cyrilzakka/clinical-trials huggingface dataset:
Denosumab Sequential Therapy

Denosumab is a potent anti-resorptive agent and is now widely used in the treatment of osteoporosis. Although denosumab has excellent effect to increase bone mass and prevent fracture in FREEDOM study with very low complications, even up to ten years, it's effect is reversible. After holding the drug, circulating denosumab levels fall rapidly, and bone resorption reaching twice baseline levels for about 6 months. How to prevent bone loss after denosumab therapy is an important issue, especially when considering the compliance, persistence, or other comorbidities of the patient. We want to verify if zoledronic acid could be used as a sequential therapy after denosumab to prevent rapid bone loss by randomized clinical trial.

Denosumab is a monoclonal antibody directed against the protein RANK-L, the principal regulator of osteoclast development. Thus, it acts as a potent anti-resorptive agent and is now widely used in the treatment of osteoporosis. Because it's easily to be used with very low risk of complications, patient has better compliance and persistence of denosumab than bisphosphonates. It's market share increasing very rapidly in Taiwan.

Although denosumab has excellent effect to increase bone mass and prevent fracture in FREEDOM study with very low complications, even up to ten years, it's effect is reversible. After holding the drug, circulating denosumab levels fall rapidly, and bone resorption reaching twice baseline levels for about 6 months. Over the first 12 months off therapy, all the bone density gained on treatment is lost4. According to previous meta-analysis study, although the persistence of denosumab therapy is better than bisphosphonates, only 62% patients keep the treatment after two years. We could image how low the persistence is after five-year or ten-year treatment in the real world.

How to prevent bone loss after denosumab therapy is an important issue, especially when considering the compliance, persistence, or other comorbidities of the patient. There is only one randomized controlled trial dealing with this problem, although the primary goal of the study is designed to compare the compliance and persistence1. After switching from denosumab to alendronate for one year, bone mineral density does not decrease rapidly, although there is mild elevation of bone turn over marker.

We want to verify if zoledronic acid could be used as a sequential therapy after denosumab to prevent rapid bone loss by randomized clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal women
2. Men \>50-year-old
3. After Denosumab treatment ≥ 2 years due to osteoporosis

Exclusion Criteria:

1. Patientshadeverusedantiosteoporosismedications other than Dmab
2. Estimated glomerular filtration rate \<35 ml/min.
3. Malignancy
4. Continuous steroid treatment, hormone therapy or other medical treatment affecting bone metabolism
5. Secondary osteoporosis
6. Metabolic bone diseases
7. Contraindications to ZOL
8. Patients older than 80 years old
9. Hypocalcemia
Telemedicine Approaches to Evaluating Acute-Phase ROP eROP Implementation Project

Evaluating retinopathy of prematurity (eROP) ancillary study Implementation Project is a multi-center observational study will focus on feasibility, and relative cost-effectiveness of an retinopathy of prematurity (ROP) telemedicine evaluation system to detect eyes of at-risk babies and provide timely feedback to the examining ophthalmologist at the Clinical Center.

Study Design: Observational Cohort Study Setting/Participants: Premature babies who are at high risk for ROP during their stay in the neonatal intensive care unit (NICU).

* The number of sites - 5 centers in the US
* The number and description of participants: 500 babies with birth weights of \<1251g

Study Interventions and Measures:

Data from RetCam digital images obtained as part of clinical care during the routine diagnostic eye exam for ROP will be uploaded and transmitted via secure server to a central reading center. These de-identified images will be graded by Certified Image Readers. Results of image gradings will be sent back via secure web-based platform to the Clinical Center. The primary outcome measure is the turnaround time from uploading the images to feedback to the Clinical Center. The secondary outcome measure is the time required to obtain retinal images for babies scheduled for ROP examination in the NICU (relative cost-effectiveness).

Eligibility Criteria:
Inclusion Criteria:

1. Babies with birth weights of \<1251g
2. Babies having clinical examinations to screen for ROP

Exclusion Criteria:

* Referral from an outside hospital for treatment of serious ROP that is performed before imaging can be obtained.
* Congenital Non-ocular Anomalies: Babies will be excluded from this study if they have a severe congenital non-ocular anomaly. Such exclusions include anencephaly, trisomy 13, trisomy 18, or severe cardiac or pulmonary abnormalities. The neonatologist caring for the baby will determine whether a particular congenital abnormality would exclude the baby from participation in this study.
* Ocular Abnormalities: Babies will be excluded from this study if they have major congenital abnormalities in one or both eyes including microphthalmos, anophthalmos, anterior segment dysgenesis, dense corneal opacity, cataract, glaucoma, chorioretinitis, optic nerve hypoplasia, and chorioretinal coloboma. Eyelid abnormalities, such as severe blepharoptosis or severe hemangioma, that would likely affect vision, would also exclude a baby from participation. Minor abnormalities that would not be expected to affect vision may not be exclusion criteria including Mittendorf dot, mild blepharoptosis, limbal dermoid, and iris coloboma.
EEG to Monitor Propofol Anesthetic Depth in Infants and Toddlers

The goal of this study is monitor anesthetic depth of children undergoing propofol anesthesia using electroencephalography (EEG). The main questions it aims to answer are:

1. EEG spectral edge frequency (SEF95) readings where 50% of patients do not respond to three stimuli.
2. The propofol blood concentration that corresponds to each of the three EEG SEF95 readings Participants will undergo EEG monitoring, stimuli (placement of oral pacifier, electrical stimulation, and laryngoscopy), and blood collection.

Sevoflurane inhalation and propofol intravenous anesthesia are the mainstays of delivering general anesthesia in children. Propofol anesthesia in children is gaining popularity due to fewer respiratory complications, less post-operative nausea vomiting and emergence delirium, compared to sevoflurane. However, unlike sevoflurane, the pharmacodynamics of propofol is less studied in infants and toddlers, particularly the biomarker for propofol brain effect site concentration (Ce), indicative of anesthetic depth. The lack of a real-time biomarker often results in over- or under-dosing of propofol in clinical practice. The goal of this study is to utilize electroencephalography (EEG) as the biomarker of propofol effect site concentration and clinical anesthetic depth, thereby improving the safety and efficacy of propofol anesthesia in this population. In infants and toddlers receiving propofol anesthesia, EEG will be recorded while the patient undergoes three stimuli used to assess anesthetic depth (placement of oral pacifier, electrical stimulation, and laryngoscopy). The EEG index (spectral edge frequency-SEF95) where 50% of patients (ED50) do not respond to each of the three stimuli will be determined as the biomarker of propofol clinical anesthetic depth. In the same cohort, the regression between EEG SEF95 and plasma propofol levels will be determined to assess relationship between EEG SEF95 and propofol Ce.

Eligibility Criteria:
Inclusion Criteria:

1. Children 3 to 24 month old undergoing surgery.
2. Planned laryngoscopy and endotracheal intubation or laryngeal mask airway (LMA) placement for clinical care.
3. Planned propofol anesthesia for anesthesia maintenance.
4. American Society of Anesthesiologists (ASA ) \< III.
5. Muscle relaxant not indicated per planned clinical care for laryngoscopy/intubation or LMA.
6. Anticipated surgery duration approximately \< 2h40min

Exclusion Criteria:

1. Patients undergoing emergency surgery.
2. Known severe neurological disease which might result in abnormal EEG SEF.
3. Deformities of forehead (difficult EEG sensor placement).
4. Known difficult airway.
5. Allergy to propofol.
6. Attending anesthesiologist on record caring for patient plans to administer additional IV medication besides propofol during study phase.
7. Currently on anti-seizure medication (might alter propofol pharmacodynamics).
Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients

The primary objective of the study is to evaluate the efficacy of Quetiapine extended release (XR) in combination with an selective serotonin reuptake inhibitor (SSRI) or Venlafaxine versus Lithium in combination with an selective serotonin reuptake inhibitor or Venlafaxine versus Quetiapine extended release monotherapy in subjects with treatment resistant depression as assessed by the changes from randomisation to week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. As an independent objective, the primary objective will also be evaluated in two subgroups of patients: (1) patients who were resistant to two previous antidepressant therapies and (2) in the subgroup of patients with one previous failure.

The secondary objectives of the study are to compare the effects of the three different treatment regimen as assessed by the following variables and, if applicable, by their changes from randomisation to week 6 (end of study). Additionally the time of onset of therapeutic effect will be assessed by evaluating efficacy data after the first four days (Day 4) of treatment as well as after the first week of treatment (Day 8). These analyses will also be performed in the subgroups of patients with 2 failed previous antidepressants and patients with 1 failure.

Eligibility Criteria:
Inclusion Criteria:

* Documented clinical diagnosis as confirmed by the M.I.N.I. meeting criteria from the Diagnostic and Statistical Manual of Mental disorders, 4th Edition (DSM-IV) for any of the following:296.2x MDD, Single Episode296.3x MDD, Recurrent Episode
* Current episode of depression present, at least 42 days prior to enrolment but not more than 18 months
* MADRS-Score ≥ 25 at enrolment and randomisation

Exclusion Criteria:

* Patients with a DSM-IV Axis I disorder other than MDD within 6 months of randomisation
* Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status
* Patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk, or have made a suicide attempt within the past 6 months
Sevoflurane General Anesthetic and Spatial Memory in Humans

The goal of this observational study is to learn about the effect of general anesthetic on spatial memory in adults who will undergo to an elective surgery. The main question it aims to answer is:

• A surgical event under general anesthesia with sevoflurane transiently impairs spatial memory in humans and induces an increase in inflammatory cytokines.

Participants will perform a virtual maze test and plasma samples will be taken before and after surgery.

Postoperative cognitive dysfunction (POCD) occurs after a surgical event under general anesthesia and is characterized by a decline in one or more cognitive functions. POCD is defined as delayed neurocognitive recovery if it takes place within the first 30 days, if it exceeds that time it is known as postoperative neurocognitive disorder. The pathogenesis of this dysfunction is not entirely clear. However, the most accepted hypothesis would be neuroinflammatory, which would take place due to the contribution of inflammatory factors typical of surgical trauma under general anesthesia, with anesthetics such as sevoflurane. Consequently, one of the areas most susceptible to this inflammatory environment would be the hippocampus, a structure responsible for learning and memory. Spatial memory is responsible for encoding and retrieving information about the environment and spatial orientation. To confirm this hypothesis, an elective laparoscopic cholecystectomy under general anesthesia with sevoflurane, plasma measurement of cytokines interleukin-1beta and tumor necrosis factor-alpha and virtual navigation tests will be performed before and after an elective laparoscopic cholecystectomy under general anesthesia with sevoflurane, in order to establish a correlation between the inflammatory component and performance in the virtual navigation test. The above will allow us to elucidate the possible occurrence of a delayed neurocognitive recovery related to spatial memory in middle-aged individuals, providing new background related to an age group that has been little studied, with a non-minor incidence (30%), where the evident concern arises for being a population exposed to activities or environments of greater risk, linked to work, sport, driving, among others. This finding will guide the doctor and the patient to decide or take the necessary safeguards when proceeding with a surgical intervention in the middle-aged population.

Eligibility Criteria:
Inclusion Criteria:

* Candidate for elective laparoscopic surgery of cholecystectomy.
* Age 30 to 50 years.

Exclusion Criteria:

* Visual or hearing difficulties.
* Malignant hyperthermia.
* Being treated with centrally acting drugs, such as anxiolytics, antidepressants, antipsychotics, anticonvulsants, anticholinergics, and first-generation antihistamines.
* Present a disorder of the sphere of neuropsychiatry
* Substance abuse disorder.
Trial of Nutritional Supplementation in Infants Born Small for Gestational Age

The purpose of this study was to determine whether giving a nutrient enriched formula to infants born small-for-gestational age benefits blood pressure, growth and body composition by six months of age.

Infants born small for gestational age often show impaired growth during childhood and reduced height as adults. Infants who are breast-fed from birth show greater 'catch-up' growth during the first few months of life than those who are formula fed but it is not clear what factors in breast milk (ie protein, nucleotides, LCPUFAs) are responsible for this 'catch-up' growth. This RCT compares the effects of using an enriched formula with increased protein and modified triglyceride (palmitate predominantly in Sn-2 position) against a standard infant formula from birth to six months on infants whose birth weights are below the 20th centiles for gestational age.

Infants are measured by a research midwife within 10 days of birth (at randomisation), 8, 16 and 26 weeks of age. At randomisation consent from the mother is taken and information collected about the pregnancy, social, demographic and medical data. At this and each further visit anthropometric measurements including skinfolds will be collected in addition to blood pressure and bio-electrical impedence at six months. A sub-sample of infants will have their body composition assessed by deuterium labelled water at six months. Data on health, weaning diets and bowel function are also collected at each visit.

Eligibility Criteria:
Inclusion Criteria:

* Infants who are formula fed from birth
* Infants whose birthweights are less than 20th centile
* Singleton births
* Gestation \> 37 weeks
* Infants free from major congenital disease

Exclusion Criteria:

* Infants who are breast-fed
* Multiple births
* Birthweight \> 20th centile
* Infants with congenital disease
* Gestation \< 37 weeks
HemoControl System Activated in Hemodiafiltration Treatments

The current study aims to assess the HemoControl prescription in On-Line Hemodiafiltration treatment.

Hemodiafiltration (HDF) is a dialysis technique that allows the removal of high molecular weight toxic solutes exploiting the convective transport through the dialyzer membrane: at the same time, the HDF has a positive impact on the systemic hemodynamic, ameliorating in this way the tolerance of the treatment. Unfortunately, also the HDF therapy can be not well tolerated, introducing in the patients serious hypovolemia during the removal of the body water accumulated in the interdialytic period.

The HemoControl system, automatically controlling the relative blood volume change of the patient, avoids the onset of the hypovolemia. Today the HemoControl system can be used only during conventional hemodialysis treatments; the objective of this study is to combine the advantages of the intradialytic hemodynamic stabilization achievable by means of HemoControl with the inherent advantages, both of depurative and cardiovascular kind, typical of the Hemodiafiltration technique.

Eligibility Criteria:
Inclusion Criteria:

* A subject must meet ALL of the following inclusion criteria in order to participate in this study:

  * ESRD in chronic dialysis treatments for at least 3 months
  * Age ≥ 18 years
  * Body weight ≥ 40 kg
  * Blood flow rate ≥ 250 ml/min with a recirculation of the vascular access \< 5%
  * Use of not fractioned heparin in continuous infusion as anticoagulant
  * Stable anticoagulation dosage over the last 6 treatments
  * Stable dialysis prescription (Qb, Qd, treatment time) over the last 6 treatments
  * Informed consent for participating to the study
  * Stable Haemoglobin concentration at beginning of the treatment lower than or equal to 14 g/dl.

Exclusion Criteria:

* A subject shall NOT participate in the study if he/she meets ANY of the following criteria:

  * HIV positivity
  * Active Hepatitis A, B or C
  * Pregnancy
  * Participating in other clinical investigations during the course of this study
  * Failed to release consent
  * Known coagulation disorders (clotting problems)
  * Known bleeding risk
  * Clinical or laboratory diagnosis of acute infection
  * Recent (last 4 weeks) surgical intervention
  * Therapy prescribed is only HD, HF or isolated UF mode
  * Active phase cancer,
  * Active phase immune disease.
  * Serious hemostasis disorders.
Acceptance of Complementary Medicine in Germany

Complementary medicine is widely practiced in Germany and worldwide. The aim of this study is to explore how many people use complementary medicine methods in Germany, for which health-related issues they do and for which they would not.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age at least 18 years
* Sufficient language skills as well as cognitive ability to participate in an online survey or interview lasting approximately 30 minutes
* Active consent to the online consent form

Exclusion Criteria:

- Lack of consent to participate in the study
Clinical Protocol of Sensitized Acupoint Changes in Knee Osteoarthritis Patients

Based on the research background and the preliminary research basis of the research group, in order to answer the material basis and micro-physical environment change characteristics of knee osteoarthritis sensitization acupoints and provide scientific basis for in-depth study of sensitization of acupoints. This study plans to use knee osteoarthritis as a research vehicle, and use microdialysis combined with high performance liquid chromatography to analyze the local material basis and key indicators of common sensitization points in knee osteoarthritis.

This trial is a single-centre, normal controlled, parallel group, clinical trial. The trial is an explorative, pilot trial designed to reveal the change of the main material group in sensitized acupoints caused by knee osteoarthritis, and provide the key signal substance and its changing characteristics of knee osteoarthritis sensitized acupoints.

Eligibility Criteria:
Inclusion Criteria:

Meets the diagnosis criteria of knee osteoarthritis. Age between 45 and 70 years. Meets imaging examination X-ray Kellgren and Laerence classification standards grade I-III.

Patients who meet the criteria for early or mid-term stage of knee osteoarthritis.

Discontinue use of pain medications and hormone drugs during the trial. The patient's vital signs are stable, can read his own medical history, and can cooperate with the relevant examination and treatment.

Signed the informed consent voluntarily.

Exclusion Criteria:

Seriously patients with surgical indications Associated systemic arthropathies, e.g. rheumatoid arthritis and gout Heart failure Bleeding diathesis Liver failure knee arthroplasty There are diseases that may seriously endanger life, such as cardiovascular and cerebrovascular diseases, renal and liver failure, hematopoietic system diseases, etc.

Patients with mental illnesses that cannot be completed or are not suitable for treatment and examination Patients who received treatment including traditional Chinese medicine, western medicine, acupuncture, massage and physiotherapy within the past month Patients on steroids History of intra articular injection of steroid within last six months Joint irrigation or arthroscopy has been performed within the past year Have had knee arthroplasty At the same time participate in other studies
Effects of Probiotic Supplementation in Hypertensive Women on Menopause

In postmenopausal women, cardiovascular risk is increased and the mechanisms involving imbalance of the Autonomic Nervous System should be extensively investigated. Recent data suggest a link with intestinal microbiota dysbiosis and probiotic supplementation could be a useful strategy for treating women with increased cardiovascular risk.

After randomization, subjects will be included in their intervention group for a period of three months with initial and final evaluations.

The study will evaluate the effects and possible benefits of probiotic supplementation on the functioning of the Autonomic Nervous System and vascular changes in hypertension in menopausal women.

The intervention groups will be as follows:

1. - Menopausal women with hypertension + Probiotic supplementation
2. - Menopausal women with hypertension + Placebo supplementation

Eligibility Criteria:
Inclusion Criteria:

* Hypertensive
* At least 1 year of menopause
* Sedentary

Exclusion Criteria:

* Smoker
* Use of psychiatric medications
* Cardiovascular events
* Recent surgeries
* Diabetic
* Use of beta blockers