cyrilzakka/clinical-trials huggingface dataset:
Mercury Levels in Premature and LBW Infants Receiving Thimerosal-containing Vaccines

The goal of the study is to find out how much mercury is in the blood, urine, and stools of premature and low birth weight infants who have received standard childhood vaccines that are given to all infants in Argentina. Seventy-two newborn premature and low birth weight infants from Durand Acute General hospital will participate in this study. Each infant in the study will need to make two visits, one at the time of vaccination and another 12 hours to 30 days later. Urine, stool, and a small sample of blood will be taken at each visit.

The primary objective is to describe the levels of mercury in the blood of premature newborns greater than or equal to 32 weeks and less than 37 weeks gestation and birth weight greater than or equal to 2000 grams but less than 3000 grams, who receive the routine birth dose of Hepatitis B immunization containing ethyl mercury in the form of thimerosal and the birth dose of BCG immunization, and to evaluate the excretion of mercury in these newborns by examining mercury levels in stool and urine. Secondary objectives are: 1) to determine the half-time of mercury in blood following vaccination of premature and low birth weight infants with thimerosal-containing vaccines, and 2) to screen premature and low birth weight infants for evidence of early effects of thimerosal on the kidney by measurement of urinary gamma glutamyl transpeptidase levels. All infants will have stool, urine, and blood samples collected prior to receipt of routine birth hepatitis B and BCG immunization. Cord blood will serve as the baseline blood specimen. Each infant will be seen once at a predetermined follow-up visit time point. There will be 6 follow-up visit time points, with sampling from 12 infants at each time point. All infants will provide blood, urine, and stool specimens at the assigned follow-up visit.

Eligibility Criteria:
Inclusion Criteria: 1) Parent/guardian gives written informed consent. 2) Good health as determined by negative gestational history, subject's medical history and physical assessment. Medical history will include a review of the major body systems (e.g., ear-nose-throat, cardiovascular, respiratory, neurological, gastrointestinal, genitourinary, hematological). 3) Newborn cohort: within 3 days of birth and gestational age = 32 weeks and \< 37 weeks and a birth weight = 2000 grams and \< 3000 grams. 4) Able to attend the scheduled visits and to comply with the study procedures. Exclusion Criteria: 1) Infant history of vaccinations and date received is unknown or undocumented. 2) Known history of high-level mercury exposure in mother or infant. 3) Any contraindication to routine vaccinations. 4) Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion). 5) Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth. 6) HIV-positive mother by history. 7) Personal or immediate family history of congenital immune deficiency. 8) Developmental delay or neurological disorders.
HER2 Expression of HER2 Affibody-based PET/CT to Predict Response in Bladder Cancer Patients Treated With ADC

To use the molecular PET radionuclide (F-18) labelled HER2 Affibody to evaluate the predictive and prognostic value of HER2 expression in bladder cancer patients treated with HER2 ADC


Eligibility Criteria:
Inclusion Criteria:

1. Aged # 18 years old; ECOG 0 or 1;
2. Is unresectable or metastatic;
3. Patients with HER2 positive or suspicious positive tumors;
4. was previously treated with trastuzumab and taxane in the advanced setting or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane;
5. Has adequate cardiac, bone marrow, renal, hepatic and blood clotting functions;
6. Receives anti-HER2 ADC treatment
7. Life expectancy \> 3 months

Exclusion Criteria:

1. Significant hepatic or renal dysfunction;
2. Is pregnant or ready to pregnant;
3. Cannot keep their states for half an hour;
4. Refused to join the clinical research;
5. Suffering from claustrophobia or other mental disorders;
6. Any other situation that researchers considered it unsuitable to participate in the trial.
Acquisition and Utilization of Skills Using Innovative Smartphone Application for Regular Eating

The study seeks to evaluate the acceptability, feasibility, target engagement, and validity of an innovative smartphone application with ecological momentary interventions to augment cognitive behavioral therapy for bulimia nervosa.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for bulimia nervosa or sub-threshold bulimia nervosa with subjective binge episodes (objective binge episodes or subjective binge episodes AND compensatory behaviors at least 1 time per week on average for the past 3 months)
* BMI \>17.5
* Have a smartphone device
* Willing and able to use smartphone device to track food intake multiple times per day for 16 weeks

Exclusion Criteria:

* Pregnant or planning to become pregnant in the next year
* Currently experiencing severe psychopathology that would limit their ability to engage in study (e.g. suicidality, substance use disorder, psychotic disorder)
* Have previously received a full trial of CBT for bulimia nervosa
* History of bariatric surgery
Adaptation of Conventional Versus Virtually Fabricated Ear Prosthesis in Patients With Auricular Defects

: patients were recruited for auricular prosthetic reconstruction. Preoperative data was collected including personal and medical history, plain photographs and CT scans. Pre-operative prosthetic and implant planning were carried out. Three endosseous implants were placed in a two-stage surgical technique. Patients were assigned into two groups with allocation ratio 1:1. In control group, Implant level impression was recorded, and a stone model of the defect was cast. waxing up of the ear was done on the stone cast followed by flasking, wax elimination, packing of heat cured acrylic resin and curing. In intervention group, CT scanning was done to the full head and optical scanning was done to the defect site with scan bodies screwed to the implants. Using Exocad software a model of the defect site with implant analogues and ear model with abutment extensions were planned and printed using SLA printing technology. A placement jig was done for ear models of both groups and adaptation was measured on the patient using silicon replica technique. The silicone replica was sectioned and the gap, represented in light consistency polyvinyl siloxane impression material was measured using digital microscope.


Eligibility Criteria:
Inclusion Criteria:

* Patients with missing or severely deformed ears.
* Patients with failed autogenous reconstruction.
* Compliant and cooperative patients.
* Patients committed to maintain the prosthesis.
* Patients willing to attend the follow up appointments.

Exclusion Criteria:

* Patients undergoing radiotherapy or chemotherapy treatment.
* Patients taking corticosteroids or bisphosphonates.
* Patients with contraindications for CT scanning.
* Patients with any debilitating medical condition.
* Patients with any type of psychosomatic disorder.
* Patients allergic to any of the materials used.
Antioxidant Supplements, Genetics and Chemotherapy Outcomes

This study will investigate the null hypothesis that use of antioxidant supplements during adjuvant chemotherapy will have no impact on toxicities and disease-free, as well as overall, survival, and also evaluate the role of polymorphisms in genes related to oxidative stress in relation to treatment outcomes.

This study will enroll 3000 women from S0221with node positive or high-risk node-negative breast cancer receiving AC+T onto this ancillary study to address the following specific aims:

1. To characterize use of antioxidant supplements with a survey instrument prior to and at completion of treatment, and to evaluate reported use pre and post treatment in relation to toxicity and disease-free survival. The potential effects of diet, physical activity, and other lifestyle factors on relationships between supplement use and treatment outcomes will also be considered.
2. To evaluate if variants (polymorphisms) in genes that produce reactive oxygen species (ROS) (MPO) and in genes that protect cells from the effects of ROS are associated with treatment-related toxicities and with disease-free survival.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of operable Stage 1, II, or III invasive breast cancer with known estrogen or progesterone receptor status
* high risk by meeting at least one of the following criteria:

  1. tumor \>= 2 cm in greatest diameter
  2. one or more axillary or intramammary nodes are involved by metastatic breast cancer
* had either a modified radical mastectomy or local excision of all tumors plus axillary node dissection or sentinel node resection
* not received prior chemotherapy or radiation therapy for the current malignancy
* no history of congestive heart failure or angina pectoris
* normal creatinine and bilirubin, alkaline phosphatase and SGOT or SGPT 2 x the institutional upper limits of normal
* ANC greater than or equal to 1,200 ul and platelet count of greater than or equal 100,000 U1
* No previous malignancies
* Age 18 or greater
* Performance status of 0 -2 by Zubrod criteria
* HIV negative (if known)
Efficacy and Safety of VDS+SU in the Treatment of OAB-dry in Children

The aim of this study is to give children with dry OAB: (1) Standard behavioral therapy combined with classical anticholinergic drugs (Solinaxine), or (2) standard behavioral therapy combined with short-term high-dose exogenous vitamin D supplementation are used to compare the outcomes of lower urinary tract symptoms in children with dry OAB during follow-up. To provide more robust supporting evidence for the broader promotion of short-term high-dose exogenous vitamin D supplements in combination with standard behavioral therapy as an effective treatment for dry OAB treatment in children.


Eligibility Criteria:
Inclusion Criteria:

1. Children older than 5 years who were admitted to the Department of Urology, Children's Hospital Affiliated to Chongqing Medical University and diagnosed with dry OAB.
2. The results of our laboratory indicated that the serum vitamin D level was lower than 35ng/mL.
3. The child (guardian) has been informed of the nature of the study, understands the provisions in the protocol, is able to guarantee compliance, and signs the informed consent.

Exclusion Criteria:

1. Patients with other urinary system malformations or serious diseases (such as hypospadias, cryptorchidism, posterior urethral valvular disease, vesicoureteral reflux, neurogenic bladder, urinary system tumors, urinary calculi, bladder and urethral injuries, etc.);
2. complicated with neurological diseases (such as epilepsy, spinal cord injury, spinal cord dysplasia, tethered cord syndrome, multiple sclerosis, autism spectrum disorder, etc.);
3. Patients with severe heart disease, abnormal liver and kidney function, lung disease, bone malformation, severe digestive tract disease, and genetic metabolic disease;
4. History of gastrointestinal surgery and urinary system surgery;
5. Dry stool, long-term constipation;
6. are taking anticonvulsant and antiepileptic drugs, hormones, antituberculosis drugs;
7. Previous history of hypercalcemia, hyperphosphatemia with renal rickets;
8. History of unexplained hematuria and urinary tract infection in the past 1 year;
9. Have a history of allergy or allergic reaction to vitamin D preparations;
10. Participating in another clinical study at the time of visit or during the follow-up of another clinical study;
11. Those who did not want to participate in the study or had poor follow-up compliance
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HGP0412 and HIP1402 in Patients With BPH

The main objective of this study is to evaluate efficacy and safety of (Tamsulosin) HGP0412 and HIP1402 in patients with Benign Prostatic Hyperplasia

A multicenter, randomized, double-blind, phase 3 clinical trial to evaluate the efficacy and safety of (Tamsulosin) HGP0412 and HIP1402 in patients with benign prostatic hyperplasia

Eligibility Criteria:
Inclusion Criteria:

* age\>=45, male, diagnosed on BPH, Total IPSS\>=13

Exclusion Criteria:

* Hypersensitivity to investigational products or components
* PSA\>=4ng/ml
Effects of Chloral Hydrate on Induction, Maintenance, and Recovery From Sevoflurane Anesthesia in Day-case Pediatric Surgery

Effects of Choral Hydrate on Induction, Maintenance, and Recovery from Sevoflurane Anesthesia in Day-case Pediatric Surgery


Eligibility Criteria:
Inclusion Criteria:

1. ASA I or II
2. 1-5 years children
3. elective day-case orchiopexy

Exclusion Criteria:

1. congenital hear disease
2. renal disease
3. liver disease
4. growth retardation
5. coagulopathy
Patient Reported Symptom Control With THC or CBD Use

This study compares patients' attitudes regarding marijuana products for medical use and other treatments for cancer-related pain. This study may help researchers gain better understanding of patient's perception on their use of marijuana products in treating cancer-related pain and other common cancer-related symptoms.

PRIMARY OBJECTIVE:

I. To determine the patient's reported preference for cancer pain improvement with opioids, opioids with delta-9-tetrahydrocannabinol (THC)-marijuana and/or opioids with cannabidiol (CBD).

SECONDARY OBJECTIVES:

I. To determine the association between perception of cancer-related symptom relief and use of THC-marijuana and/or CBD.

II. To compare patient perception of THC-marijuana and/or CBD versus (vs.) cancer treatments in treatment of cancer.

III. To evaluate patient report of adverse effects experienced while using THC-marijuana and/or CBD.

IV. To evaluate patient reported concerns while using THC-marijuana and/or CBD. V. To evaluate patient attitude of dosing, forms and use of THC-marijuana and/or CBD.

VI. To evaluate demographic, physical and psychosocial factors that influence patient perception and attitudes of THC-marijuana and/or CBD.

VII. To explore the difference of patient perception of THC-marijuana and CBD in cancer centers in a legalized vs. a non-legalized state.

VIII. To explore the patient reported preference of THC-marijuana and CBD for cancer pain and symptom relief of patients in a Supportive Care Center vs. Integrative Medicine Center at University of Texas (U.T.) MD Anderson.

OUTLINE:

Patients' medical records are reviewed and then complete questionnaires over 27 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patients (inpatient or outpatient) seen by the Palliative Care and Integrative Medicine teams at The University of Texas MD Anderson Cancer Center (Texas) and the Palliative Care team at Banner MD Anderson Cancer Center (Arizona)
* Patients must be primary residents of Texas or Arizona
* Patients able to speak and read English
* Patients are 18 years old and above
* Patients should have a cancer diagnosis, cancer-associated pain, and taking strong opioids (morphine, oxycodone, hydrocodone, hydromorphone, oxymorphone, methadone, fentanyl)
* Patients who have used in the past 3 months or are using alternative botanical pain management while under prescription opioids

Exclusion Criteria:

* Patients who are not able to speak or read English
* Altered mental status as determined by the interviewer based on the ability to understand the nature of the study and consent process
* Patients who have not used medical marijuana and/or CBD products
* Patients who do not have cancer
* Patients who do not have cancer-associated pain
* Patients who are not taking opioids
Corneal Crosslinking in Patients With Keratoconus and Post-Refractive Ectasia

The purpose of this study is to evaluate the effectiveness of using riboflavin and UV light to treat progressive keratoconus or post-refractive corneal ectasia.

The primary objective of this study is to evaluate two riboflavin-dosing regimens for corneal collagen cross-linking to slow the progressive changes in corneal curvature in eyes with progressive keratoconus or post-refractive ectasia.

Eligibility Criteria:
Inclusion Criteria:

1. 10 years of age or older
2. Having documented ectasia on topography or tomography after previous refractive surgery OR progressive keratoconus defined as one or more of the following changes over a period of 36 months or less before randomization:

   1. An increase of ≥ 1.00 D in the steepest keratometry value (or sim K)
   2. An increase of ≥ 1.00 D in regular astigmatism evaluated by subjective manifest refraction
   3. A myopic shift (decrease in the spherical equivalent) of ≥ 0.50 D on subjective manifest refraction
   4. Documented decrease in visual acuity associated with irregular astigmatism and topographic features of ectasia.
3. Subjects with keratoconus diagnosis only:

   a. Axial topography consistent with keratoconus b. Presence of central or inferior steepening on the Pentacam map. c. Presence of one or more slit lamp findings associated with keratoconus, such as: i. Fleischer ring ii. Vogt striae iii. Corneal thinning iv. Corneal scarring
4. Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction:

   Contact Lens Type Minimum Discontinuation Time Soft 3 Days Soft Extended Wear 1 Week Soft Toric 2 Weeks Rigid gas permeable 2 Weeks
5. Signed written informed consent

Exclusion Criteria:

* 1. Any keratoconus patient over 21 years of age without evidence of progression of his corneal deformity.

  2. Patients with excessively thin corneas. 3. Previous ocular condition in the eyes to be treated that may predispose the eye for future complications, for example:

  a. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) b. Clinically significant corneal scarring in the proposed treatment zone 4. A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.

  5. A known sensitivity to treatment medications. 6. Patients with a current condition that, in the treating physician's opinion, would interfere with or prolong epithelial healing.

  7. Pregnancy (including plan to become pregnant) or lactation during the course of the study
Reconstruction of Extensive Upper Extremity Long Bone Defects With a Microvascular Fibula Flap

This study assesses the long-term functional outcomes of upper extremity long bone defects treated with the free fibula bone transfer.

The study design entails a retrospective review of hospital records and a cross-sectional assessment using patient-reported outcome measures. The purpose of this study is to evaluate the reliability, complications and flap survival rate as well as the long-term functional and health-related quality of life results in patients with upper extremity long bone defect reconstructed using a microvascular fibula bone transfer.

Eligibility Criteria:
Inclusion Criteria:

* All patients of upper extremity long bone bone defect treated with a microvascular fibula transfer in Helsinki University Central Hospital.

Exclusion Criteria:

* No upper extremity free fibular transfer
Covered Metallic Stents for First-Line Treatment of Benign Bile Duct Strictures

The current standard of care for benign bile duct strictures involves placement of multiple plastic stents under endoscopic and fluoroscopic guidance to progressively dilate or stretch it open. This approach necessitates multiple procedures which may extend over one year before the stricture is adequately dilated. The investigators propose a study comparing the standard approach of plastic stenting with the use of newer, fully coated metallic stents which are self-expandable, thereby permitting successful dilation of benign bile duct strictures with fewer procedures.

Randomization, as detailed below, is stratified by etiology of the stricture: chronic pancreatitis and postoperative (such as post-liver transplant).

Eligibility Criteria:
Inclusion Criteria:

* Bismuth Type I benign bile duct stricture
* Objective signs/symptoms related to the stricture

Exclusion Criteria:

* Suspected malignant etiology for the stricture
* Prior endotherapy within one year of presentation,except in the following two scenarios: 1) Early (\< 30 days) stent placement following liver transplant; 2) in patients with chronic pancreatitis, single plastic stent placed during presenting ERCP while evaluating for malignancy
* Bismuth Type II-IV stricture
* Proximal common hepatic duct diameter \< 6 mm
* Intact gallbladder, except in cases where a stent can be deployed \> 1cm below the cystic duct insertion
* Age \< 18 years, pregnancy, incarceration, inability to provide informed consent
* Karnofsky score ≤ 40
* Inability to pass a guidewire proximal to the stricture
* Stricture \> 8cm in length
* Life expectancy \< 1 year
* Concomitant nonanastomotic biliary strictures or biliary casts
Validity of Scales to Assess Severity in Acute Heart Failure

The scales measuring the severity of acute decompensate heart failure (ADHF) in emergency departments have not achieved an adequate discriminative ability for decision making. Objectives: 1) Identify baseline variables, and evolutionary variables that may provide a good predictive ability of the model.2) Create and validate clinical predictive rules of mortality during admission/a week after ED visit in those discharged from ED, 30 and 60 days after ED visit as well as identify predicitive factors of short-term readmission (90 days)Design: Prospective cohort study. The sociodemographics and clinical variables will be collected from emergency medical records to identify predictors. Outcome variables and evolution of variables will be collected from hospital medical records / ambulatory during admission and up to 90 days after the episode of ADHF. Baseline predictors and evolutionary variables will be identified through logistic regression models using 60% of the final sample. The models that best fit will be applied in 40% of the sample to assess the predictive validity of this scale.


Eligibility Criteria:
Inclusion Criteria:

* They were diagnosed as heart failure) HF is defined, clinically, as a syndrome in which patients have typical symptoms (e.g.breathlessness, ankle swelling, and fatigue) and signs (e.g. elevated jugular venous pressure, pulmonary crackles, and displaced apex beat) resulting from an abnormality of cardiac structure or function.(8) We included the following presentation of acute heart failure (AHF) at ED: acute decompensated heart failure, hypertensive acute heart failure, pulmonary oedema, cardiogenic shock, and high output failure. (9;10)

Exclusion Criteria:

* Patients whose main diagnosis in the ER is different than acute heart failure and those not wishing to participate in the study or signing the informed consent.