cyrilzakka/clinical-trials huggingface dataset:
Coronary Artery Disease Progression in Patients With Acute Coronary Syndromes and Diabetes Mellitus

A total of 100 patients with non-ST-segment elevation acute coronary syndromes with or without diabetes mellitus will be included. All patients will undergo coronary angiography with identification of the infarct-related vessel and percutaneous revascularization with implantation of a stent/scaffold. After revascularization patients will undergo a combined positron emission tomography (PET)-coronary computed tomography (CT) protocol to quantify atherosclerotic burden (i.e. plaque volume) and activity (i.e. 18 fluorum-sodium-fluoride \[18FNaF\] uptake) in non-infarct related vessels, to assess calcium score (aim 1), and to quantify the acute results of PCI in the infarct-related vessel (aim 2). At 12-month follow-up, all patients will repeat longitudinal 18FNaF PET-coronary CT evaluation to characterize progression of atherosclerosis in the non-infarct related vessels (aim 1) and to quantify neointimal suppression at the site of the treated coronary segment in the infarct-related vessel (aim 2). Blood samples will be collected at baseline and 12 months for all patients.

The aims of the study are:

1. To evaluate coronary artery disease progression in acute coronary syndromes patients with and without diabetes mellitus, and to investigate the predictive value of metabolic profiles, patterns of circulating miRNAs and inflammatory mediators on coronary artery disease progression;
2. To evaluate the progression of disease within the infarct-related vessel treated with the use of bioresorbable stent/bioresorbable polymer stents in diabetic and non-diabetic patients with acute coronary syndromes.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 and \<80 years, evidence of non-ST-segment elevation acute coronary syndromes, ability to provide informed consent

Exclusion Criteria:

* ST-segment elevation myocardial infarction, cardiogenic shock, suspected stent thrombosis, known allergy to aspirin or ticagrelor, childbearing potential, life expectancy \<1 year due to non-cardiac disease, severe chronic kidney disease.
Investigating the Pharmacokinetics and Pharmacodynamics of Recombinant Human Insulin Administered by Dry Powder Inhaler

Evaluation of the pharmacokinetics and pharmacodynamics of different doses of spray-dried recombinant human insulin powder for inhalation administered via a dry powder uinhalation device compared with subcutaneously administered regular human insulin in healthy male volunteers under the conditions of a eugycemic clamp.

Explorative, single-center, randomized, open label, 4-way crossover study to evaluate the pharmacokinetics and pharmacodynamics of different doses of spray-dried recombinant human insulin powder for inhalation administered via a dry powder uinhalation device compared with subcutaneously administered regular human insulin in healthy male volunteers under the conditions of a eugycemic clamp.

Eligibility Criteria:
Inclusion Criteria:

* male
* non smoking for at least 12 months
* BMI equal to or less than 28
* no clinically significant abnormalities
* FVC and FEV1 equal to or more than 80%
* willing to participate and to sign informed consent form

Exclusion Criteria:

* positive results for insulin antibodies at screening
* history of substance abuse or dependency within last 5 years
* positive screening test for substance abuse
* positive blood test for HIV, hepatitis B or hepatitis C antibody
* fasting blood glucose of more than 126mg/dl
* any existing medical conditions which might interfere with absoprtion, distribution, metabolism or excretion of study medication
* history of bronchospastic disease(asthma), tachycardia, migraine headache, hypoglycemic episodes, jaundice, liver diseases, arterial hemorrhaging, severe hypertension or hypotension, cardiac abnormality, renal disease, allergies, unresolved psychiatric illness, drug-induced myopathy or any other clinically significant abnormality
* has received investigational medications within 21 days prior to receiving the first dose of study medication
* has taken or used any prescription medications within 21 days prior to receiving the first dose of study medication
* has taken or used any OTC medications,vitamins or herbal and/or nutritional supplements within 10 days days prior to receiving the first dose of study medication
* health that may be adversely affected by procedures or medications used in the study
* unwillingness or inability to understand or to follow required study restrictions and procedures
Incidence of Compliance to the ASA Preoperative Fasting Guidelines in Elective Surgery

Patients scheduled for elective surgery with general anesthesia, regional anesthesia, or procedural sedation and analgesia will be interviewed about the last time having

* clear liquid drink
* light meal
* regular meal


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective surgery requiring general anesthesia, regional anesthesia, or procedural sedation and analgesia.

Exclusion Criteria:

* Patients with the order of NPO after midnight.
* Patients with pregnancy
A Study to Explore the Effect of Sepranolone in Tourette Syndrome

The study was an open-label, randomized, multicenter, parallel, Phase 2a study in adolescents and adult patients with Tourette syndrome that aimed to explore the efficacy of Sepranolone as a treatment for Tourette syndrome, by reducing the severity and frequency of tics. The total study duration from the Screening Visit to the final follow-up visit was approximately 26 weeks and included the following periods:

* A baseline period of 4 weeks between the screening visit (Visit 1) and randomization (4 weeks of baseline period were not needed in well-known adult subjects with stable Tourette syndrome history over the past at least 4 weeks). A school holiday/annual leave period of 2-6 weeks where no study-related activities were done.
* A randomized treatment period of 12 weeks
* A safety follow-up period of 4 weeks


Eligibility Criteria:
Inclusion Criteria:

* Tic severity score ≥ 20 Yale Global Tic Severity Scale (YGTSS) Total Score at baseline
* The patient may have Obsessive-Compulsive Disease (OCD) as a comorbidity

Exclusion Criteria:

* Patient has participated in a clinical study over the past 30 days
* Evidence or history of neurological disease that may interfere with the study
* Malignant disease
* Unstable or clinical significant medical condition that could pose a risk
* HIV/ongoing hepatitis
* Clinical significant findings in vital signs
* History of anaphylactic reactions
NESP Pediatric Study

Open-label, randomized study of NESP in pediatric subjects 18 years of age or younger. Subjects will receive study drug (NESP or rHuEPO) for 28 weeks after a 2 week screening and baseline period. During the study, procedures include bloodwork for laboratory assessments and vital signs. Dose titration determined by hemoglobin values taken weekly during the study. Antibody samples taken at baseline and during the end of study assessments. A physical examination and laboratory tests will conclude the study.


Eligibility Criteria:
Inclusion Criteria:

* 1 to 18 years of age
* ESRD receiving dialysis or CRI with eGFR less than 30 mL/min
* Baseline hemoglobin 9.5 - 12.5 g/dL and iron replete
* Stable rHuEPO therapy for 8 weeks

Exclusion Criteria:

* Scheduled for a living-related kidney transplant
* Uncontrolled blood pressure
* seizure activity
* Hyperparathyroidism
* Major surgery within 12 weeks or active inflammatory disease
* Currently receiving antibiotics
* Clinical evidence of malignancy
* Pregnant or breast-feeding
Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence

To aim of this study is to establish the feasibility of undertaking a phase III trial of transcutaneous posterior tibial nerve electrical stimulation (TPTNS) to alleviate stroke-related urinary incontinence.

Stroke-related urinary incontinence (UI) persists in more than one third of stroke survivors. It is associated with significant burden including reduced quality of life, increased morbidity and disability. Urgency UI, together with overactive bladder (OAB) symptoms (frequency, urgency, nocturia), is most commonly experienced. Current continence care is limited to lifestyle advice and behavioural interventions such as voiding programmes. There is a reliance on containment approaches and a lack of available options for active treatment. Intermittent electrical stimulation of the posterior tibial nerve (TPTNS) is effective for treating non-stroke neurogenic UI and OAB, but has not been tested in the stroke population. This pilot randomised controlled trial (RCT) aims to test the potential effectiveness of TPTNS for stroke-related bladder dysfunction. Adults with stroke-related UI will be randomised to TPTNS or sham. They and/or their carer will be taught to self-deliver a programme of TPTNS over a six week period. Bladder function, associated healthcare costs and quality of life outcomes will be measured at 6, 12 and 26 weeks. A nested process evaluation will be conducted. Pilot RCT and process evaluation results will inform the design of a phase III RCT of TPTNS to treat urinary incontinence in the stroke population.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged ≥ 18 years, with a diagnosis of stroke based on the WHO criteria (WHO 1989) and stroke-related urinary incontinence of at least once weekly.
* Onset of stroke ≥ 4 weeks previously and discharged from hospital to own home following a new stroke episode within the previous 6 months.
* Physically, cognitively and communicatively able and willing to learn to apply TPTNS or has carer who is able and willing to learn.

Exclusion Criteria:

* Pre-existing urinary incontinence prior to stroke.
* Current Urinary Tract Infection.
* Voiding dysfunction requiring intermittent/indwelling catheterisation.
* Cardiac pacemaker in situ.
* Concurrent neurological diagnosis eg dementia, Multiple Sclerosis, diabetic neuropathy.
* Reduced/absent sensation at electrode placement sites.
* Post-void residual urine volume of \> 150ml.
Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease

To show that prevalence of inflammation of the small bowel in patients with anorectal disease is under-diagnosed based on colonoscopy ileoscopy alone.

IBD of the small bowel is associated with perianal disease such as ano-rectal abscesses and fistulas. Colonoscopy with ileoscopy and small bowel series are relied upon to document the presence of Crohn's disease of the small bowel. We suspect that the prevalence of inflammatory small bowel disease is underestimated.

In my practice I have cases that had negative colonoscopy ileoscopy and positive findings at capsule endoscopy. These patients are receiving therapy for Crohn's disease. It is important to prove that the prevalence is higher.

Capsule Endoscopy (CE) is the "first line tool" diagnostic procedure for the examination of the small bowel. It is performed today in more than 2,900 GI clinics in hospitals, outpatient departments and physicians' offices all over the world using the PillCam® Platform. Over 500,000 CE procedures with the Given PillCam SB have been completed to date.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 10 - 80
* Patients with anorectal abscess of anorectal fistula
* Patient is male or female
* Within three months prior to enrollment, patient has normal test results for at least one of the following tests:

  1. Colonoscopy with Ileoscopy, and/or
  2. Colonoscopy with small bowel series, and/or
  3. Colonoscopy with CT enterography
* Within three months prior to enrollment patient has the following lab tests: Blood count, sedimentation rate, CRP. IBD serology is optional.
* Sign informed consent

Exclusion Criteria:

* Can not sign informed consent
* Contraindications to colonoscopy ileoscopy or capsule endoscopy
* History of established IBD
Banded Sleeve Gastrectomy Improves Weight Loss Compared to Non-banded Sleeve: Mid-term Results

Weight regain after Laparoscopic Sleeve Gastrectomy (LSG) is nowadays a growing concern. Sleeve dilatation and loss of food restriction is considered the main mechanism. The placement of a silicon ring around the gastric tube seems to give benefits in the short-term.

The Investigators evaluate the efficacy of banded sleeve gastrectomy compared to standard sleeve in the mid-term.

Fifty patients were randomized between LSG and Laparoscopic Banded Sleeve Gastrectomy (LBSG), and they underwent a mean follow-up of 4 years.

Patients' management was exactly the same, apart from the band placement. After surgery differences in weight loss, operative time, complication rate and mortality were analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Morbid obesity
* Failure of medical treatment
* \>18yrs; \<60 yrs

Exclusion Criteria:

* Previous bariatric or GI surgery
* Psychiatric disease
* Pregnancy
* Contraindication to laparoscopy
The New Skin Stretching Device for Treatment of Limb Tension Wounds

A randomized controlled trial is performed to evaluate the effectiveness and safety of the Skin Stretching Device (SSD) on limb tension incision closure by comparing whether the differences in wounds area, wounds closure time and scar assessment between the SSD and the skin grafting are statistically significant.

Design:

This study is a multicenter and randomized control study with the participation of 15 major national or regional central hospitals. And the whole sample size is set to be 100 patients.

Patients who have been screened by inclusion and exclusion criteria will be randomly (non-transparent envelope) assigned to Skin Stretching Group (SS Group) or Skin Grafting Group (SG Group). Patients of both group will undergo surgical debridement for the same principle, while the Skin Stretching Device is used for the patients of SS Group for incision closure and the Skin Grafting is used for the patients of SG group for incision closure.

Outcome evaluation:

Wound and scar evaluation during surgery, three and six months after surgery will include the following parameters:

* surface area;
* Vancouver scar scale (VSS)
* vascularization and pigmentation;
* dermal architecture. After 3 and 6 months patients will undergo a biopsy of the scar under local anesthesia. The experimental group, treated with the SSD will undergo one extra biopsy of the formerly stretched skin.

Safety evaluation:

During the trial, adverse events are observed and evaluated. Adverse reactions to clinical manifestations are followed and recorded till the symptoms disappear. The subject with serious adverse events shall withdraw from the study and be treated accordingly.

Eligibility Criteria:
Inclusion criteria:

1. Age≥18 years old
2. Tension incision that cannot be directly closed due to limb trauma or surgical debridement
3. Incision that cannot be directly closed after the incision decompression for fascia compartment syndrome and ischemia and reperfusion injury
4. Both sides of the incision skin suitable for skin stretching

Exclusion criteria:

1. Age \<18 years old
2. Skin disease
3. Keloid history
4. Local or systemic use of hormones
5. Systemic diseases: for example, diabetes, immunodeficiency disease, vascular disease and etc.
6. Other poor general state to result in inability for trial;
7. Mental illness.
Erector Spinae Plane Block Versus Oblique Subcostal Transverses Abdominis Plane Block

Comparing the impact of bilateral erector spinae plane block and transverse abdominis plane block on improving quality of pain management after umbilical hernia repair.

Postoperative pain is an important problem after umbilical hernia repair which has negative effects on patient's hemodynamics and cause delayed ambulation resulting in prolonged duration of hospital stay and poor patient satisfaction.

Multiple analgesic strategies have been proposed including Non steroidal anti-inflammatory drugs (NSAIDs), opioids, epidural analgesia. Each of them has its limitations.

Ultra¬sound guided regional anesthesia techniques for abdominal wall can be effective components of multimodal postoperative analgesia with limited side-effects Erector spinae plane (ESP) block is a promising para-spinal bock that can achieve both visceral and somatic abdominal analgesia if the injection was performed at a lower thoracic level. Transverse abdominis plane (TAP) block which is considered a peripheral nerve block that is aimed at anesthetizing nerves supplying the anterior abdominal wall.

We will compare between erector spinae plane block and transverse abdominis plane block for controlling postoperative pain after umbilical hernia repair.

Patients will be allocated randomly into two equal groups by a computer-generated randomization table Group (E) (n=26): Patients will receive erector spinae plane (ESP) block after completion of surgery.

Group (T) (n= 26): Patients will receive oblique subcostal transverse abdominis plane (TAP) block after completion of surgery

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective umbilical hernia repair.
* Patient acceptance.
* Both sex
* Patient's age 21 - 60 years.
* Patients with American Society of Anesthesiologists (ASA) physical status I, II.
* BMI 25 - 30 kg m-2.

Exclusion Criteria:

* Uncooperative patients and patients with psychological problems.
* Patients with liver or renal impairment.
* Patients with contraindication to regional anesthesia.
* Patients with history of allergy to drug used in the study.
* Patients with chronic pain.
LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT

Older patients with non-small cell lung cancer (NSCLC) treated with stereotactic body radiation therapy (SBRT) often die from other causes than lung cancer due to age-related comorbidities. This national randomized study will include 130 patients throughout 5 Danish cancer centres and investigate if a comprehensive geriatric intervention (CGA) when added upfront to SBRT for patients with localized NSCLC will have an impact on quality of life (QoL), overall survival, physical functionality and unplanned hospital admissions.

If an upfront CGA improves patients' general health status, this study could lead to implementation of a CGA in standard clinical practice as well as further research on older patients receiving radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cytologically or histologically proven non-small cell lung cancer
* Stage T1-3N0M0
* ≥ 70 years old
* In a multidisciplinary setting the patient is considered medically inoperable, too frail for operation due to age and/or comorbidity or that the patient refuse surgery and therefore candidate for SBRT.

Exclusion Criteria:

* Missing histology/cytology
* Another current malignancy
* Higher staging at treatment planning
* Not able to provide informed consent
* Do not speak or understand Danish
Methylprednisolone Injections Treating Birch Pollen Induced Allergic Rhinitis.

This study evaluates the effect of intramuscular injected methylprednisolone treating birch pollen induced rhinitis compared to placebo.

The study was an interventional single center double-blinded human randomized trial with two groups treated parallel.The first group received an intramuscular injection of Methylprednisolone 40 mg/ml 2ml x 1 as a single dose. The second group received an intramuscular injection of NaCl 0,9 mg/ml 2ml x 1 as a single dose. Symptom score and the use of medication was registered daily during the pollen peak of the season, using an electronic diary. The study was conducted during the spring of 2019.

Eligibility Criteria:
Inclusion Criteria:

* Severe birch pollen induced allergic rhinitis.
* Signed informed consent according to International Council of Harmonisation/Good Clinical Practice, and national/local regulations.
* Women of considered childbearing potential (WOCBP) will only be included after a negative highly sensitive pregnancy test according to CTFG recommendations.

Exclusion Criteria:

* Pregnancy or nursing.
* Autoimmune or collagen disease.
* Cardiovascular disease.
* Hepatic disease.
* Renal disease.
* Cancer.
* Upper airway disease (non-allergic sinusitis, nasal polyposis, chronic obstructive- and restrictive lung disease).
* Medication with a possible side-effect of interfering with the immune response.
* Previous immuno- or chemotherapy.
* Chronic disease.
* Major metabolic disease.
* Alcohol or drug abuse.
* Mental incapability of coping with the study.
* Known or suspected allergy to the study product.
* Suspicion of or confirmed bacterial infection.
* Known allergy to the study drugs, "rescue medication".
Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples

To assess the acceptability of and participation in a group counseling intervention, including an assessment of willingness to disclose serostatus to a regular sexual partner and the willingness of that partner to participate. To evaluate the profile of adverse experiences (social, psychological, and physical harms) of individuals resulting from participation in counseling and testing and attempts to initiate condom use within a stable HIV serodiscordant partnership. To assess the potential for the intervention to result in increased condom use among stable sexual partners.

There is a significant risk of HIV transmission to HIV-uninfected partners in HIV-discordant couples. While condom use has been a major component of most AIDS prevention programs since the mid-1980s, there has been little emphasis on promoting condom use within stable partnerships. The most effective way to promote condom use among discordant couples remains largely unknown.

There is a significant risk of HIV transmission to HIV-uninfected partners in HIV-discordant couples. While condom use has been a major component of most AIDS prevention programs since the mid-1980s, there has been little emphasis on promoting condom use within stable partnerships. The most effective way to promote condom use among discordant couples remains largely unknown.

A pilot study to assess the acceptability of intervention precedes the main study. The Phase I study recruits 15 HIV-infected men and 15 HIV-infected women and their partners at each of three sites (India, Thailand, and Uganda). Volunteers participate in a multi-session group-based condom promotion program for approximately 12 months. Couples are organized into small groups consisting of 4 to 6 couples per group. Each group meets for a total of 4 sessions within a 2- to 4-week period. Follow-up interviews are conducted at Months 1 and 3 following completion of the intervention.

Eligibility Criteria:
Inclusion Criteria

Volunteers must be:

* HIV-positive through HIVNET testing or HIV-seronegative by EIA.
* Presently in a sexual relationship of at least 6 months duration with the intention to remain with this partner for the duration of the study.
* Willing to identify and recruit this sexual partner to which he/she has disclosed or will disclose HIV serostatus.
* Willing to receive counseling and HIV testing (HIV-seronegative partners only).
* Willing to agree to be interviewed with their partner and individually.
* Willing to continue engaging in sex with their partner.
* Willing to participate in a couples-based condom promotion intervention.
* Willing and able to attend each scheduled intervention/follow-up study visit.

Exclusion Criteria

Volunteers with the following are excluded:

* History of domestic violence.
* Current consistent condom use.