cyrilzakka/clinical-trials huggingface dataset:
Prospective Study of Quality of Life in Non-small Cell Lung Cancer (NSCLC) Patients Treated With/Without Postoperative Radiotherapy

The patients from 12 centers were included into the study. pN2 patients received PORT, pN1 patients did not. PORT was 3D-planned and consisted in 54-56 Gy in 27-28 fractions. One month after surgery, all patients completed EORTC QLQ C-30 questionnaires and had pulmonary function tests (PFT); cardiopulmonary symptoms were assessed by modified LENT-SOM score. Two years after, all patients free of disease repeated the same examinations. Changes in QLQ, LENT-SOM score and the results of PFT were compared for patients receiving and not PORT.


Eligibility Criteria:
Inclusion Criteria:

* complete resection by lobectomy, bi-lobectomy or pneumonectomy of NSCLC,
* pN1 or pN2 disease,
* signed informed consent for participation in the study,
* Karnofsky Performance Status (KPS) higher than 70%.

Exclusion Criteria:

* presence of distant metastases,
* N2 diagnosed before surgery in imaging and/or mediastinoscopy,
* previous radiotherapy to the chest,
* no or inadequate mediastinal nodal dissection ,
* FEV1 after surgery lower than 1.0 liter,
* any active infectious process (including fistula formation) in the chest
The Efficacy of Transcutaneous Electrical Nerve Stimulation on LUTS: One Prospective Study.

The study is a prospective study at a single institution. Investigators create strict inclusion and exclusion criteria, selecting 126 patients who undergo the pelvic reconstructive surgery. 63 patients in the intervention group accept 10 times of the transcutaneous electrical nerve stimulation.

All the patients have severe pelvic organ prolapse and undergo the pelvic reconstructive surgery. Investigators evaluate all patients' lower urinary tract symptoms, quality of life score, overactive bladder questionnaire, maximal rate and residual urine volume, at 1, 3, 6 and 12 months after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* severe pelvic organ prolapse(POP-Q:3/4 stage)
* accept pelvic reconstructive surgery

Exclusion Criteria:

* Dominant stress urinary incontinence
* Serious medical problems
* mental disease
* infectious disease
Metformin Continuation Versus Interruption Following Coronary Angiography: a Pilot Randomized Controlled Trial

This pilot randomized controlled trial aims to evaluate the feasibility for safety examination of continued metformin therapy in patients with type 2 diabetes (T2D) following invasive coronary angiography. Metformin will be continued until coronary angiography.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. On metformin therapy
3. Angiography for ACS or elective non-ACS related indications
4. Informed consent received

Exclusion Criteria:

1. Cardiogenic shock prior to randomization
2. Cardiac arrest prior to randomization
3. Established severe CKD (eGFR\<30, or on dialysis)
4. Chronic liver disease
5. Need for CABG within 48 hours of hospitalization
6. Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
Is Intraoperative PTH Monitoring Obsolete in Times of Choline PET/CT? a Prospective Multicenter Cohort Study to Determine Whether the Regular Preoperative Use of Choline-PET/CT Scan Obviate the Need for Intraoperative PTH-measurement in Patients with Primary Hyperparathyreoidism

In patients with primary hyperparathyreoidism (pHPT) in 80-90% only one of the four parathyroid glands has developed an autonomy and is causative for the disease. Localisation diagnostics are used to help identify the affected gland or glands in order to enable more focused surgical approaches and reduce morbidity of the surgery, as well as operative time. The gold standard for imaging in Germany and Austria are sonography and scintigraphy. If imaging is not conclusive, Choline-PET/CT, which has been shown to have a higher specificity than the scintigraphy, especially for multiglandular disease, is performed mostly in Austria, but only on special indications in Germany. In Switzerland, as of 2023 the Choline-PET/CT has replaced the scintigraphy and is routinely performed in patients with indication for parathyroidectomy in many hospitals.

The current S2k guideline recommends to perform an intraoperative PTH measurement before and 10 minutes after removal of the parathyroid gland in order to assess the success of the surgery. Due to the short half-life of PTH of around three minutes, a PTH drop of 50% or into the normal range within 10 minutes of removal of the suspected gland has a high sensitivity and specificity for cure. If PTH drop is inadequate, further gland exploration is performed. The intraoperative measurement of PTH is associated with waiting time in the OR and uncertainty if the next patient can be anesthetized, prolonging surgeries by 30-60 minutes depending on the local facilities. If the Choline-PET/CT is sufficiently sensitive and specific in detecting both uni- and multiglandular disease, surgery according to Choline-PET/CT findings could make waiting for intraoperative PTH drop unnecessary.

The aim of the study is to determine whether the regular use of Choline-PET/CT can obviate the need for intraoperative PTH-measurement with the potential to shorten the length of parathyroid surgeries. This could save considerable costs and justify the regular use of Choline-PET/CT.


Eligibility Criteria:
Inclusion Criteria:

* pHPT, preoperative Choline-PET, intraoperative PTH

Exclusion Criteria:

* no consent
Noninvasive Monitoring of Uterine Electrical Activity and Fetal Heart Rate: A New External Monitoring Device

The EUM (electrical uterine myography) (OB Tools, Israel) was tested and found to be reliable as a non-invasive method for evaluating uterine contractions and the fetal heart rate. It is safe and effective in monitoring uterine contractions. The investigators propose to perform a study to validate the accuracy and clinical usefulness of the EUM device by simultaneously monitoring obese patients with current method of external tocodynamometry with the EUM device. Providers will be blinded to the results of the EUM device. Caregivers will continue care as per current guidelines using the information obtained from the current monitoring methods. Information obtained from the EUM devices will not be used to determine the clinical course of action.

Purpose:

The investigators propose to perform a study to validate the accuracy and clinical usefulness of the EUM device by comparing it with simultaneous use of current methods (external tocodynamometry) among obese patients.

Objective:

Compare the interpretability of the contractions recorded using the EUM device vs. those obtained from external tocodynamometer among obese pregnant women.

Eligibility Criteria:
Inclusion Criteria:

1. Maternal age \>18 years old
2. Singleton pregnancy
3. Gestational age of 24 completed weeks or greater based on the estimated due date as calculated from last menstrual period or early ultrasound
4. Category I (reassuring) fetal heart rate tracing at time of enrollment

Exclusion Criteria:

1. Fetal anomaly or chromosome defect
2. Allergy to silver
3. Woman with implanted electronic device of any kind
4. Irritated skin or open wound on the abdominal wall
Evaluation of 1440nm Laser vs. Botulinum Toxin or miraDry® Microwave For Treatment of Axillary Hyperhidrosis

The Purpose of the study is to evaluate the 1440nm Laser Assisted Selective Photothermolysis vs. Botulinum Toxin or miraDry® Microwave Thermolysis For Treatment of Axillary Hyperhidrosis.


Eligibility Criteria:
Inclusion Criteria:

* A healthy non-smoking male or female between 18-70 years of age
* Understand/accept obligation not to receive any other procedures in anatomical areas exhibiting axillary hyperhidrosis through 3 months prior to treatment
* Understand and accept the obligation and is logistically able to present for all scheduled follow-up visits
* Clinically diagnosed for primary hyperhidrosis of the axilla.
* A self-assessed Hyperhidrosis Disease Severity Scale (HDSS) score of three (3) or four (4) a. Gravimetric \>50mg/5min in each axilla

Exclusion Criteria:

* Clinical diagnosis of secondary hyperhidrosis
* Uncontrolled systemic disease or infection
* Concurrent use of any hyperhidrosis treatments other than over the counter antiperspirants or deodorants
* Receipt of Botox® or Dysport® within the past six months
* Patients who refuse to stop using over the counter antiperspirants 24 hours prior to the day of surgery and each of the follow-up visits at 3 months and 6 months that Minors starch iodine tests may be performed.
* Patients using or having used within 7 days of baseline visit: cholinomimetic agents, anticholinergic agents, prescription antiperspirants, any herbal medicine treatments or any other treatments for hyperhidrosis except OTC antiperspirant or planning to use such agents during the course of the study.
* Any previous liposuction/liposculpture or any type of surgery for hyperhidrosis; OR any other types of treatments for hyperhidrosis in the area to be treated in the past 6 months
* Has any other medical condition, that, in the investigator's opinion would interfere with the subject's participation in the study
* Is susceptible to light induced seizures or history of seizures
* Has a history of keloid formation
* Significant cardiovascular disease
* Bleeding disorders
* Anti-platelet and anticoagulant medication
* Sensitivity to lidocaine or epinephrine
* Pregnancy or planned pregnancy
* Existing neuromuscular disorders (myasthenia gravis, Eaton-Lambert Syndrome, amyotrophic lateral sclerosis)
* Electronic implants
* Subjects requiring supplemental oxygen
* Has therapies or medications which may interfere with the treatment (including medications causing photosensitivity
* Allergic to Keflex
Age Related D-dimer Evaluation for the Exclusion of a Left Atrium Thrombus in Patients With Atrial Fibrillation (ADDIT-AF)

Patients with atrial fibrillation are at increased risk of thrombus formation in the left heart, especially in the auricula and the atrium. Their presence increases the risk of ischemic stroke, especially during cardioversion, performed either by drug or by external electric shock. The gold standard to exclude this thrombus and consider cardioversion is the transesophageal echocardiography.

D-dimers, products of the degradation of fibrin, have been studied several times to assess the presence of thrombi in the body, especially in pulmonary embolism. In cardiology and despite several studies on the matter, there is currently no blood D-dimers value allowing to detect the presence of a thrombus with a good predictive value. Correlating the D-dimer values with age, as has been done for some years in pulmonary embolism, would give the opportunity to create a simple, inexpensive and widely applicable tool to eliminate the presence of a thrombus in the left heart.

If the results are satisfactory, the investigators might consider not using transesophageal echocardiography as this examination is unpleasant for the patient and operator dependant, unlike a standard blood sampling.

This study aims to test the following hypothesis: D-dimers values superior or equal to ten times the patient's age is predictive of a thrombus.


Eligibility Criteria:
Inclusion Criteria:

* Patients with de novo or recent atrial fibrillation requiring cardioversion, either by drug, by an electric shock or an intervention.

Exclusion Criteria:

* valvulopathy
* infection
* neoplasia
* inflammatory disease
* recent surgery
* pregnancy
* aorta aneurism
* deep vein thrombosis
* pulmonary embolism
A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis

This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric participants with RRMS in Part 1. In Part 2, the study will evaluate the long-term safety of BIIB017 and further describe safety and the long-term multiple sclerosis (MS) outcomes after BIIB017 treatment in participants who completed the study treatment at Week 96 in Part 1 of the study.


Eligibility Criteria:
Key Inclusion Criteria:

Part 1:

* Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric MS.
* Must have an EDSS score between 0.0 and 5.5.
* Must have experienced \>= 1 relapse in the 12 months prior to randomization (Day 1) or \>= 2 relapses in the 24 months prior to randomization (Day 1) or have evidence of asymptomatic disease activity (Gd-enhancing lesions) on brain MRI in the 6 months prior to randomization (Day 1).

Part 2:

• Participants who completed the study treatment in Part 1 (Week 96 Visit), as per protocol.

Key Exclusion Criteria:

Part 1:

* Primary progressive, secondary progressive, or progressive relapsing. These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Participants with these conditions may also have superimposed relapses but are distinguished from relapsing participants by the lack of clinically stable periods or clinical improvement.
* History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
* Known allergy to any component of Avonex or BIIB017 formulation.
* Occurrence of an MS relapse that has occurred within 30 days prior to randomization (Day 1) and/or the participant has not stabilized from a previous relapse prior to randomization (Day 1).
* Any previous treatment with PEGylated human IFN β-1a.

Part 2:

* Any significant changes in medical history occurring after enrollment in Part 1, including laboratory test abnormalities or current clinically significant conditions that, in the opinion of the Investigator, would have excluded the participant's participation in Part 1. The Investigator must re-assess the participant's medical fitness for participation and consider any factors that would preclude treatment.
* The participant could not tolerate BIIB017 in Part 1.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply"
DESHYDRAT : Assessment of the Prevalence of Dehydration Among 9 to 11 Year-old Children

The aim of the study is to determinate the prevalence of moderate dehydration among children aged 9 to 11 who are going to school.

Many children have a limited caloric intake at the breakfast with a limited amount of water intake. There is no data about the prevalence of dehydration in children who are regularly going to school in France.

Eligibility Criteria:
Inclusion Criteria:

* Healthy child aged 9 to 11 years old.

Exclusion Criteria:

* Individual with illness
* Individual with past history of gut or metabolic diseases
* Past history of renal disease.
* Child whom parents decline to participate
Sleep and Creativity

Creativity is a complex neuro-psycho-philosophical phenomenon that is difficult to define. Neurocognitive models of creativity suggest that creativity is associated with the activity of a distributed, bilateral fronto-temporal and parietal network. Therefore, a modulation of frontal activity is necessary to allow a certain degree of "controlled disinhibition", which seems to be necessary for creative thinking. In addition, a modulation of the lower parietal lobe (IPL) might allow targeting the brain regions responsible for idea generation.

This project will investigate the application of transcranial magnetic stimulation (TMS) with the intent of modulating creativity performance of healthy subjects. Resting state electroencephalography (EEG) that will be acquired pre- and post-TMS and participants' creative performance will be measured.

Perspectives include a better understanding of the differences between high- and low-creativity groups, as measured by a creativity test battery, in their response to TMS. Additional perspectives are whether there are differences in creativity performance depending on the stimulation location.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature
* Age between 18 and 70 years
* Neurologically healthy, i.e., with no documented or present neurological disease or brain injury
* Normal or corrected-to-normal visual acuity

Exclusion Criteria:

* Any instable medical condition, in particular epilepsy (past or pre-sent, including seizures or febrile convulsions)
* Any surgical intervention to the brain
* Implanted medical devices (e.g., cochlear implants, infusion pumps, neurostimulators, pacemakers)
* Presence of metal in the region of the head (excluding fixed dental implants such as tooth fillings or fixed dental braces)
* Drug or alcohol abuse
* Intake of any medication that is likely to lower seizure threshold
* For female participants: in order to participate in the study, female patients in reproductive age need to take a pregnancy test (a stand-ard urine pregnancy test will be provided).
* Previous enrolment in a creativity study of the same PI
Combined Intracameral Lidocaine for Manual Small Incision Cataract Surgery Under Topical Anesthesia

The purpose of this study is to determine whether intraocular lidocaine increases patient comfort during the different stages of MSICS while under topical anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Both men and women
* Cataract density grade III-V according to the Emery-Little system classification system
* Patients need to do manual small incision cataract surgery

Exclusion Criteria:

* Legal guardian(s) is/are not present for permission
* Any patient with a known sensitivity or allergy to Lidocaine or the "Caine" family of medicines.
* Patients with altered levels of pain perceptions
Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis

Novel approaches to improve TB treatment outcomes (to reduce morbidity, mortality, and the duration of TB treatment) and to treat XDR-TB cases are urgently required. Host-Directed therapies (especially repurposed drugs such as Non-Steroid AntiInflammatory Drugs NSAIDS) could be useful in this context, and therefore the appropriateness and potential effect of this approach needs to be evaluated in humans. Investigators do propose a prospective, randomized, pilot study to estimate the potential efficacy and safety of using adjunctive ibuprofen for the treatment of XDR tuberculosis.

There are a need for novel approaches to improve TB treatment outcomes (to reduce morbidity, mortality, and the duration of TB treatment) and to treat XDR-TB cases. Host-Directed therapies (especially repurposed drugs such as Non-Steroid AntiInflammatory Drugs NSAIDS) could be useful in this context, and therefore the appropriateness and potential effect of this approach needs to be evaluated in humans. Investigators do propose a prospective, randomized, pilot clinical trial to evaluate the potential efficacy and safety of using adjunctive ibuprofen during two months for the treatment of XDR tuberculosis.

Eligibility Criteria:
Inclusion Criteria:

1. Females and males aged ≥ 16
2. The patient must provide written informed consent
3. Females of childbearing potential (including females less than 2 years post- menopausal) must have a negative pregnancy test at enrolment and must agree to use highly effective methods of birth control
4. M.tuberculosis (Mtb) detected by culture with available drug susceptibility results for current isolate
5. XDR- TB confirmed by drug susceptibility testing (DST)

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

1. Inability to provide written informed consent
2. First line drug treatment susceptible Mtb strain
3. Prior Treatment of either \>3 days of TB treatment prior to randomization
4. Pregnancy/Breastfeeding at inclusion
5. Any of the following laboratory parameters: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 x upper limit of normal (ULN); total bilirubin \> 2 x ULN; estimated glomerular filtration rate (eGFR) \<60ml/hr; Neutrophil count ≤ 500 neutrophils / mm3; Platelet count \< 50,000 cells / mm3
6. Receiving or anticipated to receive a daily dose of ≥ 10 mg of systemic prednisone or equivalent within the period starting 14 days prior to enrolment, or \> 5 doses per week of any NSAID for ≥2 weeks in the month prior to randomization.
7. History of sensitivity or allergy to ibuprofen.
A Prospective, Multi-center Registry to Evaluate Safety and Efficacy of Hativ® ELectrocardiogram Monitoring on Patients with Hemodialysis

The high mortality rate and costs of patients with end-stage renal disease (ESRD) are a medical and socio-economic burden, so managing their risk factors is very important. Recently, artificial intelligence (AI)-based electrocardiogram (ECG) analysis technology has made it possible to detect cardiovascular diseases using only ECGs by distinguishing minute differences in electrical currents in the heart that are difficult for humans to read, and active verification of its clinical effectiveness is in progress.

In this study, using Hativ®, a currently commercially available class II medical device, ECGs are measured every day at home and before and after dialysis. Additionally, ECGs are measured when chest discomfort or unusual symptoms were present, and the corresponding symptoms are monitored. It targets patients with smartphones over the age of 19 who are receiving maintenance hemodialysis for more than 3 months due to ESRD and excludes those with intracardiac electrodes and devices. Demographic characteristics, medications, blood tests, and echocardiography results are collected, and the results of additional questionnaires or cardiac tests are monitored for up to 3 months. During the study period, if there are any critical abnormalities or symptoms on the ECGs, the medical staff or the subject may request additional treatment.

In conclusion, by measuring ECGs before and after hemodialysis, the investigators aim to obtain data on the frequency and type of arrhythmia, confirm the relationship between cardiovascular disease and dialysis intervals. The investigators will also apply an AI-based ECG analysis model to the measured ECGs to determine the association with the mortality rate. Furthermore, the investigators plan to establish a basis for using AI analysis technology combined with a portable ECG device in the management of patients with ESRD and conduct follow-up research to improve prognosis.


Eligibility Criteria:
Inclusion Criteria:

* patients with smartphones
* patients over the age of 19 who
* patients receiving maintenance hemodialysis for more than 3 months due to ESRD

Exclusion Criteria:

* those with intracardiac electrodes and devices