cyrilzakka/clinical-trials huggingface dataset:
Association of Polymorphisms in the Androgen Receptor Gene and Finasteride Response in Women With Androgenetic Alopecia

Previous studies of finasteride treatment in women with hair loss have failed to show positive results, yet, some women have responded anecdotally. Given that polymorphisms of the androgen receptor gene which confer androgen sensitivity impact male response to finasteride therapy, it was hypothesized that the same polymorphism in women may identify the group that will respond. This study is designed to test the impact of finasteride therapy on hair loss in postmenopausal women.

Androgen sensitivity in the cell is determined by the number of Cytosine-Adenine-Guanine repeats in the Androgen Receptor gene. Lower CAG repeats have been associated in previous studies with androgenic conditions such as acne, hirsutism and hair loss in men and women. Keeping this in mind, we tested women with hair loss in the frontal or vertex area, for their AR genotype. Patients were randomized to placebo or 1 mg finasteride therapy for 6 months. Global photographs and 2 tatooed areas of 1cm2 each were measured monthly to assess global appearance and hair counts for medication impact.

Eligibility Criteria:
Inclusion Criteria:

* women with hair loss

Exclusion Criteria:

* pre menopausal,
* metabolic or medication or non-androgenetic causes of hair loss,
* diffuse hair loss
Sleep Intervention for Youth With Type 1 Diabetes

Sleep intervention for youth with diabetes

It is known that sleep disturbances in healthy youth have negative effects on neurobehavioral functioning. Further, data support that individuals with diabetes have more sleep disturbances and compromised neurobehavioral functioning than individuals without diabetes. However, the joint impact of sleep and glucose on neurobehavioral functioning in youth with type 1 diabetes (T1DM) is not yet known. Therefore, our primary study aims are to: (1) determine the relative contributions of various sleep disturbances on glucose control in youth with T1DM; (2) examine the joint impact of glucose control and sleep disturbances on neurobehavioral outcomes in youth with T1DM; and (3) determine if increasing sleep duration relative to youth's typical schedules contributes to changes in glycemic control and neurobehavioral performance. These aims will be achieved by following 120 youth with T1DM ages 10 through 16 for six days of naturalistic sleep using polysomnography, actigraphy, and questionnaires to assess sleep; continuous glucose monitors and hemoglobin A1C values to assess glucose control; and standardized cognitive tasks and behavior rating scales to assess neurobehavioral functioning. Further, the proposed study is innovative in that it will extend existing research by moving from correlational findings to an experimental paradigm by randomizing youth with T1DM to either a Sleep Extension or Fixed Sleep Duration condition for an additional six days. Once our aims are achieved and a causal link is established, the proposed Sleep Extension intervention will advance knowledge about the role of sleep in diabetes management and provide a beneficial intervention to help youth with T1DM.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of type 1 diabetes
* enrolled in school

Exclusion Criteria:

* not hospitalized within past month
* neurological, developmental, or psychiatric condition that in the opinion of the PI would significantly interfere with sleep or participation
Mind-Body Medicine Day Care Clinic in Breast Cancer Patients Undergoing Endocrine Therapy

This randomized controlled trial aims to investigate the effectiveness of a mind body day care clinic program of breast cancer patients undergoing endocrine therapy.

Breast cancer patients undergoing endocrine therapy are often suffering from side effects. This randomized controlled trial analyzes the effects of an 11-week day care clinic group program including mind body medical elements (yoga, relaxation, meditation, education) and acupuncture in breast cancer patients with menopausal symptoms under endocrine therapy.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosed breast cancer (Stage I-III), no metastases
* Current endocrine therapy (minimum 3 months)
* Score of 9 or greater on the Menopausal Rating Scale (MRS)
* Signed informed consent

Exclusion Criteria:

* Severe other somatic or psychiatric comorbidity
* Pregnancy
* Planned or existing chemotherapy, radiation or other cure treatment
* Participation in other clinical studies with behaviour-oriented, psychological or compementary medicine intervention.
Effects of GS-3K8 and GINst15 on Acute Respiratory Illness

This study was conducted to investigate the effects of daily supplementation of GS-3K8 or GINst15 on acute respiratory illness (ARI) in healthy subjects.

This study was a 8 weeks, randomized, double-blind, placebo-controlled trial. Forty five subjects were randomly divided into GS-3K8 (Ultrafiltered red ginseng extract) or GINst15 (Hydrolyzed ginseng extract) or placebo group. The primary clinical outcome measure was the incidence of ARI. The secondary clinical outcome measure was the development and duration of ARI symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Age 39-65 years with healthy adults

Exclusion Criteria:

* Subjects had been vaccinated against influenza in the previous 6 months
* Subjects with symptoms of upper respiratory tract infection
* Subjects with acute/chronic disease
* History of alcohol or substance abuse
* History of disease that could interfere with the test products or impede their absorption
* Subjects taking medications such as immune or upper respiratory tract infection related drug or functional foods
* Abnormal liver or kidney function tests
* Pregnant or lactating women and heavy smokers
* Being judged by the responsible physician of the local study center as unfit to participate in the study
Impact of Caloric and Protein Adequacy on Postoperative Clinical Outcomes of Patients Undergoing Major Abdominal Surgery

The role of nutritional therapy (TN) in the surgical patient is well described in the literature and is associated with reductions in postoperative complications, length of hospital stay, and mortality. Adequate determination of caloric and protein requirements is an essential step in the TN institution, avoiding hypoalimentation and hyperalimentation. Thus, it is essential to understand the changes in energy expenditure after surgery and its relation with nutritional status. In addition, little is known about the effect of nutritional therapy and caloric adequacy on parameters such as phase angle and dynamometry. Thus, the objective of this study is to evaluate the changes in energy expenditure after major abdominal surgeries and to evaluate the phase angle and dynamometry as possible markers of nutritional therapy. Energy expenditure will be assessed by indirect calorimetry. Functionality will be assessed by means of dynamometry and 6-minute walk test. Nutritional diagnosis will be given through subjective global assessment. Energy and protein intake will be monitored and registered daily. Phase angle will be obtained by performing bioelectrical impedance.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Patients admitted for major abdominal surgery
* Sign the consent form

Exclusion Criteria:

* Length of hospital stay less than 3 days
* Pregnancy
* Patients who, for any reason, can not perform indirect calorimetry
Comparison of Pulmonary Vein Isolation Versus AV Nodal Ablation With Biventricular Pacing for Patients With Atrial Fibrillation With Congestive Heart Failure (PABA CHF)

For patients with atrial fibrillation and heart failure, current treatment can include AV nodal ablation with biventricular pacing. Pulmonary vein isolation (PVI) is a new procedure for this patient population which attempts to restore sinus rhythm. This trial is a randomized controlled trial of AVN ablation with biventricular pacing versus PVI for atrial fibrillation patients with congestive heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic atrial fibrillation with NYHA II-III symptoms despite the use of anti-arrhythmic medications.
* Ejection fraction was required to be ≤ 40%.
* Patients were required to be on a heart failure regimen that included beta-blockers and ace-inhibitors or angiotensin receptor blockers for all patients and spironolactone for NYHA III patients.
* Patients were required to complete a 6-minute walk test and to be ≥ 18 years of age.

Exclusion Criteria:

* Reversible causes of AF and heart failure (HF) such as pericarditis, hyperthyroidism, valvular heart disease and tachycardia-induced cardiomyopathy.
* Post-operative AF, previous MAZE or MAZE-like surgery, previous left atrial instrumentation
* Life expectancy ≤ 2 years
* Likely cardiac transplant within the next 12 months
* Contraindication to anti-arrhythmic medications and/or anticoagulation
* Severe pulmonary disease
* Documented intra-atrial thrombus
* Tumor or other abnormalities which preclude catheter introduction
* Cardiac surgery, MI or PCI within the past three months.
Assessment of (Chemo)RT-related Dysphagia in HNC Patients Based on Cough-related Acoustic Features

To develop this objective and easily implementable assessment method of coughing based on acoustic features of voluntary and reflex coughs, there is a primary need in identifying and comparing acoustic cough features in healthy subjects and different disease-related coughs features. Cough is a common reason for seeking medical care. Chronic cough, defined as a cough that has lasted for longer that eight weeks, represents 10-38% of all referrals made to respiratory physicians \[1-2\]. Furthermore, between 60 and 80% of patients with chronic obstructivepulmonary disease (COPD) report cough. Following this pilot study comparing different populations, the applicability of the selected acoustic cough features should be examined in HNC patients with radiotherapy-induced dysphagia, Another frequent aspect of the clinical diagnostic examination of swallowing is perceptual analysis of voice quality immediately following deglutition. Changes in voice quality are assumed to provide information on the possible accumulation of saliva or food at the vocal folds level. It is reported that a change of voice may indicate laryngeal dysfunction or the presence of a foreign body at the laryngeal level \[3\] confirm that a normophonic voice after swallowing reflects a lack of aspiration-penetration. However, research shows that there is no strong correlation between aspiration and changes in perceptual voice quality (e.g. wet voice). A more reliable and easily implementable method could be detection of specific acoustic features of changes in voice quality.

The ultimate goal of this study is to develop an innovative and non-invasive assessment method for dysphagia and aspiration in head and neck cancer (HNC) patients using acoustic features related to voluntary and/or reflex cough as biomarkers of dysphagia and/or aspiration in this population.

Additionally, the relationship between acoustic features and aerodynamic cough and acoustic voice parameters will be investigated, extending our insight in pathophysiology of dysphagia in this population.

To the investigators knowledge, no acoustic features of coughing and throat clearing in the frame of dysphagia have ever been explored. Regarding voice quality abnormalities, no acoustic parameters of reasonable evidence of dysphagia have been found.

Eligibility Criteria:
Inclusion criteria:

* HNC patients in complete clinical remission (10 male/10 female adults \& 10 male/10 female elderly)
* Patients diagnosed with dysphagia (with evaluation by videofluoroscopy)
* Patients treated with radiochemotherapy and selected three months after the end of treatment.

Exclusion criteria:

-pulmonary diseases.
Diluted Indocyanine Green Angiography: a Novel Approach to Free Flap Perfusion Evaluation in Reconstructive Microsurgery

The evaluation of perfusion in free flaps is crucial in clinical practice. Currently, the gold standard for evaluation is subjective through clinical assessment. However, indocyanine green angiography (ICGA), a tool that uses a near-infrared (NIR) camera to depict and monitor flap vascularization, offers an objective and reproducible alternative. The population in this study were divided into three equal groups, where each groups were assessed with Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). The study was conducted with three distinct concentrations of ICGA: 5 mg/mL (100% standard concentration), 2.5 mg/mL (50%), and 0.5 mg/mL (10%). Indocyanine green was given in immediate postoperative manner, after the patient defect has been reconstructed with free flap.

Indocyanine green (ICG) angiography is a novel technique for assessing tissue perfusion. The primary outcome is gray values that being evaluated with IMAGE. Through this study optimal concentration that will show fluorescence in NIR camera can be seen. This is important in order to evaluate free flap perfusion.

This study included 47 patients who underwent free flap surgery. The subjects were consisted of postoperative patient with fibular free flap (FFF), anterolateral thigh flap (ALT), radial forearm free flap (RFFF), and deep inferior epigastric perforator flap (DIEP), with inclusion criteria of this study are individuals who have successfully undergone micro-reconstruction surgery utilizing a viable free flap, with no prior surgical intervention in the area under evaluation, and the donor area for the free flap is devoid of any history of trauma or surgery.

Eligibility Criteria:
Inclusion Criteria:

* individuals who have successfully undergone micro-reconstruction surgery utilizing a viable free flap, with no prior surgical intervention in the area under evaluation, and the donor area for the free flap is devoid of any history of trauma or surgery. Furthermore, these subjects exhibit an albumin level exceeding 3 g/dL, Haemoglobin more than 10mg/dL, and no complication intraoperative

Exclusion Criteria:

* patients with a history of allergy or hypersensitivity to iodine or ICG, those with renal insufficiency or undergoing routine hemodialysis, and those regularly consuming sodium bisulfites. Additionally, patients with hepatic dysfunction, those regularly taking anticonvulsant drugs, and those experiencing complications during and post-operation are also excluded. Furthermore, patients with psychopathology and/or mental disorders, and those whose transferred free flap has experienced trauma or damage due to external factors during care are not suitable for this study
Socioeconomic Patterning of Inflammation and Hemostasis - Ancillary to MESA

To investigate how inflammation, hemostasis, and stress may contribute to neighborhood and individual-level socioeconomic differences in cardiovascular risk.

BACKGROUND:

In epidemiologic studies, associations of cardiovascular risk with individual and neighborhood socioeconomic characteristics tend to persist after adjustment for established cardiovascular risk factors suggesting that other mediators may be involved. However, evidence regarding what these mediators may be is largely absent. Elucidating the reasons for these persistent socioeconomic differences may enhance our ability to reduce these differentials and will contribute to our understanding of the causes of cardiovascular disease generally. Two biological processes, inflammation and hemostasis, have recently emerged as potentially important in the development of atherosclerosis and the precipitation of clinical cardiovascular events. Both processes have also been recently linked to psychosocial factors and stress. However, studies investigating social gradients in inflammation and hemostasis remain rare. In addition, the relation of psychosocial factors and biological markers of the stress response to inflammation and hemostasis have not been examined in large population-based studies.

DESIGN NARRATIVE:

The study is ancillary to the ongoing epidemiologic study of atherosclerosis, the Multi-Ethnic Study of Atherosclerosis (MESA). The project will collect data on stress hormones and follow- up measures of inflammation and hemostasis which are not part of the existing MESA protocol on a subsample of the cohort. The study will also collect additional data on neighborhood sources of stress for the subsample. The new data will be linked to existing MESA data.

Using newly collected data linked to the MESA, the study will investigate (1) associations of neighborhood and individual-level socioeconomic indicators with markers of inflammation and hemostasis; (2) associations of individual-level psychosocial factors and sources of chronic stress (at the individual and neighborhood level) with inflammatory markers and hemostasis; and (3) the relationship between biological markers of the stress response (such as cortisol and adrenaline/noradrenaline) and inflammation and hemostasis). Project aims will be achieved by linking MESA data to newly-collected data on neighborhood characteristics and biomarkers of inflammation, hemostasis and the stress response in MESA participants. The project is innovative in that it will span and link three levels: the social/environmental level (neighborhood characteristics and social position), the behavioral/psychological level (behavioral and psychosocial factors), and the biological level (inflammation, hemostasis, and stress hormones). The study will provide a unique opportunity to elucidate the links between socioeconomic factors, stress, inflammation and hemostasis in a large and diverse population-based sample.

Eligibility Criteria:
Participants at NY and LA MESA sites.
Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression

Postpartum depression is a non-psychotic major or minor depressive episode that occurs during pregnancy or within 12 months of post-partum period. The nature of symptoms is same as depressive episode characterized by depressed mood, anxiety, sleep difficulties, suicidal thoughts, tiredness and diminished interest in pleasurable activities. Severe maternal depression affects children by increasing the risk of emotional and behavioral and physical health problems and cognitive difficulties. Thus early screening and intervention is critical in reducing the negative impact of PND in the mother and child, family and the community.

The purpose of this study is to assess the safety, pharmacokinetics and antidepressant efficacy of sub-anesthetic dose of intravenous ketamine in perinatal depression.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects, ages 18-45 years
* Experienced a major depressive episode in the postpartum period beginning within the first 4 weeks following delivery and with moderate or severe symptoms (\>12 EPDS or \>14 HAM-D).
* No or partial response to adequate doses of SSRI medications to treat PND for longer than 6 weeks.
* PND patients will be requested to maintain the stable dose of antidepressants while enrolled in the study trial.
* Patients that can speak and read the English language, are able to understand the study procedures and sign the informed consent

Exclusion Criteria:

* No current or past psychosis or severe personality disorder.
* No current substance abuse or dependence.
* No serious and imminent suicidal or homicidal risk.
* No recent or history of major and unstable medical problems that affect brain anatomy, neurochemistry, or function.
* Not diagnosed with cardiovascular disorders.
* No increased risk of laryngospasm or active upper respiratory infections.
* Not diagnosed with an intellectual disability or neurodegenerative diseases.
* Mothers that are currently breastfeeding.
* No current pregnancy.
Renin-Angiotensin and Fibrinolysis in Humans: Effect of Long-Term PDE5 Inhibition on Glucose Homeostasis

The purpose of this study is to determine the effect of chronic PDE5 inhibitor therapy on glucose metabolism in persons with prediabetes.


Eligibility Criteria:
Inclusion criteria:

Age \> 18 years and BMI \> 25 kg/M2 (\> 23 kg/M2 among Asian Americans) Elevated fasting plasma glucose (100-125 mg/dL) IGT (2 hour plasma glucose 140-199 mg/dL) OR metabolic syndrome and/or hemoglobin A1c 5.7-6.4%

Exclusion criteria:

* Diabetes type 1 or type 2, as defined by a fasting glucose of 126 mg/dL or greater, a two hour plasma glucose of 200 mg/dL or greater, or the use of anti-diabetic medication.
* The use of nitrates or any disease that might require the use of nitrates.
* The use of any potent CYP3A4 inhibitor.
* subjects who have participated in a weight-reduction program during the last 6 month or whose weight has increased or decreased more than 2 kg over the preceding 6 months.
* Pregnancy. Women of child-bearing potential will be required to have undergone tubal ligation or to be using barrier methods of birth control.
* Breast-feeding.
* Cardiovascular disease such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy.
* Treatment with anticoagulants.
* Treatment with metformin.
* History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack.
* History or presence of immunological or hematological disorders.
* Diagnosis of asthma.
* Clinically significant gastrointestinal impairment that could interfere with drug absorption.
* Impaired hepatic function (aspartate amino transaminase \[AST\] and/or alanine amino.

transaminase \[ALT\] \>1.5 x upper limit of normal range)

* Impaired renal function (serum creatinine \>1.5 mg/dl).
* Hematocrit \<35%.
* Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult.
* Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in

  1 month).
* Treatment with lithium salts.
* History of alcohol or drug abuse.
* Treatment with any investigational drug in the 1 month preceding the study.
* Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study.
* Inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study