cyrilzakka/clinical-trials huggingface dataset:
Prevalence and Characterisation of Asthma Patients According to Disease Severity in Portugal

This study aims to determine the prevalence of Asthma, Difficult-to-Treat and Severe Asthma in Portugal, and characterize patients to better understand their disease characteristics, treatment profile and health care resource use to improve clinical management of the disease.

Data on the epidemiology of asthma in Portugal were mainly grounded in studies using questionnaires and covering limited age groups. Studies assessing the prevalence of asthma diagnosis and of its sub-groups with more accurate methods are therefore needed This study aims to determine the prevalence of asthma, difficult-to-treat and severe asthma in Portugal, and to characterize patients to better understand their disease characteristics, treatment profile and health care resource use to improve clinical management of the disease.

We will conduct a population-based nationwide study with a multicentre stepwise approach, enrolling 7500 adult subjects, randomly selected, from the Portuguese National Health Service patients' database of 38 primary care centres:

STAGE 0 - Phone call invitation and enrolment of participants STAGE 1 - Telephone interview survey to assess respiratory symptoms. STAGE 2 - Clinical assessment, diagnostic confirmation, and patient characterization STAGE 3 - Characterization of asthma patients (sub-group) and characterization of difficult- to-treat asthma \& severe asthma patients after 3 months follow up period.

Eligibility Criteria:
Inclusion Criteria:

* Adults =\>18 years old registered in Portuguese National Health service patients' database of primary care units.
* Give voluntary signed informed consent,
* Ability to understand ans answer questionnaires.

Exclusion Criteria:

* Participants that have a physical condition that could interfere with the study assessments or prevent the participant from adequately participating in the study (e.g. mobility problems, not able to perform spirometry,...)
Estradiol and Progesterone Levels Following Frozen Embryo Transfer

The aim of the present study is to investigate serum estradiol and progesterone levels in women conceiving after natural, estradiol + progesterone or gonadotropin stimulated frozen embryo transfer (FET) cycles.

Enrolled women will be randomized based on their ovulation pattern. Ovulatory women will be randomized to either natural cycle or estradiol + progesterone substituted cycle treatment for FET. Anovulatory women will be randomized to either estradiol + progesterone substituted cycle or gonadotropin stimulated cycle treatment for FET.

Included women will undergo blood testing every two weeks for serum estradiol and progesterone levels until gestational age 9+6. Routine vaginal ultrasounds will be performed as well as additional pregnancy ultrasounds.

Secondary obstetric outcomes will be investigated using the womens medical journals.

All the treatments are considered standard treatments for FET.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years \< 40 years
* BMI \< 35 kg/m2
* Normal wet smear within the past three years
* Thawed blastocysts (day 5 or 6) after either IVF or ICSI treatment

Exclusion Criteria:

* Age \< 18 years
* BMI \> 35 kg/m2
* Oocyte donation
* HIV/ hepatitis
* Undiagnosed vaginal bleeding
* Uterine malformations
* Persisting ovarian cysts
* Tumors in Hypothalamus, pituitary, thyroid or adrenal
* Previous breast cancer
* BRCA1/2
* Unregulated thyroid disease
* Cardiovascular disease
* Breast feeding
* Present or previous chemotherapy/radiation therapy
* Present or previous malignant disease
* Smoking
* Alcohol/drug abuse
A Study on Drug-drug Interactions in Patients Treated With Anticancer Agents for a Prostate Cancer in Real Life Setting

This will be a national observational, non-randomised, multicentre study, conducted in France.

Patients will be recruited in routine clinical practice by office- or hospital-based urology and/or oncology specialists when a first line treatment for their castrate resistant prostate cancer is initiated. The decision to treat patients with either agent preceding study enrolment will be left to the investigator's decision, per routine clinical practice. The nature of treatment and clinical care of patients will not be influenced by their participation in the study. All patients meeting the study criteria who visit the study physician will be consecutively invited to participate in the study to minimise recruitment bias. All medications administered will be collected. This is a non-interventional study. The investigators are free to choose products, and modalities of administration in accordance with the local Summary of Product Characteristics Therefore, the decision to prescribe one of these therapies must be made prior to and independently from the decision to enrol patients in this non interventional study.

Potential DDI will be identified using electronic screening methods (Micromedex Software and Theriaque Software).

This design will enable assessment of treatment and subsequent outcomes based on local standards, and is likely to encompass a wider range of therapeutic decisions compared with the stricter, defined limits on therapy required by investigational study protocols. Decisions and outcomes made in real-world conditions are likely to be more widely applicable to clinical practice than those from interventional studies.

Following French regulation there is no need for an approval of ethic committee for this type of observational study.


Eligibility Criteria:
* Males aged ≥18 years;
* Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
* For patients with a nmCRPC, documented castration resistance with progression of prostate cancer on androgen deprivation therapy (ADT) (surgical or chemical);
* Initiation of first- line systemic therapy (with abiraterone, apalutamide, darolutamide, docetaxel or enzalutamide) for a non metastatic castrate-resistant or a metastatic castrate naïve prostate cancer according to the approved labels and current guidelines. The metastatic status is based on conventional imaging (CT scan, bone scan).

Patients are not eligible if they are receiving an investigational treatment for prostate cancer of any kind.
Feasibility Study of Retinal Screening Using the RetinaVue 100 Camera in Outpatient Dialysis Centers

The purpose of this research study is to look at retinal abnormalities in outpatient renal dialysis patients using the FDA approved RetinaVue 100 hand-held (non-mydriatic) camera.

There are no studies evaluating (diabetic or non-diabetic) retinopathy in the renal dialysis patient population (\~300,000 Americans). Approximately 50% of this population has End-stage Retinal Disease (ESRD) due to diabetes. Dialysis patients are among the most debilitated patients, and thus, have even more barriers to receiving their recommended annual retinal evaluation. The advent of the RetinaVue hand-held retinal camera holds great promise in this population, as dialysis patients access medical care 3 times a week, for several hours at a time at their dialysis clinic.

Eligibility Criteria:
Inclusion Criteria:

* The subject must currently be seeking treatment for end-stage renal disease (ESRD) at one of the specified dialysis clinics.
* The subject must be ≥ 18 years of age.

Exclusion Criteria:

* The subject is \<18 years of age.
* No exclusions will be made on the basis of gender, ethnicity, or race.
RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer

The purpose of this research study is to investigate if RAD001 is an effective treatment for pancreatic cancer that has spread and not responded to treatment. Experiments have shown that RAD001 can prevent cells from multiplying. RAD002 has also been tested in laboratory experiments imitating cancer conditions and the results have been promising.

* Participants taking part in this research study will be given a study medication-dosing calendar for each treatment cycle. Each cycle lasts four weeks during which you will be taking the study drug, RAD001, orally every day.
* Participants will come into the clinic every other week during the time of enrollment. At each clinic visit blood work will be taken to monitor the participants health and a physical exam will be performed. CT scans will be repeated every 2 months to assess the tumor.
* Participants will remain on the study as long as they continue to benefit from the study medication.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic confirmation of pancreatic adenocarcinoma
* 18 years of age or older
* At least one measurable site of disease according to RECIST criteria that has not been previously irradiated. If patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation.
* Treated with gemcitabine-based chemotherapy with documented tumor progression on gemcitabine or intolerance to gemcitabine.
* Prior treatment with no more than 1 prior chemotherapy regimen for metastatic disease.
* Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anti-cancer therapy.
* ECOG performance status 0-1.
* Life expectancy of greater than 12 weeks.
* Adequate bone marrow and liver function.
* Must be able to swallow tablets.

Exclusion Criteria:

* Prior treatment with an investigational drug within the preceding 4 weeks.
* Prior treatment with an inhibitor of mTOR
* Chronic treatment with systemic steroids or another immunosuppressive agent
* More than one prior chemotherapy treatment for metastatic disease
* Uncontrolled brain or leptomeningeal metastases, including patient who continue to require glucocorticoids for brain or leptomeningeal metastases.
* Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
* Patients with chronic renal insufficiency
* Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study.
* Known history of HIV seropositivity
* Impairment of gastrointestinal function or gastrointestinal disease that my significantly alter the absorption of RAD001.
* Active, bleeding diathesis or an oral vitamin K antagonist medication
* Women who are pregnant or breast feeding
Reliability of Consumer Sleep Trackers in Patients Suffering From Obstructive Sleep Apnea Syndrome

During last years, numerous sleep trackers have been commercialized. They are intended to give indications about sleep quality/duration in order to give people an internet-based feedback about their own sleep.

For clinical and research purposes, tri-axial accelerometers/multi-sensors devices are used routinely to assess objective sleep quality/patterns. Their use is also validated to estimate sleep in obstructive sleep apnea syndrome (OSA).

The purpose of the present study is to compare the accuracy of consumer-level sleep trackers and validated tools to measure sleep in OSA patients.

During last years, numerous sleep trackers have been commercialized. They are working on accelerometer-based technology. They are intended to give indications about sleep quality/duration in order to give people an internet-based feedback about their own sleep..

For clinical and research purposes, tri-axial accelerometers/multi-sensors devices are used routinely to assess objective sleep quality/patterns. Their use is also validated to estimate sleep in obstructive sleep apnea syndrome (OSA).

The purpose of our study is to compare the accuracy of consumer-level sleep trackers and validated tools to measure sleep in OSA patients.

Eligibility Criteria:
Inclusion Criteria:

* high clinical suspicion of obstructive sleep apnea syndrome

Exclusion Criteria:

* other associated sleep disorder
* inability to sign informed consent
Cerebral Abnormalities Detected by MRI, Realized at the Age of Term and the Emergence of Executive Functions

The survival of premature babies increased during the last decades. However, the neurocognitive long term development of these children is worrying, as demonstrated by EPIPAGE 1 study.

These children present high risk of deficits such as cognitive deficits, adaptive malfunction, behavior disorders and difficulties in school learning.

Understanding the specific neuropsychological disorders at the origin of these deficits is an important objective. Studies realized at school age showed that many premature children have executive functions (EF) disorders. However the specific nature of these disorders and the neuropathology associated are unknown.

The aim of this study is to realise MRI at term age in preterm babies born less than 32 GA and to correlate MRI findings with executives functions and neurodevelopmental outcome

An MRI would be realized between 39 and 41 GA

At the age of 5 years, executive functions and neurodevelopmental testing would be realized.

600 newborns were recruited.

Eligibility Criteria:
Inclusion Criteria

Infants who were :

* born between 25 and 32 WGA
* hospitalized in a neonatology service which participate to the present study
* included in EPIPAGE 2 follow-up study
* infants whose parents had signed the consent agreement and benefit from national health insurance

Exclusion Criteria

* Infants with congenital abnormalities
Cost-effectiveness Analysis of Robot-assisted Spinal Surgery

With the change of lifestyle and the aging of the population, the prevalence of Lumbar disc herniation (LDH) in my country is increasing year by year, and surgery is one of the main ways to treat LDH. Surgical robots have good application prospects in the surgical treatment of patients with lumbar degenerative diseases. Studies have shown that orthopedic robot-assisted surgery has less soft tissue damage, small surgical incisions, less bleeding, high safety, and quick postoperative recovery; it reduces the risk of spinal cord and blood vessel damage that may be caused during manual operations; does not require repeated fluoroscopy To determine the position of the nail, reduce the intraoperative radiation by more than 70%, and reduce the risk of patient infection.

The current clinical research on robotics technology mainly stays in the aspects of accuracy, effectiveness, and safety. If the technology is promoted in clinical applications, the support of health economics evaluation data is urgently needed. This study hopes to apply robot-assisted technology in LDH surgical treatment through observational research design, evaluate the therapeutic effect and treatment cost of robot-assisted surgery and conventional surgery, focus on health economics evaluation, and provide treatment options for patients and medical care in the health sector. The reasonable allocation of resources and the promotion and application of this technology provide data support.

Beijing Jishuitan Hospital is a pioneer in the research and application of orthopedic robotics in my country. At present, it has completed hundreds of orthopedic surgeries using the "Tianji" robotic system, and has completed a number of randomized controlled clinical trials, proving that robot-assisted surgery is effective in bone degenerative diseases Safety and accuracy in surgical treatment. Based on this platform, this research hopes to apply robot-assisted technology in the treatment of patients with lumbar intervertebral disc herniation, evaluate the therapeutic effect and treatment cost of robot-assisted surgery and conventional surgery, and focus on health economics evaluation, and provide treatment options for patients and health departments The reasonable allocation of medical resources and the promotion and application of this technology provide data support.

Eligibility Criteria:
Inclusion Criteria:

* Diagnose lumbar degenerative diseases and lumbar fractures
* single-level lumbar pedicle screw internal fixation
* Sign informed consent

Exclusion Criteria:

* Multi-level lumbar pedicle screw internal fixation
* QCT diagnoses severe osteoporosis (BMD \<60mg/cm3).
* Combined with abnormal coagulation function
* Combined with serious medical diseases
* Spinal cord injury, paraplegia
* The doctor or nurse believes that it is not appropriate to enroll patients (such as unable to cooperate in completing the study, unable to communicate effectively, severe mental anxiety, lower limb movement disorders, etc.)
Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD and Previously Participated in MTS Trials

This study will evaluate the long-term safety of MTS in the symptomatic treatment of children aged 6-12 diagnosed with ADHD

Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will evaluate the long-term safety of SPD485 in the symptomatic treatment of children aged 6-12 diagnosed with ADHD

Eligibility Criteria:
Inclusion Criteria:

* Subject must have participated in and completed SPD485-201 or participated in and completed a minimum of five of the seven weeks of double-blind treatment in study SPD485-302. Subjects who are participating in N17-021 may enroll in this study following completion of the End of Study/Termination visit procedures.
* Females of childbearing potential must have a negative urine pregnancy test at Baseline and must abstain from sexual activity that could result in pregnancy, or use acceptable contraceptives.

Exclusion Criteria:

* Subject was terminated from SPD485-102, SPD495-201, SPD485-302 OR N17-021 for non-compliance or experienced a serious adverse event resulting in termination from the antecedent protocols
* Female subject is pregnant or lactating
Registry of Food Allergy Oral Immunotherapy Treatment

The purpose of this patient registry is to demonstrate safety and efficacy of food oral immunotherapy in food allergic patients. Factors that lead to adverse reactions will be identified. The frequency of rescue epinephrine use will be recorded.

Each participating US clinic is assigned a site number and patients starting food oral immunotherapy will be given a four digit number starting at 0001 within each site. All data will be collected and reported electronically at each clinical site.

Eligibility Criteria:
Inclusion Criteria:

* a history of an allergic reaction following exposure to the food and positive in-vivo or in-vitro sensitivity testing to the food,
* no prior exposure to the food, but markedly high in-vitro specific immunoglobulin E (IgE) to the food

Exclusion Criteria:

* pregnancy
* severe asthma
* poorly controlled atopic dermatitis
* eosinophilic esophagitis
Comparative Acute Effects of R-MDMA and S-MDMA in Healthy Participants

Racemic ±3,4-methylenedioxymethamphetamine (MDMA) is a psychoactive substance and prototypical empathogen acutely inducing feelings of heightened mood, empathy, trust and closeness to others. These acute subjective effects of MDMA may be helpful to assist psychotherapy and MDMA has been investigated in phase 3 trials as a possible treatment in post-traumatic stress disorder.

MDMA is a racemic substance containing equal amounts of the enantiomers S(+)- and R(-)-MDMA. Preclinical research indicates that S-MDMA mainly releases dopamine (DA), norepinephrine (NE), serotonin (5-HT), and oxytocin while R-MDMA may act more directly on 5-HT2A receptors and release prolactin (PRL). Animal studies also indicate that the two enantiomers act synergistically to produce the subjective effects of MDMA and that S-MDMA is mainly responsible for psychostimulation while R-MDMA may have fewer adverse effects and have greater prosocial effects. A human study conducted between 10/2022 and 01/2024 by our team compared the effects of R-MDMA, S-MDMA, and racemic MDMA revealing that both enantiomers have generally similar effects. However, the study did not administer equivalent doses of R- and S-MDMA. In the present study a single dose of R-MDMA and a single dose of S-MDMA, now adjusted and presumed to be equivalent, will be compared.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 65 years
2. Good understanding of the German language
3. Understanding of procedures and risks associated with the study
4. Willing to adhere to the protocol and signing of the consent form
5. Willing to refrain from the consumption of illicit psychoactive substances during the study
6. Willing not to operate heavy machinery within 48 h after administration of a study substance (including driving a car)
7. Willing to use effective birth-control throughout study participation.
8. Body mass index 18 - 34.9 kg/m2

Exclusion Criteria:

1. Relevant chronic or acute medical condition
2. Current or previous major psychiatric disorder (e.g. bipolar disorder, schizophrenia), current depression or anxiety disorder
3. Psychotic disorder or bipolar disorder in first-degree relatives
4. Hypertension (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg)
5. Illicit substance use (not including cannabis) more than 20 times or any time within the previous month.
6. Pregnancy or current breastfeeding
7. Participation in another clinical trial (currently or within the last 30 days)
8. Use of medications that may interfere with the effects of the study medication
9. Tobacco smoking (\>10 cigarettes/day).
10. Excessive consumption of alcoholic beverages (\>15 drinks/week)
Small Dense Low-density Lipoprotein in Patients With Prediabetes and Type 2 Diabetes

It is known that small dense LDL particles are associated with an increased cardiovascular risk. LDL particles can be separated by gradient gel electrophoresis (GGE) according to their size. The risk to suffer from coronary heart disease is 3-7 fold elevated in subjects with small dense LDL particles compared to subjects with large LDL particles. This study aims at evaluating the predictive value of small dense LDL particles in patients with prediabetes and type 2 diabetes mellitus concerning future changes in intima media thickness, flow-mediated dilation and other risk factors of atherosclerosis (e.g. insulin resistance). 60 patients with prediabetes or type 2 diabetes will be recruited for the study. Assessment will include medical history (risk factors), physical examination (blood pressure, BMI, waist-to-hip ratio), collection of serum, oral glucose tolerance test, measurement of intima media thickness and endothelial dysfunction by ultrasound. All measurements will be repeated after 2 years. Data will be analysed to assess whether the amount of small dense LDL particles can predict further structural and functional changes of the cardiovascular system or changes in the severity of the disease (insulin resistance).


Eligibility Criteria:
Inclusion criteria: - male gender

* impaired fasting glucose OR type 2 diabetes (ADA criteria)
* BMI \> 25 kg/m2
* given informed consent

Exclusion criteria: - HbA1c \> 9.0%

* insulin therapy
* fasting glucose \> 11mmol/l
* total cholesterol \> 6.5 mmol/l OR triglycerides \> 2.5 mmol/l
* malignant or severe renal, hepatic, pulmonary, neurological or psychiatric disease
* alcohol or drug abuse
* HIV infection.