cyrilzakka/clinical-trials huggingface dataset:
Non-pulmonary Contributors of Exercise Intolerance in Patients With Cystic Fibrosis

The purpose of this research study is to examine if the use of antioxidant supplements impacts exercise intolerance in people with CF.

Exercise intolerance is a critical problem for people with cystic fibrosis (CF) able to predict hospitalization independent of lung function. Recent studies have suggested that certain supplements may help improving exercise intolerance.

Eligibility Criteria:
Inclusion Criteria:

CF

* Diagnosis of CF
* Men and women (\> 18 yrs. old)
* FEV1 percent predicted \> 40%
* Patients with or without CF related diabetes
* Resting oxygen saturation (room air) \>90%
* Traditional CF-antioxidant medications
* Ability to perform reliable/reproducible PFTs
* Clinically stable for 4 weeks (no exacerbations or need for antibiotic antioxidant within 4 weeks of testing or major change in medical status)
* Pancreatic sufficient and pancreatic insufficient patients

Exclusion Criteria:

CF

* Children 17 years old and younger
* FEV1\<40% predicted
* Resting O2 saturation \<90%
* Clinical diagnosis of heart disease
* Clinical diagnosis of PAH
* Febrile illness within 4 weeks of a study visit
* Antioxidant for pulmonary exacerbation within 4 weeks of a study visit
* Currently smoking, pregnant or nursing
* Vasoactive medications (i.e. nitrates, beta-blockers, Viagra etc.)
* Patients with B. Cepacia
Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery

This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart surgery.


Eligibility Criteria:
Inclusion Criteria:

* - Planned coronary artery bypass grafting (CABG) or CABG plus single heart valve replacement/repair or planned replacement/repair of a single heart valve

Exclusion Criteria:

* Known intolerance to protamine
* Known or suspected allergy to the used antifibrinolytic agent
* Refusal to receive blood or blood product
* Planned surgery including the aortic arch and/or descending aorta
* Planned surgery including any implantable ventricular assist device
* Adult congenital heart diseases
* Two or more previous cardiac surgery procedures
* Any known autoimmune diseases: Collagen vascular disease (Systemic lupus erythematosus, Rheumatoid arthritis, Sjögrens syndrome) - Endocrine: hyperthyroidism (Graves disease), adrenal insufficiency, Hashimoto's thyroiditis - Neurologic: Multiple sclerosis, myasthenia gravis - Skin: pemphigous vulgaris Hematologic: Pernicious anaemia, Autoimmune haemolytic anaemia - Vasculitis - Primary or secondary antiphospholipid syndrome
* Weight above 140 kg
Efficacy and Safety of 5 mg Sublingual Zolpidem vs 10mg Oral Zolpidem in the Induction and Maintenance of Sleep in Patients With Primary Insomnia

The purpose of this study is to evaluate the efficacy and safety of sublingual zolpidem presentation 5 mg in the induction of sleep in patients with primary insomnia.

* National study, phase IV, single-center, double-blind, randomized, parallel, controlled by zolpidem 10mg oral.
* Experiment duration: 93 days.
* 05 visits (days -3, 0, 15, 45 and 90).
* Efficacy will be evaluated for: Sleep induction and the maintenance of sleep.
* Adverse events evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged between 20 and 64 years;
* Diagnosis of primary insomnia according to criteria defined by DSM-IV;
* Difficulty in maintaining sleep and waking up until 3 am;
* Not having used any psychoactive drug in the last 30 days prior to their inclusion in the study;
* Signature of IC.

Exclusion Criteria:

* Previous history of serious medical illness, neurological or psychiatric disorder;
* Allergy or hypersensitivity to zolpidem;
* Obstructive Sleep Apnea syndrome;
* Polysomnography with apnea and hypopnea index \>10/hour or PLM \>15/h;
* Other secondary sleep disorders;
* History of substance abuse or dependence;
* History of daily consumption of alcoholic beverages;
* Pregnancy, lactation or refusal to use safe contraceptive methods during the study.
iCAGES-guided Precision Therapy for Cancers in Contrast to Standard Care or IHC-guided Theray

This study prospectively evaluates whether the use of iCAGES (integrated CAncer GEnome Score) tool in guiding the treatment of advanced cancers is superior to current standard care or IHC-guided therapy in progress free survival (PFS),overall survival (OS),and improvement of life quality.

Cancer is a fatal disease caused by the accumulation of various oncogene and tumor suppressor gene mutations. Studies of high-throughput sequencing for patients who suffered from cancer has found that different mutations play a different role in the occurrence and development of different cancers. Several gene panels already exist to help identify mutations in a few genes that may have corresponding FDA-approved drugs or drugs under clinical trials. However, given whole-genome/exome sequencing data, the suitable clinical analysis tool to analyze individualized cancer-related gene mutations, and recommend the most appropriate targeted treatment options among hundreds of possible drugs therapy is absent currently.

The recently proposed iCAGES is a precise biomedical informatics analysis tool, which could help increase the accuracy of cancer driver gene detection and prioritization, bridge the gap between personal cancer genomic data and prior cancer research knowledge,and facilitate cancer molecular diagnosis as well as personalized precision therapy.

IHC detection of multiple molecules such as EGFR, HER2-3, TROP3, NECTIN4, MET, B7-H3-4, B1-H7, Claudin18.2, FGFR1-4, Mesothelin, ROR1, BCMA, AXL, TF, FRα, CD70, PPARα, HIF-2α, RET, ROS1, NTRK, CDK4/6, FLT3, EZH2 are also scheduled for appropriate targeted therapy and comparison if available.

Eligibility Criteria:
Inclusion Criteria:

* Pathological and clinical diagnosis of recurrence / metastatic lung cancer or other advanced cancers.
* There are PACS images available at the Second Affiliated Hospital of Guangzhou Medical University and the collaborated Hospitals.
* The patient is informed consent and signed a written consent.

Exclusion Criteria:

* Age \> 70 or \<18 years old.
* Previous history of malignant tumors.
* Pregnant or lactating female patients.
* Any serious concomitant disease that is expected to have an adverse effect on prognosis, including the heart disease that treatment is required, unsatisfactory controlled diabetes and psychiatric disorders.
A Comparison of Large Diameter Metal Heads vs. Small Diameter Metal Heads vs/ Dual Mobility Total Hip Replacements

Does having a large diameter metal on polyethylene total hip replacement increase metal ion release. Larger metal heads are thought to have increased torsional forces on the trunion which would like release more metal ions. Increased metal ion levels have been associated with adverse local tissue reactions. Are there any differences comparing these groups to a dual mobility type total hip replacement.


Eligibility Criteria:
Inclusion Criteria:

* One total hip replacement, either a large metal head (\>40) or a small metal head (\<30) on a polyethylene bearing surface.
* 2 to 5 years s/p surgery minimum. No symptoms

Exclusion Criteria:

* Any other bearing surface besides metal on poly, no other joint replacements, symptomatic
HD Patients' Depression and Happiness

The aim of the study is to verify the mediating effect of life of meaning and post-traumatic growth in spirituality and psychological well-being (happiness, depression).

The research design is cross-sectional correlational study. Convenient sampling will be used to conduct to data collection. There are 300 patients with hemodialysis from a hemodialysis institution in the north Taiwan, and data collecting with self-administrated questionnaires. The instruments include demographic and disease-related information, Spiritual Health Scale short form, Chinese Happiness Inventory, Beck Depression Inventory-II, Life Attitude Profile, Posttraumatic Growth Inventory. The SPSS 22.0 statistical software will be used to analyze the data. Descriptive statistics, such as frequency, percentage, mean, and standard deviation (SD) will be used for participant characteristics and outcome measures. T-test, chi-square, ANOVA, post-hoc, ANCOVA, and Person's correlation will be conducted to test the relationships between the research variables.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are over 20 years old
* voluntarily participate in the study and sign the respondent consent form
* have received routine hemodialysis treatment for more than three months
* have clear consciousness and can communicate in Mandarin and Taiwanese.

Exclusion Criteria:

* Patients whose medical records record a diagnosis of schizophrenia
* patients are taking antidepressant drugs
Phase 2a Study of CG400549 for the Treatment of cABSSSI Caused by Methicillin-resistant Staphylococcus Aureus

Primary Objective:

To make a preliminary assessment of the efficacy of CG400549 (960 mg daily) in subjects with cABSSSI (major cutaneous abscesses) due to MRSA.

Secondary Objective(s):

* To assess the pharmacokinetics of CG400549 (960 mg daily) in subjects with cABSSSI due to MRSA
* To explore the in vitro susceptibility of cABSSSI-related bacteria to CG400549.
* To assess the safety of multiple doses of CG400459

This will be an open-label, exploratory study to evaluate the safety, pharmacokinetics, and efficacy of CG400549, daily for 10 to 14 days, in subjects with cABSSSI (major cutaneous abscesses) due to MRSA. All subjects will receive active treatment.

Subjects will begin study treatment upon confirmation of clinical eligibility (ie, confirmation of MRSA infection is not required pretreatment). Subjects who begin treatment with CG400549 and are subsequently not found to have S. aureus infection will be discontinued from study treatment, treated as appropriate for the identified pathogen(s), and followed for safety. These subjects will be included in the safety analyses but not in the primary efficacy analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of major cutaneous abscess suspected or confirmed to be caused by a MRSA.
2. Signs and symptoms should include at least 2 of the following: purulent drainage or discharge, erythema, fluctuance, heat or localized warmth, edema/induration, pain or tenderness to palpation

Exclusion Criteria:

1. Prior systemic or topical antibacterial therapy
2. Severe sepsis or refractory shock
Ross Operation Failure Database

A large multicentric registry to obtain data to analyse the pulmonary autograft (PA) failure phenomenon and feed more complex biomechanical models to be integrated with clinical imaging with the final aim to predict Ross operation's outcomes and define strategies to ameliorate its results.

On the basis of the current knowledge on the outcomes of Ross Operation we aim to create a large multi centric registry in order to obtain data on the preoperative intraoperative management of these patients and on the postoperative long-term results of this procedure.

Patients data will be entered by the investigators in an electronic database Preoperative variables will include age, comorbidities, functional status, indications for surgery, morphology of the aortic valve Additional morphological data and aortic and pulmonary measurements will be taken intraoperatively Postoperative follow-up data including both clinical outcomes (mortality, reoperation for pulmonary autograft failure, major cardiac events, stroke, infection) and morphological measurements by means of CT scan or echocardiography, will be inserted.

Quality of life by means of SF12 and Minnesota living with heart failure questionnaire and EQ-5D score will be collected.

Follow-up endpoints are at discharge, 1 year 5 years 10 years 15 years and 20 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergone (or undergoing) to Ross Operation

Exclusion Criteria:

* Patients requiring combined cardiac surgical procedure in association to Ross Operation
Ledipasvir/Sofosbuvir Fixed-Dose Combination With Ribavirin or GS-9669 in Subjects With Chronic Genotype 1 HCV Infection

This study will evaluate the antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) or LDV/SOF plus GS-9669 in treatment-naive or treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection. A total of 90 participants are planned to be enrolled in the study for 8 weeks of treatment, approximately 60 having had prior treatment with a regimen containing pegylated interferon (PEG) and RBV for ≥ 12 weeks. Randomization will be stratified by treatment-naive versus treatment-experienced and by HCV genotype (1a versus 1b).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18, with chronic genotype 1 HCV infection
* Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen
* HCV RNA \> 10,000 IU/mL at Screening
* Presence of compensated cirrhosis
* Screening laboratory values within defined thresholds
* Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

* Pregnant or nursing female or male with pregnant female partner
* Co-infection with HIV or hepatitis B virus (HBV)
* Current or prior history of clinical hepatic decompensation
* Chronic use of systemic immunosuppressive agents
* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection

To compare the positivity rate of the investigational assay to the currently approved QuantiFERON-TB Gold In-Tube assay.


Eligibility Criteria:
Low Risk and Known Risk Cohorts

Inclusion Criteria:

* Compensated and uncompensated members (current or future) of the Department of Veterans Affairs with no identified symptoms of active TB disease
* Age greater than 18 years or less than 80 years.

Exclusion Criteria:

* Currently taking therapy for active tuberculosis or latent TB infection for more than 14 days.
Early Identification and Treatment of Early HIV Infection in Côte d'Ivoire

Set-up of a biobank for patients with an estimated date of infection seroconverters: store plasma and cells samples at initial contact and during follow-up for future analysis and analysis in international collaborative cohort seroconverters.


Eligibility Criteria:
Inclusion Criteria:

* patients included in the last Primo-CI ANRS 1220 protocol
* All HIV infected individuals diagnosed during a blood donation with an estimated date of HIV seroconversion that will respect the following criteria: (i) age ≥18 (ii) HIV-1 or HIV-1+2 infected, (iii) HIV-seronegative at the preceding donation; (iv) who returned to the clinic to be informed of their HIV test result (v) with an HIV serology confirmed with two specific tests in two different laboratories (vi) who have never received ART for curative purpose
* informed on study objectives and have a signed informed consent.

Exclusion Criteria:

* Patient living outside of Abidjan
Mechanisms of Severe Acute Influenza Consortium (MOSAIC)

The ultimate goal of this collaborative, intensive study is to discover new and effective treatments and to develop better vaccines that can be used in future outbreaks of Influenza A. By integrating the information that we will gather, we will create a unique overview of how influenza causes illness and what might be done to improve patient management.

Influenza A is one of the best studied viruses, but continues to have a very large impact on human and animal health. In addition to causing outbreaks of winter flu, it sometimes mutates to create a new virus that spreads quickly around the world. It is puzzling that the same virus appears to cause minor or absent symptoms in some people while killing others. Much remains to be understood.

The investigators have assembled an unprecedented group of internationally renowned scientists from England and Scotland who will together focus on studying a few hundred people hospitalised during the current swine flu pandemic. Such a large scale project has never before been attempted, but we are now poised to work together and integrate the many recent advances in biomedical science that relate to understanding how influenza causes disease.

Eligibility Criteria:
Inclusion Criteria:

* Any patient admitted to hospital with suspected or confirmed influenza infection

Exclusion Criteria:

* Patients who do not give their consent
Orphenadrine and Methocarbamol for LBP

Low back pain is a common cause of visit to emergency department. It is not clear if skeletal muscle relaxants are of benefit for patients with acute low back pain. This is a randomized study to determine if skeletal muscle relaxants, when combined with naproxen, improve outcomes more than naproxen alone

Patients with acute, non-traumatic, non-radicular low back pain will be enrolled at the time of discharge from the emergency department. Participants will be followed by telephone one week and 3 months after the ED visit

Eligibility Criteria:
Inclusion Criteria:

* LBP duration \<= 2 weeks
* No trauma to low back within previous month
* No radicular symptoms
* No history of low back pain or history of only infrequent episodes

Exclusion Criteria:

* Medication allergies or contra-indications
* Not available for follow-up
* Chronic pain syndrome
Modafinil for Treatment of Fatigue in ALS Patients

The purpose of this pilot study is to evaluate whether modafinil is helpful in alleviating fatigue, low energy, drowsiness and difficulty concentrating among patients with amyotrophic lateral sclerosis (ALS), and to evaluate incidence and frequency of adverse events, if any.

ALS is an untreatable, progressive, fatal neurodegenerative disease whose etiology is unknown and whose course is relatively rapid (median survival 3 years after diagnosis). Palliative care, including symptom management, can contribute greatly to improved quality of life. In this context, alleviation of fatigue can help maintain function, extend the duration of time when employment is feasible for those still working, and can enable patients to more fully participate in and enjoy social and recreational activities. Given the prevalence of fatigue in this population, identification of effective treatment is a meaningful goal.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ALS
* Ages 18-80
* Clinically significant fatigue (4.5+ on Fatigue Severity Scale with duration 3+ months plus impairment in 1+ categories of role function)
* Speaks English
* Able and willing to give informed consent
* Can communicate verbally or with assistive device
* Can swallow capsules
* Forced vital capacity 50+%

Exclusion Criteria:

* Untreated hypothyroidism (TSH \> 4.25 UIU/ML)
* Untreated and uncontrolled hypertension
* Clinically significant anemia (HCT \< 33%)
* Untreated or under-treated major depressive disorder
* Current clinically significant suicidal ideation
* Started antidepressant medication for treatment of depression during past 6 weeks
* Currently taking psychostimulant medication
* History or current psychosis or bipolar disorder
* Fecund women not currently using barrier methods of contraception
Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Dupuytren's Contracture

Background:

Dupuytren's contracture is a common hand problem that causes certain fingers to bend towards the palm. Patients with this condition cannot perform daily activities and many are unable to work. It is usually treated by an operation to straighten the fingers followed by therapy if the angle that the fingers are bent at is large enough. However, no treatment has been able to completely prevent the angle from persisting.

Objective:

This study is designed to examine whether or not the use of a drug in combination with surgery will improve the angle at which the fingers are bent more than surgery alone.

Hypothesis:

Subjects who receive triamcinolone acetonide will have straighter fingers compared with subjects who only have the operation and no triamcinolone acetonide at both 3 months and 6 months after the operation.

Methods:

Eligible patients interested in having the operation to treat Dupuytren's contracture will be asked if they would like to join the study. Subjects will be randomly placed into one of two groups: the steroid injection group or the control group. Subjects will have a pre-operative visit, the surgery, and follow-ups at 6 weeks, 3 months and 6 months. All subjects will have the operation, but only those in the steroid injection group will receive an injection of the drug. During the 6 week and 3 month follow-ups, subjects in the steroid injection group may receive another injection if their fingers are still bent. Angles are measured at the pre-operative visit and at 3 and 6 months. The change in angle from before to after and any differences in the groups, in time points and interactions between the two will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18.
* Literate in the English language.
* Diagnosed by the PI with Dupuytren's contracture with an angle of contracture of 20° or greater.
* Candidates for percutaneous needle aponeurotomy.
* First surgery on the affected digit.

Exclusion Criteria:

* Allergy or sensitivity to triamcinolone acetonide or any of the non-medicinal components in the suspension.
* Patient is not a candidate for steroid injection for other medical reasons, which will be determined by the PI.
A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)

Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute VVC in the past 12 months. Several properties of oteseconazole (VT-1161) suggest that it might be a safer and more effective treatment for RVVC than other oral anti-fungal medicines.

This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the treatment of RVVC and consists of 2 parts. The first part of the study is a 2-week period for the treatment of the patient's current VVC episode with 3 150mg doses of fluconazole. The 2nd part consists of 12 weeks, when the patient will take either oteseconazole (VT-1161) 150 mg or a placebo (according to a random assignment), and then a 36-week follow-up period.

In addition, at participating sites, an amendment to the study allows US patients who complete the initial 48 weeks without experiencing a confirmed RVVC episode to continue in a 48-week observational extension period designed to evaluate the continued effectiveness of oteseconazole (VT-1161).

This study is identical to VMT-VT-1161-CL-012 (NCT03561701).


Eligibility Criteria:
Key Inclusion Criteria:

* 3 or more episodes of acute VVC in the past 12 months
* Positive KOH or Gram stain
* Total vulvovaginal signs and symptoms score of ≥3 at screening visit
* Total vulvovaginal signs and symptoms score of \<3 at baseline visit
* Must be able to swallow pills

Key Exclusion Criteria:

* Presence or a history of another vaginal or vulvar condition(s)
* Evidence of major organ system disease
* History of cervical cancer
* Poorly controlled diabetes mellitus
* Pregnant
* Recent use of topical or systemic antifungal or antibacterial drugs
* Recent use of immunosuppressive or systemic corticosteroid therapies