cyrilzakka/clinical-trials huggingface dataset:
S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers

The purpose of the study is to investigate the safety, tolerability, and preliminary anti-neoplastic activity of S095029 alone and in combination with Sym021 in patients with advanced solid tumor malignancies followed by an expansion phase of triple combinations.

\*The study sponsor has made the decision not to move forward to the expansion part of the study due to strategic considerations, unrelated to any safety issues or concerns. The study will be stopped after completion of dose escalation parts 1a and 1b of the study.


Eligibility Criteria:
Dose escalation part:

Inclusion Criteria:

* Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumor malignancies
* Patients with a malignancy not amenable to surgical intervention
* Patients with measurable disease and progression radiologically assessed
* Patients with disease progression after treatment with available standard of care therapies that are known to confer clinical benefit or who are intolerant to treatment.
* Patients with available archived tumor biopsy specimens or agree to mandatory biopsy
* Estimated life expectancy ≥ 12 weeks
* Adequate haematological function
* Adequate renal function
* Adequate hepatic function

Exclusion Criteria:

* Pregnant and lactating women
* Major surgery within 4 weeks prior to the first IMP administration or not recovered from the surgery
* Patients with serious/active/uncontrolled infection or infection requiring parenteral antibiotics, within 2 weeks prior to first IMP administration
* Active Hepatitis B Virus infection
* Carriers of HIV antibodies
* Patients with active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks prior to first IMP administration
* History of organ transplantation
* History of gastrointestinal perforation, or intra-abdominal abscess within 28 days of inclusion
* History of cirrhosis
* History of pulmonary fibrosis or relevant uncontrolled chronic pulmonary condition
* Treatment with systemic immunosuppressive therapy
* Active autoimmune disease
* Administration of a live vaccine within 28 days prior to inclusion
Efficacy and Safety Study of NeuroStar TMS Therapy in Patients With Major Depressive Disorder With Postpartum Onset

The purpose of this study is to evaluate the safety and effectiveness of acute NeuroStar TMS therapy in women who have postpartum depression.

Evaluate the antidepressant effectiveness of acute treatment with NeuroStar TMS Therapy in patients with MDD with postpartum onset.

Determine the safety of NeuroStar TMS Therapy by assessment of any medically significant, device-related adverse events during acute treatment.

Determine the Safety of NeuroStar TMS Therapy by assessment of maternal and infant interactions on standardized bonding questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Female outpatients, 18 to 50 years of age.
* Diagnosis of DSM-IV defined Major Depressive Disorder, single or recurrent episode, with current episode duration of at least 2 weeks.
* Onset and duration of current illness within 6 months of live childbirth.
* HAMD17 total score of greater than or equal to 18 and a score on the Edinburgh Postnatal Depression scale (EPDS) greater than or equal to 10.
* Patient cannot be on an antidepressant or other psychotropic medications during the study.
* Capable and willing to provide informed consent.
* Signed HIPAA authorization.
* Able to adhere to the treatment schedule.

Exclusion Criteria:

* Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated): Depression secondary to a general medical condition, or substance-induced Seasonal pattern of depression as defined by DSM-IV;History of substance abuse or dependence within the past year(except nicotine and caffeine);Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features in this or previous episodes;Bipolar disorder;Eating disorder (current or within the past year);Obsessive compulsive disorder (lifetime); or Post-traumatic stress disorder (current or within the past year).
* Individuals with a clinically defined neurological disorder or insult including, but not limited to:Any condition likely to be associated with increased intracranial pressure;Space occupying brain lesion;History of cerebrovascular accident;Transient ischemic attack within two years; Cerebral aneurysm; Dementia;Parkinson's disease;Huntington's chorea;Multiple sclerosis.
* History of treatment with Vagus Nerve Stimulation.
* History of failure to respond to an adequate course of ECT treatment.
* Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
* Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
* Women of child-bearing potential not using a medically accepted form of contraception when engaging in sexual intercourse.
Hyper-Arousal in Chronic Primary Insomnia

The purpose of this study is to determine whether individuals with chronic insomnia disorder have a higher degree of physiologic arousal (resulting in their trouble sleeping) than good sleepers. The primary goal is to perform a rigorous quantitative assessment of physiologic hyper-arousal across two domains (autonomic nervous system and neurophysiology) in patients with chronic primary insomnia as compared to good sleepers matched for sex, age, body mass index (BMI) and race/ethnicity.


Eligibility Criteria:
Inclusion Criteria for Insomniacs:

* Men and women with primary insomnia of at least 3 months in duration
* ages 21-65 years old
* BMI \<35 kg/m2 to enable microneurography
* Moderate to severe insomnia based on the Insomnia Severity Index (ISI) questionnaire
* Pittsburgh Sleep Quality Index (PSQI) \> 5
* Self-reported habitual sleep duration \< 6.5 hours

Inclusion criteria for good sleepers:

* 21-65 years old men and women with BMI \<35 kg/m2
* No insomnia based on ISI questionnaire
* Self-reported habitual sleep duration ≥ 6.5 hours but \< 9 hours
* PSQI\<5
* Sleep efficiency on PSG with TRT of 8 hours \> 85%
* No history of mental illness, shift work, circadian rhythm disorders

Exclusion criteria for both insomniacs and good sleepers:

* Sleep disorders other than insomnia as assessed by screening PSG (apnea-hypopnea index or AHI ≥ 10, PLM arousal index ≥ 5)
* Circadian rhythm sleep disorders
* Diabetic based on HbA1c ≥ 6.5 %. For those with HbA1c ≥ 6.0 but \<6.5%, the non-diabetic condition will be confirmed by 2-h oral glucose tolerance test
* History of meeting DSM-IVR criteria based on the Mini International Neuropsychiatric Interview version 6.0 for any major psychiatric disorder
* Unstable or serious medical conditions
* Current, or use within the past month, of psychoactive (other than stable treatment with antidepressants), hypnotic, stimulant or analgesic medications (except occasional non-narcotic analgesics), beta blockers or alpha blockers
* Shift work or other types of self imposed irregular sleep schedules
* Habitual smoking
* Habitual alcohol consumption
* Pregnancy
Optimization of the TB Treatment Regimen Cascade

- Hypothesis: Double dose rifampicin together with earlier monitoring of sputum conversion using vital staining reduces unfavorable outcome of Cat. 1 first-line TB treatment without excess serious toxicity, and allows early switch to specific treatment of MDR-TB without using Cat. 2 retreatment regimen

- General study design: This open label, randomised clinical trial is intended as a pilot study on the efficacy and safety of high-dose rifampicin and feasibility and added value of auramine and/or FDA vital staining sputum smear after 2 weeks of intensive treatment phase. If this proof-of-concept study provides substantial indication of benefit without indication of excess toxicity, the data from the study will be used to design a larger scale, cluster-randomized study. The aim of this cluster randomised study would be to provide definite proof of the benefit of the intervention on adverse treatment outcomes and lack of excess toxicity associated with high dose rifampicin. In addition, the cluster-randomized study would provide a more precise assessment of the suppression and prevention of (acquired) resistance endpoints.

An interim analysis is thus planned at the time the last recruited patient finishes treatment, i.e. about 9 months after the end of recruitment. It will focus on assessment of drug toxicity versus suggested benefits of the intervention. This analysis will be primarily performed for the go/no-go decision and design considerations for the cluster-randomized trial. The decision on proceeding to the cluster randomized study will be based on the absence of excess toxicity, a trend toward a reduction of unfavourable outcomes (excluding relapse), and possible favourable effects on initially present low-resistance mutations / mutations acquired during treatment. It will also allow to adapt the design of the larger study particularly regarding the algorithm for resistance screening, and whether or not treatment shortening could be justified with rapid initial conversion.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with smear-positive pulmonary TB
* 15 years or older
* Able and willing to provide written informed consent

Exclusion Criteria:

* contacts of MDR-TB patients and other MDR-TB suspects diagnosed with resistance on rapid DST for rifampicin performed prior to start of treatment according to NTP guidelines
* smear-negative pulmonary and extra-pulmonary TB cases
* patients in need of hospitalization because of very bad general condition or complications
* patients with clinically active liver disease, for the study defined as jaundice confirmed by a local Medical Officer (Government)
* any known HIV-positive patient (although none are expected)
* any patient with known hepatitis B or C infection
* pregnant women; in addition, patients in the intervention arm who become pregnant during treatment will be switched to the control arm
Pharmacokinetics of Biphasic Insulin Aspart 50 and 70 in Japanese Healthy Volunteers

This trial is conducted in Japan. The aim of this trial is to investigate the pharmacokinetics of biphasic insulin aspart 50 (NN-X14Mix50) and biphasic insulin aspart 70 (NN-X14Mix70) in Japanese healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Japanese
* Body Mass Index (BMI) of 19-27 kg/m\^2 (both inclusive)
* Fasting blood glucose between 3.8-6 mmol/L (68.4-108.0 mg/dL) (both inclusive
* Considered generally healthy upon completion of medical history and physical examination, as judged by the Investigator or Sub-Investigator

Exclusion Criteria:

* Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator or Sub-Investigator(s)
* Any serious systemic infectious disease that occurred during the 4 weeks prior to the screening, as judged by the Investigator or Sub-Investigator
* Any inter-current illness that may affect blood glucose, as judged by the Investigator or Sub-Investigator
* Hepatitis B or C, or HIV (human immunodeficiency virus)
* Use of prescription drugs within 2 weeks preceding the screening
* Use of non-prescription drugs, except routine vitamins or drugs that may not
* Blood donation of more than 1150 mL within the last 12 months
* Subjects with a first degree relative with diabetes mellitus
* History of or presence of diabetes
* History of or presence of cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematologic, neurologic, or psychiatric diseases or disorder
* Previous history of serious allergy or anaphylactic reaction
* Subjects who consume more than 28 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse
* Subjects who smoke more than 5 cigarettes per day
Optimized Angiomammography and Comparison With Standard Angiomammography

This study will be proposed consecutively to any patient who angiomammography examination was requested by the clinician in charge of patient. A randomization will be performed between an angiomammography examination Standard (SenoBright®) and an optimized angiomammography examination.

A blinded central re-reading of the acquisition technique will be carried out by 3 radiologists (2 seniors and 1 junior) who will evaluate:

* The intensity of lesion enhancement
* The presence and type of artefacts on the recombined images.
* The quality of low-energy images according to recognized criteria for mammography.

The gold standard will be histology (biopsies or surgery) or follow-up to 1 year for non-biopsied benign lesions


Eligibility Criteria:
Inclusion Criteria:

1. Patient for whom angiomammography examination is requested regardless of its indication (assessment of extension, clarification of a lesion doubtful after mammography and mammary ultrasound, symptom mammary MRI in a patient with contraindication to MRI)
2. Patient aged 40 to 70 years
3. Informing the patient or his / her legal representative and signing the form of non-opposition.
4. Patient affiliated to a social security system.

Exclusion Criteria:

1. Patient with breast prostheses
2. Patient with a genetic mutation (BRCA1, BRCA2, p57)
3. Contraindication to injection of iodinated contrast agent
4. Pregnant woman, likely to be pregnant or breastfeeding,
5. Persons deprived of their liberty or under guardianship,
6. Unable to undergo medical follow-up of the trial for reasons geographical, social or psychological.
Meditation to Reduce Caregiver Stress

The purpose of this study is to determine whether meditation will reduce stress and depressive of adult caregivers of a person with dementia.

This is an 8-week study to determine if meditation or listening to a relaxation CD will be effective in reducing depressive symptoms and stress, and in improving memory and cognition of caregivers who perform a daily meditation for 12 minutes a day for 8 weeks compared to caregivers listening to a relaxation CD for 12 minutes a day for 8 weeks. A second purpose of this study is to examine the role of genetic and inflammatory markers in response to listening to a relaxation CD and meditation.

Eligibility Criteria:
Inclusion Criteria:

1. Caregivers of relatives with dementia who present to the Alzheimer s Disease Center or other UCLA geriatric or memory clinics for evaluation of dementia, cognitive impairment and/or co-existing behavioral disturbances. Caregivers will be identified by the family member with dementia or the physician as the primary source of assistance and/or support, 45 years of age or older, in contact with the individual with dementia at least three times/week for no less than one year, and a relative of the care-recipient (i.e., spouse or adult child). This criteria will ensure that the caregivers had been affected by substantial chronic stress, and they will also meet criteria specified below.
2. Adequate written and oral fluency in English to understand and complete study forms and converse with study personnel.
3. Caregivers enrolled in the trial could meet the DSM-IVR criteria for minor depression or depression not otherwise specified (NOS), but not for other diagnosis of unipolar or bipolar major depression.
4. Score between 6 and 15 on the Hamilton Depression Rating Scale-24 item (HAM-D).
5. Score of 26 or higher on the Folstein Mini-Mental State Examination (MMSE).

Exclusion Criteria:

1. Current diagnosis of unipolar major depression, schizophrenia, bipolar, psychotic disorders including psychotic depression or dementia, attention deficit or hyperactivity disorder, anxiety, and alcohol or drug dependence. Those with lifetime history of psychiatric conditions other than unipolar major depression will be also excluded.
2. Medically unstable, delirious, or terminally ill (e.g. medical illness requiring hospitalization or intense outpatient management, such as heart disease; heart attack in the past 6 months; Congestive Heart failure; severe heart arrythmias; unstable hypertension; poorly controlled diabetes; recent head trauma with loss of consciousness; recent stroke with residual neurological symptoms; recent cancer with ongoing treatment, or any other medical conditions requiring weekly visits to PCP or pending surgery).
3. Level of suicidal risk precludes safe treatment on an outpatient basis with Hamilton Depression rating scale item number 3 rated as = 3.
4. Subjects reporting daily use of alcohol will be excluded.
5. Diagnosis of amnestic MCI by the analyses of delayed verbal recall on the California Verbal Learning Scale that will be 1.5 SD below the age/education adjusted norms for the general population.
A Registry Study of COVID-19 Serologic and Virologic Testing to Accelerate Recovery and Transition

The co-primary objectives of this study are to:

1. Determine and compare the COVID-19 antibody positivity rate in health care workers and patients without a known COVID-19 infection
2. Determine if PCR negativity for COVID-19 early in quarantine predicts negativity at Day 14 in quarantining individuals

This is a prospective cohort study designed to identify the prevalence of IgG antibodies to SARS CoV-2 as well as to assess risk factors for IgG positivity. It will compare rates of positivity and risk factors among healthcare workers and non-healthcare workers and assess the ability of PCR negativity at day 3 or 4, 5, 7, or 10 to predict negativity on day 14 in individuals quarantining after a COVID exposure.

In addition to having a standard of care clinical antibody test, both healthcare workers, quarantining individuals, and patients will be asked to fill out a survey to assess risk factors for COVID infection and provide a research blood sample. Quarantining individuals will also have standard of care PCR testing on days 3 or 4, 5, 7, 10, and 14 of the quarantine period.

Collected blood samples will be used to assess for the presence of neutralizing antibodies and measure antibodies with a research test. An annual blood specimen and survey will be collected from each study participant for up to 2 years total after study entry.

Eligibility Criteria:
Inclusion Criteria:

* Individuals (health-care workers and patients) undergoing standard of care assessment of SARS-CoV-2 serology testing
* Individuals with a COVID-19 exposure requiring quarantine who are asymptomatic and who will receive standard of care SARS-CoV-2 PCR testing.
* Able to understand and sign the Informed Consent and Research Authorization From.

Exclusion Criteria:

* Prisoners
* Patients with psychiatric illness that would limit compliance
* Patients with social situations that would limit compliance
Application of MDT Clinics in Arab World

Multidisciplinary clinics affect the quality of management of cancer patients. This Questionnaire is for research purposes aiming at exploring the application and implementation of multidisciplinary clinics in managing cancer patients in the Arab countries. The results of this survey will shed the light on the situation; the investigators aim at exploring the status of their implementation and who participates in them, in addition to exploring the challenges that face MDT clinics in Arab world.

Multidisciplinary teams (MDTs) are recommended as a corner stone of best cancer care nowadays. MDTs consist of many professionals such as medical, nursing, and allied professionals and diagnostic experts to determine the optimal treatment pathway for individual patients. They should be well organized and efficient. MDT clinics care is helpful in making clinical decision and improving the quality of patients' care. However, there are many challenges that face the actual implementation and application of MDT clinics in routine cancer patients' care in our Arab countries.

This study aims at describing the situation in our Arab countries and reflecting the pathway \& logistics of referring cancer patients to MDT \& the impact of that on the patients' management \& outcome, in addition to exploring the challenges that face effective implementation of MDT clinics, so that it can lead the improvement in oncology manangement

Eligibility Criteria:
Inclusion Criteria:

* Healthcare workers/Physicians involved in cancer diagnosis \& management in the Arab countries.

Exclusion Criteria:

* Health care workers/ Physicians who are not entitled for cancer management.
* Physicians who are not working in the Arab counties.
Multi-Modal Image Fusion for Precision Prostate Biopsy Navigation

This study is a prospective randomized controlled clinical trial aimed at comparing the detection rates of clinically significant prostate cancer between conventional biopsy methods and AI-assisted biopsy methods in patients undergoing initial prostate biopsy who meet the indications for prostate biopsy.

This study is a prospective randomized controlled clinical trial designed to investigate the efficacy of AI-assisted biopsy methods compared to conventional biopsy methods in detecting clinically significant prostate cancer. The target population includes patients undergoing their initial prostate biopsy who meet established indications for prostate biopsy.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18
2. PSA \> 4 ng/ml and/or abnormal DRE
3. Sign the informed consent

Exclusion Criteria:

1. Have acute or chronic prostatitis
2. Contraindications to prostate biopsy
3. Contraindications to MRI
4. Other reasons that not suitable for this trial
A Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder

The purpose of this study is to determine if galantamine augmentaion improves cognition in euthymic bipolar patients. In addition, the effect of galantamine on clinical measures of functioning and psychopathology will also be assessed.

The study length is 12 to 24 weeks depending on whether patients enter the crossover. Study also involves 3 neuropsychology testings.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60; DSM-IV diagnosis of bipolar disorder, any subtype; Baseline Mini Mental Status exam above 20; MRS \< 16; MADRS \< 16

Exclusion Criteria:

* Current substance dependence; serious unstable medical conditions; active suicidal ideation; current DSM-IV for a major mood episodes; history of COPD, epilepsy, cardiac arrhythmia, and peptic ulcer disease; meet DSM-IV criteria for dementia
Modified HFNC Oxygen in Patients Undergoing Bronchoscopy.

The purpose of this study is to determine whether the Modified High-flow nasal cannula is effective in the oxygen of the patients undergoing bronchoscopy.


Eligibility Criteria:
Inclusion criteria

1. age more than 18 years old;
2. need for bronchoscopy for diagnosis purpose.

Exclusion criteria

1. peripheral arterial pulse oximetry was \< 90%
2. platelet count \< 60 × 109/L;
3. nasopharyngeal obstruction or blockage.