cyrilzakka/clinical-trials huggingface dataset:
Study of Danicopan in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)

The purpose of this study was to determine the safety and efficacy of ACH-0144471 (also known as danicopan and ALXN2040) in currently untreated participants with PNH.

After 12 weeks of treatment, participants deriving clinical benefit were offered enrollment in a separate long-term extension study (ACH471-103, NCT03181633).

Eligibility Criteria:
Inclusion Criteria:

* Currently untreated PNH participants with PNH Type III erythrocyte and/or granulocyte clone size ≥10% and anemia (hemoglobin \<12 grams/deciliter) with adequate reticulocytosis (as determined by the Investigator).
* LDH ≥1.5 x the upper limit of normal.
* Platelets ≥50,000/microliter without the need for platelet transfusions.
* Documentation of vaccination for Neisseria meningitidis, Haemophilus influenza, and Streptococcus pneumoniae, or willingness to receive vaccinations during the screening period.
* Negative pregnancy test for females prior to dosing and throughout the study.

Exclusion Criteria:

* History of a major organ transplant (for example, heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
* Participants who had received another investigational agent within 30 days or 5 half-lives of the investigational agent prior to study entry, whichever is greater.
* Participants who had received eculizumab at any dose or interval within the past 75 days before study entry.
* Participants with known or suspected complement deficiency.
* Participants with active bacterial infection or clinically significant active viral infection, a body temperature \>38°Celsius, or other evidence of infection on Day 1, or with a history of febrile illness within 14 days prior to first study drug administration.
* History of meningococcal infection, or a first-degree relative or household contact with a history of meningococcal infection.
* Females who were pregnant, nursing, or planning to become pregnant during the study or within 90 days of study drug administration or participants with a female partner who was pregnant, nursing, or planning to become pregnant during the study or within 90 days of study drug administration.
The Effects of e+Shots Energy Beverage on Mental Energy

The aim of the research project is to determine the changes in motivation to perform mental and physical tasks, feelings of vigor and fatigue, mental task vigilance and fine motor function after consumption of a commercially available energy product. The purpose of this study is determine whether e+shot, a product containing natural caffeine, will impact mood and performance up to 108 minutes post consumption compared to a sweetened solution containing synthetic caffeine.

Enrolled participants who are low consumers of caffeine will be administered either a placebo (3mg caffeine), caffeinated placebo (\~100mg of caffeine) or e+shot first and then will be crossed over to receive the other two interventions. The study consists of 3 treatment periods of 108 minutes each with a washout period of 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-45
* Body Mass Index (BMI) \< 30
* Profile of Mood Status Short Scale (POMS) score \<13 on the energy scale
* Energy and Fatigue trait scale score \<=10
* Consumption of \<200mg of caffeine/day
* Consumption of \<150 servings of polyphenols/month

Exclusion Criteria:

* Subjects taking prescription or over the counter medications (except for oral contraceptives) for a chronic medical condition or recreational drugs will be excluded Chronic medical conditions are any health condition that is expected to last more than 3 months and requires on going medical care such as coronary artery disease, multiple sclerosis, etc..
* Women who are pregnant or may be trying to become pregnant
* Women who are breastfeeding
* People who have been diagnosed with heart conditions and/or hypertension
* People who have liver disorders
* People who have sensitivity or allergy to caffeine
* People who have bipolar disorder
* People who have iron deficiency
* People who are allergic to plants of the Asteraceae/Compositae/Daisy family
* Day of testing

  * Subjects who have had a change of ±2 hours of sleep from their regular sleep time will be re-scheduled.
  * If subjects begin taking a prescription or over the counter medication for an acute condition (i.e. required to take the prescription or over the counter medication for \< 3 months) during the study they will be given the option of continuing the study after they are no longer taking the prescription or over the counter medication or dropping out of the study.
  * If subjects are diagnosed with a chronic condition that requires the use of prescription medications for \> 3 months after they have started the study they will be eliminated from the study.
  * Resting systolic BP \> 180mmHg and diastolic BP \> 90mmHg after consuming the caffeine beverage.
BURT Efficacy in Improving Upper Extremity Strength and Function During Post-stroke Inpatient Rehabilitation

The Barrett Upper Extremity Robot (BURT) is an FDA-approved upper extremity robot that assists patients with both passive and active range of motion while providing adjustable resistance (Barrett_Medical. Robotic Assist Rehabilitation Made Easy. https://medical.barrett.com/). Activities are directed by therapists and encourage patient involvement through video game activities providing active proprioceptive, vibrational, visual and auditory feedback. Engaging and colorful games are beneficial in holding patients' interest, and gravity assistance may also allow for increased repetition in the face of patient fatigue.

In this prospective study, the investigators will determine if a standardized BURT Upper Extremity (UE) program can be consistently implemented within an acute inpatient rehabilitation facility (IRF). In addition, the investigators will see if patients who receive BURT have improved UE mobility and function as a result. The investigators will also study the perceived enjoyment and value of the intervention by patients, and perceived value by therapists.

Because BURT therapy is able to provide more repetitions of upper extremity movement in a shorter length of time than conventional therapy, the investigators hypothesize that patients who participate in neuro re-education activities using BURT will achieve greater improvements in strength, upper extremity function, fine motor coordination, activities of daily living and mobility during their time in an IRF than patients receiving conventional therapy.

In this study, eligible patients admitted to Sunnyview Rehabilitation Hospital (SRH) for rehabilitation following stroke will be randomized to receive conventional or BURT therapy. Meaningful clinical benchmarks for upper extremity function, tone, fine motor coordination, activities of daily living and mobility will be assessed using the Upper Extremity Motor Assessment Scale (UE-MAS)(Zelter, 2010), manual muscle testing (MMT), Modified Ashworth Scale (MAS) (Figueiredo, 2011) and the 9-hole peg test (9HPT)(Figueiredo, 2011). The investigators also hypothesize that patients in the BURT cohort will report greater value/usefulness and interest/enjoyment.


Eligibility Criteria:
Inclusion Criteria:

* Inpatient at Sunnyview Rehabilitation Hospital
* \>/= 18 years
* Unilateral stroke
* UE paresis affected arm with 3-/5 or less manual muscle testing throughout

Exclusion Criteria:

\>30 days post stroke

* Severe Neglect
* Bilateral stroke
* Prior stroke with residual deficits
* Patients receiving prism adaptation treatment
* Comorbid neurological disorders
* Upper limb comorbidities that could limit functional improvement (UE arthritis pain, UE fracture, fixed contracture not allowing for proper device alignment)
* Severe shoulder subluxation that cannot be accommodated by the device
* Severe osteoporosis
* Unable to follow simple directions
* Unable to tolerate sitting 30 minutes
* Expected length of stay (LOS) \< 15 days.
Bioequivalence Study of Sertraline 100 mg Tablet and ZOLOFT Following a 100 mg Dose in Healthy Subjects Under Fed Conditions

* Objective:

  * To compare the rate and extent of absorption of Torrent Pharmaceuticals Limited, India, sertraline and Pfizer, Inc., USA (Zoloft) sertaline, administered as a 1X100 mg tablet, under fasted conditions.
* Study Design:

  * Single-dose, open-label, randomized two-way crossover.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, smoker or non smoker, 18 years of age and older.
* Capable of consent.
* BMI\>= 19.0 and \<30.0 kg/m2

Exclusion Criteria:

* Clinically significant illness or surgery within 4 weeks prior to the administration of the study medication.
* Positive testing for hepatitis B, hepatitis C, or HIV at screening.
* ECG abnormalities or vital sign abnormalities(blood pressure).
* History of significant alcohol or drug abuse within one year prior to the screening visit.
* History or allergic reactions to heparin, sertraline or other related drugs.
* Use of an investigational drug or participation in an investigational study with in 30 days prior to administration of the study medication.
* Clinically significant history of gastrointestinal pathology, liver or kidney disease, neurological, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
* History of seizures, suicide attempt, bipolar disorder or manic episodes.
* Depot injection or an implant of any drugs with in 6 months prior to administration of study medication.
* Breastfeeding subject.
* Positive urine pregnancy test at screening.
* Female subject of child bearing potential having unprotected sexual intercourse with any non-sterile mail partner within 14 days prior to study drug administration. Acceptable methods of contraception:

  1. Intra-uterine contraceptive device(placed at least 4 weeks prior to study drug administration)
  2. Condom or diaphragm + spermicide.
A Comparison of Propofol Based Total Intravenous Anesthesia and Sevoflurane Based Balanced Anesthesia on Renal Protection During Lung Transplantation Under Extracorporeal Membrane Oxygenation - A Prospective, Randomized Trial

The aim of this study is to investigate whether propofol based total intravenous anesthesia reduces incidence of acute kidney injury following the lung transplantation under extracorporeal membrane oxygenation


Eligibility Criteria:
Inclusion Criteria:

* Sixty adults undergoing lung transplantation under extracorporeal membrane oxygenation

Exclusion Criteria:

* Patient having propofol allergy, BMI \> 30 kg/m2
Enhancing Speech Fluency With Non-invasive Brain Stimulation in Developmental Stuttering

This study aims to test whether the addition of transcranial direct current stimulation (TDCS) to speech fluency training results in improvements in speech fluency in adults with developmental stuttering. Half of the participants will receive anodal TDCS on five consecutive days, the other half will receive a sham stimulation for the same amount of time.

Studies using TDCS have shown improvements in motor performance, and in expressive language skills in clinical and healthy populations. The benefits of single sessions of TDCS are short-lived. However, stimulation over multiple sessions can increase and prolong learning effects that can persist for several weeks after the end of the stimulation period. We aim to target left hemisphere frontal regions involved in speech production with TDCS, and to pair this stimulation with speech fluency training.

Eligibility Criteria:
Inclusion Criteria:

* Native speaker of English.
* Right handed.
* Participant has moderate to severe Developmental Stuttering (Stammering)

Exclusion Criteria:

* Speech, language or communication disorder other than Developmental Stuttering.
* Sensory impairment (hearing loss or visual impairment)
* History of drug abuse.
* History of seizures
* History of a neurological or psychiatric illness.
* History of neurosurgical procedure.
* Currently taking certain prescription medications such as anti-depressants and anti-malarial medication (as these may lower the seizure threshold)
Action Observation Therapy on Balance in Children With Down Syndrome

Down syndrome is a condition in which a child is born with an extra copy of their 21st chromosome hence its other name is trisomy 21. The hallmarks of Down syndrome are mental retardation, hypotonia and characteristic phenotype features. Balance is one of the major issue. Action observation therapy focus on the concept of balance improvement.

The study will be randomized controlled trail used to evaluate the effectiveness of Action observation therapy on balance in children with down syndrome. subjects with down syndrome meeting the inclusion exclusion criteria will be divided into two groups using non-probability sampling technique. Assessment will be done using Pediatric balance scale(PBS) and Timed up and go test(TUG) . Control group will receive regular physical therapy with balance training and experimental group will receive regular physical therapy + Action observation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Children with age group of 6-12
* Both male and female
* Body Mass Index (BMI) within normal range (57.1%)
* Absence of any psychiatric and physical illness at the time of participation

Exclusion Criteria:

* Uncontrolled seizures
* Any kind of orthopedic condition
* Registered visually impaired
* Severe Atlanto Axial instability
* Unable or unwilling to understand and attempt the task
Study in Predicting Outcome of Patients Undergoing Radiation Therapy for Prostate Cancer

RATIONALE: Proteins found in blood and urine samples may help predict outcome and allow doctors to plan more effective treatment.

PURPOSE: Diagnostic trial to study blood and urine proteins in predicting treatment outcome in patients who are undergoing radiation therapy for prostate cancer.

OBJECTIVES:

* Correlate serum and urine protein profiles collected before or after radiotherapy with clinical outcome in patients with prostate cancer.
* Identify protein profiles that can distinguish between patients with no evidence of disease and those with biochemical and/or clinical failure.
* Determine whether those serum proteomic profiles consistent with failure can be identified at early time points in the course of treatment and follow-up of these patients.

OUTLINE: Patients are stratified according to clinical outcome (prior to radiotherapy vs no evidence of disease vs biochemical failure vs clinical failure vs clinical outcome not yet determined).

Urine and blood specimens are collected from patients either before or after definitive radiotherapy. Samples are analyzed by surface-enhanced laser desorption and ionization time-of-flight mass spectrometry to develop proteomic patterns.

Results of proteomic profiles do not influence patient care.

PROJECTED ACCRUAL: A total of 150 patients (30 per stratum) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed prostate cancer
* Completed or planned definitive radiotherapy

PATIENT CHARACTERISTICS:

Age

* Adult

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Concurrent immunotherapy allowed

Chemotherapy

* Concurrent chemotherapy allowed

Endocrine therapy

* Concurrent hormonal therapy allowed

Radiotherapy

* See Disease Characteristics
* Concurrent palliative radiotherapy allowed

Surgery

* No prior prostatectomy, including radical prostatectomy
* No concurrent radical prostatectomy
Meta-analysis in Post-marketing Surveillances for SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to integrate the post-marketing surveillances data (Specified use-results surveys on long-term treatment) of the 6 SGLT2 inhibitors approved or applied in Japan and to evaluate the safety and efficacy of long-term use of each under actual clinical practice conditions.

In each post-marketing surveillance, 3000 patients who complete a 3 years treatment are enrolled. A total of 18000 patients are assessed in the meta-analysis.


Eligibility Criteria:
Patients with Type 2 diabetes mellitus starting medication of SGLT2 inhibitors
INREAL - Nintedanib for Changes in Dyspnea and Cough in Patients Suffering From Chronic Fibrosing Interstitial Lung Disease (ILD) With a Progressive Phenotype in Everyday Clinical Practice: a Real-world Evaluation

The primary objective of this observational study is to investigate the correlation between changes from baseline at 52 weeks in forced vital capacity (FVC) and changes from baseline at 52 weeks in dyspnea score points or cough score points as measured with the pulmonary fibrosis questionnaire (L-PF) questionnaire over 52 weeks of nintedanib treatment in patients suffering from chronic fibrosing interstitial lung disease (ILD) with a progressive phenotype (excluding idiopathic pulmonary fibrosis (IPF)).


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years at Visit 1
* Subjects must be contractually capable and mentally able to understand and follow the instructions of the study personnel
* Physician's diagnosis of chronic fibrosing interstitial lung disease (ILD) with a progressive phenotype, except idiopathic pulmonary fibrosis (IPF)
* Treatment with nintedanib in INREAL will be the first and only prescription of any antifibrotic treatment for each individual patient within this observational study after a physician's decision being made for this treatment option earlier
* Outpatients not currently hospitalized with a life expectancy \> 12 months per investigator's assessment
* Written informed consent prior to study participation
* Current forced vital capacity (FVC) measurement (taken within the last 3 months) available in the patient file
* Women of childbearing potential must take appropriate precautions against getting pregnant during the intake of nintedanib

Exclusion Criteria:

* Patients with contraindications according to Summary of Product Characteristics (SmPC)
* Prior use of any antifibrotic treatment
* Lack of informed consent
* Pregnant or lactating females
* Any physician diagnosed exacerbation of ILD in the patient's history file, irrespective of time since event
* Current diagnosis of lung cancer
* Respiratory failure (pH \< 7,35 and/ or respiratory rate \> 30/min) in the patient's history
* Participation in a parallel interventional clinical trial
* Patients being spouse or lateral relatives to the second degree or economically dependent from the investigator
SERETIDE Plus Tiotropium Versus Individual Components

This study was designed to evaluate the effects on lung function of a combination of SERETIDE 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments (tiotropium bromide 18mcg once daily alone and SERETIDE 50/500mcg twice daily alone) in subjects with COPD. The study will utilise a three-way cross-over design with a 2-week wash-out period between each 2-week consecutive treatment period.

A randomised, double-blind, double dummy, 3 way cross-over study evaluating the effects of SERETIDE™ 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments (tiotropium bromide 18mcg alone and SERETIDE 50/500mcg alone) in the treatment of subjects with COPD

Eligibility Criteria:
Inclusion Criteria:

* Has an established clinical history of COPD as defined as per the GOLD definition.
* Post-bronchodilator FEV1 of \>30% to 75% of predicted normal at Visit 1, a post-bronchodilator FEV1 / FVC ratio = 70%.
* Current or ex-smoker with a smoking history of \> 10 pack-years.

Exclusion Criteria:

* Has unstable COPD (Chronic Obstructive Pulmonary Disease).
* Has a current medical diagnosis of asthma and/or allergic rhinitis or know respiratory disorders (lung cancer, sarcoidosis, tuberculosis or lung fibrosis) Requires regular (daily) or long term oxygen therapy (LTOT). (LTOT is defined as \> 12 hours oxygen use per day).
Necessity of Transnasal Gastroscopy in Routine Diagnostics - a Patient Centered Requirement Analysis

Evaluation of patients safety and comfort in nasal endoscopy.

Introduction: Numerous indications require regular outpatient upper gastrointestinal endoscopy (EGD). In most cases, peroral gastroscopy is performed. The aim of this study was to evaluate the necessity and outpatients' demand for transnasal gastroscopy (nEGD).

Methods: A questionnaire was used to assess patients' choice of method, previous experience, psychological and sociodemographic data. Furthermore, the patients' satisfaction with and potentially perceived discomfort during the examination as well as their preference for a method with regard to future examinations was evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Adequate knowledge of oral and written german

Exclusion Criteria:

* Inpatient Treatment
* For medical reasons (narrow nasal cavity, band ligation of esophageal varices, Placement of a percutaneous endoscopic gastrostomy, planned colonoscopy under sedation the same day, abnormal coagulation, emergency procedures)