cyrilzakka/clinical-trials huggingface dataset:
The RECAP2 Study: Midazolam and Psilocybin

The goal of this clinical trial is to learn about the role that inducing neuroplasticity (the brain's ability to adapt and change) plays in the behavioral effects of psilocybin in people who have experienced a mild decline in emotional wellbeing.

Researchers will compare different doses of psilocybin combined with midazolam or placebo to see what dose induces increased wellbeing.

Participants will:

* Receive one of four possible combinations of medications
* Undergo an MRI
* Complete questionnaires
* Undergo transcranial magnetic stimulation (TMS) and EEG

The purpose of this study is to investigate the role that inducing neuroplasticity plays in the behavioral effects of psilocybin in people with modest decrements in emotional wellbeing.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 70 years at screening, of any identified gender and racial/ethnic group
* Physically healthy; does not meet criteria for an exclusionary medical condition
* English-speaking (able to provide consent and complete questionnaires)
* Modest decrement in self-reported wellbeing without the presence of a DSM-5 Axis I mood or anxiety disorder

Exclusion Criteria:

* Exclusionary DSM-5 psychiatric diagnosis and/or active suicidal ideation
* Exclusionary medical conditions
* Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis)
* Clinically significant electrocardiogram (ECG)
* Use of psychotropic or CNS-altering medications within 3 months of screening
* Hypertension or tachycardia
Study of MDX-1411 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma

To determine if MDX-1411 is safe for the treatment of chronic lymphocytic leukemia or mantle cell lymphoma.

Dose-escalation, multidose study of MDX-1411, a fully human nonfucosylated monoclonal antibody (mAb) targeting the CD70 transmembrane cell-surface protein, which is highly expressed in B-cell malignancies such as CLL and MCL.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of relapsed/refractory MCL or hematologically/bone marrow confirmed relapsed/refractory CLL that is not amenable to cure by surgery or other means and has failed at least 1 prior systemic therapy;
* Subjects may have been treated with up to 6 prior systemic therapies for relapsed/refractory disease or have become intolerant to a systemic therapy
* For MCL, must have measurable disease
* At least 4 weeks since the last systemic therapy, including RT, for the treatment of MCL/CLL;
* At least 4 weeks since taking any corticosteroids prior to the first dose of MDX-1411
* ECOG Performance Status 0 to 2;
* No known positivity for human immunodeficiency virus (HIV) and no active infection with Hepatitis B or Hepatitis C;

Exclusion Criteria:

* History of severe hypersensitivity reactions to other monoclonal antibodies;
* Use of other investigational drugs within 30 days before study drug administration
* Prior treatment with any other anti-CD70 antibody;
* Active infection requiring i.v. systemic therapy within 4 weeks of receiving the first dose of MDX-1411;
* Evidence of bleeding diathesis or coagulopathy;
* Active autoimmune disease requiring immunosuppressive therapy;
* Known current drug or alcohol abuse;
* Underlying medical conditions that will make the administration of MDX-1411 hazardous
Pilot Study of the Impact of Giant Cell Arteritis and Its Treatment on the Autonomy of the Elderly in the First Year of Care

Giant cell arteritis is the leading cause of vasculitis in the elderly. No work evaluates its impact on autonomy. At the diagnosis a gerontological evaluation will be carried out including the scores ADL, iADL, MNA, SF 36, SPPB, FRIED and GDS. A monthly telephone reassessment will collect ADL and iADL. The end-of-study consultation at M12, conducted by a geriatrician, will have the same scores as at M0. This will make it possible to evaluate the difference in the functional autonomy score between M0 and M12 in the elderly with ACG.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 65 years with at least 2 comorbidities \* present, or age greater than or equal to 75 years
* Diagnosis of ACG meeting the diagnostic criteria of ACG 1990 ACR

  * comorbidity = chronic pathology

Exclusion Criteria:

* Neoplastic pathology under treatment
* Brain pathology with motor disability
* Dementia at a severe stage (MMS \<22/30)
* Unable to answer the phone
* Participation in a therapeutic clinical trial
Nutraceuticals and Drug Treatment in Frail Older Adults

Frailty is a multidimensional condition due to reserve loss leading to physical and cognitive impairment that is very common in older adults; in fact, its incidence increases with age. Frail older adults present a high risk of adverse events such as disability, hospitalization and mortality. It is very important to check comorbidities and complications to reduce the incidence of cognitive and physical impairment.

Frailty is a multidimensional condition due to reserve loss leading to physical and cognitive impairment that is very common in older adults; in fact, its incidence increases with age. Frail older adults present a high-risk of adverse events such as disability, hospitalization and mortality. It is very important to check comorbidities and complications to reduce the incidence of cognitive and physical impairment; hence, clinical evaluation is the main goal to get an early diagnosis and a timely treatment for cognitive impairment. Considering this background, the study will investigate the effects of nutraceuticals and drug treatment on cognitive impairment in frail older adults. In this scenario, global cognitive function will be evaluated with Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) test and physical impairment with the Fried criteria and 5-metres gait speed test.

Eligibility Criteria:
Inclusion Criteria:

* age \> 65 years;
* a frailty status.

Exclusion Criteria:

* age \< 65 years.
* no frailty status.
* left ventricular ejection fraction \<25%, with previous myocardial infarction or previous PPCI or/and coronary by-pass grafting.
Gynecology Beyond Gender: Cervical Cancer Screening in Transgender Men in France

In France, cervical cancer screening is the subject of a national screening programme organized for all asymptomatic individuals aged 25 to 65 years with a cervix. The latter contributes greatly to the prevention and early treatment of this disease, whose public health challenge is recognized worldwide.

One of the objectives of this programme is to reduce inequalities in access. Transgender men, i.e. individuals assigned to the female gender at birth but identifying with the male gender, are concerned by this screening as long as they still have a cervix, according to the same modalities as for cisgender women.

However, they are often excluded from health care, including organized screening programs. Gender change in civil status is one of the obstacles.

The provision of gynaecological care is sometimes inadequate. The lack of knowledge of health professionals and the problems of discrimination that transgender people may face reduce the chances of having equitable access.

This survey aims to explore the perception that transgender men have of cervical cancer screening and to identify the challenges they face, the obstacles and the levers to access this prevention program.


Eligibility Criteria:
Inclusion Criteria:

* transgender male (assigned female at birth but identifying as male)
* aged 25 to 65 years
* Having retained her cervix
* Having had sex before.

Exclusion Criteria:

* Under 25 and over 65
* Not having retained his cervix
* History of cancerous lesion of the cervix
Comparative Effects of IMT Vs EMT Along With AIT in COPD Patients

Chronic Obstructive Pulmonary Disease (COPD) is the 3rd leading cause of mortality and 7th leading cause of ill-health worldwide. It is characterized by persistent and progressive air flow resistance with expiratory flow more compromised as compared to inspiratory flow leading to CO2 retention and prominent hyperinflation of lungs. The overall effects of COPD on the patient's entire body include pulmonary, followed by extra-pulmonary manifestations in which musculoskeletal derangements are more pronounced and interfere with daily activities, further deteriorating the patient's health. Restricted air flow leads to an increase in shortness of breath on slight exertion and early fatigue or exhaustion of respiratory muscles due to over work. Literature from the past describes how COPD care has advanced and emphasizes the value of pulmonary rehabilitation in addition to medicinal management to treat decadence. Many studies show that Inspiratory muscle training has positive effect on ABG's, some PFT's and diaphragmatic function. Endurance and strength training improve patient activity of daily living and dyspnea.

This study intricate the collation of Respiratory Muscle Training and Aerobic Interval Training on functional performance, exertional dyspnea and fatigue level in patients diagnosed with COPD. A randomized controlled trial will be integrated with the sample size of 53 patients which is calculated through epi-tool. Age of selected Patients will fall between 30-55 years and will be randomly assigned into 2 groups. Group A (Experimental group A) will get Inspiratory breather training along-with Aerobic Interval Training, Group B (Experimental group B) will get Expiratory muscle training along-with Aerobic Interval Training (Same Protocol). Data will be gathered from Pulmonology wards and OPD of selected hospital. Clinical Assessment will be incorporated through Karnofsky performance scale, Fatigue Severity Scale, MmRC Dyspnea scale, Digital Spirometer, and 6MWT. Pre-intervention assessment measures and Post-intervention measures will be noted and results will be compared. Study Duration will be of 06 months after approval of synopsis. Data analysis will be done through SPSS.

Key words: Aerobic Interval training (AIT), The Breather Device (BD), 6-min walk test (6MWT), Fatigue severity scale (FSS), Modified Medical Research Council dyspnea scale (mMRC), Chronic Obstructive Pulmonary Disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a diagnosed case of COPD.
* Participants must be between the ages of 30 and 55 years old.
* Participants must have GOLD II and III stage COPD.
* Both men and women are eligible for the study.

Exclusion Criteria:

* Participants with a history of cardiovascular disease.
* Participants with a history of neurological disease.
* Participants with a history of orthopaedic disease.
* Participants with a history of neuromuscular disease.
* Participants who had experienced a recent COPD exacerbation within the past 3 months.
A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder

The purpose of this study is to investigate the efficacy of JNJ-42165279 during 12 weeks of treatment in participants with Social Anxiety Disorder (SAD).

This is a Phase 2a randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participants know about the study intervention), placebo-controlled, parallel-group, multi-center study of JNJ-42165279 in participants with social anxiety disorder. Participants will receive 25 milligram (mg) JNJ-42165279 or matching placebo orally once-daily from Day 1 up to 12 weeks. Participants will primarily be assessed for the change from baseline in Liebowitz Social Anxiety Scale (LSAS) at Week 12. Safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Must have a primary DSM-5 diagnosis of Social anxiety disorder (SAD) except those with performance only as a specifier. Participants with a diagnosis of comorbid Generalized Anxiety Disorder (GAD) or Major Depressive Disorder (MDD) may be included if the Investigator considers SAD to be the predominant diagnosis. Participants with current or lifetime history of Attention deficit hyperactivity disorder (ADHD) and specific phobia may be included as well
* Must have a Liebowitz Social Anxiety Scale score greater than or equal (\>=) 70 at Screening and Baseline
* Participants with a current episode of MDD must have a HDRS17 total score less than or equal to (\<=) 18
* Must have a body mass index (BMI) between 18 and 35 kilogram per meter square (kg/m\^2), inclusive, at screening
* Female participants must be either postmenopausal or surgically sterile

Exclusion Criteria:

* Participants who have performance only SAD are excluded. Participants with other current significant psychiatric condition(s) (Axis 1 under DSM-IV), including, but not limited to, MDD with psychotic features (lifetime), bipolar disorder (including lifetime diagnosis), obsessive-compulsive disorder, borderline personality disorder, eating disorder (e.g., bulimia, anorexia nervosa), autism spectrum disorders, post-traumatic stress disorder (PTSD) or schizophrenia are excluded. Participants with a diagnosis of comorbid GAD or MDD may be included
* Participants is currently receiving specific psychotherapy for SAD
* Has a history of more than two unsuccessful adequate pharmacological treatment trials for SAD, defined as lack of response to at least 10 weeks of treatment at adequate doses (e.g., paroxetine \>= 40 milligram per day (mg/day) or its equivalent; or clonazepam \>= 2.5 mg/day or its equivalent)
* Concurrent use of psychotropic medications
* has a history of or current thyroid disease, thyroid dysfunction and is currently untreated for it
Pulmonary Hypertension Screening in Patients with Interstitial Lung Disease for Earlier Detection

Study GMS-PH-001 is a multicenter, open-label, non-randomized study to prospectively evaluate screening strategies of pulmonary hypertension (PH) in patients with interstitial lung disease (ILD).

In this study, subjects will undergo a broad range of clinical assessments that are potentially associated with PH. Study data will be used to identify and weigh specific clinical parameters based on their prognostic significance for right heart catheterization (RHC)-confirmed PH. There is no study drug under investigation in this study. The study consists of 2 study visits: a Screening Visit and Study Visit 1.

Clinical assessments include pulmonary function tests (PFTs); high resolution computed tomography (HRCT); physical examination; 6-Minute Walk Test; blood draw for clinical laboratory parameters, plasma brain natriuretic peptide (BNP) concentration and plasma N-terminal pro-BNP (NT-proBNP) concentration; echocardiography; University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ); King's Brief Interstitial Lung Disease Questionnaire (K-BILD); 36-Item Short Form Survey (SF-36); Pulmonary Hypertension Functional Classification Self Report (PH-FC-SR); Investigator's Suspicion of PH Questionnaire; adverse event (AE) monitoring; and RHC.

As the primary objective of this study is to collect a broad range of clinical parameters in patients with ILD, it is expected that numerous exploratory and post-hoc analyses will be performed to identify and weigh specific parameters based on their prognostic significance for PH in this patient population with the goal of developing a screening algorithm for PH in patients with ILD.

Eligibility Criteria:
Inclusion Criteria

1. Patient gives voluntary written informed consent to participate in the study.
2. Patients with a diagnosis of ILD based on computed tomography imaging, including:

   1. Idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis
   2. Connective tissue disease-associated ILD with forced vital capacity (FVC) \<70%
   3. Hypersensitivity pneumonitis
   4. Scleroderma-related ILD
   5. Autoimmune ILD
   6. Nonspecific interstitial pneumonia
   7. Occupational lung disease
   8. Combined pulmonary fibrosis and emphysema
3. Patients must have at least 2 signs or symptoms suggestive of PH, as specified by the study protocol.

Exclusion Criteria

1. Prior RHC with mPAP \>20 mmHg.
2. Currently on a Food and Drug Administration (FDA)-approved pulmonary arterial hypertension medication.
3. Diagnosed with chronic obstructive pulmonary disease.
4. Uncontrolled or untreated sleep apnea.
5. Pulmonary embolism within the past 3 months.
6. History of ischemic heart disease or left-sided myocardial dysfunction within 12 months of Screening, defined as left ventricular ejection fraction \<40% or pulmonary capillary wedge pressure \>15 mmHg.
7. Any other clinical features that, in the opinion of the Investigator, might adversely affect interpretation of study data or study safety, or make the patient unsuitable for RHC.
A Study in Healthy Men to Test Whether Food Influences the Amount of BI 3731579 in the Blood

This trial investigates whether food influences the amount of BI 3731579 in the blood.


Eligibility Criteria:
Inclusion criteria:

* Healthy male 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 50 years (inclusive)
* Body Mass Index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

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
* 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.
Spinal met_radiosurgery/SBRT Study

Demonstrate the technical feasibility of treating spine metastases with image-guided radiosurgery/SBRT


Eligibility Criteria:
Inclusion Criteria:

1. The patient must have localized spine metastasis from the C1 to L5 levels by a screening imaging study (bone scan, PET, CT, or MRI). A solitary spine metastasis; two separate spine levels; or up to 3 separate sites are permitted. Each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies. A paraspinal mass ≤ 5 cm is allowed.
2. Zubrod Performance Status 0-2;
3. Age ≥ 18;
4. History/physical examination within 2 weeks prior to registration;
5. No pregnancy for women of childbearing potential;
6. MRI of the involved spine within 4 weeks prior to registration to determine the extent of the spine involvement. MRI is required as it is superior to a CT scan in delineating the spinal cord as well as identifying an epidural or paraspinal soft tissue component. If possible, an MRI with thin slice thickness (\<1mm) with 3D reconstruction quality would be most preferable for treatment planning purpose.
7. Numerical Rating Pain Scale within 1 week prior to registration. The patient must have a score on the Scale of ≥ 4 for at least one of the planned sites for spine radiosurgery. Patients taking medication for pain at the time of registration are eligible.
8. Neurological examination within 1 week prior to registration to rule out rapid neurologic decline; see Appendix IV for the standardized neurological examination. Patients with mild to moderate neurological signs are eligible. These neurological signs include radiculopathy, dermatomal sensory change, and muscle strength of involved extremity 4/5 (lower extremity for ambulation or upper extremity for raising arms and/or arm function).
9. Patients with epidural compression are eligible provided that there is no significant displacement or compression on the spinal cord itself.
10. Patients with a paraspinal mass ≤ 5 cm in the greatest dimension and that is contiguous with spine metastasis are eligible.
11. Patients must provide study specific informed consent prior to study entry.

Exclusion Criteria:

1. Histologies of myeloma or lymphoma.
2. Patients with any spine metastasis with a rating of \< 4 on the Numerical Rating Pain Scale.
3. Non-ambulatory patients.
4. Spine instability due to a compression fracture.
5. \> 50% loss of vertebral body height.
6. Significant spinal cord compression or displacement.
7. Patients with rapid neurologic decline.
8. Bony retropulsion causing neurologic abnormality.
9. Prior radiation to the index spine.
10. Patients for whom an MRI of the spine is medically contraindicated.
Study to Evaluate the Cardiac Safety of TAS-102 in Patients With Advanced Solid Tumors

The purpose of this study is to evaluate the cardiac safety of TAS-102 in patients with advanced solid tumors.

This is a Phase 1, nonrandomized study to evaluate the cardiac safety of TAS-102 in patients with advanced solid tumors. The study is conducted in 2 phases: the cardiac safety evaluation phase to investigate cardiac repolarization and the cardiac safety profile (Cycle 1) and the extension phase to assess the safety profile and antitumor activity (subsequent cycles).

Eligibility Criteria:
Inclusion Criteria:

1. Has provided written informed consent
2. Has advanced solid tumors (excluding breast cancer) for which no standard therapy exists
3. Has received no more than 5 prior cancer therapies
4. ECOG performance status of 0 or 1
5. Is able to take medications orally
6. Corrected QT interval using Bazett's correction is no more than 450 msec on resting ECG
7. Has adequate organ function (bone marrow, kidney and liver)
8. Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.

Exclusion Criteria:

1. Has had certain other recent treatment e.g. major surgery, extended field radiation, anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration
2. Certain serious illnesses or medical condition(s)
3. Has a family history of unexplained sudden death or long QT syndrome
4. Has had a documented cardiovascular complication following a fluoropyrimidine-derived treatment
5. Is a patient for whom it is not technically possible to obtain quality ECG tracings
6. Is receiving a concomitant drug that is known to affect QT interval or to be arrhythmogenic
7. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
8. Known sensitivity to TAS-102 or its components
9. Is a pregnant or lactating female
10. Refuses to use an adequate means of contraception (including male patients)