cyrilzakka/clinical-trials huggingface dataset:
Repeat Dosing of Psilocybin in Migraine Headache

In seeking to understand the capacity for psilocybin to reduce migraine headache burden, this study will investigate single and repeated dosing of psilocybin up to two doses. In seeking to identify an underlying mechanism in psilocybin's effects, neuroinflammatory markers for migraine headache will be measured.

Migraine headache is a common medical condition and a top cause of disability worldwide. Treatment options for migraine headache are many and varied, though an approximated 10% of migraineurs is refractory to medication and thus, there is a need to develop alternative treatments. There is anecdotal evidence supporting lasting therapeutic effects after limited dosing of psilocybin and related compounds in headache disorders. The cause of this unique effect remains unknown, though the drug class has demonstrable anti-inflammatory activity, a biological process relevant to migraine and other headache disorders. In seeking to understand the capacity for psilocybin to reduce migraine headache burden, this study will investigate single and repeated dosing of psilocybin up to two doses. In seeking to identify an underlying mechanism in psilocybin's effects, neuroinflammatory markers for migraine headache will be measured. The results from this study will serve in the development of larger investigations seeking to understand the effects of psilocybin and related compounds in headache disorders.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of migraine headache per ICHD-3 criteria
* Typical pattern of migraine attacks with approximately two migraines or more weekly
* Attacks are managed by means involving no more than twice weekly triptan use

Exclusion Criteria:

* Axis I psychotic or manic disorder (e.g., schizophrenia, bipolar I, depression with psychosis)
* Axis I psychotic or manic disorder in first degree relative
* Unstable medical condition; severe renal, cardiac, or hepatic disease; pacemaker; or serious central nervous system pathology
* Pregnant, breastfeeding, lack of adequate birth control
* History of intolerance to psilocybin, lysergic acid diethylamide (LSD), or related compounds
* Drug abuse within the past 3 months (excluding tobacco)
* Urine toxicology positive to drugs of abuse
* Alcohol use of \>21 drinks per week (males); \>14 drinks per week (females; NIAAA guidelines)
* Use of alcohol in the week prior to the first test day
* Use of vasoconstrictive medications (i.e., sumatriptan, pseudoephedrine, midodrine) within 5 half-lives of test days
* Use of serotonergic antiemetics (i.e., ondansetron) in the past 2 weeks
* Use of antidepressant medication (i.e., TCA, MAOI, SSRI) in the past 6 weeks
* Use of steroids or certain other immunomodulatory agents (i.e., azathioprine) in the past 2 weeks
* Use of migraine onabotulinum toxin (i.e., Botox) or monoclonal antibodies against CGRP or its receptor (i.e., erenumab) in the past month or while therapeutic effects are still present
ASCEND GO-2: Study of RVT-1401 for the Treatment of Participants With Active, Moderate to Severe Graves' Ophthalmopathy ( GO )

The purpose of the current study is to assess the efficacy and safety/tolerability of three dose regimens of RVT-1401 in the treatment of active, moderate to severe GO participants. In addition, the study is designed to characterize the effect of RVT-1401 exposure on reduction in anti-TSHR IgG


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18 years of age.
2. Clinical diagnosis of Graves' disease with hyperthyroidism associated with active, moderate to severe Graves' Ophthalmopathy (GO) with a Clinical Activity Score (CAS) ≥4 for the most severely affected eye at Screening and Baseline (on the 7-item scale).
3. Onset of active GO within 9 months of screening.
4. Moderate-to-severe active GO (not sight-threatening but has an appreciable impact on daily life), usually associated with one or more of the following: lid retraction ≥2 millimeters (mm), moderate or severe soft tissue involvement, proptosis ≥3 mm above normal for race and gender, and/or inconstant or constant diplopia.
5. Other, more specific inclusion criteria are defined in the protocol

Exclusion Criteria:

1. Use of any steroid (intravenous, oral, steroid eye drops) for the treatment of GO or other conditions within 3 weeks prior to Screening. Steroids cannot be initiated during the trial. Exceptions include topical and inhaled steroids which are allowed.
2. Use of rituximab, tocilizumab, or any monoclonal antibody for immunomodulation within the past 9 months prior to Baseline.
3. Total IgG level \<6 grams per liter (g/L) at Screening.
4. Absolute neutrophil count \<1500 cells per meter squared (cells/mm\^3) at Screening.
5. Participants with decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months at Screening.
6. Previous orbital irradiation or surgery for GO.
7. Other, more specific exclusion criteria are defined in the protocol
Efficacy and Safety Study of Peginterferon Alfa-2b in Chinese Chronic Hepatitis C Patients

The purpose of this study is to evaluate the efficacy and safety of Peginterferon alfa-2b (40KD, Y shape, the followings will refer as Ypeginterferon alfa-2b for short), at a dose of 180μg/week, in combination with Ribavirin in Chinese chronic hepatitis C patients. The study will first group patients into two sub-study, genotype 2/3 and non-genotype 2/3, depending on the HCV genotype that infected. In the genotype 2/3 sub-study about 219 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 24 weeks of interferon therapy and oral daily Ribavirin at a dose of 800mg/d. In the non-genotype 2/3 sub-study about 507 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 48 weeks of interferon therapy and oral daily Ribavirin 1000-1200mg/day , basing on body weight. All patients will be followed for 24 weeks after the end of therapy.


Eligibility Criteria:
Inclusion Criteria:

* 18\~65 years
* Hepatitis virus C chronic infection evidences: HCV RNA or anti-HCV positive\>6 months,or other evidences supporting diagnosis of chronic hepatitis C infection
* HCV RNA≥2000IU/mL, anti-HCV positive at screening
* Pregnancy tests for female patients must be negative. All patients must take effective contraception measures during the study period
* Signed informed consent

Exclusion Criteria:

* Pregnant or lactating women
* Mental or psychology disorder
* ANC\<1500/mm3, or PLT\<90,000/mm3, or Hb\<ULN(Upper limit of Normal)
* Received interferon treatment within the previous 6 months or shown no-response to previous interferon treatment
* Co-infection with HIV, HAV, HBV, HEV
* Evidence of hepatic decompensation (e.g: Child Plug≥B, prothrombin time prolonged more than 3 seconds, TBil\>2ULN, Alb\<35g/L)
* Hepatocarcinoma or suffering from any other malignant tumor
* Not well controlled endocrine diseases(e.g:thyroid disfunction, mellitus mellitus)
* Significant function damage in any major organs (e.g: heart, lung, kidney)
* Involved in other investigation within the previous 3 months
* Other conditions which in the opinion of the investigator precluding enrollment into the study (e.g: poor compliance)
The Effect of Enalapril, Losartan or Not Antihypertensive on the Oxidative Status in Renal Transplant Recipients

The clinical and biochemical improvement observed in kidney transplant (RT) recipients is remarkable. The correct functioning of the allograft depends on various factors such as the donor's age, the alloimmune response, the ischemia-reperfusion injury, arterial hypertension, and the interstitial fibrosis of the allograft, among others. Antihypertensive drugs are necessary for arterial hypertension patients to avoid or reduce the probability of affecting graft function in RT recipients. Oxidative stress (OS) is another complex pathophysiological process with the ability to alter post-transplant kidney function. The study's objective was to determine the effect of the administration of Enalapril, Losartan, or not antihypertensive medication on the oxidative state in RT recipients at the beginning of the study and one year of follow-up.

An open, randomized clinical trial is proposed with a control group. It is carried out in the Transplant Division of the High Specialty Medical Unit of the Hospital de Especialidades, Centro Médico Nacional de Occidente of the Mexican Institute of Social Security in Guadalajara, Jalisco, Mexico. The sample size was based on the formula to evaluate mean differences for clinical trials. Three study groups were formed; thirteen patients with RT who did not require any antihypertensive. Thirteen RT patients to receive Enalapril as an antihypertensive regimen. Thirteen RT patients to receive Losartan as an antihypertensive regimen in the post-transplant period. Recipients of a RT, from a living related donor (DVR) or living unrelated donor (DVNoR) who agreed to participate and signed the Letter of Consent under Information.

Patients who received an RT from a deceased donor, from a donor \>55 years, with renal comorbidities at the time of the study (urolithiasis, infections, diabetes), with blood dyscrasias, second transplantation, treatment with non-steroidal anti-inflammatory drugs, statins, spironolactone, pentoxifylline, patients with neurodegenerative processes or who withdrew the Letter of Consent under Information are not eligeble.

Eligibility Criteria:
Inclusion Criteria:

* Renal trasplant, from a living related donor (DVR) or living unrelated donor (DVNoR)
* Who agreed to participate and signed the Letter of Consent under Information.

Exclusion Criteria:

* Patients who received an RT from a deceased donor,
* With donor \>55 years,
* With renal comorbidities at the time of the study (urolithiasis, infections, diabetes),
* With blood dyscrasias,
* Second transplantation,
* Those with treatment with non-steroidal anti-inflammatory drugs,
* Treatment with statins, spironolactone, pentoxifylline, patients
* With neurodegenerative processes
* Those who withdrew the Letter of Consent under Information
Endoscopic Submucosal Dissection Versus Surgery in the Treatment of Early Gastric Cancer

In this study, patients who are going to undergo endoscopic submucosal dissection (ESD) or surgery for early gastric cancer will be enrolled and divided into ESD group and Surgery group according to the procedure they go through. The patients will be followed up for at least 5 years after ESD or surgery. Esophagogastroduodenoscopy (EDG) and biopsy will be performed 3 months and then 6 months after ESD or surgery. Thereafter, EDG will be performed along with biopsy and abdominal computed tomography annually up to 5 years. Patients' data such as age, sex, clinical diagnosis, achievement of en-bloc resection, pathological outcomes, complications and survival condition will be prospectively collected. Statistical methods such as Student's t-test, the chi-square test, the Kaplan-Meier method and the log-rank test will be used to compare the short term and long term outcomes between the ESD group and the surgery group.


Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed as early gastric cancer
* Willing to undergo endoscopic submucosal dissection or surgery for the treatment of early gastric cancer

Exclusion Criteria:

* Advanced stage gastric cancer
* Not willing to undergo endoscopic submucosal dissection or surgery for the treatment of early gastric cancer
* Not willing to participate in this study
The Impact of Delayed Diagnosis of Alpha-1 Antitrypsin Deficiency

The objective of this study is to prospectively assess whether there is any interval between first symptom and initial diagnosis that is experienced by patients with newly diagnosed alpha-1 antitrypsin deficiency (AATD) and then to assess whether this diagnostic interval is associated with worsened clinical status at the time of initial diagnosis.

The study protocol proposes to assess participants' clinical status based on the results of spirometry tests that are performed by the patient's managing physician as a routine part of clinical care of individuals with AATD within +/- 6 months of the initial diagnosis, subjects' St. George's Respiratory Questionnaire (SGRQ) at the time of initial diagnosis, and their COPD Assessment Test (CAT) result at the time of initial diagnosis of AATD (hereafter called "time zero" or T0 defined as the day on which the patient's test shows AATD from the blood work submitted for testing to Biocerna LLC by the patients' managing physicians as part of their routine clinical management). After offering verbal consent, subjects will complete a survey that assesses various clinical domains, including demographic features, how was AATD ascertained, initial symptom ascribable to AATD, the number of healthcare providers (and specific types of providers) seen before initial diagnosis, and clinical status at T0 or within a defined, relatively narrow temporal window (+/- 6 months) of T0. As in prior studies, the diagnostic interval will be defined as the duration between self-reported initial symptom of AATD (usually dyspnea in \> 80% of cases3) and initial confirmed diagnosis of AATD (T0).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Positive AATD Test Result

Exclusion Criteria:

* Previous Positive AATD Test Result
* Negative Test Result for AATD
Testing Four Feeding Approaches to Oral Feeding in Preterm Infants

The purpose of this study was to test the effect of four randomly assigned approaches to oral feeding transition on feeding outcomes in preterm infants.

The study is completed.

Eligibility Criteria:
Inclusion Criteria:

* 1) the infant's gestational age at birth was less than 32 weeks; 2) the infant was receiving enteral feedings every three hours; 3) the infant was able medically to feed orally by 32 weeks post-menstrual age (PMA); and 3) the parents gave consent for the infant's participation.

Exclusion Criteria:

* 1) they were unable to begin oral feeding at 32 weeks PMA due to gastrointestinal, craniofacial, cardiovascular, neuromuscular, and/or genetic defects; 2) had surgical necrotizing enterocolitis; or 3) needed ventilator support, including nasal continuous positive airway pressure (CPAP), beyond 32 weeks PMA. Infants receiving oxygen by cannula were included.
Diagnostic Accuracy of CT-FFR Compared to Invasive Coronar Angiography With Fractional Flow Reserve

Invasive coronary angiography is currently considered gold standard in the assessment of coronary artery disease although the method has limitations. Most importantly invasive angiography only depicts coronary anatomy without determining its physiological significance i.e the likelihood that the stenosis impedes oxygen delivery to the heart muscle. Fractional flow reserve (FFR) is a catheterization technique for assessing the physiological significance of a coronary artery lesion during invasive coronary angiography. Coronary computed tomographic angiography (CCTA) is a noninvasive imaging test that has become an alternative route to diagnosis for patients with suspected coronary artery disease. Computational fluid dynamics combined with anatomical models based on CCTA scans allows determination of coronary flow and pressure, and has emerged as a promising diagnostic modality called CT-FFR. In this Project New Mathematical algorithms are developed for computation of CT-FFR. The main objective of this study is to determine the diagnostic accuracy of CT-FFR values obtained by the new method compared with invasive coronary angiography with fractional flow reserve and state-of-the-art dobutamin stress echocardiography.


Eligibility Criteria:
Inclusion criteria

* Proven stenosis by CCTA that require further investigation with invasive coronary angiography i.e. patients with estimated stenosis ≥30- 50%.
* Informed consent

Exclusion Criteria:

* Patients with unstable coronary artery disease.
* Previously treated with PCI or coronary surgery.
* Severe renal impairment i.e. GFR \<30ml / min
* Contrast allergy
* Contraindication to adenosine / nitroglycerin / beta-blocker
* BMI\> 40
* Patients referred on the basis of technically unsuccessful CTA, motion artifact or similar
Randomized Controlled Study of the Efficacy of Hypnosis Versus Relaxation and Control in Neuropathic Pain

A randomized double-blind controlled two centers study. The primary objective of this study will be to show a superiority of hypnosis over relaxation on pain intensity in patients with neuropathic pain.

The secondary objectives of this study are:

* to show a superiority of hypnosis and relaxation over control group on neuropathic pain.
* to show a lasting effect of treatment on neuropathic pain one week after the end of treatment.
* to evaluate the clinical predictors of response to hypnosis (nature of neuropathic symptoms, severity of anxiety and depressive symptoms, pain catastrophizing, coping strategies, emotional regulation, response to the first session, positive or negative emotional reaction at the end of hypnosis sessions).
* to evaluate the effect of hypnosis at long-term (1, 3 and 6 months after the end of treatment).
* to evaluate the effect of hypnosis on emotional processes.
* to compare hypnosis to relaxation on short-term effects on pain,
* to evaluate the quality of life and the impact of pain on daily life: sleep, mood, anxiety symptoms, analgesics consumption , neuropathic symptoms, affective component of pain and pain catastrophizing.

  35 patients will be enrolled in each arm, to obtain 105 in total (3 arms). Total duration for each patient: 8 months.

Eligibility Criteria:
Inclusion Criteria:

* peripheral or central neuropathic pain, probable or definite
* Diagnostic questionnaire score DN4 ≥ 4/10
* Chronic Pain with an average of pain intensity greater than or equal to 4/10 (digital scale)
* Presence of daily or almost daily pain (i.e. at least 4 days per week)
* Patient with pre-existing pain for \> 6 months
* Patient \> 18 and \< 60 years old
* Patient with a stable analgesic treatment since 15 days before inclusion
* Patient able to participate to the trial during 33 weeks
* Patient having a health insurance
* Written informed consent signed by the patient.

Exclusion Criteria:

* Prior treatment with hypnosis
* Currently under active psychotherapy (Cognitive-Behavior Therapy, psychoanalysis)
* Work accident or litigation
* Drugs abuse or Psychoactive Substance Abuse (DSM-IV)
* Neuropathic pain associated with progressive disease (MS, HIV, cancer ...)
* Major depression with ongoing disability or psychosis (DSM IV)
* Intermittent pain
* Patient with pre-existing pain for \< 6 months
* Other more severe pain than the pain justifying inclusion
* Subject unable to understand the trial information provided in the informed consent document
* Subject under curators or guardianship
* Severe Handicap or amputation
* Participation to another study in the same period
* Deafness
* Cognitive disorders (dementia, Mild Cognitive Impairment, inability to understand the questionnaires)
* For patients of the control arm: Treatment by hypnosis and / or relaxation, transcranial magnetic stimulation, or invasive treatments (surgery)
Preventing Sexual Violence in College Men: RealConsent for Use in Vietnam

This study is a randomized controlled trial using a web-based adaptation of the RealConsent program among eligible college men in Hanoi, Vietnam. This study will test the impact of the program on promoting prosocial bystander behavior and preventing sexual violence perpetration, through improvements in the seven knowledge, attitudinal, and emotional mediators over a seven month study period, with a baseline survey and two follow-up surveys.

Sexual violence is any sexual act committed against a person without freely given consent. Men and women may experience sexual violence, but most victims are women. Women's first experiences of sexual violence often occur in adolescence. In Asia and the Pacific, about 14% of sexually experienced adolescent girls report forced sexual debut. Thus, early prevention with men is critical; yet, young men often are difficult to reach and may resist programs that target sexual violence, not seeing themselves as potential perpetrators. Prevention with men that integrates a bystander framework, which treats men as "allies" of women, is one way to target attitudes and behaviors while decreasing resistance to participation. In this study, the researchers will adapt an existing program for use with men attending one of two universities in Hanoi, Vietnam. This study will test the impact of the adapted program on knowledge/attitudinal/emotional mediators, and in turn, on sexual violence perpetration and prosocial bystander behavior in this target group. The adapted program is a novel, six-session, web-based serial drama and educational program designed to prevent sexual violence perpetration and to enhance prosocial bystander behavior in young men. The program has reduced the incidence of sexual violence among men attending an urban, public university in the Southeastern United States.

After conducting interviews with men and women, and focus group discussions with college men and university stakeholders the researchers will produce a web-based adaptation of the RealConsent program in Vietnam. The researchers will then conduct a randomized controlled trial to test the impact of the adapted program, relative to a health-education control condition, on knowledge/attitudinal/emotional mediators, and in turn, on sexually violent behaviors, and prosocial bystander behavior in freshmen men attending two universities in Hanoi. This project will be the first to adapt and to test the impact of a novel, theoretically grounded, web-based intervention to prevent sexual violence perpetration and to promote prosocial bystander behavior among young men for use in a middle-income country. If this study shows that the adapted program is effective cross-culturally, it will have exceptional potential for scale-up to prevent men's perpetration of sexual violence against women globally.

Eligibility Criteria:
Inclusion Criteria:

* Identifying as heterosexual or bisexual
* Enrolled as a freshman at Hanoi Medical University or Thang Long University on 9/1/2019

Exclusion Criteria:

* None