cyrilzakka/clinical-trials huggingface dataset:
Lutetium-177 (Lu177) Prostate-Specific Antigen (PSMA)-Directed EndoRadiotherapy

This was an open-label, multicenter, prospective trial to assess safety and efficacy of 177Lu-PSMA-617 in patients with metastatic castration resistant prostate cancer.

Upon inclusion patients were randomized in a 1:1 ratio into two treatment doses. Radioligand therapy (RLT) were performed by repeated intravenous (i.v.) injection of 6.0 gigabecquerel (GBq) (+/- 10%) or 7.4 GBq (+/- 10%) 177Lu-PSMA-617 every 8+/- 1 weeks until reaching four cycles or threshold maximum dose to the kidneys of 23 Gray (Gy). All doses after labeling were presented in buffered solution for i.v. injection.

In the initial plan for the study design a total of 200 patients with histologically proven prostate cancer and metastatic castration-resistant prostate cancer (mCRPC) were to be enrolled, however due to early stopping of enrollment only 71 patients were enrolled at time of data base lock. Each patient underwent a screening visit within 14 days prior to receiving study drug. Treatment was continued until either of the following conditions applied:

* Prostate-specific antigen (PSA)/radiographic progression at \>= 12 weeks
* Completion of four RLT cycles
* 23 Gy kidney dose would be exceeded by the next cycle as estimated by dosimetry
* Patient withdrawal (e.g. appearance of intolerable adverse events).

Eligibility Criteria:
Inclusion Criteria:

1. Prostate cancer proven by histopathology
2. Unresectable metastases
3. Progressive disease, both docetaxel naive and docetaxel treated.
4. Castration resistant disease with confirmed testosterone level ≤50 ng/ml under prior androgen deprivation therapy (ADT)
5. Positive 68Ga-PSMA-11 PET/CT (positron emission computed tomography ) or diagnostic 177Lu-PSMA-617 scintigraphy
6. ECOG 0-2
7. Sufficient bone marrow capacity as defined by WBC (white blood cell ) ≥2.500/μl, PLT (platelet) count ≥100.000/μl, Hb≥9.9 g/dl and ANC≥1500 mm3 for the first cycle and WBC≥2.000/ μl,PLT count ≥75.000/μl, Hb≥8.9 g/dl and ANC≥1000 mm3 for the subsequent cycles
8. Signing of the Informed Consent Form
9. Patients enrolling in this trail should have received either Enzalutamide or Abiraterone

Exclusion Criteria:

1. Less than 6 weeks since last myelosuppressive therapy (including Docetaxel, Cabazitaxel, 223Ra, 153Sm) or other radionuclide therapy.
2. Glomerular Filtration Rate (GFR) \<40 ml/min
3. Serum creatinine \> 1.5 ULN
4. AST and ALT\>5xULN
5. Urinary tract obstruction or marked hydronephrosis
6. Diffuse bone marrow involvement confirmed by super-scans
Using PET Scans to Study Brain Receptor Occupancy of BIIB014 in Healthy Male Volunteers

To establish the extent to which BIIB014, following 8 to 12 consecutive days of dosing at selected dose levels, occupies the brain's A2A receptors. Receptor occupancy will be assessed by PET scanning using a radiolabelled tracer.

Subjects will be enrolled sequentially into cohorts of 2 to 4 subjects. PET scan results will determine the actual number of cohorts enrolled and the BIIB014 dose given to each subject. Since all enrolled subjects will be receiving BIIB014, this study is being listed as a 1-arm, Single Group study (actual study design is dose escalation).

Participating subjects will be required to reside in the clinical unit for 10 to 14 consecutive days. Participants will receive 1 oral dose of BIIB014 daily for 8 to 12 consecutive days. During the study, subjects will undergo 2 PET scans and 1 MRI. Frequent blood sample for pharmacokinetic assessments will also be performed.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.0 and 29.0 kg/m2
* Willing to abstain from caffeine-containing products from 1 week prior to dosing until discharge from unit.
* Willing and able to practice effective contraception until 2 months following last dose of study drug.

Exclusion Criteria:

* History of severe allergic reactions or clinically significant allergies.
* History of malignancy, excluding adequately treated basal cell carcinoma.
* History of any clinically significant disease.
* History of claustrophobia or any condition incompatible with MRI/PET scanning.
* History of any exposure to ionizing radiation, with the exception of dental x-rays, within the 12 months prior to dosing.
* Serious infection within the 4 weeks prior to dosing.
* HbA1c \> 6%, positive for Hepatitis C or Hepatitis B, presence of HIV or known exposure to HIV, positive G6PD assay, or any other clinically significant abnormal laboratory parameters at Screening.
* Abnormal supine or standing blood pressure or orthostatic hypotension.
* Any prior treatment with antipsychotic medications, dopamine antagonists, or dopaminergic agonists.
* Treatment with any other investigational drug within 3 months prior to dosing.
* Treatment with any prescription medications within 4 weeks prior to dosing.
* History of drug or alcohol abuse within 1 year prior to dosing.
* Current smoker or any tobacco use within 3 months prior to dosing.
* Heavy caffeine consumption within 4 weeks prior to dosing.
A Study in Healthy People to Test How 2 Different Formulations of BI 690517 Are Taken up in the Body and How Probenecid Influences the Amount of BI 690517 in the Blood

This trial aims to test how two different formulations of BI 690517 are taken up by the body and how probenecid influences the amount of BI 690517 in the blood.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
* Signed and dated written informed consent m accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Further inclusion criteria apply.

Exclusion criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm (beats per minute)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.
Efficacy and Safety of Semaglutide Injection Vs Ozempic® in Patients with Type 2 Diabetes

This is a 32-week randomized, open-label, parallel-controlled biosimilar comparison study comparing the efficacy, safety and immunogenicity of the investigational drug and the active comparator in patients with type 2 diabetes mellitus who have inadequate glycemic control with metformin. Eligible participants will be screened and randomized to the experimental group and the active comparator group at a ratio of 1:1 , semaglutide injection or Ozempic® injection abdominal subcutaneous injection will be given according to their groups weekly for 32 weeks. Follow-up for 4 weeks after administration.

Trial product will be add-on to subject's stable pre-trial metformin.

The study included a screening period (up to 2 weeks), run-in period（6 weeks），baseline, administration period(32 weeks), and a follow-up period (4 weeks). The duration of the study will be approximately 44 weeks for a participant.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age 18-75 years (both inclusive) at the time of signing informed consent
2. Subjects diagnosed with type 2 diabetes and on stable treatment in a period of 6 weeks prior to screening with metformin ≥ 1500 mg (or maximum tolerated dose ≥ 1000 mg)
3. HbA1c 7.5 - 11.0 % (both inclusive) (screening)
4. HbA1c 7.0 - 10.5 % (both inclusive) (randomisation)
5. BMI 18.5-35 kg/m2 (both inclusive)

Exclusion Criteria:

1. Other types of diabetes besides Type 2 diabetes
2. A history of acute diabetes complications within 6 months before screening
3. A history of acute or chronic pancreatitis, symptomatic gallbladder disease, or other high-risk factors that may lead to pancreatitis
4. Personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
5. Acute coronary or cerebrovascular event within 3 months before screening or randomisation
6. Heart failure, New York Heart Association (NYHA) class IV
7. Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 6 weeks before screening. An exception is short-term treatment (≤7 days in total) with insulin in connection with inter-current illness
8. Fasting Plasma Glucose (FPG) ≥ 13.9mmol/L
9. Screening calcitonin value ≥ 35 ng/L (pg/mL)
10. Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m2
11. Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
Lockdown Impact on Spontaneous Premature Birth in a Level III NICU

Preterm labor (PL) is the leading cause of hospitalization during pregnancy and premature birth the leading cause of fetal morbidity and mortality in France. PL is defined by regular and painful uterine contractions associated with a change in the cervix, between 22 and 36 weeks of gestation.

It has been shown that the risk of spontaneous prematurity increases particularly in case of working over 40 hours per week, hard physically conditions, or prolonged daily transport time. Rest is one of the most efficient measure to prevent PL and should be proposed to all pregnant women, and combined with other therapies such as tocolysis or cerclage when needed.

The very particular period of lockdown during the COVID-19 pandemic had pregnant women to drastically reduce their activity. They suspended their work and stayed home for various reasons such as pregnancy in progress, children at home, and also collective reasons such as teleworking or workplace closure.

During the lockdown period from March 17th to May 11th 2020, fewer preterm labor and less spontaneous prematurity have been suspected by the neonatology and obstetrics teams throughout the Lorraine region.

Our study aims to objectively confirm this observation. In this investigation we aim to find a relationship between lockdown, PL and spontaneous prematurity which would need to re-evaluate public health recommendations for pregnant women outside the lockdown.


Eligibility Criteria:
Inclusion Criteria:

* Any prematurely born infant before 37 SA and care for by the level III NICU, over the predefined periods.

Exclusion Criteria:

* non premature newborn
A Novel Study Evaluating Patients Awaiting Total Hip Arthroplasty (PRIORITEES)

Hip replacements are one of the NHS's highest volume procedures, with \~14,000 operations per month before the onset of the COVID-19 pandemic. Delays to surgery can have significant implications; meaning increasing levels of pain and worsening quality of life.

As of January 2021, following the initial waves of the COVID-19 pandemic, 58,000 people had waited an average of 25 additional weeks for their total hip replacement.

The results of the study will hopefully help treating clinicians identify patients in whom there may be further deterioration if surgery is significantly delayed.

Patients attending their routine pre-operative assessment clinic who meet the inclusion criteria will be invited to take part in the study by their direct clinical care team. If they provide their consent, they will first be examined for their maximum hip internal rotation possible when supine with hip and knee flexed at 90 degrees.

They will then be asked to sit in front of a camera placed at a height 2 to 3 feet (0.6 to 0.9 m) off the ground and stand 6 feet (1.8 m) away(6). Patients will be asked to spread their feet as far apart from each other whilst sitting straight with hips and knees at 90 degrees. A photograph will be taken of their neutral position, and another with their best attempt at internal rotation.

The internal rotation angle obtained along with the photo number will be documented on a data collection sheet with a hospital sticker, BMI, oxford hip score and EQ5D score completed that day.

At the end of the day, this information shall be collated \& transcribed onto an excel spreadsheet for subsequent x-ray and photo review \& measurement, anonymisation and analysis.

Eligibility Criteria:
Inclusion Criteria:

* Native hip arthritis
* On the waiting list for elective total hip replacement surgery
* Able to give informed consent to participate
* Existing medical records demonstrating 2 AP Pelvic Xray images taken at least 3 months apart

Exclusion Criteria:

* Inability to consent to participation
* Previous surgical intervention on the joint in question.
Study to Assess Safety, Tolerability and Pharmacokinetics After Single Dose of AZD2516 to Japanese Healthy Subjects

The primary purpose of this study is to assess the safety and tolerability of AZD2516 following administration of a single dose to Japanese healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Weight between 45 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2
* Japanese males aged between 20 to 45 years old (young) and Japanese males or females aged between 65 to 80 years old (elderly)

Exclusion Criteria:

* History of previous or ongoing somatic or psychiatric disease/condition
* Abnormalities in ECG that may interfere with interpretation of data.
Identification of Oral Lesions Through an Autofluorescence System

The aim of the study will be to evaluate the efficacy of a tissue autofluorescence detection system as an aid to clinical screening in identifying lesions of the oral mucosa. The screening process will be performed by 3 clinicians with a different level of experience. Sensitivity and specificity tests will be conducted.

Tissue autofluorescence analysis will be performed using GOOCLES® glasses, a device capable of detecting variations in fluorescence when the examined area is illuminated with a common photopolymerising lamp. Three clinical professionals will be identified:

* Dental hygienist (1);
* General dentist (2);
* Dentist expert in Medicine and Oral Pathology (3).

All patients will be included in the study after receiving an initial dental visit, in order to rule out patients with noticeable oral lesions.

Dental hygienist (1) will collect the patient's data by filling the "anamnestic record". Furthermore, (1) will perform the first clinical examination (with and without GOOCLES®), reporting his observations on his own "operator module".

The same screening (with and without GOOCLES®) will be conducted blindly by the general dentist (2) who, if he deems it necessary, will refer the patient to the oral pathologist (3), who will confirm or not (with and without GOOCLES®) the presence of an oral region such as to be further investigated (follow up or biopsy) and will report the observations on its own "operator module".

Inter-operator and intra-operator comparisons will be performed and the data thus obtained will be processed for statistical processing.

Eligibility Criteria:
Inclusion Criteria:

* Male and female;
* Age ≥ 18 years;
* Non-smokers and smokers

Exclusion Criteria:

* Cancer patients;
* Patients presenting a histological diagnosis of oral mucosal dysplasia/carcinoma.
Phase II Dose Titration Study in Patients With Neuropathic Pain

The purpose of this study is to examine the effects of various increasing doses of Ralfinamide in patients with neuropathic pain.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients
* Females post-menopausal for at least 12 months, 24 months in India, Poland, and Austria
* Diagnosed by neurologist with current neuropathic pain

Exclusion Criteria:

* See inclusion criteria
Academic Self-regulation, Parenting Dimensions and Academic Procrastination

the method was the correlational way. The statistical population of the was all of the boy students of the second-period elementary school in Garmeh city (Iran). the sample size was 278. The age of participants was in the range of 9 to13 years old.


Eligibility Criteria:
Inclusion Criteria:

be the male student, having the age of 9 to 13 years, having the ability of reading and writing

Exclusion Criteria:

* be female, no be student, no having age of 9 to 13 years, disability of reading and writing, having psychotic disorders
Tenofovir Abacavir Platelet Activation Study

Some but not all observational studies have found that current exposure to abacavir is associated with increased risk of cardiovascular events such as myocardial infarction, stroke and cardiovascular death. This study aim to investigate possible adverse effect of abacavir on platelet reactivity, coagulation and endothelial activation in HIV-1 infected patients. The study is an open-labeled cross-over trial, where patients receiving antiretroviral therapy containing abacavir switch treatment to a regimen containing tenofovir and vice versa for a period of 90 days.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected
* Can understand and sign written informed consent
* Received one of the above mentioned antiretroviral regimens continuously ≥ 6 months
* HIV RNA \< 400 copies/mL for ≥ 6 months

Exclusion Criteria:

* Receiving anticoagulant therapy, adenosine diphosphate (ADP) receptor inhibitors, aspirin or nonsteroidal antiinflammatory drugs (NSAIDs)
* Previous ischemic heart disease, peripheral atherosclerotic disease or stroke
* Coagulation disorder (e.g. hemophilia, factor V Leiden mutation)
* Platelet count \< 150 x 109/L during the past 6 months from inclusion
* Estimated glomerular filtration rate (eGFR) \<70 during the past 6 months from inclusion
* Humane leukocyte antigen (HLA)-B\*57:01 positive genotype
* Hepatitis B or C positive during the past year from inclusion
* Hypersensitivity to the active substances or to any of the excipients
A Clinical Comparison of Three Bronchial Blockers for One-Lung Ventilation in Thoracic Surgery

This is a clinical trial comparing surgical conditions during one-lung ventilation with three different bronchial blockers or with double-lumen endobronchial tubes.


Eligibility Criteria:
Inclusion Criteria:

* Left thoracotomy

Exclusion Criteria:

* Contraindication to lung isolation
Suicide Prevention in Chinese Older Adults

This project aims to develop and refine a suicide intervention protocol, and pilot test a culturally tailored randomized control trial to reduce suicidal thoughts among U.S. Chinese older adults. During the first phase of the study, the investigators plan to invite the community advisory board and key stakeholders to participate in the iterative design and refinement of the study protocol. During the second phase of the project and after the initial screening and based on a specific set of inclusion criteria, the investigators will invite U.S. Chinese older adult to participate in a pilot randomized control trial of a culturally adapted intervention to reduce the frequency and intensity of suicidal thoughts in Chinese older adults. During the third phase of the project, the investigators plan to invite pilot intervention participants as well as key stakeholders and health care professionals on the cultural acceptability of the pilot intervention. Through the achievement of these objectives, the investigators will set the foundation to fully test a culturally adapted in-home intervention, which may be particularly suitable for Chinese older adults with suicidal thoughts as it addresses cultural-specific barriers and integrates care management within existing community services agencies using non-mental health professionals, including community health workers.


Eligibility Criteria:
Inclusion Criteria:

1. Self-identified as Chinese
2. \>50 years of age
3. Suicidal thoughts within the last month as detected from the Item 9 in PHQ-9
4. No plans to move for 6 months
5. No significant cognitive impairment with Chinese Mini-Mental State Examination (C-MMSE) score \>20
BestBrain Evaluation of Cognitive Memory & Executive-Function

This study is intended 1. To quantify the effects of the iRemember personalized EEG-NFB therapy on working memory and executive functions in subjects with MCI by calculating the percentage of change in the Neurotrax tests performed prior to and after the treatment, and compare the results between the active treatment and placebo cohorts

By using the BestBrain iRemember EEG-NFB System, subjects within the "treatment" arm of this clinical investigation will show improvement in working memory, executive functions and general improvement in daily life based on standard accepted cognitive tests such as the Neurotrax and Kielhfner questionnaire. This hypothesis will be accepted or rejected based on the statistical analysis of the data collected .

Subjects will be randomized either to the treatment or placebo groups. Each subject will undergo an initial and final assessment using NeuroTrax and specified questionnaires prior to and after 20 treatments. The first sessions will be dedicated to subject evaluation. Each subject will undergo either a neurofeedback (NFB) or sham treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female age 50-80 years
2. Subjects diagnosed with MCI, according to the ICD-10 criteria.
3. MoCA score 18 to 25
4. Ability to operate a computer mouse and keyboard as evaluated by the clinician.
5. Agreement to participate in approximately 12 weeks during the study.
6. Normal to near-normal vision and hearing with correction as needed (e.g. corrective lenses, hearing aid).
7. Fluent in Hebrew
8. Willing to participate twice a week for treatments

Exclusion Criteria:

1. Participation in a clinical trial with any investigational agent within 6 months prior to study enrollment
2. Subjects with one or more of the following disorders in their medical files: psychotic disorder, currently active depression, with a history of bipolar disorder, adjustment disorder, somataform disorder, anxiety disorder OCD, PTSD. (following the Axis-1 disorders listed in the ICD-10)
3. Alcoholism or drug addiction as defined by ICD-10 within last 5 years (addicted more than one year and or in remission less than 3 years) or severe sleep deprivation
4. Subjects with personal history of a clinically defined neurological/psychiatric disorder including (but not limited to): epilepsy, dementia, clinical stroke (hemiparesis, hemianopsia) , substance abuse, extra pyramidal disorders like parkinson etc) , major head trauma, multiple sclerosis; or personal history of previous neurosurgery or head trauma that resulted in loss of consciousness; use of any medication with the aim to improve cognition (cholinesterase inhibitors).