cyrilzakka/clinical-trials huggingface dataset:
Effect of Ezetimibe or Simvastatin or Both on Low Densitiy Lipoprotein -Subfractions in Patients With Type 2 Diabetes

It is of interest how ezetimibe alone or in combination with statin may influence atherogenic dense Low Density Lipoprotein (dLDL) in patients with type 2 diabetes mellitus. The primary objective of this study will be whether there is a change of the concentrations of Apolipoprotein B (ApoB) in dLDL from baseline in each of the 3 treatment groups.

The selective cholesterol resorption inhibitor ezetimibe belongs to a new class of cholesterol lowering drugs. It is of interest how ezetimibe alone or in combination with statin may influence atherogenic dense Low Density Lipoprotein (dLDL) in patients with type 2 diabetes mellitus.

The primary objective of this study will be whether there is a change of the concentrations of Apolipoprotein B (ApoB) in dLDL from baseline in each of the 3 treatment groups. The comparison between treatment groups is exploratory due to insufficient power to detect any change between treatments.

Eligibility Criteria:
Inclusion Criteria:

* men \> 18 and ≤ 75 years
* post-menopausal women ≤ 75 years (follicle stimulating hormone (FSH) \>30 mIU/ml, women \> 60 years FSH \> 20 mIU/ml )
* well controlled diabetes mellitus type II (glycohaemoglobin ≤ 8,0 %)
* LDL-cholesterol ≤ 160 mg/dl
* LDL-subfractions: concentration of apoB-100 in dLDL (LDL-5 und LDL-6) \> 25 mg/dl
* written informed consent

Exclusion Criteria:

* participation in a clinical trial within the last 30 d before screening- visit
* patient is unable to give written informed consent
* Body mass index \<15 kg/m² and \> 35 kg/m²
* clinical atherosclerotic disease (coronary heart disease, peripheral artery disease, carotid artery disease)
* malignoma
* uncontrolled arterial hypertension (\>160/\>100 mmHg)
* clinically relevant disease of liver and/or kidneys
* clinically relevant endocrinally or hematologic problems
* allergy to study medication (Ezetimibe and/or Simvastatin)
* alcohol- or drug abuse
* laboratory: alanine aminotransferase, aspartate aminotransferase, total bilirubin \> 3 x ULN, creatine kinase \> 5 x ULN
* Concurrent treatment with potent CYP3A4-inhibitors (e.g. itraconazole, ketoconazole, HIV-protease-inhibitors, erythromycin, clarithromycin, telithromycin und nefazodone)
* other relevant diseases
A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Participants 5 to 18 Years of Age With Neurogenic Detrusor Overactivity

The purpose of this study was to investigate a medicine for the treatment of symptoms and complications of neurogenic detrusor overactivity (NDO) in children and adolescents.

The NDO often occurs in patients with spina bifida or other spinal cord damage where the bladder muscle contracts more than normal during filling. These patients often have an inability to void, so that catheterization is required to empty the bladder.

The medicine being tested in this study is called solifenacin succinate. Solifenacin tablets are given to adults for the treatment of overactive bladder. A new liquid suspension has been developed to treat children and adolescents in this and other studies.

The efficacy and safety of the solifenacin suspension was investigated. The take-up and length of time that the solifenacin suspension stays in the body was also investigated during this study. Effectiveness was measured by urodynamics (the filling and emptying of the bladder) and the urine volumes during catheterization together with the diary responses relating to the number of incontinence episodes or incontinence free days.

Safety assessments included analysis of the blood and urine, review of the electrocardiogram (ECG), ultrasound of the kidney, simple memory and understanding tests (cognitive function) and the ability to see near and far objects (visual accommodation).

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of NDO, confirmed by urodynamics
* Practicing clean intermittent catheterization (CIC)
* Currently on treatment with an antimuscarinic drug

Exclusion Criteria:

* Known genitourinary condition (other than NDO) that may cause incontinence
* Bladder augmentation surgery
* Current Faecal impaction
* Electro-stimulation therapy within 2 weeks prior to screening and at any time during the study
* Subjects with the following gastro-intestinal problems: partial or complete obstruction, decreased motility like paralytic ileus, subjects at risk of gastric retention
* Reflux grade 3 or 4
* Current urinary tract infection (UTI)
* Subject has severe renal impairment (glomerular filtration rate \< 30 ml/min)
* Subject has severe hepatic impairment (Child-Pugh score \> 9).
* Subject has received intra-vesical botulinum toxin within 9 months prior to screening
Pulmonary Substudy: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)

The purpose of this study is to find out if starting anti-retroviral therapy (ART) above 500 cluster-of-differentiation-4 (CD4)+ cells/milliliter (mL) ('early ART group') slows the rate of decrease in lung function over time compared to waiting to start ART until the CD4+ drops below 350 cells/mL ('deferred ART group'). Lung function normally declines with age, and both human immunodeficiency virus (HIV) infection and ART have been shown to case a decline in lung function as well. Decline in lung function can be an early indicator of chronic obstructive pulmonary disease (COPD), a significant cause of sickness and death in people with HIV. In this study, lung function will be measured at baseline and every year thereafter by using a spirometer.


Eligibility Criteria:
Inclusion Criteria:

* Simultaneous co-enrollment in the START study
* Signed informed consent to the Pulmonary Substudy
* Age \>= 25 years

Exclusion Criteria:

* An episode of respiratory illness with 2 or more symptoms of cough, wheezing, breathlessness, or increase in sputum production within the 6 weeks before baseline spirometry.
* Use of asthma medications (bronchodilator, inhaled corticosteroid, leukotriene inhibitor, or theophylline) for 2 or more consecutive weeks within the 6 months before baseline spirometry.
* Relative contraindications to spirometry, such as chest or abdominal or eye surgery within the 3 months before baseline spirometry, known retinal detachment at the time of baseline spirometry.
* Known allergy to albuterol/salbutamol
* Relative contraindications to albuterol/salbutamol, such as resting heart rate of \>110 beats per minute, or a known serious or recurrent or uncontrolled cardiac condition (such as unstable coronary artery disease, decompensated heart failure, or recurrent tachyarrhythmias).
177Lu-PSMA-I&T Prior to Radical Prostatectomy for Locally Advanced Disease

Despite surgical advances, up to 50% of patients with high-risk locally advanced prostate cancer will die from their disease. Drug therapy before surgery has the potential to improve treatment success by lowering tumor volume in the prostate and treating small metastases. PET PSMA is an advanced imaging technique that allows the identification of areas involved by the tumor in the prostate or in the pelvis. This technique is based on the protein PSMA (prostate-specific membrane antigen) which is located on the tumor cells. The presence of PSMA on tumor cells has been recently used for treatment purposes. A chemical element (Lutetium) that binds to PSMA and emits local radiation can destroy tumors cells. This treatment has been used in patients with advanced metastatic disease and showed promising results. The investigators hypothesized that using these particles can improve long term results in patients who undergo surgery for prostate cancer which has not extensively spread. The investigators will assess both the immediate and long-term impact of this novel treatment.


Eligibility Criteria:
Inclusion Criteria:

* 1. Male aged 18 years and older. 2. Patients were diagnosed with high risk localized prostate cancer (cT3/4 and/or Gleason score ≥8 and/or prostate biopsy or PSA ≥ 20 ng/dl) or loco-regional prostate cancer (pelvic lymphadenopathy of ≥2 cm on axial imaging).

  3. High PSMA expression was confirmed. PET PSMA with tracer uptake greater than normal liver (maximal standardized uptake value ≥1.5 of liver). In addition, no PET FDG positive sites without high PSMA expression.

  4. Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status score5 of 1 or lower and life expectancy of \> 10 years.

Exclusion Criteria:

* 1. Clinically significant impaired bone marrow defined by platelet count lower than 150×103/µl, white blood cells count lower than 4×103/µl, hemoglobin concentration lower than 12mg/dl.

  2. Impaired liver function defined by albumin concentration lower than 3.5 gr/dl.

  3. Impaired kidney function defined by glomerular filtration rate (GFR) lower than 40 mL/min.

  4. Recent radiotherapy (within two months) 5. Concomitant usage of nephrotoxic drugs 6. Evidence of distant metastatic disease (distal lymphadenopathy, visceral or bone metastases).
Trial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal Microbiome

This is a randomized, open-label pilot study to assess whether treatment with chlorhexidine mouthwash can alter the esophageal and gastric cardia microbiome

Patients scheduled for upper endoscopy for clinical indications will be randomized to 3 weeks of either no treatment or use of twice daily chlorhexidine mouthwash leading up to the endoscopy. There will be 2-3 study visits, at Day 0 and Day 21, and for those subjects in the mouthwash arm, a final visit 1-2 weeks following the Day 21 visit. Subjects will be required to fast overnight prior to the visits on Days 0 and 21.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Scheduled for upper endoscopy for clinical indications
* No allergy or other contraindication to chlorhexidine

Exclusion Criteria:

* Use of proton pump inhibitors or H2 receptor antagonists within 1 month of enrollment. Acid suppressant medications raise the gastric pH and can dramatically alter the gastric and esophageal microbiome.
* History of upper gastrointestinal cancer
* History of histologically proven Barrett's esophagus
* History of antireflux or bariatric surgery, or other gastric or esophageal surgery
* Use of antimicrobial mouthwash within 1 month of enrollment
* Use of antibiotics or immunosuppressant medications within 3 months of enrollment
* Use of steroid inhalers or nasal sprays within 1 month of enrollment
* HIV or other immunosuppressed states or conditions (e.g. active malignancy)
* Pregnant or breast feeding
* Inability to give informed consent
Virtual Reliability System for Visual Spatial Attention Evaluation in Stroke Patients

The researchers designed a software based on a head-mounted displays for virtual reality (HMD-VR) to evaluate the reaction time to stimuli presented at right or left visual field. The study will recruit 100 stroke patients with hemisphere lesions (50 patients for right and left each) and 100 age-matched healthy controls. The participants will conduct a simple reaction time task in VR, with stimuli designated in the left or right hemi-field. The stroke patients will also received traditional tests for hemi-neglect. Test-retest reliability of the assessment will be conducted in a subset of the control group. The stroke patients will be followed in 3-4 weeks.

The researchers designed a software based on a head-mounted displays for virtual reality (HMD-VR) to evaluate the reaction time to stimuli presented at right or left visual field. The study will recruit 100 stroke patients with hemisphere lesions (50 patients for right and left hemisphere each) and 100 age-matched healthy controls. The participants will conduct a simple reaction time task in VR, with stimuli designated in the left or right hemi-field. The stroke patients will also receive traditional tests for hemi-neglect. The researchers will also collect the demographic data, cognition function and daily activity function. Test-retest reliability of the assessment will be conducted in a subset of the control group. The stroke patients will be followed in 3-4 weeks. The researchers will compare the results of a traditional hemi-neglect tests and VR-based tests and their changes in two occasions.

Eligibility Criteria:
Inclusion Criteria for stroke patients:

1. aged at least 20 years old
2. diagnosed with stroke involving unilateral MCA and ACA territory
3. with unilateral upper limb with normal function
4. neurologically and medically stable.

Inclusion criteria for control group:

1) healthy adults, age-matched to stroke patients

Exclusion Criteria for both groups:

1. with history of neurological or psychiatric conditions other than stroke;
2. significant cognitive or speech problems that cause difficulties to cooperate with testing;
3. significant visual problems (such as color blindness, visual loss, cataract, glaucoma or other major eye condition)
4. upper limb musculoskeletal disorders to cause difficulties to use the keyboard or controller;
5. history of seizure, vestibular dysfunction or vertigo
6. can't tolerate HMD-VR
Clinical Study on Intensive Multi-acupuncture in the Treatment of Lumbar Muscle Strain.

Acupuncture is widely used as a routine treatment for lumbar muscle strain. The aim of this randomized controlled trial is to evaluate the effectiveness of the intensive multi-acupuncture method. This trial will include 108 patients with lumbar muscle strain injury from two outpatient clinics. All participants will be randomized in a 1:1 ratio to the intensive multi-acupuncture method group and the normal needling group. Outcomes will be assessed before the intervention, after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment. The primary outcome indicator will be the clinical efficacy evaluation criteria, and the secondary outcome indicators will be the pain visual analog scale (VAS) score, the Japanese Orthopaedic Association Assessment Treatment Score (JOA) score, the lumbar joint mobility measurement scale, and the Modified Ashworth Grading Scale. This study will provide evidence as to whether the intensive multi-acupuncture method is safe and effective.


Eligibility Criteria:
Inclusion Criteria:

1.Meet the above Chinese and Western medicine diagnostic criteria; 2.18 years old ≤ age ≤ 70 years old, gender is not limited; 3.The duration of the disease is more than 3 months, no other treatment has been received in the last month, and the VAS score is ≥4 at the time of participating in the treatment; 4.Voluntarily cooperate with the examination and treatment, and sign the Informed Consent Form.

Exclusion Criteria:

1. Those with severe cardiac, hepatic and renal insufficiency and those with bleeding tendency;
2. Previous history of lumbar spine surgery, spinal cauda equina tumor, lumbar spondylolisthesis, lumbar spinal stenosis, scoliosis deformity, tumors and other diseases caused by low back pain;
3. Women who are in the period of pregnancy or breastfeeding should not perform acupuncture treatment;
4. Those who have needle-sickness, blood-sickness and so on;
5. Those who have cognitive impairment and cannot complete the relevant scale assessment independently or under the guidance of the investigator.
Effect of Peer-mentor Mediated Interventions on Cardiovascular Risk Factors at Worksites

The investigators propose conducting a pilot study to identify 6 worksites (2 India, 2 Sri Lanka, 2 Bangladesh) explore barriers to optimum cardiovascular disease(CVD) care at these worksites, quantify risk factor level in worksite populations and identify and train peer mentors to deliver an educational intervention to improve life style and enhance medication adherence among those at moderate to high risk of cardiovascular disease (CVD).

Eligibility Criteria -

All employees aged above 35 years at selected workplaces.

Study design - Mixed methods methods Phase 1 - Qualitative study; Phase 2 - Quantitative - Single group, non-randomized before-after comparison study + KAP survey

Sample size - Approximately 334 participants.

The study entails the following steps -

Step 1 - An evaluation for knowledge, attitudes and practices (KAP) related to cardiovascular health/ disease at worksites.

Step 2 - A qualitative study for barriers and facilitators of behaviors associated with optimal cardiovascular health

Step 3 - Baseline assessment of cardiovascular risk using a non-lab based risk assessment score

Step 4 - Piloting a trained peer mentored educational/ intensive follow-up intervention for 3 month with a re-assessment at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* All criteria must be met to be eligible

  1. Employees (Men \& Women) above the age of 35 years.
  2. permanent employees with at least 6 months for retirement.
  3. Willing to provide Informed Consent.

Exclusion Criteria:

* Subject ineligible if even one criterion is met

  1. Pregnant or intent to get pregnant in one year.
  2. Inability to attend follow up visits.
  3. Any active malignancy or known malignancy on treatment.
  4. Will relocate during the study period.
  5. Unwilling or unable to comply with study procedures.
Adjunctive Photodynamic Therapy in the Treatment of Chronic Periodontitis

The aim of this randomized clinical trial is to clinically evaluate the effectiveness of the adjunctive use of photodynamic therapy (PDT) with an light-emitting diode (LED) light source in the treatment of chronic periodontitis.


Eligibility Criteria:
Inclusion Criteria:

1. clinically diagnosis of advanced chronic periodontitis with more than 3 mm clinical attachment loss
2. presence of at least two teeth with probing depth of 4 to 6 mm without furcation involvement in each quadrant
3. at least 16 remaining teeth
4. no periodontal treatment in the past 12 months
5. no evidence of systemic disease related to periodontal problems
6. no use of antibiotics for the past 6 months
7. No smoking more than 10 cigarettes per day
8. no addiction to any kind of drugs
9. no pregnancy
Enhanced Consent for Symptom Provocation Research

The overall goal of the proposed study is to insure the protection and safety of human subjects who have been previously exposed to interpersonal traumatic events and who are participants in symptom provocation research. The investigators intend to examine trauma history, cognitive, interpersonal, and genetic predictors of participants' unfavorable reaction to participation in research involving trauma-related script-driven imagery (SDI). The design includes comparing participants in a consent as usual group to participants in an enhanced consent group to see which minimizes unfavorable effects of participating in a research provocation study. In addition, the two different consent groups will be assessed for their effects on psychobiological and neurobiological stress response. Furthermore, the investigators will examine the relationship between the psychobiological responses and neural mechanism during SDI, and unfavorable reactions to participation in symptom provocation research.

The overall goal of the proposed study is to insure the protection and safety of human subjects who have been previously exposed to interpersonal traumatic events and who are participants in symptom provocation research. The investigators intend to examine trauma history, cognitive, interpersonal, and genetic predictors of participants' unfavorable reaction to participation in research involving trauma-related script-driven imagery (SDI). The design includes comparing participants with and without Posttraumatic Stress Disorder (PTSD) in a consent as usual group to participants in an enhanced consent group to see which group minimizes unfavorable effects of participating in a research provocation study. In addition, the two different consent groups will be assessed for their effects on psychobiological and neurobiological stress response. Furthermore, the investigators will examine the relationship between the psychobiological responses and neural mechanism during SDI, and unfavorable reactions to participation in symptom provocation research.

Eligibility Criteria:
Inclusion Criteria:

* nonsmoker
* female
* between 18-55
* experienced trauma
* willing to have a brain scan
* provide consent

Exclusion Criteria:

* alcohol abuse or dependence
* bipolar disorder
* suicidal intent
* metal in the body or anything else that would interfere with an MRI
* claustrophobia or inability to lie still for 45 minutes
* receiving current counseling
* on certain antidepressants, benzodiazepines, or other psychotropic medication
* pregnant or nursing
Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

The objective of the study is to determine the effectiveness of Spheno-Palatine (SP) ganglion block to alleviate the pain of post-dural puncture headache (PDPH).

The primary objectives of the study are to study the effectiveness of SP ganglion block in relieving post-dural puncture headache in terms of :

1. Number of subjects who get relief of pain
2. The onset time to pain relief after application of block
3. The duration of pain relief
4. The incidence of recurrence of post-dural puncture headache

Secondary objectives are to:

1. Monitor any complications due to SP ganglion block
2. Measure patient satisfaction
3. Monitor any residual effects at 1 months after the SP block

Eligibility Criteria:
Inclusion Criteria:

1. Complains of symptoms suggestive of post-dural puncture headache
2. Has a history of dural puncture (lumbar puncture or accidental dural puncture during epidural placement) within the previous 7 days
3. Fluent in written and spoken English

Exclusion Criteria:

1. Those with a known history of hypersensitivity to local anesthetics of the amide type or to other components of GLYDO
2. Those with any congenital or acquired, anatomical deformity of the nostril, which preclude performing the block
3. Those who refuse to consent to participate in the study
4. Patients who have had a failed epidural blood patch
5. Cognitive Impairment
6. Prisoner
Clinical and Biochemical Evaluation of 1% Metformin in Non-surgical Treatment of Periodontitis

The aim of the study to evaluate the clinical and biochemical efficacy of 1% Metformin gel in treatment of periodontitis patients


Eligibility Criteria:
Inclusion Criteria:

* Patients with Stage III Grade A Periodontitis.
* Systemically free according to the modified Burkitt's health history questionnaire, Group I. (Glick et al., 2021).
* Good compliance with the plaque control instructions following initial therapy.
* Availability for follow up and maintenance program.

Exclusion Criteria:

* Smokers
* Pregnant and lactating females.
* Vulnerable groups of patients' e.g (prisoners, handicapped patients and decisionally impaired individuals).