cyrilzakka/clinical-trials huggingface dataset:
Effect of Morning Versus Evening Perindopril on Blood Pressure Control in People With Type 2 Diabetes

We assessed the influence of time of administration of ACE inhibitors on circadian blood pressure control in sub Saharan type 2 diabetes patients with stage 1 hypertension over 56 days as first line treatment.

Background: Renin-angiotensin system antagonists represent the mainstay of blood pressure (BP) lowering treatment options in people with diabetes. ACE inhibitors have a long half-life and offer the advantage of a single daily dose, usually empirically taken in the morning.

Objective: We assessed the influence of time of administration of ACE inhibitors on circadian BP control in type 2 diabetes (T2D) patients with stage 1 hypertension.

Methods: Twenty T2D patients (9 being women) with a mean age of 58.7 years, diagnosed with stage 1 of hypertension and naive to BP lowering medications, were included. They were randomly allocated to receive perindopril 10 mg/day as a monotherapy either in the morning or in the evening for 28 days, with crossover without washout period on day 29th and additional 28 days follow-up. A 24-hour ambulatory BP monitoring (ABPM) was performed at baseline, days 28 and 56.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Grade 1 hypertension
* Informed consent

Exclusion Criteria:

* estimated creatinine clearance≤ 60ml/min
* White coat hypertension after initial 24 hour ABPM
* Previous antihypertensive treatment
* Pregnant women
* Individuals working during the night
* Hyperkalemia
Open-Label Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Type 2 Diabetic Adults

This study is an extension of a study that has been ongoing for 1 year. The purpose of this open label study is to see the how well type 2 diabetics respond to VI-0521(phentermine/topiramate) in controlling blood sugar and how safe VI-0521 is over an extended period of time. All subjects eligible to enroll into this study will receive study drug.


Eligibility Criteria:
Inclusion Criteria:

* Have completed the qualifying DM-230 trial
* If females of child-bearing potential, subjects must be using adequate contraception
* Provide written informed consent
* Be willing and able to comply with scheduled study visits, treatment plan, lab tests and other study procedures
* Be greater than 80% compliant in study medication use during the last three visits for DM-230

Exclusion Criteria:

* Subjects who have developed one or more morbidities during the DM-230 trial that would pose a safety concern
A Prospective Multi-center Study on Total Hip Arthroplasty With E1

The primary objectives of this clinical study include:

* Evaluate E1 Wear including early bedding-in process, clinical outcomes on patients who received Total Hip Arthroplasty with E1
* Compare E1 wear used with CoCr and Biolox Delta heads

This study is designed as PROSPECTIVE, RANDOMIZED, MULTI-CENTER Study to compare two different materials (CoCr and Delta ceramic) articulating against E1 Highly Crosslinked polyethylene in Hip Replacement.

Patient population is 160 (80 each). Follow-up period is 10 year postoperatively. E1 liners with thickness of 4.8mm at 45 degrees position (load bearing direction) will be used in all cases.

Randomization will occur via random number generator by 4 blocks randomization.

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis
* Age between 20 - 75 at the time of operation
* Patients with limited co-morbidity -ASA I-III
* Patients must be able to understand instructions and be willing to return for follow up

Exclusion Criteria:

* In accordance with approved Absolute and Relative Contraindications for use in participating countries for E1 liner and Delta Ceramic and CoCr femoral head hip system System.

Absolute contraindications include: infection, sepsis, and osteomyelitis.

Relative contraindications include:

1. uncooperative patient or patient with neurologic disorders who are incapable of following directions,
2. osteoporosis,
3. metabolic disorders which may impair bone formation,
4. osteomalacia,
5. distant foci of infections which may spread to the implant site,
6. rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and
7. vascular insufficiency, muscular atrophy, or neuromuscular disease.
8. pregnancy
Different Treatments in Chronic Pain Patients.

The goal of this observational study is to compare different treatment options in a chronic pain population. The main questions it aims to answer are:

* What is the effectiveness of the different therapy options in the pain center of Sint-Lucas on outcomes related to pain and disability?
* What are predictive factors for the different therapy options in the pain center of Sint-Lucas? Which factors predict improvement in pain related outcomes?

Participant data will be gathered as part of their routine care. They can be advised to 4 different treatment options:

* Consultations with the pain specialist
* Interventions by the pain specialist (infiltrations, denervations)
* Baxter therapy
* Interdisciplinary treatment

Researchers will compare patients with different dominant pain mechanisms to see which treatment are most effective for which dominant pain mechanisms.

The aim of the present study is to describe the natural flow of the chronic pain patients at the pain center AZ Sint-Lucas. Patients will be examined before starting the therapy, and receive standardized questionnaires at several fixed time points (before, during, and after their therapy trajectory). Information about the present dominant pain mechanism will be gathered during the examination. The questionnaires will gather demographic data, information about the present dominant pain mechanism, psychosocial factors, catastrophizing, fear and avoidance, illness perceptions, fatigue and information about therapy success. During the examination, typical signs of a dominant nociplastic pain mechanism will be gathered. By processing the data of the questionnaires and the examination, knowledge about (1) the amount of patients with a dominant nociplastic pain mechanism at intake, (2) the treatment trajectory for a specific diagnosis, and (3) the prediction of the therapy effect and prognosis will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Chronic pain patients
* Dutch speaking, or good understanding

Exclusion Criteria:

* Adults unable to give consent
* Adults who do not understand Dutch
HCV Treatment With Fluvastatin, Simvastatin to Improve Interferon Sensitivity

Objective: The goal is to improve peginterferon sensitivity in previous poor responders. "Sensitivity" here means the host's ability to kill more HCV.

Design: Twenty poor responders to prior PIFN/RBV will be given 48 weeks of statin monotherapy. Veterans and civilians between the ages of 18 and 70 are eligible.


Eligibility Criteria:
Inclusion Criteria:

Hepatitis C positive by HCV RNA within 180 days. - No anti-HCV medicine within 30 days of screening

Exclusion Criteria:

* decompensated liver disease
* severe cardiac disease (ejection fraction \< 20% or uncontrolled angina)
* unexplained muscle pain at time of screening
* pregnancy
* renal insufficiency (creatine clearance \< 50 ml/min)
Influence of Cincalcet on Cognitive Functions in Healthy Human Subjects

To investigate the effects of the calcimimetic agent cinacalcet on cognitive functions in healthy humans.


Eligibility Criteria:
Inclusion Criteria:

* healthy
* normotensive
* native or fluent German-speaking
* caucasian (European ancestry)
* BMI between 19 and 27 kg/m2

Exclusion Criteria:

* acute or chronic psychiatric or somatic disorder
* pathological ECG
* Low serum calcium
* known hypersensitivity to the IMP
* pregnancy
* breast-feading
* long-term medication within last 3 months
* smoking more than 3 cigarettes per day
* seizures in participants and first degree relatives
* concurrent participation in another study
The Effect of Massage and Musıc Therapy on Birth Pain, Posttravmatic Comfort and Posttraumatic Development

Birth pain is the most severe painful experience faced by primiparous people. Massage and music therapy reduce tension in the muscles and reduce the feeling of pain. Massage and music therapy will be applied to pregnant women. No intervention will be made to a group of pregnant women. Numerical Pain Assessment, Post Traumatic Development Scale and Birth Comfort Scale will be used in the research.

Birth pain is one of the most severe and difficult to control pains known. Non-pharmacological methods used to cope with labor pain are cheap and reliable. Massage and music therapy in the first stage of labor are non-pharmacological methods used to reduce labor pain. The purpose of this research; non-pharmacological methods applied to primiparous in labor; The aim of this study is to examine the effects of massage and music therapy on labor pain, postpartum comfort and posttraumatic development. A total of 114 primiparous pregnant women who had a normal delivery expectation and were in the active phase of labor (4-5 cm dilatation) were planned to be included in the study. Massage and music therapy will be applied to pregnant women. No intervention will be made to a group of pregnant women. Numerical Pain Assessment, Post Traumatic Development Scale and Birth Comfort Scale will be used in the research.

Eligibility Criteria:
Inclusion Criteria:

* Expectation of normal vaginal delivery
* Having a term pregnancy
* Being primiparous - Being in the active phase of labor (Cervical dilatation 4 cm)
* Single pregnancy
* Being in vertex presentation
* Uncomplicated prenatal process
* Volunteering to participate in the study
* Being pregnant without back pain

Exclusion Criteria:

* Pregnant women whose birth resulted in cesarean section due to failure of labor to progress during labor
* Pregnant women who did not undergo induction
* Pregnant women who underwent pharmacological intervention for labor pain
SynapDx Autism Gene Expression Analysis Study

This study will prospectively enroll approximately 660 children, at least 18 months and less than 5 years of age, who have been referred to a pediatric developmental evaluation centers. Enrolled children will have blood drawn for RNA gene expression analysis and undergo a clinical evaluation to determine the presence or absence of a diagnosis of ASD.

The sequential co-primary objectives of this study are:

* To develop an algorithm to classify blood RNA gene expression patterns to maximize agreement between the classification and a clinical assessment of presence or absence of Autism Spectrum Disorders (ASD).
* To prospectively assess the clinical sensitivity and specificity of the blood RNA gene expression classification algorithm (the SDX-002 test) in children referred to a developmental evaluation clinic for a possible developmental disorder.


Eligibility Criteria:
Inclusion Criteria:

1. Referred to a developmental evaluation centers for evaluation of a possible developmental disorder, other than isolated motor problems.
2. Age \>= 18 months and \< 5 years.
3. Parent/legal guardian has been informed about the study and has signed an informed consent form.

Exclusion Criteria:

1. Prior reliable diagnosis of Autism Spectrum Disorder (i.e. prior evaluation by a multi-disciplinary team has already reliably established Autism Spectrum Disorder diagnosis).
2. Unable or unwilling to complete study procedures
A Comparison Between Sonoguided Injection Corticosteroid and Hyaluronic Acid Injection in Treatment of Trigger Finger

The study is to compare the effect between steroid injection and Hyaluronic acid in treatment trigger finger. Using sonoguided injection technique achieves more accurate injection location and therapeutic effect. We hypothesize hyaluronic acid has both lubricant and anti-inflammation effect in treatment of trigger finger, and can provide better outcome and lower adverse effect than steroid injection.

This is a prospective, randomized, double-blinded controlled study. Patients with the diagnosis of trigger finger will be recruited and enrolled from Taipei Veteran General Hospital PM\&R outpatient clinic. Subjects will be randomized into two groups; hyaluronic acid and triamcinolone acetonide injections, both via ultrasound-guided with one injection only.We hypothesize that through the anti-inflammatory property of the hyaluronate acid, the treatment effects will be as effective as the traditionally used steroid injections with equal or even lower recurrence rate for treatment of trigger finger. We expect that injections of hyaluronate into tendon sheath could become a new treatment option for trigger finger.

Eligibility Criteria:
Inclusion Criteria:

* patients with trigger digits and patients
* without previous treatment of the trigger digit

Exclusion Criteria:

* patients with prior treatment of the trigger digit (eg, splinting, injection, or therapy),
* patients less than
* 20 years old,
* patients with allergy or contraindication to hyaluronic acid,
* patients with trigger digits due to rheumatoid arthritis,
* and patients with infection at the site of injection.
Beginning Relationships in a Native Community

The purpose of this study is to to conduct a randomized controlled trial comparing an intervention group and a control/wait list group to evaluate the feasibility of the Promoting First Relationships method in an American Indian community through their tribal Maternal and Child Health program, and to assess the efficacy of the method in this community.


Eligibility Criteria:
Inclusion Criteria:

1. Primary caregiver for a child aged 10 to 30 months
2. Caregiver lives with the child full time for the past three months and plans to continue for at least 6 more months.
3. Child is an American Indian or Alaska Native living on or near the Tribe's reservation.
4. Caregiver has telephone access
5. Caregiver is willing to have researchers come to their house
6. Caregiver is English speaking
7. Caregiver is willing to participate in a home-visiting program which includes video-recorded sessions of caregivers and their children playing

Exclusion Criteria--Caregiver is

1. hospitalized or imprisoned
2. living in a Treatment facility or shelter
3. unable to give consent
4. live in a household that already has a dyad enrolled in the study.
Effects of Sustamine(TM) on Cycling Time Trial Performance

Acute supplementation of Sustamine(TM), a combination of two amino acids, will improve cycling performance and mental acuity in a dose-dependent response.


Eligibility Criteria:
Inclusion Criteria:

* Competitive cyclist or triathlete
* Male (VO2max \>= 55 ml/kg/min) or Female (VO2max \>= 45 ml/kg/min)
* Healthy
* Blood pressure below 140/90
* Non-smoker

Exclusion Criteria:

* Anti-depressant medications
* Inconsistent regular medications
* Consumption performance-enhancing substances
* Type I or Type II diabetes
* Renal, hepatic or cardiac disease Current infectious disease
Neuropathic Pain Management

This is a prospective, randomized, double blind, comparative, experimental controlled Phase 3 clinical trial to assess the efficacy, safety and superiority of F0343 (gabapentin combined with B vitamins) compared to gabapentin alone for treating neuropathic pain in subjects with chronic distal diabetic polyneuropathy.

Subjects will be assigned to one of the two arms of the study, after having been deemed eligible during the screening visit in random double-blind design. Subjects will be evaluated for a 4 week period.

OBJECTIVES

* To assess the effects of F0434 and gabapentin alone on neuropathic pain and Quality Of Life (QOL) of subjects with diabetic neuropathy through a current and validated neuropathic pain scale along with the QOL questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with diabetes mellitus type 2
* Subjects with a history of neuropathic pain in the last 3 Months
* Men and women in reproductive age with a family planning method
* Subjects aged between 18 to 70 years
* Subjects with glycosylated haemoglobin (HbA1c) greater than 7% and less than 15%
* Subjects that obtain a grade equal or greater than 4 in the visual analogue scale during the screening visit

Exclusion Criteria:

* Subjects diagnosed as being pregnant or in state of lactation
* Subjects with serum creatinine greater than 1.2 or creatinine depuration in 24 hour urine, less than 60mL/min
* Subjects who are receiving treatment with anti-depressants, anti-epileptics, and are taking vitamin B1 and B12 for treatment of neuropathic diabetes
* Subjects who are being pharmacologically treated for epilepsy
* Subjects diagnosed with rheumatic and hepatic disease and diagnosed with neuropathy for other causes
* Subjects with psychological and psychiatric alteration that hinders adequate collaboration in the study
* Subjects with any orthopaedic alteration of any extremity
* Subjects with peripheral artery disease
* Subjects taking more than two neuropathic pain medicines
* Subjects with history of alcohol, cocaine, marijuana or benzodiazepine substance abuse
* Subjects with acid-peptic disease
* Subjects with history of neoplasm of any type
A Study in Healthy Men to Test How Different Doses of BI 3031185 Are Tolerated and How Food Influences the Amount of BI 3031185 in the Blood

This trial starts the clinical development of BI 3031185. The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of a range of single doses of BI 3031185 as basis for further development.

The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3031185 tablet formulation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests without any clinically significant abnormalities
* Age of 18 to 45 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 139 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 89 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease. This does not include acceptable concomitant conditions that were not assessed as clinically relevant by the investigator (e.g. possible cases of myopia, hyperopia, astigmatism, non-active pollinosis, or mild acne of the skin)
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
Chest Trauma :Prediction of Thoracic Injuries Clinically and Radiologically

• Trauma is a major cause of morbidity and mortality worldwide. Despite the advent of specialized trauma centers the outcome of patients who sustain major trauma remains disappointing. Plain radiography and more advanced imaging techniques such as ultrasound, computerised tomography (CT) and angiography, have a major role to play in the early decision making and subsequent management of patients who sustain polytrauma. This article discusses the choice of emergency imaging techniques available in chest trauma for clinicians and radiologists; their evaluation and some of the common pitfalls that may lead to errors of interpretation.

Imaging plays a key role for both, the primary diagnostic work-up, and the secondary assessment of potential treatment. Despite its well-known limitations, the posteroanterior chest radiograph remains the starting point of the imaging work-up. Adjunctive imaging with computed tomography, that recently is increasingly often performed on multidetector computed tomography units, adds essential information not readily available on the conventional radiograph. This allows better definition of trauma-associated thoracic injuries not only in acute traumatic aortic injury, but also in pulmonary, tracheobronchial, cardiac, diaphragmal, and thoracic skeletal injuries. This article reviews common radiographic findings in patients after chest trauma, shows typical imaging features resulting from thoracic injury, presents imaging algorithms, and recalls to the reader less common but clinically relevant entities encountered in patients after thoracic trauma.

Eligibility Criteria:
Inclusion Criteria:

* chest trauma 2. recent trauma: presented within48 h

Exclusion Criteria:

* Old trauma more than 48h 2-Pt transferred urgently to operating room
Measurement of Fibroid Volume and 2D, 3D US

Objective: To compare 2-dimensional and 3-dimensional ultrasound measurements with the actual myomas volume after surgical removal, to clinically test the validity and usability of 3D ultrasound technology as opposed to conventional 2D real-time ultrasound and to assess the reliability of different ultrasound methods to measure volume of uterine fibroids.


Eligibility Criteria:
Inclusion Criteria:

* surgical intervention

Exclusion Criteria:

* unfit for surgery