cyrilzakka/clinical-trials huggingface dataset:
A Retrospective Observational Study to Evaluate the Utilization, Outcomes, and Adverse Events in Participants Treated With Minocin® (Minocycline) for Infections Caused by Gram-negative Bacteria in a Real World Setting

This study is a retrospective, observational study to evaluate minocycline use in participants under real world conditions.

This study is a retrospective, observational study to evaluate minocycline use in participants under real world conditions.

Eligibility Criteria:
Inclusion Criteria:

* The participant was treated with Minocin IV for a presumed or culture-confirmed gram-negative infection, as monotherapy or part of a broader regimen, for at least 48 hours.
* The participant treatment for gram-negative infection was initiated May 1, 2015, or later.
* The participant was at least 18 years old.
* This was the first course of Minocin IV administered to the participant within the study period for the treatment of gram-negative infection.
* At least 60 days has elapsed since the participant received the last dose of Minocin IV therapy for a presumed or confirmed gram-negative infection (prior to data entry into the electronic case report form, including step-down to oral therapy.

Exclusion Criteria:

* The participant received Minocin IV as a part of a controlled clinical trial.
* The participant received Minocin IV as a part of a Medicines Company- or Rempex Company-sponsored pharmacoeconomic outcomes study.
* Pregnancy (in the participant's or participant's partner) occurred after the first dose of Minocin IV through hospital discharge.
* Female participants were pregnant or nursing at the time of enrollment.
Building Resilience in Cyberbullying Victims

This study evaluates the effectiveness of a wise intervention based on self-affirmation (SA) and Implicit Theories of Personality (ITP) building resilience in victims. Half of the participants will receive the experimental intervention, while the other half will receive a control intervention.

Bullying victimization can harm victims' mental health. Numerous studies have shown that, when an adolescent is a victim of cyberbullying, the risk of developing numerous mental health problems increases. Tackling the problem of cyberbullying victims' worsening mental health involves at least (1) reducing bullying itself, as this would reduce the prevalence of victimization, and (2) building resilience in the victims so that their mental health does not worsen. In recent years, a number of preventive interventions have been developed aimed at reducing cyberbullying but not so much focused on building resilience in the victims. Very recently, interest in scientific social psychology has grown due to a new approach to interventions, which have been called "wise interventions." This approach involves a set of rigorous techniques, based on theory and research, that address specific psychological processes to help people thrive in various life environments. The main objective of this project is to extend the previous findings to the mental health effects of online victimization in adolescents. In this project it will be designed and evaluated the effectiveness of an wise intervention aimed at (1) reducing online bullying, as this would reduce the prevalence of victimization; and (2) building resilience in victims so that the negative impact of victimization on their mental health will be reduced. The secondary objective will be to evaluate the moderating role of gender and the degree of development in the effects of the intervention.The study will involve the evaluation of the intervention in a sample of around 600 adolescents randomly allocated to experimental and control condition.

Eligibility Criteria:
Inclusion Criteria:

* Spanish or Basque understanding
* Permission by parents
* Voluntarity

Exclusion Criteria:

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Acupuncture to Treat Insulin Resistance in Women With and Without Polycystic Ovary Syndrome

The central hypothesis is that acupuncture break the vicious circle of androgen excess and reverse insulin resistance and improve health related quality of life and affective symptoms in overweight and obese women with and without Polycystic Ovary Syndrome.

Polycystic ovary syndrome (PCOS) is the most common endocrine and metabolic disorder in women. The main metabolic phenotype is hyperinsulinemia and insulin resistance, which are independent of body weight and worsen hyperandrogenism and ovulatory dysfunction. Pharmacological treatments are symptom oriented and usually effective but have metabolic and gastrointestinal side effects. Therefore, it is important to evaluate new nonpharmacological treatment strategies, as most women with PCOS require long-term treatment.

Hypothesis and Aims Our central hypothesis is that acupuncture break the vicious circle of androgen excess and reverse insulin resistance and improve health related quality of life and affective symptoms in overweight and obese women with and without PCOS.

The specific aim are designed to test the hypotheses that

1. Acupuncture (acute and chronic i.e. 5 weeks treatment, 3 times per week) improves insulin sensitivity in overweight and obese women with and without PCOS
2. Acupuncture (acute and chronic i.e. 5 weeks treatment, 3 times per week) regulate key signaling molecules and mitochondrial oxidation/biogenesis in skeletal muscle and adipose tissue in overweight and obese women with and without PCOS
3. Acupuncture (chronic i.e. 5 weeks treatment, 3 times per week) improve health related quality of life and symptoms of anxiety and depression in overweight and obese women with and without PCOS

Time frame of the study is 5-6 weeks. No long term follow up.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 25 to \< 35 and
* Clinical signs of hyperandrogenism (hirsutism or acne) and
* At least one of the following two signs; oligo/amenorrhea and/or ultrasound-verified polycystic ovaries

Controls should have BMI \> 25 to \< 35, regular cycles with 28 days ± 2 days, no signs of hyperandrogenism.

Exclusion Criteria:

Exclusion criteria for all women

1. Age \> 38 years
2. Exclusion of other endocrine disorders such as hyperprolactinemia (s-prolactin \< 27µg/L), nonclassic congenital adrenal hyperplasia (17-hydroxyprogesterone \< 3nmol/L), and androgen secreting tumors.
3. Autoimmune disorders, cancer, Type I diabetes and Type 2 diabetes.
4. Pharmacological treatment (cortisone, antidepressant, antidiabetic, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 wks accounts for all participants.
5. Blood pressure \>160 / 100 mmHg
6. Pregnancy or breastfeeding the last 6 months
7. Acupuncture last 2 months
8. Language barrier or disabled person with reduced ability to understand information.
Cervical Preparation Before Dilation and Evacuation

The purpose of this research study is to compare three different ways of opening a woman's cervix before her second-trimester surgical abortion.

* Osmotic dilators: small rods that, when inserted into the cervix, gently expand to open the cervix
* Osmotic dilators plus mifepristone, a medicine that is swallowed
* Osmotic dilators plus misoprostol, a medicine that is placed between the cheek and gum

Hypotheses:

* adding buccal misoprostol 3 hours preoperatively will significantly improve dilation compared to laminaria alone, making procedures faster, easier and safer.
* adding oral mifepristone at the time of laminaria placement will confer a similar benefit.
* the efficacy of adjunctive misoprostol and mifepristone will be influenced by gestational age, with women later in gestation having increased efficacy from these agents.
* significantly more patients who receive adjunctive misoprostol or mifepristone will have adequate initial dilation, fewer will require manual dilation or additional cervical preparation and there will be fewer complications in these arms, although complication rates will be low and we will only be able to detect relatively large differences.
* patients will prefer to have the procedure done as quickly as possible with as little discomfort as possible, that cervical ripening with adjunctive misoprostol will be associated with more cramping than osmotic dilators alone and that mifepristone will be well tolerated and may not cause more cramping or other side effects than osmotic dilators alone.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Able to give informed consent
* Medically eligible for outpatient second trimester pregnancy termination at the clinical site
* English-speaking or Spanish-speaking at sites with ability to obtain informed consent in Spanish

Exclusion Criteria:

* Active bleeding (\>1 pad/hour) or hemodynamically unstable at enrollment
* Signs of chorioamnionitis or clinical infection at enrollment
* Signs of spontaneous labor or cervical insufficiency at enrollment
* Spontaneous intrauterine fetal demise
* Patient incarcerated
* Allergy to mifepristone or misoprostol
* Chronic steroid use or adrenal insufficiency
* Porphyria
* Inflammatory bowel disease requiring treatment
Stone Disease of the Urinary Tract in Children

The incidence of stone disease of the urinary tract in children is increasingly increasing with a remarkable economic impact for its management.

This incidence is variable according to race, geographic region, socio-economic status and dietary habits.

Oxalo-calcium stones are the most common but the biochemical nature of urinary stones varies depending on the region where those of a phosphatic nature are characterized by a higher incidence in Europe.

The diagnosis is confirmed by imaging. The unprepared abdomen (ASP) has low diagnostic accuracy. The scanner is the reference tool but remains an irradiating examination.

Risk factors for disease recurrence include primarily the presence of an underlying urinary metabolic abnormality and young age. Urinary metabolic abnormalities vary from one study to another.

The understanding of lithogenesis, its evaluation as well as the therapeutic options is essential for adequate and adapted management in the pediatric population.


Eligibility Criteria:
Inclusion criteria:

* Patients aged less than 18 years.
* Both sexes.
* Subjects presenting with lithiasis of the urinary tree in one of the two departments concerned between 01/01/2010 and 12/31/2022
* Subject not opposing, after information, the reuse of their data for the purposes of this research.
* Holders of parental authority who do not object, after being informed, to the reuse of their child's data for the purposes of this research.

Exclusion criteria:

* Subject or holder of parental authority having expressed opposition to participating in the study.
* Non-usable patient files: insufficient data.
Delayed-release Bedtime Caffeine and Sleep Inertia Symptoms Immediately Upon Awakening

Sleep inertia (sometimes also referred to as sleep drunkenness) is a disabling state of increased sleepiness, impaired mood and reduced vigilance immediately upon awakening. Sleep inertia is highly prevalent in various neurological diseases, including neurodegenerative, affective and circadian sleep-wake rhythms disorders, as well as in frequent societal conditions such as chronic sleep restriction, jetlag and shiftwork. Reactive countermeasures against sleep inertia, i.e., strategies implemented upon wake-up, are not sufficiently effective, yet current recommendations are limited to proactive strategies, including long enough sleep at optimal times of day. These recommendations are not always easy and sometimes impossible to apply. To address this unmet medical need, the investigators developed an innovative, time-controlled, pulsatile-release formulation of 160 mg caffeine targeting an efficacious dose briefly before planned awakening.

Sleep inertia is a disabling state of grogginess and impaired vigilance immediately upon awakening. The adenosine receptor antagonist, caffeine, is widely used to reduce sleep inertia symptoms, yet the initial, most severe impairments are hardly alleviated by post-awakening caffeine intake. To ameliorate this disabling state more potently, the investigators developed an innovative, delayed, pulsatile-release caffeine formulation targeting an efficacious dose briefly before planned awakening.

The investigators comprehensively test this formulation in two placebo-controlled, double-blind, cross-over studies. First, the investigators establish the in vivo caffeine release profile in young men. Subsequently, they investigate the formulation's ability to improve sleep inertia in sleep-restricted volunteers. Following oral administration of 160 mg caffeine at habitual bedtime \[22:30\], the investigators keep the participants awake until 03:00, to increase sleep inertia symptoms upon scheduled awakening \[at 07:00\]. Immediately upon awakening, the investigators quantify subjective state, psychomotor vigilance, cognitive performance, and the cortisol awakening response. They also record polysomnography during nocturnal sleep and a 1-hour nap opportunity at 08:00.

Eligibility Criteria:
Inclusion Criteria:

* male sex in order to avoid the potential impact of menstrual cycle on sleep physiology or HPA axis activity,
* age within the range of 18 to 34 years,
* a body-mass-index below 25,
* an Epworth Sleepiness Score (ESS) below 10,
* habitual sleep onset latency below 20 minutes,
* regular sleep-wake rhythm with bedtime between 11 pm and 1 am,
* absence of any somatic or psychiatric disorders,
* no acute or chronic medication intake,
* non-smoking,
* no history of drug abuse (lifetime use \> 5 occasions, except occasional cannabis use)
* caffeine consumption of less than 4 units per day (coffee, tea, chocolate, cola, energy drinks)

Exclusion Criteria:

- Failure to meet inclusion criteria
Metabolic Anomolies Associated With the 6 Month Clinical Evolution of Patients Suffering From Motor Conversion Disorder

The main objective of this study is to make a first evaluation of the relationship between metabolic abnormalities objectified by Positron emission tomography with 2-deoxy-2-\[fluorine-18\]fluoro- D-glucose integrated with computed tomography (PET CT 18 FDH) performed at rest at the onset of symptoms in patients with a first episode of motor conversion disorder and the persistence of a motor disability at 6 months measured by the modified Rankin score (mRS).

The secondary objectives of this study are:

A. To assess whether metabolic abnormalities objectified by PET CT 18 FDH performed at rest at the onset of symptoms may be predictive of persistent disability at 6 months as measured by the EDSS, the NIHSS and WHO status.

B. To assess whether metabolic abnormalities objectified by PET CT 18 FDH performed at rest at 3 months after diagnosis may be predictive of persistent motor disability at 6 months (EDSS, NIHSS, mRS, WHO) C. To search for and characterize any abnormalities of metabolism objectified in the initial PET CT 18 FDH predictive of persistent motor disability at 3 months.

D. To determine if there are persistent metabolic abnormalities 3 months post-diagnosis independently of the clinical course (marker trait).

E. Define the brain areas whose metabolism is often altered in patients with motor conversion disorders.

F. Establish a collection of biological samples from patients for future research studies of prognostic biomarkers of a motor conversion disorder.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given free and informed consent and signed the consent
* The patient must be affiliated with or beneficiary of a health insurance plan
* The patient meets DSM-IV criteria for motor conversion disorder (with paralysis, motor weakness or abnormal movements) lasting for less than 1 month and euthymic (HAMD score \< or = 7, as evaluated by a psychiatrist)
* First episode (incident cases)
* The latest symptom dates to within a month
* The patient is not under neuroleptics

Exclusion Criteria:

* The subject is participating in another study
* The subject is in an exclusion period determined by a previous study
* The subject is under judicial protection, guardianship or curatorship
* The subject refuses to sign the consent
* It is not possible to correctly inform the patient
* The patient is pregnant, parturient or she is breastfeeding
* Specialized clinical neurological examination and brain and spinal cord MRI revealed an organic neurological cause
* The subject has a HAMD score \> 7
* The subject currently has manic/hypomanic episode, a diagnosis of substance abuse or dependency (excluding tobacco), a diagnosis of schizophrenia (any time in the past) or chronic neurological disease (active epilepsy, stroke, brain tumor)
* Suicidal or high risk for suicide (according to MINI assessment)
* Contra-indication for a PET scan
* Patient under neuroleptics at inclusion
* The last symptom happened over 1 month ago
* The patient has had previous episodes (prevalent cases)
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis

To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.

To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.

Eligibility Criteria:
Inclusion Criteria:

Individuals must meet the following criteria to be eligible for study participation:

1. Must be at least 18 years old.
2. Must have a confirmed prior diagnosis of PBC
3. Evidence of cirrhosis
4. CP Score A or B
5. Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male individuals who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose
6. Individuals must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA)

Exclusion Criteria:

Individuals must not meet any of the following criteria to be eligible for study participation:

1. Prior exposure to seladelpar
2. A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study
3. History of liver transplantation or actively listed for cadaveric or planned living donor transplant.
4. Decompensated cirrhosis
5. Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI
6. Hospitalization for liver-related complication within 12 weeks of Screening
7. Laboratory parameters at Screening:

   1. Alkaline phosphatase (ALP) \< 1.5× Upper limit of normal (ULN) or ≥ 10×ULN
   2. Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥5×ULN
   3. Total bilirubin (TB) ≥5×ULN
   4. Platelet count ≤50×10\^3/µL
   5. Albumin ≤2.8 g/dL
   6. Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m\^2
   7. MELD score \>12. For individuals on anticoagulation medication, baseline International normalized ratio (INR) determination for MELD score calculation should take anticoagulant use into account, in consultation with the Medical Monitor.
   8. Serum alpha-fetoprotein (AFP) \>20 ng/mL
   9. INR \>1.7
8. CP-C cirrhosis
9. History or presence of other concomitant liver diseases
Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum

Study 2B: Ciclosporin in the management of chronic or recurrent Erythema Nodosum Leprosum Aim: To assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients whose ENL is not controlled with standard Prednisolone.

Objective: A pilot double blind controlled study randomizing patients whose ENL is not controlled with standard Prednisolone, and comparing a group treated with Ciclosporin to a group treated with additional steroid only.

A pilot double blind controlled study randomizing patients whose ENL is not controlled with standard Prednisolone, and comparing a group treated with Ciclosporin to a group treated with additional steroid only.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with clinical evidence of recurrent or chronic ENL
* Aged 18-65
* Weigh more than 30Kg

Exclusion Criteria:

* Unwillingness to give informed consent
* Patients with severe active infections such as tuberculosis
* Pregnant or breastfeeding women (see Appendix II)
* Those with renal failure, abnormal renal function, hypertensive
* Patients taking thalidomide currently or within the last 3 months
* Patients not willing to return for follow-up
* Women of reproductive age not willing to use contraception for the duration of the study ( see Appendix II)
* HIV positive patients
Adolescent Self-Management of Type 1 Diabetes: an Intervention (Completed)

The goals of this R21 exploratory pilot and feasibility study were to: 1) design an Internet-based self-management intervention for adolescents with type 1 diabetes; 2) test that intervention in a small randomized trial to establish technical feasibility, intervention acceptability, and competence in completing the necessary recruitment and research procedures. Although not powered to detect statistically significant changes, possible outcomes of this study include improvements in problem-solving, coping, and self-management behaviors.


Eligibility Criteria:
Inclusion Criteria:diagnosed for at least 6 months, age 13-17; Internet access, parental consent -

Exclusion Criteria: Any sensory deficits that would preclude seeing or hearing.

-
Prevalence of Chagas Disease in Immigrant Patients With Conduction Abnormalities on Electrocardiogram

Chagas disease is endemic to the Americas, infecting between 16-18 million individuals. In immigrant populations in the United States from endemic areas, it is estimated up to 4.9% may be asymptomatic carriers of Trypanosoma cruzi, the organism which causes Chagas disease. Between 10-20% of these patients progress to development of end-stage cardiomyopathy with a high associated morbidity. Following acute disease, patients enter into an indeterminate phase which can last 10-20 years. The earliest sign of cardiac involvement usually is electrocardiogram abnormalities. The most common abnormality is right bundle branch block (RBBB), followed by left anterior fascicular block (LAFB), and left bundle branch block (LBBB). Recent studies have shown that treatment of patients at this stage with antiparasitics may delay the progression of overt cardiomyopathy.

At the University of California, Los Angeles, there is a large population of immigrant patients from countries endemic to Chagas disease. The researchers propose that screening patients with conduction abnormalities on electrocardiogram may be a potentially useful method to identify patients with early cardiac manifestations of Chagas disease. The researchers hope to enroll approximately 300 individuals with RBBB, LAFB or LBBB on electrocardiogram to determine the incidence of Chagas disease in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* One of the following EKG abnormalities:

  * Complete or incomplete right bundle branch block (RBBB)
  * Left anterior fascicular block (LAFB)
  * Left bundle branch block (LBBB)
* Residence at any point in past in an endemic area (any country in Central or South America or Mexico) for at least 12 months.
* Age \>18 and \<60.

Exclusion Criteria:

* Ejection fraction \<40%
* Symptomatic heart failure
* Documented coronary artery disease