cyrilzakka/clinical-trials huggingface dataset:
Comparison of Topical Minoxidil 5% in Ethanol Plus Propylene Glycol Versus Minoxidil 5% in Ethanol Alone in Treatment of Women With Female Pattern Hair Loss

The study will be included 60 women with FPHL. The diagnosis of FPHL will be established by clinical (Ludwig classification) and trichoscopic evaluation of frontal and occipital regions of the scalp.

Enrolled women will be randomly assigned into 3 treatment groups: group A will apply topical minoxidil 5% in 90% ethanol and 5% propylene glycol, group B will apply topical minoxidil 5% in pure ethanol alone and group C will apply pure ethanol (placebo) twice daily.

The treatment will be continued for six months with regular visits at 3 months intervals.

The medications will be provided in bottles which were identical in shape and color, and were coded by a third party.

Both patients and investigator will be blinded to the medication. Disclosure of the codes will be done, by a third party, at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* FPHL

Exclusion Criteria:

* No
Effects of Novel Flash Glucose Monitoring System on Glycemic Control in Adult Patients With Type 1 Diabetes Mellitus

This trial is a randomized, multi-center, parallel-group, efficacy and safety study with a 26-weeks follow- up(after 2-week recruitment). The study aims to: 1)compare the effects of novel flash glucose monitoring system (FGMS) and conventional Self Measurement of Blood Glucose (SMBG); and 2) optimize integrated management for glycaemic control in adult patients with type 1 diabetes who are sub-optimally controlled.

Subjects with Type 1 diabetes who meet criteria will be enrolled at up to eight clinical research sites in China. Subjects will be randomized to either flash glucose monitoring system(Freestyle Libre®;Abbott Diabetes Care,Witney, Oxon,UK) or conventional Self Measurement of Blood Glucose (Bayer®)alone at least three times per day. Primary outcome variable is the difference in HbA1c which will be analyzed in a central laboratory between baseline and the 26weeks follow-up. Secondary outcome variables such as time-in-range, frequency and duration of and hyperglycemic episodes etc. will be assessed at baseline (Week 0 to 2), Week 12-14 and Week 24-26 via professional continuous glucose system (Ipro2®; Medtronic). At the same time, demographic factors, clinical data, patient reported outcome (PROs) will be collected. Assessment of Adverse Events will occur via self-reporting at each visit and/or phone call. All patients will receive same ordinary diabetes education.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years and older;
2. Diagnosed with type 1 diabetes with the criteria established by WHO in 1999,with duration more than 1 year;
3. Glycosylated Hemoglobin A1c concentration between 7% and 10%;
4. Self-monitor of blood glucose levels on a regular basis for 2 months previous( at least 3 times per day) and have willing to insist for at least 6 months
5. Using CSII or MDI for at least 3 months, stable diabetes medication regimen for 3 months prior to study entry(change in insulin ≦20%).
6. Willing to wear CGM;
7. Able to speak, read, and write Chinese

Exclusion Criteria:

1. Having used CGM 3 months prior to study entry;
2. Had severe diabetic complications such as PDR in diabetic retinopathy and ESRD of diabetic nephropathy, assessed by investigators;
3. Receiving oral steroid therapy for any disorders and continuous use of paracetamol.
4. Had known allergy to medical-grade adhesives or CGM and its affiliated components;
5. Being pregnant or planning pregnancy (as demonstrated by a positive test at study entry);
6. Recent severe diseases like myocardial infarction,stroke,psychiatric diseases(historical/recent),malignant tumor, kidney disease(defined as eGFR\<45), dermatosis, decided by investigator.
7. Current participation in another investigational study (must have completed any previous studies at least 30 days prior to being enrolled in this study);
8. Currently abusing illicit drugs, alcohol, or prescription drugs;
9. Any condition that could impact reliability of the HbA1C measurement,（e.g.hemoglobinopathy, hemolytic anemia, chronic liver disease),decided by investigator.
Effect of CV4 and Rib Raising Techniques on Autonomic Balance

Background. Heart rate variability (HRV) and skin conductance (SC) highlight autonomic activity and the balance of autonomic nervous system (ANS) which regulates involuntary physiological functions. The modulation of ANS tonic activity is a target of osteopathic manipulative treatment (OMT). The main aim of the present study was to verify whether CV4 and RR osteopathic techniques influence ANS activity.

Trial design. A randomized-controlled clinical trial was performed from June 2010 to January 2011.

Methods. 32 healthy adults were selected. At enrollment, all healthy subjects were randomized in three groups: CV4 group (CV4 technique), Rib Raising group (RR technique), and Placebo group (PL technique). HRV and SC was recorded during the session respectively with heart rate monitor Polar S810i and with Onda Scanner Domiana (OSD-Microsale model). All data analysis was performed using SPSS statistical software and the significance level set at p≤0.05.


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects
* between 18-65 years old
* both gender

Exclusion Criteria:

* BMI ≥ 30
* pregnancy
* menstrual flow during the session
* chronic pain
* chronic drug treatment
* presence of skin, cardiovascular, psychiatric and neurological diseases
* medical history of surgical interventions
* OMT in the previous 3 months
Pain Relief After Corneal Collagen Cross-Linking

Keratoconus is a progressive corneal ectasia that can lead to significant visual impairment and decreased quality of life. The introduction of corneal cross-linking (CXL) with riboflavin and ultraviolet-A (UVA) light has revolutionized the treatment of keratoconus by increasing corneal rigidity and arresting disease progression. The epithelium-off protocol, which induces heightened post-surgical discomfort, is the prevailing approach. Despite the success of CXL, postoperative pain is a common side effect that can negatively impact patients' quality of life and impede recovery.

Pain management after CXL is essential for optimizing patient outcomes and satisfaction. Systemic painkillers, though not researched enough, may potentially aid in healing and recovery, minimizing complications and discomfort for the patient.

In this study we will provide evidence-based recommendations for clinicians to optimize pain control after CXL in collaboration with pain specialists.


Eligibility Criteria:
Inclusion Criteria:

* Patients above the age of 15 years
* Patients who are undergoing CXL treatment

Exclusion Criteria:

* Renal and/or hepatic failure
* Patients under the age of 15
Comparative Bioavailability Study of 600mg Azithromycin Monohydrate Tablets Under Fasting Conditions

The purpose of this study is to demonstrate the bioequivalence of Azithromycin Monohydrate 600 mg Tablets.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results on screening

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C
* Treatment for drug or alcohol dependence
* Female subjects who are pregnant or lactating
STOP-Bang Questionnaire: a Predictor of Obstructive Sleep Apnea and Difficult Mask/intubation?

Difficult airway management remains the leading cause of anaesthesia-related morbidity and mortality. Obstructive sleep apnea syndrome (OSAS) is a warning sign of difficult airway management. Polysomnography is the gold standard for diagnosis of this syndrome, but the STOP-BANG questionnaire is the preferred screening test. In this study, we wanted to find an answer to the question How successful is the STOP-BANG questionnaire in screening for obstructive sleep apnea syndrome (OSAS) in predicting OSAS, difficult mask and difficult intubation in patients undergoing thoracic surgery?


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing thoracic surgery
* 18-65 years old
* ASA 1-3

Exclusion Criteria:

* Having a history of obstructive sleep apnea syndrome,
* Having a history of previous head and neck surgery/radiotherapy,
* Patients who did not agree to participate in the study
The Positive Family Support Project - Partnering With Families for a Successful Transition to School

The Positive Family Support Project seeks to understand some of the factors that increase success for children in early elementary school, such as positive family support at home. This study will inform us on ways to help children learn and succeed in school.

The transition to elementary school is a critical time for the development of key skills that are necessary for school success, including sustained attention, self-regulation, initiating and sustaining successful peer relationships, and academic competence. Parent support at home, such as positive parenting and support for learning, is associated with school readiness indicators that predict successful adaptation to the school context. For many children at risk for poor developmental outcomes this transition can be difficult and may lead to early academic problems, which in turn may define a trajectory that culminates in more severe forms of problem behavior and learning difficulties. The purpose of this study is to evaluate the efficacy of implementing the Family Check-Up (FCU), a school-based, ecological approach to family intervention, during the transition into elementary school.

Eligibility Criteria:
Inclusion Criteria: 700 Kindergarten children and their families entering Kindergarten in the Clackamas School District in 2014 and 2015 -

Exclusion Criteria:

-
Concurrent Chemotherapy and Radiotherapy With Nitroglycerin in Patients With Locally Advanced Non-Small Cell Lung Cancer

Nitroglycerin will increase the effectiveness of treatment with induction chemotherapy and concurrent chemo-radiotherapy by reducing chemo-radio resistance through an increased oxygen pressure in tumoral tissue. The combination treatment of nitroglycerin and chemotherapy will result in longer disease-free and over-all survival in patients with locally advanced NSCLC

Nitroglycerin decreases hypoxia-induced resistance to antitumor drugs due to inhibition of Hypoxia Inducible Factor alfa (HIF-1α), it increases oxygen pressure in tumoral tissue by augmenting tumor blood flow, increases apoptosis, activation of p53, and induces cellular growth inhibition. Randomized studies showed that the addition of transdermal nitroglycerin to non small cell lung cancer (NSCLC) patients with metastasis treated with vinorelbine and cisplatin achieved a significantly better global response to treatment than conventional treatment

Eligibility Criteria:
Inclusion Criteria:

* Histopathologic diagnosis of non small-cell lung cancer
* Clinical stage IIIA and/or IIIB without pleural effusion
* ECOG functional status 0 or 1
* No renal function alteration (GFR \>50%)
* No hepatic function alteration (ALT and AST less than 2 times its normal value)
* Leucocytes more than 2,000/mcl
* Hemoglobin more than 10mg/dL
* Platelets more than 100,000/mcl

Exclusion Criteria:

* Ischemic heart disease
* Abnormal electrocardiogram
Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women

1. Sex hormone including estrogen have synergistic effect to serotonin activity and decrease activity of monoamine oxidase activity so the norepinephrine is not be metabolized, these substance are important to regulate hemostasis and circadian process of sleep
2. Estrogen also regulate gamma-aminobutyric acid (GABA) secretion

   * GABA substance is in order to initiate sleep and continue sleep
3. According to epidemiologic data, problem of sleep was increasing in postmenopause group compare to premenopause group (aged-match)
4. This research perform to find out the actual effect of estrogen in improving sleep quality.

1. 40-60 year-old postmenopausal women with insomnia and mild-moderate vasomotor symptom were screened and included in project
2. Block of four randomization was use to categorize participants into 2 groups

   * Study group (estrogen patch)
   * Control group (placebo patch)
3. Sleep quality was measured before intervention by subjective and objective sleep quality

   * Subjective sleep quality (self sleep questionnaire)
   * Objective sleep quality (wrist actigraphy and sleep diary):

   wrist actigraph sleep test at home for 1 week
4. Intervention phase : continuous use of weekly patch for 8 weeks

   * Estrogen patch in study group
   * Placebo patch in control group
5. Follow up phase

   * At 4 weeks of use, investigator will telephone call for follow up the participant's compliance and the side effects during patch use.
   * After completed use of 7th patch, sleep quality was measured again, self sleep quality questionnaire and 1 week-wrist actigraphy and sleep diary test
6. Then the data will be analysed and open label, in nonhysterectomized postmenopausal women in study group will take the medroxyprogesterone acetate for washing out the endometrium for 2 weeks
7. The participants will be counseled, further investigate and proper treatment.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women 40-60 years old
* Mild to moderate vasomotor symptom
* Insomnia
* fluent read and write in Thai language
* Inform consent

Exclusion Criteria:

* Acute liver and gall bladder disease
* undiagnosed abnormal bleeding per vagina
* History of BIRADs 3 from mammogram
* History or current venous thrombosis, embolism
* diagnosis of sleep disorder
* use of hypnotic drug or antihistamine in the past month
* Diagnosis of psychiatric disorder such as depressive disorder, schizophrenia, anxiety disorder
* No past history of malignancy
* No history of chronic renal disease, alzheimer's disease, uncontrolled hypertension, uncontrolled diabetes mellitus
* history of estrogen use in past 6 months
* drug abuse, Alcohol
Efficacy of the ASPEN Intervention Program in Low-Resource Communities

The ASD Screening and Parent ENgagement (ASPEN) program is a culturally adapted, parent-mediated intervention program. The ASPEN program is tailored to address social communication and behavioral difficulties that young children with developmental delays may experience in early childhood. The ASPEN Program includes 12 sessions where parents are provided with psychoeducation about self-care, child development, and evidence-based strategies. Coaching is also provided to train parents on using evidence-based strategies within the home setting. The ASPEN program is delivered by a student clinician and a peer leader. We hypothesize that coaching strategies delivered by the clinician will lead to primary family caregivers learning evidence-based strategies and this will result in improved child outcomes. We hypothesize that education and family support delivered by peer leaders will help primary family caregivers learn social support strategies and this will lead to improved parent outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Child is between 18 months through 6 years of age
* Child has a medical diagnosis or educational classification of Autism or Autism Spectrum Disorder (ASD) or child is at-risk for Autism/ASD as determined by the Modified-Checklist for Autism in Toddlers - Revised/Follow-up Interview (M-CHAT-R/F) and/or Social Communication Questionnaire (SCQ)
* Child resides in a low-resource household as determined by at least one of the following criteria:
* -Child or family has Medicaid as an insurance provider
* -Child's primary caregiver has achieved a high school or lower education
* -Child resides in a household with an annual income of 200% of the Federal Poverty Level

Exclusion Criteria:

* Primary caregiver does not speak/understand English or Spanish
* Child is younger 18 months or older than 6 years of age
* Child does not have a medical diagnosis or educational classification of Autism/ASD or does not meet at-risk criteria on the M-CHAT-R/F and/or SCQ
* Child does not reside in low-resource household
Can Sensorimotor Function Predict Graft Rupture After ACL Reconstruction

In this longitudinal prospective cohort study including young people with anterior cruciate ligament (ACL) reconstruction, the investigators will evaluate if poor sensorimotor function at baseline can predict 1) graft rupture 2) the risk of contra-lateral ACL injury and 3) failure to return to sport/previous activity level within 3 years following ACL reconstruction.

In this longitudinal prospective cohort study including young athletic men and women (aged 15-35) with ACL reconstruction (ACLR), it will be investigated if poor sensorimotor function at baseline (1 year post ACLR), such as hop performance, muscle strength and postural orientation can predict 1) graft rupture 2) the risk of contra-lateral ACL injury and 3) failure to return to sport/previous activity level within 3 years following ACLR.

Statistics Separate logistic regression models will be used to elucidate the influence of each muscle sensorimotor function variable on the outcomes (graft rupture, contra-lateral injury, return to sport/activity level failure), adjusted for potential confounders. With the LSI for the single-leg hop test as main outcome, power calculations show that with a re-injury rate of 7%, an estimated odds ratio of 0.95, power=80% and alpha=5 %, at least 174 individuals are needed. Based on this calculation, 200 individuals will be included for the prospective analysis, allowing for an approximate drop-out of 10%.

Eligibility Criteria:
Inclusion Criteria:

* 8-16 months after ACL reconstruction
* With or without associated injuries to other structures of the knee (e.g., collateral ligament(s), meniscal injury)
* Age 15-35 years.

Exclusion Criteria:

* ACL injury other knee and previous ACL injury index knee
* Diseases or disorders overriding the knee condition (e.g., neurological or rheumatological disease)
* Not understanding the languages of interest (any Scandinavian language or English).
A Study of the Pharmacokinetics and Pharmacodynamics of MK1809 (1809-001)(COMPLETED)

The goal of this study is to identify at least one safe and well tolerated dose of MK1809 that has similar pharmacokinetic qualities as 100 mg losartan.


Eligibility Criteria:
Inclusion Criteria:

Part 1:

* Nonsmoker for at least 6 months
* Body Mass Index (BMI) less than or equal to 29 kg/m2
* In overall good health

Part 2:

* Body Mass Index (BMI) greater than 18kg/m2 and less than or equal to 35kg/m2
* In overall good health (patients with hypertension and/or hyperlipidemia are accepted)

Exclusion Criteria:

Part 1:

* History of any cardiovascular disease or any clinically significant family history of cardiac arrhythmias or conduction abnormalities at an age less than 60 years
* History of any major endocrine, vascular, hematologic, gastrointestinal, hepatic, renal or genitourinary disease/disorder
* History of cancer
* Clinically significant history of a neurological disorder (includes epilepsy,stroke, transient ischemic attack, classic migraines)
* Active or history of a psychiatric disorder (includes depression, bipolar disorder, schizophrenia, anxiety)
* History of asthma, severe wheezing, COPD, or other pulmonary disease
* Individual or family history of bleeding or hemorrhagic diathesis, or bleeding difficulties
* Major surgery, donated blood or participated in another investigational drug(s) trial within 30 days
* Illicit drug use (including recreational); or history of drug or alcohol abuse (within 2 years)
* Nitrate therapy within 4 weeks
* History of significant drug allergy or history of food allergies

Part 2

* History of any clinically significant cardiac or cardiovascular disease (other than hypertension)
* History of any major endocrine, vascular, hematologic, gastrointestinal, hepatic, renal or genitourinary disease/disorder
* History of cancer
* History of a neurological disorder (includes epilepsy,stroke, transient ischemic attack, classic migraines)
* Active or history of a psychiatric disorder (includes depression, bipolar disorder, schizophrenia, anxiety)
* History of asthma, severe wheezing, COPD, or other pulmonary disease
* Individual or family history of bleeding or hemorrhagic diathesis, or bleeding difficulties
* Illicit drug use (including recreational); or history of drug or alcohol abuse (within 2 years)
* Surgery, significant blood loss, donated blood, or participated in another investigational drug(s) trial within 30 days
* Nitrate therapy within 4 weeks
* History of significant drug allergy
Warfarin Dosage Adjustment Model Analysis Study

Despite the wide availability of Direct oral anticoagulation (DOAC), warfarin remains an important oral anticoagulant1 especially in patients with mechanical valve replacement or chronic renal failure where the evidence of DOAC is limited. However, the dosing of warfarin is challenging as it has a narrow therapeutic index and is highly influenced by dietary vitamin K intake and drugs that interacts with cytochrome (CYP) P4501. The time outside therapeutic range will carry the risk of adverse events such as thrombosis and bleeding. Numerous algorithms have been proposed that utilized either clinical or pharmacogenetics factors. The Clinical Pharmacogenetics Implementation Consortium (CPIC) has recommended the use of 4 dosing algorithms. However, these algorithms require the input of genetic information such as CYP2C9 and VKORC1 type which are not widely available locally and are less relevant in maintenance phase. Furthermore, these algorithms target mainly at predicting the initiation and the maintenance dose of warfarin. This has provided us with the opportunities to explore the Prediction model for on-treatment warfarin dose titration for outside therapeutic range.

Despite the wide availability of Direct oral anticoagulation (DOAC), warfarin remains an important oral anticoagulant1 especially in patients with mechanical valve replacement or chronic renal failure where the evidence of DOAC is limited. However, the dosing of warfarin is challenging as it has a narrow therapeutic index and is highly influenced by dietary vitamin K intake and drugs that interacts with cytochrome (CYP) P4501. The time outside therapeutic range will carry the risk of adverse events such as thrombosis and bleeding. Numerous algorithms have been proposed that utilized either clinical or pharmacogenetics factors. The Clinical Pharmacogenetics Implementation Consortium (CPIC) has recommended the use of 4 dosing algorithms. However, these algorithms require the input of genetic information such as CYP2C9 and VKORC1 type which are not widely available locally and are less relevant in maintenance phase. Furthermore, these algorithms target mainly at predicting the initiation and the maintenance dose of warfarin. This has provided us with the opportunities to explore the Prediction model for on-treatment warfarin dose titration for outside therapeutic range.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have been on maintenance warfarin treatment
2. Patients whose INR have fallen outside therapeutic range will be identified using CDARS enquiry

Exclusion Criteria:

1. No exclusion criteria