cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HS-10561 Capsule in Healthy Chinese Adults and Patients With Chronic Spontaneous Urticaria.

This is a randomized, double-blind, placebo-controlled phase 1/2 clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HS-10561 capsule in healthy Chinese adults and patients with chronic spontaneous urticaria.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed.(SD)
* Healthy adults aged 18-45 years (inclusive) at the time of signing the informed consent form;(SD)
* Male participants weighing ≥ 50 kg and female participants weighing ≥ 40 kg; body mass index (weight/square of height (kg/m2)) within the range of 18-30 kg/m2 (inclusive);(SD)
* Female participants and male participants (including their female partners) agree to use highly effective methods of contraception from the date of signing the informed consent form until 30 days after the last dose;(SD)
* Without history of severe respiratory, gastrointestinal (such as inflammatory bowel disease, Crohn's disease, chronic diarrhea, etc.), neurological, circulatory, urinary, endocrine, musculoskeletal, immune system disorders, or a history of tumors prior to screening.(SD)
* Written informed consent must be obtained before any assessment is performed.(MD and Phase 2)
* Healthy adults aged 18-65 years (inclusive) at the time of signing the informed consent form;(MD and Phase 2)
* Have been diagnosed with chronic spontaneous urticaria for ≥6 months at the time of screening;(MD and Phase 2)
* Female participants and male participants (including their female partners) agree to use highly effective methods of contraception from the date of signing the informed consent form until 30 days after the last dose.(MD and Phase 2)

Exclusion Criteria:

* Have clinically significant abnormalities in vital signs, physical examination, laboratory tests, chest X-ray/CT, or abdominal ultrasound during the screening period, which, as assessed by the investigator, may increase the participants' risk or affect the scientific validity of the study;(SD)
* Females with a positive blood pregnancy test, breastfeeding females, or participants planning to become pregnant during the study period;(SD)
* Any physiological or psychological condition or disease, as determined by the investigator, that could increase the risk, affect the participants' compliance, or impact the participants' ability to complete the study.(SD)
* Chronic urticaria with a clear primary or sole trigger (chronic inducible urticaria);(MD and Phase 2)
* Clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria);(MD and Phase 2)
* Other diseases with symptoms of urticaria or angioedema;(MD and Phase 2)
* Other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results;(MD and Phase 2)
* Pregnant or nursing (lactating) women.(MD and Phase 2)
Conservative Treatment of Rectosigmoid Endometriosis Monitored by Transvaginal Ultrasound

Background: Endometriosis is a disease affecting 8-15 % of fertile women and is a cause of abdominal pain and suffering during women's menstrual periods. A subgroup of patients with DIE has an infiltration into the rectosigmoid bowel wall (4-37%). Knowledge of the growth pattern of rectosigmoid lesions related to subjective symptoms is mandatory in order to assess the need for follow-up with transvaginal ultrasound during medical treatment.

Hypotheses:

Symptoms will follow growth of rectosigmoid endometriosis.

Material and methods:

Two different cohorts of women, based on time of diagnosis of rectosigmoid endometriosis and treatment with hormonal intrauterine device or continuous oral contraceptives will receive a questionnaire and a transvaginal ultrasound scan (measuring size and volume) at inclusion, (6) and 12 months later.

Perspectives:

Patients treated conservatively may be followed by questionnaires, thereby reducing the need for time consuming clinical controls.


Eligibility Criteria:
Inclusion Criteria:

* Medically treated bowel endometriosis

Exclusion Criteria:

* Age below 18 years
* Bowel resection of any kind
* Cancer
Cytokine Filter Usage During Open Thoracoabdominal Aortic Aneurysm Repair- a Single-center Randomized Prospective Trial

Prospecrtive study including 20-30 randomized patients treated by open repair because of an TAAA larger than 55 mm During the surgery, a heart lung machine is applied for distal perfusion during aortic cross clamping to enable distal organ perfusion.

Regardless an intensive inflammatory reaction is a well known effect after reperfusion, leading to a uncontrolled inflammation during th first days after surgery. This may be associated to bad outcome and decreased survival rates. By the application of a intraoperative cytokine and DAMP filter this negative ffect could be reduced, resulting in a better outcome after surgery.

Prospecrtive study including 20-30 randomized patients treated by open repair because of an TAAA larger than 55 mm During the surgery, a heart lung machine is applied for distal perfusion during aortic cross clamping to enable distal organ perfusion.

Regardless an intensive inflammatory reaction is a well known effect after reperfusion, leading to a uncontrolled inflammation during th first days after surgery. This may be associated to bad outcome and decreased survival rates. By the application of a intraoperative cytokine and DAMP filter this negative ffect could be reduced, resulting in a better outcome after surgery.

Eligibility Criteria:
Inclusion Criteria:

Suffering from a TAAA larger than 55mm

Exclusion Criteria:

immunosupprive therapy pregnancy

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Diurnal BP Patterns in Those at Increased Risk of CVD

In health, blood pressure (BP) falls at night by \>10% compared with day-time values. This natural dipping pattern is important as without it there is an increased risk of cardiovascular disease (CVD). Recent evidence suggests that chronotherapy (taking anti-hypertensive medication at bedtime instead of in the morning) may enhance nocturnal BP dipping and reduce the risk of CVD events. There is therefore an urgent need to characterise diurnal BP patterns in patients who may be at risk of reduced nocturnal dipping in order to maximise protective therapy in all those who would benefit. Similarly, it has previously been demonstrated that increased arterial stiffness is associated with increased CVD risk, however little is known about whether loss of diurnal variations in arterial stiffness confer addition risk. Kidney disease is independently associated with increased CVD events, but the exact makeup of this risk is not clear. Within this heterogenous cohort several very distinct groups exist including those with acute kidney injury (AKI), chronic kidney disease (CKD), inflammatory conditions like small vessel vasculitis (SVV), and those who have either donated or received a kidney transplant. Diurnal BP and arterial stiffness patterns within these patient groups are not well characterised. The investigators will recruit patients at increased risk of CVD from the Royal Infirmary of Edinburgh Renal and Vasculitis Clinics. Participants will undergo 24-hour ambulatory BP and arterial stiffness measurement in conjunction with day- and night-time blood and urine sampling on two separate occasions. This study aims to characterise diurnal patterns of BP and arterial stiffness in patients at increased risk of CVD and compare findings with healthy controls. In doing so, the investigators aim to allow more targeted CVD risk reduction strategies and improve long-term patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible to take part in the study if they attend NHS Lothian inpatient or outpatient services and can be classified as being at increased risk of CVD. This will include, but is not limited to, the following subgroups:

  1. CKD as defined by the Kidney Disease Outcome Quality Initiative (K/DOQI) classification
  2. AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) classification
  3. Small vessel vasculitis
  4. Kidney transplant recipient
  5. Kidney donor We will also recruit a healthy control group from the community.

Exclusion Criteria:

1. Age \<18 years and \>90 years
2. Lack of ability to provide informed consent
Influence of Probiotic and Symbiotic in Body Weight, Blood Sugar and Lipemia of Obese Women

The purpose of this study is to evaluate whether gut microbiota modulation by probiotic and symbiotic contribute with weight loss and improvement of metabolic parameters in women with obesity.

We will evaluate the effects of probiotic and symbiotic on weigh loss, blood glucose, lipid profile, metabolomic profile, and gut microbiota composition variables in women with obesity.

Eligibility Criteria:
Inclusion Criteria:

* Women;
* Adult;
* Obese (BMI between 30 and 39,9 Kg/m²).

Exclusion Criteria:

* Pregnancy or nursing;
* Smokers;
* Drinkers;
* Use of drug or phytotherapic;
* Diagnosis of any cronic disease;
* Daily consumption of yogurt.
AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip

This is a pilot multi-centre RCT of 40 patients (ages 18-55 years, inclusive) undergoing primary hip arthroscopy with a focal articular cartilage defect of the acetabulum to compare the effect of using autologous matrix-induced chondrogenesis (AMIC) in comparison to microfracture on hip function, health-related quality of life, hip pain, cartilage regeneration, health utility, and any adverse events at 2 years. Follow-up will occur at 6 weeks, 6 months, 12 months, 18 months, and 24 months post-surgery.


Eligibility Criteria:
Inclusion Criteria:

1. All patients aged 18-55 years
2. Hip pain lasting 6 months or more with no relief from documented non-operative modalities
3. Focal articular cartilage defects of the acetabulum on MRI, confirmed to be full thickness (International Cartilage Regeneration and Joint Preservation Society (ICRS) grade 3 or 4) during arthroscopic examination
4. Focal acetabular articular cartilage lesions measuring between 3 cm2 and 25 cm2 on MRI and confirmed on arthroscopic examination
5. Patient agrees to participate in the study-specific postoperative rehabilitation protocol
6. Patient can speak, read, and understand the language of the site
7. Patient has provided informed consent

Exclusion Criteria:

1. Cartilage defects of the femoral head
2. Previous surgery on the study hip
3. Traumatic chondral injury of the hip from a single event
4. Presence of advanced osteoarthritis (Tonnis grade 3) or any other acute or chronic inflammatory joint disease
5. Known hypersensitivity or allergy to porcine collagen
6. Acute or chronic infection at the surgical site
7. Evidence of hip dysplasia (i.e., lateral centre edge angle \< 20˚)
8. Evidence of acetabular over coverage such as coxa profunda or coxa protrusion
9. Immunosuppressive or anti-proliferative medication use
10. Chronic pain syndromes
11. Significant medical co-morbidities (requiring assistance for activities of daily living (ADLs))
12. History of paediatric hip disease
13. Uncontrolled diabetes
14. Contraindications to MRI imaging (e.g. claustrophobia)
15. Patient is involved in ongoing legal or workplace claims
16. Patient is incarcerated
17. Patient is pregnant or breastfeeding
18. Patient who will likely have problems, in the judgement of the investigator, with maintaining follow-up
19. Any other reason(s) the investigator feels is relevant for excluding the patient
Multidisciplinary Research Into the Effects of Resistance Exercise and Whey Protein Supplementation in Healthy Older Men

The aim of this randomised, double-blind, placebo-controlled, parallel groups trial is to investigate the effects of 12 weeks resistance exercise and whey protein supplementation on energy metabolism, markers of appetite, inflammation and hormonal response and body composition and strength and functional performance.

Generally healthy, retired men aged 60-80 years will be recruited (n = 52 in total, n = 13 per group). Participants will be randomised to either: a) control group, b) whey protein supplement group, c) resistance exercise + control group or d) resistance exercise + whey protein supplementation group.

With demographics indicating that the world's population aged \>60 years will increase from 600 million reported in 2000, to \>2 billion by 2050, there is an increasing interest in health issues related to ageing. One area of particular interest is sarcopenia, defined as the progressive loss of muscle mass, strength and physical function as a consequence of ageing. Sarcopenia has been associated with an increase in cardiovascular disease, poor metabolic and cognitive function, reduced quality of life and early mortality. Studies have reported beneficial effects of both resistance exercise and increasing protein intake independently and in combination on markers of sarcopenia (mostly increases in muscle mass, strength and physical function). However, little is known about the effects of combined intervention on energy metabolism, appetite and cognitive and endocrine function. This randomised, double-blind, placebo-controlled, parallel groups trial will investigate these, alongside assessing the effects of combined intervention on total lean tissue mass, muscular strength and functional performance.

Eligibility Criteria:
Inclusion Criteria:

* Retired Men aged 60-80 years
* Body Mass Index 18.5-30 kg/m2
* Not participated in resistance exercise within the last 6 months
* Free from musculoskeletal injury

Exclusion Criteria:

* Retired Men aged \<60 or \>80 years
* Current smokers, or ex-smokers ceasing \<6 months ago
* Body Mass Index \<18.5 and \>30 kg/m2
* Currently participating in resistance exercise regularly (within last 6 months)
* Not weight stable and/or looking to start a weight loss programme
* Individuals participating in another research project (within the last 6 months) involving dietary and/or exercise intervention
* Existing or past medical history of vascular disease, cancer, diabetes, neurological, kidney, pulmonary, digestive (Coeliac disease), thyroidal disease, osteoporosis or history of falls
* Currently taking protein/amino acid supplements regularly
* Currently prescribed non-steroidal anti-inflammatory medication, hormone replacement therapy (HRT), diabetic medication, beta-blockers, statins
* Uncontrolled blood pressure (Blood pressure \>160/100 mmHg)
* Self-reported lactose intolerant or allergic to wheat or potatoes
* Individuals with a pacemaker
* Neuromuscular disorders or injuries
A Prospective Study Using SupraSDRM® in Promoting Healing and Reducing the Time to Grafting of Full-thickness Wounds

This is a prospective, randomized, controlled, multi-center clinical study comparing SupraSDRM® to standard of care wound dressing, BTM, in the treatment of full-thickness wounds deemed not immediately suitable for definitive grafting will be performed.

Twenty-four patients with full-thickness wounds fulfilling inclusion criteria of the study will be consented and enrolled into the clinical trial. An area (≥ 5 and ≤125 cm2) deemed not immediately ready to accept skin graft will be designated as the study site. The study site will be randomized to receive either SupraSDRM® or the SoC wound dressing, NovoSorb® BTM.

Eligibility Criteria:
Inclusion Criteria:

* Patient age ≥18 years and ≤85 years
* Full-thickness traumatic injury, surgical wound, or excised full-thickness burn (e.g., friction, contact, flame, scalding etiology), where immediate grafting is not deemed suitable by the treating surgeon
* Wound size ≥ 5cm2 not immediately suitable for graft application
* Subject or legally authorized representative is able and willing to sign informed consent

Exclusion Criteria:

* Study wound may not include areas of the face, and neck and genitalia.
* Wound with metal hardware exposure
* Pressure sores
* Wounds with residual malignancy
* Wound infection at the time of planned wound dressing application
* Wound that is a part of an active treatment arm of an interventional study (within 90 days of Screening Visit)
* Pregnancy/lactation
* Subjects who are unable to follow the protocol or who are likely to be non-compliant
* Subjects with uncontrolled diabetes (defined by Hgb A1C \>10)
* Subjects who are receiving systemic steroids or immune suppressive treatment
* Subject with a known allergy to polylactide, polycaprolactone, polyvinyl alcohol, trimethylene carbonate or resorbable suture materials.
* Prisoners
SUBSUS (SUBglottic Secretion at Ultrasound Score)

To compare the performance of ultrasound in detecting subglottic secretion above the ETT tube cuff in comparison to computed tomography (CT) scan.

Airway ultrasound will be performed at the bedside prior to CT scan in all intubated patients who fulfiled the criteria. The image of subglottic secretion was then compared to the plain CT cervical. The findings of the CT was examined by a radiologist.

Eligibility Criteria:
Inclusion Criteria:

* age more than 18 years old
* ETT in situ
* indicated for CT cervical scan

Exclusion Criteria:

* neck subcutaneous emphysema
* neck scar or surgical dressing around the neck which can lead to difficulty in obtaining an optimal ultrasound image.
A Clinical Trial to Study the Impact of a Nutritional Beverage on Tests of Memory in Healthy Preschool Age Children

The effect of supplementation using both protein and multiple micronutrients in preschool age children on cognitive performance and growth is unknown. The study will compare the effect of combination of protein and multiple micronutrients on indicators of cognitive performance and growth in preschool age children. Cognitive performance and anthropometric assessments will be measured at baseline and at 6 months.


Eligibility Criteria:
Inclusion Criteria:

1. Consent: Demonstrates understanding of the study and willingness to participate as evidenced by subject's parents or legally authorised representative's voluntary written informed consent and has received a signed and dated copy of the informed consent form.
2. Compliance : Understands and is willing, able and likely to comply with all study procedures and restrictions
3. General Health : Good general and mental health with, in the opinion of the investigator
4. Child with BMI for age between \<+1 standard deviation (SD) to \> -2SD

Exclusion Criteria:

1. Children in Care (CiC): A child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.
2. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (lactose, wheat gluten, soy protein) or any of their stated ingredients.
3. Child with severe anaemia (Haemoglobin \< 7 g/dl) as determined by the non invasive spectrophotometry results.
4. Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
5. Participation in any nutritional study or didactic nutrition education in the last 6 months of the screening visit

5. Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the subject unlikely to fully complete the study or any condition that presents undue risk from the study product or procedures in the opinion of the investigator.

6. Recent history (3 months) of serious infections, injuries and/ or surgeries. 7. Children consuming iron, calcium and/or other nutritional supplements and/ or health food drinks on a regular basis (more than 3 times a week, in the recommended dosage) in the last 1 month prior to screening visit.

8. Use of any prescription medications during the study period for more than or equal to two weeks.
Comparison of Cognitive Processing Therapy (CPT) and Dialogical Exposure Therapy (DET) for Posttraumatic Stress Disorder

This study aims to compare two active psychological treatments for PTSD. One is an established therapy, Cognitive Processing Therapy (CPT) which operates as a control condition for a newly developed intervention, an integrative Gestalt-based trauma therapy, Dialogical Exposure Therapy (DET). There is no inactive control condition. We expect the two therapies to perform on a similar level, which would constitute evidence for the efficacy of DET.


Eligibility Criteria:
Inclusion Criteria:

* main diagnosis of posttraumatic stress disorder
* time since trauma is at least three months

Exclusion Criteria:

* acute suicidal ideation
* severe personality pathology
* substance dependence
* early childhood trauma (e.g. child sexual abuse)
* history of psychosis
* dissociative identity disorder
* neurological impairment (e.g. craniocerebral injury with functional impairment)
* severe pre-traumatic depression
* ongoing psychotherapy
* lack of motivation
* lack of German language skills
CoolSculpting of the Flank With Alternate Treatment Parameters

The purpose of this study is to evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction with an alternative treatment parameter.

The study evaluated the use of the Zeltiq CooSculpting System for non-invasive fat removal in the flank.

Eligibility Criteria:
Inclusion Criteria

1. Male or female subjects \> 18 years of age and \< 65 years of age.
2. Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
3. Subject has not had weight change exceeding 10 pounds in the preceding month.
4. Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
5. Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
6. Subject has read and signed a written informed consent form.

Exclusion Criteria

1. Subject has had a surgical procedure(s) in the area of intended treatment.
2. Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
3. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.
4. Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
5. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
6. Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
7. Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
8. Subject is taking or has taken diet pills or supplements within the past month.
9. Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
10. Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
11. Subject is pregnant or intending to become pregnant during the study period (in the next 5 months).
12. Subject is lactating or has been lactating in the past 6 months.
13. Subject has a history of hernia in the areas to be treated.
14. Subject is unable or unwilling to comply with the study requirements.
15. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
16. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.