cyrilzakka/clinical-trials huggingface dataset:
Study to Access Safety of Durvalumab in Indian Adult Patients With Locally Advanced NSCLC

A prospective, multicenter, Phase-IV clinical trial to assess safety of Durvalumab in Indian adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC)


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed, written and dated informed consent prior to any study specific Procedures
2. Male or female aged 18 years or older
3. As per local prescribing information and in view of positive benefit-risk assessment, patient prescribed Durvalumab treatment as per independent clinical judgment of treating physician for either

Exclusion Criteria:

1. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study
2. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Systemic steroid administration required to manage toxicities arising from radiation therapy delivered as part of the chemoradiation therapy for locally advanced NSCLC is allowed.
3. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody including durvalumab.
4. For NSCLC cohort only:

   1. Mixed small cell and non-small cell lung cancer histology
   2. Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy.
   3. Patients with ≥Grade 2 pneumonitis from prior chemoradiation therapy
5. Active or prior documented autoimmune disease within the past 2 years, inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), primary immunodeficiency, organ transplant that requires therapeutic immunosuppression, hypersensitivity to study drug or any excipient, leptomeningeal carcinomatosis, tuberculosis.

   NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
6. Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
7. Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results.
HUTT to Assess Cardiac Autonomic Nervous Function

Autonomic nervous system diseases can cause abnormalities in the circulatory system, leading to malignant arrhythmia and sudden cardiac death. Standardized, operable, and simplified diagnostic indicators are urgently needed to evaluate autonomic nervous function, particularly cardiac autonomic nervous function. The investigators use HUTT in order to provide data support for cardiac autonomic nervous system evaluation.

In this study, 169 samples with vertical tilt test and 24-h Holter ECG data from February 13, 2023 to October 31, 2023 were selected. The AC, DC, and 24-h HRV were compared with the CASS to identify the indicators with the strongest correlation with the CASS sympathetic and vagus nerve scores. The best index was selected, and the score intervals were delimited. The sensitivity and specificity of the defined vagal and sympathetic intervals were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Vertical tilt test and 24-hour holter electrocardiogram were performed at the same time

  * Receive treatment in our hospital.

Exclusion Criteria:

* Taking benzodiazepines or hypotensive drugs within 24 hours

  * Combined with mental illness, severe dementia, serious organ disease

    * Severe arrhythmia, deep breathing and poor coordination of Valsaval movements affected the interpretation of results.
New Technologies for Enhancing Health in Older Adults

New technologies, such as mobile apps, health monitoring devices, interactive video games, and telemedicine platforms, have become invaluable for improving the physical, mental, and cognitive health of older adults. They help maintain flexibility, strengthen muscles, improve balance and posture, alleviate chronic pain, enhance sleep quality, and reduce stress and anxiety. Tools like the Nintendo Wii promote physical activity, improve coordination, and offer social interaction. Overall, these technologies support better mental health, emotional well-being, and independence, contributing to a higher quality of life for older adults.


Eligibility Criteria:
Inclusion Criteria:

* Be 60 years old or older.
* Present physical autonomy to participate in the technological and physical activities required by the study.
* Present current affiliation to the social health security system.
* Sign the informed consent.
* Understand the instructions, programs and technological protocols of this project.
* Complete more than 90% of the intervention with technology and exercise.

Exclusion Criteria:

* Present medical contraindications for performing physical tests or using technologies.
* Present diseases that limit cognitive performance and physical activity.
* Present vestibular diseases.
* Present rheumatological diseases that can be exacerbated by the use of technologies or stress articulate.
* Refusing to sign the informed consent
Effects Of PF-02545920 On Ketamine-Induced Abnormal Prefrontal Brain Response To Associative Learning In Healthy Subjects

To evaluate whether PF-02545920 reduces the effects of ketamine on brain activation during causal learning as measured by fMRI compared to placebo in healthy human subjects, and to evaluate whether behavioral measures of abnormal causal learning under ketamine are reduced by treatment with PF 02545920.

The study was terminated on November 2, 2012 due to a reassessment of the likelihood of the study meeting its scientific objectives in light of data with the investigational drug obtained from another clinical study. The decision to terminate the trial was not based on any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 45 years, inclusive. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
* Right handed as determined by handedness questionnaire.
* Able to read and write English as a primary language.

Exclusion Criteria:

* Female subjects who are pregnant or breastfeeding.
* Any evidence of significant psychosis-like symptoms.
* Known sensitivity to ketamine.
Pilot Study Intended to Provide Input for Future Designs Using the PET Alpha Ring Detector

A standard PET/CT scanner is comprised of two different machines: An X-ray computed tomography scanner (CT), which gives information about your anatomy, and a Positron Emission Tomography scanner (PET) that provides information about how the body functions. Both of these work together to make the final images for doctors to review. As part of this research study the investigators would like to test a new scanner technology by evaluating the quality of the images obtained using this new PET system.

The scanner the investigators would use is able to do both types of examination, the standard PET/CT and the additional research PET. The new PET system adds a second scanner ring to the standard PET/CT. This allows the patient to stay on the same imaging table for both studies. Being in this study does not change how the standard PET/CT will be done.


Eligibility Criteria:
Inclusion Criteria:

* Patients are at least 18 years
* Patients are medically stable
* Patients scheduled for clinically necessary PET/CT examination

Exclusion Criteria:

* Patients who are pregnant
* Patients who are unwilling/unable to sign the Informed Consent Form
* Patients who are cognitively impaired and unable to provide informed consent
* Patients who have experienced adverse events to PET/CT examinations
Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies

This is a pilot study to find a correlation between MRI and ICD therapy in patients with known cardiomyopathies, aiming to determine if cardiac scarring identified by MRI correlates with ventricular arrhythmias and the occurrence of ICD therapy.

This is an observational study over a 3 year period of 50 patients with known cardiomyopathy and LVEF of 35% or less who will have ICD implantation as part of their standard of care. All subjects will undergo a contrast-enhanced cardiac MRI using gadolinium to determine the morphological characteristics of their left ventricle prior to ICD implant. Subjects will not be offered sedation to minimize risk, thus those suffering from claustrophobia will be excluded or dropped from participation. MRI will be evaluated, and subjects will be followed during standard of care device interrogations for 12 months after implant.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* cardiomyopathy with LVEF 35% or less
* indication for ICD implantation
* able to provide informed consent

Exclusion Criteria:

* prior device implantation
* contraindication for MRI (i.e., metallic foreign body)
* claustrophobia
* pregnant women
Improving Maternal Mental Health & SUD Screening and Treatment

The purpose of the study is to compare a text message-based mental health and substance use screening and referral to a treatment program, called Listening to Women and Pregnant and Postpartum People (LTWP), to standard of care in-person mental health and substance use screening to look at rates of treatment attendance and retention in treatment. Participation would involve completing online questionnaires. You may be eligible to participate if you are age 18-45 years, are pregnant and entering prenatal care in one of MUSC's OB clinics, and attended a prenatal appointment at an MUSC clinic.

Aim 1: To determine differences in rates of treatment attendance and retention for Perinatal Mood and Anxiety Disorders (PMADs) and Perinatal Substance Use Disorders (PSUDs) between participants assigned to LTWP, compared to SBIRT.

Aim 2: To determine differences in Patient-Reported Outcomes (PROs) including depressive symptoms, quality of life, substance use, and maternal functioning and well-being measured at baseline and 2, 5, 8, and 11 months postpartum.

Eligibility Criteria:
Aim 1:

This study is a cluster RCT step wedge design so we are randomizing on the clinic level, not the individual level. The clinics are made up of 4 "wedges" (3 clinics/wedge). Pregnant women receiving prenatal care in these clinics will receive SBIRT as part of usual care. Clusters of clinics will be randomized to an LTWP start date where they will transition from SBIRT to LTWP for the purposes of screening and referral to treatment.

EHR Data Collection (PPP):

Inclusion:

1. Age 18-45
2. pregnant and entering prenatal care in one of MUSC's OB clinics
3. attended a prenatal appointment at an MUSC clinic

Exclusion:

a.) primary language is not English or Spanish

Aim 2:

Study Assessments at baseline and 2, 5, 8, and 11 months postpartum (PPP):

Inclusion:

1. Age 18-45 years
2. pregnant
3. attended an initial prenatal appointment at an MUSC OB clinic

Exclusion:

1. Unable to complete study assessments
2. primary language is not English or Spanish
Proton Re-Irradiation for Recurrent Head and Neck Cancer

The purpose of this study is to evaluate the tumor control and the side effects of using proton therapy for head and neck cancer that has come back.


Eligibility Criteria:
Inclusion Criteria:

* Patient willing and able to provide written informed consent
* Age ≥18 years at the time of consent
* Pathologically confirmed diagnosis of a recurrent or a new primary head and neck cancer
* A history of prior radiation to the head and neck (\>/= 40 Gy, in 2 Gy/fraction equivalent)
* The recurrent or the second primary tumor is unresectable, the patient elects against surgical resection; patients who underwent surgery who has indications for postoperative radiation therapy is also eligible
* Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months after treatment Note: Patient with \<6 months of life expectancy will be treated with palliative QUAD shot radiotherapy and those with \> 6 months of life expectancy will be treated with conventionally fractionated full dose re-irradiation approach. Additional other factors determining which patients will be treated with Quad Shot therapy rather than full dose are if the patients have poor performance status, bulky or diffuse disease, significant medical co-morbidities, and significant metastatic disease burden.

Exclusion Criteria:

* Women who are pregnant or lactating
* Inability to comply with study and/or follow-up procedures
* \<6 months between completion of prior RT and initiation of reirradiation using proton therapy
Pupillometry and Nociception Level Index for the Evaluation of Pain in Intensive Care Unit.

Pain is a frequent symptom in the intensive care unit (ICU). Critical ill patients are often intubated and sedated which makes self-evaluation of pain impossible.

Pupillary dilatation is a reflex directly related to stimuli such as pain, which can be measured by quantitative pupillometry.

Several studies in ICU showed a significant relationship between pupillary diameter variation and pain.

The nociception level index (NOL-index) is a recent noninvasive and continuous monitoring of pain essentially used in operating room.

The aim of this study is to evaluate the pupillometry and NOL index in critical ill patients in sedated patients under mechanical ventilation during the mobilization plus toilet (described in literature as not painful procedure) and tracheal suctioning (described as a painful procedure)

Pain will be evaluated via i) pupillometry with 3 successive measurements ii) Behaviour Pain Scale (BPS) and Critical Care Pain Observation Tool (CPOT) score evaluated by an investigator (physician) iii) evolution of physiological parameters (ie heart rate, blood pressure, respiratory rate) iv) Nociception level index (NOL-index).

The evaluation times will be 5 minutes before care procedures (mobilization plus toilet and tracheal suctioning), during the procedures (with the worst value recorded) and 5 minutes after the procedures.

The procedures are:

* A mobilization and toilet of the patient: a priori, not a very painful procedure. The pain will be evaluated every 5 minutes during the toilet.
* Tracheal suctioning: a procedure known to be painful. The painful will be evaluated just at the end of tracheal suctioning (once the tracheal suctioning catheter is removed from the endotracheal intubation).

Eligibility Criteria:
Inclusion Criteria:

* older than18 years old
* Under invasive mechanical ventilation
* Sedated with i) a Richmond Agitation Sedation Scale (RASS) : ≥ -4 and \<1, ii) being unable to evaluate their pain by a visual numeric scale

Exclusion Criteria:

* Ophthalmological diseases which could modify the pupillometric parameters
* Neurological diseases (damage of nerve III, intracranial hypertension, stroke)
* Admitted in ICU after resuscitated cardiac arrest
* Drugs that inhibit the effect of the sympathetic system (clonidine, dexmedetomidine)
* Patient under Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO)
* Patient treated by a neuromuscular blockade
* A do-not resuscitate order
* Major hemodynamic instability prohibiting planned care procedures
Detemir: Role in Type 1 Diabetes

Study of blood sugars in the children with Type 1 Diabetes Mellitus (T1DM), who are given insulin detemir and a rapid acting insulin (aspart). It is hypothesized that there is no difference in the patterns of blood sugars when detemir is given in the same syringe or in separate syringes with rapid acting insulin.

One of the barriers to good glycemic control in children with type 1 diabetes is multiple daily insulin injections. Mixing rapid-acting (detemir) and slow- acting insulins (aspart) in the same syringe would decrease the number of injections and may improve adherence

This study hypothesized that slow-acting insulin detemir mixed with aspart would have equivalent effects on blood glucose versus giving them as separate injections in children with type 1 diabetes.

Eighteen pediatric subjects with type 1 diabetes (11 males and 7 females) were recruited. However only 14 subjects completed this 20-day, randomized, crossover, and open-labeled study. The subjects were randomly assigned to either Study A (both insulin detemir and rapid acting insulin (RAI)) or Study B (either detemir or aspart) for the first 10 days. They were then crossed over for the last 10 days. Each subject underwent 72 h of continuous glucose monitoring (CGM) during the last 72 h, for both Study A and Study B.Data of 48 h from midnight of the 1st day to mid- night of the 3rd day of the 72-h (CGM) were used for analysis to ensure the same starting and ending times of monitoring for all subjects.Sustained glucose values over time were calculated as area under the curve (AUC), index of blood glucose control as M-value and glucose excursion as mean amplitude of glucose excursion (MAGE)

Eligibility Criteria:
Inclusion Criteria:

* Subjects with antibody positive Type 1 Diabetes Mellitus (T1DM)
* On insulin glargine for at least 3 months
* Age 10-25 years
* Not on medications that may affect glucose concentrations
* Hemoglobin A1C (HbA1C) of less than 9 %
* Body Mass Index (BMI) less than 95th % and more than 10th%
* Supportive family

Exclusion Criteria:

* Subjects with undetermined diabetes or Type 2 Diabetes Mellitus (T2DM)
* Unable to adhere to insulin regimen
* Positive urine pregnancy test
Treatment of Keloidscars With Intralesional Triamcinolone and 5-fluorouracil Injections-prospective, Randomized, Controlled Trial - Pilot Study

The aim of study is examine the efficacy of intralesional 5-fluorouracil injections in keloid disease treatment.


Eligibility Criteria:
Inclusion Criteria:

* Person who has a keloidscar which could be treated with injection treatment

Exclusion Criteria:

* Pregnancy, lactating, renal or liver failure
Trial of Magnesium Sulfate Tocolysis Versus Nifedipine Tocolysis in Women With Preterm Labor

Primary Hypothesis:

Acute tocolysis (48 hours) using oral nifedipine is more effective than intravenous magnesium sulfate in prolonging pregnancy in women with preterm labor with intact membranes between 24 and 32 6/7 weeks' gestation.

Primary Objective:

To compare the efficacy of oral nifedipine versus IV magnesium sulfate on the rate of preterm delivery at \<37 weeks in women with preterm labor between 24 and 32 6/7 weeks gestation.

Secondary Objective:

1. To compare maternal side effects between the two tocolytic agents
2. To compare neonatal morbidities between the two study groups.

Eligibility Criteria:
Inclusion Criteria:

* Women in preterm labor between 24 to 32 6/7 weeks' gestation with intact membranes with an age range of 15 to 50 years old.

Exclusion Criteria:

* Cervical dilatation of ≥ 6 cm
* Maternal contraindication to tocolysis
* Known fetal anomalies
* Suspected chorioamnionitis
* Nonreassuring fetal heart tracing
* Vaginal bleeding due to placenta previa or abruptio placenta
* Preterm premature rupture of membranes
* Prolapsed membranes
* Human immunodeficiency virus positive
* Multiple gestation
* Patients on procardia within 24 hours of po intake
* Magnesium sulfate tocolysis prior to randomization
* Patient refusal
The Effect of Brain Stimulation (tDCS) in Food Cravings Control in Overweight/Obese Women

This study is a randomized clinical trial to test the effect of a type of non-invasive brain stimulation on the response to a behavioral intervention designed to enhance cognitive control over food cravings in obese and overweight women. The brain stimulation is called transcranial Direct Current Stimulation (tDCS). All eligible participants will engage in a behavioral intervention known to enhance control over food cravings and will be randomly assigned to receive either tDCS or sham stimulation to the prefrontal cortex of the brain.

This study is a randomized clinical trial to test the effect of a type of non-invasive brain stimulation on the response to a behavioral intervention designed to enhance cognitive control over food cravings in obese and overweight women. The brain stimulation is called transcranial Direct Current Stimulation (tDCS) which is a form of stimulation that delivers a low amplitude electrical current to the brain via the scalp (i.e. trans-cranial) to modify brain activity.

All eligible participants will engage in a behavioral intervention (Go-No Go task), known to enhance control over food cravings, and will be randomly assigned to receive either tDCS or sham stimulation to the right prefrontal cortex of the brain during 8 20-min daily sessions.

Primary outcome: score changes in eating behaviors scales (YFAS and TFEQ), scales will be applied at baseline and at the end of the 8 brain stimulation sessions.

Secondary outcomes: changes in diet, brain function (brain MRI/MRS) Other outcomes: food cravings scales and impulse control scales and cognitive function.

Eligibility Criteria:
Inclusion Criteria:

BMI between 28 and 40 kg/m2 high scores in the Yale-Food Addiction-Scale right-handed

Exclusion Criteria:

* History of anorexia nervosa or bulimia or binge eating disorder
* Any contraindication to undergo MRI
* Use of psychotropic medications and/or opiate pain medications.
* Current or past alcohol or drug abuse problem or smoking
* Pregnancy
* Current use of weight loss medication or currently participating in a weight loss program.
* History of seizures, epilepsy or factors/medications associated with lowered seizure threshold.
* History of brain disease or major neurological disorder or mental disorder
* History of brain surgery or history of loss of consciousness \>15 min
* History of major gastrointestinal surgery including weight loss surgery
* History of endocrine imbalances including diabetes, thyroid disease, Cushing's disease, metabolic syndrome and polycystic ovary.