cyrilzakka/clinical-trials huggingface dataset:
Treatment of Leishmaniasis With Impavido® (Miltefosine): Pregnancy Registry

The purpose of this observational study is to fulfill FDA Post Marketing Requirement (PMR) 2127-1 for miltefosine (NDA204684): implement a pregnancy registry for the time period Mar 2015-Mar 2024.

This study is a prospective observational study in which female patients undergoing Impavido who become pregnant during treatment or within 5 months after completing treatment can volunteer to provide information about their pregnancy and the outcome of the pregnancy.

Objective: The purpose of this observational study is to fulfill FDA Post Marketing Requirement (PMR) 2127-1 for miltefosine (NDA204684): implement a pregnancy registry for the time period Mar 2015-Mar 2024.

Study Design: This study is a prospective observational study in which female patients undergoing Impavido who become pregnant during treatment or within 5 months after completing treatment can volunteer to provide information about their pregnancy and the outcome of the pregnancy. Information will be collected from patient's provider of Impavido treatment, obstetrical treatment, and if applicable, the child's pediatrician.

Population: Leishmaniasis patients or patients who take Impavido off-label who become pregnant while taking Impavido or within 5 months after taking Impavido.

Drug Product:

Drug name: Impavido (50 mg capsules). Dosing regimen: as per the Impavido Product Label (PL)

Study Procedures: Pregnant women will become aware of the Impavido Pregnancy Registry via the product label (PL) or the Impavido website or her physician. By calling 1-866-588-5405, the patient will be connected to the Impavido Pregnancy Registry Coordinating Center. A trained staff member will acquaint the patient with the goals and procedures of the study. If the patient tentatively agrees to participate in the study over the telephone, the patient will be mailed information forms, the Consent Form and Assent Form as appropriate, and the Consent for the patient's physician and obstetrician and the child's pediatrician to release medical information. Receipt of the four signed Consent Forms and Assent Form as appropriate by the Coordinating Center will signify patient and/or legal guardian consent/assent. The Coordinating Center will contact the patient and/or the patient's physicians each trimester until delivery to collect data on maternal adverse events (AEs), pregnancy outcome, and fetal outcome.

Sample Size And Study Duration: Estimated 0-1 patients per year for 10 years.

Outcome Parameters:

Maternal AEs. Pregnancy outcome. Fetal outcome.

Analysis Plan: Baseline data, compliance to prescribed treatment, and outcomes will be reported for individual patients and for all patients.

Eligibility Criteria:
Inclusion Criteria:

1. Has the subject received Impavido?
2. Is the subject a female?
3. Did the subject become pregnant during Impavido treatment or within 5 months after completing treatment?
4. Did the subject or legal guardian give consent/assent for the study and to collect data from her physicians?

Exclusion Criteria:

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Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs

This study is undertaken to find out whether prophylactic antibiotics can decrease the infection rate in third and fourth degree perineal tear repairs done in the immediate postpartum period.

After obtaining consent patients who sustained third or fourth degree perineal laceration after vaginal delivery were randomly assigned to a single dose of antibiotic (cefotetan or cefoxitin, 1 g intravenously or clindamycin, 900 mg intravenously, if allergic to penicillin), or placebo (100ml normal saline) intravenously.

Eligibility Criteria:
Inclusion Criteria:

- third and fourth degree perineal laceration

Exclusion Criteria:

- chorioamnionitis, HIV positive, inflammatory bowel disease
Smoking Cessation Program With CBT and Mindfulness Audio Support: A Randomized Controlled Trial

This protocol describes a randomized controlled trial evaluating the effectiveness of a smoking cessation program with two intervention methods. One method provides only CBT text messages (Group A), while the other combines CBT text with mindfulness audio (Group B). The study aims to compare the two approaches in reducing smoking frequency, managing cravings, and improving emotional regulation.

This study investigates the effects of two different smoking cessation interventions: (1) CBT text-based program alone (Group A), and (2) CBT text combined with mindfulness audio (Group B). The primary outcomes include reductions in smoking frequency and cravings, as well as improvements in emotional regulation and quality of life.

Design: A randomized controlled trial (RCT) will be used to compare the outcomes of the two intervention groups.

Setting: The study will be conducted online. Participants will access the CBT text materials through a dedicated platform and the mindfulness audio via a compatible device. Recruitment will be done through social media, community outreach, and online advertisements.

Eligibility Criteria:
Inclusion Criteria:

* Who smoke at least 5 cigarettes per day.
* Express a desire to quit or reduce smoking.
* Who has the ability to access and use the provided digital materials.

Exclusion Criteria:

* Those currently enrolled in other smoking cessation programs.
* Individuals with severe psychiatric disorders that may interfere with participation.
* Those without access to the necessary digital devices.
The Effectiveness of Music on Pain During Heel Blood Collection in Premature Infants

Premature babies receiving treatment and care in the Neonatal Intensive Care Unit (NICU) are exposed to various painful procedures. Repetitive and untreated painful procedures have a negative impact on the physiological, cognitive and behavioral development of the baby.

Various approaches such as white noise, music, lullaby, kangaroo care, breastfeeding, swaddling, massage, and therapeutic positioning are used to reduce the painful processes that newborns are exposed to in the NICU.

Premature babies receiving treatment and care in the Neonatal Intensive Care Unit (NICU) are exposed to various painful procedures. Repetitive and untreated painful procedures have a negative impact on the physiological, cognitive and behavioral development of the baby.

Various approaches such as white noise, music, lullaby, kangaroo care, breastfeeding, swaddling, massage, and therapeutic positioning are used to reduce the painful processes that newborns are exposed to in the NICU.

Eligibility Criteria:
Inclusion Criteria:

* Parent being voluntary to participate in the study
* Being born at 32-36+6 gestastional week
* The baby's condition is stable
* Having passed hearing test
* Having not congenital malformation

Exclusion Criteria:

* Birth weight below 2500 g
* Receiving analgesics or sedatives
* Need for mechanical ventilation
* Heel blood collection is not successful in the first time
ART Restorations With High-viscosity Glass-ionomer Cement Versus Hall Technique in Primary Molars

Primary molars are the teeth with the highest caries tendency among primary teeth due to their anatomical features such as wide and flat interface areas. However, some difficulties are encountered during the removal of caries due to the structural features of primary molars and the young age of the child. Therefore, in the treatment of primary molars, Atraumatic Restorative Treatment (ART), in which the soft parts of the carious lesion are cleaned with the help of a sharp hand tool and restored with an adhesive glass ionomer cement (GIC) that releases fluoride, in the following years, the deciduous teeth were removed with a minimally invasive approach. Hall technique, in which a stainless steel crown (SSC) is placed without preparation for treatment, has come to the fore.

Many restorative materials, especially GIC, have been used for ART procedures, and with the advancing technology, high-viscosity glass ionomer cements with improved mechanical and chemical properties have emerged. In recent years, zinc-added HVGICs and nano-filled resin-modified HVGICs have been introduced.

The Hall Technique has been suggested in the treatment of asymptomatic decayed primary molars in anxious and fearful patients to ensure patient cooperation. In this technique, it is aimed to stop the progression of caries by covering the carious deciduous molars with SSC and cutting their relationship with the oral environment, without the need for local anesthesia and tooth preparation. Thus, as the bacteria cannot use the carbohydrates in the oral environment, the number of bacteria in the environment will also decrease.

Eligibility Criteria:
Inclusion Criteria:

* children with no systemic disease,
* children who had a Frankl Behavioral Scale score 2,
* children who have no occlusal problems or bad habits,
* children presenting between 2-5 caries lesion in primary molars.

Exclusion Criteria:

* teeth with presence of radyolusens in furcation and/or periradicular areas,
* teeth with pathologic resorption and internal/external resorption
Efficiency and Safety of High-frequency Radio Wave Electrotherapy With a Radio Frequency of 448 kHz in the Treatment of Patients With Organic Erectile Dysfunction.

Efficiency and safety of high-frequency radio wave electrotherapy with a radio frequency of 448 kHz in the treatment of patients with organic erectile dysfunction. Sham comparator, parallel study including both the main and control group to demonstrate the efficiency of the device to treat erectile dysfunction.

The objectives of this study are:

* To evaluate the effectiveness of the course treatment with the apparatus for continuous capacitive resistive monopolar electrotherapy with a radio frequency of 448 kHz in patients with organic erectile dysfunction.
* Assess the safety and tolerability of continuous capacitive resistive monopolar electrotherapy with a radio frequency of 448 kHz in patients with organic erectile dysfunction.
* To evaluate the duration of the effect of continuous capacitive resistive monopolar electrotherapy with a radio frequency of 448 kHz.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 to 79 years;
2. The diagnosis is confirmed by assessing the functional criteria of arterial factors of panel hemodynamics (dopplerography);
3. The diagnosis is confirmed by the assessment of the IIEF-5 questionnaire
4. Patients with organic erectile dysfunction lasting at least 6 months.
5. Patients with IIEF from 6 to 22 points.
6. Patients with a permanent sexual partner for more than 3 months;
7. Sexually Active Patients.

Non-inclusion criteria:

1. The use of other treatments for erectile dysfunction
2. Age under 18 and over 79 years old;
3. Anatomical deformation of the penis (angulation, cavernous fibrosis or Peyronie's disease);
4. The presence of diseases predisposing to the development of priapism (sickle cell anemia, multiple myeloma, leukemia, thrombocytopenia);
5. Running coagulation disorders;
6. The presence of tumors in the area of electrotherapy;
7. The presence of aneurysms in the propagation of radio frequency waves;
8. Angina pectoris;
9. Myocardial infarction, stroke, life-threatening arrhythmias;
10. Thrombosis, thromboembolic disease;
11. Arterial hypertension (blood pressure ≥ 170/90 mm Hg) or hypotension (blood pressure ≤ 90/50 mm Hg.);
12. The patient has a mental illness that does not allow an assessment of the effectiveness of therapy; history of alcoholism and drug addiction;

14. Active tuberculosis, chronic somatic diseases in the acute stage; 15. Condition after coronary artery bypass grafting (CABG); 16. Patient's involvement in another clinical trial in the last 3 months;

Exclusion Criteria:

1. Serious unwanted phenomenons associated with exposure to the apparatus.
2. Incorrect inclusion in the study.
3. A marked deterioration in the patient's condition due to an increase in the severity of the disease or the attachment of another disease.
4. The patient's appearance of non-inclusion criteria during the study.
5. Serious deviation from the protocol.
6. The desire of the patient or his legal representative.
Long-term Safety and Efficacy Follow-up Study of PNEUMOSTEM® in Patients Who Completed PNEUMOSTEM® Phase-I Study

This is a 5-year long-term follow-up study of open label, single-center, phase I clinical trial to evaluate the safety and efficacy of PNEUMOSTEM® in premature infants with bronchopulmonary dysplasia.

Bronchopulmonary dysplasia (BPD) is the most common cause of death for prematurely born babies with low birth weights. In addition, many children who recover from this disease suffer from various complications such as prolonged hospitalization, pulmonary hypertension, and failure to thrive.

It has been reported that bone marrow-derived mesenchymal stem cells (BM-MSC) can differentiate into pulmonary epithelial and pulmonary endothelial cells. Some animal studies showed that BM-MSCs differentiate into bronchial cells and type 2 pneumocytes in rats with pneumonia and improve the fibrosis that occur after administration of bleomycin. Based on the findings, it is considered that mesenchymal stem cell therapy can help regenerate the damaged lung as well as BPD that cause lung inflammation, fibrosis, deficiency of type 2 pneumocytes, and so on.

PNEUMOSTEM® consists of human umbilical cord blood-derived mesenchymal stem cells and is intended to treat BPD in premature infants. The purpose of the study is to evaluate 3-5 year long term safety and efficacy in patients who completed the earlier part of the phase I clinical trial of PNEUMOSTEM®.

Eligibility Criteria:
Inclusion Criteria:

* All infants who were enrolled in the 2-year follow-up study (NCT01632475) of phase 1 clinical trial for the safety and efficacy evaluations of PNEUMOSTEM® treatment in premature infants with bronchopulmonary dysplasia
* Infants with a written consent form signed by a parent or legal guardian

Exclusion Criteria:

-Infants whose parent or legal guardian does not consent to participate in this follow-up study
Sonography in an Unselected Population of Acute Admitted Patients With Respiratory Symptoms

The purpose of this study is to determine whether focused sonography of the heart, lungs and deep veins can increase the number of patients with respiratory symptoms correctly diagnosed in an emergency department.


Eligibility Criteria:
Inclusion criteria:

All 4 of the following must be present:

1. The sonographic examination can be performed before or within 1 hour after the primary evaluation
2. Patient is 18 years or older
3. Patient able and willing to give informed consent
4. One ore more of the following symptoms or clinical findings at admission to the emergency department

   * Respiratory rate \> 20 breaths per minute
   * Saturation \< 95%
   * Oxygen therapy initiated
   * The patient has a principal complaint of dyspnoea
   * The patient has a principal complaint of coughing
   * The patient has a principal complaint of chest pain

Exclusion Criteria:

One of the following:

1. The sonographic examination can not be performed within 1 hour after the primary evaluation
2. The patient is 17 years or younger
3. The patient not able or willing to give informed consent
A Multi-center, Randomized, Blinded Evaluator, Active Control, Parallel, Phase III Study to Evaluate the Efficacy and Safety of TJO-002 in POAG or Ocular Hypertension Patients

TJO-002 or Acitve Control was administered on primary open-angle glaucoma or ocular hypertension patients for 12 weeks. This clinical trial study has hypothesize TJO-002 administration groups are not inferior to Active control administration groups.


Eligibility Criteria:
* Inclusion Criteria:

  * Male or female, age 19 or over
  * Written informed consent to participate in the trial
* Exclusion Criteria:

  * Any other Galucoma except POAG(ex, Closed anterior chamber angle, angle-closure glaucoma)
  * Any laser or ocular surgery within 3months prior screening
  * Use of contact lenses
  * Known reactive airways disease
  * Any condition limiting patient's ability to participate in the trial
Ketamine / Propofol Admixture "Ketofol" at Induction in the Critically Ill Against Etomidate: KEEP PACE Trial

The hypothesis of this study is that a Ketamine / Propofol mixture will produce more stable hemodynamics as compared to Etomidate during emergent intubations in the intensive care unit. Patients that require a breathing tube to be placed in the ICU will be randomized to receIve either a Ketamine / Propofol mixture or Etomidate for sedation in order to place the breathing tube.

Endotracheal intubation is a procedure that may cause significant hemodynamic perturbations and can severely impact the outcome of the critically ill. To ensure a safe outcome during this particular procedure, there are many factors that the clinician is faced with. One decision that confronts the critical care physician involves the correct combination of medications with which to facilitate such a safe outcome. Given the reported hemodynamic stability, etomidate is a medication that is chosen by many providers in this particular situation. However, its association with a possible increase in mortality makes it less than ideal for a number of critical care physicians. In recent years, an admixture of propofol and ketamine has been studied that demonstrates hemodynamic stability based on the balancing of the hemodynamic effects of these two individual agents alone. This novel medication combination, sometimes referred to as "ketofol", may offer a valuable alternative to the critical care physician. Therefore, a randomized parallel-group clinical trial of adult critically ill patients admitted to a medical and/or surgical intensive care unit at Mayo Clinic Rochester who meet the criteria designated below for which urgent and/or emergent intubation is needed will receive one of two interventions based on stratified randomization. The "active" intervention arm will receive ketamine/propofol (ketofol) to facilitate endotracheal intubation. The comparison arm will receive etomidate. The primary outcome will focus on hemodynamic data recorded during the first 5 minutes post-administration with secondary outcomes looking at hemodynamic data at 10 and 15 minutes and addressing intensive care unit length of stay, mortality, adrenal function, and vasoactive medication use, among others.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Surgical or medical intensive care unity patients requiring endotracheal intubation
* Consulting physician agrees to study plan and will follow drug randomization

Exclusion Criteria:

* Known intracranial pathology
* Known chronic opiate-dependence
* Received continuous sedative infusion in the last 24 hours
* Known severe psychiatric illness
* Known egg allergies
* Known contraindication to fentanyl, midazolam, ketamine, propofol or etomidate
* Intubation in which standard practice is not to use sedation
* No known documented weight or weight greater than 140 kg or less than 30 kg
* Prior participation in the study
* Of childbearing age (18-50) with no known negative pregnancy test on this admission.
Interdialytic Kt/V Variability Measurement With Adimea (IVP STUDY)

Session-to-session variations in delivered Kt/V that may cause failure to achieve the prescribed dialysis dose may be significant in regular clinical practice. To date, this is not recognized due to monthly blood Kt/V measurements only. Suboptimal delivery of prescribed dialysis dose may be caused by low effective treatment time, vascular access dysfunction, hemodynamic stability, blood pump speed, membrane influences, lab value variability or others which may vary from session to session. Patients close to recommended target limits of dialysis dose may thus be "randomly" attributed to be adequately or inadequately dialyzed. Therefore, in the literature, use of average Kt/V values is recommended.

Adimea allows easy Kt/V determination in every session and thus documentation of the monthly achieved Kt/V in patients who repeatedly miss Kt/V. Knowledge, therefore, of session-to-session variability as well as knowledge of dialysis dose monitoring at every dialysis may enhance and secure delivery of adequate dialysis.

The main objective is the estimation of the pooled within-patient SDs (standard deviation) for single treatment Adimea and of urea kinetic modeling (UKM)/ blood spKt/V. Failure of Kt/V\>1.2 delivery as well as its potential causes will be assessed. spKt/V target achievement is assessed by monitoring dose by Adimea at every dialysis. This shall demonstrate that session-to-session variability can be decreased with usage of Adimea.


Eligibility Criteria:
Inclusion Criteria:

* Patient on chronic hemodialysis for at least 6 months
* Thrice dialysis therapy weekly
* Stable fistula access
* Documented three, monthly blood spKt/V from 1.0 to 1.4 or
* Average of spKt/V\<1.35 out of three consecutive blood measurements
* Age ≥ 18 years
* Voluntary participation and written informed consent

Exclusion Criteria:

* Severe hematologic disorders (e.g. multiple myeloma)
* Life expectancy less than 6 months
* Single-needle dialysis
* Patient was monitored with Adimea
Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy

Many studies address safety of non-anesthesiologist propofol sedation (NAPS) for gastrointestinal endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for providing optimal sedation regimen and avoiding under or oversedation. The objective of the study is to compare standard moderate sedation during upper endoscopy and colonoscopy versus propofol NAPS.


Eligibility Criteria:
Inclusion Criteria:

* age \< 18 years
* American Society of Anesthesiologists risk I-II
* patients undergoing to Gastroscopy or Colonoscopy

Exclusion Criteria:

* significant systemic disease
* allergic reactions to any of study drugs
* chronic use of opioids or psychiatric disorders
* pregnancy
* Mallampati score \> 2
* age \< 18 years
A Safety and Efficacy Study of ALPHAGAN® P and LUMIGAN® in Subjects Previously Treated With Latanoprost for Glaucoma and Ocular Hypertension

This study will evaluate the efficacy and safety of either bimatoprost 0.01% ophthalmic solution (Lumigan®) alone or bimatoprost 0.01% ophthalmic solution (Lumigan®) and brimonidine tartrate 0.1% ophthalmic solution (Alphagan® P) in combination in patients previously treated with latanoprost 0.005% ophthalmic solution monotherapy who require additional intraocular pressure (IOP) lowering medication.


Eligibility Criteria:
Inclusion Criteria:

* Ocular hypertension or glaucoma in at least 1 eye
* Visual acuity of 20/100 or better in both eyes

Exclusion Criteria:

* Corneal refractive laser surgery (LASIK, LASEK, PRK, RK) in the study eye(s)
* Intraocular or glaucoma surgery in the past 3 months
Diet Quality and LTL in NHANES

In our study, we used data from 4,758 healthy adults from the 1999-2002 National Health and Nutrition Examination Surveys to examine the associations between evidence-based diet quality indices and leukocyte telomere length. Our study assessed the four most widely recognized and commonly used diet quality indices in nutritional epidemiology: the USDA-developed Healthy Eating Index-2010, the Alternate Healthy Eating Index-2010, the Mediterranean Diet Score, and the DASH diet score. Analyses were adjusted for sociodemographic and health variables known to influence dietary intake and cellular aging.


Eligibility Criteria:
Inclusion Criteria:

* Ages 20 to 65 years
* No prior diagnosis of major chronic disease (coronary heart disease, angina, myocardial infarction, stroke, diabetes, congestive heart failure, and cancer)

Exclusion Criteria:

* Prior diagnosis of major chronic disease (coronary heart disease, angina, myocardial infarction, stroke, diabetes, congestive heart failure, and cancer)
* Younger than age 20 or older than age 65