cyrilzakka/clinical-trials huggingface dataset:
A Phase I Study of LX-039 Tablets

This is a phase I dose escalation and expansion study in patients with ER+, HER2- advanced breast cancer to explore the tolerance, PK/PD(pharmacokinetics/pharmacodynamics) profiles and preliminary anti-tumor activity of different doses of LX-039 tablets. The trial consists of two parts, dose escalation and dose expansion. Part 1 is the dose escalation phase with initial 6 dose groups, and "3 + 3" design is used to explore MTD of the drug; Part 2 is the dose expansion phase with 2 \~ 3 doses selected for expansion according to the escalation results of Part 1, and more subjects are enrolled to further observe the tolerance and preliminary anti-tumor activity of the drug. After the completion of dose expansion, the recommended phase II dose (RP2D) will be determined after discussion based on the obtained tolerance and PK/PD data.


Eligibility Criteria:
Inclusion Criteria:

1. Be able to read and sign the informed consent form.
2. Adult females (aged ≥18 and ≤75 years).
3. Be diagnosed with breast cancer confirmed by pathological examination.
4. Be histologically or cytologically confirmed estrogen receptor positive (ER+≥1% positive staining).
5. Be postmenopausal.
6. Subjects who have previously received endocrine therapy and obtained benefit.
7. ECOG(Eastern Cooperative Oncology Group) score ≤ 1.
8. Subjects in part2 of the study need to have measurable lesions that meet RECIST 1.1 criteria.
9. Has recovered from toxicity or injury from prior chemotherapy/radiotherapy .
10. Enough hematology and organ function.
11. Expected survival\>3 months.

Exclusion Criteria:

1. Subjects with HER2-overexpressing breast cancer.
2. Subjects with known brain metastases or other central nervous system metastases that are symptomatic or untreated.
3. Patients with symptomatic advanced disease who have spread to the viscera and are at risk of life-threatening complications.
4. Subjects who received second-line or above chemotherapy.
5. Subjects with known allergy to this product or any of its components.
6. Subjects who previously used other estrogen receptor down regulators than fulvestrant.
7. Subjects who received endocrine therapy or other anti-tumor agent or radiotherapy within 4 weeks prior to study entry.
8. Subjects who received cell therapy or tumor vaccine therapy;
9. Subjects with severe immunosuppression .
10. Severe or uncontrolled disease.
11. Subjects with diseases or abnormalities that may affect the administration and absorption of drugs.
12. Subjects with other malignancy within 5 years prior to study entry.
13. Subjects with other high risks of thrombosis or require long-term use of antiplatelet drugs.
14. Subjects with history of definite neurological or psychiatric disorders in the past.
15. Subjects who are HIV(human immunodeficiency virus) antibody positive, HBsAg(hepatitis B surface antigen) positive or HCV(hepatitis C virus)antibody positive.
16. Subjects with other uncontrolled malignant/non-malignant diseases, significant laboratory abnormalities, participation in the study may increase the risk.
Stimulation Parameters and Non-motor Symptoms in PD Treated With DBS

This study evaluates the role of subthalamic nucleus (STN) stimulation location and frequency on a range of cognitive processes in Parkinson's patients who have undergone Deep Brain Stimulation (DBS).

Pre- and post- DBS implantation brain scans will be reviewed by the study team to see if patients' DBS settings can be personalized. If so, study subjects will undergo adjustments to their DBS settings and be asked to perform cognitive tests. Some patients will be asked to come back for a second visit for brain scans.

Eligibility Criteria:
Inclusion Criteria:

1. Between 40 and 70 years of age,
2. Ability to provide informed consent,
3. Clinical diagnosis of idiopathic Parkinson disease (PD) by a movement disorders neurologist,
4. Disease duration of at least 4 years,
5. Treated with bilateral STN DBS for at least 3 months prior to study enrollment.

Exclusion Criteria:

1. History of prior neurosurgical intervention for PD (e.g., DBS, thalamotomy, pallidotomy)
2. History of other central nervous system disease (excluding migraine),
3. Presence of active psychiatric symptoms meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Axis-I disorder on formal psychiatric evaluation, with the exception of mild depression (Beck Depression Inventory-2 score below 19),
4. Cognitive impairment meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for dementia on formal neuropsychological evaluation,
5. Current alcohol or substance abuse,
6. Lack of fluency in English which would invalidate cognitive testing,
7. Hearing or visual impairment precluding cognitive testing.

   Exclusion criteria for Day 2 procedures:
8. Inability to safely undergo MRI procedure (i.e., metal objects like prostheses, pacemakers)
Influence of Co-diagnosis of Chronic Fatigue Syndrome in Patients With Fibromyalgia.

The purpose of this study is to evaluate differences in neuroimmunoendocrine response and quality of live in patients diagnosed with Fibromyalgia, with or without a co-diagnosis of Chronic Fatigue Syndrome.

The limited literature published in concordant relation affects the chronic fatigue syndrome comorbidity in the daily life of fibromyalgia patients leads us to design this study with the main objective of evaluating differences in the quality of life associated with pain and stress, mainly in relation to levels of physical activity, sedentary lifestyle and sleep in patients diagnosed with fibromyalgia, with or without a parallel co-diagnosis of chronic fatigue syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia and/or Chronic Fatigue Syndrome diagnosis by rheumatologists or internal medicine professionals.
* Age not less than 40 years old and not more than 65 years old.

Exclusion Criteria:

* Suffering from diagnosed "major depression".
* Suffer diagnosed multiple chemical sensitivity.
* Corticosteroid treatment or anti-cytokine therapies.
* Periodically carry out programmed therapeutic physical activity in the two months prior to the accelerometry tests.
Honest, Open, Proud for Soldiers with Mental Illness

The purpose of the study is to evaluate the feasibility and efficacy of the group-based intervention "Honest, Open, Proud" among soldiers with mental illness.

Soldiers with mental illness typically face a two-fold problem. On the one hand, they have to cope with the symptoms of their mental illness; on the other hand, they often have to deal with stigma and discrimination. Both due to fear of public stigma and due to self-stigma or shame, soldiers with mental illness may decide to keep their condition a secret or even to withdraw from other people altogether in order to minimize the risk of being labeled. Secrecy can help on the short term to protect individuals from public stigma, but usually it has negative long-term consequences such as social isolation, distress and avoidance of help-seeking. Disclosure, on the other hand, carries the risk to be discriminated by others, but can reduce the burden of secrecy, lead to support by others and reduce public stigma.

In this study investigators aim to test the efficacy (see our outcomes above) of Honest, Open, Proud run by soldiers with lived experience of mental illness.

Eligibility Criteria:
Inclusion Criteria:

* At least one self-reported current axis I or axis II disorder according to DSM-5, which is not restricted to only substance-related disorder(s)
* Age 18 or above
* Ability to provide written informed consent
* Fluent in German (needed for self-report measures)
* At least a moderate level of self-reported disclosure-related distress/difficulty (score 4 or higher on the screening item 'In general, how distressed or worried are you in terms of secrecy or disclosure of your mental illness to others?', rated from 1, not at all, to 7, very much)
* Current inpatient, day-clinic or outpatient treatment at the Center for Military Mental Health, Berlin, Germany
* from April 2018 onwards we decided to also include non-military first responders (fire fighters or police officers) who are treated in the Center for Military Mental Health, Berlin, Germany

Exclusion Criteria:

* Self-reported diagnosis of only a substance- or alcohol-related disorder, without non-substance related current psychiatric comorbidity. We will exclude people who only have a substance-/alcohol-related disorder because the disclosure of these disorders is not the topic of the HOP intervention
* Intellectual disability
* Organic disorders
Comparison of Two Respiratory Physiotherapy Treatments in Postcovid-19 Patients.

To test the effectiveness of a respiratory physiotherapy treatment plan in patients who have passed COVID-19, comparing two randomized groups, for the performance of different respiratory musculature training protocols. To objectify the results data obtained by means of ultrasound measurements and spirometry, observing the differences obtained at the beginning and end of the study, verifying the effectiveness of the PowerBreathe® ,Therosold PEP® tools and the effectiveness of diaphragmatic, abdominal and expiratory exercises.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Covid and suffering from functional limitations in the respiratory system.
* Patients over 18 years of age.
* Patients under 65 years of age.
* Patientes with cognitive ability to perform spirometry.
* Patients with the physical capacity to perform spirometry

Exclusion Criteria:

* - Patients diagnosed with Covid and without functional limitations in the respiratory system.
* Patients under 18 years of age.
* Patients over 65 years of age.
* Patients without cognitive capacity to perform spirometry.
* Patients without physical capacity to perform spirometry.
Modeling Tic Change During Behavior Therapy for Tics

Chronic tics are a disabling neuropsychiatric symptom associated with multiple child-onset mental disorders. Chronic tics affect 1-3% of youth and can be associated with impaired functioning, emotional and behavioral problems, physical pain, diminished quality of life, and peer victimization. Chronic tics are the primary symptom of Tourette Syndrome (TS) and Persistent Motor/Vocal Tic Disorders.

CBIT is a manualized treatment focused on increasing tic controllability. Its core procedure is competing response training (CRT), in which patients learn to inhibit tics by learning and applying a competing motor action to one tic at a time. CBIT is recommended as a first-line treatment relative to medications and other therapies. However, only 52% of children and 38% of adults show clinically meaningful tic improvement. Large randomized trials have demonstrated the superiority of CBIT over supportive therapy in child and adult patients, and meta-analysis shows comparable effect sizes for CBIT and medication. Although increasing tic controllability is the primary goal of CBIT, tic controllability nor its correlates have been examined longitudinally during the intervention.

The overall objective of this study is to use fine-grained data collection strategies to identify patterns in tic controllability and other relevant related variables that are associated with treatment response to CBIT. Participants with chronic tics will complete a manualized course of 8-session CBIT. Behavioral, psychosocial, and global functioning will be assessed longitudinally to examine predictors and correlates of response. CBIT sessions will be video recorded.


Eligibility Criteria:
Inclusion Criteria:

* Age 12-21 years at time of enrollment.
* Current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. Tics must not be due to a medical condition or the direct physiological effects of a substance.
* At least moderate tic severity, defined as a Yale Global Tic Severity Scale total score

  ≥14 (≥9 for those with motor or vocal tics only).
* Full scale IQ greater than 70
* English fluency to ensure comprehension of study measures and instructions.

Exclusion Criteria:

* Active suicidality.
* Previous diagnosis of psychosis or cognitive disability.
* Substance abuse or dependence within the past year.
* Concurrent psychotherapy focused on tics.
* Neuroleptic/antipsychotic medications.
* Taking a medication that has not reached stability criterion (same medication and dose for 6 weeks with no planned changes over the intervention period)
Virtual Reality for Pain Management in Orthopaedic Patients

1. Investigators will determine the feasibility of a virtual reality pain control program (VR-PCP) as a non-pharmacologic adjunct for pain management while in the hospital (i.e. patient ability and willingness to use the system measured by average time spent on the device).
2. Investigators will evaluate if there is a difference between the average daily use of opioid medications taken by patients who received usual care pain management versus patients using a VR-PCP.
3. Investigators will assess for differences in short-term postoperative patient-reported pain intensity (PROMIS Patient Intensity v1.0) for patients who received usual care pain management versus those who also have access to a VR-PCP.

Orthopedic surgeons rank third amongst physician prescribers of opioids to adults in the United States4. The deleterious effects of the opioid epidemic have been well studied at both the individual and population level.2 3 Orthopaedic trauma patients in particular have high rates of psychological stress and disability related to protracted narcotic usage 5. However, opioid medications may not need to be the mainstay of pharmacologic pain management for patients with orthopaedic injuries. For example, one recent study from the Netherlands showed that 82% of patients with ankle fractures treated in the United States were prescribed opioids at discharge, whereas only 6% of Dutch patients were given narcotics. 6

Non-pharmacologic interventions for pain management in the acute orthopaedic injury setting deserve full investigation. Virtual reality for pain management has been used in burn patients, pediatric patients, for procedures under local anesthesia and in the chronic pain setting. Results of these investigations are promising and demonstrate reduced narcotic usage and improved pain scores.7 8 9 Currently, there are no published reports on the use of virtual reality for pain management in the orthopaedic literature. By investigating VR as a non-pharmacologic intervention for pain, orthopaedic trauma patients may be able to avoid the known risks of narcotic medication while still controlling their pain and regaining function after their injury. Our study will lay groundwork for longer-term studies to evaluate the impact of virtual reality on functional outcomes, opioid usage after hospital discharge and patient satisfaction scores. VR can also be investigated for post-operative pain control across other orthopedic subspecialties.

Eligibility Criteria:
Inclusion Criteria:

* 18 and older
* Patients who sustained factures treated with open reduction internal fixation. Polytrauma patients whose fractures are definitively fixed in one discrete operating room visit will be included.

Exclusion Criteria:

* Cognitive impairment
* Injuries requiring staged surgical fixation (i.e. ex-fix to ORIF)
* Seizure disorder or other contraindication to VR usage
* Significant medical complications during hospitalization precluding use of a VR headset
* Significant surgical complication during hospitalization requiring unanticipated return to the operating room during index admission.
The Effect of Virtual Reality (VR) Versus Conventional Vestibular Rehabilitation and Progressive Muscle Relaxation (PMR) to Improve Balance and Stress Among Patients of Persistent Postural Perceptual Dizziness (PPPD).

To compare the effect of virtual reality (VR) versus conventional vestibular rehabilitation and progressive muscle relaxation (PMR) to improve balance and stress among patients of persistent postural perceptual dizziness (PPPD).

Through this randomized controlled trial, we evaluate the effectiveness of three modern interventions in patients with persistent postural perceptual dizziness. In order to study the novel facets of PPPD and to cover a large research gap, it is necessary to explore the psychological and physiological aspects of PPPD. At individualized levels, this study aimed to enable patients to become more independent in their social and personal lives by overcoming stress and balance issues. Socially, it reduces stigma by raising awareness, promoting understanding, providing better health access, facilitating communities, and promoting a more supportive and inclusive environment. This research can refine rehabilitation therapies at the institutional level and enhance health care provider training. It increases treatment and resource allocation, leading to better outcomes in the field. It provides a new platform for research.

Eligibility Criteria:
Inclusion Criteria:

* age groups ranging 18-25 years and having symptoms of dizziness, and lightheadedness over the period of \&gt;3months while having predisposing stress factor. The Individuals who are ready to take part willingly in the follow up sessions should be included in the research

Exclusion Criteria:

* The participants who have any other neurological disease and cause of dizziness are excluded from this study. There should be no history of smoking, drug abuse and alcohol, and any other neurological condition that affects the balance. Subjects with active Meniere's disease /BPPV/bilateral vestibulopathy are also excluded.
An Open Label, Multi-Center, Follow-on Study Examining the Long-Term Safety and Efficacy of Insulin VIAject™ in Subjects With Type 1 Diabetes Mellitus

Follow-on study to the VIAject™ 06J study to evaluate the long-term safety and efficacy of VIAject™ when used as prandial insulin in combination with Lantus® in subjects with type 1 diabetes mellitus.

The VIAject™ 06J study is the efficacy and safety study for insulin VIAject™ to demonstrate equivalent blood glucose control in patients with type 1 diabetes mellitus with insulin and regular human insulin as prandial insulin and to demonstrate an equivalent safety profile for VIAject™ in comparison to human insulin


Eligibility Criteria:
Inclusion Criteria:

1. Completed the VIAject™-06J protocol
2. Informed consent must be obtained in writing for all subjects

Exclusion Criteria:

1. History of frequent severe hypoglycemia within the prior six months which prevent study participation at the discretion of the investigator
2. History of known hypersensitivity to any of the components in the study medication
3. Progressive disease likely to prove fatal
4. Known significant hepatic disease or serum AST or ALT values \> 3 X upper limit of normal or bilirubin levels \> 1.5 X upper limit of normal
5. Severe complications of diabetes mellitus including a history or finding of Stage III or IV diabetic retinopathy (see Appendix B), proteinuria \> 2+ by urine dipstick, serum creatinine of \>1.8 mg/dl for males or \>1.5 mg/dl for females, history of renal transplant, severe peripheral vascular disease, which has resulted in amputation or recent onset of chronic foot ulcers or claudication, or the recent, clinically documented loss a pedal pulse.
6. History of moderate to severe ketoacidosis within the 3 months preceding screening for the study
7. Current drug or alcohol abuse, or a history which in the opinion of the Investigator will impair subject safety or protocol compliance.
8. Current significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the Investigator
9. A sexually active woman of childbearing age not actively and consistently practicing birth control by using a medically accepted device or therapy or a woman intending to become pregnant during the study
10. Abnormal ECG, safety lab or physical examination results which, in the opinion of the investigator, render the participation of the subject in the study to be inappropriate or unsafe
11. A history of lack of compliance with medical instructions, recent drug or alcohol abuse, or other reasons which, in the opinion of the investigator, render the participation of the subject in the study to be inappropriate or unsafe
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)

This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).


Eligibility Criteria:
Inclusion Criteria:

* Meets current Diagnostic and Statistical Manual for Mental Disorders-Fourth Edition (DSM-IV) diagnostic criteria for AD and demonstrates serious behavioral problems. Diagnosis confirmed by Autism Diagnostic Interview- Revised (ADI-R)
* CGI score \> = 4 AND and Aberrant Behavior Checklist (ABC) Irritability/Agitation subscale score \> = 18 at screening and baseline (randomization)
* Mental age of at least 18 months
* Male or female 6 to 17 years of age, inclusive, at the time of randomization

Exclusion Criteria:

* Patients considered treatment resistant to neuroleptic medication based on lack of therapeutic response to 2 different neuroleptics after treatment of at least 3 weeks each.
* Patients previously treated and not responding to aripiprazole treatment
* The patient is currently diagnosed with another disorder on the autism spectrum, including PDD-NOS, Asperger's Disorder, Rett's Disorder, Fragile-X Syndrome or Childhood Disintegrative Disorder
* Current diagnosis of bipolar disorder, psychosis, or schizophrenia, or major depression
* A seizure in the past year
* History of severe head trauma or stroke
* Patients undergoing non-pharmacologic therapies (e.g., psychotherapy, behavioral modification) must have started at least 2 months prior to the initial screening visit and must remain in a consistent treatment program for the duration of the study.
Evaluation of Microcirculation With Photoplethysmography (Pulse Oximetry) in Healthy Volunteers and Ventilated Patients

The objective of this observational study is to explore microcirculation in healthy volunteers and in ventilated patients in the operating room and in critical care.

The general objective of this study is to evaluate microcirculation with photoplethysmography (PPG) in different pathophysiological situations and to compare PPG with available standard methods. Specifically, evaluate the correlation between the determinations of AC-DC waves obtained by Photoplethysmography (PPG) and those obtained in different dynamic tests in healthy volunteers.

To compare microcirculation assessments \[capillary refill time (CRT), perfusion index (PI), perfusion index variability (PIV)\] with measurements obtained by PPG in the context of critically ill patients.

To compare microcirculation assessments (CRT, PI PVI) with measurements obtained by PPG in the context of patients on invasive mechanical ventilation (IMV) in the operating room and in critical care.

An attempt is made to explore different physiological aspects that affect microcirculation such as vascular tone and blood volume.

Photoplethysmography usually examines the AC wave equivalent to the pulsatile wave, however the DC component has been less explored and can account for the microcirculation and volemia status of the subjects.

Since there is no gold standard, it will be compared against different validated methods.

Eligibility Criteria:
Healthy Volunteers:

Inclusion Criteria:

* Written informed consent.
* Age \> 18 years.

Exclusion Criteria:

* Pregnancy.
* Smokers.
* Respiratory and/or cardiovascular pathologies.
* Peripheral vascular disease.

Operation room or Critical care Unit patients

Inclusion criteria:

* Written informed consent.
* Age \> 18 years.
* Critical patients ventilated in the ICU of any origin.

Exclusion criteria:

* Known peripheral vascular disease.
* Burns on both upper limbs.
* Trauma to both upper limbs.