cyrilzakka/clinical-trials huggingface dataset:
Role of Subsequent Atrial Tachycardia in Mechanisms of Persistent AF

In this study, the investigators aim to examine the prognostic role of subsequent Atrial Tachycardias (ATs) in the mechanisms of atrial fibrillation (AF). Therefore, the investigators compare patients who were randomly assigned to either undergo cardioversion after AF has been terminated to AT or further ablation until the achievement of sinus rhythm.


Eligibility Criteria:
Inclusion Criteria:

* persistent AF for at least 1 months,
* age \> 18 years,
* refractory to drug therapy,
* no prior ablation

Exclusion Criteria:

* prior AF ablation
The Effect of Laser Photocoagulation on the Soft Tissue Healing During Socket Preservation

The main aim of this study was to evaluate clinically the effect of laser photocoagulation in comparison to the non-resorbable dense polytetrafluroethylene (dPTFE) membrane on the soft tissue healing during socket preservation with bovine bone xenograft.

The study was designed as randomized, controlled, clinical trial. patients who were undergoing tooth extraction and socket preservation were divided into two groups: Group I:980 nm Diode laser was used to seal the socket by photocoagulation .Group II : a non-resorbable dPTFE was used to seal the socket and stabilized by suturing to the soft tissue margins of the socket

All patients were clinically and radiographically evaluated at the baseline and on the second , third and fourth weeks postoperatively.Then recalled after 4 months for the final radiographic examination.

Eligibility Criteria:
Inclusion Criteria:

1. The need for the extraction of nonrestorable maxillary anterior tooth for untreatable caries, endodontic treatment failure or root fracture.
2. Type I postextraction sockets according to the classification proposed by Elian et al. with all bony walls intact .
3. Adult patients (aged 18-50 years).
4. A good standard of oral hygiene, as determined by the registration of an O'Leary Plaque Index of less than or equal to 10% after phase I therapy.

Exclusion Criteria:

1. The presence of any systemic disease that could complicate bone and soft tissue healing of the grafted socket.
2. The presence of any local factor that may interfere with extraction as tooth ankylosis.
3. Smoking.
4. The presence of bone dehiscence and fenestrations of the post-extractive alveolus (Type II and III sockets).
5. Subjects who had undergone radiation therapy.
6. Patients who had been subjected to or who were under bisphosphonate therapy.
Success of Dailies Total1 for Astigmatism Contact Lenses in Patients That Have Previously Failed With Toric Contact Lenses

The objective is to determine the percentages of past toric CL wearers (who dropped out of contact lens wear due to dissatisfaction with comfort or vision) who are satisfied with the comfort and vision of DT1fA contact lenses.

This is a single arm, prospective, non-comparative, open-label post market clinical study of satisfaction of past toric CL wearers, with DT1fA contact lenses. Subjects will be assessed at a screening visit, and 2 follow-up visits. Clinical evaluations will include measurement of visual acuity, manifest refraction, and administration a questionnaire

Eligibility Criteria:
Inclusion Criteria:

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

* Gender: Males and Females.
* Subjects will be 18-39 years old.
* History of previous unsuccessful astigmatism contact lens wearer with qualifying answer to screening questions:

  * I used to wear astigmatism correcting (toric) soft contact lenses.

    - (YES)
  * I stopped wearing my previous astigmatism correcting soft contact lenses because of one or more of the below reasons:

    * Poor or fluctuating vision
    * Discomfort
    * Other
* Subjects must have 20/25 or better distance visual acuity in each eye with current best correction.
* Good general health (defined by prescription medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI).
* Ability to give informed consent.
* Willing and able to spend time for the study (Subjects will be required to attend three study visits and wear contact lenses on days between study visits).

Exclusion Criteria:

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

* Previous ocular surgery.
* Inability to be fit with the DT1fA lens design.
* Subjects that should be wearing a toric contact lens for best acuity but have chosen to continue in spherical contact lens wear.
* History of Accutane use.
* Ocular surface disease that in the investigator's opinion would interfere with contact lens wear.
* History of comorbidities, including autoimmune disorders and diabetes.
* Irregular astigmatism as identified by Pentacam.
* History of Amblyopia.
* History of Strabismus and/or history of eye muscle surgery.
* History of Monovision.
* Potential subjects who are pregnant.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
An Open-Label, Pilot Study to Evaluate the Efficacy of Narrowband Ultraviolet-B Phototherapy Three Times Weekly for Twelve Weeks in Moderate-to-Severe Psoriasis Patients

A single center study of 30 patient receiving Narrowband UVB phototherapy three times weekly for 12 weeks. Patients will be evaluated through week 36 to evaluate maintenance of response.

30 subjects will be treated with increasing doses of Narrowband Ultraviolet phototherapy three times weekly for 12 weeks. Patients will then be evaluated every 6 weeks through week 36 to determine maintenance of response.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female adults ≥ 18 years of age.
2. Diagnosis of chronic plaque-type psoriasis for at least 6 months
3. Moderate to Severe plaque psoriasis as defined by BSA ≥10 PASI ≥12 IGA ≥3
4. Able to give written informed consent prior to performance of any study related procedures
5. Subject is able to attend Narrowband UVB phototherapy sessions three times a week and all other protocol specified visits
6. Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination.

Exclusion Criteria:

1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and/or guttate psoriasis) or drug induced psoriasis
2. History of photosensitivity
3. Subject has used ustekinumab and/or anti-IL-17 biologic therapy within 24 weeks or other experimental or commercially available biologic immune modulator(s) within 12 weeks prior to the first IP dose.
4. Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
5. Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine).
6. Patient used topical therapies to treat within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).
7. Initiated within 3 months, planned initiation of, or changes to, concomitant medications that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors ) during the trial
8. Active infections requiring antibiotics in the 2 weeks prior to Baseline
9. Patient received UVB phototherapy within 4 weeks of Baseline.
10. Patient received PUVA phototherapy within 4 weeks of Baseline.
Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB

Evaluation of the functional changes in the stomach and esophagus of patients undergoing One Anastomosis Gastric Bypass (OAGB)


Eligibility Criteria:
Inclusion Criteria:

* BMI\> 35 kg/m2
* 2 years of controlled conservative obesity treatment without weight reduction
* patients should give their consent to participate in the study

Exclusion Criteria:

* Less than 2 years of conservative obesity treatment
* cancer
* cirrhosis Child-Pough score A
* Crohn's disease
* serious psychiatric disorder, which led to in-hospital treatment in psychiatric clinic in the past two years
* drug consumption
* non-compliance
* hiatal hernia \> 4cm
* gastric pouch \< 10cm
* Barett esophagus
* erosive esophagitis Grade C or D according to the Los Angeles Classification
* endoscopically proven gastric stricture
* acid exposition time \> 6% (Lyon criteria)
* reflux episodes\> 80 /24 hours (Lyon criteria)
* insufficient low esophageal sphincter according to manometry findings
* pathological findings in the impedance pH-metry (acid and non-acid reflux)
Effects of Biofunctional Orange Juice on Cardiometabolic Risk Markers

The effects of orange juice enriched with vitamin D3 and encapsulated probiotics (Lacticaseibacillus casei Shirota and Lacticaseibacillus rhamnosus GG) compared to conventional orange juice on several cardiometabolic and anthropometric parameters in individuals at risk of cardiovascular disease.

This randomized, double-blind, controlled clinical trial aims to evaluate the effects of the consumption of orange juice enriched with vitamin D3 and encapsulated probiotics (Lacticaseibacillus casei Shirota and Lacticaseibacillus rhamnosus GG) compared to conventional orange juice in 50 high cardiometabolic risk volunteers. The participants must be overweight/obese with either prediabetes, and/or hypertension, and/or hyperlipidemia, and will be divided and randomly assigned into 2 groups of 25 individuals each. Participants will consume 250 ml of either orange juice enriched with vitamin D3 and encapsulated probiotics (Lacticaseibacillus casei Shirota and Lacticaseibacillus rhamnosus GG) or conventional orange juice daily for 8 weeks as an addition to their usual dietary intake. Participants will be asked to maintain their usual physical activity during the intervention period. At the beginning of the study and at 8 weeks, blood samples will be collected after 12 hours of fasting. Two-hour oral glucose tolerance test (OGTT) will be performed using a continuous glucose monitoring system at the beginning and at 8 weeks. Anthropometric measurements will be performed at the beginning and every week for 8 weeks. Basal metabolic rate (BMR) and central aortic blood pressure will be measured at the beginning, 4 weeks, and 8 weeks of intervention. Fecal samples will be collected and analyzed to study gut microbiome compositob at the intervention's beginning and at 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index \>= 25 kg/m2
* Prediabetes \[fasting blood glucose \> 100 mg/dL\], or/and
* Hypertension \[Systolic blood pressure (SBP) \> 130 mmHg or Diastolic blood pressure (DBP) \> 80 mmHg\], or/and
* Hyperlipidemia \[total cholesterol \> 200 mg/dL, and/or LDL-C \> 100 mg/dL, and/or triglycerides \> 150 mg/dL\]

Exclusion Criteria:

* Severe chronic disease (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver diseases, endocrine conditions)
* Medication that affects glycemia such as metformin, glucocorticoids, thiazide diuretics
* Gastrointestinal disorders
* Pregnancy
* Lactation
* Alcohol abuse
* Drug dependency
* Body weight lowering medications and/or history of bariatric surgery
* Depression and other psychiatric diseases
* Cancer
* Probiotic, prebiotic, and vitamin D supplemental intake
Pain After Breast Surgery

This is a pilot observational study assessing various predictors for acute pain and persistent pain following breast surgery for cancer.


Eligibility Criteria:
Inclusion Criteria:

* English speaking undergoing elective breast cancer surgery

Exclusion Criteria:

* Patients with recurrent cancer, metastasis, and previous breast surgery
Prospective Clinical Study of Intraoperative Assessment of Resection Margin of Colo-Rectal Cancer Liver Metastases

This prospective single arm double-blind study approved by the Ethics Committee of the institution, will be conducted on at the Oncology Institute of Vojvodina in Sremska Kamenica, Serbia. Patients with colo-rectal cancer liver metastases (CRLM) is presented to the multi-disciplinary team (MDT).Screening and enrolment is conducted after established of indication for resection. The surgeons assesses resection margin (RM) for every resected liver specimen (RLS) intra-operatively by inspection and palpation. These data will be compared with pathological RM examination as a "gold standard". Resection margin of 1 mm or more will be rated as negative RM (RM-) otherwise RM is positive (RM+). Taking the result of the pathohistological examination as "gold standard" it is determined that RM is true positive when the pathologist and surgeon agreed that the RM is positive. False negative RM is when the surgeon assesses RM as negative and pathologist as positive. The sensitivity of the surgical assessment of RM+ is defined as the rate of RM+ which was correctly identified. True negative RM is determined when the pathologist and surgeon agreed that it is negative RM. False positive RM defined when the surgeon assessed RM as positive, but pathologist found that it was RM-. The specificity of the surgical assessment of RM is defined as the rate of RM- which is correctly identified. Total accuracy represents the rate of correctly recognized positive and negative RM, relative to the total number of samples. Agreement between surgeon and pathologists finding will be analyzed as well as difference between them. Disease recurrence and disease-free survival (DFS) will be analyzed by RM.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Preoperative diagnosis of liver metastases of colorectal adenocarcinoma
* Indication for surgical resection of liver metastases of colorectal adenocarcinoma

Exclusion Criteria:

* RM is not defined by surgeons and pathologists as positive or negative
* Surgical resections and application of ablative procedures at the same time
* Surgery for relapse of CRLM, if the first CRLM surgery is performed before this study start
* Resection was not done from any reason
A Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults

This is an open label, parallel group study to evaluate the pharmacokinetics (PK) and safety of a single dose of CVT-301 in smoking and non-smoking adults.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) 18 to 32 kg/m2;
* Forced expiratory volume in one second (FEV1) ≥80% of predicted for race, age, sex, and height;
* FEV1/FVC (forced vital capacity) ratio ≥70%;
* Smokers are defined as those currently smoking at least 10 cigarettes/day for at least 12 months with a positive urinary cotinine result and with no past (within 5 years) or present history of intrinsic lung disease (e.g. asthma, chronic obstructive pulmonary disease \[COPD\], chronic bronchitis, or other relevant conditions);
* Non-smokers are defined as those who never smoked or were exposed to less than 1 pack year within at least 12 months and with a negative urinary cotinine result.

Exclusion Criteria:

* Subject who is not surgically sterile or female subject who is less than 2 years postmenopausal, and who does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product;
* Any flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit;
* History of chronic obstructive pulmonary disorder (COPD) requiring intermittent or continuous use of any oral or inhaled medication therapy within last 3 years;
* Renal impairment as defined by a calculated creatinine clearance of ≤ 80 mL/minute;
* History of syncope within the last 6 months.
Gemcitabine and Cisplatin in Treating Patients With Refractory or Recurrent Cancer of the Cervix

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and cisplatin in treating patients who have refractory or recurrent cancer of the cervix.

OBJECTIVES:

* Determine the antitumor activity of gemcitabine and cisplatin in patients with refractory or recurrent squamous cell carcinoma of the cervix.
* Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive cisplatin IV and gemcitabine IV over 1 hour on days 1 and 8. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 28-69 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed refractory or recurrent squamous cell carcinoma of the cervix that has failed local therapy and is considered incurable
* Must have had 1 prior chemotherapy regimen for cervical cancer

  * No more than 1 prior chemotherapy regimen (single or combination drug therapy), unless used as a radiosensitizer
  * No prior chemotherapy for recurrent or persistent disease including retreatment with initial chemotherapy
* Bidimensionally measurable disease
* Ineligible for higher priority GOG protocol

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* GOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Platelet count at least lower limit of normal
* Absolute neutrophil count at least 1,500/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 times normal
* SGOT and alkaline phosphatase no greater than 3 times normal

Renal:

* Creatinine no greater than 2.0 mg/dL

Other:

* Not pregnant
* Fertile patients must use effective contraception
* No significant infection
* No other malignancies within past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 3 weeks since prior biologic therapy for cervical cancer

Chemotherapy:

* See Disease Characteristics
* At least 3 weeks since prior chemotherapy for cervical cancer and recovered
* No prior gemcitabine

Endocrine therapy:

* At least 3 weeks since prior endocrine therapy for cervical cancer

Radiotherapy:

* At least 3 weeks since prior radiotherapy for cervical cancer and recovered
* No prior radiotherapy to more than 25% of marrow-bearing areas

Surgery:

* At least 3 weeks since prior surgery for cervical cancer and recovered

Other:

* No concurrent amifostine or other protective reagents
* No prior anticancer therapy that contraindicates study
Exploratory Investigation of Advanced PET/MRI Metrics for Bladder Cancer Characterization

The overarching goal of this project is to explore whether associations exist between metrics obtained from PET/MRI incorporating advanced MRI sequences and features of bladder cancer, including grade, stage, and treatment response.

The investigators will assess an advanced non-Gaussian diffusion-weighted imaging (DWI) model termed diffusion kurtosis imaging, multi-echo T2 mapping, dynamic contrast-enhanced (DCE) MRI using a motion-robust high-temporal and high-resolution radial acquisition scheme employing compressed sensing, and simultaneously acquired 18-fluoro (18F)- fluorodeoxygluclose (FDG) data. Preliminary data demonstrates the investigators ability to execute and evaluate all of these techniques at the investigators center. The investigators hypothesize that these techniques will be sensitive to functional and metabolic differences between subsets of bladder cancer cases and will improve upon the performance of current imaging protocols in bladder cancer characterization. Moreover, the investigators believe that these techniques will provide complementary information, such that they may be combined in a synergistic fashion for bladder cancer evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Histologic or imaging evidence of urothelial carcinoma of the bladder
* Age ≥ 18 years of age
* If female of childbearing potential, pregnancy test is negative. (In these instances, the patient will need to provide documentation of negative pregnancy test results.)

Exclusion Criteria:

* Inability to tolerate MRI including conditions such as claustrophobia or inability to lay flat for \> 45 minutes.
* Presence of pacemaker/implantable cardiac device (ICD) or perfusion pumps
* Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants.
* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study
Efficacy of Enteral Iron Supplementation in Critical Illness

The purpose of this study is to investigate the efficacy of enteral iron supplementation for improving anemia, decreasing the risk of blood transfusion, and decreasing mortality in patients who are hospitalized in the intensive care unit. This study will also address any relationship between enteral iron supplementation and risk of infection.

Critical illness is characterized by the anemia of inflammation, which is partially caused by sequestration of iron from bone marrow sites of erythropoiesis into storage within the reticuloendothelial system as ferritin. Also the majority of critically ill patients are hypoferremia, the efficacy of iron supplementation remains unknown. Furthermore, several retrospective studies have found an association between iron overload and infection. However, the relative risk/benefit profile of enteral iron supplementation with respect to infection has not been studied. The purpose of this study is to evaluate the efficacy of enteral iron supplementation in critically ill patients. The hypothesis is that enteral iron supplementation will result in both an improved hematocrit and a decreased need for blood transfusion, without increasing the risk of infection.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Anemia (Hemoglobin \< 13.0 g/dL)
* ≤ 72 hours from hospital admission
* Current tolerance of enteral medications
* Expected ICU LOS \> 5 days

Exclusion Criteria:

* Active bleeding
* Chronic inflammatory disease
* End-stage renal disease
* Hematologic disorders
* Macrocytic anemia
* Current use of erythropoietin
* Pregnancy
* Prohibition of RBC transfusions
* Moribund state in which death is imminent
* Enrollment in another clinical trial