cyrilzakka/clinical-trials huggingface dataset:
Blood Pressure Lowering Effects of Amosartan Regarding Proviso iN Patients With High Blood Pressure

Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients with Hypertension

After taking Amozatan (AMS, amlodipine / rozanthin combination) in patients with essential hypertension, the percentage of patients who reached the mean systolic target blood pressure was evaluated

Eligibility Criteria:
Inclusion Criteria:

* Patients with essential hypertension whose blood pressure is not adequately controlled by amlodipine or rosartan monotherapy
* In patients with stage 2 hypertension (SBP 160-179 mmHg), patients requiring a combination therapy to reach the target blood pressure
* Patients who were changed to amosartan while using other hypertensive agents

Exclusion Criteria:

* Patients with hypersensitivity to dihydropyridine derivatives of amosartan
* Women who are pregnant or who may be pregnant and breastfeeding
* Patients with severe hepatic dysfunction
* Patients with severe aortic stenosis
* Patients at risk of shock
* Patients participating in other clinical studies
Programming by Estrogen Treatment in Gonadotropin Releasing Hormone Antagonist Protocol

The purpose of this study is to determine if pretreatment with Estrogen can assist in the planning and programming of In Vitro Fertilization treatments.

A randomised controlled trial in which study group will be given estrogen derivative before ovarian stimulation in GnRH antagonist protocol and compared to the classical GnRH agonist protocol.Estrogen will be given P.O , "PROGYNOVA' , in a dose of 2 mg /d, starting day 2 of menses and until first Monday to follow. Main outcome measure will be ability to control the ovum pickup day, calculated as a rate of ideal pickups divided by the entire pickup number. All women enrolled will be under 38 years of age, with a clear indication for IVF other than ovulatory dysfunction. women with past 4 treatment failures will be excluded as well as cases in which sperm achieved in surgical methods.

Eligibility Criteria:
Inclusion Criteria:

* IVF treatment in the following indications: Male, Mechanical, Unexplained
* Age\<38 years
* Treatment Cycle number 1-4

Exclusion Criteria:

* Ovulatory disorder as an indication for IVF
* Repeated failure in previous IVF treatments (\> than 4 cycles)
* Sperm used for treatment was retrieved by surgical procedure
An Extension Trial to a Phase I Dose Escalation Study of Gimatecan Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor

CLBQ707A1101 assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients.


Eligibility Criteria:
Inclusion criteria:

* Patients completing the core protocol (CLBQ707A1101, NCT00410358) exhibiting stable disease, or a partial or complete response as defined by the core protocol. If patients only have non-measurable lesions, he/she must not be exhibiting progressive disease

Exclusion criteria:

* Documented progressive disease as defined by the core protocol
* Patients with performance status of 3 or 4 on the ECOG scale

Other protocol-defined inclusion/exclusion criteria may apply
Safety and Efficacy of STSP-0601 in Adult Patients with Hemophilia a or B with Inhibitor

This study will assess the safety and efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitor.


Eligibility Criteria:
Inclusion Criteria:

1. 18 ≤age≤70 years of age,male.
2. Hemophilia A or B patients. (No less than 3 patients with hemophilia B)
3. Peak historical inhibitor titer ≥ 5 BU and apositive inhibitor test when enrolled.
4. Establish proper venous access.
5. There were at least 3 bleeding events that requiring treatment occurred in the past 6 months before screening (Only applicable to the on-demand treatment stage).
6. Agree to use adequate contraception to avoid pregnancy. Agree not to donate sperm or eggs.
7. Provide signed informed consent.

Exclusion Criteria:

1. Have any coagulation disorder other than hemophilia.
2. Plan to receive prophylactic treatment of coagulation factor during the trail.
3. Patients plan to receive Emicizumab during the trial.
4. Patients received anticoagulant or antifibrinolytic therapy 7 days before enrollment or plan to receive these drugs during the trial.Patients received anticoagulation therapy (such as coagulation factor replacement therapy, prothrombin complex, plasma, etc.) 7 days before enrollment.
5. Have a history of arterial and/or venous thrombotic events.
6. Platelet \<100×109/L.
7. Hemoglobin\<90g/L.
8. Severe liver or kidney disease.
9. Severe bleeding event occurred within 4 weeks before enrollment.
10. Accepted major operation or blood transfusion within 4 weeks before enrollment.
11. Have a known allergy to STSP-0601.
12. Pregnant, lactating, or blood pregnancy test positive female subjects
13. Participate in other clinical research within 4 weeks before enrollment(except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails).
14. Within 1 day prior to enrollment, FVII, FVIIa, tranexamic acid, and aminocaproic acid were used. Within 3 days prior to enrollment, prothrombin complex, FVIII, and FIX were used. Within 4 weeks prior to enrollment, treatment with amisulumab was received.
15. Patients not suitable for the trail according to the judgment of the investigators.
Pulmonary Vein Isolation (PVI) Combined With Renal Denervation (RDN) in Atrial Fibrillation (AF) and Hypertension (HTN)

The close relationship between the increase of sympathetic tension, AF, and HTN cannot be ignored. In addition, the significant failure rate of PVI (20-50%) in the treatment of AF makes it very necessary to explore the effect of RDN on AF. Therefore, this study aims to compare the effects and safety of PVI alone and PVI combined with RDN with AF combined with HTN, which will open a new chapter for PVI combined with RDN in the treatment of AF.


Eligibility Criteria:
Inclusion Criteria:

* 18\<age\<75years
* clinic blood pressure≥140/90mmHg or 24-hour ambulatory blood pressure monitoring average blood pressure ≥135/85mmHg
* Ecg diagnosis of atrial fibrillation ;
* who signed informed consent and were approved by the Ethics Committee of the First Affiliated Hospital of Xiamen University.

Exclusion Criteria:

* pregnant women or lactating patients;
* Patients who were unsuitable for ablation before surgery （unilateral or bilateral renal artery shape and structure were found： renal artery stenosis exceeding 50%, renal aneurysm, previous renal artery interventional surgery, renal artery malformation, renal artery diameter \< 4mm or length of treatable segment \< 20mm）
* Patients who only have one kidney or have a history of kidney transplantation
* Patients with a history of renal arterial intervention or renal denervation
* identified secondary hypertension or Pseudo hypertension except for renal parenchymal hypertension;
* malignant tumors or end-stage diseases;
* Severe peripheral vascular disease, abdominal aortic aneurysm
* whose left atrium is larger than 55mm
* obvious bleeding tendency and blood system diseases;
* Severe peripheral vascular disease, abdominal aortic aneurysm;
* A history of the acute coronary syndrome within two weeks;
* acute or severe systemic infection;
* drug or alcohol dependence or refusal to sign informed consent.
* Other conditions that are not suitable for PVI and RDN
Mindfulness, Exercise and Nutrition To Optimize Resilience for Individuals With a Spinal Cord Injury.

The purpose of this study is to examine the effects of onsite and telehealth programs for individuals with spinal cord injury. The primary aim of this study is to compare the effectiveness of a blended 5-day onsite health promotion program followed by a 12-month telehealth package composed of exercise, nutrition, and mindfulness, to a 12-month telehealth-only package in individuals with spinal cord injury. The investigators hypothesize that the blended onsite and telehealth program will achieve better gains in fitness, dietary control, body composition, and pain management scores across a one-year period in comparison to the telehealth-only group. The secondary objective of this study is to examine changes in psychosocial mediators between the two groups to determine if key social cognitive theory constructs were significantly different between the two groups. The investigators hypothesize that the blended onsite and telehealth program will achieve better improvements in these outcomes compared to the telehealth only group.


Eligibility Criteria:
Inclusion Criteria:

* SCI ≥ 1 year post injury
* Able to use arms for exercise
* 18-60 years old
* Reliable access to the internet
* Ability to prepare own food, or have input into person responsible for food preparation
* Can provide own self-care.

Exclusion Criteria:

* Cognitive impairment
* Depression
* Poorly controlled blood pressure (SBP ˃ 159 or DBP ˃ 95 mm HG)
* Cardiovascular disease event within the past six months
* Severe pulmonary disease
* Renal failure
* Current use of insulin or sulfonylurea agents
* Current use of medications for psychosis or bipolar disorder
* Active pressure ulcers
A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity

The main purpose of this study is to evaluate the efficacy and safety of retatrutide compared to tirzepatide in adults who have obesity. The study will last about 89 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight.

Exclusion Criteria:

* Have a self-reported change in body weight \>5 kilograms (kg) (11 pounds) within 90 days before screening.
* Have a prior or planned surgical treatment for obesity.
* Have a prior or planned endoscopic procedure and/or device-based therapy for obesity.
* Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
* Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2).
* Have had within the past 90 days before screening:

  * acute myocardial infarction
  * cerebrovascular accident (stroke)
  * coronary revascularization
  * hospitalization for unstable angina, or
  * hospitalization due to congestive heart failure.
* Have New York Heart Association Functional Classification Class IV congestive heart failure.
* Have a history of chronic or acute pancreatitis.
Nexalin Therapy for the Treatment of Depressive Symptoms

The primary objectives of this Phase II study are to demonstrate the safety of Nexalin Therapy and to investigate the efficacy of Nexalin Therapy.

This randomized, double-blind, placebo-controlled, multi-center trial has 3 different treatment arms.

Study Tools:

* Hamilton Depression Rating Scale (HAM-D21)
* Clinical Global Impressions (CGI)
* Montgomery-Asberg Depression Rating Scale (MADRS)
* Beck's Depression Inventory
* Hamilton Anxiety Rating Scale (HAM-A)
* Hospital Anxiety and Depression Scale (HADS)

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with mild to moderate depression episode, based on the HAM-D21 Rating Scale (10-13 = mild; 14-17 = mild to moderate)
* Diagnosed with mild to moderate depression episode based on ICD-10 Diagnostic Guidelines
* Is willing and able to spend 4 weeks as a hospital inpatient
* Is willing and able to return to the clinic during follow-up period

Exclusion Criteria:

* A HAM-D21 Rating Scale of \<10 or \>17
* Diagnosed outside of mild to moderate depression episode range based on the ICD-10 Diagnostic Guidelines
* Unable to complete wash-out interval without taking antidepressants or psychotropic medications
* Is pregnant or may be pregnant
* Sensitivity to electrodes and/or their conductive gels or adhesives
* Break in skin integrity at the areas of electrode placement
* Currently taking immune suppressing drugs or suspected use of narcotics
* Presence of any implanted electronic devices, cardiac stimulator, or pacemaker
* History of brain injury, including seizures, epilepsy, stroke, tumor of central nervous system, or hydrocephalus
* History of heart attacks, congestive heart failure, or uncontrolled hypertension
* History of schizophrenia or manic-depressive syndrome
Fibre and Appetite Regulation Trial (FART)

High intake of cereal fibre has been shown to be associated with reduced weight gain and improved insulin sensitivity. We hypothesize these effects are due to the short chain fatty acids derived from the bacterial fermentation (breakdown) of fibre in the colon (large intestine). Insulin resistant subjects will be randomized to receive 2 servings of a low-fibre cereal (eg. puffed rice) or 2 servings of a high-fibre cereal (wheat bran cereal) per day for one year. The effects of the diets on body weight, appetite, abdominal fat, blood short chain fatty acids, glucose, insulin, lipids and hormones will be measured


Eligibility Criteria:
Inclusion Criteria:

* Non-diabetic male or non-pregnant females
* aged 18-60
* BMI\<36
* fasting insulin \>40pmol/L (70%ile)

Exclusion Criteria:

* intention to lose \>5kg in weight
* presence of diabetes (fasting glucose \>6.9mmol/L)
* use of diuretics, beta-blockers or weight reducing drugs
* use of antibiotics in last 3 months and use of antibiotics more than once annually for the last 2 years
* significant gastrointestinal, liver or kidney disease
* use of lipid-lowering drug
* major medical or surgical event in last 6 mo.
* fibre intake \>30g/d
* inability to eat low or high fibre breakfast cereals
* unwilling or unable to give consent or comply with protocol
Intraocular Pressure Change Following Intravitreal Injection of Anti-vascular Endothelial Growth Factor Agent

The introduction of additional fluid into the vitreous cavity by intravitreal therapy would be expected to cause an immediate rise in the intraocular pressure. This transient, short-term intraocular pressure elevation (lasting up to 30 minutes) after intravitreal anti-vascular endothelial growth factor therapy has been well describe. The investigators aim to study the prevalence of the sustained intraocular pressure elevation associated with intravitreal injection of anti-vascular endothelial growth factor agents.

Intravitreal injections of anti-vascular endothelial growth factor agents are commonly used to treat a variety of retinal and choroidal neovascular diseases. The introduction of additional fluid into the vitreous cavity by intravitreal therapy would be expected to cause an immediate rise in the intraocular pressure.

Although there is one study showed no significant changes in the intraocular pressure many retrospective studies showed the impacts on the intraocular pressure elevation. The investigators aim to prospective evaluate the intraocular pressure change in non-glaucomatous patients receiving an intravitreal anti-vascular endothelial growth factor therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to receive intravitreal injection of anti-vascular endothelial growth factor agent (either bevacizumab or ranibizumab), and
* Age of 18-85 year-old, and
* Initial intraocular pressure \< 21 mmHg

Exclusion Criteria:

* Diagnosis of open angle, or
* Diagnosis of angle-closure glaucoma, or
* Diagnosis of glaucoma suspect (intraocular pressure \> 21 mmHg on 2-consecutive visit and/or cup to disc ratio \> 0.5) , or
* Currently receive systemic beta-blocker
* Previously received intravitreal injection of anti-vascular endothelial growth factor agent
* Previously received intravitreal injection of steroid or gancyclovir
* Current use of steroid eye drop
* Any ocular surface disease preclude a reliable intraocular pressure measurement
Computer Cognitive Training for Post-acute COVID-19 Syndrome

This study will assess the acceptability, feasibility, and impact of game-based computer-delivered cognitive training on cognitive function in persons with cognitive symptoms that persist after recovery from acute coronavirus-19 (COVID) infection.

Over the course of the past several years, it has become apparent that a number of individuals have residual symptoms after COVID-19 infection after they have recovered from the acute phase of the illness (Al-Aly, Xie, \& Bowe, 2021; Davis et al., 2021; Greenhalgh, Knight, A'Court, Buxton, \& Husain, 2020; Hewitt et al., 2021). The constellation of symptoms experienced by these individuals has been termed "post-acute COVID syndrome" or PACS (Nalbandian et al., 2021). A key part of helping affected individuals is supporting their efforts at self-management of these symptoms (National Institute for Health and Care Excellence, 2020; Wade, 2020). Although a diverse number of physical and psychological symptoms have been seen as sequelae of COVID (Davis et al., 2021), among the most troubling for patients have been difficulties in attention, concentration, working memory, and long-term memory, commonly referred to as "brain fog" (Graham et al., 2021; Hampshire et al., 2021; Hewitt et al., 2021). In the proposed study, we will complete a pilot study of game-based cognitive training in persons with symptoms of long COVID using a protocol that was useful and acceptable to participants in a previous study (Ownby \& Kim, 2021). We will explore participants' views on the cognitive training intervention, its effects on their perceived cognitive functioning, and assess the intervention's impact on participants' processing speed. We will also explore their preferences for type of cognitive training activity and the impact of information about memory functioning.

Eligibility Criteria:
Inclusion Criteria:

* Persons with a history of COVID-19 infection confirmed through screening of symptom pattern or testing and report of mental symptoms (difficulties in attention, memory, or executive functions such as coordinating two activities at once) more than 30 days after resolution of the initial acute infection.

Exclusion Criteria:

* Cognitive or psychiatric conditions of a severity that precludes the person's ability to give informed consent for their participation or to attend and cooperate with assessment and training, as judged by the investigators.
Effect of Quality Improvement Tools in Congestive Heart Failure (CHF)

Hypothesis: Quality Improvement tools like "Heart Failure Discharge Checklist" which emphasizes on proper education to patients, ensure appropriate dose titration and counselling improve outcome in congestive heart failure (CHF).


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to SJMO with principal diagnosis of acute decompensated heart failure

Exclusion Criteria:

* Age less than 18 years
* Pregnant women
Fractional Flow Reserve (FFR) Versus Instant Wave-Free Ratio (iFR)

Comparison of Fractional Flow Reserve versus instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice

* To compare FFR to iFR in arbitrary consecutive patients referred for percutaneous coronary intervention (PCI).
* To investigate the influence of hyperemia on iFR.
* To test reproducibility of iFR and FFR.


Eligibility Criteria:
Inclusion Criteria:

* all consecutive patients undergoing FFR assessment for standard clinical indications.

Exclusion Criteria:

* prior CABG
* extremely tortuous, calcified lesions
* coronary artery occlusion
* acute MI within 5 days
CONTRAST (Can cONTrast Injection Better Approximate FFR compAred to Pure reSTing Physiology?)

The purpose of this study is to determine the diagnostic performances of iodine contrast medium and resting conditions to predict fractional flow reserve (FFR). Reference FFR will be measured using standard adenosine. We hypothesize that contrast FFR will offer superior diagnostic agreement compared to resting conditions.

We are conducting a diagnostic accuracy study. The reference standard is adenosine-derived FFR. The diagnostic tests undergoing evaluation are resting conditions and hyperemia induced by intracoronary injection of contrast medium. While all these tests give a continuous result, we will apply binary cutoffs for comparison to FFR≤0.8 as the reference standard. Subjects will be selected prospectively from consecutive patients undergoing FFR assessment for standard clinical indications. The paired comparative design means that each patient will undergo resting (baseline), post-contrast, and adenosine-derived measurements. To enhance test integrity, all pressure recordings will be analyzed in a central physiology core laboratory blinded to clinical data and recruiting site.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Undergoing FFR assessment for standard clinical indications.
* Ability to understand and willingness to sign a written informed consent.

Exclusion Criteria:

* Prior coronary artery bypass grafting (CABG).
* Extremely tortuous or calcified coronary arteries precluding intracoronary physiologic measurements. Operators may exclude subtotal or similar high-grade lesions, which in their judgment may be threatened by pressure wire placement.
* Known severe left ventricular hypertrophy (septal wall thickness at echocardiography of \>13 mm).
* Inability to receive adenosine (for example, severe reactive airway disease, marked hypotension, or advanced atrioventricular block without pacemaker).
* Recent (within 3 weeks prior to cardiac catheterization) ST-segment elevation myocardial infarction (STEMI) in any arterial distribution (not specifically target lesion).
* Culprit lesions (based on clinical judgment of the operator) for either STEMI or non-STEMI cannot be included.
* Severe cardiomyopathy (ejection fraction \<30%).
* Renal insufficiency such that an additional 12 to 20 mL of contrast would, in the opinion of the operator, pose unwarranted risk to the patient.
Recognition of Second Twin. Second Training vs Naive Performer. PROMPT Mannequin

Anterior foot identification in second twin delivery Two different population of resident in ObGyn Group 1 previous formal lecture on twin vaginal delivery followed by PROMPT mannequin scenario.

Group 2 naive residents

The present study is addressed to evidential skills in residents with and without previous specific didactical approach to twin vaginal delivery in identification of anterior fetal foot.

The two group are randomized by age, sex, seniority. Both the naive and the previous lecture groups are invited to scenario without knowing the intention to test their skills.

The time to reach, the number of attempts are recorded.

Eligibility Criteria:
Inclusion Criteria:

* residents in Ob Gyn

Exclusion Criteria:

* none
Apical Pelvic Support in Infertility Patients

This study aims to evaluate apical pelvic compartment support in infertility patients at the time of hysteroscopy. Apical pelvic compartment evaluation for pelvic organ prolapse will be performed in infertility patients undergoing hysteroscopy.

The incidence of pelvic organ prolapse in the whole population has been demonstrated several times in previous studies. However, pelvic floor defects in young infertility patients are not known. In this study, a clinical pelvic floor assessment with the pelvic organ quantification system will be performed in infertility patients during standard physical examinations or hysteroscopy.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 18-45
* Patients who cannot become pregnant despite regular sexual intercourse for more than one year

Exclusion Criteria:

* Malignity
* Patients who become pregnant during infertility assessment
Culturing TM Cells From Primary Open-angle Glaucoma Patient Biopsies

In this study, the investigators will collect tissue from patients undergoing trabeculectomy for primary open-angle glaucoma treatment. This tissue would normally be discarded. These trabecular meshwork (TM) cells can be cultured and used experimentally to better understand the mechanisms of glaucoma. These TM biopsies will be cultured on the same day as the trabeculectomy using established techniques.


Eligibility Criteria:
Inclusion Criteria:

* Patients having glaucoma and undergoing a trabeculotomy
* Sign ICF (Informed Consent Form)

Exclusion Criteria:

* None