cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Maxillary and Mandibulary Nerve Blocks on Morphine Consumption

Background and Objectives: Double-jaw surgery is one of the most painful oral surgery, requiring multimodal analgesia including controlled morphine pump and its secondary effects. The aim of this study was to evaluate the effectiveness of face block (mandibulary and maxillary block analgesia) on the first 24 hours on morphine consumption in patients admitted for double jaw surgery.

Methods: Patients undergoing double-jaw surgery between January 2015 and May 2017 were enrolled. Patients were separated into 2 groups: patients receiving maxillary-mandibulary nerve block and those no receiving it. The primary endpoint was the morphine consumption within 24 hours post-surgery. Secondary endpoints were the intra-operative remifentanil consumption, incidence of postoperative nausea and vomiting at 24 hours, morphine consumption in recovery room, length of stay in hospital.

Eligibility Criteria:
Inclusion Criteria:

- Male and female who underwent double jaw surgery

Exclusion Criteria:

* opposition to the study
* an additional surgical procedure
* preoperative consumption of morphine or derived from morphine
* perioperative N20
Study of Longitudinal Plasma PD-L1 Testing With Immunotherapy in Lung Cancer

This is a prospective pilot study to assess dynamic changes of plasma cell-free RNA (cfRNA) PD-L1 expression in patients with lung cancer undergoing immune checkpoint inhibitor (ICI) based therapy. Results will be correlated with radiographic assessment of immunotherapy treatment response and plasma NGS ctDNA.


Eligibility Criteria:
Inclusion Criteria:

1. All patients with a diagnosis of stage IV or inoperable stage IIIB NSCLC without planned primary radiation therapy undergoing anti-PD-1/L1 based ICI treatment.
2. Chemo-immune or dual anti-PD-1/L1 with anti-CTLA-4 based regimens are eligible as long as receiving an anti-PD-1/L1 monoclonal antibody.
3. A documented informed consent will be obtained prior to inclusion in the study. All discussions with patients will be held in strictest confidence and out of earshot of the general public. Patients will be fully informed that their participation in the study is voluntary. Patients may decline to be part of the study. Their decision to participate in the study will not affect the care they receive.

Exclusion Criteria:

1. No anti-PD-1/L1 monoclonal antibody treatment.
2. Planned primary radiation therapy.
3. Small-cell lung cancer histology.
Family Centred Early Intervention of Infants With Congenital Heart Disease

In this study the investigators aim to test the feasibility for therapists and acceptability to parents of an early motor intervention for infants with congenital heart disease (CHD) after open heart surgery. This intervention will be compared to the standard care of treatment that is recommended for infants with congenital heart disease at the University Children Hospital Zurich.

In this feasibility pilot randomised study children will be randomly assigned to a control and an intervention group. Children of the control group will receive standard of care for infants with severe CHD: cardiac surveillance, counselling and screening at the University Children's Hospital Zurich and standardised developmental checkups by their paediatrician. Physiotherapy is normally not comprised in standard of care, but some infants may receive physiotherapy, if they present with obvious signs of motor developmental delay, detected by the paediatrician later on in their life. Once enrolled in this study, an infant of the control group will not receive early motor intervention as an infant enrolled in the intervention group.

Infants randomly assigned to the intervention group will receive early motor intervention, which will be based on the results of our qualitative study. It will comprise supporting parents by a paediatric physiotherapist. Parents will be guided on how to best stimulate their infant's development during daily activities. Parents will be actively involved in the intervention with the aim to challenge their infant at the limit of its postural capacity and thus help the infant to optimize its motor repertoire. The intervention will start after baseline with infants aged 3-6 months and end after three months with infants aged 6-9 months.

The intervention will start at home, then alternating at the Children's Hospital and at home. Telephone or video counselling will be provided to support parents if needed. The order may change according to the needs of the family when necessary and adjusted to best fit the daily routine the family.

Eligibility Criteria:
Inclusion Criteria:

* Infants born with severe cyanotic and acyanotic congenital heart disease (e.g. tetralogy of Fallot, pulmonary atresia, transposition of the great arteries, atrial/ventricular septal defects, double outlet right ventricle, ...) who undergo open-heart surgery once before the first 3-6 months of their life
* Parents able to comprehend the patient information linguistically and cognitively
* Informed consent of parents as documented by signature

Exclusion Criteria:

* Infants with hypoplastic left heart syndrome as they need to undergo several open-heart surgeries within the first period of their life.
* Infants with trisomy 21 and other syndromes like 22q11 microdeletion syndrome, CHARGE syndrome that are often associated with CHD. These infants often show additional cognitive impairments that might confound the effect of our intervention.
Self-expandable Metallic Stent Versus Multiple Plastic Stents in Post Orthotopic Liver Transplantation Biliary Stenosis

Biliary complications are one of the most common problems after orthotopic liver transplantation (OLT),occurring in up to 24% of patients.

Anastomotic strictures have been endoscopically managed with plastic stents placement. Recently, partially and fully covered metal stents have been alternatively used to treat refractory benign biliary stenosis. The investigators purpose is to compare efficacy and safety of metallic stents versus multiple plastic stents in the endoscopic management of post transplant biliary complications.

Patients with biliary stricture after OLT will be randomly assigned following simple randomization to temporary placement of fully covered self-expandable metal stent (SEMS) or multiple plastic stents placement were randomized according to a computer generated randomization sequence and allocated in a 1:1 ratio to one of two treatment groups.

Final success will be defined as clinical resolution of the stricture without the need to repeat endoscopic, percutaneous or surgical treatment.

Eligibility Criteria:
Inclusion Criteria:

* post-OLT biliary anastomotic stenosis (at least 1 month post-operative)
* jaundice, cholestasis and/or biliary tree dilation on US

Exclusion Criteria:

* biliary fistulae
* non-anastomotic stricture
* combine anastomotic and non-anastomotic stricture
Augmented Reality Perioperative Training and Patient Satisfaction

The purpose of this study is to learn more about how augmented reality systems can influence perioperative experience and patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* All patients 18 years old or greater
* Patients who have a scheduled ambulatory procedure with University of Miami Orthopaedic providers.

Exclusion Criteria:

* Any patient not scheduled for procedures
* Minors
* Cognitively incapacitated
* Prisoners.
* Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
The Effect of Coenzyme Q10 on Hearing and Tinnitus Characteristics of Chronic Tinnitus Patients

The study is a randomised double-blinded trial. A group of 40 tinnitus patients with a naturally low Q10 level will be selected out of a preselected group of 160 screened out of a pre-existed database or patients which visited the ENT-consultation. The 40 patients with the lowest level will be asked to take 2 months Q10 (n=20) or the placebo (n=20). To evaluate the effect on hearing and tinnitus characteristic; audiometric test, tinnitus analysis and auditory evoked responses will be used as outcome measurements.


Eligibility Criteria:
Inclusion Criteria:

* chronic non-pulsatile tinnitus \> 3 months
* tinnitus has a clear otological cause
* age \> 18 years

Exclusion Criteria:

* pulsatile tinnitus
* persons who take already Q10
* pregnancy
* cervical tinnitus
* holocranial tinnitus
* depression
* mental of neurological disorders
* history of chemotherapy
* middle ear diseases
Qlaira Post-authorization Safety Study Related to Most Common Adverse Events in Mexican Women Who Wish to Avoid Pregnancy

Qlaira is a combined oral contraceptive (COC) containing dienogest/estradiol valerate being the first oral contraceptive delivering estradiol. It has been recently approved in Mexico. To evaluate the clinical profile of this drug combination under routine medical condition, a post-authorization safety study required by Mexican Health Authorities will be conducted in Mexican women.

The study will be performed as a descriptive study, no hypothesis will be tested. The cohort consists of 300 new users (first-ever users or switchers) of Qlaira under routine medical conditions. Subjects should provide all necessary information on health-related events or changes in health status during Qlaira use.

Primary variable will be the incidence of Adverse Events (AE) at any time point, whether or not related to Qlaira during at least 2 years of observation.

In order to comply with the criteria of a non-interventional study, women only will be informed about the study, asked to participate and included in the study after Qlaira has been prescribed.

Study patients follow-up will be done in accordance with common clinical practice as described at Mexican Official Guidelines for prescription of Family Planning Methods (NOM 005-SSA2-1993).


Eligibility Criteria:
Inclusion Criteria:

Healthy women of reproductive age who are:

* Seeking fertility control with oral contraception at least for one year
* Able to go back to medical office on regular basis

Exclusion Criteria:

Women with risk parameters of arterial or venous thrombotic diseases such as:

* Smoke, if over age 35
* Deep vein thrombosis or pulmonary embolism, now or in the past
* Cerebrovascular disease
* Coronary artery disease
* Thrombogenic valvular or thrombogenic rhythm diseases of the heart
* Inherited or acquired hypercoagulopathies
* Uncontrolled hypertension
* Diabetes with vascular disease
* Headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35
* Undiagnosed abnormal genital bleeding
* Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past
* Liver tumors, benign or malignant, or liver disease
* Pregnancy
Multifocal Visual Performance Study

The purpose of this trial was to compare the functional visual performance of Precision Profile Multifocal (MF) contact lenses to Progressive Addition Lens (PAL) spectacles in a presbyopic population.

Habitual contact lens wearers were randomized 1:1:1 to one of three commercially available multifocal contact lenses. Progressive addition lens wearers wore their habitual spectacles. Subjects were expected to attend 1 or 2 office visits. This study was terminated early by Alcon due to slow enrollment and inconsistency in measurement of the primary endpoint.

Eligibility Criteria:
Inclusion Criteria:

* Normal eyes, other than correction for refractive error;
* Habitual correction of either any multifocal contact lens with a maximum add of +2.00 Diopter (D), or progressive addition lens spectacles with a maximum add of +2.00 D;
* Wears habitual correction at least 5 days per week and at least 6 hours per day.

Exclusion Criteria:

* Monocular subjects;
* Subjects fit with only one contact lens;
* Known pregnancy or lactating;
* History of or planned refractive surgery or irregular cornea in either eye.

Other protocol-specified inclusion and/or exclusion criteria may apply.
Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS

The purpose of this study is to determine whether LNG/EE is effective in the treatment of menstrual cycle related symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women aged 18 to 49 years
* Regular 21 to 35 day menstrual cycles for 3 months prior to study visit 1
* History of menstrual cycle related symptoms as determined by the investigator.

Exclusion Criteria:

* Contraindication to combination oral contraceptives
* Depression requiring hospitalization or associated with suicidal ideation within the last 3 years
* Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.
Calypso Knee System Clinical Study

A clinical study to evaluate the safety and effectiveness of the Calypso Knee System when used in subjects with symptomatic osteoarthritis of the medial compartment of the knee.

Prospective, multicenter clinical study of the Calypso Knee System. 81 subjects were enrolled in this study. Male or female subjects age 25 to 65 years, with a diagnosis of medial knee osteoarthritis and study knee pain with an overall WOMAC pain score ≥ 40 (scale 0-100).

The Calypso group was investigated under two clinical protocols, CP0001 in the USA, and CP0002 in Europe. Both clinical protocols followed the same supporting protocols and plans, such as radiographic, statistical, Clinical Events Committee (CEC), etc. The results from the combined analysis have been reported in both NCT03671213 (CP0001) and NCT03838978 (CP0002).

Eligibility Criteria:
Inclusion Criteria:

1. Participants age - 25 to 65 years
2. Body Mass Index (BMI) of \< 35, Weight \< 300 lbs
3. Knee osteoarthritis pain on the inner side of knee that has continued after at least 6 months of non-operative treatment

Exclusion Criteria:

1. Symptoms of osteoarthritis in the other knee or in lateral (outer) or patellofemoral compartments of the target knee
2. Knee ligament or meniscal instability
3. Other bone or joint conditions such as Rheumatoid arthritis, Paget's disease, Charcot's disease or general conditions such as allergy or hypersensitivity to certain metals, active infection, certain neurological conditions, use of medication such as steroids or chemotherapy that could impact study participation or results
Osteoporosis, Trabecular Bone Score and Fracture Risk Assessment in Male Patients After Radical Cystectomy

Radical cystectomy (RC) with ileal urinary diversion (UD) is a standard treatment for muscle-invasive bladder cancer. However, emerging evidence indicates that this procedure may significantly impact bone health. Patients with UDs have a 21-48% higher risk of experiencing a fragility fracture compared to the general population. The underlying mechanisms are not entirely understood, but one prevailing hypothesis implicates substantial bone mineral density (BMD) loss due to the metabolic changes induced by UD, particularly driven by metabolic acidosis.

Dual-energy X-ray absorptiometry (DXA) remains the gold standard for measuring BMD and provides an indirect assessment of fracture risk. However, the trabecular bone score (TBS), a non-invasive imaging technique that evaluates bone microarchitecture, offers additional insights into bone quality that are independent of BMD and enhances the understanding of bone strength and fracture resistance. Furthermore, the use of tools such as the FRAX® (Fracture Risk Assessment Tool) helps in identifying patients at higher risk of osteoporotic fractures by estimating the 10-year probability of major fractures (MOF) (spine, forearm, hip, or shoulder) and hip fractures (HIP) based on various clinical risk factors. The predictive accuracy of FRAX® can be further refined by incorporating femoral neck BMD and adjusting for TBS.

Osteoporosis in men is a frequently underdiagnosed and undertreated condition. This underdiagnosis is also evident in patients with UDs. This study aims to evaluate the prevalence of bone alterations in men post-RC, employing both BMD and TBS measurements. Additionally, it seeks to identify key risk factors and critically assess the utility of FRAX® as a screening tool for pinpointing patients at elevated fracture risk.

To the best of the investigator's knowledge it will be the first study assessing the bone health after RC evaluating BMD, TBS and the fracture risk using the FRAX algorithm.


Eligibility Criteria:
Inclusion Criteria:

* All patients who understand, agree to participate and sign the informed consent.
* Males older than 50 years old.
* Patients undergoing radical cystectomy with ileal conduit or neobladder.
* Time over one year after radical cystectomy.

Exclusion Criteria:

* Female gender.
* Males below 50 years old.
* Radical cystectomy performed less than one year before.
* Radical cystectomy with cutaneous ureterostomy.
* Patients diagnosed with primary hyperparathyroidism.
* Patients receiving treatments that could influence bone metabolism, such as antiresorptive agents (including bisphosphonates or denosumab), chronic corticosteroids, androgen deprivation therapy for prostate cancer. Patients receiving treatment with Vitamin D were not excluded.
* Patients previously diagnosed with osteoporosis.
* Patients with a history of hemodialysis or renal transplantation.
* Patients receiving systemic cancer therapies for bladder tumor progression or other malignancies.
* Any patient who does not agree to participate or does not sign the informed consent
RGD PET/MRI in Sporadic Vestibular Schwannoma

The aim of this non-randomised, prospective study is to investigate the applicability and prognostic value of angiogenesis PET/MR with the radioligand 68Ga-NODAGA- E\[c(RGDyK)\]2 in patients with sporadic Vestibuarl Schwannomas.

The radioligand 68Ga-NODAGA- E\[c(RGDyK)\]2 targets the Arg-Gly-Asp (RGD) sequence known to bind with the αvβ3 integrin that is expressed on the surface of angiogenic blood vessels or tumor cells. The radioligand can be used to visualize tumor angiogenesis using PET/MR.

A total of 40 patients diagnosed with sporadic vestibular schwannomas will be subjected to an angiogenesis-PET/MR scan. Follow-up MR-only scan will be performed (from the time of the angiogenesis PET/MR) minimum 2 months later in regards to calculate growth rate. The uptake of 68Ga-NODAGA-E\[c(RGDyK)\]2 (Standardized Uptake Values, SUVmax) in tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean) and compared with PFS, DSS and OS (dichotomized above/below median SUVmax and analyzed by Kaplan-Meier).

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years with MRI verified sporadic vestibular schwannomas
* Patients \> 18 år whom max has been in watchful waiting regime in 12 months and/or max. received 1 follow-up MRI scan.
* Must be able to read and understand the patient information in Danish and to give informed consent

Exclusion Criteria:

* Pregnancy
* Breast-feeding
* Weight more than the maximum weight limit for the PET/MR bed of the scanner (140 kg)
* History of allergic reaction attributable to compounds of similar chemical or biologic composition to 68Ga-NODAGA-E\[c(RGDyK)\]2
* Recent systemic treatment with steroids
* Hormone treatment incl. birth control pills.
* Claustrofobia
* Non-MRI compatible implants.
Seniors Integrated Longitudinal CardioVascular Evaluation of Coronary Heart Disease: a Multicenter, Prospective Registry in China (SILVER-China)

This study aims to establish a nationwide cohort and biobank of elderly patients with coronary heart disease (CHD) and to develop risk prediction models and clinical treatment optimization plans based on this data. The specific research content is as follows:

The Study plan to continuously enroll hospitalized elderly CHD patients across 50 centers nationwide. Using networked electronic data collection technology, standardized methods and protocols will be used to gather demographic information (such as age, gender, education level, income, etc.), clinical information (medical history, past treatment records, current treatment plans, surgical records, medication use, etc.), lifestyle information (dietary habits, exercise frequency, smoking, drinking, etc.), biological information (such as inflammatory markers, etc.), and physical examination data (such as blood pressure, ECG, sleep monitoring, imaging examinations, etc.). These patients will be followed up long-term (1 month, 6 months, 1 year, and annually thereafter for up to 5 years) to establish a database that meets international standards. Centers meeting the criteria will also retain biological samples, creating a multicenter biobank for elderly CHD patients.

Second, based on the established clinical cohort, a risk prediction model for elderly CHD patients will be developed, including mortality risk, ischemic risk, bleeding risk, etc. Additionally, optimized clinical diagnostic and treatment plans will be formulated to improve the treatment outcomes and quality of life for elderly CHD patients. This research is expected to provide scientific evidence and technical support for the prevention, diagnosis, and treatment of CHD in elderly patients.


Eligibility Criteria:
Inclusion Criteria:

① Age requirements: Participants are ≥ 75 years old;

* This time he was admitted to the hospital due to angina pectoris and other coronary heart disease-related symptoms

  ③ Conform to the diagnosis of coronary heart disease: meet any one of the following conditions:
  1. This admission was performed for coronary angiography, coronary artery CTA confirmed coronary heart disease;
  2. Previous clear coronary angiography, coronary artery Coronary heart disease diagnosed by imaging evidence such as CTA evidence;
  3. The attending physician according to the patient's symptoms, medical history, myocardial injury markers, electrocardiogram, echo cardiography, myocardial radionuclide imaging, etc. diagnosed coronary heart disease.

     ④ Informed consent: Participants must be able to understand the content of the study, voluntarily participate in the study, and sign the informed consent form.

     Exclusion Criteria:
     * Combined with severe non-cardiovascular disease: life expectancy does not exceed 6 months, such as advanced cancer or other end-stage disease;
* Unable to cooperate with long-term follow-up: such as patients with severe cognitive impairment or severe mental illness; ③ Non-cardiogenic death within 24 hours after admission.