cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Virtual Warrior Renew Therapy for Veterans Who Experienced Military Sexual Trauma

Group treatments may be helpful for Veterans who have experienced military sexual trauma (MST). By doing this study, the investigators hope to learn if two different groups: Warrior Renew and Health \& Wellness are effective in reducing mental health symptoms in Veterans who have experienced MST and if either is more effective than the other. Participation in this research will last about 16 weeks.

This project will examine mental health treatment in a group setting for Veterans who have experienced military sexual trauma. Military sexual trauma or MST is defined as any experience of sexual assault or sexual harassment experienced during military service. Survivors of MST may develop mental health symptoms. Group treatment for survivors of MST may be helpful. This study will compare two different group treatments: 1) Warrior Renew; and 2) Health \& Wellness.

By doing this study, the investigators hope to learn: 1) if one or both of the group treatments are safe and effective in reducing mental health symptoms in Veterans who have experienced MST; and 2) if there are differences based on gender that should be addressed differently in developing treatments for survivors of MST.

Eligibility Criteria:
Inclusion Criteria:

1. Has established care with VA medical or mental health provider.
2. Reports having experienced military sexual trauma.
3. Between the ages of 18 and 75.
4. Is an outpatient and is able to comply with all study procedures, including the eight weeks of group treatment and the assessment measures.
5. Positive screen on the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5).
6. Able to participate in virtual group therapy via telehealth.

Exclusion Criteria:

1. Impaired decision-making capacity that in the clinical judgment of their provider would affect their ability to provide informed consent.
2. Current/active suicidal ideation as evidenced by a positive screen on the Columbia Suicide Severity Rating Scale (C-SSRS), or a suicide attempt or psychiatric hospitalization within the past year
3. Current or past diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, psychotic or dissociative disorders.
4. Current/active diagnosis of a substance use disorder or an alcohol use disorder as measured by the Alcohol Use Disorders Identification Test-Concise (AUDIT-C).66
5. Unable to read English.
6. Currently receiving trauma-focused group or individual psychotherapy treatment. (Previous psychotherapy or current pharmacotherapy is acceptable).
7. Concurrently enrolled in another research protocol involving a mental health intervention during this study
8. Has had previous Warrior Renew treatment.
Comparison of FiAsp and Aspart During Postprandial Exercise in Adults With Type 1 Diabetes

Hypoglycemia is the main barrier for physical activity practice of patients with type 1 diabetes (T1D). For postprandial exercise, anticipation with meal insulin bolus reduction is the recommended method to reduce exercise-associated hypoglycemic risk. The impact of faster acting Aspart (FiAsp) pharmacokinetic on hypoglycemic risk has not yet been explored. This study will explore two different timings for exercise onset.

Objective: To compare the impact of rapid-acting insulin Aspart and faster acting Aspart (FiAsp) on glucose reduction during exercise.

Design: This study is a randomized, four-way, crossover study to compare the efficacy of 1) rapid-acting insulin Aspart, and 2) FiAsp on glucose reduction during an exercise performed 60 minutes or 120 minutes after breakfast. The insulin used and the timing of the exercise will be randomized. This project will be conducted at Institut de recherches cliniques de Montréal (IRCM, Montreal, Canada).

Hypothesis: Faster acting Aspart (FiAsp) will be non-inferior to insulin Aspart for hypoglycemic risk.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥ 18 years of old.
2. Clinical diagnosis of type 1 diabetes for at least one year.
3. HbA1c ≤ 9.5%.
4. Patients using multiple daily injections with basal-bolus insulin regimen and insulin analogs (pre-meal: Aspart, Lispro, Guilisine or Fiasp; basal: Detemir, Glargine U100 \& U300, Degludec U100).
5. Written informed consent given.

Exclusion Criteria:

1. Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
2. Recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
3. Anemia (Hb \< 100g/L).
4. Ongoing pregnancy or breastfeeding.
5. Severe hypoglycemic episode within two weeks of screening.
6. Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
7. Ongoing treatment with CSII (Continuous Subcutaneous Insulin Infusion) "insulin pump therapy".
8. Participation to a clinical trial in the last 3 months prior to inclusion in this study.
Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany

This is a Pilot/ feasibility study for a population-based Screening in all children 2 to 6 years in Lower Saxony, Germany during the compulsory (U7 (from the age of 2) U7a, U8, U9) routine check-ups and any voluntary visits to the pediatricians office.

The Fr1dolin-Study will be presented to the parents of ca. 320,000 children living in Lower Saxony, Germany. The recruitment of subjects, collection of written consent, the capillary blood sample and the screening questionnaire will be done by the registered pediatricians in their local medical practices.

After study enrolment 200 µl of capillary blood are be taken from the subject and are sent pseudo-anonymized to the lab. LDL-C and the diabetes-associated antibodies are identified. Based on the results a second blood sample will be required. In case of pre-type-1 diabetes or signs for a familial hypercholesterolemia the pediatrician will be informed. He will contact the parents and discuss the further procedure in cooperation with the study center.

In case of a positive result by measuring diabetes-related antibodies and LDL-C the goal of this trial is to advise and educate the families appropriate and to treat them if necessary. In addition families should have the possibility to participate in prevention trials.

All data will be registered in a study database.

Follow-up pre-type 1 diabetes:

During the first year, follow-up will be performed after 6 and 12 months and thereafter annually until the age of 12 years or up to 6 months after the clinical onset of type 1 diabetes.

Follow-up familial hypercholesterolemia:

During the first year, follow-up will be performed after 6 and 12 months and thereafter annually until the age of 12 years.

Eligibility Criteria:
Inclusion Criteria:

* Children living in Lower Saxony (primary residence)
* Age between 2 and 6 years (both included)
* Written consent by at least one parent / legal representative
* Willingness to deliver 200 µl of capillary blood
* Willingness to complete a questionnaire
* Willingness to participate to the follow-up visits

Exclusion Criteria:

• none
A Parenting and Self-Care Intervention for HIV Infected Mothers

The IMAGE intervention was developed to improve parenting and self-care skills in mothers infected with HIV. It is expected that an improvement in these areas will in turn improve the mother's physical and mental health as well as the child's mental health and behavioral adjustment.

Worldwide, close to half the adults living with HIV are women and a large proportion of these women are of child-bearing age. Whereas anyone living with HIV faces the physical challenges of living with a chronic disease, as well as the material and social impact of the stigma associated with the disease, mothers living with HIV must also meet the demands of childrearing while mitigating the negative impact of the disease upon their family. Mothers with HIV report that this is their greatest source of stress. Moreover, children of these mothers, growing up with a parent with a chronic, stigmatized, and often fatal disease, are considered a high-risk group. The IMAGE intervention was designed to improve parenting and self-care skills in mothers with HIV in order to improve the mother's physical and mental health as well as the child's mental health and behavioral adjustment.

Eligibility Criteria:
Inclusion Criteria:

* mother has confirmed diagnosis of HIV
* well (HIV-) child, 6 to 14 years of age
* mother is English or Spanish speaking
* child is English speaking

Exclusion Criteria:

* low cognitive/intellectual functioning (\<75) in mother or child
* psychosis in mother or child
The Contributions of Age Related Changes in the Sound Localization Pathway to Central Hearing Loss

Age-related hearing loss, presbycusis, affects up to 50% of American adults. There are two main causes for presbycusis: 1) Progressive death of hair cells in the inner ear, and 2) Central hearing loss, or the reduced ability to decipher the sound source of interest from other competing sounds in a multi-source complex environment. The first cause is better understood and treatment options, such as hearing aids and cochlear implants, are available. However, central hearing loss is not as well understood and there is not a treatment available at this time. This study aims to advance our understanding of central hearing loss by evaluating the abilities of younger and older listeners in two primary outcome measures: to 1) neurologically process sound stimuli and 2) focus on conversational speech in the presence of spatially-separated competing background noise. A test using Auditory Brainstem Responses (ABR) will be used to evaluate the brain's response to clicking sounds.

This study will assess all waveform data, but will focus particularly on wave III. Sentence in noise tests will be used to assess each subject's ability to process speech in noisy situations. Both the ABR and sentence in noise tests are non-invasive and are commonly used in audiology practices to diagnosis and treat a variety of audiological pathologies.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects age ranges

   a. 21 years (inclusive) and 89years (inclusive)
2. Subjects exhibiting no poorer than a mild hearing loss, defined as hearing thresholds no worse than 40dBHL at any test frequency 250-4000 Hz based on pure tone audiometry
3. Subjects scoring 26 or higher on a screening measure of cognitive status (Montreal Cognitive Screening Assessment; MoCA)

Exclusion Criteria:

1. Patients outside the age range of 21-89
2. Patients with an air-bone gap greater than 10dBHL at any frequency
3. Patients who are decisionally challenged and/or unable to complete speech perception testing. These patients are excluded based on the study requiring behavioral responses to some tests
4. Patients with little command of the English language who are unable to understand and repeat back simple everyday English sentences.
5. Illiterate patients
6. Patients with neurodegenerative diseases.
Study to Compare the Diopsys NOVA and LKC RETeval Devices

To compare the Diopsys NOVA and LKC RETeval Devices using the Diopsys Lid Electrodes and LKC RETeval Self-Adhering Electrode Arrays.

This study is an open label, prospective study comparing the Diopsys NOVA and LKC RETeval devices using the Diopsys Lid Electrodes and the LKC RETeval Self-Adhering Electrode Arrays.

Subjects will receive the PhNR test three times using the Diopsys device and Diopsys Electrodes. Next, subjects will receive the FL Flicker test three times using the Diopsys device and Diopsys Electrodes. There will be a short break (10 to 15 minutes), then subjects will receive the PhNR test three times using the Diopsys device with LKC Electrode Arrays, followed by the FL Flicker test three times using the Diopsys device with the LKC electrode arrays. Subjects will receive another short break (5 to 10 minutes), then receive the PhNR test three times using the LKC device with the LKC electrode arrays, followed by the FL Flicker test three times using the LKC device with the LKC electrode arrays.

Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 22 years of age on day of enrollment
* BCVA letter score of 75 or better (Snellen equivalent of 20/32 or better) on day of enrollment
* Eyes are healthy/normal based on prior examinations, record review, and/or patient intake questions. Subject has not been diagnosed with any ocular pathology that could affect ERG results.
* Able to communicate well with the Investigator and able to understand and comply with the requirements of the study
* Informed of the nature of this study and has provided written, informed consent in accordance with institutional, local and national regulatory guidelines

Exclusion Criteria:

* A spherical refraction outside + 5.0 D and cylinder correction outside + 3.0 D on day of enrollment
* Intraocular surgery (except non-complicated cataract or refractive surgery performed more than 1 year before enrollment)
* Any prior macular or panretinal photocoagulation laser treatment
* History of ophthalmic or neurologic condition known to affect visual function
* Inability to obtain a reliable ERG test
* History of Diabetic retinopathy
* History of Glaucoma
* History of ARMD
* History of seizure disorder
* Has an open sore(s) or dermatological condition that may come in contact with the electrodes/electrode arrays
* In the opinion of the Investigator, is unlikely to comply with the study protocol
Effects of Alcohol After Bariatric Surgery

The investigators wish to study the effects of three forms of bariatric surgery: gastric bypass, sleeve gastrectomy, and lap banding. The surgery is not part of the clinical trial. If insurance does not cover the procedure, then the patient is responsible for payment of the surgical process. The investigators are doing pre- and post-surgery testing to provide a better understanding of the effect of bariatric surgery-induced weight loss on 1) alcohol absorption, distribution and elimination from the body; 2) the effects of alcohol on blood sugar; and 3) the effects of alcohol on mood.

The study includes seven groups of women: One group will be undergoing gastric bypass, another group will be undergoing lap banding, a third group will be undergoing sleeve gastrectomy, the fourth group will be women who underwent gastric bypass 1-5 years ago, the fifth group will be women who underwent lap banding 1-5 years ago, the sixth group will be women who underwent sleeve gastrectomy 1-5 years ago, and the seventh group will be a control group who have not undergone bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Drink alcohol at least once per month

Exclusion Criteria:

* Men
* Drinks more than 7 standard drinks per week or more than 4 standard drinks in a period of 2 hours for the month before enrolling in the study.
* Regular use of drugs of abuse or use of any medication interacting with alcohol pharmacokinetics or pharmacologic effects.
* Alcohol dependence
* Pregnancy, lactation or not using effective methods of birth control
* Smoking
* Anemia
* Liver disease
Study of ARO-ALK7 in Adult Volunteers With Obesity With and Without Type 2 Diabetes Mellitus

This study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of single and multiple doses of ARO-ALK7 in adult volunteers with obesity (Part 1) and the safety, tolerability, and PD of multiple doses of ARO-ALK7 in adult volunteers with obesity with and without Type 2 Diabetes Mellitus (T2DM) receiving tirzepatide (Part 2). In Part 1A eligible participants with obesity will be randomized to receive a single dose of ARO-ALK7 or placebo (PBO) administered on Day 1. In Part 1B, eligible participants with obesity will be randomized to receive two doses of ARO-ALK7 or PBO administered on Day 1 and Day 29. In Part 2, eligible subjects with and without diabetes will randomized to combined therapy with tirzepatide and ARO-ALK7 or PBO (intervention arm) or tirzepatide monotherapy (control arm). Tirzepatide will be initiated on Day 1 and administered by subcutaneous injection (sc) weekly. ARO-ALK7 or PBO will be administered by sc injection on Day 1 and Day 29. All subjects in Part 2 will undergo adipose aspiration at Screening and Days 57, 113, 169 and 253.


Eligibility Criteria:
Inclusion Criteria:

* Obesity, defined as BMI between 30-50 kg/m2, inclusive, with weight at Screening not to exceed 159 kg (350 lbs)
* At least one self-reported, unsuccessful attempt at weight loss with lifestyle modification
* No abnormal finding of clinical relevance at Screening that could adversely impact participant safety during the study or adversely impact study results
* Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later. Participants must not donate sperm or eggs during the study for at least 90 days following the end of the study or last dose of study drug, whichever is later

Exclusion Criteria:

* Self-reported (or documented) weight gain or loss \>5% within 3 months prior to Screening
* Use of GLP-1RAs (liraglutide, semaglutide, etc.) for any indication within 6 months prior to Screening
* Use of non-GLP-1R medications for weight loss within 3 months prior to Screening including but not limited to naltrexone/bupropion, orlistat, phentermine/topiramate and other prescription or over-the-counter medication or supplement taken for weight loss purposes
* Obesity attributable primarily to medication use, endocrinologic or monogenic disorders
* History of prior surgical or device-based therapy for obesity (including endoscopic bariatric procedures)
* Use of medications or therapies strongly associated with weight gain, alterations in body composition, or increase in muscle mass, within 3 months prior to Screening
* Type 1 diabetes mellitus

Note: Additional inclusion/exclusion criteria may apply per protocol
Scintigraphy Study to Assess Gastric Emptying in Healthy Subjects Given GSK716155 or Placebo.

This study will use scintigraphy techniques to measure gastric emptying rate of liquid and solid food at baseline and after administration of GSK716155 or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men or women, between the ages of 18 and 65, and have a Body Mass Index (BMI) of between 20 and 32.
* If female, the subject must be not be capable of having children.

Exclusion Criteria:

* Subjects must not use tobacco, nicotine, or illegal drugs of abuse, and must not take caffeine or alcohol for 24 hours before dosing and before each set of scintigraphy procedures.
* Subjects may not have HIV, hepatitis, elevated fasting blood sugar levels, high blood pressure, heart, lung, liver, gall bladder, gastrointestinal, pancreatic, or kidney disease, or untreated thyroid disease.
* Subjects must not have a history of alcohol abuse, must not take prescription or non-prescription drugs within 7 days of Day 1 and Day 8 of the study, and must not have previous exposure to any GLP-1 mimetic or exenatide.
* Prior radiation exposures must meet certain limits in order to participate in this study.
Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients With Stage III/IV and Relapsed NSCLC

This is a Phase II study of paclitaxel (Taxol R) administered as a 96-hour (4 day) continuous infusion followed by a bolus of cisplatin for previously untreated patients with stage III/IV or relapsed non-small cell lung cancer (NSCLC). The goal of this phase II study is to determine the response rate of this infusional paclitaxel and bolus cisplatin regimen in patients with advanced NSCLC.

This is a Phase II study of paclitaxel (Taxol R) administered as a 96-hour (4 day) continuous infusion followed by a bolus of cisplatin for previously untreated patients with stage III/IV or relapsed non-small cell lung cancer (NSCLC). The goal of this phase II study is to determine the response rate of this infusional paclitaxel and bolus cisplatin regimen in patients with advanced NSCLC. In addition, the plasma levels of paclitaxel will be measured, and the in vitro paclitaxel chemosensitivity of the tumor cells from as many patients as possible will be determined. This will allow further study of the relationship between in vitro drug sensitivity, achievable plasma concentrations of paclitaxel, and patients' response to therapy.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Histologically confirmed non-small cell lung cancer, including: Squamous cell carcinoma, Adenocarcinoma, Large cell carcinoma, Mixed histologies in the absence of a predominant small cell component.

Eligible Stages Include:

Stage IV, Stage IIIA/B ineligible for resection or radiotherapy, Postsurgical recurrence that is histologically or cytologically proven.

CNS Metastases Allowed Provided:

Radiotherapy completed prior to entry.

No requirement for concurrent steroids.

No carcinomatous meningitis.

No epidural metastases.

Measurable disease not required.

PRIOR/CONCURRENT THERAPY:

Biologic Therapy: Not specified.

Chemotherapy: No prior chemotherapy for lung cancer.

Endocrine Therapy: Not specified.

Radiotherapy: No prior chest irradiation for lung cancer.

Surgery: Prior surgery allowed.

PATIENT CHARACTERISTICS:

Age: 18 and over.

Performance Status: ECOG 0-2.

Hematopoietic:

Absolute granulocyte count greater than 2,000.

Platelet count greater than 100,000.

Hepatic: Bilirubin no greater than 1.5 mg/dL.

Renal: Creatinine no greater than 1.5 mg/dL.

Cardiovascular:

No CHF unless fully compensated.

No second- or third-degree heart block.

No uncontrolled, symptomatic atrial dysrhythmia except sinus bradycardia.

No sustained ventricular tachycardia.

No MI within 3 months.

OTHER:

No uncontrolled infection unless due to an obstructed bronchus.

No major psychiatric problems requiring hospitalization.

No psychotropic medications such as phenothiazines.

No contraindication to transfusion, if required.

No second malignancy within 5 years except: Nonmelanomatous skin cancer.

In situ cervical cancer.

No pregnant or nursing women.

Effective contraception required of fertile patients.
Efficacy and Tolerance of Hypertonic Sodium Chloride (NaCl 5%) Eye Drops Without Preservatives in Corneal Edema

Corneal edema is frequently found in clinical practice as a common sign of acute corneal disease due to different etiologies that cause an accumulation of extracellular fluid in the cornea. The present unicentric clinical trial aims to evaluate the efficacy and tolerance of an ophthalmic solution of hypertonic sodium chloride (NaCl 5%) without preservatives in participants suffering from symptomatic corneal edema.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Clinical diagnosis of symptomatic corneal edema related to chronic epithelial, secondary to corneal dystrophies, controlled infectious and inflammatory pathologies and surgical trauma already resolved.
* No need for keratoplasty in the 6 months following the start of the study

Exclusion Criteria:.

* Visual acuity less than 1/20 in both eyes
* Corneal edema caused by the following acute etiologies: trauma, infection, inflammation or Stevens-Johnson syndrome.
* Glaucoma or uncontrolled hypertension.
* Known allergy to any of the ingredients of the product.