cyrilzakka/clinical-trials huggingface dataset:
Iron-fortified Whole Maize Flour Trial

The purpose of this study is to assess whether NaFeEDTA and electrolytic iron improve iron status of young school children, when added as iron fortificants in whole maize flour.

Fortification of staple foods with iron may be an effective method of addressing the problem of iron deficiency. Questions however remain of the type of iron fortificants to use, the appropriate fortification levels and suitable food vehicles. Cereals form attractive vehicles because they are widely consumed in parts of the world that bear a large burden of the iron deficiency problem. They are however high in phytates and would reduce the bioavailability of commonly used iron fortificants. Isotope studies have shown that even in the presence of phytates, iron from NaFeEDTA is relatively more bioavailable than that from other fortificant sources. Its efficacy has however not been assessed in human trials. Electrolytic iron, on the other hand is widely used and was legislated as the iron fortificant of choice in South Africa. Its efficacy in a high-phytate vehicle has also not been assessed. We have therefore undertaken to assess the efficacy of NaFeEDTA at two doses, as an iron fortificant in whole flour, and the efficacy of electrolytic iron at a dose similar to the high-dose NaFeEDTA. The results will contribute information on the suitability of these fortificants in whole maize flour, a food commonly consumed in sub-Saharan Africa.

Eligibility Criteria:
Inclusion Criteria:Children:

* 3-8 years age (for the purposes of this study this will include children born within the period December 15th 1995- May 1st 2001).
* Whohave been resident in the area for 6 months or more.
* Enrolled in the selected schools
* Able to consume the target amount of porridge, at least 50% of the time during the run-in period
* Will be present in the study area for the entire study period (April - December 2004).

Exclusion Criteria:

* Children below 3 years and above 8 years of age (born after December 15th 1995 and before May 1st 2001).
* Children who have been resident in the area for less than 6 months at the time of recruitment.
* Children with obvious physical and mental disability.
* Severely malnourished children.
* Severely anaemic children (Hb \<70g/L).
Inactivated Convalescent Plasma as a Therapeutic Alternative in Patients CoViD-19

Convalescent plasma is a way to provide passive immunity to a person exposed to an infectious agent. It has been used as a therapeutic tool for emerging viral infections without specific treatment and with high morbidity and mortality, such as Influenza H1N1, H5N1, H7N9, Ebola, MERS, SARS-CoV1, and even SARS-Cov2, with satisfactory results regarding evolution clinic of patients treated and without significant adverse events reported. One of its main advantages of convalescent plasma is to generate a rapid immune response (even faster than a vaccine), against a pathogen that circulates in a specific geographic area, probably common for both donor and recipient.

This study consists of obtaining convalescent plasma by means of apheresis, from recovered donors, who meet the eligibility criteria to donate. Then this plasma will be inactivated by riboflavin and UV based photochemical treatment (Mirasol technology - Terumo BCT®), in order to add more transfusion security to the procedure. Finally, it will be transfused to CoViD-19 patients hospitalized in any of the participating clinics. There are currently no reported significant adverse events associated with this therapy. Have been published two serial cases reports,more evidence is necessary to standardize the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Confirmed laboratory diagnosis for qRT-PCR to SARS-CoV-2
* Meet any of the following medical criteria (Defined by WHO): Be currently hospitalized with: Pneumonia, Severe pneumonia, Acute Respiratory Distress Syndrome (moderate or severe), Sepsis or Septic shock
* The patient, or his representative, must sign an informed consent

Exclusion Criteria:

* Participate in another clinical trial for CoViD- 19
* History of acute allergic transfusion reactions due to transfusion of blood or other components, especially plasma components (fresh frozen plasma, cryoprecipitate and platelets),
* History of allergic reaction due to IgA deficiency
* Allergic reaction to sodium citrate or riboflavin (vitamin B2)
* History of immunosuppression
IVW-1001 Phase 1/2 in Subjects With Dry Eye Disease

Double-masked, dose-response, trial of IVW-1001 in subjects with dry eye disease.

This is a randomized (1:1:1), multicenter, parallel, vehicle-controlled, double-masked study to evaluate the safety, tolerability, and efficacy of IVW-1001 Ophthalmic Eyelid Wipes in subjects with DED. Treatments will be IVW-1001 Ophthalmic Eyelid Wipe 0.2% (high dose), IVW 1001 0.1% (low dose), or IVW-1001 Ophthalmic Eyelid Wipe Placebo (vehicle). Subjects will participate in a 7-day, run-in period followed by a 28-daydosing period.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects of any gender at least 18 years of age at the Screening Visit
2. Able to voluntarily provide written informed consent to participate in the study
3. Able and willing to comply with all study procedures and restrictions, follow study instructions, and complete required study visits
4. Diagnosis of Dry Eye Disease (DED)

Exclusion Criteria:

1. Corneal fluorescein staining score of 4 using the NEI grading system
2. Intraocular pressure ≥23 mmHg
3. History of glaucoma or ocular hypertension in either eye requiring past or current medical or surgical intervention
4. Subjects with ocular inflammatory conditions (eg, conjunctivitis, keratitis, severe anterior blepharitis, etc.) not related to DED
A Study of LY3873862 in Healthy Participants

The main purpose of this study is to evaluate the safety and tolerability of LY3873862 when administered either in single or multiple doses in healthy participants. The study will also assess how fast LY3873862 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 58, 72, and 72 days for Part A, B, and C, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation
* Body mass index (BMI) within the range 18.0 to 32.0 kilograms per meter squared (kg/m²)
* Are male or female participants, including those of childbearing potential

Exclusion Criteria:

* Have a history or presence of medical illness including, but not limited to, any cardiovascular, renal, hepatic, gastrointestinal, respiratory, hematologic, endocrine, psychiatric, or neurological disease, convulsions, or any clinically significant laboratory abnormality that, in the judgment of the investigator, indicate a medical problem that would preclude study participation.
* Are unwilling to comply with the dietary restrictions required for this study, including the avoidance by 5 days prior to study drug administration until the final ambulatory visit the ingestion of fruits, sauces, and juices containing furanocoumarins that irreversibly inhibit cytochrome P450 (CYP)3A4. The following fruits, sauces, and juices are excluded: grapefruit, Seville oranges, pomelos, cranberry, Goji berry, and apple.
Comparison of Gait in Syndesmosis Injuries Treated With Screw Fixation vs Suture Button

Injuries to the distal tibiofibular syndesmosis are common and occur in an estimated 25% of all rotational ankle fractures. Anatomic reduction of the syndesmosis has been associated with improved functional outcome as well as decreased rates of posttraumatic arthritis. Both screw fixation and suture fixation have become accepted standards of care for treatment of syndesmotic injuries. Recent literature would suggest trends favoring suture fixation over screw fixation with improved quality of syndesmotic reduction, postoperative range of motion, and improved maintenance of syndesmotic reduction. However, the evidence remains heterogeneous, and patient reported outcomes have failed to show a superiority of one method over the other. Additionally, there have been no studies that demonstrate objective gait outcomes comparing screw versus suture fixation for syndesmotic injuries.

This will be a prospective randomized study. Patients with isolated rotational ankle injuries with syndesmotic instability will be randomized to either screw fixation or suture fixation for treatment of their syndesmotic injury. Patients will be followed postoperatively for one year following surgery with documentation of both clinical outcomes and subjective patient reported outcomes. Additionally, postoperative gait patterns will be measured and compared between patients who had syndesmotic injuries treated with screw fixation versus suture fixation

Eligibility Criteria:
Inclusion Criteria:

* Adults 19 years of age and older.
* Isolated rotational ankle injury
* Syndesmotic instability (determined either pre- or intra-operatively)
* Length-stable fibula fracture pattern

Exclusion Criteria:

* Open fracture
* Length-unstable fracture pattern (including Maisonneuve fracture pattern)
* Syndesmotic stability (determined either pre- or intra-operatively)
* Lower extremity neuropathy
* History of prior trauma or surgery to injured ankle
* Non-ambulatory patient
* Baseline use of ambulatory assistive device prior to injury
Effects of Colesevelam HCl, Rosiglitazone, Sitagliptin on Control of Blood Glucose and Lipids in Type 2 Diabetes Patients Whose Blood Glucose Isn't Completely Controlled With Metformin

A 16 week open-label study with subjects receiving background metformin monotherapy. 150 subjects randomized 1:1:1 to receive 1 of the following: open-label colesevelam HCl, open label rosiglitazone, or open-label sitagliptin.


Eligibility Criteria:
Inclusion Criteria:

* HbA1C 7.0 % to 10.0% on metformin monotherapy; may be withdrawn from other (non-metformin) drugs if HbA1C is 6.5% to 9.5 % at screening.

Exclusion Criteria:

* Subjects currently treated with a thiazolidinedione are excluded.
Use of Tamsulosin to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery

Postoperative urinary retention is a frequent complication of spinal surgeries and impacts a large portion of this population which results in increased morbidity as a result of increased number of catheterizations, urinary tract infections (UTIs) and prolonged hospital stays. With the addition of Tamsulosin, the investigators would anticipate a reduction in the incidence and duration of postoperative urinary retention and therefore a reduction in morbidity related to treatment of urinary retention as well as shortened hospital stays.

Decompressive laminectomy and spinal fusion procedures are among the most common neurosurgical procedures performed. Postoperative urinary retention (POUR) is a frequent complication of such surgeries and impacts a large proportion of this population resulting in multiple intermittent bladder catheterizations for bladder decompression, increased incidence of bacteremia, increased incidence of UTIs, and prolonged hospital stays. Use of a uroselective alpha-1-adrenergic receptor antagonist, such as tamsulosin, in the perioperative period (medication started five days prior to surgery and taken until hospital discharge) could reduce both the incidence and duration of postoperative urinary retention, resulting in shorter hospital stays and decreased healthcare costs.

Eligibility Criteria:
Inclusion Criteria

* ≥ 35 years (Males \& Females)
* Cervical Laminectomy
* Cervical Posterior Fusion
* Cervical Anterior/Posterior Fusion
* Lumbar Laminectomy
* Lumbar Posterolateral Fusion
* Lumbar Interbody Fusion

Exclusion Criteria

* \< 35 years
* Cervical Anterior Discectomy and Fusion
* Cervical Anterior Corpectomy
* Cervical Posterior Discectomy
* Cervical Foraminotomy
* Lumbar Discectomy (METRx or Open)
* Lumbar Foraminotomy
* Lumbar Anterior Fusion
* Myelopathy with bladder dysfunction
* Patients currently taking an alpha-antagonist
* Patients with history of allergy or sensitivity to tamsulosin or other alpha-antagonist (alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, and phenoxybenzamine)
* History of prostatectomy or urologic surgery involving the bladder or urethra
* Severe liver disease or end-stage renal disease
* Patients taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir/ritonavir, and conivaptan)
* Patients with a mental disability
* Prisoners
Safety and Effectiveness of 3 Anti-HIV Treatments in Patients Who Have Failed Previous Treatments Containing Nelfinavir

The purpose of this study is to see if 3 anti-HIV drug combinations are safe and effective in patients who have failed previous anti-HIV treatments using nelfinavir (NFV).

Patients receive 1 of 3 salvage regimens. Treatments A and B include delavirdine, 1 of 2 doses of indinavir, and 2 nucleoside reverse transcriptase inhibitors (NRTIs) to which the patient has not been exposed. Treatment C includes ritonavir, indinavir, and 2 NRTIs to which the patient has not been exposed. When virologic failure is first observed, the patient must return in 2 weeks for confirmation of failure and start the salvage regimen within 1 month of the first assay in which failure was observed. Patients who have less than 400 copies/ml HIV RNA after 16 weeks of therapy are considered responders and continue on the study. Those who have more than 400 copies/ml after 16 weeks of therapy are considered nonresponders and should be discontinued from the study. In addition, patients who respond and subsequently rebound with a viral load 0.5 log above the nadir and greater than 400 copies/ml on 2 consecutive assays at least 2 weeks apart are considered treatment failures and should be discontinued from the study. Patients have regular physical exams, as well as virologic, immunologic, and pharmacokinetic assessments.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Had a viral load of less than 400 copies/ml, followed by an increase in viral load while taking an anti-HIV drug combination including NFV (treatment failure).
* Can start the study treatment within 1 month of treatment failure.
* Have a viral load of less than 30,000 copies/ml when they enter the study.
* Have not taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) other than NFV.
Varenicline Treatment for Excessive Daytime Sleepiness in Parkinson's Disease

The effect of varenicline, an alpha4beta2 nicotinic receptor partial agonist on excessive daytime sleepiness in Parkinson's disease will be studied in a randomized, double blind, placebo-controlled clinical trial with a within-subject crossover design.

Sleep disturbances are common in Parkinson's disease and include excessive daytime sleepiness that has been reported in up to 50% of patients. Relatively little therapeutic research has addressed the problem of excessive daytime sleepiness and current treatment is largely aimed at reducing the dose of dopaminergic medication while trying to maintain sufficient motor control which unfortunately often fails. Apart from degeneration of dopaminergic neurons, a decrease in cholinergic projections to the brain arousal areas may be at least partly responsible for the occurrence of excessive daytime sleepiness in Parkinson's disease. Smoking in narcoleptic patients diminishes sleep attacks and excessive daytime sleepiness , thus one may hypothesize that nicotinergic stimulation of the brain arousal areas may improve excessive daytime sleepiness in Parkinson's disease. Therefore the effect of varenicline, an alpha4beta2 nicotinic receptor partial agonist, on excessive daytime sleepiness in Parkinson's disease will be studied in a placebo-controlled cross-over study.

Eligibility Criteria:
Inclusion Criteria:

* idiopathic Parkinson's Disease according to clinical diagnostic criteria United Kingdom Parkinson's Disease Society Brain Bank
* receiving stable Parkinson's medications for at least four weeks before and throughout study
* suffering Excessive Daytime Sleepiness, defined by a score of \>10 on the Epworth Sleeping Scale
* written informed consent

Exclusion Criteria:

* Parkinson's Disease patients receiving medications with known central depressant effects (benzodiazepines, neuroleptics, anticholinergics)
* dementia defined by a Mini Mental State Examination \<24
* depression defined by a Beck Depression Inventory \>16
* a known diagnosis of sleep apnea or narcolepsy
* current smoking or smoking cessation in past 6 months
* presence of contra-indications for treatment with varenicline, including:

  * known psychiatric diseases such as panic disorder, psychosis, bipolar disorder, eating disorder and alcohol or drug abuse
  * unstable angina, a history of cardiac disease or stroke in previous 6 months
  * severe renal failure (glomerular filtration rate ≤ 30 ml/min)
  * insulin-dependent diabetes
Psychological First Aid With Children in a High Risk Group - a Repeated Single Case Design

The purpose of this pilot-study is to evaluate a cognitive behavioral method "Psychological First Aid" used with a group of children (11-16 years) in high risk of developing psychological problems. Participants are recruited from a low-threshold program ("The Children's House in Oslo") where counseling is given to children suspected of being physically or sexually abused, or having witnessed domestic violence. The study includes twelve children and teenagers that receive 2 to 6 sessions of counseling. Psychological problems (e.g. anxiety, depression, reactions to trauma) and quality of life will be assessed at pre- post and follow-up (after 3, 6 and 12 months). In addition, some symptoms of will be assessed daily.


Eligibility Criteria:
Inclusion Criteria:

* Children/adolescents that:

  * contact "The Children's House in Oslo" after having experienced potential traumatic event(s).
  * are assessed as having psychological symptoms related to potential trauma
  * are between 11 and 16 years old
  * agree to participate in the study (both the youth and his/her parents(s)
* understand and speak Norwegian

Exclusion Criteria:

- Children/adolescents with:

* mental retardation
* reading skills below 8 year
* psychosis
* high risk of suicidal behavior is assumed
Evaluation of Immunoprotection Provided by Hepatitis B Vaccine After Birth in Healthy Children

Worldwide, hepatitis B virus (HBV) infection is a major cause of acute hepatitis,and chronic infection with HBV often leads to chronic hepatitis, liver cirrhosis,and hepatocellular carcinoma. So far, the most effective way to prevent HBV infection in susceptible population is to inject hepatitis B vaccine. However, long-term protection against hepatitis B virus (HBV) after vaccination remains widely debated. This study aims to evaluate the existence of immune protection in healthy children with negative hepatitis B surface antibody and find a method to evaluate the immune protection induced by hepatitis B vaccine.

One method to determine the long-term protection provided by hepatitis B vaccine against HBV infection is to estimate the cumulative incidence of chronic carrier status and breakthrough infection of previously vaccinated individuals in different periods. Up to now, no international standard suggests that hepatitis B vaccine should be used as a routine immunization program. However, it is an important issue to discuss the immune protection of healthy children with negative hepatitis B surface antibody and the duration of this protection in the future. Therefore, this study aims to evaluate the existence of immune protection of healthy children with negative hepatitis B surface antibody, find a method to evaluate the immune protection induced by hepatitis B vaccine.

The main content of the study: To recruit healthy children. Children lacking HBsAb were selected for immune memory test and receive a Hep B booster. The results of Antibody positive group and antibody negative group were compared and analyzed. To find out the most suitable method for evaluating immune protection.

Eligibility Criteria:
Inclusion Criteria:

* Children who are 1-15 years old in Chongqing
* After birth, three injections of Hep B were inoculated in time according to the procedure of 0, 1 and 6 months(The vaccination certificate record)
* No HBV booster vaccine given since primary HBV immunization
* Children or guardian knew and agreed to accept the study
* Follow - up study and blood collection after vaccination can be accepted

Exclusion Criteria:

* Unwilling or impossible to participate in this research project;
* Have a history of allergy or have had a serious vaccine reaction
* Have immune impairment diseases and appear immune impairment;
* Immunosuppressive treatment, receive any injection or oral administration of cortisone or cancer chemotherapy;
* Any kind of vaccine or any kind of observation drug has been vaccinated in the past four weeks;
* Any acute disease or other infection requiring antibiotic or antiviral treatment in the past four weeks;
* Fever symptoms occurred in the past week ( axillary temperature ≥ 38 °C)
* Blood transfusion experience;
* Has a history of more serious infectious diseases ( five types of hepatitis, AIDS, syphilis, gonorrhea, etc. );
* Hepatitis B infection or carriers(lineal relationship);
* Abnormal physical examination
Satisfaction of Patient With Anaphylaxis in the Use of a Medical Device

Through several questionaries the investigators will measure the satisfaction of patients diagnosed with anaphylaxis in the use of a medical device for the adrenaline autoinjector, a smart case for an epinephrine autoinjector connected via Bluetooth to a mobile application.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years old or above
* Patients diagnosed with Anaphylaxis and an epinephrine auto-injector prescribed
* Patients with a smartphone
* Patients who signed the informed consent

Exclusion Criteria:

* Patients who have not signed the informed consent
* Patients with some limitations for understanding or following correctly the trial procedures
* Pregnant or nursing women