cyrilzakka/clinical-trials huggingface dataset:
Ketamine for Older Adults Pilot

This pilot study will assess the safety and feasibility of intravenous (IV) ketamine in older adults with Treatment-Resistant Depression (TRD). In addition, this study will develop and utilize innovative methodological approaches to demonstrate the feasibility of precision medicine and mobile health approaches in depression treatment.

Participants in this study will receive ketamine infusions twice a week for 4 weeks (acute phase). Participants who respond or remit will continue with an additional 4 weeks of weekly ketamine infusions (continuation phase). Participants will be assessed at baseline, end of acute phase, and end of continuation phase for effectiveness, safety, and executive functioning. Participants will be asked to complete daily surveys of their depression symptoms during their participation.

Eligibility Criteria:
Inclusion Criteria:

1. Community-living men and women age 65 years and older;
2. Treatment-resistant depression: defined as unipolar major depressive disorder, non-delusional (diagnosed by SCID-5) that persists despite ≥ 2 adequate antidepressant trials of different classes in the current episode; including at least one evidence-based second-line treatment in the current episode (including serotonin norepinephrine reuptake inhibitors, bupropion, tricyclics, monoamine oxidase inhibitors, or augmentation with an atypical antipsychotic, stimulant, bupropion, lithium, or triiodothyronine
3. Persistent moderate to severe depressive symptoms determined by Patient Health Questionnaire 9-item (PHQ-9)26 score ≥15 at baseline
4. Able to provide informed consent.

Exclusion Criteria:

1. Dementia per history, score \< 24 on the Montreal Cognitive Assessment (MoCA), or determined by clinical interview with geriatric psychiatrist to have high likelihood of dementia;
2. Psychotic spectrum or bipolar disorder or severe personality disorder that at the PIs discretion would interfere with safe participation. Anxiety disorders are not an exclusion.
3. Unstable medical conditions such that IV ketamine is not safe or tolerated or that would interfere with participation in a long-term study (i.e., poorly controlled hypertension, life expectancy \< 1 year because of terminal illness, unstable angina).
4. Baseline systolic BP \> 165 systolic or 100 diastolic at evaluation.
5. Current alcohol or substance use disorder or lifetime recreational ketamine use or other dissociative agent (e.g., PCP).
6. Use of naltrexone, memantine, or any medication that could be considered contraindicated with ketamine.
7. Taking more than 2 adequately-dosed oral antidepressants.
8. High acute risk for suicide and unable to be managed safely in the clinical trial.
Cognitive Processing Therapy Versus Prolonged Exposure for Treating Women With Post-Traumatic Stress Disorder Brought on by Sexual Assault

This study will evaluate the effectiveness of cognitive processing therapy versus prolonged exposure therapy in treating women with post-traumatic stress disorder (PTSD) brought on by sexual assault.

PTSD is a psychiatric disorder that can occur following exposure to a traumatic event in which grave physical harm occurred or was threatened. PTSD is marked by clear biological changes as well as psychological symptoms. Many people with PTSD repeatedly relive the trauma in the form of flashback episodes, memories, nightmares, or frightening thoughts. This study will evaluate the effectiveness of cognitive processing therapy (CPT) versus prolonged exposure therapy in treating women with PTSD brought on by sexual assault.

Participants in this single-blind study will be randomly assigned to one of three conditions: CPT, prolonged exposure therapy (PE), or minimal attention (MA). Individuals assigned to receive CPT will attend therapy sessions twice weekly for 6 weeks. Each session will be 1 hour long, except for sessions 4 and 5, which will be 1.5 hours long. CPT will focus on helping each individual to process accurate memories of the traumatic event and to work through any memories that cannot be completely ignored, nor completely integrated back into their thinking. Also included in CPT will be an exposure component, in which participants will be encouraged to recall the traumatic event and experience any emotions connected to it. Participants assigned to receive PE therapy will attend an initial 1-hour therapy session, followed by 4 weeks of additional sessions that will meet twice weekly. Each of these 8 sessions will be 1.5 hours long. PE will entail oral exposure without modification of the participant's cognitions. Participants will discuss their traumatic experiences in detail during each session to aid in emotional processing. All PE sessions will be audio taped. Participants will listen to the tapes of their sessions on their own to further assist with emotional processing. Individuals assigned to receive MA will receive no therapy for the first 6 weeks. At the end of this initial phase, they will be assigned to receive either CPT or PE if they still meet diagnostic criteria for PTSD. Symptoms of PTSD, feelings of guilt and shame, and overall perception of self and surroundings will be assessed at baseline, post-treatment, and at follow-up visits at 3, 6, and 9 months post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* History of at least one incidence of rape
* Diagnosed with post-traumatic stress disorder

Exclusion Criteria:

* Rape occurred before the age of 13 and was committed by a family member
* Rape was committed by a spouse who is currently living in the same household
* Psychosis
* Mental retardation
* Current pathology that may complicate symptoms of post-traumatic stress disorder
* Currently suicidal or parasuicidal
* Currently addicted to drugs or alcohol
* Illiterate
Recipients With Limited Bimodal Benefit: HA or CROS

The rationale is to determine (in individuals with limited perceived bimodal benefit) whether the CROS device may be a better solution for obtaining two-sided input. If yes, this study would be practice-changing.

It is well accepted that bilateral input can significantly improve speech understanding in noise for patients with cochlear implants. For cochlear implant (CI) recipients who have a CI on only one side, two sided input can be provided with simultaneous use of a hearing aid (HA) or a CROS device on the opposite side. The decision about which device to use depends on the level of residual hearing a recipient has in non CI-implanted ear, and more specifically what level of useable residual hearing s/he has. Access to useable low frequency hearing can not only improve speech understanding in noise, it can also improve sound quality, pitch perception and music perception.

Clinicians can reasonably predict that a recipient with hearing thresholds better than 60 dB HL at low frequencies (below 750 Hz) would benefit from amplification. For recipients with no measurable acoustic hearing in the contralateral ear, CROS would be a reasonable option, especially if bilateral implantation is not feasible or desired. However, it is more difficult to predict the appropriate device in individuals who have some measurable acoustic hearing but may be receiving limited benefit from it. This can be especially challenging because audiometric thresholds are not a reliable predictor of bimodal benefit. Additionally, acoustic hearing can provide subjective benefits which could hold different intrinsic value or significance for different individuals depending on their life style and listening needs.

Eligibility Criteria:
Inclusion Criteria:

* Adults (\> 18 years of age)
* Unilaterally implanted with an Advanced Bionics implant (CII or later)
* At least six months of CI use
* Limited bimodal benefit as perceived by the recipient and/or the clinician
* Participants may or may not currently be using a hearing aid in the unimplanted ear.
* Open set performance with current device configuration:
* ≥40% AzBio sentence score in quiet (S0) and? (i.e. do both these apply)

If currently bimodal:

* Hearing aid ear only CNC score \<50%
* AzBio Scores bimodal benefit \<15% increase in score compared to CI only?
* Unaided audiometric threshold of ≤100 dBHL up to 500 Hz
* Ability and willingness to participate in multiple sets of open speech testing (and ongoing evaluation of HA and CROS benefit)

Exclusion Criteria:

* Patients who are not proficient in English as the AzBio testing is available in English only.
* Patients with agenesis of the contralateral ear
Perception of Unpleasant Sensations During Study Procedures in ALS Patients

Diagnosis of Amyotrophic Lateral Sclerosis (ALS) is considered a traumatic life event for both the patient and their next-of-kin/carers, due to the lack of treatment. Clinical Trials can offer pioneering treatment to reduce the impact of the disease and improve future treatments worldwide. Research protocols may involve routine diagnostic and/or therapeutic procedures which the patients may be already aware of and, therefore, expecting specific sensations. These could compromise participation or drop-out rate. Despite everything, participation in a clinical trial can guarantee continuity of care also thanks to the execution of these same procedures, through preferential access compared to other patients.

Aim of this study is to investigate the unpleasant sensations perceived by ALS patients during procedures in clinical trials. Analysing what type of pain/discomfort frightens patients during diagnostic and/or therapeutic procedures, including the different methods of administration of the study drug. Provide data to implement effective therapy and offer constant patients support throughout ALS specific and needed procedures. Evaluate if this support could influence adherence rate of ALS patients to conduct clinical trials as required. Provide information for future studies to create an ALS Clinical Trials multiple-retention-factors adherence scale. Create and implement an ALS-specific pain scale accounting for its impact on daily activities, aiding an interdisciplinary approach of pain management. Identify the best pain management strategies and compliance techniques to address ALS, not merely in clinical trials. Provide the best individualized care for ALS patients improving their quality of life and mental state.

This is a descriptive phenomenological study and data will be analyzed according to Sundler's method. Based on the experience of the researchers and the recommendations proposed by Sandelowski, a total of 20 interviews are estimated in order to reach the theoretical saturation per category of reference. Data collection will be carried out through in-depth semi-structured interviews recorded (13 open-ended questions after the execution of the procedures).


Eligibility Criteria:
Inclusion Criteria:

* Spinal or bulbar Amyotrophic Lateral Sclerosis (ALS)
* Age \> 18 years
* Adequate understanding of Italian language
* Full understanding of the study
* Informed consent signed
* Current or past participation in interventional clinical studies
* Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) score of item # 4 ≥ 2, or score of item #1 ≥ 1

Exclusion Criteria:

* Clinically relevant cognitive dysfunction
* Inability to answer orally or by writing to the questions of the interview
* Hospital Anxiety and Depression Scale (HADS) scale ≥ 11
The Impact of Provider Demographics on Patients' Continuity of Care

The race concordance of providers to their patients impacts a patient's investment and agency in the patient-provider relationship. The mistrust of medicine within the African American population remains and patients feel unengaged in their care. Race concordant provider-patient rela-tionships would improve the equity of patient care in our clinic.

The patients of the obstetrics and gynecology resident clinic at Good Samaritan Hospital have a poor follow-up rate for their gynecologic and prenatal care visits. In addition, patients oftentimes voice frustration over the care that they receive and sometimes remark that they feel their provider was "racist." These patients often have complex social situations that cannot be solved in one office visit but perhaps the providers' ability to gain the trust of the minority patients is inadequate. The residents in the OB/GYN program are 80% white with no African American representation. If patients are unable to connect with caregivers due to cross-cultural differences, this could be remedied by training current residents in cross-cultural communication or re-cruitment of a resident class more representative of the majority African American patient population. This project will provide perspective on the minority patients' needs in the provider-patient relationship and allow providers to reexamine their ability to gain trust with the ultimate goal to increase follow-up rates. Follow-up rates for prenatal care are directly linked to improved maternal and fetal outcomes. The investigators goals are threefold: to gain clarity on whether or not a more diverse resident group would be helpful in gaining the trust of patients, to assess the current state of the well-established historical and generational mistrust of medical care by the African American patients of the clinic, and to explore how patient perception of their provider impacts their rate of follow up in the large community hospital clinic.

Eligibility Criteria:
Inclusion criteria

* Female Patient seeing OB/GYN resident at FMC
* 18 years or older
* \<36 weeks pregnant or GYN patient
* If GYN patient, must have problem requiring follow-up within 6 months
* Have not previously completed the survey

Exclusion criteria

* Less than 18 years of age
* High risk clinic patients (Tuesday afternoons)
* Patients without a follow-up less than 6 months as scheduled at check out
OTO-413 in Subjects With Speech-in-Noise Hearing Impairment

The purpose of this study is to evaluate the safety, tolerability, and exploratory efficacy of OTO-413 administered as an intratympanic injection for the treatment of speech-in-noise hearing impairment.


Eligibility Criteria:
Inclusion Criteria:

* Subject has audiometrically-defined normal hearing or up to moderately severe hearing impairment.
* Subject has self-reported difficulty hearing in noisy environments for at least 6 months prior to Screening.
* Subject exhibited a speech-in-noise hearing deficit in at least one ear.

Exclusion Criteria:

* Subject is pregnant or lactating.
* Subject has the following hearing disorders or any other hearing disorders that may impact the efficacy assessments or safety of the subject in the opinion of the Investigator: Meniere's disease, congenital hearing loss, or genetic sensorineural hearing loss.
* Subject has a cochlear implant or consistently uses a hearing aid.
* Subject has worked at least 5 years as a professional musician or has had at least 15 years of formal musical training.
* Subject self-reports bothersome, subjective tinnitus and is consistently aware of their tinnitus throughout much of the waking day.
A Trial of INS068 in Patients With Type 2 Diabetes Not Adequately Controlled With One or Two Oral Antidiabetics

The study is being conducted to evaluate the efficacy and safety of IND068 once daily (QD) in subjects with type 2 diabetes not adequately controlled with one or two oral antidiabetics compared to insulin degludec QD for 16 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that will not have been performed during normal management of the subject.)
* Age is 18-75 years
* Diagnosed with Type 2 diabetes (according to the diagnosis criteria applicable locally) for at least 3 months
* Treatment with one or two oral anti-diabetic drug (OADs): metformin at astable daily dose of ≥ 1500 mg or maximum tolerated dose (at least 1000mg daily), with or without insulin secretagogue (SU or glinides) or DPP-4 inhibitors or SGLT-2 inhibitors or alpha-glucosidase inhibitors for at least 8 weeks at a stable dose. The dose(s) of OAD other than metformin should be minimum half of the daily maximal dose according to local labelling or maximum tolerated dose.
* Insulin naïve. short-term insulin treatment (consecutive or cumulative treatment of ≤14 days) and insulin treatment for gestational diabetes are allowed.
* HbA1c 7.0-10.0 % (53-85 mmol/mol) (both inclusive)
* BMI 19-40 kg/m2 (both inclusive)

Exclusion Criteria:

* Known or suspected allergy or intolerance to the active substance or to any of the excipients of the investigational medical products
* Severe hypoglycemia during the previous 6 months.
* Hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome during the previous 6 months.
* Cardiovascular disease within the last 12 months, defined as: stroke, decompensated heart failure (New York Heart Association \[NYHA\] class III or IV), myocardial infarction, or hospitalization for unstable angina pectoris or transient ischemic attack.
* Diagnosis of malignant neoplasms (except basal cell or squamous cell skin cancer, polyps and in-situ carcinomas) within the last 5 years or increased risk of cancer or relapse of cancer.
* Any antidiabetic medication other than permitted in the inclusion criteria or any weight-loss drug within the last 8 weeks..
* Systemic or intra-articular corticosteroids treatment within the last 3 months.
A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis

The purpose of this study is to evaluate the efficacy and safety of CNTO 1959 in the treatment of patients with moderate to severe plaque psoriasis.

This is a multicenter, dose-ranging study of CNTO 1959 in patients with moderate to severe plaque psoriasis. Patients who satisfy all inclusion and exclusion criteria will be assigned by chance to one of 7 treatment groups: a placebo group (a placebo is a treatment identical in appearance to CNTO 1959 but does not contain active drug), 1 of 5 dose groups for CNTO 1959, or adalimumab. Patients assigned to adalimumab will be dosed according to the labeled dosing for psoriasis. At Week 16, patients initially assigned to placebo will begin receiving CNTO 1959. Patients initially assigned to CNTO 1959 will continue to receive the same assigned dose level of study agent from Week 16 through Week 40. Patients receiving adalimumab will continue the labeled dosing regimen. All patients will be reassessed for clinical response every 4 weeks from Week 4 through Week 40. Patients will continue dosing through Week 40, with a subsequent efficacy and safety follow-up visit at Week 52. Patient safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent
* Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment)
* Must be considered, in the opinion of the investigator, suitable candidates for adalimumab therapy
* If a woman, she must be postmenopausal, or if premenopausal, she must be either surgically sterile, practicing a highly effective method of birth control, or not heterosexually active during the study and for 5 months after receiving the last dose of study drug
* If a man, he must agree to use a double-barrier method of birth control (or must have been surgically sterilized) and to not donate sperm during the study and for 5 months after receiving the last dose of study drug.

Exclusion Criteria:

* History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
* Has a contra-indication to anti-TNF therapy
* Has a history of chronic or recurrent infectious disease
* Has a nonplaque form of psoriasis or has drug-induced psoriasis
* Has been previously treated with adalimumab
* Has received any therapeutic agent directly targeted to IL-12, IL-17, or IL-23, (including but not limited to ustekinumab, briakinumab \[ABT-874\], AIN457, and SCH900222) within 6 months of the first administration of study agent.
Evaluation of Nicotinamide Riboside in Prevention of Small Fiber Axon Degeneration and Promotion of Nerve Regeneration

This study will evaluate the effects of a nutritional supplement called nicotinamide riboside in preventing small fiber nerve degeneration that is experimentally induced by applying capsaicin to skin in otherwise healthy study participants. Furthermore, the effects on nerve regeneration will also be evaluated. The results will be compared to a placebo control drug.

Small fiber neuropathy (SFN) is a type of peripheral neuropathy that affects the small unmyelinated fibers, including both somatic innervation of the skin and autonomic nerves. Although diabetes and prediabetes are the two most common causes, up to 50% of all SFN remain idiopathic. Currently there is no effective treatment that prevents it or reverses it through regeneration of nerve fibers.

Recent advances in understanding the molecular machinery that mediates Wallerian degeneration (i.e. degeneration of nerve fibers after physical transection) showed that key molecular players in this pathway and nicotinamide (NAD+) metabolites play a similar role in degeneration of axons in a distal-to-proximal manner seen in many peripheral neuropathies including SFN. Pre-clinical studies have shown that rapid depletion of NAD initiates a cascade of molecular events that leads to axon degeneration and that supplementation of a NAD precursor, nicotinamide riboside (NR) can prevent this degeneration.

In this study investigators plan to evaluate the ability of NR to prevent degeneration of small somatic sensory axons innervating the epidermis as well as its ability to promote regeneration of these same fibers in a human experimental model of nerve degeneration and regeneration. This experimental human model has been used previously to evaluate the rate of nerve degeneration and regeneration in several peripheral neuropathies and in healthy subjects.

Since NR is available as a nutritional supplement, if successful, this research can lead to development of a therapy for a variety of peripheral neuropathies very rapidly.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65
* BMI\<32
* Normal neurological examination defined as Neuropathy Impairment Score \<2

Exclusion Criteria:

* History of peripheral neuropathy
* Any peripheral neuropathy risk factor including diabetes, Vitamin B12 deficiency, HIV-infection, chronic kidney or hepatic disease, hypothyroidism, chemotherapy or other know neurotoxic exposure.