cyrilzakka/clinical-trials huggingface dataset:
The Application of Zishen Yutai Pill in Aged Women Undergoing IVF-ET

To explore the application of Zishen Yutai Pill in controlled ovarian stimulation and effect on pregnancy outcome in aged women undergoing in vitro fertilization-embryo transfer.

This will be a multi-center double-blind randomized controlled trial, which aims to explore the application of Zishen Yutai Pill in controlled ovarian stimulation and effect on pregnancy outcome in aged women undergoing in vitro fertilization-embryo transfer.The target population will be infertile women aged between 35 and 42 years, BMI\<28kg/m2 and bilateral ovaries who undergo IVF-ET (long or antagonist protocol). Qualified 1,466 patients are randomized into either of two groups.They will be randomized to receive either Zishen Yutai Pill or the placebo. The pregnancy test results and pregnancy complications will be followed up by checking medical records and telephone calls.

Eligibility Criteria:
Inclusion Criteria:

* infertile women aged ≥35 and ≤42 years;
* intend to undergo IVF/ICSI-ET (GnRH-a long protocol or GnRH-ant protocol);
* BMI\<28kg/m2;
* bilateral ovaries exist;
* patients who voluntarily signed the informed consent and agreed to be followed up as required by the study protocol.

Exclusion Criteria:

* repeated implantation failure (previous three times or more IVF/ICSI-ET failure);
* adenomyosis, uterine line constricted by uterine fibroid;
* untreated bilateral hydrosalpinx;
* endometrial diseases that have not been cured ;
* known diseases that are not suitable for undergoing assisted reproductive technology or at the present not suitable for pregnancy;
* patients who have taken traditional Chinese medicine or Chinese patent medicine for infertility treatment in the last month(30 days).

Exit Criteria:

* subjects who have adverse events cannot be tolerated;
* severe breach of the protocol;
* for subjects who exit due to personal or unpredictable reasons, please describe specific details;
* subjects considered inappropriate to continue to participate in the study for other medical reasons.
Efficacy Study of Cilostazol and Aspirin on Cerebral Small Vessel Disease

There may be a difference in efficacy of cilostazol and aspirin on progression of white matter changes in cerebral small vessel disease.

The primary objective of this study is to compare the efficacy of aspirin and cilostazol on volume of white matter changes in cerebral small vessel disease.

The secondary objectives are to compare the impact of aspirin and cilostazol on DTI parameters, lacune, microbleeds, brain atrophy, cognition, depression, neurologic signs, gait, urination, and activities of daily living.

We also investigate risk factors associated with progression of cerebral small vessel disease.

Eligibility Criteria:
Inclusion Criteria:

* 50 to 85 years of age
* He/She can walk to the hospital (walker or cane is permissible).
* Cerebral small vessel disease is observed on brain MRI.

  1) presence of one or more lacunar infarction and 2) moderate or severe confluent leukoaraiosis (defined as grade 2 or 3 on a modified Fazekas scale): periventricular WMCs with cap or rims lager than 5mm and deep subcortical WMCs \>10 mm in maximum diameter
* written informed consent

Exclusion Criteria:

* Any patient with contraindication of antiplatelets
* Any patient with cardioembolic source
* Carotid bruit or large cerebral artery stenosis \>50%
* Cortical infarction or subcortical infarction lager than 1.5 cm
* bleeding tendency
* chronic liver disease (AST or ALT \>100 IL/L)
* chronic renal disease (Creatinine \>3.0mg/dL)
* active gastrointestinal ulcer
* any patients with any severe or unstable medical disease that may prevent them from completing study requirements (i.e., unstable or severe asthma)
* Anemia (Hb \<10g/dL) or thrombocytopenia
* Cardiac pacemaker or contraindication to MRI
* Pregnancy or breast-feeding
* drug or alcohol addiction
* Any other white matte disease (i.e., Multiple sclerosis, sarcoidosis, or brain irradiation, etc) or brain tumor
* Parkinson's disease, Alzheimer's disease or any other neurodegenerative disease
* any hearing or visual impairment that can disturb the efficient evaluation of the patient
* recent cerebral infarction with 3 months
Deacylated Ghrelin and Beta Cell Function

Use of human unacylated ghrelin (UAG, also called des-octanoyl ghrelin) to study physiology in healthy subjects. The proposed research is an investigator-initiated study funded by the National Institutes of Health designed to examine the effect of physiologic levels of UAG on the regulation of glucose homeostasis as well as beta cell function.


Eligibility Criteria:
Inclusion Criteria:

1. Apparently healthy men and women. Only premenopausal women who are using an adequate method of contraception at Screening and who agree to continue the contraception during the study will be included. Male subjects do not need to use on birth control.
2. Ages between 18 and 50 years, inclusive.
3. BMI between 18.5 and 29.9 kg/m2, inclusive

Exclusion Criteria:

1. History or clinical evidence of impaired fasting glucose or impaired glucose tolerance or diabetes mellitus, myocardial infarction, history or symptoms of congestive heart failure, history of cancer or anorexia nervosa, history or active liver or renal disease (AST or ALT \>2x upper limits of normal, calculated glomerular filtration rate \[GFR\] \<60).
2. A baseline resting systolic blood pressure of less than 100 mm Hg.
3. History of growth hormone deficiency or excess disorders (acromegaly, pituitary gigantism, panhypopituitarism); history of adrenal insufficiency or Cushing's disease/syndrome; history of neuroendocrine tumors.
4. Anemia defined as hematocrit \<33%.
5. Use of medications that alter insulin sensitivity: niacin, glucocorticoids, metformin, thiazolidinediones, exenatide, or atypical anti-psychotics.
6. Pregnancy or lactation.
7. BMI \<18 kg/m2 or BMI \>30 kg/m2; fasting plasma glucose \>100 mg/dl and/or 2 hr plasma glucose \>140 mg/dl on a 75 g oral glucose tolerance test.
8. Electrocardiogram (ECG) abnormalities: specifically, myocardial ischemia, previous myocardial ischemia, atrial fibrillation, second or third degree heart block and complete right or left bundle branch block.
9. Females who are on progesterone-only contraception and those who have irregular menses.
Fundus Oculi and Erectile Dysfunction

The purpose of this study is to evaluate the correlation between fundus oculi's vascularization in patients with erectile dysfunction and not, and, in the same patients, before and after using drugs for ED.

The purpose of this study is to evaluate the correlation between fundus oculi's vascularization in patients with erectile dysfunction and not, and, in the same patients, before and after using drugs for ED.

In this monocentric, prospective, observational case-control study 40 eyes of 40 patients affected by erectile dysfunction and 20 healthy age-matched controls will be enrolled.

Patients will undergo DVA examination at baseline and 6 months after PDE5I therapy. Healthy subjects will be examined with DVA at baseline only.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with erectile dysfunction diagnosis (organic and psychogenic);
* Subjects with Erectile Dysfunction diagnosis defined by IIEF score ≤ 25
* Subjects with stable partner for at least 6 months and sexually active.
* Subjects aged between 40 - 60 years;
* Signature of informed consent for patients

Exclusion Criteria:

* Subjects with ED secondary diagnosis to hormonal alterations (i.e. hypogonadism, hypo / hyperthyroidism, hyperprolactinemia);
* Subjects with a diagnosis of ED post-traumatic and iatrogenic, since after pelvic surgery;
* Subjects suffering from any ocular pathology that involves use of contact lenses and / or glasses;
* Subjects smoking;
* Individuals with uncontrolled systemic diseases;
* All persons who do not confirm at least one criterion for inclusion.
Social Forces to Improve Statin Adherence (Study B)

To assess the effectiveness of social comparison in improving the outcome of statin adherence versus usual care as measured by an electronic pill bottle.

Subjects receiving weekly reports with their adherence and information about their place in the distribution of their peers will have the highest statin adherence of any arm, as measured by electronic pill bottle.

We propose to complete a randomized controlled trial (RCT) of 201 subjects with medication treated diabetes and evidence of poor adherence to a statin medication (\<70% medication possession ratio (MPR) determined through pharmacy records; no combination meds). Study subjects will use GlowCaps to store their statin medication.

Arm 1 will receive weekly feedback containing general information about the subject's adherence (i.e., reminding the subject how many days that week he or she took the medication). Arm 2 will be provided the same weekly feedback and the information of whether his or her adherence is above or below the average adherence in their arm, along with a message of encouragement tailored to their place in the arm distribution. Subjects with perfect adherence will receive: "You took your pill every day for the last 7 days. Great job! Keep it up" with their weekly adherence report. Subjects with less than perfect adherence and adherence rate in the top 50% of the arm will receive: "You took your pill for \*\* days out of the last 7 days. Your medication adherence was as good or better than half of people in this study. Taking your pill every day would improve your health even more" with their weekly adherence report. Subjects with less than perfect adherence and adherence rate in the bottom 50% of the arm will receive: "You took your pill for \*\* days out of the last 7 days. Your medication adherence was in the bottom half of the people in this study. If you took your pill more often, you could be in the top half of people in the study" with their weekly adherence report. Adherence records will be displayed on each subject's Way to Health (WTH) account in all arms. Arm 3 will be the usual care control.

Eligibility Criteria:
Inclusion Criteria:

* The subject is Humana insured
* The subject is an English speaking adult
* Age range ≥18 years
* The subject has diagnosis with diabetes for ≥12 months
* The subject has an MPR \<70% to a statin medication
* Subjects denies side-effects to their statin medication

Exclusion Criteria:

* The subject is \<18 years old
* The subject is considered part of a vulnerable population (is a prisoner, a cognitively impaired person, or a pregnant woman)
* On statin combination medication
* The subject does not identify an individual who agrees to serve as their MAP
* The subject reports a clinically important side effect to the statin medication or active liver disease
Parkinson Disease Before and After Medication and Rehabilitation Treatment

In this three-year project, our research teams are going to consecutively explore these important clinical, drug and physical rehabilitation treatment effects, noradrenergic network, autonomic dysfunction and microRNA signalling data as well as the correlations between them in early Parkinson Disease (PD) patients. The investigators hypothesize that the explorations of the above insights are unique and can provide an important source data for Taiwanese Parkinson Disease (PD).

(1) 70 patients with PD. (2) 30 age and sex-match controls.

Methods:

-1st year To built up the biobank of 30 early PD patients (Hoehn and Yahr stage 1-3) and 30 health controls in all examination.

The PD patients will accept the MRI, autonomic dysfunction, and peripheral microRNA examination and their correlations among each other at least 12 hours after the least medication.

-2nd year Second year, the investigators will follow-up the 30 PD patients enrolled in the 1st years.

The PD patients will receive studies to evaluate the pharmacokinetics effect before medication, including MRI, autonomic dysfunction, and peripheral microRNA examination.

-3rd year the investigators will study the rehabilitation effect in PD (3 days per week, for 12 weeks).

30 PD with rehabilitation and 30 PD without rehabilitation will be enrolled and compared their difference in MRI study, autonomic dysfunction, and peripheral microRNA examination before and after 3 month follow-up.

Goals

1. To define the effect of norepinephrine network to autonomic dysfunction in PD
2. To define the effect of peripheral microRNA level to norepinephrine network in PD
3. To associate drug/physical rehabilitation effect to alteration of norepinephrine network, autonomic dysfunction, and peripheral microRNA and their interactions to striatal dopaminergic network in PD.
4. According to previous results, to verify the role of norepinephrine network and autonomic dysfunction in long-term PD evolution.

Eligibility Criteria:
Inclusion Criteria:

* In this study, the patients should be 40-75 years of age and identified as PD. PD patients with an early clinical stage (Hoehn and Yahr stage 1-3) will be enrolled in this study. The informed written consent which is approved by Ethics Committee of our hospital will be obtained from the patient or their family.

Exclusion Criteria:

* Patients with the following conditions are excluded:

  1. Atherosclerotic narrowing on intracranial and extracranial vessels (\>50% stenosis) with or without evidence of old cerebral infarctions, coronary artery diseases status post percutaneous transluminal coronary angioplasty or bypass surgery and renal failure requiring hemodialysis or peritoneal dialysis
  2. Moderate to severe heart failure (NYHA class III and IV).
  3. Central or peripheral disorders known to affect autonomic nervous systems.
Pressure Ulcer Monitoring Platform (PUMP)

This study will employ two monitoring device prototypes. The devices are sensors containing accelerometers and gyroscope. The raw output data will be analyzed to determine when patients are moved or are repositioned in their beds. The data is captured within a modem which will correlate these movements with video recordings for interpretation by the research team. One sensor is wearable on the patient gown or sleepwear, and the other is placed underneath the frame of the hospital bed. The investigators propose a non-blinded trial with n=10 where all subjects will undergo the two devices. A video camera will be placed in each subject room for recording the repositioning events to correlate the monitor signals with the actual subject repositioning captured by the video. The goal of the trial is to validate the ability of each of the sensor prototypes to accurately detect when subjects are turned, in order to reduce stationary positioning which contributes to the incidence of pressure ulcers and to improve compliance with patient repositioning trials.

The investigators propose a non-blinded trial with n=10 where all subjects will undergo the two devices. A video camera will be placed in each subject room for recording the repositioning events to correlate the monitor signals with the actual subject repositioning captured by the video. The goal of the trial is to validate the ability of each of the sensor prototypes to accurately detect when subjects are turned, in order to reduce stationary positioning which contributes to the incidence of pressure ulcers and to improve compliance with patient repositioning trials. The repositioning events recorded by the sensor devices will be automatically uploaded and abstracted by the research team, along with the events captured by the simultaneous video recording of patient repositioning.

Eligibility Criteria:
Inclusion Criteria:

* Subject is over 18 years of age
* Subject is immobile and/or unable to independently re-position self

Exclusion Criteria:

* Subject is under the age of 18 years
* Subject is able to independently re-position self
Screening for Obstructive Sleep Apnea Among Members of an Internet Weight Loss Community

The current study was a pilot, double blind, randomized controlled trial to (1) evaluate the feasibility of an online obstructive sleep apnea (OSA) screening intervention, (2) estimate effect size for planning of future studies, and (3) test the hypothesis that the intervention, compared to a control condition, would lead more individuals to discuss OSA with their healthcare provider.


Eligibility Criteria:
Inclusion Criteria:

* Member of SparkPeople.com community and logged on within previous month
* Live in the US

Exclusion Criteria:

* Prior diagnosis of OSA
* Prior discussions with healthcare provider about OSA
Prevalence of Congenital Uterine Malformations

Aims: We plan to investigate how common uterine malformations are in high-risk women (with history of miscarriage or preterm delivery), by analysing different characteristics in these groups. This study will also investigate other ultrasound characteristics detected on these women. This study will point towards the possible mechanism of how uterine malformations may affect pregnancy outcomes.

Background: Congenital abnormally shaped wombs (uterine malformations) have long been thought to be more common in women with poor pregnancy outcomes, e.g. miscarriage (Rackow and Arici 2007) and preterm delivery (Tomazevic, Ban-Frangez et al. 2007). However, the true prevalence is difficult to assess as there are no universally agreed classification systems and some of the best investigations are invasive. In addition, previous prevalence studies have not examined the details of subfertility or pregnancy loss, such as duration of subfertility, the gestation of pregnancy loss, or miscarriage pattern.

Aims: We plan to investigate how common uterine malformations are in high-risk women (with history of miscarriage or preterm delivery), by analysing different characteristics in these groups. This study will also investigate other ultrasound characteristics detected on these women. This study will point towards the possible mechanism of how uterine malformations may affect pregnancy outcomes.

Methods: We plan to recruit women who have had miscarriage or preterm delivery into our study. A sample of women who had normal term deliveries will be recruited as comparison. All women will undergo one 3-dimensional ultrasound scan each.

Outcomes: The proportions of women with congenital uterine malformations will be determined. Any ultrasound-detected markers found especially in women with poor pregnancy outcomes may point towards how uterine malformations affect pregnancies.

Eligibility Criteria:
Inclusion Criteria:

1. Women with a previous miscarriage

   * Age: 18 years old or more
   * Definition of miscarriage: the spontaneous pregnancy loss up until 24 weeks of gestation, where the pregnancy was confirmed histologically or with previous presence of a gestational sac with or without fetal pole and fetal heart activity on ultrasound scanning.
   * At least 8 weeks after the end of last pregnancy
2. Women with preterm birth

   * Age: 18 years old or more
   * Definition of preterm birth: birth at less than 37 weeks of gestation.
   * At least 8 weeks after the end of last pregnancy
3. Control group (women with term birth)

   * Age: 18 years old or more
   * Definition of term birth: birth at 37 or more weeks of gestation
   * At least 8 weeks after the end of last pregnancy

Exclusion Criteria:

* Pregnant at the date of the 3D TVUS
* Recent uterine or endometrial surgery
* Women unable to tolerate 3D TVUS
* Unable to give informed consent
A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris

The objectives of this study are to assess the safety and efficacy DRM01 Topical Gel compared to vehicle in patients with acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Male or non-pregnant, non-lactating females.
* Age ≥ 18 years.
* Clinical diagnosis of facial acne vulgaris defined as:
* At least 20 inflammatory lesions
* At least 20 non-inflammatory lesions
* Investigator Global Assessment of 3 or greater.

Exclusion Criteria:

* Active cystic acne or acne conglobata, acne fulminans, and secondary acne.
* Two or more active nodulocystic lesions.
* Screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the Investigator.
* Abnormal findings on screening ECG, deemed clinically significant, by the Investigator.
* Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days or 5 half-lives (whichever is longer) of the Baseline visit.
* Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections, in the opinion of the investigator.
* Treatment with over-the-counter topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, α-hydroxy/glycolic acid on the face within 2 weeks prior to Baseline.
* Treatment with systemic corticosteroids (use of intranasal and inhaled corticosteroids allowed for seasonal allergies and asthma) within 4 weeks prior to Baseline.
* Treatment with systemic antibiotics or systemic anti-acne drugs or systemic anti-inflammatory drugs within 4 weeks prior to Baseline.
* Prescription topical retinoid use on the face within 4 weeks of Baseline (e.g., tretinoin, tazarotene, adapalene).
* Treatment with a new hormonal therapy or dose change to existing hormonal therapy within 12 weeks prior to Baseline. Dose and frequency of use of any hormonal therapy started more than 12 weeks prior to Baseline must remain unchanged throughout the study. Hormonal therapies include, but are not limited to, estrogenic and progestational agents such as birth control pills.
* Prior use of androgen receptor blockers (such as spironolactone or flutamide).
* Oral retinoid use (e.g., isotretinoin) within 12 months prior to Baseline or vitamin A supplements greater than 10,000 units/day within 6 months of Baseline.
* Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8 weeks or during the study.
Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation

Constipation following elective Caesarean sections (CS) is a common problem experienced by up to 50% of patients (1). The causes for this are multifactorial and include manipulation of the bowel during surgery, immobilisation and opiate based anaesthetic and analgesic techniques. To try to alleviate the problem of postoperative constipation, some anaesthetists prescribe postoperative lactulose in addition to postoperative analgesia, although no data exists that shows whether this has any beneficial effect on postoperative constipation.

1. Short term morbidity associated with Caesarean delivery. Hillan EM. Birth. 19 (4): 190-4).


Eligibility Criteria:
Inclusion Criteria:

* All patients aged 16 years or older able to give informed consent undergoing their first or second elective CS

Exclusion Criteria:

* Unable to give informed consent
* A basic level of literacy sufficient to complete postoperative form.
* History of constipation
* Regular opiate use
* Previous bowel surgery or bowel adhesions
* Lactose intolerant
* Diabetic
* Any patient unable to have spinal Anaesthesia
* Allergies/intolerant to bupivacaine, diamorphine, diclofenac, cocodamol, lactulose
* Patients receiving injury to bowel intraoperatively
* Patients receiving additional opiates perioperatively