cyrilzakka/clinical-trials huggingface dataset:
Comparison of Efficacy of Tranexamic Acid Mesotherapy Versus 0.9% Normal Saline for Melasma

It is a randomized controlled trial in which investigators determine the efficacy of tranexamic acid (TA) by mesotherapy in comparison to normal saline on participants having Melasma.

In this prospective single blind split face controlled trial.Total 30 patients referred to Dermatology Ward were selected. At first, patients were examined under wood lamp for determination of melasma type (epidermal, dermal). Then, patients underwent Tranexamic acid microinjections with a concentration of TA 4 mg/ml with 0.9 % normal saline on their left half of the face and only 0.9%normal saline on their right half of the face, with mesotherapy technique. This procedure was done total of six times with 2-week intervals. Participants were assessed by Hemi Modified Melasma Area and Severity Scoring (mMASI) at start and end of the study for each half of face. Statistical Package for Social Sciences (SPSS) , version 23 was used for analysis. P value \< 0.01 was taken significant.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* age between 18 to 55 years
* bilateral symmetrical mild to severe melasma

Exclusion Criteria:

* pregnancy and lactation
* history of taken any topical treatment for melasma in previous 1 month
* history of bleeding disorders
* concomitant use of anticoagulants,
* any known drug allergy especially to the study drug,
* having associated medical illnesses.
The Effect of Sugammadex During Transcranial Electrical Motor Evoked Potential Monitoring in Spinal Surgery

Transcranial motor evoked potential (TcMEP) monitoring is conventionally performed during neurosurgical procedures without or with minimal neuromuscular blockade (NMB) because of its potential interference with signal interpretation. However, full blockade offers increased anesthetic management options and facilitates surgery. Here, investigators want to assess the effect of Sugammadex during TcMEP in adult patients. Sugammadex is designed to encapsulate rocuronium and reverse rocuronium-induced neuromuscular blockade. 64 patients undergoing thoracic or lumbar spinal surgery will be randomly allocated into sugammadex group or control group under a ratio of 1 to 1. Patients will receive either continuous infusion of rocuronium to produce blockade maintained at least two twitches in Train-of-Four (TOF), rocuronium infusion will be discontinued and 2 mg/kg of sugammadex will be infused while dura opening in sugammadex group. Whereas no muscle relaxant will be given after anesthetic induction in control group. The primary aim of this study is to compare mean value of amplitudes of TcMEPs in abductor pollicis brevis muscles of both upper extremities 5 minutes after dura opening.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years
* ASA status I-II
* Patients undergo thoracic or lumbar spinal surgery
* tcMEP monitoring during the surgery
* Informed consent signed by patients

Exclusion Criteria:

* BMI ≥35 Kg/m-2
* history of epilepsy or use of antiepileptic drugs, neuromuscular disorder(s)
* history or family history of malignant hyperthermia
* allergies to sugammadex, NMBs or other medication(s) used during general anesthesia
* anemia, hemoglobin \<110g/L,
* TcMEPs stimulate or record site infection
* preoperative neurological dysfunction in both upper extremities
* cardiac pacemaker
* pregnancy and breast-feeding
Fludarabine/Busulfan and Cyclophosphamide Conditioning for Adult Lymphoid Malignancies

Allogeneic stem cell transplantation is potential curative therapy for adult lymphoid malignancies. Based on our previous study, the condition with iv-busulfan (iv-BU) and cyclophosphamide (CTX) is feasible with low toxicity and transplantation mortality and long-term survival is comparable to most data reported with slightly higher relapse rate particularly for patients in CR2. In this study, the investigators aim to further improve the conditioning with Fludarabine + iv-BU and to use CTX after stem cell transfusion as consolidation for lymphoid malignancies and graft-versus-host disease (GVHD) prophylaxis.

Patients with adult lymphoid malignancies received conditioning with Fludarabine + iv-BU. The GVHD was consisting of D+3 and D+4 CTX after stem cell transfusion. CSA will be added for all patients after D+5.

Eligibility Criteria:
Inclusion Criteria:

* adult acute lymphocytic leukemia in 1st or second remission; lymphoid malignancies in 1st or second remission
* age 16-60 years
* with inform consent
* no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage
* HLA matched related (6/6), unrelated donors (at least 8/10) or mismatched related donor (haplo)

Exclusion Criteria:

* age less than 16 years or over 60 years
* liver function/renal function damage (over 2 X upper normal range)
* with mental disease
* other contraindication of all-HSCT
Tele-educative Program to Improve Adherence to the Use of Hearing Aids in Patients With Hearing Loss

Hearing loss is the third most common chronic condition in over 65 years people, it is estimated that 77.8% of older adults suffer from it. However, there are reports of adherence to the use of hearing aids of only to 40%. The objective of this project is to measure the effectiveness of a tele-educative intervention to improve adherence to the use of hearing aids. A randomized controlled trial was performed. The active branch consists of the implementation of an educational program called Active Communication Education, consisting of 4 sessions with a trained rehabilitator. Participants will be also monitored by telephone headset use by personnel trained for three months. The control arm will consist of the usual care received by these patients. All participants will be assessed at home at 3, 6, 9, and 12 months after randomization.

Introduction: Hearing loss is the third most common chronic condition in over 65 years people, it is estimated that 77.8% of older adults suffer from it. Delivery of hearing aids to older adults with bilateral hearing loss is included in the Garantías Explícitas en Salud (GES) Guidelines of Chile. However, there are reports of adherence to the use of hearing aids of only to 40%. The GES guideline establishes the conducting of programs in audiological rehabilitation counseling, but there is no evidence that this is being developed in Chile.

Objective: The objective of this project is to measure the effectiveness of a tele-educative intervention to improve adherence to the use of hearing aids.

Material and Methods: A randomized controlled trial was performed. Demographic and audiometric variables were recorded. The active branch consists of the implementation of an educational program called Active Communication Education, consisting of 4 sessions with a trained rehabilitator. Participants will be also monitored by telephone headset use by personnel trained for three months. The control arm will consist of the usual care received by these patients. All participants will be assessed at home at 3, 6, 9, and 12 months after randomization. The primary outcome will assess adherence to the use of hearing aids. Secondarily related quality of life was assessed with hearing loss.

Analysis Plan: Data will be analyzed mediantes bivariate tests, student t for normally distributed continuous variables, and Fisher exact test for categorical variables. A model of multilevel mixed effects will be drawn considering the repeated measurements of outcomes assessed. For all analysis is considered an alpha=5%.

Eligibility Criteria:
Inclusion Criteria:

* Hearing loss worst than 40 db in the better ear
* 65 years old or more

Exclusion Criteria:

* Dementia
* Prior surgery for hearing loss
A Pilot Randomized Controlled Trial for Feasibility of Administering an AR Game to Postoperative Pediatric Cancer Patients

This is a pilot study to evaluate the feasibility of SpellBound's AR (augmented reality)-enabled scavenger hunt use among 20 pediatric cancer patients undergoing surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Ages 3-18
2. English speaking parents/legal guardians and patients
3. Undergoing major surgery for cancer requiring postoperative hospitalization defined as ≥2 hours of duration of surgery and requiring postoperative hospital admission of at least one night
4. Expected to be prescribed postoperative inpatient opioids
5. Have never taken opioids or have had no daily opioid use within the last 30 days
6. Sufficient cognitive capacity to comprehend and interact with the game. This is defined as ability to utilize mobile technology (use iPad with or without assistance) and activate and respond to AR experiences within the app as determined by the clinician.
7. Both child and a legal guardian are willing and able to provide informed consent.

Exclusion Criteria:

1. History of documented peripheral neuropathy secondary to cancer treatment
2. Inability to demonstrate an understanding of the game from English instructions
3. Have previous played the ARISETM digital scavenger hunt game
4. Any additional concerns based on the study physicians' assessments
Sleep Apnea and Gestational Diabetes

The investigators hypothesize that pregnant women with gestational diabetes will have a high incidence of sleep apnea, and that the treatment of sleep apnea will lead to improved glucose control in these women.


Eligibility Criteria:
Inclusion Criteria:

* gestational diabetes

Exclusion Criteria:

* pre-gestational diabetes
Evaluation of Topical Citrullus Colocynthis Fruit Oil Efficacy in Treatment of Painful Peripheral Diabetic Neuropathy

This study is designed to evaluate the topical Citrullus colocynthis fruit oil efficacy in treatment of painful peripheral diabetic neuropathy (PDN) in a randomized double blind placebo-controlled clinical trial design. This study includes 60 patients from SUMS endocrinology and diabetes clinic. Patients with painful conditions other than PDN such as radiculopathies will be excluded. After giving the Informed consent the patients will be underwent NCS (Nerve Conduction Study) for confirming the diagnosis before recruitment. They will be followed for 12 weeks and after 12 weeks the outcome measures including Neuropathic Pain Scale (NPS), WHOQOL-BREF (World Health Organisation Quality of Life Brief) questionnaire and electrodiagnostic criteria will be evaluated.


Eligibility Criteria:
Inclusion criteria:

* Controlled type 1 or 2 diabetes mellitus
* Painful Peripheral diabetic neuropathy for more than 3 months
* Age more than 18 years old
* Patients consent on enrolling study and admitting study protocol

Exclusion criteria:

* Other causes of pain in lower extremities like lumbar disk herniation
* Ulcerative lesions in lower extremities
* Dermatitis
* Pregnancy
* Lactation
* Citrullus colocynthis allergy
* Unstable cardiac, neurological or renal disease
* Diagnosed other types of neuropathy
Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB)

The primary objectives of this study are to evaluate the safety and tolerability of the 12 week treatment regimens of inarigivir soproxil plus tenofovir alafenamide (TAF) or commercially available nucleoside/nucleotide (NUC) in adults with chronic hepatitis B (CHB), to evaluate the antiviral activity of 12 weeks of inarigivir soproxil plus TAF versus TAF alone in viremic CHB participants (Groups 1-3, 5), and to evaluate the antiviral activity of 12 weeks of inarigivir soproxil with commercially available NUC(s) in virally suppressed CHB participants (Group 4).


Eligibility Criteria:
Key Inclusion Criteria:

* Groups 1-3 and 5:

  * Individuals not taking any prescribed hepatitis B virus (HBV) NUC treatment
* Group 4:

  * HBV deoxyribonucleic acid (DNA) ≤ 20 IU/mL at Screening by Central Lab.
  * Have been on a commercially available HBV NUC treatment(s)

Key Exclusion Criteria:

* Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus (HDV).
* Extensive bridging fibrosis or cirrhosis
* Evidence of hepatocellular carcinoma on imaging
* Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage).
* Chronic liver disease of a non-HBV etiology
* Current alcohol or substance abuse

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Length of Adaptation and Threonine Requirement

This study aims to determine if the body's needs for threonine (an amino acid which is an essential building block for protein) is different when assessed after 1, 3 or 6 days of adaptation to the level of threonine intake being studied.

Our method, the Indicator Amino Acid Oxidation (IAAO) method has been used before to look at amino acid requirements. Over the years, we have changed our method to make our studies on amino acid requirements safer to use in specific vulnerable populations like babies or older adults. For example, we have shown that we only need to collect breath and urine samples instead of collecting blood.

Another feature of our method is that we require subjects to consume personalized diets for 3 days at a time, repeated for up to 7 times. These personalized diets are important as they allow us to study the amount of amino acids needed by the body. The body's metabolism changes with different intakes of amino acids. We measure this change in metabolism by collecting breath and urine samples on the 3rd day of each diet period. However, we do not know if this specific length of time for the personalized diets (i.e. 3 days) is sufficient or whether more time is needed for the body to adjust to the amount of amino acids provided. There is a possibility that 3 days is not enough time and our results (i.e. our estimates of amino acid needs) may be different if we allow more time.

The purpose of this study is to find out if the threonine requirement determined using IAAO in adult men changes if the length of time on the personalized diets increases from 3 days to 5 and 9 days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult men, 19 to 35 years of age
* Willingness to participate in the study and completed the screening procedures (height, weight, fasting blood sample and medical history questionnaire).
* No recent history of weight loss
* BMI between 18.5 - 27 kg/m 2
* Absence of chronic disease or acute illness that could affect protein and AA metabolism (diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications).
* Non-smoking
* Willingness to consume the diet provided for 9 days

Exclusion Criteria:

1. Presence of disease known to affect protein and AA metabolism (diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications).
2. On medications known to affect protein and amino acid metabolism (steroids).
3. Recent significant weight loss. ≥ 5% of body with in the last 3 months.
4. Individuals on weight reducing diets.
5. Inability to tolerate the diet
6. Unwilling to have blood drawn from a venous access, or using a ventilated hood indirect calorimeter for the purposes of the study.
7. Significant coffee consumption of more than 2 cups/day
8. Significant alcohol consumption of more than one drink/day
9. Failure to disclose any of the information needed to assess eligibility.
The Effects of a Botanical Moisturizer, an Oral Supplement, and an Unscented Soap on Eczema and Itch

The purpose of this study is to examine the effects of a botanical moisturizer, an oral supplement, and an unscented soap on eczema severity, itch, mood, and various skin measures (such as skin hydration) in those with mild to moderate eczema.


Eligibility Criteria:
Inclusion Criteria:

* Sex: female and male;
* Age : 18 years old and above;
* Phototype: I to IV;
* Type: Caucasian;
* Subjects with active eczema condition the body (showing flakiness, irritation, itch and intense dryness);
* Subjects with a SCORAD of 25 - 50;
* Subjects with dry skin on the study areas (cutaneous hydration rate \< 50 A.U);
* Subject barely wearing makeup;
* Subjects must not take antibiotics and / or apply any antifungal treatments (body/scalp) for 1 month before study start and during the entire study duration;
* No change in hygiene, cosmetics, and make-up habits - except for the product(s) under study - during the entire study duration;
* Subjects agreeing not to change lifestyle habits during the study duration.
* Healthy subject;
* Subject having given her free informed, written consent;
* Subject willing to adhere to the protocol and study procedures;
* Subject with Polish citizenship.

Exclusion Criteria:

* For women with childbearing potential: pregnant or nursing woman or woman planning to get pregnant during the study;
* Cutaneous pathology on the study zone (other than eczema);
* Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the cutaneous acceptability/efficacy of the study product (the subjects are allowed to use their topical corticosteroids during the study if needed; the information about the treatment and the number of applications must be noted in the daily log);
* Subject having undergone a surgery under general anesthesia within the previous month;
* Excessive exposure to sunlight or UV-rays within the previous month;
* Subject enrolled in another clinical trial during the study period (concerns the studied zones).
A Multicenter Study Comparing the Analgesic Effects and Safety of ABT-639 Compared to Placebo in Subjects With Diabetic Neuropathic Pain

People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.


Eligibility Criteria:
Inclusion Criteria:

* Subject is between the ages of 18 to 75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months.
* Subject must have an average score of greater than or equal to ( ≥) 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit.

Exclusion Criteria:

* Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from Diabetic Neuropathic Pain (DNP) or interfere with the pain assessments of DNP.
* A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with DNP assessments or other functions.
* Subject has clinically significant abnormalities in clinical laboratory tests.
Study of Environmental Enteropathy and Malnutrition in Pakistan

Environmental Enteropathy (EE) is an acquired sub-clinical inflammatory gut condition in which alterations in intestinal structure, function, and local and systemic immune activation lead to impaired vaccine responses, decreased cognitive potential and undernutrition in low-middle income countries. Approximately half of all global deaths in children aged less than five years are attributable to undernutrition making the study of EE an area of critical priority. However, given the operational limitations and ethical considerations for safely obtaining intestinal biopsies from young children in low resource settings, there have been few detailed investigations of human intestinal tissue in this vulnerable patient group for whom reversal of EE would provide the greatest benefit. EE biomarkers have been studied in different settings but these have not been correlated with the gold standard histopathology confirmation. The Study of Environment Enteropathy and Malnutrition in Pakistan (SEEM Pakistan) is designed to better understand the pathophysiology, predictors, biomarkers, and potential management strategies of EE to inform strategies to eradicate this debilitating pathology.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 0-6 months from Matiari, Pakistan with weight for height Z score (WHZ) \< -2 at the time of enrollment
* Children aged 0 to 6 months from Matiari, Pakistan who would be growing normally, with WHZ \> 0, to serve as controls
* Healthy control children under the age of 3 years, who will undergo endoscopy at CCHMC
* Children under the age of 6 years with newly diagnosed celiac disease per endoscopy at CCHMC
* Children under the age of 10 years with newly diagnosed Crohn's disease per endoscopy at CCHMC

Exclusion Criteria:

* For healthy control children \< 3 years old undergoing endoscopy at CCHMC, biopsies and diagnoses should not supportive of eosinophilic esophagitis
* For healthy control children \< 3 years old undergoing endoscopy at CCHMC, biopsies and diagnoses should not supportive of celiac disease
* For healthy control children \< 3 years old undergoing endoscopy at CCHMC, biopsies and diagnoses should not supportive of inflammatory bowel disease
* For healthy control children \< 3 years old undergoing endoscopy at CCHMC, children should not have been treated with antibiotics ≤ 4 weeks prior to endoscopy
The Effects of Stainless Steel Crowns Applied With Hall Technique on Occlusal Vertical Dimension

In recent years restoring carious of fractured primary teeth with stainless steel crowns (SSC) has became more popular than ever. On the other hand the traditional operative approach of complete removal of caries is steadily losing support due to successful results with materials of high microleakage resistance.

Treatment time and pain control in asymptomatic teeth has always been a problem in children. Hall technique is a minimally invasive treatment protocol that doesn't require local anesthesia, use of rotating devices for caries removal to restore primary teeth with SSC.

But this protocol also raised questions in the scientific community about its possible effects on the dentition and temporomandibular joint (TMJ) for causing primary occlusal contact and increasing vertical dimension.

The aim of our research is to study the effects of Hall technique's premature occlusal contact on TMJ.


Eligibility Criteria:
Inclusion Criteria:

* No systemical illness
* Willing to come to control appointments
* No symptoms of pulpal inflammation
* To have at least 1, 3 at most dentin caries primary teeth without infection, mobility, Angle class I profile and molar relation
* Willing to participate the study

Exclusion Criteria:

* History of diagnosed systemic illness
* Anterior/ posterior crossbite
* Presence of dental pain
* Root resorption exceeding 2/3's of the treated tooth
* Gingival inflammation, periodontal disease
* Signs of parafunctionism, bruxism
* Facial asymmetry
* Signs or symptoms of temporomandibular disfunction
* Not willing to participate