cyrilzakka/clinical-trials huggingface dataset:
A Study to Learn About the Study Medicines Called Enzalutamide and Abiraterone in People With Metastatic Castration-resistant Prostate Cancer

The purpose of this real-world study is to learn about the effects of 2 study medicines called enzalutamide and abiraterone used to treat metastatic castration-resistant prostate cancer (mCRPC).

Prostate cancer is one of the most common cancers in men. The prostate is a gland in the male body that helps make semen. Most prostate cancers need male sex hormones, such as testosterone, to grow. Prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels is known as "castration-resistant". Metastatic cancer is a cancer that has spread to other parts of the body.

This is a real-world study, not a clinical trial. This means that researchers will look at what happens when men receive the treatments prescribed by their own doctor as part of their usual healthcare treatment. In this study, researchers will use information from the Flatiron Electronic Health Record (EHR) database.

The study will include patients' information from the database for men who:

* Were confirmed by medical tests to have mCRPC
* Started first-line treatment with enzalutamide or abiraterone (index date) for mCRPC
* Had not received chemotherapy treatment before index date
* Were 18 years of age or older on index date

Men who are part of this study will receive enzalutamide or abiraterone as part of their usual treatment for mCRPC.

We will compare the following between men receiving enzalutamide and men receiving abiraterone:

* time from treatment start until death,
* treatment duration, and
* time to next treatment. This study will use patient information from the database until the end of information that is available.


Eligibility Criteria:
Inclusion Criteria:

* Male with metastatic prostate cancer diagnosis and abstracted castration-resistant prostate cancer diagnosis
* Initiated enzalutamide or abiraterone within 14 days prior to or after the metastatic castration-resistant prostate cancer diagnosis. The initiation date of enzalutamide or abiraterone will be defined as the index date.
* At least 18 years old at the index date

Exclusion Criteria:

* Received chemotherapy, novel hormonal therapy, radium-223, olaparib/rucaparib, or immunotherapy prior to the index date
* Had a prior history of other cancers
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA): Comfort & Performance Trial

This investigation is designed to evaluate the performance (treatment and leak), comfort (subjective feedback), stability (subjective feedback, leak) as well as the participant's overall acceptance of the Saturn mask amongst OSA participants. An important factor in this investigation will be the testing of our two different seal sizes on the participants (small and medium size). A total number of 15 participants who currently use nasal or nasal pillow masks will be recruited for the trial. A subset of participants have been selected based on their anthropometric measurements collected in previous trials using nasal and nasal pillow masks at this site (CIA-103). Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited by WellSleep, Wellington.

Participants will use the trial mask in home for a period of 7 ± 3 days. Baseline data will be collected from the participant during the first visit, the prior 7 days of CPAP usage data will be downloaded and stored for our analysis. The participant will use the trial device on their usual CPAP/APAP setting and device for the duration of the trial.

This study will be conducted in accordance with ICH/GCP guidelines. No deviation from the protocol will be implemented without prior review and approval of the sponsor except where it may be necessary to eliminate an immediate hazard to a research participant. In such case, the deviation will be reported to the sponsor as soon as possible.


Eligibility Criteria:
Inclusion Criteria:

* Adult (18+ years of age)
* Able to give consent
* AHI ≥ 5 on diagnostic night
* Prescribed a CPAP device after successful OSA diagnosis
* Existing nasal or nasal pillow mask user

Exclusion Criteria:

* Inability to give consent
* Participants who are in a coma or a decreased level of consciousness.
* Anatomical or physiological conditions making APAP therapy inappropriate (e.g. unconsolidated facial structure)
* Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
* Current diagnosis of CO2 retention
* Pregnant or may think they are pregnant.
Sleep Goal-focused Online Access to Lifestyle Support

The overall goal of the study is to develop a novel weight loss intervention for postpartum people by providing strategies to improve sleep, diet, and physical activity behaviors. In this study, we will recruitment and enroll 40 postpartum people and randomize them to receive the Sleep GOALS intervention or education control to evaluate the intervention's feasibility, acceptability, and preliminary efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Stated willingness to comply with all study procedures and availability for the duration of the study,
* Primiparous, singleton pregnancy,
* Between 3+1 and 6+1 months postpartum,
* Has a body mass index \>25 kg/m2,
* Physically inactive, defined as self-reporting \<150 minutes/week of moderate-to-vigorous intensity physical activity,
* Endorse \>1 indicator of poor sleep health based on the RU_SATED questionnaire, and
* Has smartphone and home Internet access

Exclusion Criteria:

* current use of medications that affect weight,
* currently pregnant or plan to become pregnant during the study period (18 weeks), and
* participating in another weight loss intervention.
Basmisanil Positron Emission Tomography Study in Japanese Volunteers

This study will evaluate the relationship between basmisanil plasma concentrations and the occupancy of Gamma-Amino Butyric Acid A (GABAA) receptor subtypes containing an alpha5 (α5) subunit in healthy Japanese volunteers. Each participant will have two post-screening imaging sessions. In the first imaging session, participants will have a baseline Positron Emission Tomography (PET) scan. In the second imaging session, participants will receive a single oral dose of basmisanil, followed by two on-treatment PET scans at about 4 and 10 hours post-dose.


Eligibility Criteria:
Inclusion Criteria:

* Male or female Japanese healthy volunteer, who was born in Japan, has 4 ethnically Japanese grandparents and has lived outside Japan for no longer than 5 years
* A body mass index (BMI, Quetelet index) in the range 18.0 to 32.0 kilograms per square meter (kg/m\^2)
* Willingness and ability to comply with study restrictions

Exclusion Criteria:

* A history of epilepsy, convulsions or significant head injury, or other structural brain abnormality
* Pregnant or lactating or not using acceptable contraception
* Presence or history of severe adverse reaction to any drug or a history of sensitivity to basmisanil or the PET radioligand (RO15-4513)
* Significant exposure to radiation within the previous 12 months
* Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions
Stimulate Brain and Reduce Knee Pain Due to Degeneration

Osteoarthritis (OA) knee is chronic, slowly progressive, degenerative disease of joint which affects articular cartilage and accompanied by pain, swelling and loss of function . OA is often considered as the serious joint disease as it has negative impact on quality of life among elderly population, it is the major cause for the reduced mobility. At cental level, due to imbalance in endogenous pain modulation there is reduce capacity of brain to inhibit the pain. Therefore, dysregulation in the central modulation of pain further leads to maladaptive changes in the brain structure. Transcranial direct current stimulation is a non-invasive method to modulate the brain structure by using a week direct current applied through the scalp in painless way. Multi-session for prolonged time can induce neuroplastic changes in the brain.

The aim of the study is to demonstrate the effectiveness of tDCS in reducing the pain among patients with chronic knee OA and to modulate the plastic changes in brain structure.

A total of 80 patients with KOA will be recruited by the convenience sampling to participate in this two group pretest-posttest, double blinded randomized clinical study. After the demographics, recruited 80 patients with KOA will be randomly divided into two groups, transcranial direct current stimulation (tDCS) group and conventional physiotherapy (CPT) group with by block randomization. Patients with KOA in tDCS group will be provided with Active tDCS and conventional physiotherapy and CPT group will receive structured exercises protocol. Pre-post changes in the outcome measures will be documented at baseline and end of 8-week post intervention. Each session will last for approximately 30 minutes duration.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with clinical knee OA according to the diagnostic criteria of ACR were included in the study

Exclusion Criteria:

* Unwillingness to participate in the study
* Recent history (within the last 3 months) of physical therapy to the same joint
* Recent history (within the last 3 months) of intra-articular procedure (injection and/or lavage) to the knee
* History of knee surgery/fracture
* Acute synovitis/arthritis including the infectious conditions
* Taking pain relief medications
* Any metal implantation near site of stimulation
Pediatric Kidney Transplantation, Ureteroneocystostomy Techniques

In this study the researchers want to retrospectively compare non-refluxing ureteroneocystostomy (UNC techniques to reflux UNC techniques in paediatric kidney recipients with regard to urinary tract infections and uteral obstruction.

Multi-center retrospective study and survey on clinical practice among different urologists. The researchers will retrospectively study data on patients that received their kidney graft between 1994-2018 in either Radboudumc or UW Health University Hospital in Winsconsin.

Additionally, all urologist currently employed at those hospitals will be asked to fill in a survey on preferences in UNC techniques and suture material.

Eligibility Criteria:
Inclusion Criteria:

* received kidney graft in the participating centres at an age \<19
* received kidney graft between 1994-2018
* follow-up data of at least 1 year

Exclusion Criteria:

- Loss of follow up \< 1 year
PROgram to Enhance Cardiovascular Risk Trough an Intervention of Nutrition in Bipolar Disorder

Individuals with Bipolar Disorder (BD) have twice the risk of being affected by metabolic comorbidities and a 1.8-fold increased risk of mortality from cardiovascular diseases when compared to the general population. These factors are fundamental in the 14-year reduction in the life expectancy of people with TB reported in recent meta-analyses. This occurs mainly due to the increased inflammation associated with the disease, the adverse effects of pharmacological treatments and unhealthy lifestyle habits that are more common in people diagnosed with BD. Nutrition has been studied as an adjunctive treatment in other psychiatric disorders, but there is a lack of studies about the role of nutrition in TB. Considering that diet can impact metabolic health, this randomized controlled study aims to evaluate the effect of a nutritional intervention on cardiovascular risk in patients with TB. The intervention is based on the dietary pattern recommended in the Dietary Guidelines for the Brazilian Population and will be applied by a registered dietitian. According to the literature, the sample size will be 72 individuals with TB (36 in the control group with usual treatment + 36 in the intervention group added to the usual treatment). The intervention will be carried out in 7 individual sessions and 8 group sessions with specific themes. The primary aim of this protocol will be an intervention to contribute to cardiovascular health - verified by serum markers, anthropometric measurements and the Framingham Cardiovascular Risk Score (algorithm used to estimate an individual's 10-year cardiovascular risk). The secondary stages will be the adherence of the intervention and the impact on the quality of life of the participants. The possible positive results of this nutritional intervention can open new clinical perspectives. Meaning that might show that better food choices can protect the cardiovascular health of individuals with TB, leading to a reduction in morbidity and mortality associated with the disease.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Bipolar disorder types I and II diagnosis
* Adults of both genders, from 18 to 60 years old
* In typical pharmacotherapy for BD, for at least one month
* Agreement to participate in the study with signature of the consent form

Exclusion Criteria:

* Patients with "very good or excellent" diet quality assessed by the diet quality scale (ESQUADA): \>275 out of a score of 375
* Patients in a state of hypomania or mania: score \>8 (Young Mania Rating Scale - YMRS)
* Patients with severe depression \>21 Montgomery-Åsberg Depression Rating Scale
* Patients at low cardiovascular risk (\<7 points for men or \<9 points for women on the Framingham Global Risk Score)
* Low weight or eutrophic body mass index: \<25kg/m² as in similar studies
* Pregnant or breastfeeding women
* Patients diagnosed with anorexia and bulimia nervosa
* Patientes diagnosed with Irritable Bowl Syndrome or other diagnosed conditions that affect the gastrointestinal function
A Chinese Patent Medicine Yangzhengxiaoji Capsule to Improve the Nausea of Niraparib in the Maintenance Treatment in Ovarian Cancer

This study is an open-label, single-Arm， phase II clinical trial of a Chinese Patent Medicine Yangzheng Xiaoji Capsule to improve the adverse reaction nausea of Niraparib in the first-line maintenance treatment in advanced epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

This study will investigate a Chinese Patent Medicine Yangzheng Xiaoji Capsule improve the adverse reaction nausea of Niraparib in the first-line maintenance treatment in advanced EOC, who have previously received ≥ 3 cycles of prior combined bevacizumab chemotherapy and a complete or partial response with platinum-based chemotherapy.

Approximately 50 eligible subjects are planned to be enrolled, given Yangzheng Xiaoji Capsule and niraparib maintenance treatment.

The dosing regimen is:Niraparib 200mg QD combined with Yangzheng Xiaoji Capsule 0.36g\*4 tid，28 days/cycle. Subjects will receive Niraparib plus Yangzheng Xiaoji Capsule up to 3 cycles.

Eligibility Criteria:
Inclusion Criteria:

1. Sign a written informed consent form before conducting any research-related procedures;
2. Women aged 18 or above;
3. Ovarian cancer, fallopian tube cancer or primary peritoneal cancer diagnosed histologically can be treated with Niraparib after evaluation by clinicians;
4. Life expectancy \> 3 months;
5. Patients' ECOG physical condition score is 0-1, KPS score is ≥70;
6. Patients received ≥ 3 cycles bevacizumab in combination within platinum-based chemotherapy
7. Good organ function, including:

   * Neutrophil count ≥ 1500/L
   * Platelet ≥ 100,000/L
   * Hemoglobin ≥10g/dL
   * Serum creatinine ≤1.5 times the upper limit of normal value, or creatinine clearance ≥60mL/min (according to Cockcroft-Gault Formula calculation)
   * Total bilirubin ≤1.5 times the upper limit of normal value or direct bilirubin ≤1.0 times the upper limit of normal value
   * AST and ALT ≤2.5 times the upper limit of normal value, and liver metastasis must be ≤5 times the upper limit of normal value.

7. No serious abnormalities of heart, brain, lung, liver and kidney function; 8. No serious mental illness; 9. Ability to comply with the plan; 10. the toxic and side effects of any previous chemotherapy have recovered to ≤CTCAE 1 grade or baseline level, except for sensory neuropathy or alopecia with stable symptoms ≤CTCAE 2 grade.

Exclusion Criteria:

1. People who are allergic to the ingredients in Yangzhengxiaoji Capsule
2. Have undergone major surgery within 3 weeks before the start of the study, or have not recovered any surgical effects after surgery, or have received chemotherapy.
3. patients who are combined with other cancers;
4. Patients with severe heart, liver, kidney and hematopoietic diseases; 5 Patients with poor compliance cannot take drugs according to regulations.
Application of hybridAPC in the Treatment of Barrett

The purpose of this study is to evaluate the efficacy and safety of the new technique of HybridAPC in the treatment of Barrett.

After thermal ablation of Barrett's esophagus, stricture formation is reported in 5 to over 10% of patients. Submucosal fluid injection prior to ablation may lower the risk of stricture formation. The new technique of HybridAPC which combines submucosal injection with APC is considered to reduce the complication.

Eligibility Criteria:
Inclusion Criteria:

1. Patients age is from 18 to 70.
2. Patients who were diagnosed with Barrett's esophagus.
3. Informed consent.

Exclusion Criteria:

1. Patient with severe cardiopulmonary dysfunction is unable to tolerated by endoscopy.
2. Severe bleeding tendency.
3. Poor compliance.
4. Patient is very ill and life expectancy is less than 2 years.
5. Esophageal varices or venous aneurysms, and no effective prevention or treatment for bleeding.
6. Severe esophageal stenosis.
7. Pregnancy.
8. Lesion is located in esophageal diverticulum or spread their diverticulum.
The Effect of Continuous Epidural Analgesia on Intracranial Pressure by Measuring the Optic Nerve Sheath Diameter Using Ultrasound in Pediatric Patients

Ultrasonography of optic nerve sheath diameter shows a good level of diagnostic accuracy for detecting intracranial hypertension. The aim of this study is to evaluate the effect of continuous epidural block on intracranial pressure in pediatric patients undergoing osteotomy of lower extremity. Forty patients, aged 4 years to 13 years, receiving epidural analgesia before osteotomy will be divided into bolus group (n=30) and infusion group (n=30). Randomly selected patients of the bolus group are given 0.3 ml/kg bolus/hr of 0.15% ropivacaine for epidural analgesia. In contrast, patients in the infusion group are administered 0.3 ml/kg/hr 0.15% ropivacaine at a constant rate for epidural analgesia. The primary endpoint is the difference in the optic nerve sheath diameter after epidural analgesia measured by optic nerve ultrasonography between groups.


Eligibility Criteria:
Inclusion Criteria:

* 1. Pediatric patients from 4 to 13 years of age undergoing osteotomy of lower extremity

Exclusion Criteria:

* 1. Patients with contraindications to epidural analgesia (local infection, clotting disorders, anatomical abnormalities, sepsis, etc.)
* 2. Patients with symptoms or signs associated with a history of elevated intracranial pressure or elevated intracranial pressure
* 3. Patients with ophthalmic disease or surgery
* 4. The estimated operation time is less than 180 minutes.
* 5. All parents of the subject are foreigners or illiterate
Sleep Disorders and the Onset and Progression of ALS

200 cases of ALS patients were collected to explore whether sleep disorders are related to earlier onset age, and whether sleep disorders accelerate the progress of ALS and shorten the survival time of ALS patients.

200 patients with ALS were collected. 1) sleep disorders were assessed by Pittsburgh sleep quality index (PSQI) and Epworth Sleepiness Scale (epworth) at baseline Sleeping Scale，ESS）； 2) Name, age, gender and onset site were collected to explore whether sleep disorders were associated with earlier onset age; 3) The patients' function (ALSFRS-R) at baseline and every 3 months within 2 years were collected, and the end-point time (death and invasive breathing) was recorded to evaluate whether sleep disturbance accelerated the decline of patients' function and shortened their short-term survival.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been diagnosed in the Department of Neurology of the Third Hospital of Beijing Medical University since August 2020. The clinical diagnosis of patients with amyotrophic lateral sclerosis includes: probable and define;
* Informed consent has been signed.

Exclusion Criteria:

* Those who can not cooperate to complete the scale and receive follow-up.
Cervical Cancer Screening Strategies

This study is to investigate retrospectively the results of cervical cytology and high-risk human papillomavirus in the past 20 years recorded in Peking Union Medical College Hospital. The histological findings after cervical cancer screening were reviewed. The diagnostic values of different screening strategies were compared based on the results of cervical histology. The primary endpoint is the diagnosis of grade 2 cervical intraepithelial neoplasia (CIN2) or more severe lesions (CIN2+). The secondary endpoints include following objectives: (1) the invasive procedures needed according to the screening results; (2) the diagnosis of vaginal and/or vulval intraepithelial neoplasia; (3) the persistence and recurrence of human papillomavirus infection; and (4) the cost-effectiveness of screening strategies for CIN2+.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* With definite cervical histology after cervical cancer screening, ore with at least one screening test after first testing

Exclusion Criteria:

- Not meeting all of the inclusion criteria
Efficacy and Safety of Three Times a Day BIAsp-70 Compared to Two Times a Day BIAsp-30 in Subjects With Type 2 Diabetes

This trial is conducted in Japan. This a clinical trial to study the efficacy and safety of three times a day BIAsp-70 compared to two times a day BIAsp-30 in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes
* Current treatment using intermediate-acting, long-acting insulin (including long-acting insulin analogue) or pre-mixed human insulin for at least 24 weeks
* HbA1c at least 7.5% and below 10.0%

Exclusion Criteria:

* Proliferative retinopathy or maculopathy requiring acute treatment
* Impaired hepatic and/or renal function
* Cardiac diseases
* Uncontrolled hypertension
* Known hypoglycemia unawareness or recurrent major hypoglycemia