cyrilzakka/clinical-trials huggingface dataset:
Gender-based Impact on Safety and Efficacy of Lenvatinib in Patients With Differentiated Thyroid Cancer

Lenvatinib is approved for the treatment of radioiodine refractory differentiated thyroid cancer. Despite gender can play a crucial role un in safety and efficacy of oncological product, little is know on gender difference in lenvatinb effacacy and safety in the context of radioiodine refractory differentiated thyroid cancer.

The primary objective of the study is to assess safety and toxicity profile in male and female patients in terms of dose reduction. The secondary objectives are to assess sex and gender difference in: the number and the incidence of adverse events; response rate according to RECIST criteria 1.1; progression free survival, overall survival and duration of response.

Lenvatinib is an orally available potent inhibitor of the split-kinase family of transmembrane growth factor receptors including Flt-1/VEGFR-1 and KDR/VEGFR. Lenvatinib has been investigated in hepatocellular carcinoma and in RAI-resistant thyroid cancer (Phase III trials) and in other malignancies, showing high rates of activity. In RAI-resistant thyroid cancer, lenvatinib showed a remarkable response rate over placebo (65% vs 2), combined with a prolonged progression free survival (18.3 vs 3.6 months). It has been approved for the treatment of locally recurrent or metastatic, progressive RAI resistance-DTC in the United States, Europe, and Japan, based on the results from SELECT trial. Moreover, lenvatinib demonstrated a meaningful clinical activity (response rate 64.8% in treatment arm vs 1.5% in placebo arm, p\<0.001;) significantly reducing the tumour burden, with a median maximum percentage change in tumour size of -42.9%. Response was mostly pronounced at the first assessment (median -24.7% at 8 weeks after randomization) but it has been observed even in the following months (-1.3% per month). Recently, the efficacy of lenvatinib was confirmed in specific patient population, such as elderly. Although the efficacy is remarkable toxic effects are considerable and not all patients have the same risk to benefit ratio from lenvatinib treatment. Results derived from controlled clinical trials are rarely replicable in the real-life because these trials are usually conducted in selected populations, in a highly controlled setting, optimized to show the effect of the drug.

In this context growing evidences are showing gender associated functions playing a role in cancer incidence, progression and response to therapy; gender disparities in toxicities and effectiveness of certain drugs used in the treatment of the most common cancer is already well known.The aim of the present study is to evaluate the safety and efficacy profile of Lenvatinib based on gender in patients with refractory iodine DTC.

Eligibility Criteria:
Inclusion Criteria:

* Patients with refractory iodine DTC treated with lenvatinib
* Signed written informed consent

Exclusion Criteria:

- Age \< 18 years
Infant Immunity Comparison of Breastfed and Bottlefed Infants

This study will follow 40 healthy, vaginally delivered infants that are primarily (\>/- 75%) breast fed and 40 infants that are exclusively formula fed for at least the first 4 months of life from birth until 12 month age. Visits - Subjects will be consented prior to delivery, visit 1. Subject will be seen if possible after delivery for instruction on stool collection and distribution of supplies, visit 2. Subject will be seen at 6 months of age post immunization, visit 3. Subject will be seen prior to 12 month visit. Study staff will contact via phone/email to collect information about feeding changes.

Cord Blood will be collected at birth if possible and peripheral blood will be collected at 6 month of age (5 to 10 days after receiving their standard 6 month immunizations) and at 12 months of age prior to their 12 month immunization. Additionally, stool samples will be collected within the first week of live and once monthly through 12 months of age. Breastfeeding mothers will collect breast milk once monthly at the same time as the stool specimen during the period of breastfeeding.

Eligibility Criteria:
Inclusion Criteria:

* Self-declared pregnant woman
* Age 18 years or older at the time of consent
* Willing and able to sign consent and follow study schedule
* Planned vaginal delivery
* Willing to primarily breastfed or formula feed for the first four months

Exclusion Criteria:

* Planned delivery by C-Section
* Unwillingness to exclusively breast feed or formula feed their infant for at least the first 4 months
* Unwillingness to receive standard immunizations on the schedule recommended by the American Academy of Pediatrics
* Chronic maternal condition that may influence infant immunity including but not limited to: maternal HIV, immunodeficiency, use of immunosuppressive medications, malignancy or autoimmunity
* Known fetal medical conditions such as congenital malformations
* Use of immune modulating/immune suppressive medication and prophylactic antibiotics during pregnancy
* Any condition that may prevent a mother who plans to breast feed from breast feeding
* Any condition that in the opinion of the investigator would interfere with the conduct of the study
Interdisciplinary Scoliosis Correction Program.

The aim of this study is to compare the outcomes after scoliosis surgery before and after the implementation of an interdisciplinary juvenile scoliosis correction program in teenager based on ERAS (enhanced recovery after surgery) principles.

Creating an optimal protocol for interdisciplinary care in the perioperative period in terms of therapeutic management (anesthesia and surgery schedule), as well as care, rehabilitation and ensuring mental well-being determines the real impact on the reduction of the risk of complications in the perioperative period. Enhanced recovery after surgery (ERAS) protocol has been found to result in reduced lenght of stay and complications in adult patients. Data in pediatric population remains modest. In addition to ERAS principles our terapeutic team has created a special educational application for better patient preparation for surgery. The purpose of the application is to explain the general rules of conduct in the process of preparing and carrying out surgery, anesthesia, prehabilitation and physiotherapy in children undergoing orthopedics surgery (e.g. spine surgery for adolescent idiopathic scoliosis).

Hypothesis: Implementing an interdisciplinary juvenile scoliosis correction program based on ERAS principles and special educational app. will improve patient outcomes leading to a statistically significant reduction in post-operative pain and opioids demand, complication rate, length of stay without increasing readmissions and cost.

Eligibility Criteria:
Inclusion Criteria:

* patient with age \< 18 years
* patient scheduled for idiopatic scoliosis surgery

Exclusion Criteria:

* patient with age \> 18years others type of scoliosis
Propranolol and Misoprostol Versus Misoprostol Alone for Induction of Labor in Primigravidas

To compare propranolol and misoprostol versus misoprostol alone for induction of labour in primigravidas

Candidates will be randomized into 2 groups according to a computer generated sequence. Each candidate will be assigned an opaque sealed envelope containing a paper with her group on it. Both the patient and doctor on duty will be blinded to which group the patient was assigned to.

- Study procedure:

1. Written informed consent will be obtained from all participants prior to the study.
2. Full history taking.
3. General examination.

Patients will be subjected to the following:

* Patients attending labour room for induction of labour will be divided into two groups.
* Both groups, women are induced with Tab misoprostol 25μg applied to posterior vaginal fornix under aseptic precaution and every 6 hours for a maximum of 4 doses.
* In group 1, after induction is started with misoprostol placement, 30 minutes will pass before administration of oral Propanolol 20mg
* In group 2, after induction is started with misoprostol placement, 30 minutes will pass before administration of oral placebo in the form of sugary tablets.
* After induction, women will be monitored for fetal and maternal wellbeing and progress of labour.

Eligibility Criteria:
Inclusion Criteria:

* • Primigravidas.

  * Full term patients with ultrasound confirmed dates.
  * Singleton.
  * Cephalic presentation.
  * Fetal heart rate between 120 to 160 beats per minute.

Exclusion Criteria:

* • Any history of previous surgery on the uterus.

  * Patients in active labour, with ruptured membranes.
  * Fetal distress.
  * Macrosomia or polyhydramnios
  * Hypersensitivity to prostaglandins.
  * Asthmatic patient .
  * liver or kidney impairment .
  * known cardiac patient with abnormal ECG.
Study of New Imaging Criteria for the Diagnosis of Caroli's Disease

The Caroli disease is a very rare pathology that can be revealed early in childhood or in adulthood, whose diagnosis is based on Magnetic Resonance CholangioPancreatography, which shows the communication of these malformations with the rest of the biliary tree and allows to eliminate biliary stenosis. The radiologist has a central role in the diagnostic orientation between malformative intra-hepatic bile duct dilatation and obstructive benign or malignant intra-hepatic bile duct dilatation dilatation. However, imaging of Caroli disease is polymorphous and therefore subject to misinterpretation. The benefit of this research is to reduce diagnostic errors by highlighting imaging criteria specific to the Caroli disease

The Magnetic Resonance CholangioPancreatography will have been performed in all patients using different Magnetic Resonance Imaging systems (Gyroscan Intera, Philips Medical Systems, Best in the Netherlands, Magnetom Avanto, Siemens Medical Solutions, and Signa Hdxt, General Electric Medical Systems) with a free-breathing three-dimensional high-spatial-resolution Fast Spin Echo sequence and/or a breath-hold two-dimensional single-shot sequence. Magnetic Resonance CholangioPancreatography may also include a Fast Spin Echo weighted T2-weighted sequence with fat-spectral saturation, a T1-weighted breath-suppressed gradient echo pulse sequence and a chemical shift sequence in phase and opposite phase, in the axial plane, and a weighted three-dimensional T1 saturated fat sequence after intravenous administration of gadolinium chelate. Images will be analyzed in consensus by two abdominal radiologists on a Picture Archiving and Communication System station and compared with the pathological results.

Eligibility Criteria:
Inclusion Criteria:

* were patients identified in the database of the hospitals who underwent
* a diagnosis of Caroli disease on an imaging report with bile duct dilatation limited to the intrahepatic biliary tree and
* an available Magnetic Resonance CholangioPancreatography on a Picture Archiving and Communication System.

Exclusion Criteria:

* obstructive benign or malignant proximal biliary stricture on Magnetic Resonance CholangioPancreatography
* prior surgical interventions for hepatobiliary disease except cholecystectomy
Revascularisation or Medical Therapy in Elderly Patients With Acute Anginal Syndromes

For octogenarian patients with NSTEMI (non-ST segment elevation myocardial infarction) an invasive-guided strategy will prove superior to a conservative strategy with respect to a combined endpoint of all cause mortality and non-fatal myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* AGE\>80 Non-STEMI - characteristic chest pain accompanied by
* Typical ischaemic ECG changes
* A troponin rise

Suitable for conservative or invasive strategy

Exclusion Criteria:

* Lack of suitability for whatever clinical reason to be randomised eg dementia, co-morbidity
* Acute STEMI
* Cardiogenic shock
* Platelet count =50 x 109/mm3
* Patient life expectancy \< 1 year
* Known allergies to clopidogrel, aspirin, heparin, stainless steel, IV contrast or stent drug elutant
* Recent major GI haemorrhage (within 3 months)
* Any previous cerebral bleeding episode
* Participation in another investigational drug or device study
* Patient unable to give consent
* Clinical decision precluding the use of stents
Normal and Pathological Values of Postvoiding Residual Volume in Early Postpartum Period and Their Predisposing Factors

Aim of this study is to asses post voiding residual volume by ultrasound scan 3th day after delivery with consecutive scan after 6 weeks, and determination of data dispersion among the population of primiparas. In women with excessive retention (+2SD), risk factors such as duration of labour, use of epidural analgesia, instrumental delivery, maternal birth injury and weight of the newborn will be noted down.

Pregnancy itself and vaginal delivery are well known risk factors for pelvic floor dysfunction. The rise in progesterone related to pregnancy has an inhibitory effect on bladder smooth muscle - decreased smooth muscle tonus in lower urinary tract. Weight and pressure of pregnant uterus and loosening of some of the pelvic ligaments changes the statics of pelvic floor. In addition, delivery itself influence lower urinary tract; an overdistension of urinary bladder can occur easily, also as oedema of urethra or urethral hinge apparatus injury during "crowning" of the fetal head.

All of these factors can affect consecutive function of lower urinary tract right after delivery. It is known that in 1,5% of women giving birth, symptomatic urinary retention develop in early postpartum period, with necessity of insertion of an indwelling catheter. Discussed risk factors are: epidural analgesia, instrumental delivery and primiparity. The investigators can assume that every woman in early postpartum period has (to some extend) even in normal circumstances postvoiding residual volume. There is few evidence in a literature about this postpartum residual volume and its predisposing factors.

Postvoiding residual volume can be risk factor for postpartum urinary infection, which forms second largest part in infectious morbidity of women. By determination of risk factors (for increased post voiding residual volume) the investigators could narrow the group of women which necessitate increased attention in postpartal monitoring.

Eligibility Criteria:
Inclusion Criteria:

* The investigators involve every primipara giving birth at 2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic in a period of two years

Exclusion Criteria:

* Unwilling to participate
* Minors (under 18 years old)
* Foetus mortus or perinatal death of the newborn
* Admission of the newborn to the ICU
* Unfamiliar with slovak language
* Multiple pregnancy
The Role of Periodic Alveolar Recruitment Maneuvers in Intraoperative Protective Ventilation

The goal of this clinical trial is to compare three open-lung strategies on respiratory function and lung injury in protective ventilation for laparoscopic anterior resection. It aims to answer whether a periodic alveolar recruitment maneuvers (PARM) strategy alone was an appropriate open-lung strategy in intraoperative protective ventilation. Patients were randomly assigned (1:1:1) to receive one of three open-lung strategies in protective ventilation: PARM alone (alveolar recruitment maneuvers \[ARM\] repeated every 30 min), positive end-expiratory pressure (PEEP) alone (a PEEP of 6 to 8 cm H2O), or a combination of PEEP and PARM (a PEEP of 6 to 8 cm H2O combined with ARM repeated every 30 min). The primary outcome is the mechanical power before the end of intraoperative mechanical ventilation. Secondary outcomes included the accumulative intraoperative mechanical power, an arterial partial pressure of oxygen (PaO2) / inhaled oxygen concentration (FiO2) ratio (P/F ratio) before the end of intraoperative mechanical ventilation, the rates of respiratory failure at post-anesthesia care unit (PACU) and three postoperative days, the concentration of soluble advanced glycation end products receptor (sRAGE) and Clara cell protein 16 (CC16) at the end of surgery, postoperative pulmonary complications score, postoperative hospitalization days and so on.


Eligibility Criteria:
Inclusion Criteria:

1. Undergoing elective laparoscopic anterior resection and expected duration of mechanical ventilation 2 to 5 h.
2. Had an intermediate risk of developing postoperative pulmonary complications.
3. Pulse oxygen saturation in room air ≥ 94%.
4. Aged 60 to 80 years.

Exclusion Criteria:

* 1. Had received invasive mechanical ventilation for longer than 1 h within the last 2 weeks prior to surgery.

  2. Had a history of pneumonia within 1 month prior to surgery. 3. Had severe chronic obstructive pulmonary disease or pulmonary bullae. 4. Had a progressive neuromuscular illness. 5. With an American Society of Anesthesiologists (ASA) physical status of IV or higher.

  6. Intracranial hypertension. 7. Body mass index (BMI) ≥30 kg/m2. 8. Were involved in other interventional studies.
Effects of Work Shop for Children With Developmental Delays

To identify the effects of family work shop for children with speech developmental delays.

To assess the improvement of functional performance of children with speech developmental delays by 2-3 hours per session, one session per week, a total of 6 weeks of family work shop

Eligibility Criteria:
Inclusion Criteria:

* 18 M/O to 36 M/O of children with speech development delay

Exclusion Criteria:

* less than 18 M/O older than 36 M/O
An ACT Website for College Students With Insomnia

College students experience higher rates of insomnia compared the general population, and accessibility and availability for the appropriate intervention is difficult due limited resources available to them in a college environment. Theorefore, it is vital to offer an intervention that can be just as effective yet more accessible than other available treatments targeting insomnia. That is why this study will investigate the efficacy and feasibility of an online ACT intervention for insomnia among college students. Specifically, Is an online ACT for college students effective in treating insomnia? And, is an online ACT for college students feasible and acceptable in treating insomnia? Participants will be randomized into one of two conditions: waitlist or online ACT guide. Participants will receive questionnaires at baseline, post-treatment (4 weeks), and 1-month follow up.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. enrolled in a 2- or 4-year college (includes graduate students)
3. fluent in English
4. have access to the internet
5. meets diagnosis for at least acute insomnia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5
6. searching/wanting in treatment
7. currently residing in the US

Exclusion Criteria:

1. diagnosed with another sleep disorder that is not insomnia
2. currently attending therapy for an emotional disorder (anxiety or depression) or insomnia
3. prescribed medications to treat insomnia or another sleep-inducing medication
InORS - International Observational Registry on Schizophrenia With Injectable Risperidone and Oral Antipsychotics

International Observational Registry on Schizophrenia

This is an observational, non-interventional registry designed to assess medication usage patterns and to explore, in clinical routine practice, long-term outcomes and relevant factors for patient adherence to treatment, in patients receiving antipsychotic treatment with risperidone long-acting injectable (RLAI) or oral antipsychotics. Six month retrospective data and 1 year prospective data will be collected. According to label

Eligibility Criteria:
Inclusion Criteria:

* Patients must satisfy the following criteria to be eligible for documentation in this non-interventional study: Diagnosis of schizophrenia as well as 6 months of retrospective clinical records
* Newly initiated on or switched to RLAI or an oral antipsychotic treatment (either atypical or conventional), not longer than 2 weeks ago
* Signed informed consent (either signed by the patient or his/her legal representative) is available at the beginning of documentation
* any schizophrenic patient (including those for whom a legal representative must sign consent) can be involved in the study

Exclusion Criteria:

* Established treatment refractory schizophrenia, defined as treatment failures with adequate trials (adequate as judged by the treating physician) of more than 2 second generation (atypical) antipsychotics and/or clozapine
* History of neuroleptic malignant syndrome
Evaluation Of Deep Anterior Lamellar Keratoplasty By Anterior Segment Ocular Coherence Tomography

Investigators' research is concerned observing the post-operative anterior segment OCT changes throughout the post- operative follow up of the patient and relating to improve the visual outcome of the surgery which is the goal of surgery

Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, ...):

* Complete medical and ocular history, including patients' age, sex, type of pathology of the cornea such as keratoconus, opacity , history of previous corneal intervention , and other ocular surgeries.
* Thorough ophthalmological examination, including visual acuity, intraocular pressure (IOP) measuring by Goldman applanation tonometer (Haag Streit, Koeniz, Switzerland), slit lamp biomicroscopic examination of anterior segment, investigations for keratoconus as pentacam , preoperative anterior segment OCT if needed , slit lamp photography for the cornea .

Candidate patients will be operated through DALK , then will be examined post operative clinically and be followed up at 3 months , 6 months for best corrected visual acuity, Intraocular pressure , refraction , graft healing , and anterior segment OCT for the anterior chamber angel , graft healing , descemet's membrane state , tear film . The interpretation of the clinical data with the changes in the ant. Segment OCT will give us the clue to get the best visual outcome of surgery .

2.4.5 -Research outcome measures:

1. Primary (main):

   To evaluate the post-operative changes after DALK surgery through ant segment OCT and its relation to clinical findings.
2. Secondary (subsidiary): To improve the outcome of the surgery through the graft creation , stitching of the graft , following up the IOP clinically and state of AC angel through OCT , the tear film and changes after surgery , all these factors to improve the target of the surgery which is the post operative best corrected visual acuity .

Data collection Data to be collected include patients' age, sex, cause of corneal surgery ,BCVA, IOP levels, clinical examination of the eye and if there are findings , and ant. Segment OCT of the eye Computer software Data analysis will be done via SPSS version 26 windows 10 Statistical tests Data will be statistically described in terms of mean, SD, and range when appropriate. Comparisons between the preoperative and postoperative data will be done using Student's t-test. Study groups' comparisons will be done using Student's t-test for independent normally distributed samples data.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing DALK surgery older than 18 years old ( keratoconus and corneal opacity ).

Exclusion Criteria:

* Patients suffering from active corneal ulcer
* Active infection.
* Posterior segment diseases.
* Recent ocular surgery in the study eye in the 2 months prior to enrolment,
* Media opacities as vitreous haemorrhage,
* Vasculitis , patients with macular edema related to, glaucoma, chronic uveitis, or pre-existing ocular pathologic features or abnormalities.