cyrilzakka/clinical-trials huggingface dataset:
A Study Examining Adolescents With Non-Suicidal Self-Injury

This study will examine longitudinal brain development in young adolescent girls with a history of Non-Suicidal Self-Injury (NSSI). Specifically, three constructs outlined by the the Research Domains Criteria (RDoC) will be examined through self-assessment, MRI, and a cognitive battery.

This study is designed to study brain development in 12-14 year old females with a history of NSSI. Assessments will take place over the course of three years, with three visits per year - a total of nine visits.

The first visit will take place at the Ambulatory Research Center (ARC) at the Fairview Riverside hospital complex. This visit will include a number of questionnaires designed to gather information about the participant's physical and psychological health. Additionally, measures of intelligence quotient (IQ) and demographics will be assessed.

The second visit will again take place at the ARC. For this visit, participants will be asked to partake in the Trier Social Stress Test (TSST) in which they prepare a short, five-minute speech and deliver the speech to an audience with an additional task to follow. The TSST will be videotaped. Following the completion of this task, the participant will complete computer tests in order to measure things like attention and memory. During the second visit, five saliva samples will be collected to measure levels of the hormone Cortisol. The participant will need to collect additional saliva samples at home.

The third visit will take place at the University of Minnesota Center for Magnetic Resonance Research (CMRR) and will involve a brain MRI. Before the MRI the participant will be asked to provide a urine sample and complete a drug and pregnancy test. During the MRI, the participant will be asked to lie quietly in the scanner. The participant will do activities such as resting, listening to music, and playing games using a button box while in the scanner.

The participant will need to come in to complete these assessments twice more at one and two years following the completion of the first set of visits - a total of nine visits overall.

Eligibility Criteria:
Inclusion Criteria:

* 12-16 years old
* Female
* Has had first menstruation
* Willingness to have de-identified data shared with RDoC database

Inclusion Criteria - Adolescents with Non-Suicidal Self-Injury:

* Any history of self harm

Inclusion Criteria - Healthy Controls:

* No history of self harm

Exclusion Criteria:

* Male
* Pregnancy
* MRI Incompatibility
* IQ of less than 80
* Major Medical Illness
* Diagnosis of any of the following: Primary Psychotic Disorder, Bipolar Spectrum Disorder, Autism Spectrum Disorder, Current or Past Substance Use Disorder
Text Messaging for Adherence in Adolescent Liver Transplant Recipients

Text message reminders will improve adherence to lab tests in adolescent liver transplant recipients.

Adolescent patients who received a liver transplant will be recruited to participate in receiving text message reminders for lab tests. They will be send de-identified messages according to their required lab schedule. The investigators will monitor their adherence to lab tests as well as medication and clinic visits. They will also have a questionnaire about their medical regimen before and at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patient \>12 years
* Received liver transplant
* Followed by Stanford Liver Transplant Team

Exclusion Criteria:

* No personal cell phone
GBV Prevention, Mitigation, and Response in Colombia

As of August 2021, Colombia hosts the vast majority of Venezuelan refugees and migrants (UNHCR, 2022). For vulnerable refugees and migrants in Colombia, and especially for women, gender-based violence (GBV) is present during transit and continues in their new homes where xenophobia, lack of accessible and adequate services, lack of safe economic opportunities, and lack of information on access to services, further increase risk. Lack of livelihood opportunities also affect vulnerable refugees and migrants, especially women, with barriers to employment including lack of information; precarious working conditions with lower payments and longer working days with increasing risks of labor exploitation; xenophobia and discrimination; limited access to formal labor markets; lack of access to financial services, among others. To address these issues, the investigators are conducting a pilot randomized-controlled trial (RCT) of HIAS' Entrepreneurship School with Gender Lens (ESGL), a methodology that targets GBV survivors and women at-risk to help them develop business ideas, access needed support for the prevention of and response to GBV, exploitation and trafficking, and improve participants' overall self-reliance. The pilot RCT will be conducted within three cities in Colombia; approximately 80 eligible participants will be enrolled in each city and randomized to a treatment or control arm. Survey questionnaires will be administered to participants at baseline, eight months following baseline (endline), and 3-4 months after endline. Outcomes of interest include household self-reliance, mental health, empowerment, decision-making, and GBV risk and knowledge.


Eligibility Criteria:
Inclusion Criteria:

* Woman
* At least 18 years of age
* At risk of gender based violence (GBV) or ever experienced GBV
* Have a migratory permit (for migrants/refugees)
* Colombian or Venezuelan, living in Colombia for at least six months
* Hold an entrepreneur profile registered with HIAS (the implementing partner).

Exclusion Criteria:

* Man or does not self identify as a woman
* Less than 18 years old
* Not at risk of GBV and never experienced GBV
* Does not have a migratory permit
* Not Colombian or Venezuelan
* Living in Colombia for less than six months
* No entrepreneur profile registered with HIAS (the implementing partner).
Psychotherapy Outcome and Self-selection Effects in Panic Disorder

The efficacy of two forms of psychotherapy with panic disordered patients, a cognitive-behavioral and a psychodynamic one, are compared under two different, randomized conditions: randomization or self-selection. The basic hypotheses are that the efficacy of both treatments is higher and that the efficacy difference is smaller under self-selection than randomized conditions.

After thorough assessment persons with a panic disorder diagnosis are randomly assigned to three arms: one randomization, one self-selection, and one a low-contact waiting list one. In the randomization arm (R) 95 persons are randomly assigned to Panic Control Treatment (PCT) or Panic-Focused Psychodynamic Psychotherapy (PFPP); in the self-selection arm (SS) 95 persons are offered, after adequate information, to choose which of the two they prefer. Twenty-six persons are initially randomized to a three-month waiting list (with sparse contact over telephone), after which they will be re-randomized, either to further randomization (to PCT or PFPP) or to self-selection. The four groups (R/PCT; R/PFPP; SS/PCT; SS/PFPP) will be compared on the basis of intake and repeated outcome/follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

* A Diagnostic and Statistical Manual (DSM-V) diagnosis of Panic Disorder, with or without Agoraphobia
* Age between 18 and 60
* Willingness to stop other on-going psychotherapy treatments and to refrain from nonstudy treatments during follow up
* Ability to complete the active treatment phase (not including follow-ups) within 16 weeks

Exclusion Criteria:

* Active substance dependence (6 months remission necessary)
* Current psychosis, delusions, mania, or active addiction
* Acute suicidality
* A history and clinical presentation of at least one clinically-significant medical condition if, due to their cognitive or physical impairments, they are unable to fully participate in the psychotherapy treatments being offered
* Active involvement in a legal dispute related to their mental health issues
* Three or more unexcused absences
Cognitive Behavioural Group Therapy for Perinatal Anxiety

This study evaluated the effectiveness of a 6-week, group-based, cognitive behavioural therapy (CGBT) program for women with anxiety disorders (with or without comorbid depressive symptoms) during pregnancy or early postpartum. The CBGT program was evaluated compared to a 6-week waitlist condition.

Anxiety disorders affect up to 15% of women in the perinatal period (i.e., pregnancy, postpartum) and are a serious mental health concern. Anxiety disorders often coexist with depression and result in high distress and an impaired ability for new mothers to take care of themselves and their babies. In spite of the high prevalence of anxiety disorders during pregnancy and postpartum, research and clinical attention in this area is lacking and no empirically supported psychological treatments exist. Further, since many pregnant or postpartum women are unable or choose not to take medication for their mental health symptoms, establishing an effective non-pharmacological alternative is imperative. Cognitive-behavioural therapy is a well established psychological treatment for anxiety and mood disorders, with moderate to large effect sizes (Cohen's d = 0.5-1.3). The investigators developed a novel group-based cognitive-behavioural treatment program (CBGT) for perinatal women with anxiety disorders. In an initial, single-sample pilot study (Green et al., 2015), a significant reduction in symptoms of anxiety and depression was found from pre to post-treatment, along with reported high levels of treatment satisfaction. The purpose of the current study is to evaluate the effectiveness of this treatment using a larger sample and a randomized controlled trial (RCT).

Eligibility Criteria:
Eligibility criteria:

1. 18-45 years of age
2. pregnant or within the first six months postpartum
3. principal diagnosis of an anxiety disorder with or without comorbid depression
4. not taking psychoactive medication or, if taking these medications, no change in dose and type ≥ 6 weeks prior to the baseline assessment
5. no changes in psychoactive medication during the 6-week CBT treatment or 6-week waitlist
6. fluent in English

Exclusion criteria:

1. severe depression or active suicidal ideation
2. current psychosis or substance use disorder
A Behavioral Trial for the Treatment of Methamphetamine Dependence. - 1

The purpose of this study is to examine behavioral treatment for methamphetamine dependence.

To characterize meth. withdrawal symptoms using a multidimensional withdrawal questionnaire; to field test and investigate the effect of using an algorithm developed for discriminating between new use and residual carry-over of meth metabolites in urine and to evaluate the treatment response of meth. users to participation in the thrice weekly psychosocial protocol to be used as a "platform" in future pharmacotherapy trials.

Eligibility Criteria:
Inclusion Criteria:

Male or Female at least 18 yrs of age; DSM-4 diagnosis of methamphetamine (METH) dependence; be willing to comply with study procedures; verbalize understanding of consent and provide written consent and willingness to complete study procedures; be seeking treatment for METH dependence.

Exclusion Criteria:

Additional criteria available during screening at the site.
A Phase 1 Study of CDX-0159

This is a study to determine the safety of CDX-0159 in healthy subjects.

CDX-0159 is a humanized monoclonal antibody that binds to a protein called KIT that is expressed on mast cells.

This study will evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-0159 in healthy subjects.

Eligibility Criteria:
Key Inclusion Criteria:

* An informed consent signed and dated by the subject.
* Healthy volunteer aged 18-55.
* In generally good health and without significant medical conditions based on physical exam, ECG, and laboratory test results.
* Body mass index (BMI) ≥ 18.5 kg/m2 to ≤ 30 kg/m2
* No medication other than mild analgesics, vitamins and mineral supplements or, oral contraceptives
* Both males and females of child bearing potential must agree to use a medically accepted contraceptive regimen during study and up to 150 days afterwards.
* Not a current smoker (or regular user of any nicotine containing product).
* Willing to follow all study rules

Key Exclusion Criteria:

* Women who are pregnant or nursing
* History of anaphylaxis, food allergies, or allergies (chronic or seasonal) requiring prescription medication
* Autoimmune disorders requiring more than topical medication
* History of asthma requiring the use of inhaled medication within the past 5 years.
* Vaccination with live vaccines within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study).
* Positive urine test for alcohol and drugs of abuse.

Other Protocol defined inclusion and exclusion criteria could apply.
Treatment of Anemia in the 2nd Year of Life. Comparison of the Efficacy of Two Different Iron Preparations.

Healthy toddlers (age 9-18 month) following a routine blood count will be placed in three groups:

1. Iron deficiency with no anemia
2. anemia
3. no anemia and no iron deficiency Following a nutritional questionnaire, parents of all toddlers will receive instruction regarding appropriate nutrition in the 2nd year of life. Groups 1 and 2 will randomly receive one of two preparations currently in use for treatment of iron deficiency in Israel (Aktiron 35 - Ferrous gluconate and Ferripel-3 - iron polysaccharide complex). Followup blood count will be taken 3 month after recruitment. The study aims to compare the effectiveness of the Iron preparations regarding compliance and efficacy.

The hypothesis is that a significant difference will be detected between the two preparations.


Eligibility Criteria:
Inclusion Criteria:

* Healthy toddlers age 9-18 months

Exclusion Criteria:

* Toddlers with: chronic diseases, prematurity, inherited hematological disease.
MAAT For Young Adult Cancer Survivors

The goal of this clinical trial is to pilot-test a modified version of telehealth-delivered Memory and Attention Adaption Training (MAAT) that is tailored to young adult childhood cancer survivors (ages 18-39; MAAT-YS) with cancer-related cognitive impairment (CRCI). MAAT-YS consists of 8 weekly visits (45-minutes in duration) and participants use a survivor workbook and complete homework between visits. Participants in this single-group pilot trial (N=9) will complete online self-report measures of cognitive symptoms, quality of life, treatment satisfaction and a brief online neuropsychological test battery at baseline and post-MAAT-YS timepoints.

The goal of this clinical trial is to pilot-test a modified version of telehealth-delivered Memory and Attention Adaption Training (MAAT) that is tailored to young adult childhood cancer survivors (ages 18-39; MAAT-YS) with cancer-related cognitive impairment (CRCI). MAAT-YS consists of 8 weekly visits (45-minutes in duration) and participants use a survivor workbook and complete homework between visits.

This pilot trial will determine MAAT-YS feasibility, treatment satisfaction and size of effect in self-report and objective measures of neurocognitive function.

Eligible participants will be 9 individuals who were diagnosed with non-central-nervous system (CNS) cancer (including leukemia/lymphoma without known CNS involvement) prior to the age of 18, are at least 1-year from completion of cancer treatment, including chemotherapy.

Participants will complete online self-report measures of cognitive symptoms, quality of life, treatment satisfaction and a brief online neuropsychological test battery at baseline and post-MAAT-YS timepoints.

If successful, further research is planned with a larger, multi-site randomized controlled trial of MAAT-YS.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18-39
2. Diagnosed prior to 18 years of age with non-CNS solid tumor or leukemia/lymphoma without known CNS involvement
3. At least 1 year after completion of treatment including chemotherapy, cancer-free
4. English fluent
5. Memory or other cognitive problems attributed to cancer and/or cancer treatment
6. Score of \<10 on the FACT-Cog Impact on Quality of Life Scale
7. Willing to use telehealth with internet access
8. Willing to provide informed consent to participation

Exclusion Criteria:

1. Severe non-cancer brain injury such as severe traumatic brain injury, stroke or toxic injury causing memory impairments;
2. Currently meeting Diagnostic and Statistical Manual-5 (DSM-5) criteria for a severe psychiatric disorder, including substance abuse, mood, anxiety, or psychotic disorders, as assessed by the PRIME-MD;
3. Scoring 3 or below on the 6-item cognitive screen designed to detect severe memory disorders;59
4. Severe uncorrected sensory impairment (severe hearing or visual impairment).
Choline Dehydrogenase and Sperm Function: Effects of Betaine

The ability of sperm to swim is important for normal fertility. Men with a genetic variation in the gene coding for Choline Dehydrogenase (CHDH) have decreased energy production by sperm, and their sperm do not swim normally. The metabolic product of this gene is a nutrient called betaine (found normally in the diet as a part of many foods such as spinach, beets and grain products). This study tests whether treatment with betaine is safe and whether it can normalize energy production in sperm of these men and restore normal swimming ability.

Unidentified genetic aberrations such as single nucleotide polymorphisms (SNPs) may be the underlying cause of many cases of idiopathic infertility in men. Choline dehydrogenase (encoded by CHDH) converts choline to betaine in the mitochondria. 5-9% of men have 2 alleles for a functional SNP in CHDH (rs12676), and they have low sperm adenosine triphosphate (ATP) concentrations with impaired sperm motility (asthenospermia) that should decrease fertility. Male mice in which CHDH is deleted also have very low sperm ATP, asthenospermia and are infertile. Supplementation of these mice with dietary betaine increases sperm motility and ATP concentrations.

This purpose of this study is to conduct a phase I study of betaine treatment in men with 2 minor alleles for CHDH rs12676 to determine whether betaine supplementation is safe and to obtain preliminary data on the effects of betaine on sperm mitochondrial ATP concentrations and sperm motility in these men.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 60 year old men of multiple races and ethnicities
* Estimated dietary intake of betaine of \<150 mg/day
* Carrying two alleles of the rs 12676 single nucleotide polymorphism

Exclusion Criteria:

* Cystathionine-beta-synthase (CBS) deficiency
* Currently taking betaine supplements
* Currently receiving chemotherapy, radiation or any gonadotoxic drug
* Female gender
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ESR 1150 CL in Healthy Subjects

The objective of this study was to obtain safety and tolerability data and first pharmacokinetic and pharmacodynamic data of escalating doses of ESR 1150 CL.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female Caucasian subjects as determined by results of screening
* Written informed consent in accordance with Good Clinical Practice and local legislation given
* Age ≥ 18 and ≤ 50 years
* Broca ≥ - 20 % and ≤ + 20 %
* for first part of study: extensive metabolizers of CYP2D6 and/or "spartein" type; for second part of study: poor metabolizers of CYP2D6 and/or "spartein"

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders of neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) (≤ 1 month prior to administration or during the trial, except for oral contraceptives)
* Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial except for oral contraceptives)
* Participation in another trial with an investigational drug (≤ 2 months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/days)
* Drug abuse
* Blood donation \> 100 ml (≤ 4 weeks prior to administration or during the trial)
* Excessive physical activities (≤ 10 days prior to administration or during the trial)
* Any laboratory value outside the reference range of clinical relevance
* Females only:

  * No reliable contraception (examples of reliable contraception: oral contraceptives, 3-month injection, intrauterine device, sterilisation, condoms + spermicide)
  * pregnancy or breast feeding period
Prospective Study Assessing the Validity of Y-PAS (Yale Preoperative Anxiety Scale) to Predict Patients Undergoing Magnetic Resonance Imaging Without the Use of Sedation/General Anesthesia

The mYPAS (Modified Yale Preoperative Anxiety Scale) is a quick, easy, validated and "gold standard" assessment tool to measure pediatric anxiety in the perioperative period. Therefore the objective of the current prospective study is examine if the mY-PAS is an effective screening tool to differentiate patients who would succeed versus fail for MRI without sedation/anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* all patients and parents who are willing to participate in the simulated practice MRI on the day of or prior to their scheduled MRI.

Exclusion Criteria:

* patients/parents who refuse to go through the practice MRI sessions.
Inflammation and Treatment of Bacterial Vaginosis Near Term

Most studies demonstrate that untreated bacterial vaginosis increases the rate of preterm birth. Despite this, there is no evidence that screening and treatment of asymptomatic bacterial vaginosis nor interpregnancy treatment of endometritis decreases the subsequent rate of preterm birth. However, treatment of symptomatic bacterial vaginosis has been associated with a modest reduction in subsequent preterm birth. Potential mechanisms for this reduction include a decrease in peripheral maternal pro-inflammatory activation of the TH1 inflammatory cascade with treatment, however this direct pathway has not been elucidated. The approved treatment for bacterial vaginosis during pregnancy consists of Metronidazole 500mg BID for 7 days. A more complete understanding of the effect of Metronidazole on maternal inflammation would be useful in designing strategies to reduce the rates of preterm birth.

This study proposes to determine the effect of standard treatment of BV carriage on maternal serum markers of inflammation. This will be accomplished by giving patients with asymptomatic BV either the standard treatment of metronidazole or a placebo for 7 days. Blood will be drawn to compare levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha.


Eligibility Criteria:
Inclusion Criteria:

* 32 weeks gestation or greater
* Multiparity
* No history of preterm birth
* English speaking
* Ability to provide informed consent
* Bacterial vaginosis by gram stain

Exclusion Criteria:

* Acute infections at any site
* Active autoimmune disease
* Current anti-inflammatory use
* Symptomatic bacterial vaginosis
* Previous adverse reaction to metronidazole
* Reports ongoing ethanol consumption