cyrilzakka/clinical-trials huggingface dataset:
Ulipristal Acetate 10 mg and Asisted Reproduction

Demonstrate an 15% increase in the rate of clinical pregnancy in women with inoperable intramural fibroids not distorting the uterine cavity within a program OVD, after administration of uPA in a dose of 10 mg orally daily for 12 weeks


Eligibility Criteria:
Inclusion Criteria:

Patients\> 18 and \<50 years Patients who undergo a first / second cycle OVD Patients who present within 1-3 intramural myomas\> 2 cm and \<5 cm that do not distort the cavity, Type 3 and 4 of the FIGO classification (Figure 1). Miomas inoperable for medical judgment or patient desire, you want to avoid the post-surgical time waiting 6 months / 1 year before you can submit to TRA Patients who have undergone previous myomectomy who prefer to avoid having surgery

Exclusion Criteria:

History of endometrial changes in patients (hyperplasia) Presence of other endometrial pathologies: polyps, scars of previous cesarean complicated adenomyosis foci, suspected adhesions Simultaneous participation in another clinical study
Exercise and Pain Neuroscience Education for Patients With Neck Pain: Impact on Pain and Disability

This study will compare the effectiveness of pain neuroscience education and neck/shoulder traditional exercises versus pain neuroscience education and neck/shoulder suspension training exercises for patients with chronic idiopathic neck pain (CINP).

The investigators anticipate that 66 patients with chronic idiopathic neck pain will be randomized to receive pain neuroscience education and shoulder/neck traditional exercises (n=33) or pain neuroscience education and shoulder/neck suspension exercises (n=33). Data on pain intensity (Visual Analogue Scale), pain disability, neck flexor and extensor muscles endurance, scapulae stabilizers endurance, pain catastrophizing (Pain catastrophizing Scale), trait and state anxiety (State-Trait Anxiety Inventory) and knowledge of pain neurophysiology (Neurophysiology of Pain Questionnaire) will be collected. Measurements will be taken before, after the intervention and at 3 months follow up.

Statistical analysis will be performed using a mixed-methods ANOVA.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic idiopathic neck pain.

Exclusion Criteria:

* Cervical radiculopathy
* Neck fractures
* Tumors
* Rheumatological disorders
* Any other serious cause of neck pain
Acute Posttraumatic Osteomyelitis in Patients With High-energy Tibial Fractures and Biomarkers

The present trial was aimed to identify which biomarkers could be associated in perioperative period after surgical treatment of tibial fracture to the development of POM.

Early diagnosis of acute posttraumatic osteomyelitis (POM) is of vital importance for avoiding devastating complications. Diagnosing POM is difficult due to the lack of a highly specific and sensitive test, such as in myocardial infarct, stroke and intracranial bleeding. Serum inflammatory markers, C-reactive protein (CRP), procalcitonin (PCT), white blood cells (WBC) can support clinical findings but they are not able to differentiate between inflammatory response to infection and the host response to non-infection insult with high specificity and sensitivity.

The prospective nonrandomised cohort study included 86 patients after high-energy injury to the shin requiring primary surgical treatment (open or closed reduction and internal fixation of tibial fracture). Values of the biochemical and immunoinflammatory profile were measured on admission (ADD), first postoperative day (POD1) and fourth-postoperative day (POD4).

The objectives of the study were to investigate that the biochemical and immunoinflammatory profile could facilitate postoperative monitoring, guide the antibiotic treatment and timing of revision surgery.

Eligibility Criteria:
Inclusion Criteria:

* high-energy injury to proximal, shaft or distal tibia,
* tibial fracture requiring primary surgical treatment /ORIF

Exclusion Criteria:

* ankle fracture,
* patella fracture,
* avulsion fracture of the knee,
* malignant neoplasm and pathological tibial fracture,
* systemic autoimmune disease of connective tissue,
* immature patients under 15 years of age (children),
* immunocompromised patients.
Safety and Efficacy Study of NGGT002 in PKU Adult Subjects

This investigator initiated trial is an open-label, dose escalation study to evaluate the safety, tolerability and efficacy of NGGT002, an AAV derived investigational gene therapy product expressing human PAH enzyme in adult Phenylketonuria (PKU) subjects with PAH deficiency. All participants will receive a single administration of NGGT002 and will be followed for safety and efficacy for 5 years.

This study will evaluate the safety and efficacy of NGGT002 gene therapy with three dose cohorts in adult subjects with diagnosis of PKU characterized by PAH deficiency with confirmed PAH gene mutations. NGGT002 will be administered through intravenous infusion. Dose escalation will be initiated from the low dose of NGGT002. After evaluating the safety and efficacy data, a decision will be made regarding the cohort expansion or the escalation to the next dose level. The same process will be followed for subsequent dose cohorts.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily sign informed consent form;
* Male and female subjects with diagnosis of PKU caused by confirmed PAH mutation as per the "Clinical Practice Guidelines for Phenylketonuria 2020";
* Age ≥ 18 years;
* Phe concentration ≥ 600 μmol/L at screening and ≥ 600 μmol/L at least once within 2 years prior to screening;
* Subjects who are willing and able to maintain their baseline diet throughout the study, regardless of phenylalanine restriction, except at the investigator's request;

Exclusion Criteria:

* Presence of anti-AAV8 neutralizing antibody
* Prior gene therapy
* Positive hepatitis B virus surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or treponema pallidum-specific antibody
* Hepatic function abnormal: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 1.5 × ULN; alkaline phosphatase (ALP) \> 1.5 × ULN; total bilirubin (TBil) \> 1.5 × ULN; international normalized ratio (INR) \> 1.3
Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow

This study is designed to evaluate the within-woman effect of oral micronized progesterone (Progesterone 300 mg at bedtime) on semi-quantitative menstrual flow measured by the DivaCup® (menstrual cup with volume indicators at 7.5, 15 and 30 ml) or by counting the number of soaked normal-sized sanitary products such as normal-sized tampons or pads as well as length of flow and frequency and severity of menstrual cramps (on a 0-4 scale) in women with hot flushes and night sweats who are qualified to enroll in the primary perimenopausal hot flush trial stratified by whether they are in Early or Late Perimenopause.

The study will be a double-masked, placebo-controlled 28-day (4 week) baseline, 84-day (12 week) experimental trial, with a maximum number of 125 potential enrollees, with stratified random therapy assignment by Early or Late Perimenopause. Participants who meet the inclusion criteria for the original Progesterone for Perimenopausal Vasomotor Symptoms Study will be invited to join this additional sub-study. As part of the primary trial they will be randomly assigned into either the Progesterone or placebo group on a 1:1 basis. Primary and secondary data will be collected continuously throughout the study by completion of the Daily Perimenopause Diary-flow starting at baseline and continuously throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* \>35 to \<58 years of age
* Willingness to participate in this sub-study
* Perimenopausal status either based on irregularity of menstrual periods, or by onset of hot flushes/night sweats in women with regular periods
* Ability and willingness to complete the -flow recording instrument
* Ability to understand, speak, read and write English.

Exclusion Criteria:

* Less than 35 or greater than 58 years of age
* More than 1-yr without menstrual flow at study enrollment, including those with a hysterectomy ± ovariectomy
* Peanut allergy (because peanut oil is used in the progesterone formulation)
* Current or recent (within 6-mo of study enrollment) use of hormonal therapies (estrogen, progesterone, progestin-releasing intrauterine device (IUD), hormonal contraceptives, hormonal fertility treatments), or plans to initiate use during the study period
* Planned pregnancy or fertility treatment during the study period
* Inability to understand, speak, read and write English
Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient with Pancreatic Cancer

This study is a single center, open-label, non-comparative, phase I/II clinical trial to assess the maximum tolerated dose (MTD), safety and efficacy of BEY1107 in monotherapy and in combination with gemcitabine in patient With locally advanced or metastatic pancreatic cancer.

The key purpose of the main part of the study is to assess the MTD, safety and efficacy of BEY1107 as monotherapy and combination therapy for locally advanced and/or metastatic pancreatic cancer. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of BEY1107, to determine the MTD.

Patient will receive BEY1107 for 4 weeks in monotherapy for each cohort (administered in a 3-weeks-on / 1-week-off) during Phase I-1 trial.

At next stage, patient will receive BEY1107 with gemcitabine for 4weeks in phase I-2 trial.

Final stage, patient will receive BEY1107 with gemcitabine for 24weeks in phase II trial.

Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival of fresh biopsy tissue will also be collected for biomarker analysis.

Eligibility Criteria:
Inclusion criteria :

1. Histologically or Cytologically confirmed with pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
2. At lease one measurable lesion according to RECIST v.1.1
3. Eastern Cooperative Oncology Group (ECOG) 0,1 or 2
4. Over 12 weeks of Life expectancy
5. Adequate Bone marrow, Renal and Liver function at screening

Exclusion criteria :

1. A patient who has treatment history with locally advanced and/or metastatic pancreatic cancer
2. Major surgery history at screening
3. Uncontrolled brain metastasis evidence
4. Active bacterial infection patients
5. Malignant tumor other than basal cell carcinoma, cervix carcinoma in situ and papillary thyroid cancer
6. expected Pregnant or breast-feeding patients
7. HIV, Active hepatitis B or C infection
8. A patient who has hypersensitivity with BEY1107 or Gemcitabine
A Study to Assess the Improvement of Pain and Health-Related Quality of Life in Patients With Chronic Non-Malignant Pain Taking Tramadol Hydrochloride and Acetaminophen

The purpose of this study is to evaluate the impact of extended release tramadol hydrochloride (75 mg) and acetaminophen (650 mg) tablets on improvement of pain.

This is a multi-center (study conducted at multiple sites), open label (all people know the identity of the intervention), prospective (in which the participants are first identified and then followed forward as time passes), observational study to assess the improvement of pain and health-related quality of life in patients with moderate to severe chronic non-malignant pain. The study will enroll patients who had already filled a prescription for extended release tramadol hydrochloride 75 mg and acetaminophen 650 mg (ULTRACET ER). The study medication will be administered according to local label insert. The study medication will be taken twice daily, 1 to 2 tablets each time, for a maximum of 4 tablets. Safety evaluations for adverse events will be performed throughout the study. The total duration of the study will be approximately of 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the prescription of ULTRACET ER for the treatment of moderate to severe pain
* Complaining of chronic pain for more than 3 months

Exclusion Criteria:

* Patient who had been treated with extended release tramadol hydrochloride (75mg) and acetaminophen (650mg) or strong opioids (eg, morphine, fentanyl, oxycodone, hydromorphone) within the past 4 weeks
* Patient with a severe mental disease and with a medical history of hypersensitivity to opioid analgesics
* Pregnant females or the females likely to become pregnant during the study period
* Patient who had been believed likely to complain of more pain than the real pain he or she is experiencing because of industrial disaster, car insurance, and others
* Patients who are contraindicated according to the warnings, precautions and prohibitions regarding extended release tramadol hydrochloride (75mg) and acetaminophen (650mg)
Application of Deuterated Water (D2O) to Define the Etiology of Musculoskeletal Decline in Ageing and the Efficacy of Nutritional Supplementation

Maintaining muscle mass and function is important in healthy ageing to maintain quality of life. Loss of muscle mass is major problem, as beyond the age \~50, muscle mass declines by \~1-2% a year. To prevent this loss, the investigators need to understand the mechanism regulating muscle mass as we age. In this project the investigators aim to determine these mechanisms using a new technique of heavy water ingestion, this allows measurement of multiple aspects of skeletal muscle mass metabolism e.g. protein synthesis, over long periods (6 weeks) as people go about their normal everyday activities. The investigators also aim to determine the influence of resistance exercise training on older muscle, as well as differences between men and women in muscle responses to exercise and nutrition HMB (beta-hydroxy-beta-methylbutyrate).


Eligibility Criteria:
Inclusion Criteria:

* Young (18-30y) and old (60-75y) individuals who are generally healthy and recreationally active

Exclusion Criteria:

* Active cardiovascular disease
* Cerebrovascular disease including previous stroke, aneurysm (large vessel or intracranial)
* Respiratory disease including pulmonary hypertension or Chronic obstructive pulmonary disease, Hyper/ hypo parathyroidism, hyper/ hypothyroidism,
* Cushing's disease, diabetes
* Active inflammatory bowel disease
* Renal disease
* Malignancy
* Recent steroid treatment (within 6 mo), or hormone replacement therapy Clotting dysfunction
* Musculoskeletal or neurological disorders
* Any disease requiring long-term drug prescriptions, including statins
Procedures, Complications and Follow-up of Tracheostomy in Intensive Care Units.

Tracheostomy is worldwide used for critically ill patients. The aim of our study is to assess the mortality, quality of life, laryngeal function, procedures, early and late complications of tracheostomy performed for critically ill patients admitted in intensive care units.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* indications for tracheostomy

Exclusion Criteria:

* Infection/inflammation of neck tissue
* Previous neck surgery causing abnormal anatomy of the site
* Recent surgery of cervical spine
Catastrophism Among Chronic Pain Patients in Rheumatology

Pain catastrophizing is conceptualized as a negative cognitive-affective response to anticipated or actual pain and has been associated with a number of important pain-related outcomes.

The aims of this study are

1. To describe the characteristics of the patients and determinants of catastrophizing in chronic painful patients hospitalized in rheumatology in the Nîmes University Hospital
2. To describe the impact of the catastrophizing on the level of insomnia and the drugs consumption in chronic painful patients hospitalized in rheumatology in the Nîmes University Hospital


Eligibility Criteria:
Inclusion Criteria:

* adults hospitalized in the department of rheumatology of the Nîmes University Hospital with chronic pain (≥ 6 months)

Exclusion Criteria:

* benzodiazepine or neuroleptic use for epilepsia, alcool, psychiatric disorders
* Restless Legs syndrom
* Obstructive Sleep Apnea
* narcolepsy
Comparative Effectiveness of COPD Treatments

To assess the effectiveness of maintenance treatment of Chronic obstructive pulmonary disease (COPD) with the combination of a long-acting bronchodilators (LABA and the long-acting muscarinic antagonists (LAMA) tiotropium (LABA-TIO)) compared with the combination of a LABA and an ICS (LABA-ICS) on the time to COPD exacerbation.


Eligibility Criteria:
Inclusion Criteria:

* New users of long-acting bronchodilators, LABA and tiotropium on the same date or of LABA and ICS, either as a fixed-dose combination or free combination, on the same date between January 2002 and December 2015
* Diagnosis of COPD and age ≥ 55 years

Exclusion Criteria:

* Less than one year of medical history information prior to the date of combined treatment initiation (cohort entry)
* Asthma diagnosis
Study on Structum® in Adult Patients with Osteoarthritis (TRUST)

Chondroitin sulfate (CS) is a SYSADOA and a natural biomacromolecule belonging to the class of glycosaminoglycans. CS is a major component of the extracellular matrix (ECM), where it constitutes an essential component of proteoglycans.

To this date, no real-world studies have been conducted to precisely describe the burden associated with OA among patients treated with CS.Therefore, an observational, descriptive, prospective, national study will be conducted to describe the burden associated with OA and the quality of life of patients treated with Structum® in Poland.

This is an observational, descriptive, national, multicentric, prospective, longitudinal study, which will be conducted over a 6-month follow-up period for each patient. The study will not provide or recommend any specific treatment or procedures.

All patients affected by OA in the knee, for whom Structum® is prescribed in a participating center, will be screened in a consecutive manner for eligibility. The study will focus exclusively on patients with OA in the knee as this is the joint most frequently affected and most easily assessed for OA patients.

Two additional data collections can be anticipated for these patients as part of their standard of care follow-up visits, which will usually occur around 3 and 6 months after the initial study visit.The patient enrolment period is expected to be 6 months, with a total study duration of 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 50 to 80 years at inclusion
* of knee OA (either a patient newly diagnosed \[at inclusion\] or with history of knee OA) based on at least the following items 1 and/or 2:

  1. knee pain lasting for at least 3 months;
  2. patient in the active phase of knee OA disease (knee pain score ≥ 40mm at inclusion on the Visual Analog Scale \[VAS\] 0-100 mm);
  3. knee radiographs showing knee joint narrowing and/or osteophytes.
* Patients who have been prescribed, for the first time or not, Structum®.
* If patient is taking any NSAIDs or other analgesics, patient could be on stable dose at least one week before inclusion to the study.
* Patients able to visit the clinic and attend follow-up visits.
* Patients having signed an informed consent form, according to local regulations.

Exclusion Criteria:

* Patients with any ongoing chondroitin sulfate treatment at inclusion or during the last 3 months.
* plasma (in the last 3 months). No glucocorticoids administration in the last 3 months before inclusion. That does not include NSAIDS, paracetamol and other analgesic medications (e.g. tramadol).
* Patients with an artificial knee joint, including unilateral.
* Patients scheduled to undergo knee replacement surgery in the next 6 months.
* Patients with a severe general condition that prevents them from being included in the study as assessed by the investigator.
* Patients participating in interventional trials on investigational drugs at the time of inclusion.
Nebulized Hypertonic Saline for Mechanically Ventilated Children

Children who need to be on a ventilator often have thick secretions/mucus in their lungs. These secretions can obstruct the breathing tube and their windpipe, which can worsen lung function and prolong the need for the ventilator. Hypertonic saline is a medicine that is used to thin out secretions in patients with cystic fibrosis (and other conditions). We hypothesize that having children on a ventilator inhale this medication will shorten the amount of time that they need to be on the ventilator.

Recent pediatric data shows that less than 80% of children mechanically ventilated for ≥ 96 hours survived to PICU discharge, while 100% of children mechanically ventilated for \< 96 hours survived to PICU discharge. Interventions that decrease duration of mechanical ventilation may improve outcome by limiting ventilator-induced lung injury, sedative medication usage and ventilator-associated pneumonia. Obstructive airway secretions may prolong mechanical ventilation by causing atelectasis and endotracheal tube obstruction, with resultant cardio-respiratory instability. Nebulized hypertonic saline (HTS) is used to decrease mucus viscosity and increase mucociliary clearance in patients with diseases such as cystic fibrosis and bronchiolitis, and has been used to enhance airway clearance in mechanically ventilated children. Administering nebulized HTS to mechanically ventilated children may facilitate airway clearance and shorten mechanical ventilation.

In a randomized study of children \< 2 years old following cardiac surgery, patients given dornase, another mucolytic agent, had a significantly decreased duration of mechanical ventilation versus those given saline placebo (52 hrs vs. 82 hrs). HTS may be even more effective, as mechanically ventilated newborns with persistent atelectasis had more improvement in radiographic findings and oxygen saturation when randomized to receive hypertonic saline compared to those randomized to receive dornase. This may be because dornase may only be effective in patients with leukocytes or bacterial present in tracheal aspirates, while HTS may be effective in all ventilated patients. Further study of the impact of prophylactic mucolytic therapy on the duration of mechanical ventilation in children is warranted.

Eligibility Criteria:
Inclusion Criteria:

* invasive mechanical ventilation of \< 12 hrs duration prior to enrollment
* expected duration of mechanical ventilation of \> 48hrs from enrollment
* age \< 18yo

Exclusion Criteria:

* inclusion in another clinical study
* cystic fibrosis
* status asthmaticus
* pulmonary hemorrhage/contusion
* home O2 use
* home non-invasive positive pressure (CPAP/BiPAP) ventilation use
* pre-existing tracheostomy
* prescription of mucolytic medication by primary clinical team
* allergy to inhaled saline/hypertonic saline or albuterol
Use of Transvenous Pacing Wire During Minimally Invasive Port Access Aortic Valve Surgery

The study is being done to determine if the Endovent pulmonary catheter kit, used for port access surgery, can be used as a passageway for a pacing wire. The study hypothesis is that the Endovent kit can be used effectively as a passageway for a pacing wire system.

Many times cardiac surgery requires the use of epicardial pacing in order to wean the patient from bypass. During minimally invasive port access valve surgery, it may not be possible to place the leads on the surface of the heart because of the limited surgical exposure. In this case, transvenous pacing is used. Minimally invasive port access surgery uses specially designed, FDA approved catheters for the procedure. We wish to review the effectiveness of being able to place the wires through the catheters and pace the patient.

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years of age patients having aortic valve port access surgery

Scheduled for Minimally Invasive Port Access Aortic Valve Study

Patient must agree to study participation; understand and sign the written informed consent

Exclusion Criteria:

* \< 18 years of age Patients are excluded if they are not having minimaly invasive aortic valve surgery not having aortic valve port access surgery