cyrilzakka/clinical-trials huggingface dataset:
This Study Evaluates the Superiority of Daily Self-pH Monitorization of Lit-control®pH Meter Compared to the Monitorization of Reactive Strips (Standard of Care).

This study evaluates the superiority of daily self-pH monitorization of Lit-control®pH meter compared to the monitorization of reactive strips (standard of care).

Cystinuria is a disease of autosomal recessive inheritance. This disease belongs to the so-called orphan diseases although its prevalence may change depending on the country.

It is known that urinary pH is a risk factor for the formation of cystine crystals because their solubility is pH-dependent. In different studies it has been shown that the solubility of cystine in urine increases when alkalinizing urinary pH, thus reducing the likelihood of crystal formation. Therefore, the control of urinary pH along with hygienic-dietetic measures that alkalize the urine or decrease the urinary concentration of cystine (abundant intake of water, food, etc.) are highly recommended as a preventive method to prevent the formation of cystine crystals whose retention and growth results in the formation of stones.

The Lit-control®pH Meter is a pH meter that allows a patient to self-monitor its urinary pH in a comfortable and simple way. With this tool the patient is able to know if his urinary pH is within the recommended limits. In other medical fields it has been observed that home monitoring of clinically relevant physiological parameters is a way of empowering the patient that can positively affect their attitudes and behaviors (adherence to received treatment, quality of life) and potentially improve their medical condition. Specifically, in patients with chronic diseases, the self-monitoring has been associated with a significant reduction in hospitalizations and hospital readmissions.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old.
* Cystinuric patients, with or without urinary lithiasis at the time of inclusion.
* Patients who accept their participation in the study and give their informed consent.

Exclusion Criteria:

* Patients with pathologies that require pH control other than the one established in the study protocol to avoid the formation of kidney stones.
The Accuracy of Ultrasound in the Detection of Placenta Site in the First Trimester.

The investigators speculate that ultrasound examination in the first trimester can accurately detect placental location. By performing both transabdominal ultrasound and later hysteroscopy on women with a first trimester missed abortions and comparing the ultrasound findings to those of the hysteroscopy the investigators will evaluate the performance of the ultrasound in detecting the placenta location.

All women with a first trimester missed abortion who will sign an informed consent form will undergo an ultrasound examination. During the examination, the operator will assess the location of the placenta/sac insertion. After the performance of the ultrasound, the women will undergo hysteroscopy with a different operator who will be blinded to the results of the previous exam result. During the hysteroscopy the second operator will assess again the location of the sac insertion .The investigatorswill then compare the results of the two tests using the histeroscopy as the gold standard and evaluate the performance of abdominal ultrasound exam in the evaluation of placenta/ sac inserion.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women .
* Clinical diagnosis of first trimester spontaneous abortion.

Exclusion Criteria:

* viable pregnancy
* women below 18 years
* women with chronic disease
Efficacy and Safety of Three Different Latanoprost 0,005% Eyedrops in Subjects Affected by Primary Open Angle Glaucoma

This study examines efficacy and tolerability of 3 different Latanoprost 0.005% eyedrops preparations, commercially available in Italy, in subjects affected by primary open angle glaucoma.

Prospective, randomized, single blinded study of the duration of 3 months, involving subjects affected by POAG or OH under therapy with different Latanoprost drugs (Galaxia, Iopize or Latanoprost Rathiopharm).

A total of 120 patients affected by POAG or OH newly diagnosed or already under topical therapy. will be recruited.

After a recruitment visit to assest eligibility of each subject, a "run-in" therapy composed of timolol 0,5% 2 drops per day will be prescribed for 4 weeks.

Then a baseline visit will be performed to evaluate IOP values and adverse effects in each subject. All subjects elegible for a therapy with a single dose of Latanoprost will be randomized into 3 arms.

After 4 weeks of therapy a second visit will be made to assest IOP changes and safety. Therapy will be continued for another 4 weeks, and after that, a final visit will be made.

Eligibility Criteria:
Inclusion Criteria:

* Age ranged between 18 and 80
* Untreated IOP ranged between 21 and 30 mmHg
* IOP already treated with a single drug (monotherapy) ranged between 10 and 28 mmHg

Exclusion Criteria:

* History of adverse events or any controindication to drugs administred during sperimentation, i. e. Latanoprost and Timolol.
* Narrow or closed iridocorneal angle.
* History of acute angle-closure glaucoma.
* Previous laser trabeculoplasty within 3 months before screening.
* Severe visual field defects within 10° from fixation in at least one eye (at least 2 points with a p\<0,5 in a pattern deviation map obtained from a reliable 24-2 Sita Standard SAP).
* History of refractive surgery or any keratoplasty procedure, corneal opacities or diseases that make not suitable applanation tonometry.
* Use of contact lenses.
* BCVA less than 20/200.
* Ocular inflammation/infection occurring within three months before screening.
* History of bradicardia, systemic hypotension, bundle branch or any atrio-ventricular block
* Asthma
* Women of childbearing potential who were not using adequate contraceptive methods or who were pregnant or nursing
Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine (QIV) in Children Previously Vaccinated in Trial V118_05

Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously Vaccinated in Trial V118_05


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject who has completed their Day 181 clinic visit for non-naïve subjects or their Day 209 clinic visit for naïve subjects in parent study.
2. Individuals who give written informed consent, who can comply with study procedures, and who are available for follow-up

Exclusion Criteria:

1. Individuals recently vaccinated against influenza.
2. Subjects with contraindications to receive influenza vaccine.
3. Please contact the site for additional eligibility criteria.
Umbilical Cord Clamping and Infant Iron Status

The aim of the study was to determine whether delayed umbilical cord clamping, as compared to early umbilical cord clamping, improves infant iron status at 6 months of age.

In developing countries, up to 50% of children become anemic by 12 months of age. Risk factors for iron deficiency (ID) include low birth weight, maternal prenatal ID, and male sex. Iron deficiency anemia (IDA) during infancy and childhood is of particular concern because of the potentially detrimental effects on development, some of which may be irreversible even after treatment to correct the deficiency. Delayed umbilical cord clamping is an intervention that increases the infant's iron endowment at birth and has been shown to increase hemoglobin (Hgb) concentration at two months of age. We determined whether a two-minute delay in the clamping of the umbilical cord of normal-weight, full-term infants significantly affected infant iron and hematological status through 6 months of age. In addition, we determined whether the effect of delayed cord clamping was significantly enhanced in subgroups of infants at higher risk of developing iron deficiency.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women delivering at study site hospital

Exclusion Criteria:

* Delivery by Cesarean section
* Pregnancy ≤ 36 or ≥ 42 weeks gestation
* Multiple gestation
* Diagnosis of any of the following in the current pregnancy: hemorrhage requiring clinic/hospital admission, placental abnormalities, fetal anomalies, Down's syndrome of the fetus
* Diagnosis of pre-eclampsia or eclampsia in current or previous pregnancies
* Diagnosis at any time for the mother of any of the following: Diabetes, hypertension, cardiopathies, chronic renal disease
* Infant with major congenital malformation
* Infant birth weight less than 2500 g
* Mother not planning to breast feed for at least 6 months
* Mother smoked during current pregnancy
* Unwilling to return for follow-up study visits at the hospital
Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise

This is a Phase 2a randomized, placebo-controlled study designed to investigate the efficacy, safety and tolerability of COVI-MSC in treating post COVID-19 "long haul" pulmonary compromise.

This is a Phase 2a randomized, placebo-controlled multicenter study designed to investigate the efficacy, safety and tolerability of COVI-MSC in treating post COVID-19 "long haul" pulmonary compromise.

COVI-MSC will be administered intravenously on Day 0, Day 2, and Day 4.

Eligibility Criteria:
Inclusion Criteria:

* Has had prior laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen
* Has had a recent (within a week) negative SARS-CoV-2 test (an approved PCR or antigen test)
* Has had at least moderate or severe post-COVID-19 pulmonary symptoms for at least 3 months which have resulted in reduced physical functioning compared to pre-COVID-19 status
* Willing to follow contraception guidelines

Exclusion Criteria:

* Clinically improving pulmonary status over the month prior to screening
* Undergone a previous stem cell infusion unrelated to this trial
* Pregnant or breast feeding or planning for either during the study
* Suspected uncontrolled active bacterial, fungal, viral, or other infection
* Any significant medical condition, laboratory value or other illness that in the investigator's opinion would interfere or prevent safe participation in the study
* History of a splenectomy, lung transplant or lung lobectomy
* Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)
Survey on Cardiovascular Events in Patients With Metabolic Disease on Chronic Carnitine Supplementation

The purpose of this study is to learn about the effects of long term carnitine use in patients with metabolic disorders and its potential relationship to cardiovascular events.

This online cross-sectional survey will examine the self-reported long-term carnitine use in patients with metabolic disorders and any potential relationship to cardiovascular events.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mitochondrial disease or any other metabolic disorder
* Any age group
* NAMDC or RDCRN registry participant

Exclusion Criteria:

* Inability to provide informed consent and complete survey
* Lack of participation in NAMDC or RDCRN registry
Dermatological Assessment of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Photosensitization of a Scar Gel

Evaluate the potential of Primary Dermal Irritability, Accumulated Dermal Irritability, Dermal Sensitization, Photoallergy and Photosensitization, of health products through the application of Patch Test, proving the safety of the product for topical use. The study will be conducted with a Brazilian sample in which 55 research participants will be included. Depending on the results, the present study may support the claim: dermatologically tested, non-irritating, non-sensitizing, non-photoirritating and non-photosensitizing.


Eligibility Criteria:
Inclusion Criteria:

* Participants of both sexes aged 18 to 70 years;
* Phototypes: I, II, III, and IV (For the phototest trial, only phototypes II and III will be considered);
* Intact skin in the application area;
* Willingness to follow the trial procedures and attend the center on the specified dates and times for medical evaluations and for application and reading of dressings;
* Understanding, consent, and signing of the Informed Consent Form (ICF).

Exclusion Criteria:

* Pregnancy or risk of pregnancy/lactation;
* Use of anti-inflammatory drugs within 30 days and/or immunosuppressive drugs up to three months before selection;
* Immunosuppression due to drugs or active diseases;
* Uncompensated endocrinopathies;
* Personal history of atopy;
* Intense sun exposure or tanning sessions up to 15 days before the evaluation or during the study period;
* Plans to bathe in the sea, pool, or sauna during the study;
* Practice of water sports during the study;
* Dermographism;
* Use of oral or topical treatments with vitamin A acid and/or its derivatives up to one month before the start of the study;
* Aesthetic and/or dermatological treatments on the body within three weeks prior to selection;
* Scheduled vaccination during the study period or within three weeks prior to selection;
* History of sensitization, irritation, or photosensitization to topical products;
* Active skin conditions (local and/or widespread) that could interfere with study results;
* Skin reactivity;
* Use of new medications during the study;
* Previous participation in studies with the same product;
* Congenital or acquired immunodeficiency;
* Clinically significant or current evidence of alcohol or drug abuse;
* Known or suspected history of intolerance to any ingredient in the study product;
* History of non-adherence or unwillingness to adhere to the study protocol;
* Employees of Medcin or the sponsoring company involved in the study, or close family members of an employee involved in the study;
* Other conditions deemed reasonable by the researcher for disqualification from study participation. If applicable, this must be noted in the clinical record.

Exclusion Criteria for the Phototest:

* Previous history of conditions exacerbated or triggered by ultraviolet radiation;
* Use of photosensitizing drugs;
* History or presence of photodermatoses;
* Personal or family history of skin cancer.
Intensive TMS for Bipolar Depression

The research study is being conducted to test whether using high dose spaced theta-burst rTMS (a form of transcranial magnetic stimulation) produces a significant reduction in depressive symptoms compared with sham. This project will recruit patients aged 18-70 with symptoms of bipolar depression who have failed (or not shown signs of improvement) after at least two prior treatments.

The research study is being conducted to test whether using high dose spaced theta-burst rTMS (a form of transcranial magnetic stimulation) produces a significant reduction in depressive symptoms compared with sham. This project will recruit patients aged 18-70 with symptoms of bipolar depression who have failed (or not shown signs of improvement) after at least two prior treatments. The null hypothesis is that there will be no difference in reductions in depressive symptoms by the end of a five-day treatment period. The alternative hypothesis is that, compared with sham, active TMS will result in a greater reduction in depressive symptoms by the end of the treatment period. Participants will be randomly assigned to active or sham conditions: 50% to active and 50% to sham.

Eligibility Criteria:
Inclusion Criteria:

* Bipolar depression (BP I and BP II) by Diagnostic and Statistical Manual 5 (DSM 5) criteria
* Age 18-70
* Right or left handed
* All genders
* Treatment resistant depression, as in they must have treatment resistant depression with 2 or more prior antidepressant trials that have failed to produce a response (\> 50% reduction in symptoms) using ATHF criteria
* Able to provide informed consent to participate in the study
* Must be on a stable medication regimen, requiring at least one mood stabilizer
* Depression severity as represented by scoring at least 20 on Montgomery-Asberg Depression Rating Scale (MADRS)

Exclusion Criteria:

* No current substance abuse disorder for the past 6 months (previous substance abuse not exclusionary)
* Any psychotic disorder or current active psychotic symptoms (personality disorders not exclusionary unless in the opinion of the referring psychiatrist it would jeopardize participation)
* No dementia or other major neurological disorders
* Not having depression as primary disorder
* No major medical illness, for example metastatic cancer, end stage renal disease
* Not able to verify contact information. Participants must be able to follow through with the study \& must have verified contact information and at least one verified contact
* Pregnancy. While there are no known risks to a fetus this is a new use of TMS, which has not been tested, thus pregnancy is exclusionary
* Score on Young Mania Rating Scale (YMRS) greater than 12 (patients with mixed features have been shown not to respond well to TMS treatment)
* Rapid cycling Bipolar illness (patients with \> 4 mood episodes within the past year will be excluded, as they have a higher risk of switch to mania)
* Any implants, conditions, or contraindications that would be deemed unsafe for TMS or MRI
* Currently using benzodiazepines (such as lorazepam) with a dose \>1 mg per day or equivalent.
Post-operative Pain Reduction

Recruited patients with necrotic pulp after application of conventional calcium hydroxide paste are assigned to group, Calcium hydroxide nanoparticle group and Combined Calcium hydroxide with silver nanoparticle group and record postoperative pain afterwards.

The investigator will recruit patients who are found eligible to the criteria, conventional calcium hydroxide paste , Calcium hydroxide nanoparticle and Combined Calcium hydroxide with silver nanoparticle . After 48 hours, patients will be randomly assigned to removal of intracanal medication

After the visit, patients will be asked to record post operative pain by Numerical Rating Scale)in a given sheet

Eligibility Criteria:
Inclusion Criteria:

* • Medically free patients.

  * Patient's age between 25-50 years.
  * Sex includes both male and female.
  * Radiographic evidence of a periapical radiolucent lesion associated with tooth.
  * Necrotic pulp as indicated by thermal pulp testing.
  * No history of previous endodontic treatment of the tooth.

Exclusion Criteria:

* • Teeth with unfavorable conditions for rubber-dam application.

  * Teeth with acute periapical abscesses swelling.
  * Medically compromised patients.
  * Immature teeth with open apices.
  * Multi rooted teeth.
  * Pregnant women.
A Study to Evaluate Role of Inhaled Amikacin to Prevent Ventilator Associated Pneumonia in Patients With Cirrhosis

The recent AMIKINHAL trial found that prophylactic inhaled amikacin was effective in lowering the incidence of ventilator-associated pneumonia in ICU patients. Since aspiration is a common complication of cirrhosis patients with HE (7 out of 10 patients develop some type of HE) who are hospitalized to the liver ICU also have an elevated risk of Ventilator associated pneumonia. Despite supportive care and appropriate antimicrobial therapy pneumonia is linked to greater mortality in cirrhosis. This poses a significant challenge to physicians. Due to the lack of randomized controlled trials (RCTs) on the prophylaxis of VAP in cirrhosis patients with HE, conducting this study is necessary to evaluate the efficacy of inhaled amikacin. The study results may provide evidence -based guidance for therapy in this patient population.


Eligibility Criteria:
Inclusion Criteria:

1. Patients admitted to the liver ICU with hepatic encephalopathy (Grade 2 or higher), requiring intubation for at least 48 hours, without pneumonia.
2. Patient is aged ≥18 years.
3. Written informed consent of the patient or a proxy.

Exclusion Criteria:

1. Suspected or confirmed Pneumonia at the day of inclusion.
2. Patients with Chronic kidney disease on maintenance hemodialysis
3. Stage 2 or 3 Kidney Disease Improving Global Outcome (KDIGO) classification AKI the day of inclusion. Patients undergoing renal replacement therapy or for whom decision has been made to initiate renal replacement therapy can be included whatever the KDIGO stage
4. Pregnancy or breast-feeding.
5. Clinical indication for systemic aminoglycoside therapy the day of inclusion: as deemed necessary by the clinician in charge.
6. Patients known to be allergic to aminoglycosides.
7. Patients who received intravenous Amikacin before 7 days of inclusion in this study.
A Proof-of-concept RCT of Version 3.0 of the Smoking Cessation Smartphone App "Smiling Instead of Smoking" (SiS)

This is the third study in a series of 3 studies to develop a smartphone app to support nondaily smokers in quitting smoking, as funded by the American Cancer Society grant #RSG CPPB - 130323 (project dates: 07/01/2017 - 6/30/2021). Study 1 (2017P001106) demonstrated feasibility and acceptability when smokers were onboarded in person. Study 2 (2018P002699) demonstrated feasibility and acceptability when smokers were onboarded remotely, nationwide. The present study is Study 3. It is a 3-group proof-of-concept RCT, in which we seek to test if our app (i.e., Version 3 of our developed smartphone app, called 'Smiling instead of Smoking' (SiS)) is superior to treatment as usual (i.e., TAU) and superior to a control app (i.e., the National Cancer Institute's smartphone app "QuitGuide" (QG).

This is a nation-wide proof-of-concept randomized controlled trial conducted entirely remotely. Participation will last 6 months and entails:

* Completing a scripted onboarding call (approximately 30-45 minutes)
* Making a quit attempt
* Engaging with smoking cessation support (randomized) over the course of seven weeks, one week prior and 6 weeks following the originally chosen quit day
* Completing five online, REDCap-administered surveys, administered prior to the quit day (online, as part of a screening test), and at 2-week, 6-week, 3-month, and 6-month follow-ups of the participant's chosen quit day

The Aims of the study are:

1. Test for differences between randomized groups on the primary outcome (i.e., self-efficacy to remain abstinent, as measured via the Smoking Self-Efficacy Questionnaire), as measured at end of treatment (i.e., 6 weeks after the participants' chosen smoking quit day)
2. Test for differences between randomized groups on secondary outcomes (as listed in Detailed Protocol)
3. (exploratory) To test, via mediational modeling, how treatment via the proposed app conferred benefit; or, if not effective, if failure is due to the treatment failing to impact hypothesized mechanisms of change, or because these mechanisms fail to impact outcome.

Eligibility Criteria:
Inclusion Criteria:

* 18+ years of age
* smartphone ownership (Android or iPhone only)
* current nondaily smoker, who smokes at least weekly, and no more than 25 out of the past 30 days
* lifetime history of having smoked 100+ cigarettes
* willing to make a smoking quit attempt
* currently residing in the United States of America

Exclusion Criteria:

* Under 18 years of age
* Does not own an Android or iPhone
* Is not a nondaily smoker, who smokes at least weekly, and no more than 25 out of the past 30 days
* Does not have a lifetime history of having smoked 100+ cigarettes
* Is not willing to make a smoking quit attempt
* Is not currently residing in the United States of America