cyrilzakka/clinical-trials huggingface dataset:
Gene-polymorphisms Relating to Human Subfertility

Estradiol is synthesized by granulosa cells of ovaries under control of follicle-stimulating hormone (FSH) and luteinizing hormone (LH). It is known that Estradiol plays a crucial role in maturation and fertilization of oocytes. Furthermore it is involved in development of secondary female sexual organs, fertility and maintenance of pregnancy.

Estradiol influences these processes by binding to estradiol receptors (ER). They are ligand-depending transcription-factors. In humans there are two subtypes: ERa and ERb, which are synthetized from gene ESR1 on chromosome 6 and ESR2 on chromosome 14. Both subtypes are expressed in the ovary. Both genes are polymorph. Especially for ERa subtype several polymorphisms and mutations are known which can be linked to breast cancer, spontaneous abortions, osteoporosis and the point in time of menarche. Furthermore some studies have shown a relationship between certain polymorphisms and the risk of infertility associated gynecological malfunctions and the result of IVF treatments.

Progesterone is a hormone which plays a crucial role in initiation and maintenance of pregnancy. It induces the transformation of the endometrium, which facilitates the implantation of the fertilized oocyte and supports the pregnancy. Progesterone acts by binding to its receptor. The gene for this receptor is polymorph within the population, whereas some variants seem to account for implantation failure of embryos.

In the investigators study the investigators will analyse the role of ERP and PRP polymorphisms in the context of IVF treatment. The analyzed genotypes are two polymorphisms of ESRI, called Pvu and Xba, as well as a variant of ESRII, ER2. In the progesterone receptor gene a single nucleotide exchange at position +331 (G-\>A) plays a role.

The parameters correlated with are concentrations of estradiol, progesterone and FSH, number of follicles, number of fertilized oocytes and pregnancy rate.

The investigators hope to optimize established treatment protocols and to improve the chances of success of IVF treatments depending on the genotype of the patient.


Eligibility Criteria:
Inclusion Criteria:

* IVF/ ICSI treatment with hormonal stimulation
* reproductive age
* high response OR low response OR male subfertility

Exclusion Criteria:

* other fertility treatments like IUI or timed intercourse
Prognostic Markers for a Better Follow-up in Head and Neck Cancer.

To identify tumor specific DNA mutations and aberrations and to follow these in blood over time to predict treatment response/survival and secondly to correlate presence of these markers in blood to pathological parameters (LVI, Pn, WPOI and margins), radiological findings and to tumor stage.


Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with head and neck cancer
* Treatment includes surgery
* Consent to participate

Exclusion Criteria:

* No consent
* Age below 18 years
* No surgery
* No tumor material to sample
Post Market ATS 3f® Aortic Bioprosthesis, Model 1000, Size 19mm

The purpose of this study is to evaluate the safety and efficacy of the ATS 3f® Aortic Bioprosthesis, Model 1000 (Equine Pericardial Bioprothesis) size 19mm in a patient population undergoing isolated aortic valve replacement of his/her native aortic valve, or replacement of a failed prosthesis.

A multi-center, post market, non-randomized trial, designed to obtain safety and efficacy data from patients implanted with the size 19mm Model 1000 heart valve. Each enrolled patient will be followed until one year post-implantation. Data will be collected both retrospectively and prospectively, on patients who were implanted from 1-Jan-2009 to 31-Dec-2009 with the 19mm Model 1000. The data collected will be pooled with the data currently collected, under the U.S. Food and Drug Administration (FDA) IDE Number G01284 for submission to the U.S. FDA.

Eligibility Criteria:
Inclusion Criteria:

* The patient required isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve reconstruction with an ATS 3f® Aortic Bioprosthesis Model 1000 (size 19mm) between the dates of 1-Jan-2009 and 31-Dec-2009. The three remaining heart valves must be of native tissue.
* The patient is geographically stable and willing to return to the implant center for any required follow-up visits.
* The patient has been adequately informed and consents to his/her participation in the clinical study, and of what will be required of him/her, in order to comply with the protocol.

Exclusion Criteria:

* The patient is twenty (20) or less than twenty years of age.
* The patient is an intravenous drug and/or alcohol abuser.
* The patient presented for implant with active endocarditis.
* The patient presented for implant with congenital bicuspid aortic anatomy.
* The patient had a previously implanted prosthetic valve that was not replaced by the study valve.
* The patient required mitral, tricuspid or pulmonic valve replacement.
A Dose-finding Study to Evaluate mRNA-3210 in Participants With Phenylketonuria

The main goal of this study is to assess the safety, and tolerability of multiple doses of mRNA-3210 in participants with phenylketonuria (PKU).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of PKU due to phenylalanine hydroxylase (PAH) deficiency by molecular genetic testing from a central lab.
* At least 3 blood phenylalanine levels ≥600 micromole(μmol)/Litre (L) regardless of diet: 2 obtained during the screening period (at least 72 hours apart) and at least one historical value 6 to 24 months prior to start of screening.
* Have received documented approval from a study dietitian confirming that participant is willing and able to maintain dietary protein intake consistent with baseline intake during study participation.
* If applicable, maintained stable dose of neuropsychiatric medication (that is, for attention deficit hyperactivity disorder (ADHD), depression, anxiety, or other psychiatric disorders) prior to enrollment and willing to maintain stable dose throughout study participation unless, per investigator assessment, a change is clinically indicated.

Exclusion Criteria:

* Receipt of sapropterin or large-neutral amino acids within 14 days or 5 half-lives (whichever is longer) of the start of screening.
* Receipt of pegvaliase within 2 months of start of screening.
* For participants previously on pegvaliase: use or planned use of any injectable drugs containing polyethylene glycol (PEG), including medroxyprogesterone injection, within 3 months prior to the start of screening and during study participation with the exception of COVID-19 vaccinations.
* Receipt of any investigational drug within 30 days or 5-half-lives (whichever is longer) of screening.
* History of hypersensitivity to any component/excipient used in this study.
* Any other clinically significant medical condition that, in the Investigator's opinion, could interfere with the interpretation of study results or limit the participant's participation in the study

Note: Other protocol-defined inclusion/exclusion criteria apply.
Thulium Laser Versus Bipolar Enucleation of the Prostate

Comparing the peri-operative outcomes in patients with benign prostatic hyperplasia (BPH) who will undergo bipolar enucleation of the prostate versus thulium laser enucleation.

* Benign prostatic hyperplasia (BPH) is one of the most common and bothersome diseases influencing the quality of life of aging males. For decades, transurethral resection of the prostate (TURP) has been recognized as the standard treatment for BPH .Recently, endoscopic laser treatments of BPH has been developed as the result of advances in laser technology and better understanding of tissue-laser interactions and nowadays it represents a challenge for TURP as regards the peri-operative outcomes.
* Both the European Association of Urology (EAU) and American Urological Association (AUA) recommend endoscopic enucleation of the prostate (EEP) as one of the techniques for management of benign prostatic hyperplasia (BPH) with various techniques that could be implemented including enbloc and three/two lobe enucleation.
* The classical laser enucleation technique consists of a three-lobe enucleation of the adenoma with separate enucleation of the median and lateral lobes. Scoffone and Cracco developed an "en-bloc" enucleation technique for HoLEP (holmium laser enucleation) in 2016, showing a potential role to ease some difficult intraoperative steps of enucleation and to improve the learning curve and both of the techniques mentioned were found to be applicable for bipolar endoscopic enucleation as well.
* Regarding the thulium laser physical properties; its wavelength is very close to the peak for absorption in water about 1940 nm being similar to the holmium laser wavelength which is about 2010 nm. However, unlike the pulsed wave holmium laser, this high density energy of thulium laser is best delivered in a continuous wave. This is translated into more efficient vaporization and shallower depth of penetration in tissue, which has been reported to be 0.2 mm as compared with 0.4 mm for holmium lasers. In thulium laser; the continuous wave mode is more suitable for hemostasis and coagulation of tissue, whereas the pulsed mode is more suited for lithotripsy.
* BipolEP (Bipolar enucleation of the prostate) has been performed as an effective method for the management of BPH in some institutions. Bipolar enucleation of prostate is a done using energy source of a bipolar electrosurgical unit. Enucleated prostatic tissues are then removed with a morcellator.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with BPH who are unsatisfied with medical treatment having a Qmax of less than 15 cm/s.
2. Patients with BPH who had refractory retention.
3. Patients with complicated BPH (eg; chronic retention, refractory hematuria, bladder stones).
4. Prostate size of at least 80 grams or more.

Exclusion Criteria:

1. Patients with a bladder mass.
2. Patients with prostate cancer.
3. Patients suffering from a urethral stricture.
4. Patients with previous endoscopic or surgical prostate intervention.
5. Prostate size less than 80 grams.
A Randomised Trial Comparing Supraclavicular Block vs Supraclavicular and Pecs II Block in Arteriovenous Grafting

This study evaluates the addition of Pecs II block to ultrasound-guided supraclavicular brachial plexus block in patients undergoing arteriovenous graft creation surgery. Participants will be randomised into two equal groups, one receiving supraclavicular and pecs II blocks, the other receiving supraclavicular block and sham block (Grade 1).

Regional anaesthesia (RA) for arteriovenous grafting surgery has advantages of avoiding risks of general anaesthesia (GA) in this group of patients with significant co-morbidities, and beneficial vasodilatation, which may prevent early fistula thrombosis. Hence, RA is preferable to GA for this surgery.

Brachial plexus blocks (BPB) are the most commonly employed RA technique to anaesthetise the upper limb for this surgery. According to the results of a recent 2-year retrospective audit in our centre, ultrasound-guided supraclavicular BPB are the most popular RA technique for this surgery. Anatomically, the T1 and T2 dermatomes are often missed by the supraclavicular BPB. This means that the upper medial arm and axilla (sites involved in brachiobasilic and brachioaxillary arteriovenous grafting) may not be adequately anaesthetised, mandating intraoperative local anaesthetic supplementation by the surgeon. This may affect patients' and surgeons' acceptance of, and satisfaction with the RA technique. The ultrasound-guided Pecs II block, described by Blanco et al, seems to address this problem, as the intercostal T1-6, intercostobrachialis, long thoracic nerves and nerve to serratus anterior are targeted by this block.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for arteriovenous grafting under regional anaesthesia in Changi General Hospital
* American Society of Anaesthesiologists (ASA) physical status 3 to 4
* Elective or emergency surgery

Exclusion Criteria:

* Patients unable to give consent, unable to communicate or cooperate with simple instructions
* Patients with regular consumption of strong opioids (eg. morphine, oxycodone) or steroids
* Patients with allergy or contraindications to local anaesthetics or any of the drugs included in this study
* Patients with pre-existing upper limb neurological deficits
* Patients who refuse or are unsuitable for regional anaesthesia (eg. severely coagulopathic)
Manual Versus Sonic-powered Toothbrushing for Plaque Reduction in Patients with Peri-implant Mucositis

Aim: To compare the effect of manual and sonic-powered toothbrushing on biofilm control in patients with peri-implant mucositis.

Materials and methods: The study was completed with a total of 41 patients, 21 in the sonic tooth brushing group and 20 in the manual tooth brushing group. The patients' baseline, 3rd-month, 6th-month and 9th-month periodontal examination data (Modified Gingival İndex (MGI), Modified plaque index (MPI), Bleeding on the probing index (BOP), Pocket depth (PD), Gingival Recession (GR) and Gingival Biotype (GB)) were analyzed.


Eligibility Criteria:
Inclusion Criteria:

1. Bleeding on probing around the implant
2. No bone loss around the implant in the radiograph
3. Having adequate keratinized gingiva around the implant
4. The presence of an implant prosthesis that was installed at least three months previously
5. No systemic disease
6. no smoke
7. No use of antibiotic medications within the previous three months

Exclusion Criteria:

1. Patients with missing data and who do not allow data use
2. Smoker
3. Data from pregnant and lactating patients
4. Pocket depth around the implant is ≥ 5
5. Patients with peri-implantitis (bone loss around the implant)
6. Patients with insufficient attached gingiva around the implant
Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs

This study, which will be conducted at the emergency room of the Sacré-Cœur hospital, requires the recruitment of 60 subjects and involves some telephone follow-up.

Calcitonin administered as an intranasal spray is already used to relieve pain caused by broken vertebrae and we seek to determine if it can be as efficient in the case of pain caused by broken ribs.This study aims at testing the hypothesis that subjects suffering from the accidental fracture of one or more ribs will get relief through the intranasal spraying of calcitonin and/or will use less opiate medication for pain relief (a combination of oxycodone chlorhydrate and acetaminophen called Percocet®).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or more.
* Accidental rib fracture (one or more) visible on a lung\\thorax radiography, or on a CT Scan of the thorax, as determined by the emergency physician or the radiologist.
* The rib fracture is the main cause of pain.
* The patient says yes to the question "do you wish something for your pain" (the result of the quantitative assessment of the pain in not taken into consideration) or the patient has already received an analgesic before the initial assessment by the emergency physician.
* The patient is seen no more than 48 hours after the accident.

Exclusion Criteria:

* The patient is already receiving SC.
* Allergy or intolerance to SC, oxycodone chlorhydrate or acetaminophen
* Active neoplasia history for at least 5 years
* Toxicomania history as revealed by case history
* Osteoporosis linked to hyperparathyroidism
* Patient already using opiate analgesics or other analgesics on a regular basis (excluding aspirin at doses of 325 mg or less, as a prophylactic for cardiovascular diseases and under stable posology for at least 15 days)
* Steroid use within the past month
* Pregnancy, breast feeding
* Non-availability of patient for telephone follow-ups or follow-up appointments.
Effect of Biological Nurturing Education to Pregnant Women on Breastfeeding Status

Aim: This study was randomized to determine the effect of biological nurturing education given to nulliparous pregnant women on breastfeeding status.

Method: The population of the study consisted of pregnant women who are visiting Istanbul Training and Research Hospital Suleymaniye Obstetrics and Pediatrics Hospital between October 2022 and August 2023. F test at 90% effect power 0.25 medium effect level on the sample of the study analyzed using the Gpower (3.1.9.2) Programe. As a result of the analyze, it was planned to recruit 207 nulliparous pregnant women. According to the calculation made, there should be at least 69 people in each groups. Accordingly, 69 people in the experimental 1 group (biological nurturing), 69 people in the experimental 2 group (classical breastfeeding), 69 people should be included in the control group. Experimental 1 group and experimental 2 group will be given breastfeeding training on their first visit and after two weeks. Breastfeeding success in the postpartum period will be compared in all groups.


Eligibility Criteria:
Inclusion Criteria:

GROUP 1:

* 18-35 age range
* Nulliparous Pregnancy
* Single Pregnancy
* Gestational week 34- 36
* Those who are literate
* Those who have a smart phone and have the opportunity to benefit from teaching methods

GROUP 2:

* 18-35 age range
* Nulliparous Pregnancy
* Single Pregnancy
* Gestational week 34-36
* Those who are literate

GROUP 3:

* 18-35 age range
* Nulliparous Pregnancy
* Single Pregnancy
* Gestational week 34-36 gw
* Those who are literate

Exclusion Criteria:

GROUP1:

* Presence of chronic disease
* Nipple problems
* Admission of the baby to the neonatal intensive care unit
* The presence of anomaly related to the baby (chromosomal anomaly, cleft palate/lip, tongue tie)
* Mothers in whom breastfeeding will be prohibited/suspected in the postpartum period
* The presence of a disease in the mother that will prevent breastfeeding
* Pregnant women with vision and hearing problems

GROUP 2:

* Presence of chronic disease
* Nipple problems
* Admission of the baby to the neonatal intensive care unit
* The presence of anomaly related to the baby (chromosomal anomaly, cleft palate/lip, tongue tie)
* Mothers in whom breastfeeding will be prohibited/suspected in the postpartum period
* The presence of a disease in the mother that will prevent breastfeeding
* Pregnant women with vision and hearing problems

GROUP 3:

* Pregnant women who go to pregnancy school
* Presence of chronic disease
* Nipple problems
* Admission of the baby to the neonatal intensive care unit
* The presence of anomaly related to the baby (chromosomal anomaly, cleft palate/lip, tongue tie)
* Mothers in whom breastfeeding will be prohibited/suspected in the postpartum period
* The presence of a disease in the mother that will prevent breastfeeding
* Pregnant women with vision and hearing problems
Atrial Flow Regulator in Heart Failure

The aim of the study is to assess invasive and non-invasive parameters that may predict clinical improvement in patients with congestive heart failure after implantation of Occlutech® Atrial flow regulator (AFR) device.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Symptomatic heart failure (HF) in NYHA class III or IV ambulatory
* Optimal medical therapy of HF according to European Society of Cardiology (ESC) guidelines for last 6 months
* Hospitalization because of HF decompensation in last 12 months
* Absence of significant valvular disease requiring cardiac surgery
* Life expectancy ≥ 1 year
* Written informed consent obtained from the patient
* Left ventricle ejection fraction (LVEF) ≥ 15%
* Elevated left heart filling pressures:

  1. Pulmonary artery wedge pressure (PAWP) at rest \> 15 mmHg or
  2. PAWP \> 25 mmHg during hand grip test

Exclusion Criteria:

* Participation in another clinical trial in last 30 days
* Acute infection or sepsis
* Severe coagulation disorder
* Allergy to nickel or titanium
* Severe peripheral artery disease disabling 6 minutes walk test
* Allergy to antiplatelet drugs, oral anticoagulants or heparin
* Contraindication to trans-oesophageal echocardiography (TEE)
* Pregnancy
* Atrial septal defect (ASD) or presence of atrial septal occluder
* Severe patent foramen ovale (PFO) with significant left to right shunt in rest
* Intracardiac thrombus
* Acute coronary syndrome or Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG) in last 6 months
* Severe pulmonary hypertension:

  1. Right atrial pressure ≥ PAWP (measured in right heart catheterization)
  2. Right atrial pressure \> 20 mmHg (measured in right heart catheterization)
* Planned heart transplantation
* Transient ischemic attack or stroke within last 6 months
* Cardiac resynchronisation therapy (CRT) within last 6 months
Monitoring luminAl Breast Cancer Through the Evaluation of Mutational and epiGeNEtic alteraTIons of Circulating ESR1 DNA

The purpose of the study is to determine the diagnostic role of ctDNA when used to monitor metastatic breast cancer (MBC) during first-line endocrine therapy.

Patients with hormone receptor-positive MBC are eligible for endocrine therapy (ET) as first line treatment which is based on strategies aimed to either block signaling pathways depending on the estrogen receptor (ESR1) or using ESR1 antagonists. Only a few accepted predictive factors are associated with treatment benefit for MBC (i.e., hormone receptor status and HER2 status). Furthermore, a standardized assessment evaluation for MBC is still lacking. Because of these unmet needs, ET is continued until disease progression, or if toxicity requiring discontinuation occurs. Resistance is frequent in the treatment of early BC and unavoidable in MBC. Recently, mutations in ESR1 have been described in MBC that had been previously exposed to aromatase inhibitors (AIs) and are rarely detectable in primary BC. Besides that, resistance phenomena have been also linked to ESR1 cisregulatory elements (CRE, i.e. enhancers and promoters) hypermethylation, both related to ESR1 silencing.

According to the literature, the aim of the study is to detect tumor response with liquid biopsy technique compared to conventional clinical pratice algorithms.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven diagnosis of adenocarcinoma of the breast with evidence of metastatic disease.
* ER positive tumor ≥ 1%
* HER2 negative breast cancer by FISH or IHC (IHC 0,1+, 2+ and/or FISH HER2: CEP17 ratio \< 2.0)
* Females, 18 years of age or older
* Candidate to first-line endocrine therapy (LH-RH analogue for premenopausal women is allowed)
* Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.

Exclusion Criteria:

* Diagnosis of any secondary malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
* Prior endocrine therapy for metastatic disease