cyrilzakka/clinical-trials huggingface dataset:
Stop Menstruation and Pregnancy Rates in Antagonist Protocol

The proposal of this study is to evaluate the association between the achievement of ongoing pregnancy and hormonal levels on the first day after the period had stopped in rec-FSH/GnRH- antagonist cycles.

Ovarian stimulation will be achieved by rec- FSH, Puregon® starting on day 2 of the cycle at a dose of 200 IU/day. The dose of rec-FSH remains unchanged during stimulation until day 10 of the cycle. If it is necessary to increase the dose of rec-FSH after 10 days of stimulation, or to decrease the dose of rec-FSH due to a risk of OHSS, the patient will be dropped out of the study.

To inhibit premature LH surge daily GnRH - antagonist (orgalutran 0,25mg ) is used from the morning of day 6 of stimulation.

Final oocyte maturation will be achieved by administration of 10.000 IU of HCG (Pregnyl®) as soon as ≥ 3 follicles ≥ 17 mm are present. E2 levels should not be criteria for HCG administration. Oocyte retrieval will be carried out 36 hours after HCG administration. Conventional IVF or ICSI will be carried out. Embryo transfer will be carried out day3 or day5 after oocyte retrieval.

Similar luteal support for all patients with vaginal administration of 600mg natural micronised progesterone in three separate doses (Utrogestan® 200mg 3xday) starting one day after oocyte retrieval will be used. Hormonal assessment (E2,FSH,LH,Progesterone) will be performed at initiation of stimulation, on the first day after the period had stopped and every 2 days until the day of HCG administration.

Eligibility Criteria:
Inclusion Criteria:- Age ≤ 39 years

* Body mass index between 18 and 29 kg/m²¬
* Regular cycles between 25-34 days
* Presence of both ovaries
* Basal levels of estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle
* Treatment with IVF/ICSI
* Embryo transfer day 3 or day 5 (1 or 2 embryos)
* Patients can enter in the study only once

Exclusion Criteria:

* Presence of endometriosis stage ≥3(AFS)
* Polycystic ovarian syndrome (Rotterdam criteria)
* Need for preimplantation genetic diagnosis (PGD)
* Azoospermia testicular sperm extraction (TESE)
Normal Saline Flushes at 12 vs 24 Hours Intervals for Maintaining Peripheral Intravenous Catheters Patency

Children admitted in a ward often require a peripheral intravenous catheter to provide access for administration of medications, nutrients, fluids, blood products. Vascular access in children is a frequent and stressful procedure that should be performed as infrequently as possible in order to reduce the child's pain experience and the child's and family's level of distress. The maintenance of patency of indwelling catheters is therefore relevant to minimize need for replacement and children discomfort.

Recent studies investigated the most effective and safe method of maintaining peripheral intravenous lock (peripheral IVL) in children. Most of these studies focused primary on the use of heparin versus saline flushes, showing similar efficacy of the two approaches.

To the best of the investigators knowledge no study addressed the issue of the optimal flushing frequency of normal saline . The aim of this study was to evaluate the efficacy of normal saline flushes, at 12 and 24 hours intervals.


Eligibility Criteria:
Inclusion Criteria:

* age between 1 and 17 years
* peripheral intravenous catheter 22 G or 24 G
* need to maintain the access for at least 24 hours without infusion

Exclusion Criteria:

* need for continuous infusion therapy
* programmed therapy
Analgesia iv vs Epidural Analgesia vs Port-sites Infiltration After Laparoscopic Sleeve Gastrectomy

A prospective randomized study of patients undergoing laparoscopic sleeve gastrectomy between 2012 and 2015 will be performed. Patients will be divided into 3 groups: Analgesia iv exclusively (Group 1), epidural analgesia+analgesia iv (Group 2) and port-sites infiltration+analgesia iv (Group 3). Pain will be quantified by means of a Visual Analogic Scale and morphine rescue needs were determined 24 hours after surgery.

A prospective randomized study of patients undergoing laparoscopic sleeve gastrectomy between 2012 and 2015 will be performed. Patients will be randomized using a computerized simple randomization scheme in a 1:1:1 ratio into 3 groups: those patients receiving only intravenous analgesia (Group 1), those ones receiving intravenous analgesia associated to epidural analgesia (Group 2) and those patients receiving intravenous analgesia associated with port-sites infiltration with bupivacaine. Pain quantification as measured by Visual Analogic Scale (VAS), ranging from 0 (absence of pain) to 10 (unbearable pain) will be evaluated 24 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) \>40 Kg/m2
* BMI \> 35 Kg/m2 with the presence of comorbidities associated to obesity

Exclusion Criteria:

* patients undergoing other bariatric techniques
* severe underlying cardiovascular diseases
* chronic renal failure
* hepatic dysfunction
* previous foregut surgery
* patients with any contraindication for bariatric surgery
Regorafenib Treatment Patterns and Survival Outcomes in Advanced Colorectal Cancer: A Real-world Study

This is a multi-center, retrospective, real-world study. The purpose of this study is to observe the effectiveness and safety of regorafenib in Chinese advanced colorectal cancer patients.

The main observational goals include overall survival(OS), 6 month OS rate, 1 year OS rate, and treatment time failure (TTF), other study goals include objective response rate( ORR)、Disease control rate（DCR）and adverse event(AE) of regorafenib.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with colorectal cancer confirmed by pathological tissue or cytology；
2. The pathological type of colorectal tumor was adenocarcinoma；
3. Patients with recurrent or metastatic, unresectable advanced colorectal cancer；
4. Patients who received regorafenib at least one period treatment.

Exclusion Criteria:

1. Patients participating in other interventional clinical studies while taking regorafenib;
2. Patients with other malignant tumors within 5 years before regorafenib treatment, except for cured cervical carcinoma in situ, skin squamous cell carcinoma or basal cell carcinoma, early papillary thyroid carcinoma, etc.;
3. The investigator deems that there are other factors that are not suitable for patients who participate in this study.
The Role and Mechanism of Immune Regulation in Acute Lung Injury in Children

Acute lung injury is a highly prevalent disease in children, posing a serious threat to their health and causing economic burden on society and families. It has received high attention. Blocking the cascade immune inflammatory response that occurs in the respiratory tract and finding key targets for the prevention and treatment of acute lung injury has become an important challenge faced by the medical community. The pathogenesis of acute lung injury is complex, involving the combined action of multiple cells and cytokines in the immune system. Therefore, it is necessary to further study the function of immune cells and specific immune pathogenesis, providing new ideas and theoretical basis for clinical treatment of acute lung injury. The omics technology includes Genomics, Transcriptome, proteomics, metabolomics, etc. Through qualitative and quantitative analysis of changes in low molecular weight molecules or metabolites of biological samples, it provides a new way to find biomarkers and pathogenesis. We plan to study the peripheral blood of children with acute lung injury and healthy children, and use network analysis to screen for differential genes and related enrichment pathways in acute lung injury. We aim to explore the correlation between immune regulation and inflammatory repair in children with acute lung injury, and analyze the regulatory mechanisms between immune cells related to it. Provide assistance for clinical diagnosis and treatment.

1. Inclusion criteria of the test group: (1) Meeting the specific diagnostic criteria for related lung diseases; (2) The factors of lung diseases were infection and sepsis;
2. Inclusion criteria of the control group: control 1: (1) Meeting the specific diagnostic criteria for related lung diseases; (2) The factors of lung diseases were non-infectious factors.

   Control 2: Healthy children
3. Exclusion criteria of the test group: (1) Patients with hemodynamic instability Patients with pulmonary hypertension;(2) Patients with congenital heart disease, congenital genetic metabolic disease, epilepsy, acute and chronic renal insufficiency, nephrotic syndrome, diabetes, et al.
4. The collection of clinical data includes: name, sex, age, hospitalization number, date of hospitalization, main diagnosis, course of disease, main examination and test results, medication, respiratory support, prognosis, etc.
5. Collect peripheral blood serum, sputum or alveolar lavage fluid samples for target sequencing.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ALI/ARDS.
* Voluntary inclusion of researchers.

Exclusion Criteria:

* Patients with hemodynamic instability
* Patients with pulmonary hypertension
* Patients with congenital heart disease, congenital genetic metabolic disease, epilepsy, acute and chronic renal insufficiency, nephrotic syndrome, diabetes, etc.
A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease

The main purpose of this study is to investigate the safety and efficacy of the study drug solanezumab in participants with prodromal Alzheimer's disease (AD).


Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis by the study investigator of a clinical syndrome of cognitive impairment consistent with prodromal AD per International Working Group (IWG) diagnostic criteria or mild cognitive impairment (MCI) due to AD per National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria.
* Scores 17-28 on Montreal Cognitive Assessment (MoCA) at screening.
* Scores \<27 on free recall cutoff score from the Free and Cued Selective Reminding Test (FCSRT) (Picture version) at screening.
* Scores ≤4 on Modified Hachinski Ischemia Scale (MHIS).
* Scores \>0 on the Functional Activities Questionnaire (FAQ).
* Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (CSF) result at screening consistent with the presence of amyloid pathology.

Exclusion Criteria:

* Has had MRI or computerized tomography (CT) of brain within previous 2 years showing pathology that would be inconsistent with a diagnosis of AD.
* Has known allergy to humanized monoclonal antibodies.
* Has an ongoing clinically significant laboratory abnormality, as determined by the investigator.
* Has screening MRI with results showing \>4 amyloid related imaging abnormalities H (ARIA-H) micro-hemorrhages or presence of ARIA-E.
* Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI.
* Has received treatment with a stable dose of an acetylcholinesterase (AChEI) inhibitor or memantine for less than 2 months before randomization. (If a participant has recently stopped AChEIs and/or memantine, he or she must have discontinued treatment at least 2 months before randomization.)
3DUS Imaging of Needles in Gynecological Brachytherapy

Brachytherapy treatment in gynecological cancers is an essential component to delivering adequate doses of radiation to a tumour while sparing normal tissue. Interstitial or intra-cavitary brachytherapy are often needed in advanced or recurrent disease, in cases where intrauterine brachytherapy may not deliver the optimal outcome. Interstitial or intra-cavitary brachytherapy are based on a defined template-and-needle system, and the procedure relies on clinical examination and pre-treatment imaging to guide needle insertion. There is currently no standard image-guided process to help direct needles in the pelvis. We propose using 3D ultrasound to provide real-time imaging for the brachytherapy procedure, which will aid in avoiding needle insertion into pelvic organs and result in optimal dose coverage to the tumour.


Eligibility Criteria:
Inclusion Criteria:

* Females of age eighteen (18) or greater.
* Patients with locally advanced or recurrent gynecological malignancies who are offered interstitial or ring and tandem brachytherapy treatment. These typically would include patients with primary or recurrent vaginal cancers, endometrial cancers or cervical cancers. Histologies of these cancers are typically adenocarcinomas or squamous cell carcinomas

Exclusion Criteria:

• Above patients who are not offered interstitial brachytherapy as a treatment modality
My Coach Connect: An Automated Telephone-based Reporting System for Patients With Mental Illness

This is a pilot study for a novel, automated telephone system called "My Coach Connect". The purpose of the study is to evaluate the feasibility and effectiveness of this telephone tool while engaging clients and providers in discussion groups and surveys to better understand how this tool impacts the care provided and their overall experience in healthcare.

Clients will use this tool (My Coach Connect) to leave voice messages and survey answers which their providers will have access to by logging in to a secure website. Providers will also be able to indicate using the website whether they found a particular narrative helpful or not. Providers will have access to audio recordings of the voice responses, transcribed text of the responses, as well as "word clouds" generated from the text. Word clouds are a method of displaying the content of text such that words that are used more frequently are displayed in a larger size than words used less frequently. Clients will call in to the system approximately twice a week for a period of four months.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the ROADS program
* English speaking
* Have a working telephone

Exclusion Criteria:

* Must speak english
Evaluation of the Impact of Pulsed Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation

The objective of this clinical trial is to evaluate the impact of pulse field (PF) energy, both alone and in combination with radiofrequency (RF) energy, on vagal modulation during point-by-point pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (PAF). The effect of PF energy on ganglionated plexi (GP) will be assessed using heart rate variability (HRV) as a surrogate marker. Participants will be randomized into three groups: the PF-only group and the Hybrid group (PF posterior/RF anterior) as the experimental arms, and the RF-only group as the control arm. HRV will be measured before and 24 hours after the PVI procedure. Additionally, cardio and neuro biomarkers (Troponin and S100B) will be measured pre-procedure and 20 minutes post-ablation. All participants will be followed for 12 months, with 24-hour Holter-ECG evaluations scheduled at 3, 6, and 12 months after the initial ablation procedure.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic Paroxysmal Atrial Fibrillation (AF) that terminates spontaneously or with intervention within 7 days of onset
* Age range: 18-70 years
* Willing and capable of providing informed consent
* Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion Criteria:

* Previously diagnosed Persistent AF (\&gt; 7 days in duration)
* Previous LA ablation
* Previous cardiac surgery
* Myocardial Infarction within the previous 3 months
* Severely compromised Left Ventricular Ejection Fraction (LVEF\&lt;40%)
* Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the pulsed electric field energy
* Acute illness, active systemic infection, or sepsis
* Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
* Severe mitral regurgitation
* Woman who are pregnant, lactating, or who are planning to become pregnant during the course of the clinical investigation
A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002)

To investigate the long-term efficacy and safety of treatment with esmirtazapine (Org 50081, SCH 900265, MK-8265) compared to placebo, in participants with chronic primary insomnia. Primary efficacy variable is Total Sleep Time (TST).

Insomnia is a common complaint or disorder throughout the world. About one third of the population in the industrial countries reports difficulty initiating or maintaining sleep, resulting in a non-refreshing or non-restorative sleep. The majority of the insomniacs suffer chronically from their complaints.

The maleic acid salt of Org 4420, code name Org 50081 (esmirtazapine), was selected for development in the treatment of insomnia. The first clinical trial with esmirtazapine was a proof-of-concept trial with a four-way cross-over design. All 3 esmirtazapine dose groups showed a statistically significant positive effect on TST (objective and subjective) and Wake Time After Sleep Onset (WASO), as compared to placebo.

The current study is designed to assess the long-term efficacy and safety of esmirtazapine in a double-blind, randomized, placebo-controlled, parallel group outpatient trial in participants suffering from chronic primary insomnia. During the 6-month treatment period, participants are randomly assigned to receive either esmirtazapine or placebo. Then, during the 7-day discontinuation period, participants who received esmirtazapine in the 6-month treatment period are randomly assigned to receive either esmirtazapine or placebo, while participants who received placebo in the 6-month treatment period continue to receive placebo.

Eligibility Criteria:
Inclusion Criteria:

* are at least 18 and less than 65 years;
* sign written informed consent after the scope and nature of the investigation have been explained;
* have shown capability to complete the LogPad questionnaires;
* have difficulty falling asleep, maintaining sleep or have early morning awakening;

Exclusion Criteria:

* Significant medical or psychiatric illness causing sleep disturbances.
* Have a history of bipolar disorder or attempted suicide or have a family (immediate family) history of suicide.
* Have a sleep disorder such as sleep-related breathing disorder, restless leg syndrome, narcolepsy.
* Significant other medical illness such as acute or chronic pain, heart-, kidney-, or liver disease within the last year.
* Currently diagnosed or meet the criteria for Major Depressive Disorder (MDD) or have been treated for MDD in the last 2 years.
* Substance abuse, excessive use of alcohol (determined by the physician) or drug addiction within the last year.
* Are night workers or rotating shift workers or plan to travel through more than 3 time-zones.
* Routinely nap during the day.
* Have a Body Mass Index (BMI) of 36 or more.
Measuring Exhaled Nitric Oxide (eNO) Using the Apieron INSIGHT System and the Aerocrine NIOX System

Collection of quantitative data to demonstrate the accuracy (bias) and precision (repeatability) of the Apieron INSIGHT(tm) eNO Breath System as compared to the FDA cleared NIOX eNO Breath System when testing is performed by asthma patients.

A non-randomized, prospective study of up to 150 subjects with asthma. Patients will perform eNO testing with the Apieron INSIGHT(tm) eNO system and the NIOX eNO system at the physician's office/clinic after a short demonstration and training by a healthcare professional trained in the use of the devices. Exhaled NO testing involves inhaling to lung capacity, and then performing a controlled exhalation into a mouthpiece connected to each of the Apieron INSIGHT(tm) and NIOX systems. Patients will perform an eNO measurement with the Apieron INSIGHT(tm) system and with the FDA cleared NIOX system for the accuracy portion of the study. Patients will perform 2 sequential eNO measurements on each system for the precision part of the study. Subjects that measure eNO values over 100 ppb will be asked to repeat 2 sequential eNO measurements on each system.

Eligibility Criteria:
Inclusion Criteria:

* Age 5 or older
* Pre-existing diagnosis of asthma
* Non-smoker

Exclusion Criteria:

* Chronic inflammatory lung disease other than asthma
* Medical conditions that preclude hand-eye coordination
Comparison Of Resistance Training And Core Strengthening Exercises Vitamin D In Postmenopausal Women With Low Back Pain

This study aims to evaluate the effectiveness of resistance training, core strengthening exercises, and vitamin D supplementation in reducing low back pain (LBP) among postmenopausal women.

Postmenopausal women are particularly susceptible to LBP due to physiological changes such as reduced estrogen levels, decreased muscle mass, and bone density. The randomized controlled trial (RCT) will be conducted over six months in various clinical settings in Lahore, with a sample size of 36 participants, divided into two groups. The inclusion criteria focus on postmenopausal women aged 50-70 years experiencing LBP for at least three months and who are not currently taking vitamin D supplements. Data on pain intensity, functional disability, muscle strength, endurance, and vitamin D levels will be collected and analyzed to assess the interventions' impact. The study's findings could provide evidence-based recommendations for managing LBP in postmenopausal women, combining physical activity with nutritional supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women aged 50-70 years.
* Experiencing low back pain for at least 3 months.
* Capable of engaging in light to moderate physical exercise.

Exclusion Criteria:

* History of spinal surgery.
* currently taking vitamin D supplements.
* Diagnosed with severe osteoporosis.
* Chronic use of pain medication that cannot be temporarily ceased.
* Current participation in another clinical trial.