cyrilzakka/clinical-trials huggingface dataset:
GGT and Uric Acid to Predict Gestational Diabetes Mellitus

Gestational Diabetes Mellitus (GDM) is a common metabolic complication of pregnancy defined as new onset hyperglycemia during gestation. GDM conveys significant risk of morbidity and mortality for both mother and infant. An estimated 268,900 infants were born to mothers with GDM in the USA, accounting for approximately 6.9% of births. Although individual correlations have been found between elevated GGT and uric acid levels and later development of GDM, no research has established and validated combined criteria for GGT and uric acid levels that would lead to their use in identifying women at high risk of GDM in the first trimester.

Central Hypothesis: Serum GGT and serum uric acid collected between \>9-14.0 weeks gestation will be significantly elevated in women who later develop GDM compared to those who do not. Combined analysis of serum uric acid and GGT levels within the first trimester allows for accurate prediction of the development of GDM.

Study population includes women between 9-14 weeks gestation undergoing a standard first trimester blood draw. Additional blood will be drawn during the standard blood draw to assess GGT and uric acid levels. Research participants will be tracked afterwards to determine whether they tested positive for gestational diabetes during the standard testing process which typically occurs at 24-28 weeks gestation. The data will then be analyzed to estimate the sensitivity, specificity, positive and negative predictive values of the first trimester GGT and uric acid tests. The GGT and uric acid levels which maximize the area under the receiver-operator characteristic curve will be identified.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between \> 9 weeks and \< 14.0 weeks gestation

Exclusion Criteria:

* Known history of or current diagnosis of type I or type II diabetes mellitus
* Known liver disease
* Known kidney disease
* Known history of or current diagnosis of gout
* Known history of alcoholism or current alcohol use
* Multiple gestation
* \< 18 years of age
Comparing the Consolidation Regimens of IDA With Intermediate-dose Cytarabine Versus Intermediate-dose Cytarabine Alone for Elderly AML Patients

This study evaluates Idarubicin (IDA) in combination with the intermediate-dose cytarabine, compared with intermediate-dose cytarabine alone, as a consolidation treatment for elderly AML in first remission.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed de novo AML who achieved complete remission (CR), including CRi and CRp after a maximum number of 2 cycles of induction chemotherapy.
* Histologically or morphologically confirmed diagnosis of AML except for AML M3 (acute promyelocytic leukemia)
* No contraindication to anthracyclines : decompensated or uncontrolled heart failure, recent myocardial infarction, current signs of cardiac impairment, uncontrolled arrhythmias, LVEF (left ventricular ejection fraction) \< 50%
* Age ≥ 60 years and \< 75 years
* ECOG performance status ≤2
* Written informed consent
* No psychological, familial, social, or geographic reason that would compromise clinical follow up

Exclusion Criteria:

* Relapsed or refractory AML
* Patients with acute promyelocytic leukemia (APL)
* Patients with secondary type AML (post myelodysplastic syndrome MDS or therapy-related AML)
* Severe pshyciatric or organic disorder, supposed to be independent from AML, that would contraindicate treatment
* Subjects for which allogeneic HSCT is planned in CR1
* Known allergic or hypersensitivity to idarubicin or cytarabine or to any of the test compounds, materials
* Concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the subject at unacceptable risk
* A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications
Somnotouch-NIBP Compared to Standard Ambulatory 24-hours Blood Pressure Measurement

Comparison of 24 hours blood pressure measurement with puls-transit time versus cuffs.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Ability to give informed consent

Exclusion Criteria:

* Age \< 18 years
* Medical reasons that forbid blood pressure measurements on upper extremities
* Not able to give informed consent
Let's Get REAL: Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy

The investigators will conduct a pilot feasibility and efficacy trial of a newly developed family health communication tool (called Let's Get REAL) in increasing youth involvement in real-time stem cell transplant and cellular therapy decisions (SCTCT). The investigators will pilot the intervention among 24 youth and their parents, stratified by youth age (stratum 1, 8-12 years of age and stratum 2, 13-17 years of age).


Eligibility Criteria:
Inclusion Criteria Youth:

* Children or adolescents 8-17 years of age referred for SCTCT.
* Diagnosis of malignant or nonmalignant disorder.
* Referred for any type of SCTCT. Autologous and allogeneic stem cell and cellular therapies are eligible.
* Planning to meet with a provider to discuss SCTCT.
* Must have the ability to understand and willingness to consent to participate after reviewing an IRB approved informed assent document.
* Must speak English and be cognitively able to participate.

Inclusion Criteria Parents:

* Parent or guardian of a child 8-17 years of age with any diagnosis referred for any type of SCTCT. Diagnoses may include malignant and nonmalignant disorders. Autologous and allogeneic stem cell and cellular therapies are eligible. Parent or guardian is defined as an adult who usually cares for the youth and has authority to make medical decisions for them.
* Must have the ability to understand and willingness to consent to participate after reviewing an IRB approved informed consent document.
* Must speak English and be cognitively able to participate.

Exclusion Criteria Youth:

* Active medical problems severe enough to preclude study participation at the time of recruitment.

  * Patients who are otherwise eligible, but whose primary transplant physician does not want them to participate in the study.
* Lacks cognitive capacity to complete study activities, as determined by consenting professional.

Exclusion Criteria Parents:

* Their youth referred for SCTCT does not assent to participate.
Cardiac Magnetic Resonance for Risk Stratification in Dilated Cardiomyopathy

Dilated cardiomyopathy (DCM) is an increasingly recognized cause of morbidity and mortality with heterogenous etiologies (eg, genetic, environment) and clinical manifestations, characterized by left ventricular (LV) systolic dysfunction and LV or biventricular dilation. Previous publications reported the three-year treated mortality rates remain high at 12%-20% and a reported 5-year mortality rate up to 50%, with death resulting from ventricular arrhythmia leading to sudden cardiac death (SCD) or advanced heart failure (HF). With large fields of view and high spatial resolution, Cardiac magnetic resonance (CMR) is the reference standard for assessing cardiac mass, volume, and function. CMR also provides non noninvasive characterization of the myocardium benefiting to differential diagnosis and risk stratification.


Eligibility Criteria:
Inclusion Criteria:

1. reduced left ventricular ejection fraction (LVEF\<50%)
2. LV end-diastolic volume \>2SD from normal according to normograms corrected by body surface area (BSA) and age.

Exclusion Criteria:

1. Any evidence indicating the presence of ischemic heart disease:

   Coronary angiography, perfusion imaging Medical documentation that indicated the presence of ischemic heart disease An infarct pattern of late gadolinium enhancement on cardiac magnetic resonance studies and/or acute coronary syndrome or coronary revascularization during follow-up
2. Any evidence of hypertrophic cardiomyopathy, or moderate-to-severe valvular disease\[18\], or infiltrative disease (such as amyloidosis, sarcoidosis, Fabry disease)
3. Incessant arrhythmias
4. Inability to lie flat
5. Pregnancy
6. Contraindication to cardiac magnetic resonance including severe claustrophobia, defibrillators, pacemakers, certain types of intracranial aneurysm clips, intraocular metal, and Stage IV/V chronic kidney disease
7. Diabetes mellitus with end organ damage
8. Inability to provide informed consent.
Effects of Musculoskeletal Rehabilitation Courses on Work Ability

The goal of this observational study is to learn about the effects of two different musculoskeletal rehabilitation programs in working-age people with musculoskeletal disorders. The main question it aims to answer is:

Do musculoskeletal rehabilitation programs A or B improve work ability in people with musculoskeletal disorders?

Participants starting in rehabilitation programs A and B will answer survey questions about their work ability and related factors three times: when starting, immediately after the rehabilitation ends, and 4 months after ending the rehabilitation. Participants in study group C will answer the same questions during the same time period.

Researchers will compare participants in rehabilitation programs A and B to participants in group C, who have musculoskeletal disorders but will not participate in rehabilitation programs. The comparison is done to see if there are differences in the changes in work ability and related factors, such as pain or quality of life.


Eligibility Criteria:
Inclusion Criteria:

Groups 1 ja 2:

* diagnosed musculoskeletal disorder
* 18 years or older
* in employment, returning to work, studying, or receives rehabilitation subsidy
* participating in either of the following:

  * Kela's face-to-face musculoskeletal rehabilitation (A)
  * Kela's musculoskeletal telerehabilitation (B)
* willingness to participate in the study

Group 3 (Controls):

* diagnosed musculoskeletal disorder
* 18 years or older
* in employment, returning to work, studying, or receives rehabilitation subsidy
* musculoskeletal symptoms have lasted at least 3 months and the person has participated in physiotherapy or self-rehabilitation without satisfactory results
* willingness to participate in the study

Exclusion Criteria:

Group 3 (Controls):

* Current rehabilitation needs are related to post-treatment care or post-discharge rehabilitation.
* acute or untreated substance use disorder
* participating in or apply for Kela's musculoskeletal rehabilitation services (A or B) during the next few months
CD4^LVFOXP3 in Participants With IPEX

This first-in-human, Phase 1 clinical trial will test the feasibility of the manufacturing and the safety of the administration of CD4\^LVFOXP3 in up to 30 evaluable human participants with IPEX and evaluate the impact of the CD4\^LVFOXP3 infusion on the disease.

Treatment with CD4\^LVFOXP3 is expected to replace the defective Treg cells of the participants, and restore control of the immune system and therefore ameliorate symptoms of IPEX.

We expect to learn the following from this study:

1. That CD4\^LVFOXP3 can be consistently produced and be of expected quality to be used in humans,
2. That CD4\^LVFOXP3 are safe in children and young adults with IPEX, and determine its effects, both good and bad,
3. That CD4\^LVFOXP3 can improve overall health and allow reduction of medication/s.

This Phase 1 (feasibility and safety) trial will gather data about CD4\^LVFOXP3 in vivo persistency and early signs of impact on symptoms of IPEX.

Eligibility Criteria:
Inclusion Criteria:

* Body weight greater than 8 kg, unless assessed as able to tolerate leukapheresis
* FOXP3 gene mutation
* Medical history of progressive symptoms of IPEX with persistency of some symptoms and/or signs requiring immune suppressive medication. The participant may or may not be on immunosuppression at time of starting the study.
* Uncontrolled IPEX disease but unable to tolerate immune suppressive medication
* Recurrent IPEX symptoms, requiring immune suppressive medications, in participants who have had prior allogeneic (allo) blood stem cell transplantation (HSCT).
* ≥ 50% Performance rating on Lansky/Karnofsky Scale
* Organ and marrow function within acceptable levels of function
* Absence of ongoing infections
* Must be able to consent if an adult

Exclusion Criteria:

* Medical instability
* Less than 6 months life expectancy
* Inability to meet limits for steroid dosing
* Eligible for an HLA matched sibling or matched unrelated donor blood stem cell transplant, and be willing to undergo transplant.
* Unrelated or comorbid cardiac, renal, pulmonary, liver, or hematologic disease
* Allergy to any study medication, product, or intervention
* Currently receiving another experimental treatment
* History of malignancy, unless disease free for at least 2 years, with the exception of non melanoma skin cancer or carcinoma in situ
Effect of Oral Supplementation With Curcumin (Turmeric) in Patients With Proteinuric Chronic Kidney Disease

The purpose of this study is to determine if the oral supplementation with curcumin reduces proteinuria in patients with chronic kidney disease regardless the ethiology.

Curcumin is a potent antioxidant found in extracts of the rhizome of the plant Curcuma longa L.

Different studies have demonstrated that curcumin has potent biological activity and therefore is an effective therapeutic agent for the treatment of various ailments.

This compound acts as a bifunctional antioxidant:

ه is capable of reacting directly with highly reactive oxygen species. ه acts indirectly by its ability to induce the expression of various cytoprotective proteins through Keap1/Nrf2/ARE pathway.

Although RAAS blockade is the cornerstone to prevent the progression of proteinuric nephropathy, a significant number of patients remained with proteinuria and progress to end-stage renal disease.

Due to the low cost and few side effects of curcumin, this could become an adjuvant treatment of proteinuric nephropathy purposes attenuate the progression of chronic kidney disease.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of proteinuric chronic kidney disease with 1g or more of proteins in a daily recollection.
* Individuals taking Angiotensin II Receptor Blocker or ACE inhibitors in monotherapy with maximum dose or in combination.

Exclusion Criteria:

* Hepatic damage.
* Malignancy.
* Pregnancy.
* Peritoneal or hemodialysis.
* Organ transplantation.
* Heart failure classification III or IV (New York Heart Association).
* History of chemotherapy within 2 years prior to screening.
SPY Intra-Operative Angiography & Skin Perfusion in Immediate Breast Reconstruction w/ Implants

The investigators hope to learn the value of the SPY ELITE® intra-operative angiography in reducing post-operative complications associated with low breast skin blood flow after breast reconstruction using implants.

Breast cancer is the most common malignancy among women, and over 180,000 women will be diagnosed with this disease in 2008. Last year, over 57,000 breast reconstructive procedures were performed, of which prosthetic reconstruction constituted 76%. Immediate reconstruction has been favored over delayed procedures for psychological and technical reasons. However, immediate breast reconstruction is associated with significantly higher complication rates (50-52%) than delayed procedures (32-36%), especially when a prosthetic technique is used. For prosthetic reconstructions, the most significant early complications include necrosis of the mastectomy skin flaps, infection, delayed wound healing and exposure of the implant. The published incidence of these complications ranges between 10% and 40% and is predominantly associated with malperfusion of mastectomy skin flaps. Thus, evaluation of skin perfusion and elimination of poorly vascularized areas could help reduce the high rate of complications in immediate breast reconstruction.

Eligibility Criteria:
Inclusion Criteria:

3.1.0 Ability to understand and the willingness to sign a written informed consent document.

3.1.1 Signed written informed consent.

3.1.2 Women with local or regional recurrences after previous breast conserving surgery.

3.1.3 Women undergoing delayed post mastectomy reconstruction.

3.1.4 Women undergoing prophylactic mastectomy.

3.1.5 Women with invasive or non-invasive breast cancer, receiving breast conserving surgery with or without reduction mammoplasty or mastectomy, with or without immediate reconstruction.

3.1.6 Women of 18 years of age or older.

3.1.7 ECOG or Karnofsky Performance Status 0,1,2.

3.1.8 Basic Metabolic Panel within 6 months

3.1.9 Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.

Exclusion Criteria:

3.2.1 History of liver or kidney failure will not be eligible.

3.2.2 Allergies to iodine containing products will not be eligible.

3.2.3 Women who are pregnant will not be eligible.
Cognitive Dysfunction in MDD Patients

Major Depressive Disorder (MDD) is one of the most prevalent mental diagnosis within the worldwide population. Although there is evidence about relationship between MDD and cognitive dysfunction, still the correlations between biomarkers and the severity of the disorder or the level of cognitive dysfunction need further research. Therefore, the aim of the study is to determine such relationships in Ukrainian population.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient 18 to 65 years of age
* Meets DSM-5 criteria for MDD
* Depressive episode duration ≥ 2 months
* The participant has MARDS total score ≥ 7
* Free of psychotropic medications for at least 5 half-lives before baseline
* Fluent in Russian/Ukrainian

Exclusion Criteria:

* Current diagnosis or history of manic/hypomanic episode
* Any other psychiatric diagnosis that is considered the primary diagnosis
* Any significant personality disorder diagnosis
* High suicidal risk, defined by clinician judgment
* Substance dependence/abuse in the past year
* Significant neurological disorders, head trauma, or other unstable medical conditions
* History of endocrinological diseases
* Pregnant or breastfeeding
* Psychosis in the current episode
* High risk for hypomanic switch
* Cognitive or language impairment of such severity as to adversely affect the performance of tests
Pakistan Flocculent Health Outcome Study

This study is designed to evaluate the effect of different methods of drinking water treatment on the occurrence of diarrhea among children living in squatter settlements in Karachi, Pakistan, and the marginal benefit of adding handwashing to water treatment. 260 households will receive a new product which combines flocculation with chlorination to produce clearer, less chemically contaminated drinking water. 260 households will receive dilute sodium hypochlorite, i.e. bleach to treat their water. 260 households will receive soap and encouraged to wash their hands regularly. 260 households will receive both soap and the combination flocculation/chlorination water treatment. 260 households will continue their standard water treatment and handwashing practices. The households will be visited each week for 9 months, and the episodes of diarrhea from each child in the household recorded. The rate of diarrhea between the groups will be compared. At the end of 9 months, households who were part of the standard habits and practice group will receive a water storage vessel and disinfectant.


Eligibility Criteria:
Inclusion Criteria:

* households in study neighborhoods
* contain a child \< 5 years old
* have access to water for handwashing

Exclusion Criteria:

* participated in handwashing or drinking water treatment programs with HOPE previously
The Effects of the Myofascial Trigger Point Injections on Pain and Sleep Disturbance in Patients With Nocturnal Leg Cramps With Trigger Points on Gastrocnemius Muscle

Nocturnal leg cramps is involuntary strong contraction of leg muscle, mostly in calves. It occurs suddenly and induces pain. Patients with frequent nocturnal leg cramps suffer from sleep disturbance in company with pain. In the present study, we examined the effects of the myofascial trigger point injections, which are known to be helpful for ease of nocturnal leg cramps, on pain and sleep disturbance in patients with nocturnal leg cramps with trigger points on gastrocnemius muscle.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (20-80 years of age) scheduled for myofascial trigger point injections on gastrocnemius muscle due to nocturnal leg cramps at least once a week

Exclusion Criteria:

* Patients with no trigger points on gastrocnemius muscle,
* electrolyte abnormality,
* congenital musculoskeletal disorder,
* local or systemic infection, bleeding disorder or the use of anticoagulation medications,
* known allergy of local anesthetics, or the use of hypnotics or sedatives in the last 1 month
Safety and Efficacy of Stent Deployment for Intracranial Aneurysms (SESIA)

Intracranial aneurysms (IA) regarded the third cause of cerebral vascular disease is the majoy cause of subarachnoid hemorrhage (SAH). The mortality and morbidity account for 22% to 25% in cerebrovascular disease. More than half of the ruptured IA survivors has serious nerve dysfunction such as hemiplegia, aphasia,which seriously harms to human health. Endovascular embolization is one of the main treatment ways of IA.However,there are no studies on the multicenter cases of stent selection strategy at home and abroad.Therefore, the investigators conduct a prospective study by comparing the clinical efficacy, follow-up results, and hemodynamics between preoperative and postoperative patients with different types of stent assisted embolization treatment of IA.The investigators also study the relationship between cyclin dependent kinase inhibitor 2B antisense RNA 1 gene（CDKN2BAS1 gene）of IA patients and the results, for making indication of stents, improving the cure rate, reducing the recurrence rate of IA patients, providing theory gist for interventional therapy of complex IA and simplying slection of stent.

Studies showed 3.6% - 6% for the incidence and 1% - 2% for the ruptctued rate of IA.The mortality and morbidity account for 22% to 25% in cerebrovascular disease ,which is a growing trend. IA is one of the major diseases which relate with people's living standards. Endovascular embolization is one of the main treatments of IA with less invasive, Better cure rates and higher safety. It has been developed rapidly and improve quality of patients' lives after treatmen.With the rapid development of neural intervention and the proliferation of specialized stents in IA, stent-assisted embolization technique is becoming more and more common .Especially, stents play an important role in intracranial aneurysmal aneurysm.

There are many kinds intracranial stents for clinical surgery, but how to choose the appropriate stent type is one of the key issues that clinicians need to settle. And, there is no relevant multicenter cases study about selection strategy of intracranial stent at home and abroad.

Eligibility Criteria:
Inclusion Criteria:

* Subject has intracranial aneurysms confirmed by CT arteriography (CTA) or magnetic resonance angiography (MRA) or digital subtraction angiography(DSA)
* Subject has accepted stent - assisted embolization or flow-diversion treatment of intracranial aneurysm

Exclusion Criteria:

* Subject has secondary intracranial aneurysms(e.g.traumatic aneurysm, infected aneurysm)
* Subject has received previous surgical clipping or endovascular treatment
* Subject has no intracranial aneurysms by DSA
* Subject with poor image quality
* Subject cannot use stent because of the small parent artery
* Subject do not need to use stent because of narrow-neck aneurysm
* History of aneurysm