cyrilzakka/clinical-trials huggingface dataset:
Clinical Study of DMT in Healthy Adults

This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine in healthy individuals.

Participants will receive N, N-Dimethyltryptamine administered in two dosing sessions: an initial low-dose safety session and subsequent intermediate-dose treatment, in a fixed order and 2h apart.

Eligibility Criteria:
Inclusion Criteria:

* prior experience with N,N-Dimethyltryptamine (DMT)
* present proof of vaccination against COVID-19 (Coronavírus)

Exclusion Criteria:

* heart failure
* liver failure
* kidney failure
* resistant hypertension
* arrhythmia
* valvular heart disease
* chronic obstructive pulmonary disease
* asthma
* severe obesity
* epilepsy
* pregnancy
* thyroid disorders
* family diagnosis or suspicion of genetic monoamine oxidase deficiency
* previous adverse response to psychedelic substances
* present or past symptoms or family members with a psychotic disorder
* dissociative identity disorder
* bipolar disorder
* prodromal symptoms of schizophrenia
* abuse of alcohol or other psychoactive substances, except tobacco
* acute or sub-acute risk of suicide
* flu-like symptoms
An Extension Study of Xolair in Moderate to Severe, Persistent Asthma Patients Who Completed Study Q2143g

This is a Phase IIIb, multicenter, open-label, extension study available to subjects who successfully complete Study Q2143g and have not participated in Study Q2195g. Subjects should be registered via the IVRS (Interactive Voice Response System) within 48 hours prior to their baseline visit. All subjects in this study will be treated with Xolair for 24 weeks. Subjects in the New Treatment Group may require additional visits for study drug injections (as frequently as every 2 weeks). Data collection during these additional visits will be limited to the assessment of adverse events. The study will evaluate all serious and nonserious adverse events, laboratory assessments, data on asthma exacerbations, and concomitant medication usage.


Eligibility Criteria:
Inclusion Criteria:

* Successful completion of the 24-week study period in Study Q2143g
* Signed informed consent (in the case of a minor, consent must be given by the child's parent or legally authorized representative)
* For subjects who have never received Xolair, a serum IgE level \>=30 IU/mL and \<=1300 IU/mL and have a body weight \>=20 kg and \<=150 kg
* Females of childbearing potential must, in the opinion of the investigator, be using an effective method of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.

Exclusion Criteria:

* Thrombocytopenia as evidenced by a platelet count of \<100,000/uL
* Pregnant or breastfeeding
* Significant systemic disease (e.g., infection, hematologic, renal, hepatic, coronary heart disease or other cardiovascular diseases, endocrine or gastrointestinal disease) within the previous 3 months
* History of neoplasia
* Any systemic condition requiring regular administration of an immunoglobulin
* Known hypersensitivity to any ingredients of Xolair, including excipients (sucrose, histidine, polysorbate 20)
* History of noncompliance with medical regimens
* Current participation in a study using an investigational new drug other than Xolair
* Participation in Study Q2195g
Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH

The main objective of the study is to determine the diagnostic performances of an ultraportable diagnostic ultrasound system for the assessment of liver fibrosis severity in patients with NASH, and to compare them to other non-invasive tests.

This is a prospective cross-sectional study that will recruit approximately 1000 patients across 30 clinical sites in Europe and the USA.

The target recruited population will include adult patients at risk of, or with known chronic liver diseases, whether or not screened for inclusion in NASH pharmaceutical trials.

After being informed about the study objectives and potential risks, patients who consent to participate will undergo an non-invasive external ultrasound exam of their liver using an ultraportable diagnostic ultrasound system. The system will derive quantitative information related to physical and acoustic properties of the liver tissue, which are known to correlate with the severity of chronic diffuse liver diseases such as fibrosis and steatosis.

The study will also assess the repeatability, reproducibility and robustness of quantitative parameters. Collected data will also enable exploring ultrasound-based liver tissue characterization correlated to NASH-specific histological lesions such as intra-hepatic inflammation and hepatic cell ballooning.

Eligibility Criteria:
Inclusion Criteria:

* Any of the following criteria:

  * Patients with known chronic liver diseases referred to liver-specific exams by their referring physician as part of the routine practice, including a VCTE exam, with or without a blood test, a MRI/MRE exam, a liver biopsy,
  * Patients screened for fibrotic NASH in the context of NASH pharmaceutical trials, for which a data sharing agreement has been signed between E-Scopics and the pharmaceutical trial promoter,
* Patients who consent in written to participate in the Clinical Investigation after being orally informed on the objectives and methods of the Clinical Investigation,
* European patients covered by a social security program

Exclusion Criteria:

* Patients under 18 years of age or over 80 years of age,
* Patients with active implants such as pacemakers, defibrillators, pumps, etc.
* Patients presenting wounds at the location where the ES1 probe shall be placed on patients' skin,
* Adult patients under social tutorship, or unable to provide informed consent when not subject to tutorship measures,
* Pregnant and breastfeeding women,
* People deprived of their freedom rights
* People who have been hospitalized without giving informed consent or under emergency situation,
* People admitted in a social or sanitary institution for other reasons than the Clinical Investigation,
* Patients included in another research study that could interfere with the present Clinical Investigation.
A Clinical Study of 9MW2821 in Advanced Malignant Solid Tumors

This study is a Phase 1, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, preliminary antitumor activity and immunogenicity of 9MW2821 administered by intravenous (IV) infusion.


Eligibility Criteria:
Inclusion Criteria:

* Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
* Male or female subjects aged 18 to 80 years (including 18 and 80 years).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Phase Ia：Histologically or cytologically confirmed advanced malignant solid tumors (except sarcoma). Phase Ib：Only local advanced or metastatic UC tumors.
* Subjects must have received ICIs or GC/GP therapies in the previous treatment.
* Subjects must submit tumor tissues for test.
* Life expectancy of ≥ 3 months.
* Subjects must have measurable disease according to RECIST (version 1.1).
* Adequate organ functions.
* Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.
* Subjects are willing to follow study procedures.

Exclusion Criteria:

* Chemotherapy、radiotherapy or immunotherpy within 14 days prior to the first dose of study drug.
* Preexisting treatment related toxicity Grade ≥ 2 (except alopecia).
* Major surgery within 28 days prior to first dose of study drug.
* History of uncontrolled diabetes mellitus.
* Preexisting peripheral neuropathy Grade ≥ 2.
* Received treatment of ADCs with MMAE payload.
* Any live vaccines within 4 weeks before first dose of study drug or during the study.
* Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
* Other severe or uncontrolled disease, i.e. severe respiratory system disease, thromboembolic events, active bleeding or active infection.
* Uncontrolled central nervous system metastases.
* History of another malignancy within 3 years before the first dose of study drug. Subjects with curable malignancies are allowed.
* History of autoimmune disease requiring systemic treatment within 2 years before the first dose of study drug.
* Has ocular conditions that may increase the risk of corneal epithelium damage.
* Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.
* Any P-glycoprotein (P-gp) inducers/inhibitors or CYP3A4 inducers/inhibitors for high and medium effect within 14 days prior to the first dose of study drug.
* Use of any investigational drug or device within 30 days prior to the first dose of study drug.
* Conditions or situations which may put the subject at significant risk.
Study to Assess the Efficacy of the iTind in Subjects With Symptomatic BPH

A total of up to 200 Symptomatic BPH subjects subjects will be enrolled into the study.

Study duration will be 12 months post implantation with a follow-up visits at Year 2 and Year 3.

Primary Study Objective:

The study's primary objective is to assess the efficacy of the Medi-Tate iTind in subjects with symptomatic BPH by reduction of IPSS) (International Prostate Symptoms Score) score.

Secondary Study Objectives:

* To further evaluate the efficacy of Medi-Tate iTind as determined by increase of maximal urinary peak flow, satisfaction from the device and procedures, sex performance capabilities and ejaculation.
* Safety will be assessed by the rate of complications attributed to the Medi-Tate iTind and its implantation/retrieval procedures.

Eligibility Criteria:
Inclusion Criteria:

Subject signed informed consent prior to the performance of any study procedures.

* Male with symptomatic BPH: IPSS symptom severity score ≥ 10
* Peak urinary flow of \< 12 ml/sec at flowmetry with minimum voided volume of at least 120 cc.
* Prostate volume 25 ml to 80 ml (as assessed by TRUS)
* Subject that is able to complete the study protocol
* Normal Urinalysis and urine culture.

Exclusion Criteria:

* Previous prostate surgery
* Prostate cancer
* Urethral stricture
* Bladder stones
* An active urinary tract infection.
* Obstructing median lobe demonstrated by IPP grade 3 (\>1 cm) as assessed by TRUS.
* Neurological conditions potentially affecting voiding function.
* A post void residual (PVR) volume \> 250 ml measured by ultrasound
* Previous diagnosis or treatment for Over Active Bladder
* Acute Urinary Retention
* Any anatomical or physiological condition that in the opinion of the investigator likely to impede successful completion of the study

Intra-Operation Exclusion:

• Obstructing median lobe or any other anatomical or physiological pathology that can interfere the device implantation as assessed by cystoscopy.
Connection, Navigation, Engagement in Care and Treatment for Opioid Use Disorder

The overarching goal of the study is to develop, pilot, and evaluate an intervention that aims to retain patients who initiate buprenorphine at Denver Health in ongoing treatment for opioid use disorder.

Initiating patients identified with opioid use disorder in hospital settings onto buprenorphine is a relatively new strategy to prevent overdose. While the literature is beginning to amass showing the effectiveness of this strategy for initiating people into treatment, a dearth of data to describe how well people are maintained in treatment remains. The current research project aims to 1) develop an intervention to enhance engagement and retention in treatment for individuals with opioid use disorder who initiate buprenorphine at Denver Health and 2) assess acceptability, feasibility, and initial efficacy of an intervention to enhance engagement and retention in treatment for individuals with opioid disorder compared to usual care.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* inducted onto buprenorphine at Denver Health
* successfully completed an intake visit at Denver Health's Outpatient Behavioral Health Services clinic.

Exclusion Criteria:

* unable to provide informed consent
* unable to provide detailed contact information
* previously enrolled in the current study
* pregnant women will be excluded given that they are a priority treatment population and receive special services
Study of the Safety, Tolerability and Pharmacokinetics of 1 Mg/Eye and 3 Mg/Eye Pegaptanib Sodium in Patients With Exudative Age-Related Macular Degeneration (AMD)

The objectives of this study are to characterize the safety, tolerability and pharmacokinetics of pegaptanib when given as 1 or 3mg/eye intravitreous injections every 6 weeks for 54 weeks in patients with subfoveal choroidal neovascularization (CNV) secondary to AMD.


Eligibility Criteria:
Inclusion Criteria:

Best corrected visual acuity in the study eye between 20/40 and 20/320 and better or equal to 20/800 in the fellow eye.

Subfoveal CNV, secondary to AMD, w/ a total lesion size \[including blood, scar/atrophy \& neovascularization\] of less than or equal to 12 disc areas, of which at least 50% must be active CNV.

Patients of either sex, aged greater than or equal to 50 years.

Exclusion Criteria:

Previous subfoveal thermal laser therapy. Any subfoveal scarring or atrophy \& no more than 25% of the total lesion size may be made up of scarring or atrophy.

More than one prior PDT w/ Visudyne is not permitted. Pts may not have rec'd their 1st PDT w/in less than 8 wks or more than 13 wks prior to the BSL angiography/photography for the study.
Plasma Adiponectin Level and Sleep Structures in Children With Prader-Willi Syndrome

Context: Adiponectin is an adipose tissue-derived hormone with an insulin sensitizing effect, and has been related to obstructive sleep apnea syndrome. In addition, children with Prader-Willi syndrome (PWS) suffer from excessive daytime sleepiness and the abnormality of rapid eye movement (REM) sleep.

Objective: To determine if the sleep stages are related to the plasma levels of adiponectin, resistin, and RBP4 (retinol binding protein-4), and whether these relationships are influenced by age, obesity and insulin resistance.

This comparative study was carried out in 28 PWS children and 18 controls. The enrolled PWS children were volunteers out of a pool of approximately 100 PWS children followed at Samsung Medical Center \[median age 8.0 years, interquartile range (7.0-10.5 years), BMI: median 24.2 kg/m2 (23.0-27.5 kg/m2)\] and 18 obese healthy children \[median age 9.0 years interquartile range (7.0-11.0 years), BMI: median 24.2 kg/m2 interquartile range (23.1-27.6 kg/m2)\].

Eligibility Criteria:
Inclusion Criteria:

* Prader Willi syndrome healthy children

Exclusion Criteria:

* history of seizure,
* mental or brain illness,
* adenoidectomy,
* tonsillectomy,
* craniofacial anomalies and any treatment at the time of the study.
Impact of Virtual Reality on Pre-procedural anxieTy Prior to Heart cathEterIzAtion - VR-THEIA

The primary aim of this study is to test the hypothesis that use of VR combined with standard procedural education will result in less pre-procedural anxiety than standard procedural education alone among patients undergoing first-time cardiac catheterization. The VR technology being evaluated in this study will allow patients to experience a 3-D simulation of certain aspects of their upcoming procedure prior to the actual procedure date.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo a left-heart catheterization procedure at the Meijer Heart Center
* 18-75 years of age
* Signed study consent form

Exclusion Criteria:

* History of cardiac procedure(s) in a cardiac catheterization laboratory
* History of seizures, migraine headaches or severe susceptibility to motion sickness
* Currently taking psychotropic drugs or on long-term psychotropic treatment
* Unable to read and speak English
* Visually impaired
* Unable to provide written consent
Impact of Botox Treatment Into the Upper One Third of the Face an Area on Mood and Self -Appearance Satisfaction

Botox treatment into the upper one third of the face (glabella, forehead lines and/or lateral canthal lines) to analyze mood and self -appearance satisfaction in a Post Covid period on non-naïve Botox patients

A historical period that will never happen again provides us a unique opportunity to evaluate the impact Botox Cosmetic has on the mood and self appearance satisfaction after a societal crisis such as the COVID19 pandemic.

Many regular users of Botox Cosmetic will have exceeded their normal treatment interval and their glabellar wrinkles will likely have returned to baseline. Many will want to get treated as soon as stay at home orders are rescinded and clinics are permitted to open back up. It would not be surprising that these patients also are experiencing a decrease in their mood secondary to weeks of social isolating and distancing. Many can expect to have a rebound elevation in their happiness and overall mood following the modified return to normalcy.

Botox Cosmetic has been studied as a mood elevating drug by reducing the animation of a glabellar furrow via the facial feedback mechanism hypothesis. This has been shown in patients who are not diagnosed with a major depressive disorder. Following a natural disaster, does the administration of Botox Cosmetic, in patients who are frequent Botox Cosmetic users, synergistically amplify the elevation in mood beyond what would be achieved had they not had their Botox Cosmetic treatment. Perhaps regular Botox Cosmetic users have a secondary gain desire for Botox Cosmetic beyond wrinkle reduction but also as a mood elevator.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between the ages of 18-75
* Subjects will be non-naive Botox users with a glabellar wrinkle severity score of 2 or 3 who are at least 20 weeks from their last BOTOX Cosmetic treatment
* Subjects that understand the purpose and aspects of the study, freely sign the consent and complete the required treatment and follow up visits.

Exclusion Criteria:

* Males and females below the age of 18
* Subjects that received neuromodulator injections to the glabella region in the last 20 weeks
* Subjects who do not meet a 2-3 wrinkle severity score in the glabellar region
* Subjects who have received other invasive or semi invasive cosmetic forehead or glabellar treatments
* Subjects who have had a change in antidepressant or anti- anxiety medication in last 6 weeks
* Subjects with severe depression, bipolar disorder, pregnant,
* Subjects who are pregnant, attempting to get pregnant, or breast feeding
* Subjects with a known allergy or sensitivity to any component of the study ingredients.
* Subjects that do not understand the purpose and aspects of the study, do not sign the consent and do not complete the required treatment and follow up visit will also be excluded.
Effectiveness of the Use of the Nintendo Switch Combined With Conventional Therapy in People With Acquired Brain Injury

Purpose: to observe the possible benefits produced by conventional therapy through virtual reality with the Nintendo Switch to try to improve motivation and increase the degree of care satisfaction. The aim is to improve postural control in both seated and standing positions and to maintain and improve cognitive capacity.

Material and methods: one group (experimental group) will receive a total of 8 one-hour sessions or 16 half-hour sessions, depending on their individual needs, for 8 weeks using the Nintendo Switch. The other group (control group) will continue to receive their conventional scheduled therapy.

Measures: Abilhand, MEC-Lobo, FIST, Fugl-Meyer, Berg Balance Scale and CSQ-8.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women, over 30 years of age who have suffered an acquired brain injury.
* Mild or moderate cognitive impairment as measured by the MEC-Lobo test (score greater than 23/35).
* Regularly attend some conventional therapy (neuropsychology, physiotherapy or occupational therapy).
* Agree to participate voluntarily by signing the informed consent form.

Exclusion Criteria:

* Present severe cognitive impairment as measured by the MEC-Lobo test (less than 23/35).
* Present aphasia of comprehension or expression.
* Present associated neurodegenerative pathology.
* Present any pathology underlying the acquired brain damage (diabetes, heart disease, COPD, etc.), heart disease, COPD, etc.).
* Voluntarily refuse to participate in the study.
Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation

This study is to evaluate the efficacy and safety of combination of Camrelizumab (Immunotherapy, PD-1 inhibitor), Fluzoparib (PARP inhibitor) and Nab-paclitaxel in neoadjuvant therapy of Her-2 negative breast cancer patients with HRR gene mutation.

This is a prospective, single-center, open-label phase II clinical trial investigating the activity of Camrelizumab+Fluzoparib+Nab-paclitaxel combination therapy in breast cancer patients with Her2-negative and HRR gene mutation for neoadjuvant therapy.

Anticipated 66 candidates meeting all study eligibility criteria will receive 8 cycles of Nab-paclitaxel (260mg/m2) every 3 weeks, which will add Camrelizumab (200mg, d1) and Fluzoparib (100mg BID) from the second cycle.

HRR gene mutation contains at least one pathogenic or likely pathogenic variant in germline or somatic BRCA1, BCRA2 and PALB2 genes, or in germline ATM, BARD1, BRIP1, CDK12, CHEK2, RAD51C, RAD51D genes.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented Her-2 negative
* TNM stage: T1c, N1-N2；T2-4, N0-N2；any T, N3
* No distant metastatic disease
* Eastern Cooperative Oncology Group Performance Status: 0\~1
* HRR gene mutation: at least one pathogenic or likely pathogenic variant in germline or somatic BRCA1, BCRA2 and PALB2 genes, or in germline ATM, BARD1, BRIP1, CDK12, CHEK2, RAD51C, RAD51D genes.

Exclusion Criteria:

* Patients who are pregnant or lactating at the time of randomization or refuse to contraception.
* Patients who have other malignant diseases within 2 years, except for cured skin basal cell carcinoma, breast carcinoma in situ or cervical carcinoma in situ
* Patients with psychiatric disorder, peripheral or central nerve system disease or any disorder, which compromises ability to give informed consent or participate in this study.
* Patients who have myocardial infarction or congestive heart failure, or other serious cardiac disease.
* Patients who have used immunosuppressive drug or corticosteroids within 14 days.
* Patients who have other diseases which researchers.
* Patients who allergy to any of the drugs in this trail.
A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration

This study will assess the safety and efficacy of the brimonidine intravitreal implant in participants with geographic atrophy due to age-related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Geographic atrophy due to age-related macular degeneration in the study eye
* Visual acuity better than or equal to 20/125 Snellen equivalent in the study eye and 20/200 Snellen equivalent in the fellow eye.

Exclusion Criteria:

* Cataract surgery or Laser-Assisted in situ Keratomileusis (LASIK) in the study eye in the last 3 months
* Infections in either eye in the last 3 months