cyrilzakka/clinical-trials huggingface dataset:
Natural Cycles With Spontaneous Versus Induced Ovulation in FET

In recent years, frozen-thawed embryo transfer procedure (FET) has been widely used to increase the cumulative pregnancy rate per IVF-cycle: which is the best preparation protocol remains a matter of debate.

A retrospective analysis was conducted between 2012-2017. The aim was comparing clinical pregnancy rate (CPR) of pure natural cycle frozen-thawed embryo transfer (NC-FET) versus natural cycle frozen-thawed embryo transfer with hCG-triggered ovulation (mNC-FET).

Compared to repeated oocyte retrieval procedure, frozen-thawed embryo transfer (FET) has been widely used to increase the cumulative pregnancy rate per IVF-cycle, with demonstrated superiority in preventing ovarian hyperstimulation syndrome and improving cost-efficiency and time to pregnancy.

It is controversial whether triggering ovulation of the dominant follicle using human chorionic gonadotrophin (hCG) may benefit or reduce embryo implantation, when compared with a natural cycle environment. Unfavourable clinical outcomes of controlled ovarian stimulation have been reported by recently published studies, compared to the spontaneous LH surge.

This study aimed to compare the effectiveness in terms of better clinical pregnancy rates (CPR) of pure natural cycle frozen-thawed embryo transfer (NC-FET) versus natural cycle frozen-thawed embryo transfer modified by HCG administration\\with hCG-triggered ovulation (mNC-FET).

A retrospective analysis was conducted between 2012-2017. In patients with regular ovulatory cycles, the timing of embryo thawing and transferring was based on spontaneous LH surge (NC-FET). Patients attended for ultrasound evaluation of the dominant follicle from Day 8 to 10 of their menstrual cycle (depending on cycle length), detecting luteinizing hormone (LH) surge in urine/ taking an ovulation test for urinary LH measurement. In selected cases, a serum assays of LH, progesterone and estradioI has been further obtained. When the endometrial thickness reached 8 mm and dominant follicle 16-20 mm in diameter, hCG was administered in absence of urinary LH surge. Embryo thawing and transfer was planned 7 days after LH surge or HCG administration, whether G5 or G6 blastocyst. Exogenous progesterone supplementation started 2 days after hCG administration versus the same day of embryo transfer procedure in NC- ET. To limit potential confounders, only single blastocyst transfer cycles were included, vitrified on Days 5 or 6, excluding PGT-a (Pre Gestational Test for aneuploydia) cycles and cleavage stage embryo transfers. A unilevel and multi level logistic regression analysis was conducted using Stata Software versione15.

Eligibility Criteria:
Inclusion Criteria:

* only single blastocyst transfer cycles were included

Exclusion Criteria:

* PGT-a cycles and cleavage stage embryo transfers
Electronic Health Record Sharing System (eHRSS) Encounter Notification Service Pilot Project

This study evaluates the value of the automated notification service that allows more timely information access and sharing. A 12-month RCT will be conducted to determine the efficacy of the provision of the service to an elderly care and service provider in improving care and health outcomes of the elderly. Researchers will also examine whether the notification service will better support the carers for the coordination and prioritization of care and service delivery.

A research team at the University of Hong Kong is commissioned to conduct a study of the efficacy of providing an automated notification service, i.e., the "Encounter Notification Service," via the Electronic Health Record Sharing System (eHRSS) to an elderly caring and service provider that aims to facilitate more timely provision and coordination of healthcare services for home-dwelling elderly. With the access to the automated notification service containing up-to-date encounter information of the elderly in the eHRSS (e.g. discharge date from the public hospital, outpatient appointments), it is expected that the elderly caring and service provider can improve its allocation of resources and prioritize the provision of service to elderly patients who are in need, i.e., during the transition of care. As a result, the caring support and services provided by the elderly caring and service provider to the elderly can be more timely and effective, and an improvement in patient health outcomes can be expected.

To obtain evidence to determine the value of the automated notification service, a systematic study of the efficacy is suggested. Thus, researchers set out to conduct a 12-month randomized controlled trial (RCT) to examine whether the provision of the automated notification service to the caring and service provider will result in improvements in care and health outcomes of the elderly. Also, researchers will assess whether the notification service will better support the carers for the coordination and prioritization of care and service provision and improve workflow and administrative procedures amongst different sectors.

In this pilot study, the Senior Citizen Home Safety Association (SCHSA) is the participated elderly caring and service provider.

Eligibility Criteria:
Inclusion Criteria:

* are aged 18 years or older
* have registered in eHRSS as healthcare recipients and given consent for sharing their records in the eHRSS with the SCHSA
* are able to understand spoken Cantonese

Exclusion Criteria:

* with mental incapacity
* with hearing difficulties
A Study in Healthy Men to Test How BI 456906 is Processed in the Body

This trial is intended to examine the basic pharmacokinetics of BI 456906 and total \[14C\]-radioactivity, including mass balance, excretion pathways and metabolism following a single subcutaneous (SC) dose of BI 456906 (C-14) in (otherwise) healthy male volunteers with normal body weight, overweight or obesity.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects with normal Body mass index (BMI) or otherwise healthy male subjects with overweight/obesity according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 65 years (inclusive)
* BMI of 23.0 to 34.9 kg/m2 (inclusive); body weight of at least 70 kg.
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 45 to 90 mmHg, or pulse rate outside the range of 40 to 100 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy

The improvement of conventional imaging techniques has led to an increased detection rate of different adrenal tumors. Since those tumors can belong to a variety of entities the therapeutic consequences also show considerable variation. In order to definitely determine the type of tumor, invasive procedures like CT guided biopsies are often required, which could be avoided by a tumor specific imaging method. The presently available scintigraphic procedures are either time consuming and lead to high radiation exposure or are technically demanding. The steroidogenic enzymes CYP11B1 (11ß-hydroxylase)and CYP11B2 (aldosterone synthase)are expressed exclusively in the adrenal cortex and therefore represent suitable targets for a specific imaging technique. In our project we evaluate 123I-Iodometomidate which binds to both CYP11B enzymes as radiotracer for adrenal scintigraphy.


Eligibility Criteria:
Inclusion Criteria:

1. Adrenal tumor seen by CT or MRT-scan with diameter of at least 2 cm or patient with adrenocortical carcinoma and suspected metastasis or local recurrence or patients with primary hyperaldosteronismus and adrenal tumour \> 1 cm
2. Hormonal work up of of the adrenal tumor according to ENS@T (European network for the study of adrenal tumours)-criteria
3. Age ≥ 30 Jahre
4. Effective contraception (pearl index \<1%)
5. Written informed consent

Exclusion Criteria:

1. Pregnancy or breast feeding
2. Renal insufficiency (serum creatinine \> 2,0 mg/dl or MDRD \< 60 ml/min)
3. Known allergy to etomidate or constituents of the test drug
Mpact 3D Metal Monolit Study

Total hip arthroplasty (THA) is one of the most common operations performed in orthopaedics to improve a patient's quality of life.

Surgeons are constantly seeking to improve all aspects of care related to this procedure, whether it be improving implant technology, improving instrumentation or the technique involved in performing the procedure.

In recent years, a new porous titanium coating has been introduced to promote good osseointegration of uncemented cups. High friction torque and a feeling of immediate anchorage provide excellent primary stability, while high porosity ensures bone growth providing secondary stability. With higher porosity than standard coatings, a greater volume of bone can be present in the porous surface, giving a proportional increase in force at the interface. he Mpact 3D Metal Monolith cup has been designed to provide greater range of motion and improved joint stability, with a reduced risk of dislocation. It is an innovative design that improves stability and provides a favourable environment for long-term biological metal-bone fixation.

The current study aims to collect clinical and radiological data to assess the function of the operated hip and the stability of the Mpact 3D Metal Monolith cup at 2 years and survival at 5 years for the treatment of patients requiring hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with a disease that corresponds to the indications for use of Medacta implants (according to the instructions for use)
2. Patient eligible for primary total hip arthroplasty
3. Patient aged between 18 and 75 years
4. Patient covered by the French Social Security system or an equivalent protection scheme.
5. Patient able, in the investigator's opinion, to comply with the requirements of the study.

Exclusion Criteria:

1. Patient suffering from inflammatory arthritis
2. Previously operated hip
3. Patient requiring a transplant
4. Hip tumour involved
5. Patient with progressive local or systemic infection
6. Severe acetabular dysplasia
7. Patient with muscle loss, neuromuscular disease or vascular impairment of the affected limb.

4. Patient with known medical problems that may compromise independent recovery of mobility 5. Patient with a BMI greater than 40 kg/m². 6. Patient with major cognitive impairment that prevents him/her from fully understanding the requirements of the study 7. Patient living in a geographical area where study follow-up is not possible. 8. Patient taking part in interventional research 9. Minor patient 10. Protected adult patient 11. Vulnerable person according to article L1121-6 of the Public Health Code
"Nanotechnologies Applied to General Surgery and Emergency Surgery: Buckypaper as a New Fixing Method for Prosthetic Materials for the Treatment of Hernia and Incisional Hernia in Laparotomy and Laparoscopic

"Nanotechnologies applied to General Surgery and Emergency Surgery: The Buckypaper as a new fixing method for prosthetic materials in the treatment of abdominal wall hernias, diaphragmatic hernias, diaphragmatic rupture, incisional hernia and abdominal wall disaster in laparotomy procedure and laparoscopic procedures". Experimentation on breed pig Lantrace ANIMAL MODEL.


Eligibility Criteria:
Inclusion Criteria:

* animal model: lantrace female pigs of 20 kg of body weight

Exclusion Criteria:

* any kind of illness in porcine subjects
Characterization of Immune Genotypes and Antibody Profiles to Foster the discoVERY of diagnosticbioMARKERS of Liver Cancer Development

Hepatitis C virus (HCV), which infects more than 185 million people, is a major risk factor. Direct-acting antiviral (DAA) therapy has significantly improved the eradication of the virus, but has not completely eliminated the risk of HCC, so careful surveillance is necessary. The genetic diversity of the natural killer receptor, histocompatibility antigens (HLA) and interferon lambda 4 (INFL4) activity, among other factors, have been found to be crucial in directing disease progression. Importantly, these markers are detectable years before the diagnosis of HCC. In addition, polymorphic variants attributable to the expression of genes involved in innate-type immune response, such as IFNL4 and HLA-E, have been shown to be predictive for the development of HCC and have not yet been extensively studied. The aim of the study is to evaluate novel circulating biomarkers, including the presence of antibodies to specific HCV proteome peptides, IFNL4 expression, and the interaction of specific HLA receptors/ligands in a large cohort of HCV-positive subjects in order to create a screening strategy for the early diagnosis of HCV-associated HCC.

Part of the study will be devoted to describing the immune microenvironment associated with the expression of IFNL4 and HLAE, evaluating them as potential prognostic indicators for HCC in HCV-infected subjects undergoing surgery for HCC, as well as in those with advanced/metastatic HCC.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years with the presence of chronic infection, fibrosis, cirrhosis or HCV- associated HCC
* Patients able to understand and willing to sign the of informed consent
* Patients to answer the questions in the questionnaire of enrollment

Exclusion Criteria:

* Treatment for other oncological diseases
* Immunodepression congenital or acquired (HIV, organ transplantation, pharmacological)
Post-operative Emesis and Pain Outcomes After Cesarean Delivery

Approximately 20% women who undergo cesarean delivery would suffer from severe post-operative pain, which may further increase their risks from developing postpartum depression. Predictive factors such as pre-operative pain, age and anxiety could significantly contribute to post-operative nausea and vomiting (PONV) and pain in general surgery, however little information is available with regards to cesarean delivery. The investigators would investigate the risk factors of causing post-operative emesis after cesarean delivery, and to reaffirm that there is a positive correlation between pain on local anesthetic injection, presence of mechanical temporal summation (MTS) and post-Cesarean pain scores.

Previous studies demonstrated that pain scores upon local anesthetic injection is positively correlated to post-cesarean pain scores. Anxiety, anticipated post-operative pain score and anticipated medication need are also found to be promising risk factors to post-cesarean pain management.

The investigators would investigate the risk factors of causing post-cesarean emesis, and to reaffirm that there is a positive correlation between pain on local anesthetic injection, presence of mechanical temporal summation (MTS) and post-Cesarean pain scores. 470 parturients undergoing cesarean delivery and requiring regional anaesthesia will be recruited. Pain and anxiety assessment will be conducted via visual analogue scoring (VAS), MTS assessment and a series of questionnaires. After delivery, patients will be given appropriate analgesia, and pain score at movement will be recorded. Secondary outcomes include pain scores at rest, analgesia consumption, time-to-first-rescue analgesia, opioid-related side effects, patient satisfaction and postpartum depression. A separate 125 patients will be recruited to evaluate the feasibility and patient acceptability of the use of Headspace, a mindfulness mobile application during the pre- and postnatal period to improve the maternal outcomes (emesis, pain, anxiety, depression).

Eligibility Criteria:
Inclusion Criteria:

* Pregnant and going to have caesarean delivery (36 weeks gestation or more; nulliparous and multiparous);
* Healthy or have mild medical problems that are well-controlled (American Society of Anesthesiologists physical status 1-2).

Exclusion Criteria:

* History of intravenous drug or opioid abuse;
* Previous history of chronic pain syndrome;
* Emergency cesarean section;
* Undergo general anaesthesia during cesarean delivery;
* Non-English speaking.
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with open-angle glaucoma (with ot without pseudoexfoliation or pigment dispersion component) or ocular hypertension
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Under 18
* Other protocol-defined exclusion criteria may apply.
Longterm Followup of Patients With Rheumatoid Arthritis Treated With Methotrexate

Longterm followup of patients with rheumatoid arthritis 30 years after starting a baseline treatment with Methotrexate.

Objective. 30-year follow-up of rheumatoid arthritis (RA) patients treated with methotrexate (MTX) in the 1980s to analyze the association of the degree of response to MTX with long-term mortality.

Methods. In this observational cohort study, 271 RA patients who had started treatment with MTX between 1980 and 1987 were included (mean age 58 years, mean disease duration 8.5 years). One year after baseline, the treatment response to MTX was evaluated. Responders were defined as patients with at least 20% improvement. Thereafter, assessments were performed at 10 and 18 years after baseline. This re-evaluation was done to provide the data after 30 years of follow-up. Standardized mortality ratios (SMR) are calculated, Cox regression and logistic regression are performed.

Eligibility Criteria:
Inclusion Criteria:

* rheumatoid arthritis
* treatment with methotrexate
* active disease

Exclusion Criteria:

* low disease activity
* previous treatment with methotrexate
TMHT - New Method of Difficult Intubation Prediction

The purpose of this study is to assess the usefulness of the Thyromental Height Test in prediction of difficult intubation using double lumen endotracheal tubes in patients scheduled for elective thoracic procedures.

Proper prediction of the occurrence of difficult intubation plays a crucial role in anaesthesiology. For years attempts have been made to develop methods allowing anaesthesiologists to correctly predict the occurrence of difficult intubation. None of the currently used tests and anthropometric measurements present satisfying predictive value. Recent studies show promise in Thyromental Height Test (TMHT), which base on the height between the anterior borders of the mentum and the thyroid cartilage, measured while the patient lies in the supine position with closed mouth, as a single, non-invasive predictor of difficult intubation. Use of double lumen endotracheal tubes during thoracic procedures, due to greater diameter of the tube, may lead to higher occurrence of difficult intubation. That is why, the purpose of this study is to assess the usefulness of the TMHT in prediction of difficult intubation using double lumen endotracheal tubes in patients scheduled for elective thoracic procedures and relate it to other, commonly used predictive tests.

During routine, preoperative anaesthetic visit thyromental height, thyromental distance, sternomental distance and Mallampati scale score are assessed. Then, during direct laryngoscopy and intubation, score in Cormack-Lehane scale and occurrence of difficult intubation are noted.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for elective thoracic procedures, requiring general anaesthesia, direct laryngoscopy and intubation with a Robertshaw type double lumen endotracheal tubes
* consent for participation in the trail
* older than 18

Exclusion Criteria:

* emergency procedures
* visible anatomic abnormalities
* patients scheduled for awake fibre optic intubation
* lack of consent for participation in the trail
Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis

In order to determine whether rebaudioside consumption can be used as a treatment for adolescents with Non-alcoholic Fatty Liver Disease (NAFLD) by demonstrating a decrease in alanine aminotransferase (ALT) levels participants will be randomized to receive one of three 8-week liquid diet interventions:

1. Standard of care
2. Water delivery
3. Water with Rebaudioside (stevia natural sweetener)

Rationale: Current treatment strategies for Nonalcoholic fatty liver disease, NAFLD, have focused on lifestyle management through a combination of diet and exercise but there are no recommendations for dietary changes that have been proven superior to others. Preliminary data showing an improvement in liver enzymes and fibrosis in mice has demonstrated a novel use of rebaudioside, the non-caloric sweetener (NCS) Stevia leaf's extract, potentially identifying this NCS as a therapeutic intervention where currently there are no targeted treatments.

Intervention: All participants will receive standard of care for diet and nutrition. Additionally, participants will be randomized to one of four 8-week liquid diet interventions:

1. Standard of Care
2. Water Delivery
3. Water with Rebaudioside (Stevia Natural Sweetener)

Objectives and Purpose: To determine whether rebaudioside consumption can be used as a treatment for adolescents with NAFLD by demonstrating a decrease in ALT levels.

Eligibility Criteria:
Inclusion Criteria:

* Age: 10-18 years
* ALT \> 45 IU/L (twice the normal amount)
* BMI \>85%
* Fat \>5% and kPa\> 2.7

Exclusion Criteria:

* Physician diagnosis of a major medical illness including, but not limited to, chronic liver disease, immunodeficiency disorder, hypothalamic obesity, or a genetic cause of obesity.
* Familial hyperlipidemia
* Positive hepatitis lab
* Antibiotics within 1 month of beginning the study
* Physical, mental, or cognitive issues preventing participation
* Pregnancy
* Smoking or drinking