cyrilzakka/clinical-trials huggingface dataset:
A Trial of Cognitive Behavioral Therapy in Familial Dysautonomia

To determine the effect of cognitive behavioral therapy (CBT) in the severity of anxiety and depression in adult patients with familial dysautonomia. Patients will be enrolled in an 8-week CBT program. All CBT sessions will be done either in person at the NYU Dysautonomia Center or over the phone to help accommodate disability and potential physical limitations of our patient population.

Cognitive behavioral therapy (CBT), defined as a program of interventions that utilize education to teach relaxation, healthy coping skills, stress management, assertiveness training in order to help the individual identify and correct maladaptive beliefs in combination with education to help practice symptom reduction and improve quality of life and function. Patients will participate in eight forty-five minute sessions of CBT with a mental health therapist in order to help treat generalized anxiety disorder, anxiety disorder due to another medical condition (familial dysautonomia), major depressive disorder, persistent depressive disorder (dysthymia), substance/medication- induced depressive disorder, depressive disorder due to another medical condition.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of FD (genetically confirmed)
* DSM-V criteria of major depressive disorder OR anxiety disorder
* STAI score ≥ 25 OR a PHQ-9 depression scale score ≥ 5 or greater
* Willing and able to complete 8 CBT sessions
* Maintain constant psychoactive medication through out study and no concurrent talk therapy from another therapist.

Exclusion Criteria:

* Currently suicidal or having current suicidal ideations
* Currently under psychiatric treatment for depression or anxiety
* Have started any psychoactive medication within 3 months prior to screening
PEG-Intron For Chronic Myelogenous Leukemia Patients Unresponsive To Or Intolerant Of Roferon Or Intron

The purpose of this study is to determine if PEG-Intron is better tolerated and more efficacious than standard interferons (Roferon, Intron) in patients with Philadelphia-positive Chronic Myelogenous Leukemia. These patients should have previously received standard interferon therapy and have been intolerant, resistant, or have relapsed disease.

It has been shown that patients who experience complete hematologic or at least a partial cytogenetic response to interferon will have improved survival times. In addition, evidence exists that even patients who do not demonstrate a cytogenetic response to interferon treatment can still benefit from treatment, in terms of survival, compared to patients not treated with interferon. This indicates that if a patient is better able to tolerate interferon, he or she may have improved survival even without cytogenetic response. Preliminary studies suggest that PEG-Intron is more convenient for patients (administered once weekly rather than daily), is better tolerated than interferon, and can produce hematologic remission in interferon-a resistant patients. Phase II studies are needed to ascertain the overall hematologic and cytogenetic response rates to PEG-Intron in such patients.

Eligibility Criteria:
Inclusion Criteria:

* Chronic phase CML, documented by the presence of Philadelphia chromosome or bcr/abl rearrangement at time of diagnosis, confirmed by either cytogenetics or PCR.
* WBC \>/= 3000/ul \</=100,000/ul.
* Patients must have received prior interferon therapy \& proven to have primary refractory disease, secondary resistance or intolerance to interferon-a
* Patient must have ECOG status of 0, 1, or 2
* Labs: SGOT/SGPT\<2xULN; serum bilirubin\<2xULN; serum creatinine \<2.0mg/dl
* Recovered from effects of major surgery
* Life expectancy \> 12 wks.
* Signed informed consent.
* Women of childbearing potential must have negative serum pregnancy test within 72 hrs prior to administration of PEG-Intron \& use effective contraception during the study.

Exclusion Criteria:

* NO accelerated Phase CML patients with peripheral blood: blasts\>/=15%, basophils\>/=20%, blasts+promyelocytes\>/=30%, platelets\<100,000/ul (unrelated to therapy). Blastic phase CML:\>/=30% in peripheral blood/bone marrow.
* NO patients with known hypersensitivity to interferon-a.
* NO severe cardiovascular disease, i.e. arrhythmias requiring chronic treatment or congestive heart failure (NYHA classification III/IV).
* NO history of neuropsychiatric disorder requiring hospitalization.
* NO patients requiring therapy for refractory thyroid dysfunction
* NO patients with uncontrolled diabetes mellitus.
* NO patients who have had treatment for a 2nd malignancy in the past 5 yrs, except for localized basal cell/squamous cell carcinoma of the skin or cervical carcinoma in situ.
* NO pregnant or lactating patients.
* NO patients known to be actively using alcohol or drugs
* NO patients receiving any experimental therapy within 30 days of enrollment in study.
HIIT and MICT on Nitric Oxide-mediated Erythrocyte Rheology

Erythrocyte rheological properties affect blood viscoelasticity and consequently regulate vascular resistance to flow shear force, whereas rheological impairments of erythrocytes may result in circulatory disorders. The aim of this study was to establish an effective exercise strategy for improving individual aerobic capacity and for simultaneously ameliorating the risk of hemorheological dysfunction evoked by a graded exercise test (GXT) and the hypotheses is exercise intervention will improved hemorheological functions by enhancing deformability of erythrocytes via NO-mediated mechanism. This study included 60 healthy sedentary mens (age 20\~30) from Chang Gung university than were randomized into the HIIT \[3-min intervals at 40% and 80% V̇O2 reserve (V̇O2R),n=10\] and MICT(sustained 60% V̇O2R,n=10)on a bicycle ergometer for 30min·d-1, 5 d·wk-1 for 6 wk.

Recently, the role of erythrocyte has been more emphasized, which also related with endothelial cell. For coronary artery patients, the endothelial nitric oxide synthase activity in red blood cell (RBC-eNOS activity) is lower than age-matched health people, and it is related with dysfunction of endothelial cell. In cardiovascular diseases. the erythrocyte arginase-1 is active and seize L-arginine with eNOS. When the Arg-1 stimulated by reactive oxygen species (ROS), the nitric oxide (NO) bioactivity decrease and produce more ROS, meanwhile, ROS can go around to stimulate Arg-1. When the RBC-NO production is lowering, it will increase the adhesion activity to endothelial cell due to erythrocyte can be quite close to blood vessel well then release Nitric Oxide, induce the dysfunction and oxidative pressure of endothelial cell. The NO can also regulate the deformability of erythrocytes, and extremely affect oxygen supply to tissue once the deformability and aggregation of erythrocyte become abnormal. Besides NO, the deformability will be affected if erythrocyte is continuously exposed to the endogenous or exogenous ROS, which also increase adhesion to endothelial cell with the exposure of phosphatidylserine. Exercise can regulate the mechanism of NO release from erythrocyte, affecting the rheology of erythrocyte, and improve the anti-oxidation ability. Therefore, as mentioned above which make erythrocyte, as many aspects, become an important role on atherosclerosis disease treatment.

Eligibility Criteria:
Inclusion Criteria:

* Having a sedentary lifestyle (without regular exercise, exercise frequency ≤ once weekly, duration \< 20 min).

Exclusion Criteria:

* Exposed to high altitudes (\> 3000 m) for at least 1 year.
* Smoker
* Taking medications or vitamins
* Having any cardiopulmonary/hematological risk.
Factors Influencing the Abortion Interval of Second-trimester Termination of Pregnancy Using Misoprostol

This study aims to analyze the factors influencing the abortion interval of second-trimester termination of pregnancy using misoprostol.

Misoprostol is the primary drug of choice for medical termination. It is not only cheap, but also stable at room temperature and easily available worldwide. It is indicated for the treatment of gastritis, but is widely used off-label for a variety of indications in the practice of obstetrics and gynecology, including medication abortion, induction of labor, and the treatment of postpartum hemorrhage. The optimal dosage and route of administration have not been well defined and vary with physicians. The potency of misoprostol's effect varies with dosage, route of administration and dosing interval; both maternal and fetal factors may, to certain extent, affect the abortion interval. This study aims to analyze the factors influencing the abortion interval of second-trimester termination of pregnancy using misoprostol.

Eligibility Criteria:
Inclusion Criteria:

1.All female patients who were admitted for medical termination of second-trimester pregnancy

Exclusion Criteria:

1. Patients who are allergy to Cytotec.
Sugammadex Vs Neostigmine/glycopyrrolate on Urinary Retention After Spine Surgery

This is an active-comparator controlled study to evaluate the effect of sugammadex compared to neostigmine/glycopyrrolate for reversal of rocuronium on the incidence of urinary retention after subjects undergo elective ambulatory spine surgery.

Subjects requiring elective ambulatory posterior lumbar laminectomy, will receive either an intravenous infusion bolus of Sugammadex (2 mg/kg dosed by actual body weight) or intravenous infusion bolus of Neostigmine (50 μg/kg, up to 5 mg maximum dose) plus Glycopyrrolate (10 μg/kg, up to 1 mg maximum dose). Additionally, all subjects will receive hospital standard of care therapy for their surgery and hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* ASA Physical Status I-III

Exclusion Criteria:

* Inability to obtain written informed consent
* Allergy to medications used in the protocol
* Known or suspected neuromuscular disorders
* Significant renal disease with a serum creatinine ≥ 2 mg/dL
* Significant liver disease
* A family history of malignant hyperthermia
* History of genitourinary surgery, cancer, or radiation within the last year
* Currently prescribed urological medications or diuretics
* BPH or symptoms of BPH (interrupted or weak urine stream or wake up to urinate more than two times per night)
* History or diagnosis of urinary incontinence or urinary retention
* History of PONV with use of scopolamine
* Use of Foley catheter pre- or intra- operatively
* Perioperative medications that influence micturition (e.g., diuretics or intraoperative anticholinergic medication use other than NMB reversal)
Evaluation of a LAMP Assay for T. Pallidum. Pertenue

This is a diagnostic evaluation comparing the performance of real-time PCR performed at a national reference laboratory and a LAMP assay performed at a regional hospital for the diagnosis of yaws


Eligibility Criteria:
Inclusion Criteria:

* Lesion consistent with yaws
* Positive treponemal and non-treponemal antibodies assessed by the DPP Syphilis Screen and Confirm RDT

Exclusion Criteria:

* Unable to give consent
Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy

Patients with colorectal adenomas are suggested to receive polypectomy. A substantial number of adenomas may be missed in patients with polyps found by previous colonoscopy. And water exchange (WE) method may increase the detection of missed adenoma compared with traditional air insufflation (AI) colonoscopy. The investigators aim to investigate whether water exchange colonoscopy method, compared with air insufflation method, can improve the detection of missed adenomas in patients undergoing selective polypectomy.

For WE method, the air pump was turned off for the full duration of insertion to avoid inadvertent air insufflations and colon elongation. Residual air in the lumen was suctioned to minimize angulations at flexures. Water at 37°C was infused with a pump (Olympus) through the biopsy channel to confirm correct tip orientation for scope advancement. The infused water was removed predominantly by suction when the colonoscope was smoothly advanced during the insertion phase, and turbid luminal water due to residual feces was exchanged by clean water until the lumen was clearly visualized. Occasionally, if it was difficult to determine whether the colonoscope tip was in the cecum, air was allowed to be insufflated for observation. If the position of the scope tip was confirmed to be not in the cecum, insufflated air would be removed by suction and the WE method would be continuously used until successful intubation.

For the AI method, water was not used, and air was insufflated during insertion.

Air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal for both methods. Polyps will be removed by forceps biopsy (polyps size \<3mm), cold snare technique (3-6mm) or endoscopic mucosal resection (size≥6mm).

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 patients undergoing selective polypectomy

Exclusion Criteria:

* Polyps found more than 6 months
* Patients with polyposis syndrome or hereditary nonpolyposis colorectal cancer
* Patients with history of inflammatory bowel disease
* Patients with planning to undergo Endoscopic Submucosal Dissection(ESD)
* Patients not undergoing standard bowel preparation
* Patients with solid feces in the last stool after bowel preparation
* Patients considered to be high risk for bleeding during Endoscopic mucosal resection (EMR), e.g. using antiplatelet drugs (clopidogrel) within 5 days before the current colonoscopy
* Hemodynamically unstable
* Pregnant women
* Unable to provide informed consent
Pilot Study of a Text Message Platform to Reduce Risky Drinking in Young Adults

Young adults are in a critical period where they can be influenced to avoid a trajectory of high-risk drinking and harmful outcomes in the later adult years. The Emergency Department might offer a unique opportunity to reach young adults, if an easy to implement screening, brief intervention and referral to treatment was available. The investigators are investigating the feasibility and accuracy of ED-initiated and outpatient-continued assessment of drinking behavior in young adults using a computer-driven text messaging platform. Based on the subject's response to weekly assessments, the computer platform will send personalized motivational messages in real-time.

Greater than 45% of young adults have heavy episodic drinking (HED; 5/4 drinks per occasion form men/women), resulting in significant health risks, including injury and death. Early identification and secondary prevention of HED using screening, brief interventions and referral to treatment (SBIRT) is advocated by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) as a way to reduce injury and health consequences. Each day in the United States, there are over 2700 emergency department (ED) visits associated with alcohol, unfortunately, SBIRT is rarely performed in the ED due to time and training requirements. Our application seeks to solve this problem by integrating SBIRT into ED care through the use of ecological assessments with interventions. We will incorporate components of the NIAAA 2005 Clinicians Guide into automated weekly assessments (EA) and branching algorithms for personalized interventions (EA\&I) delivered in real-time through mobile phone text messaging to young adults with a history of at-risk drinking behavior. We will assess the feasibility of EA\&I to study young adults with a history of at-risk drinking and assess the variability in outcomes in patients undergoing EA\&I, EA or standard care. We expect to find that this ED-initiated and outpatientcontinued platform will improve collection of drinking behavior, delivery of real-world motivational feedback and follow-up in young adults with at-risk drinking histories. We anticipate that short-term HED will be reduced in those subjects randomized to EA\&I. We will use this information to support further studies with adequate power to show ED-initiated EA\&I reduce long-term HED and its adverse consequences in young adults.

Eligibility Criteria:
Inclusion Criteria:

* 18-24 years
* English speaking
* Owns a personal phone with text messaging

Exclusion Criteria:

* Pregnant
* Prisoner
* Treated for alcohol dependence or abuse
* Treated for psychiatric disorder
A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency

This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, availability and distribution in the body of once-weekly long-acting growth hormone (NNC0195-0092, somapacitan) compared to once daily Norditropin NordiFlex® in adults with growth hormone deficiency (GHD).


Eligibility Criteria:
Inclusion Criteria:

* Adults with GHD as defined in the consensus guidelines for the diagnosis and treatment of adults with GHD
* Stable human growth hormone (hGH) replacement therapy for at least 3 months

Exclusion Criteria:

* Participation in another clinical trial within 3 months or receipt of any investigational medicinal product within 3 months prior to randomisation
* Active malignant disease or malignant disease within the last 5 years with exception of fully treated local basal cell carcinoma or carcinoma in situ of cervix
* Proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes
* Heart insufficiency, New York Heart Association (NYHA) class above 2
* Adults with GHD with poorly controlled diabetes mellitus with a glycosylated haemoglobin (HbA1c) 64 mmol/mol (8.0%) and/or insulin treatment
* Stable pituitary replacement therapy for less than 3 months
A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study

This is a Phase II, multicenter, open-label extension (OLE) study to evaluate the long-term safety and efficacy of fenebrutinib in participants with Chronic Spontaneous Urticaria (CSU) who have completed the treatment period in a fenebrutinib CSU parent study. Participants may enroll in this OLE study at any time after completing the treatment period of the parent study. Participants will receive open-label fenebrutinib at a dose of 200 milligram (mg) orally twice a day. Treatment may continue until the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Ability to comply with the study protocol, in the investigator's judgment
* Completion of the treatment period as specified in the parent study
* Acceptable demonstration of tolerance to study drug during the parent study as determined by the investigator or Medical Monitor
* For participants receiving treatment with proton-pump inhibitors (PPIs) or H2-receptor antagonists (H2RAs), agreement to maintain treatment at a stable dose for the first 12 weeks of the study
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Exclusion Criteria

* Pregnant or breastfeeding, or intending to become pregnant during the study or within 4 weeks after the final dose of fenebrutinib
* Treatment with any investigational agent or live/attenuated vaccine in the preceding 6 weeks
* Any signs or symptoms of infection judged by the investigator to be clinically significant since completing the treatment period of the parent study
* Any significant changes (e.g., events, changes in medication) occurring after completion of participation in the parent study that, in the investigator's judgment, would increase the risk of adverse events in this OLE study
Brief Alcohol Interventions With Mobile Phone Applications for University Students: A Randomized Controlled Trial

Objectives: This study evaluates the efficacy of two mobile phone applications, Promillekoll and PartyPlanner among university government members at two universities in Stockholm, Sweden. The design is a three-armed randomized controlled design, and outcomes are measured in terms of changes in problematic alcohol use at follow up 7 weeks after study initiation and baseline data gathering. Both the Promillekoll and PartyPlanner apps feature real time registration of alcohol consumption and giving feedback of estimated blood alcohol concentration levels. Both apps inform and warn the user when the estimated alcohol level is above 0.6%, a level set that is below risky consumption levels. PartyPlanner additionally provides the possibility of simulating and planning an alcohol consumption event in advance and later on comparing it with the real time registration at the event.

Method: Participants with problematic alcohol use (AUDIT \>7 for men and \>5 for women) are randomized into one of three groups: 1. Access to Promillekoll, 2. Access to PartyPlanner and 3. Control group. Outcomes on alcohol use as well as information on the users' satisfaction with the app assigned to them gathered after 7 weeks.

The hypotheses are: 1. The groups receiving the Promillekoll and PartyPlanner interventions will reduce their alcohol use to a larger extent than the control group at follow-up compared to the baseline level. 2. The addition of the possibility to plan events beforehand (PartyPlanner) will lead to an increased decrease in alcohol consumption to only real-time use (Promillekoll).

Background Brief interventions via the internet have been shown to reduce university students' alcohol intake. This study tested two smartphone applications (apps) targeting drinking choices on party occasions, with the goal of reducing problematic alcohol intake among Swedish university students.

Methods Students were recruited via e-mails sent to student union members at two universities. Those who gave informed consent, had a smartphone, and showed risky alcohol consumption according to the Alcohol Use Disorders Identification Test (AUDIT) were randomized into three groups. Group 1 had access to the Swedish government alcohol monopoly's app, Promillekoll, offering real-time estimated blood alcohol concentration (eBAC) calculation; Group 2 had access to a web-based app, PartyPlanner, developed by the research group, offering real-time eBAC calculation with planning and follow-up functions; and Group 3 participants were controls. Follow-up was conducted at 7 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Access to a smartphone running iOS or Android OS.
* AUDIT \>7 for men or AUDIT \>5 for women.

Exclusion Criteria:

* AUDIT \<8 (men) or \<6 (women)
* No access to a smartphone running iOS or Android OS.