cyrilzakka/clinical-trials huggingface dataset:
GlycoCholic Acid Treatment for Patients With Inborn Errors in Bile Acid Synthesis

The purpose of this research study is to determine the way (mechanisms) by which your defect in bile acid handling (metabolism) causes your liver disease or abnormality in absorption of vitamins and the effect of an investigational bile acid therapy (glycocholic acid) on your vitamin absorption and your liver disease. An investigational therapy is one that not approved by the United States Food and Drug Administration (FDA) and is being provided to you under an Investigational New Drug application from the FDA.

Inborn errors of bile acid metabolism have been established as a well recognized cause of neonatal cholestasis and fat-soluble vitamin malabsorption. Although there is extensive experience with metabolic defects in the biosynthetic pathway, few patients have identified with defects in conjugation with taurine or glycine that allows bile acids to become effective detergents. This protocol is designed to study the effect of defects of conjugation of bile acids on growth and fat-soluble vitamin malabsorption. Study subjects will have liver function studies performed, serum and urinary bile acid measurements, vitamin levels, growth measurements, bile acid pool size measurements made by stable isotope dilution mass-spectrometry, and measurements of absorption of two fat-soluble vitamins, tocopherol and vitamin D. Subjects will be treated orally with conjugates of cholic acid with follow-up laboratories performed as an outpatient and then subjects will have all of the initial studies repeated during an inpatient stay 3-12 months after starting treatment. Subjects with previous liver biopsies indicating the presence of significant liver disease will have a repeat liver biopsy after 3-12 months treatment to assess the histologic response to treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmation of a diagnosis of an inborn error of bile acid synthesis/conjugation based upon urine analysis by FAB-MS.
2. Any age
3. Participant must be willing and able to comply with study assessments and procedures.
4. The participant and/or parent/legal guardian must have signed the written informed consent document prior to study start.

Exclusion Criteria

1. No confirmed diagnosis of inborn error of bile acid synthesis/conjugation based upon urine analysis by FAB-MS.
Acupuncture Treatment for Hot Flashes Study

Patients with prostate cancer who are / were treated with hormonal treatment and developed hot flashes as a side effect are offered Acupuncture as an investigational intervention. The treatment is performed twice a week for four weeks, then once a week for the following six weeks

Patients with prostate cancer who are / were treated with hormonal treatment and developed hot flashes as a side effect are offered Acupuncture as an investigational intervention. The treatment is performed twice a week for four weeks, then once a week for the following six weeks. Acupuncture was done according to specific guidelines and mapping.

Eligibility Criteria:
Inclusion Criteria:

* Treatment for prostate cancer using hormonal ablation therapy
* Average of three or more hot flashes a day
* Performance Status (Karnofsky ≥ 60)
* Patients must be ≥ 18 years of age
* No other clinically significant disease
* Signed study-specific consent form prior to study entry

Exclusion Criteria:

* Initiation of a new chemotherapy regimen, immunotherapy; or initiation/ cessation of hormonal therapy during the study or for 3 weeks before the start of the study
* Pharmacological treatment of hot flashes or use of selective serotonin reuptake inhibitors (unless the dose and patients' condition have been stable for 4 weeks)
* Skin infections
* Patients who had acupuncture treatment in the 6 weeks prior to entering the study, or acupuncture given specifically for the treatment of hot flashes in the previous 6 months.
Postoperative Pain in Neonates After Abdominal Surgery Using Quadratus Lumborum Block

Postoperative pain scores and analgesic requirements will be evaluated in neonates after abdominal surgery, with regional quadratus lumborum block performed at the beginning of the procedure.


Eligibility Criteria:
Inclusion Criteria:

* abdominal surgery under general anesthesia
* spontaneously breathing before the procedure

Exclusion Criteria:

* multiple organ failure
* mechanical ventilation before the procedure
Study to Evaluate Frozen Versus Refrigerated MMRV (Combined Measles, Mumps, Rubella, and Varicella) Investigational Vaccine (V221-016)

The purpose of this study is to demonstrate that an investigational refrigerated vaccine with measles, mumps, rubella, and varicella is well tolerated and has similar immune response when compared to a frozen vaccine with measles, mumps, rubella, and varicella.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children 12-23 months of age

Exclusion Criteria:

* Previously had measles, mumps, rubella, or varicella
* Compromised immune system
Predictive Factorsfor Final Pathologic Ureteral Sections

To identify preoperative predictive factors for final ureteral section invasion after radical cystotomie (RC) and to validate significant factors on an external independent cohort. The investigators retrospectively reviewed data of all consecutive RC performed for bladder cancer in 2 high-volume institutions. Clinical, pathological, and follow-up data were collected prospectively and reviewed retrospectively. Pathological evaluation was performed by 2 well-trained uropathologists in each center. Logistic regression analyses were performed to identify predictive factors for final ureteral sections involvement. Significant factors in cohort A were validated in cohort B. Receiver operating curve and area under curve were modeled to evaluate predictive accuracy of the markers

To identify preoperative predictive factors for final ureteral section invasion after radical cystotomie (RC) and to validate significant factors on an external independent cohort. Pathological evaluation was performed by 2 well-trained uropathologists in each center (Y.A. and C.C). The investigators retrospectively reviewed data of all consecutive RC performed for bladder cancer in 2 high-volume institutions. Clinical, pathological, and follow-up data were collected prospectively and reviewed retrospectively. Pathological evaluation was performed by 2 well-trained uropathologists in each center. Logistic regression analyses were performed to identify predictive factors for final ureteral sections involvement. Significant factors in cohort A were validated in cohort B. Receiver operating curve and area under curve were modeled to evaluate predictive accuracy of the markers

Eligibility Criteria:
Inclusion Criteria:

* patients \> 18 years
* patients reoperative predictive factors for final ureteral section invasion after radical cystectomy

Exclusion Criteria:

* patients \< 18 years
Safety, Tolerability, PK, PD, ADA of Escalating Single Dose of CJ-40002 in Healthy Male Subjects

The objectives of this study are:

* To evaluate the safety and tolerability of CJ-40002 after single SC injection in healthy male volunteers.
* To evaluate the PK of CJ-40002 after single SC injection in healthy male volunteers.
* To evaluate the PD of CJ-40002 after single SC injection in healthy male volunteers.
* To evaluate the ADA of CJ-40002 after single SC injection in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers in the age between 19 and 45 years old (inclusive)
* Body mass index (BMI) in the range of 18.5 to 25 kg/m2 and weighing at least 55 kg
* Subject who have voluntarily agreed to participate in the trial and signed the written informed consent form, after having listened to the purpose, method, and effect of the clinical trial

Exclusion Criteria:

* History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal or cardiovascular disease or any other condition
* History of allergy or sensitivity to any drug
* Subject with the following clinically significant laboratory abnormalities:

  * AST or ALT \> 1.25 x Upper Limit Normal (ULN)
  * Total bilirubin \> 1.5 x Upper Limit Normal (ULN)
  * CPK \> 1.5 x Upper Limit Normal (ULN)
  * eGFR \< 60 mL/min/1.73 m2
* Systolic blood pressure outside the range of 90 to 150 mmHg or diastolic blood pressure outside the range of 50 to 100 mmHg
* History of drug abuse
* History of caffeine, alcohol, smoking abuse
* Participation in any clinical investigation within 60days prior to study medication dosing
* Subjects with whole blood donation within 60days, component blood donation within 30days prior to study medication dosing
* Positive test results for HBs Ab, HCV Ab, HIV test
* Subjects considered as unsuitable based on medical judgement by investigators
Computer Assisted Orthognathic Surgery. Facial Asymmetry

The specific aims of the study were to measure and compare the rates of alignment and cant reduction of the dental and facial midlines among the two groups.

The purpose of this randomized, controlled, clinical study, was to evaluate the most accurate procedure for orthognathic correction of facial asymmetry. The investigators compared two different methods of surgical planning: classical (esthetic analysis of the face, cephalometric study of the skull in lateral and posteroanterior cephalograms, analysis and surgical simulation of plaster casts mounted in semi-individual articulators, development of a surgical acrylic resin intermediate splint) and digital planning (cone-beam computed tomography, data acquisition, software-assisted virtual surgery -Maxilim; Medicim, Mechelen, Belgium- and CAD/CAM processing of the surgical intermediate splint).

Eligibility Criteria:
Inclusion Criteria:

* facial asymmetry or mandibular deviation (cant of the occlusal plane \> 3° and/or midline discrepancies \> 2.5 mm)
* presence of all central incisors,
* pre- and postoperative radiographs and plaster casts (group 1)
* cranial CBCT images (group 2)
* pre- and postoperative digital photographs.

Exclusion Criteria:

* previous trauma involving the hard or soft facial tissues
* functional deviation of the mandible
* incomplete records (CBCT, radiographs, casts or digital photographs).
Blood-aqueous Barrier Changes After the Use of Timolol and Prostaglandin Analogues Fixed Combination in Pseudophakic Patients With POAG

Glaucoma, a progressive optic disc neuropathy causing visual field reduction, is the second leading cause of world blindness. The treatment of glaucoma is mainly based in reducing intraocular pressure (IOP) with topical medications. Many patients required two or more medications to achieve a target IOP. Combinations of B-blockers and prostaglandin analogs (PGA) are frequently used in clinical practice because their additive effect in lowering IOP levels. The aim of this study was to investigate the effects of fixed combinations of timolol maleate and PGA on the blood-aqueous barrier and evaluate the measurement of foveal thickness in pseudophakic patients with primary open-angle glaucoma (POAG).

Most studies found a lower incidence of systemic and ocular adverse events with fixed combinations than with the unfixed combinations. Fixed combinations are better tolerated than their respective prostaglandin analogue. However, among the most serious side effects induced by PGA are the breaking down of the blood-aqueous barrier (BAB) and the development of cystoids macular edema (CME). Also, timolol maleate drops increase protein concentration in the human and benzalkonium chloride, eye drops preservative induces anterior chamber inflammation. This randomized, masked-observer, prospective clinical trial was approved by the Ethics Committee of the University of Campinas, and it adhered to the tenets of the Declaration Of Helsinki. Written informed consent was obtained from each patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients were eligible for participation if they met the following inclusion criteria: age older than 18 years, pseudophakia and diagnosis of primary open angle glaucoma (an untreated IOP levels of more then 21 mmHg, specific changes in the optic disc or specific visual fields changes. Optic disc changes were focal notching, optic disc haemorrhage, retinal nerve fiber layer (RNFL)defects, overpass-blood vessel crossing over an area of neuroretinal rim loss.Visual fields changes were the glaucoma hemifield test outside normal limits or a cluster of three or more non-edge points in a typical location of glaucoma or a corrected pattern standard deviation that occurs in less than 5% of normal visual fields

Exclusion Criteria:

* Exclusion criteria included history of uveitis or CME, substantial ocular irritation at baseline, or a history of intraocular surgery or a laser procedure within 6 months of baseline, the presence of systemic disorders that could be associated with uveitis or CME (ie, diabetes mellitus and rheumatologic diseases), presence of age-related macular degeneration and other macular diseases, pregnancy, breastfeeding, and inadequate contraception (in females), treatment with systemic beta-blocker, history of bronchial asthma, chronic obstructive pulmonary disease , sinus bradycardia, second and third degree atrioventricular block , sinoatrial block and functionally significant visual field loss
Improving Utilization of Lung Cancer Screening in Underserved PA Populations

This study is an interventional study intended to assess the impact of a centralized outreach intervention that includes shared decision-making about lung cancer screening (LCS) in LCS-eligible primary care patients. The study's goal is to increase LCS rates compared to usual care and thus reduce lung cancer deaths.

The research team will select primary care practices included in areas where lung cancer mortality is high. An outreach registry of primary care patients obtaining care at participating practices who meet study eligibility criteria will be created from the electronic medical record. 500 primary care patients will be randomly selected for the Outreach Contact with Decision Counseling (OCDC) Group from this outreach registry. Patients targeted for inclusion in the study will have a scheduled primary care appointment 18-23 days after initial outreach contact.

Eligibility Criteria:
Inclusion Criteria:

* Have an upcoming office visit with a primary care physician in one of the study practices
* Between the ages of 50 and 77 (inclusive)
* History of smoking (current or former) in the electronic medical record (EMR)

Exclusion Criteria:

* Chest CT performed in the last 10 months before study initiation according to EMR
* Diagnosis of lung cancer indicated in the problem list in the EMR
* Current cancer treatment or other qualifying diagnoses that would make outreach inappropriate (e.g., dementia, hearing disability)
Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children

A Phase I clinical trialto evaluate the safety of an Inactivated Enterovirus Type 71 Vaccine in healthy children (3-11y) and infants (6-35m).

36 eligible children aged from 3 to 11 years and 96 eligible infants aged from 6 to 35 months will be enrolled in the study, they will be randomized to receive different dosage of vaccine candidate or placebo to evaluate the safety of this vaccine

Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females, aged from 6 months to 11 years old Health is determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator
2. Provided legal identification for the sake of recruitment.
3. Subjects and/or parent(s)/legal guardian(s) are able to understand and sign informed consents.
4. Birth weight more than 2500 grams

Exclusion Criteria:

1. Histroy of Hand-foot-mouth Disease
2. Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine
3. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
4. Congenital malformations or developmental disorders, genetic defects, or severe malnutrition
5. Epilepsy, seizures or convulsions history, or family history of mental illness
6. Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency
7. History of asthma, angioedema, diabetes or malignancy
8. History of thyroidectomy or thyroid disease that required medication within the past 12 months
9. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
10. Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen
11. Acute illness or acute exacerbation of chronic disease within the past 7 days
12. Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
13. History of any blood products within 3 months
14. Administration of any live attenuated vaccine within 28 days
15. Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 days
16. Axillary temperature \> 37.0 centigrade before vaccination
17. Abnormal laboratory parameters before vaccination
18. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
Retrospective Clinical Investigation of the Safety and Performance of 640PM Trifocal IOL Implantation in Patients With Cataract and/or Ametropia (Hyperopia, Myopia) and/or Presbyopia

The clinical investigation objective is to evaluate safety and performance outcomes of trifocal IOL implantation to improve vision in patients with cataract and/or ametropia (hyperopia, myopia) and/or presbyopia.

Retrospective data from preoperative status up to 12 month postoperative status will be collected from patients that were implanted with Medicontur's 640PM intraocular lens:

* Preoperative status: Preoperative Screening and Baseline
* Surgery: IOL implantation
* M1: 1 month +/- 2 weeks postoperative follow-up
* M3: 3 months +/- 1 month postoperative follow-up
* M12: 12 months +/- 3 months postoperative follow-up


Eligibility Criteria:
Inclusion Criteria:

* Adult males or females above 18 years of age;
* Pseudophakic patients implanted with 640PM IOLs (Medicontur Medical Engineering Ltd. Inc., Zsámbék, Hungary);
* Diagnosis of cataract and/or ametropia and/or presbyopia;
* Subject who provided express consent authorizing the use of medical record data for biomedical research purposes. Patients who have participated in at least two follow up visits in the 12 months following IOL implantation
* Patients for which the retrospective data for the primary endpoint is available and at least half of all the secondary endpoints measured in the time ranges specified in the protocol.

Exclusion Criteria:

* Patients with any eye condition that could affect vision (corneal ectasia, retinal diseases, glaucoma, uveitis, dry eye or amblyopia, etc.);
* regular anterior corneal astigmatism ≥ 1.20 D or irregular astigmatism ≥ 0.5 μm measured with Pentacam at 4 mm.
"System Medicine" Approach for Prevention Strategies for Comorbidities in Infertile Men

By applying a "system medicine" approach, the project aims to identify new biomarkers and/or prognostic tools aimed at developing personalized strategies to prevent the onset of comorbidities in infertile men.

By applying a "system medicine" approach, the project aims to identify new biomarkers and/or prognostic tools aimed at developing personalized strategies to prevent the onset of comorbidities in infertile men.

The findings will provide new insights into the relationship between male infertility and somatic health, and shed light on the role of the microbiome in modulating the activity of the immune system. A "signature" of lack of immunological tolerance and biomarkers could be useful to predict future oncologic and non-oncological comorbidities in infertile men. This will let the development of a more clinically reliable and cost-effective personalized primary/secondary prevention strategy in a population at high risk of clinically relevant diseases.

Eligibility Criteria:
Inclusion Criteria:

* Signature of the informed consent;
* Be adults aged \> 18;
* Caucasian race;
* Documented diagnosis of primary male infertility with pure male factor;

Exclusion Criteria:

* Failure to obtain informed consent;
* Patients with a known history of haematological disease;
* Patients undergoing antibiotic treatments in the last 6 months
Effects of High Intensity Laser on Mechanical and Physiological Findings in Pregnant Women With Carpal Tunnel Syndrome

This study will propose a novel approach to treat pregnant women with mild to moderate carpal tunnel syndrome (CTS) using the recently introduced High intensity laser therapy with its deep penetration and high-power characteristics. It's hopeful that the results of this study can fill the gap of knowledge surrounding the conservative treatment options for CTS in order to help patients restore their nerve function properly and promote new ways of addressing CTS.


Eligibility Criteria:
Inclusion Criteria:

(1) Pregnant women with mild to moderate CTS diagnosed by a physician according to the American Association of Electrodiagnostic recent guidelines \[18\] (2) The age ranged between 20 to 40 years (3) Had positive clinical provocative tests for the CTS (Tinel test and Phalen test) and (5) Had a history of pain, paresthesia or numbness in the median nerve distribution, nocturnal pain, and night waking

Exclusion Criteria:

Patients were excluded from the study if they had cervical disc prolapse, cervical spondylosis, thoracic outlet syndrome, diabetes, gestational diabetes, cardiovascular disorders and hypertension. Patients who had carpal tunnel release surgery and patients who were diagnosed with CTS before pregnancy were also excluded from the study.