cyrilzakka/clinical-trials huggingface dataset:
Home Sleep and Circadian Phase: Mediators of Diabetes Risk

The purpose of this study is to determine if deficient sleep and/or disruption with the body's internal clock ("circadian rhythms") are associated with diabetes risk. This study is being done to look at the possible relationships between sleep and risk of diabetes by examining sleep in the home and diabetes risk in the laboratory.


Eligibility Criteria:
Inclusion Criteria:

1. Ages 21-50 years
2. BMI \<40 kg/m2.
3. No major illness.
4. No history of psychiatric, endocrine, cardiac or sleep disorders,
5. Premenopausal, non-pregnant women.
6. Those with dyslipidemia and hypertension will be included if these conditions are controlled by a stable treatment, such as lipid-lowering or antihypertensive medications (except beta blockers).

Exclusion criteria include:

1. Persons with diabetes.
2. Persons with diagnosed sleep disorders or apnea-hypopnea index\>15.
3. History of cardiovascular event or disease (excluding controlled hypertension).
4. Major psychiatric disorder or other major illness.
5. Persons taking medications, including but not limited to antidepressants and hypnotics (but excluding lipid-lowering drugs and anti-hypertensive medications as mentioned above).
6. Persons regularly taking medication that affects melatonin such as beta blockers and exogenous melatonin.
7. Anyone who tests positive for common drugs of abuse.
8. People with color blindness.
9. People who have had Lasik eye surgery.
10. People who work night shifts.
11. Participants who travel across multiple time zones will be studied only after they have remained in the Central Time Zone (or Indiana) for one month prior to the study.
A Clinical Study of Precision TACE (P-TACE) With Surefire

The purpose of this research study is to learn about 2 types of FDA-approved catheters used in angiographic (X-ray of blood vessels, with radiopaque substance) procedures like DEB-TACE treatment. The Principal Investigator will check the beads given during the DEB-TACE. They will compare the way in which they are spread out in the tumor and density (how condensed something is).


Eligibility Criteria:
Inclusion Criteria:

1. Patients \> 18 years with confirmed diagnosis of unresectable hepatocellular carcinoma who are candidates for TACE therapy
2. Barcelona Clinic Liver Cancer Classification (BCLC) A or B
3. Child-Pugh Class A or B
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
5. 1 to 5 target tumors that are \< 6cm with at least one tumor ≥ 3cm in size
6. Vessel size ≥ 1.5 mm
7. Subject must be able to provide written informed consent

Exclusion Criteria:

1. Extra-hepatic spread of the cancer
2. Macrovascular tumor invasion
3. Diffuse HCC (\>50% liver involvement)
4. Previous chemotherapy, radiotherapy, transarterial embolization or ablations in the targeted tumor(s)
5. Advanced liver disease (bilirubin \> 3 mg/dl, aspartate aminotransferase (AST) or ALT \> 5x upper limit of normal or \> 250 U/I
6. Extrahepatic supply to the tumor
7. Hypovascular tumors
8. Heart failure with reduced ejection fraction or Left Ventricular Ejection Fraction (LVEF) ≤ 40 percent
9. Any serious medical or psychiatric illness/condition that will interfere or limit compliance with study requirements/treatments.
Role of Oral Steroids in Reducing Recurrence of Urethral Stricture After Direct Vision Internal Urethrotomy

It was a randomized controlled trial conducted at department of Urology, Armed Forces Institute of Urology, Rawalpindi from 1st January, 2018 July 2019 to 31st March 2021 to determine the role of oral steroids after Direct Vision Internal Urethrotomy to reduce the recurrence rate of urethral strictures.


Eligibility Criteria:
Inclusion Criteria:

* Patients with urethral stricture with restricted urine flow of \< 15 ml/min on uroflowmetry

Exclusion Criteria:

* Patients presenting with post-anastomotic urethroplasty strictures (assessed on history and medical record),
* Patients with post-TURP strictures
* Patients with neurogenic bladder
* Patients with prior history of steroid use
* Patients with extravasation during optical internal urethrotomy
Long-term Hemodialysis Catheter Removal and Delayed Replacement, Versus Exchange Over a Guidewire to Treat Catheter Related Blood Stream Infection

Prospective, randomized Study of tunneled cuffed hemodialysis catheter removal and delayed replacement, versus exchange over a guidewire to treat catheter related blood stream infection

The aim of this study was to compare the clinical outcomes of catheter-related (CRBSI) managed with two different strategies: Guidewire exchange of the infected catheter with a new one over a guidewire versus catheter removal with delayed replacement.

Eligibility Criteria:
Inclusion Criteria:

* All patients end stage renal disease on hemodialysis from tunneled cuffed dialysis catheters with suspected catheter-related bloodstream infection with no identifiable infection source except the catheter were included.

Exclusion Criteria:

* metastatic infection,
A Study of NM21-1480 in Adult Patients With Advanced Solid Tumors

This is a first-in-human, open-label, multi-center, Phase 1/2, dose-escalation study with expansion cohorts to evaluate NM21-1480 for safety and immunogenicity, to determine the maximal tolerated dose and recommended Phase 2 dose, define the pharmacokinetics, to explore the pharmacodynamics, and to obtain preliminary evidence of the clinical activity in adult patients with selected advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

Part A

* Patients with any previously treated solid tumor-type other than hepatocellular carcinoma or intrahepatic cholangiocarcinoma that is advanced, or recurrent and progressing since last anti-tumor therapy, and for which no alternative, standard therapy exists.
* Prior chemotherapy, radiation therapy or immunotherapy must have been completed at least 4 weeks prior to the administration of the first dose of study drug, and patient has recovered

Part B:

* Patients with Non-small Cell Lung Cancer (NSCLC) or other protocol specified solid tumors with locally advanced or metastatic, non-resectable disease, which has progressed despite treatment with first-line standard of-care treatment, or first- and second-line treatment, dependent on expansion cohort.
* Prior therapy must have been completed 2-4 weeks prior to the administration of the first dose of study drug as specified per protocol according to type of prior therapy

Exclusion Criteria:

* Patient previously had known immediate or delayed hypersensitivity reaction or idiosyncrasy to the excipients
* Part A: Treatment with any PD-1, or Cytotoxic T-Lymphocyte Associated Protein (CTLA)-4 directed antibody, or with any other immunotherapy within 4 weeks prior to initiation of the study drug.
* Part A: Use of other biological investigational drugs (drugs not marketed for any indication), including use of investigational drugs targeting CD137/4-1BB within at least 5 half-lives (or within 8 weeks, whatever is longer) prior to the administration of the first dose of study drug.
* Part B: As defined per protocol for each expansion cohort, has not been treated with specified first/second-line standard-of-care therapies biological drugs (marketed or investigational) for treatment of the current cancer, or has not adequately recovered from AEs that occurred with prior therapy.
* Patient has an active autoimmune disease or a documented history of autoimmune disease.
Aponermin, Pomalidomide, Dexamethasone for Patients With Relapsed/ Refractory Multiple Myeloma

This study aims to evaluate the efficacy and safety of a three drug combination therapy of aponermin, pomalidomide, and dexamethasone in the treatment of relapsed or refractory multiple myeloma


Eligibility Criteria:
Inclusion Criteria:

1. RRMM patients who have received 1-3 line treatment;
2. Age above 18 years old, male or female not limited;
3. ECOG score ≤ 2;
4. Expected survival period is greater than 3 months;
5. For female patients, (1) they have been menopausal for at least 24 months before the screening visit, or have undergone surgical contraception; (2) Women with fertility must have two negative urine HCG pregnancy tests within 72 hours before starting to take the study drug; For male patients must agree to absolute abstinence or effective barrier contraception throughout the entire study treatment period until 28 days after the last study drug treatment, and have no sperm donation behavior;
6. The patient understands the purpose and steps of this trial, voluntarily participates in this trial, and signs a written informed consent form.

Exclusion Criteria:

1. Allergic or intolerant to the investigational drug or its components;
2. Received any experimental drug treatment within 4 weeks;
3. Simultaneously suffering from other tumors, or having undergone anti-tumor treatment (including major surgery) in the past 4 weeks;
4. Currently, there are poorly controlled heart diseases, such as heart function grade III or IV (NYAH classification),uncontrolled atrial fibrillation, unstable angina, and myocardial infarction within the 12 months prior to enrollment;
5. Suffering from mental illness;
6. Accompanied by severe lung infection, skin and soft tissue infection, or urinary tract infection;
7. There was a serious thrombotic event before treatment;
8. Unable or unwilling to receive prophylactic antithrombotic therapy;
9. Serious, uncontrolled medical disorders or active infections;
10. Researchers determine situations that are not suitable for inclusion.
The Mobility Toolkit: Electronically Augmented Assessment of Functional Recovery Following Lower-extremity Trauma

The study will prospectively enroll and follow 300 participants ages 18-60 surgically treated for a lower-extremity articular injury including fractures of the tibial plateau, pilon, ankle, and calcaneus.

The study will prospectively enroll and follow 300 participants ages 18-60 surgically treated for a lower-extremity articular injury including fractures of the tibial plateau, pilon, ankle, and calcaneus. All participating centers will undergo training to implement the Mobility Toolkit (MTK). Research Staff will facilitate a series of performance tests while participants wear the MTK device. MTK assessment will also be conducted on 150 non-injured adults matched to the injured cohort on age and gender. These individuals will be enrolled and assessed once at two participating centers. Study flow and data capture are summarized in the figure on the next page.

Eligibility Criteria:
Inclusion Criteria:

1. 18-60 years of age
2. Open or closed fractures of the tibial plateau, pilon, ankle or calcaneus requiring surgical fixation.

Exclusion Criteria:

1. Gustilo type IIIB or IIIC injuries
2. No other surgically or non-surgically treated injuries that impact gait (e.g. upper extremity injury proximal to the elbow; spinal cord injury; contralateral or ipsilateral fractures).
3. Neurologic impairment or deficit that impairs gait
4. Prior injuries or conditions that alter gait (e.g. severe osteoarthritis)
5. Severe problems with maintaining follow-up (e.g. participants who are prisoners, who are intellectually challenged without adequate family support, or have documented psychiatric disorders).
6. Unable to provide informed consent in English or Spanish.
Feasibility of the Sinex Program for Shoulder Instability

An optimal treatment for traumatic anterior shoulder instability (TASI) remains to be identified. A shoulder instability neuromuscular exercise (SINEX) program has been designed for patients with TASI, but has not yet been tested in patients eligible for surgery. The purpose of this study was to investigate and evaluate the feasibility and safety of the SINEX program for patients diagnosed with TASI and eligible for surgery.

A feasibility study with an experimental, longitudinal design using both quantitative and qualitative research methods. Participants undergo the SINEX program, a twelve week exercise program including physiotherapist supervised sessions. Feasibility data on recruitment, retention, compliance, acceptability and safety was collected through observation and individual semi-structured interviews. Clinical tests and self-report questionnaires were completed at baseline and 12 weeks follow-up. Clinical assessments included apprehension and relocation tests, shoulder joint position sense (SJPS), shoulder sensorimotor control measured by center of pressure path length (COPL) on a force platform, isometric strength measured by Constant Score - Isometric Maximal Voluntary Contraction (CS-iMVC), self-report questionnaires included Western Ontario Shoulder Instability Index (WOSI), Tampa Scale of Kinesiophobia (TSK) and Global Perceived Effect questionnaire (GPE).


Eligibility Criteria:
Inclusion Criteria:

* men and women, between 16 and 45 years of age, minimum one traumatic anterior shoulder dislocation diagnosed with TASI, eligible for stabilizing Bankart surgery

Exclusion Criteria:

* complex shoulder injuries not suitable for a Bankart procedure as determined by an orthopedic surgeon, insufficient Norwegian language skills, and/or not being able to participate in a supervised exercise program
Multi Detector-Row Computed Tomography (MDCT) Calcium Score of Heart Transplanted Patients

The purpose of the study is to determine if calcium score can be used as a predictor of coronary artery disease in heart transplanted patients, as it is used in non-transplanted persons.

Several studies have shown that a negative calcium score is a strong independent negative predictor of coronary artery disease (CAD). CAD in heart transplants (HTx) differs from CAD lesions in native hearts. The aim of this study is to see if there is a similar relation between coronary artery calcium and CAD in transplanted hearts as in native hearts.

Eligibility Criteria:
Inclusion Criteria:

* Heart transplanted patient
* Aged 18 or above.

Exclusion Criteria:

* Pregnancy
* Atrial fibrillation
* Severe heart failure New York Heart Association (NYHA) class IV
* Severe pulmonary disease making the patient unable to hold his/her breath for more than 10 seconds.
Role of Bronchoscopy in Assessment of Patients With Post-intubation Tracheal Stenosis

1. To estimate the importance of bronchoscopic treatment of tracheal stenosis and its effectiveness and safety.
2. To diagnose and evaluate tracheal stenosis characteristics as location, vertical extension and severity of obstruction.

Post intubation tracheal stenosis (PI) was recognized in 1880, after prolonged endotracheal intubation in 4 patients with upper airway obstruction.The most common causes of acquired tracheal stenosis are endotracheal intubation and tracheostomy. Tracheal stenosis is a surgical problem managed non operatively by bronchoscopic dilation, endoluminal treatment with lasers, and stenting. Bronchoscopic management have a good success rate. PI and post tracheostomy stenosis (PT) are recognized with an 4.9 cases per million per year in the general population. Prolonged intubation can result in tracheal stenosis at various levels within the trachea.Tracheal stenosis occurs at the endotracheal tube cuff site in one third of the reported PI cases \[9\] and appears as a web-like fibrous. The mainly postulated cause is loss of regional blood flow.This injury begins within the first hours of intubation, and healing of the damaged areas within 3 to 6 weeks. Large volume, low pressure cuffs has reduced the occurrence of cuff injury.Patients in the ICU are common to have respiratory involvement, with 30-50% of the admissions requiring the use of mechanical ventilation.Flexible bronchoscopy has become the procedure of choice in most examinations of the tracheobronchial tree.The incidence of PI tracheal stenosis ranges from 6-21% and following tracheostomy ranges from 0.6-21%.

Eligibility Criteria:
Inclusion Criteria:

1. Meticulous History and Clinical Examination
2. Chest x-Ray (CXR)
3. Spirometry
4. Flexible bronchoscopy
5. Rigid Bronchoscopy (when needed).

Exclusion Criteria:

1. Patient refusal.
2. Any coagulation disorder.
3. Untreatable life-threatening arrhythmias.
4. Allergy to anaesthesia.
5. Poor general condition.
M-Gard Particulate EW Efficacy Study on Seasonal Allergic Rhinitis

The goal of this clinical trial is to assess the efficacy and safety of M-Gard supplementation for alleviating the symptoms of allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-65 years.
* Generally healthy
* Individuals with a history of recurrent seasonal allergic rhinitis
* Positive RAST test for grass allergy
* BMI 18-35kg/m2
* Able to provide informed consent
* Agree not to change current diet and/or exercise routine during entire enrolment period
* Agree to not participate in another clinical trial during the study period

Exclusion Criteria:

* Serious illness e.g., liver disease, kidney disease, heart disease, mood disorders, neurological disorders such as multiple sclerosis.
* Unstable illness e.g., diabetes and thyroid gland dysfunction.
* Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years.
* Individuals with symptomatic perennial allergic rhinitis, non-allergic rhinitis, chronic respiratory conditions (e.g., asthma, chronic obstructive pulmonary disease).
* Participants with cognitive damage.
* Acute illness experienced in the past 1 month.
* Active smokers and/or nicotine or drug abuse.
* Allergic to any of the ingredients in the active or placebo formula.
* Chronic past and/or current alcohol use (\>21 alcoholic drinks per week)
* Attempting to conceive, pregnant or lactating women
* Use of medications that would affect the immune and/or the inflammatory response e.g. immunotherapy, antihistamines (daily use), corticosteroids, mast cell stabilizers, leukotriene modifiers, and decongestants.
* Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy including low dose aspirin; tricyclic antidepressants; Clonidine and other central acting alpha-2-agonists.
* Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month.
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.
Blood Pressure and Cardiac Autonomic Adaptations to Isometric Exercise Training

A randomized, sham-controlled intervention measuring the effects of isometric exercise training (IET) on blood pressure and cardiac autonomics.

IET has been proven effective in a plethora of randomized trials, but very little research has employed a sham-controlled design. This researched involved the recruitment of 30 participants who completed a 4 week IET intervention, sham control of the IET intervention, or a non-intervention control period. Pre and post blood pressure and cardiac autonomic measures were acquired and analysed.

The hypothesis of this trial was a significant effect of IET on blood pressure, with no such effects following the sham control or normal control interventions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy with no significant health conditions contraindicating exercise
* Over 18 years of age
* Physically inactive

Exclusion Criteria:

* Achieving current physical activity guidelines
* Abnormal resting ECG
* under 18
Retrospective NIS to Evaluate the Patient Benefit of TES

In this retrospective non-interventional study (NIS), the subjective and objective benefit of patients with retinitis pigmentosa (and other dystrophies like Usher, Choroideremia or cone-rod dystrophy), who have been prescribed the therapy of transcorneal electrostimulation (TcES) with the OkuStim System, is assessed.

The medical device OkuStim received the CE mark (a symbol of free marketability in the European Economic Area) in 2011 and is commercially available for patients in Europe since 2014. Since then, patients with retinitis pigmentosa and other dystrophies have regularly applied the therapy of transcorneal electrostimulation (TcES) with OkuStim. So far, the benefits of the therapy and the experiences of the patients with regular, multi-year use have not been systematically recorded.

In this retrospective non-interventional study (NIS) with patients which have been using TcES since \>1 year, data present for visual field, best-corrected visual acuity (BCVA) and central foveal thickness (as assessed via OCT) is collected. In addition, reasons for discontinuation of therapy and patient satisfaction with TcES are assessed via a questionnaire. Side-effects are also recorded, if present in the patient files.

Eligibility Criteria:
Inclusion Criteria:

* Use of TcES for \>1year
* Willing and able to consent

Exclusion Criteria:

* Not willing and able to consent
The Role of Ultrasonography in Labor in Predicting the Outcomes of Childbirth

Ultrasound in the delivery room represents a useful diagnostic tool and is used for the assessment of fetal presentation, fetal malpresentation/malposition, and prior to any operative delivery. Transperineal ultrasonography, performed by placing the ultrasound probe covered by a sterile glove at the level of the labia majora, has proven useful in providing information on the progression of the presented fetal part in the birth canal and in predicting birth outcomes. Many studies have shown a correlation between the above ultrasound indices and birth outcomes. These ultrasound indices are therefore used in clinical practice to assess the progression of the presented fetal part in the birth canal and the presence of fetal malpresentation/malposition. Despite this, to date, few studies have evaluated the correlation between dynamic changes in these ultrasound parameters between rest and maximal maternal pushing during the second stage of labor and birth outcomes.

Knowing before delivery which parameters are suggestive of possible dystocia would allow the clinician to adopt therapeutic strategies aimed at resolving them and thus increase the rate of spontaneous vaginal deliveries.

The investigators want to evaluate the role of an ultrasound parameter obtained by transabdominal ultrasound in the second stage of labor, the occiput-column angle, in predicting spontaneous delivery vaginally in fetuses with transverse occiput

Participants will be recruited at the time of admission or in the delivery room. Routine clinical practice involves transabdominal ultrasound, performed in the lithotomy position, placing the probe transversely and longitudinally at the abdominal level for evaluation of the fetal situation and presentation.

In addition to normal ultrasound, the position of the fetal occiput will also be assessed in women who agree to participate in the study, and in fetuses with a transverse occiput, the occipitecolumn angle will be measured. All study participants will then undergo transperineal ultrasound, performed by placing the probe, covered by a sterile glove, at the level of the labia majora, first longitudinally and then transversely. In this way, a series of ultrasound landmarks will be visualized: pubic symphysis, bladder, urethra, vagina, rectum, pubo-rectal muscle, and fetal head.

Eligibility Criteria:
Inclusion Criteria:

* Women aged \>= 18 years
* Single pregnancy at term (37-42 gestational weeks)
* Fetus in cephalic presentation and in expulsive period (complete cervical dilatation and premature sensation)
* Acquisition of informed consent form

Exclusion Criteria:

* Placenta previa
* Uterine malformations
* Previous uterine surgery
* Cardiotocographic tracing (CTG) abnormalities
* Any contraindication to vaginal delivery