathologic subtypes of ground glass opacity featured lung adenocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Ground glass opacity featured lung nodule diagnosed by thin-section computed tomography(TSCT)
* Pre-operation clinical IA stage
* Pulmonary lobectomy or segmentectomy
* Provision of informed consent

Exclusion Criteria:

* Postoperative diagnosis of non-adenocarcinoma or mucinous adenocarcinoma
* The surgical specimens fail to satisfy requirement of inflation and formalin fixation
Intraoperative Music Application and Postoperative Behaviour in Children and Adolescents.

The purpose of the study is to evaluate whether intraoperative music application has a positive impact on postoperative behavior in children and adolescents.

After induction of anesthesia, paralyzation of the patient and subsequent intubation, a caudal block is applied. After positioning of the patient, headphones are placed on the patients head and in case of the interventional group, music is played. Previously, the volume of the music is adjusted to a range from 50 to 60 decibel. Headphones are removed before extubation.

Postoperative behaviour is evaluated by parents and by caretaking personnel in the recovery room at arrival, after 15 minutes and before discharge to the ward and at home by parents after one, two and four weeks using questionnaires.

sample size calculation: n = minimal number of required probands π = 70% (proportion of interest) → 0.7 π0 = 50% (null hypothesis proportion) → 0.5 μ = (100% - 90%power) → 1.28 v = 1.96 (level of significance p=0.05)

n \> \[ μ√ π(1- π) + v√ π0(1- π0)\]2 / (π - π0) n \> 61.4 + correction for drop-outs (+10%) n = 70 per group → 140 probands in total

Eligibility Criteria:
Inclusion Criteria:

* age: 4-16 years
* American Society of Anesthesiologists (ASA) physical status of 1 and 2
* elective inguinal herniotomy or circumcision
* general anaesthesia with sevoflurane and caudal block
* written informed consent available

Exclusion Criteria:

* age \<4 or \>16.99 years
* ASA physical status of 3 or higher
* emergency surgery
* no general anaesthesia with sevoflurane or/and caudal block
* no written informed consent available
Use of Single Versus Double Foley's Catheter in Pre-induction Cervical Ripening

Cervical ripening should be present before labor induction, which can generally be divided into two categories: pharmacological and mechanical

With appropriate decision and timely intervention, labor induction decreases the risk of fetal and maternal morbidity and mortality. The single balloon catheter (i.e. Foley catheter \[FC\]) and Cook cervical ripening balloon have been the most commonly used mechanicalwith a minimal increase in risk of cesarean section.

The single balloon catheter (i.e. Foley catheter \[FC\]) and Cook cervical ripening balloon have been the most commonly used mechanical method.

The FC applies pressure on lower uterine segment and cervix in the direction from the uterus to the vagina.

The Cook cervical ripening balloon is composed of a cervicovaginal balloon and a uterine balloon. Its mechanism is similar to that of the Foley balloon, but it can apply pressure in two directions simultaneously, on both the external and internal os.

Although many studies have shown that the Cook cervical ripening balloon and FC have similar efficacy and safety.

They each have district advantages and disadvantages in labor induction. In addition to the cost advantage and wide avail- ability of the FC, the safety of labor induction with the FC has been proven by many studies.

However, some study have shown that the FC results in a higher pain score, and consequently, higher maternal request for cesarean section and higher cervical laceration incidence compared with the Cook cervical ripening balloon.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 34 years old
2. Postdate Primigravida
3. Single viable fetus.
4. Cephalic presentation.
5. Normal biophysical .
6. Bishop score of four or less.
7. RH positive women.

Exclusion Criteria:

1. Premature rupture of membranes (PROM).
2. Oligo or Polyhydramnios
3. Antepartum hemorrhage and placenta praevia.
4. Current cervical cerclage.
5. Invasive cervical carcinoma.
6. Known fetal anomaly.
7. Previous uterine scar due to myomectomy or metroplasty.
8. Cephalopelvic disproportion due to pelvic contraction or Macrosomic baby.
9. Active genital Herpes infection.
10. Chronic maternal illness.
Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke

The objective of this study is to collect data on the use of the SOLITAIR FR device for treatment of acute ischemic stroke with large artery occlusion i.e. to investigate, whether the application of SOLITAIR is a safe and feasible method for interventional recanalization of large vessels with favorable patient outcome in acute stroke therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-85 years
* Acute ischemic stroke with occlusion if ICA, MCA, VA or BA (TICI 0 or 1 flow) within the first 6 hours

Exclusion Criteria:

* Rapidly improving neurological signs
* NHISS\>30 or coma
* Female patients, who are pregnant or lactating
* Use of warfarin anticoagulation with INR \> 1.5
* Platelet count \< 30,000
* Glucose \< 50 mg/dL
* Life expectancy of less than 90 days
* Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of hemorrhage on presentation
* CT showing hypodensity on presentation
Clinical Investigation of the Vision-R800 Device.

Randomized, bilateral, cross-over dispensing study of a standard and VR800 refraction and associated spectacle lenses.


Eligibility Criteria:
Inclusion Criteria:

* current adaptated progressive addition lens wearer, if bifocal lens required
* wearable pair of glasses \< 2 years old
* wear glasses at least 6 hours per day

Exclusion Criteria:

* Eye Disease with an impact on visual acuity or binocular vision abnormalities (by self-report)
* Formal training in optometry, vision science or in the eyecare field
Deep Learning for Intelligent Identification of Arrhythmias

This study aims to design and train a deep learning model for the diagnosis of different arrhythmias.

This study aims to retrospectively and prospectively collect routine clinical data such as electrocardiograms from patients with arrhythmias who meet the inclusion and exclusion criteria. Then we will design and train a deep learning model to analyse the electrocardiographic features of the arrhythmias, and identify the types of arrhythmias and evaluate the value of the model for the diagnosis of different arrhythmias.

Eligibility Criteria:
Inclusion Criteria:

* For retrospective study: 1.Patients with arrhythmia diagnosed by routine surface 12-lead electrocardiogram or Holter; 2.The type of arrhythmia is diagnosed by intracardiac electrophysiological examination.
* For prospective study: 1.Patients with arrhythmia diagnosed by routine surface 12-lead electrocardiogram or Holter; 2.Intracardiac electrophysiological examination is planned.

Exclusion Criteria:

* Lack of routine surface 12-lead electrocardiogram or holter data;
* Lack of intracardiac electrophysiological examination;
* Patients refused to sign informed consent and refused to participate in the study.