cyrilzakka/clinical-trials huggingface dataset:
Examining Strategy Monitoring and Remediation Training

Executive Function Training is a cognitive training approach that specifically trains executive functioning for people with schizophrenia-spectrum disorders. The current study compares full executive function training to computerized training alone and to strategy monitoring alone.

All interventions will involve 4 weeks of group treatment consisting of two 1-hour group sessions per week and additional practice at home between sessions. The Executive Training condition will consist of 50% of the session practicing computerized cognitive training exercises, and 50% of the session developing cognitive strategies to use in the computerized exercises. Participants are encouraged to complete 40 minutes of computerized training per day, and complete strategy worksheets, at home between sessions. In Computerized Cognitive Training only participants will spend the entire one-hour session practicing computerized training exercises. Between sessions participants will be encouraged to practice the computerized exercises at home for 40 minutes per day. There will be no strategy development in this condition. In Strategy Development only participants will engage in cognitive strategy discussions to develop new executive function strategies that can be used in daily life. Between sessions, participants will be encouraged to practice their cognitive strategies in their daily life and track their strategies using the strategy worksheet. There will be no computerized cognitive training in this condition. All interventions will be delivered virtually in the participant's home and group sessions will be conducted using the online platform Zoom.

90 participants with schizophrenia-spectrum disorders will be recruited. Power analyses, conducted with GPower, indicate that 90 participants (30 per treatment condition), accounting for an upper limit of 25% attrition observed in my previous trials of ET, provides 80% power to detect a medium effect size (cohen's f = 0.2) difference between conditions.

Primary and secondary outcomes will be examined using Linear Mixed Models on the Intent-to-Treat sample with missing data interpolated using maximum likelihood estimation. The primary endpoint is the 3-month follow-up assessment, and secondary endpoint of post-treatment will also be examined.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of schizophrenia, schizoaffective disorder or any other psychotic disorder (based on DSM-V)
* 18-65 years of age
* know how to use a computer
* not abusing drugs or alcohol
* can read and speak English.

Exclusion Criteria:

* enrolled in a cognitive training program in the last 6 months
* neurological disease or neurological damage
* medical illnesses that can change neurocognitive function
* medical history of head injury with loss of consciousness
* physical handicaps
An RCT of NBI vs. White Light Guided Endobronchial Biopsy in Suspected Sarcoidosis

In the diagnosis of patients with sarcoidosis, there is paucity of literature on the diagnostic yield of the endobronchial biopsies obtained with narrow band imaging (NBI) bronchoscopy. The present study aims to compare the diagnostic yield of endobronchial biopsyperformed under direct narrow band imaging or white light bronchoscopy guidance in suspected sarcoidosis.We hypothesize that the use of NBI will improve the yield of endobronchial biopsy in patients with sarcoidosis.

The present study will be a randomized controlled trial. It will be performed in the Bronchoscopy suite of the Department of Pulmonary Medicine, PGIMER. Subjects meeting the selection criteria will be randomized 1:1 to undergo EBB under real-time visualization with NBI or white light bronchoscopy. The randomization sequence will be computer generated and the study group allocations will be placed in opaque sealed envelopes. They will be opened just before the performance of the bronchoscopic procedures.

Primary outcome:the diagnostic yield of EBB (demonstration of granulomatous inflammation in EBB specimen, in subjects with a final diagnosis of sarcoidosis)

Secondary outcomes:

1. Complications related to the procedure (bleeding)
2. Duration of procedure (from the time of entry into the trachea till the completion of the endobronchial biopsy)

Eligibility Criteria:
Inclusion Criteria:

1. Age more than 18 years.
2. Clinical presentation and radiological findings (enlarged hilar and or mediastinal lymph nodes \>10 mm \[short axis\], and/or perilymphatic nodules or peribronchovascular thickening on computed tomography \[CT\] chest) suggesting sarcoidosis.
3. Willing to give informed consent.

Exclusion Criteria:

1. Hemodynamic instability (systolic BP \<100 mm Hg).
2. Pregnancy.
3. Treatment with systemic glucocorticoids for more than three weeks in the preceding three months.
4. Diagnosis of sarcoidosis possible with another minimally invasive technique such as skin biopsy or peripheral lymph node biopsy.
Yoga for Youth With IBD: a Pilot Feasibility Study

An 8-week yoga intervention to determine the feasibility and acceptability of yoga as a supplemental therapy in the management of inflammatory bowel disease in the adolescent population.

Youth with IBD experience abdominal pain, diarrhea, weight loss, and psychological suffering related to their disease process. While many biologic and non-biologic therapies are available to target the inflammatory component of IBD, youth with IBD could benefit from a more holistic therapy that addresses psychological wellness, which has been shown, in turn, to reduce disease burden. It is known that stress (multiple varieties) leads to IBD flares. It is also known that mind-body intervention reduces stress. The mind-gut connection is widely discussed in medical circles, however, current therapies have not capitalized on it. The investigators would like to know if an easily accessible mind-body intervention (yoga) can improve wellness, lower stress levels, and reduce intestinal inflammation in youth with IBD.

The study will be an 8-week feasibility pilot. Participants will be asked to participate in online yoga videos and in-studio yoga sessions. Participants will be asked to complete multiple surveys throughout the intervention and continue receiving standard care from their primary gastroenterology team.

Eligibility Criteria:
Inclusion Criteria:

* Age 10-21
* Diagnosis of Crohn's Disease or Ulcerative Colitis
* Patient of a Stanford Children's Health or Stanford-affiliated Pediatric Gastroenterologist
* Ability to attend in-person meetings/training

Exclusion Criteria:

* Initiation of biologic therapy in prior 3 months
* Hospital admission in prior 2 months
* Major surgery in prior 1 month
* PUCAI/PCDAI \>65
* Current pregnancy
* Severe developmental or intellectual disability
* Non-english speaking
* Not participating in another concurrent clinical trial
Aesthetic and Functional Outcomes of Eyelid Reconstruction After Excision of Periocular Tumors

* To determine the aesthetic and functional outcomes of different techniques used in eyelid reconstruction following periocular defects.
* To determine the complications of eyelid reconstruction and how to prevent them

Patients will undergo the following :

Direct eyelid closure will be done in small defects with or without canthyolysis Larger defects will be reconstructed with anterior and posterior lamella reconstruction using grafts and flaps

Patients will be followed up as regard

* The stability of flap or graft
* The vertical and horizontal measurements of palbepral fissure
* Detection of any complications
* Donor site follow up
* Patient degree of satisfaction

Eligibility Criteria:
Inclusion Criteria:

* Patients with periocular tumors and candidate for excision

Exclusion Criteria:

* patients with history of radiotherapy or chemotherapy
Brighter Bites/Legacy Produce Rx Program

The purpose of this study is to assess the effectiveness of the produce prescription program at improving weight status and obesity-related health outcomes of participants, to examine the impacts of the program on household food insecurity and nutrition security, to examine the impacts of the program on participating adolescents' dietary behavioral outcomes, their home nutrition environment and feeding practices and to examine the impacts of the program in reducing healthcare use and associated costs


Eligibility Criteria:
Inclusion Criteria:

* Must be a patient at one of the four Legacy Community Health School-based clinics in Galena Park, Texas
* BMI greater than or equal to 85th percentile
* reside within a 10-mile radius of Houston Food Bank
* Medicaid recipients or low-income uninsured
* parents must be able to read and write in English or Spanish to complete surveys
* patient and parents must confirm their willingness to complete the participant's well-child visit for the entire period of the study (approximately one year).

Exclusion Criteria:

* currently participating in Brighter Bites
* with a family member/sibling currently participating in Brighter Bites
Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis

Liver carcinoma is becoming the main complication of cirrhosis. Treatment of symptomatic or large tumors is disappointing. Regular ultrasonographic screening of small (curable) tumors is currently recommended, but the best periodicity is unknown.This randomized trial is aimed to compare 6-month (current recommendation) and 3-month ultrasonographic screenings.

Patients: All consecutive patients with compensated HBV, HCV, alcohol or hemochromatosis-related cirrhosis (without any previous clinical complication including liver cancer).

Randomization: factorial: ultrasonography (3-month versus 6-month); serum alfa-fetoprotein assay (none versus 6-month).

End points: rate of small tumors (first main criteria); survival (second main criteria).

Eligibility Criteria:
Inclusion Criteria:

* Compensated cirrhosis

Exclusion Criteria:

* Antecedent of osmic acid synoviorthesis or of isotopic synoviorthesis of the studied knee
* Intra-articular injection of triamcinolone hexacetonide in three months preceding the inclusion or by a different corticoid in the month preceding the inclusion
* Evolutionary infectious or neoplastic pathology
Evaluation of the Aurora Xi New Nomogram Software 2.0

A clinical trial to evaluate the safety and effectiveness of the Aurora Xi Plasmapheresis System with a new plasma collection volume nomogram.

A controlled, prospective, randomized, multicenter, IDE clinical trial to evaluate the safety and effectiveness of a new plasma collection volume nomogram on the Aurora Xi Plasmapheresis System (test arm) as compared to the currently marketed Optimized Nomogram on the Aurora Xi Plasmapheresis System (control arm). The new plasma collection volume nomogram will provide a more individualized approach to determining the volume of plasma collected from each donor. The trial will be conducted at a minimum of 3 plasma collection centers. Subjects will be randomized into the test and control arms.

Eligibility Criteria:
Inclusion Criteria:

* All subjects must meet current safety guidelines for plasma donation as set forth by the FDA as well as those in the standard operating procedures established by the participating institution.
* Enrolled subjects who do not meet inclusion criteria at a later donation attempt are eligible to remain in the clinical trial and to subsequently donate plasma once they meet eligibility criteria again.

Exclusion Criteria:

* Subjects not able or unwilling to give consent to participate.
* Subjects withdrawn by a qualified healthcare provider due to safety concerns.
* Subjects who are employed by the clinical site or Sponsor.
Proton Boost in Prostate Cancer

This study uses photon radiation with a proton boost to treat prostate cancer. The purpose of this study is to determine if proton therapy as a boost following photon intensity modulated radiation therapy (IMRT) produces decreased toxicity as compared to conventional photon IMRT alone in the treatment of prostate cancer. Our secondary objective is to determine the effectiveness of this treatment regimen. Effectiveness will be determined by length of time to progression or recurrence of disease and overall survival. Patients on this study will be treated with a course of photon radiation therapy followed by a boost course of proton radiation.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Diagnosis of low risk prostate cancer (T1c-T2a, Gleason 6, Prostate Specific Antigen (PSA) \<10) -OR-
* Diagnosis of intermediate risk prostate cancer (T1c-T2c, Gleason 7 and/or PSA 10- 20)
* Life expectancy \>10 yrs
* Physically and mentally capable of signing the consent form of their own volition

Exclusion Criteria:

* \< 18 years of age
* Diagnosis of high risk prostate cancer (T3 or higher, Gleason \>7 and/or PSA \>20)
* Current or historical use of androgen deprivation therapy
* Nodal positivity
* Previous cancer excluding non-melanoma skin cancer
* History of prostatectomy
* History of brachytherapy for prostate cancer
* Life expectancy \<10 yrs
* Physically or mentally incapable of signing the consent form of their own volition
Secured Internet-mediated Psychotherapy With Psychiatry Patients

This is the second phase (Phase B) of the main project "Bank for Thoughts", which has the following aims:

1. Improvement of software for secured (encrypted and access-controlled) asynchronous text-based communication within health services. (Adjustments for use in psychiatry.)
2. Open clinical trials with Internet-mediated psychotherapy or counselling in out-patient child and adolescent psychiatry.
3. Development of indications and precautions for text-based Internet-mediated psychotherapy.

This phase (Phase B) concentrates on qualitative evaluation of open clinical single case trials using asynchronous Internet-mediated text-dialogue for psychotherapeutic purposes.

Single patients in differing treatment phases, conditions, age and sex categories are interviewed after using Internet-contact as a supplementary tool in psychotherapy. Their therapists are interviewed as well.

The purpose is systematically gathering single-case experiences with the tool, to build a hypothesis for research and preliminary guidelines for experimental clinical use of Internet-mediated psychotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Motivation for e-mail contact
* Therapist evaluation for suitability

Exclusion Criteria:

* Paranoia
* Psychosis
* Eating disorders
* Addictive problems
* Denying or concealing symptoms
ANG-First Trial (Angiotensin II as First-Line Vasopressor Therapy in Cardiac Surgery)

The purpose of this research is to evaluate the use of Angiotensin II in patients with low blood pressure post-surgery. Your information will be collected for 28 days post the procedure and initiation of the study drug to assess for safety events and complications.


Eligibility Criteria:
Inclusion Criteria:

* 1. Adult patients ≥ 18 years of age. 2. Patients must have clinical features of vasodilation, as determined by a MAP \< 65 mmHg requiring any dose of vasopressors intra/post-operatively 3. Patients must be adequately volume resuscitated in the opinion of the treating physician.

Exclusion Criteria:

-1. Patients with active bleeding as the primary reason for hypotension AND an anticipated need for transfusion of \> 4 units packed red blood cells within the next 48 hours.

2. History of atrial fibrillation 3. Patients already on renal replacement therapy or creatinine of \> 4 mg/dl within 2 weeks of surgery
Effect of Covid-19 on Outcomes of Pregnancy

To study the effect of getting Covid-19 infection during pregnancy on the outcomes of the mother and the fetus including morbidity and mortality


Eligibility Criteria:
Inclusion Criteria:

* Normal single pregnancy

Exclusion Criteria:

* Pregnancy with any chronic diseases
* Multiple pregnancy
Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) for Achalasia

Achalasia is an esophageal motility disorder, which leads to clinical symptoms such as dysphagia, regurgitation, chest pain and consecutive weight loss.

Although conventional treatment such as laparoscopic Heller myotomy (LHM) and balloon dilatation (BD) can provide sufficient symptom relief in many patients, both interventions have their individual drawbacks. Additionally, treatment after failed LHM or BD can be challenging and in few might even lead to esophagectomy.

Per oral endoscopic myotomy (POEM) and prolonged dilatation (PRD) are two novel endoscopically performed therapeutic options for achalasia and other esophageal motility disorders. Both not only appear to provide good results, when performed as initial treatment but also might be an excellent option after e.g failed LHM.

The purpose of this study is to evaluate the long-term efficacy of four different treatment options, such as POEM, PRD with stent-fixation, PD and conventional LHM for achalasia in an individualized treatment setting.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of achalsia, hypertensive lower esophageal sphincter, nutcracker esophagus, or diffuse esophageal spasm

Exclusion Criteria:

* Contraindication for EGD
Effect of PPE on Children's Fear in Dental Office

the aim of the current study is to compare the effect of conventional facial PPE as 1)goggles + surgical masks, and 2)face shields + surgical masks versus 3)half-face and 4)full-face reusable respirators; on preoperative child's fear in the dental office.

Each patient meeting the inclusion criteria and assigned to a specific study group will enter the clinic for dental examination. The examining dentist, wearing the selected PPE will communicate with patient and parent, taking personal, previous and current history, and carrying out simple examination not involving the use of sharp instruments, provoking pain or investigations as radiographs. The process should take from three to five minutes. Then, the child will be escorted to another room to meet a blinded accessor, where he assesses the child's anxiety using the Arabic version of children's fear survey schedule-dental subscale CFSS-DS.

Eligibility Criteria:
Inclusion Criteria:

* Six to ten-year-old patients

Exclusion Criteria:

* emergency patients
* patients who have systemic, mental or psychological conditions as indicated by their medical history,
Special Drug Use Investigation for AMERGE® Tablet (Long-term)

To investigate the long-term safety and efficacy of AMERGE (naratriptan hydrochloride) on Japanese patients with migraine headache in clinical setting


Eligibility Criteria:
Inclusion Criteria:

* Must use AMERGE for the first time

Exclusion Criteria:

* Patients with hypersensitivity to naratriptan or any of the components.
* Patients with history, symptoms, or signs of myocardial infarction, ischemic cardiac or angina inversa
* Patients with history of cerebral vascular disturbance or transient ischaemic attack
* Patients with peripheral vascular syndromes
* Patients with uncontrolled hypertension
* Patients with severe renal or hepatic impairment
* Patients using treatment with another 5-HT1 agonist, an ergotamine-containing or ergot-type medication
Clinical and Electrophysiological Predictors of Arrhythmic Recurrence in Patients With Paroxysmal AF Undergoing First Ablation Procedure of AF by Pulmonary Vein Isolation

From the literature, the success rate (i.e., absence of AF recurrence) of ablation in cases of paroxysmal AF at one year changes between 70 and 85 percent. This rate is considered suboptimal. Currently there are no data that can assess which factors are predictive of recurrence both clinically and electrophysiologically. In particular, it is not known whether and to what extent the atrial substrate present under baseline conditions affects the success rate of the procedure and what relationships exist with other predictors such as age, sex, atrial size at echo, and duration of arrhythmia.

This is a multicenter prospective and retrospective observational study aimed at examining the role of the left atrial substrate and other baseline clinical variables on the efficacy of transcatheter ablation in patients with paroxysmal atrial fibrillation (AF) who underwent pulmonary vein isolation regardless of the power source and balloon or "point by point" catheters used.

The study will evaluate whether there are baseline clinical or electrophysiological features that can predict the success of transcatheter atrial fibrillation ablation even before it is performed, so as to assess which patients may actually benefit, and which patients should instead undergo more extensive ablative procedures in conjunction with pulmonary vein isolation to achieve an optimal success rate.

Eligibility Criteria:
Inclusion Criteria:

* Patients with indication for AF ablation
* Adequate anticoagulation therapy according to CHADs VASC

Exclusion Criteria:

* patients who had already undergo an AF ablation procedure
* Presence of intracavitary thrombus
* Ejection fraction \<35%
* Pregnancy
* Hematologic contraindications to ionizing radiation exposure
* Congenital heart diseases
* Cardiac Surgery \< 1month
* Uncontrolled heart failure
* Valvular disease
* Contraindications to general anesthesia
Response to Endotracheal Tube Intubation at Different Time of Fentanyl Given During Induction

Opioids have been used to modify the hemodynamic response associated with laryngoscopy and tracheal intubation. To seek the correlation of Fentanyl given time, we will analysis the data collected from vital signs monitoring machine. Patients'details will be recorded too.

Laryngoscopy and intubation often provoke hypertension and tachycardia due to the stimulation both sympathetic and sympathoadrenal activities. While the adverse hemodynamic effects of laryngoscopy and endotracheal intubation can precipitate myocardial ischemia, even in patients without hypertension, the responses are exaggerated in patients with hypertension . In the previous studies , many drugs, including opioids and beta-blockers, have been used to modify the hemodynamic response associated with laryngoscopy and tracheal intubation. To seek the correlation of Fentanyl given time, we will analysis the data collected from vital signs monitoring machine.

All patients were premedicated with Midazolam 0.1mg/kg , Lidocaine 0.5mg/kg (L), Propofol 2mg/kg (P), Rocuronium 1mg/kg (R) before induction of general anesthesia. Laryngoscopy lasting a maximum of 30 s was attempted 3 min after administration of the induction agents. Fentanyl 2mcg/kg was given at different time before intubation.

Eligibility Criteria:
Inclusion Criteria:

* with American Society of Anesthesiologists (ASA) physical status classification 1\&2
* undergo elective surgery
* intubation

Exclusion Criteria:

* Opioids allergy history
Repletion of Ergothioneine in Patients With Kidney Failure

Dialysis removes potentially harmful chemicals from the blood but can also remove potentially valuable chemicals. One potentially valuable chemical called ergothioneine, which comes from our diet, is low in the blood of people receiving dialysis. For this research study, we hope to learn how well a daily ergothioneine supplement will replenish the levels in the blood of people with kidney failure.


Eligibility Criteria:
Inclusion Criteria:

* kidney failure receiving hemodialysis or peritoneal dialysis

Exclusion Criteria:

* blood transfusion within 90 days
* taking supplements which contain ergothioneine