cyrilzakka/clinical-trials huggingface dataset:
A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.

The purpose of this study is to improve port wine stain therapeutic outcome in response to laser therapy. The researchers want to determine whether the combined use of pulsed dye laser therapy and rapamycin will improve PWS therapeutic outcome.

The researchers want to combined use of pulsed dye laser to induce port wine stain blood vessel injury, and rapamycin directly inhibits the proliferation of vascular endothelial cells driven by vascular endothelial growth factor which preventing port wine stain angiogenesis and recanalization, to improve port wine stain lesion blanching.

Eligibility Criteria:
Inclusion Criteria:

* port wine stain birthmarks suitable for comparison testing.

Exclusion Criteria:

* Pregnancy.
* Abnormal blood hematology or chemistry blood tests or urine analysis.
* History of cancer, History of high cholesterol, lipids or liver disease
* Allergy to macrolide drugs (e.g., erythromycin).
* Any therapy within the previous two months to the proposed PWS treatment sites.
* Concurrent use of known photosensitizing drugs,immunosuppressive drugs or systemic steroids,antifungals, antiepileptics, HIV protease inhibitors, cimetidine, cisapride, clarithromycin, dannzol, diltiazem, erythromycin, metoclopramide, rifabutin, rifampin, rifapentine, troleandomycin, or verapamil.
Safety, Tolerability and Pharmacokinetic Study of MRG-201 in Healthy Volunteers

The primary objective of this study is to evaluate the safety and tolerability of the investigational drug, MRG-201, in healthy volunteers. MRG-201 is designed to mimic the activity of a molecule called miR-29 that decreases the expression of collagen and other proteins that are involved in scar formation. MRG-201 is being studied to determine if it can limit the formation of fibrous scar tissue in certain diseases.

MRG-201 will be tested in healthy volunteers by injection into intact skin or adjacent to a short skin incision. Volunteers may receive one or several doses of MRG-201, and will be monitored for local reactions in the skin, signs or symptoms of adverse effects on the body, and for the levels of MRG-201 in the blood over time. Skin biopsies will also be collected to study how cells in the skin respond when exposed to MRG-201.

Study Design:

Cohorts of 3-6 healthy male volunteers, ages 18-45, will receive single or multiple ascending doses of MRG-201 by intradermal injection at one site and placebo at a second site over a period of up to 15 days, with follow-up for up to 28 days after the last dose to determine the maximum tolerated dose in intact or incised normal skin and the tendency for active drug to diffuse through the skin.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males between 18 and 45 years of age inclusive
* Body Mass Index (BMI) 18-35 kg/m\^2 inclusive
* Must have 2 regions on the lower back/upper buttocks free of striae, scars, tattoos or other skin pathologies
* If engaged in sexual relations with a female of child-bearing potential, must be willing to use two effective contraceptive methods throughout the treatment period and for at least 12 weeks after the last treatment administration

Exclusion Criteria:

* Clinically significant abnormalities in medical history or physical exam which in the opinion of the Investigator would make the subject unsuitable for inclusion in the study
* History of cutaneous disorder that could interfere with the study or put the subject at risk
* History of renal or liver dysfunction or evidence of renal or liver dysfunction at screening
* History of clinically significant anemia or evidence of clinically significant anemia at screening
* Positive for blood borne pathogen (HBV, HCV, HIV) at screening
* Prior malignancies within the past 3 years (allowing squamous cell and basal cell carcinomas that have been successfully treated)
* Use of systemic steroids or topical steroids on the target area within two months of the Baseline visit or use of topical steroids outside the target area within 14 days of the Baseline visit
* Use of an investigational small molecule drug within 28 days of the baseline visit or use of an investigational oligonucleotide or biologic drug within 90 days of the baseline visit
Improving Propulsion of the Paretic Leg In Chronic Stroke

Stroke survivors may have a latent, propulsive capacity of the paretic leg, that can be elicited during short, intensive gait training interventions. The aim of this study was therefor to investigate the effect of a five-week gait training on paretic propulsion, propulsion symmetry, gait capacity, and daily-life mobility and physical activity in chronic stroke survivors.

Stroke survivors may have a latent, propulsive capacity of the paretic leg, that can be elicited during short, intensive gait training interventions. The aim of this study was therefor to investigate the effect of a five-week gait training on paretic propulsion, propulsion symmetry, gait capacity, and daily-life mobility and physical activity in chronic stroke survivors. We hypothesize that the robotic gait training will improve propulsion symmetry and, thereby, gait speed and functional gait tasks. In addition, we expect that improved gait capacity might lead to less impact of stroke on daily-life mobility and a higher physical activity level. Thirty-three chronic stroke survivors with impaired paretic propulsion (≥8% difference in paretic vs. non-paretic propulsive impulse) will be enrolled in this proof-of-concept study. Participants receive five weeks individual robotic gait training targeting paretic propulsion (60 minutes, two time a week). The robotic gait training is complemented with daily home exercises (15 minutes/day) focusing on increasing strength and practice of learned strategies in daily life. Propulsion measures, self-selected gait speed, performance on functional gait tasks, and daily-life mobility and physical activity are assessed five weeks (T0) and one week (T1) before the start of the intervention, and one week (T2) and five weeks (T3) after the end of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* adults (\>18 years of age) with unilateral ischemic or heamorrhagic supratentorial stroke
* at least 6 months post-onset
* impaired propulsion of the paretic leg during walking at a self-selected speed (≥ 8 percent propulsion asymmetry)
* ability to walk 10 meter without support or use of a walking aid (Functional Ambulatory Categories (FAC) 3-5)
* ability to walk for 5 consecutive minutes, with or without the use of a walking aid
* at least 10 degrees passive hip extension and able to stand plantigrade with extended knee

Exclusion Criteria:

* inability to move the body upward against gravity (calf muscle - Medical Research Council (MRC) scale \< 3)
* severe cognitive problems assessed with Mini-Mental State Examination (MMSE \< 24)
* depressed mood assessed with the Hospital Anxiety and Depression Score (HADS \> 7)
* persistent unilateral visuospatial neglect assessed with the Star Cancellation Test (score \< 44)
* any medical condition interfering with gait
* inability to understand verbal instructions
* inappropriate or unsafe fitting of the robotic gait trainer, due to severe lower limb spasticity (Modified Ashworth Scale (MAS) ≥ 3), severe lower limb contractures, body weight ≥ 140 kg, or skin problems at body sites where the harness or straps were to be fitted
Efficacy of PAP Therapy on Blood Pressure

The aim of the study was to determine the long term effects of compliance with positive airway pressure therapy on blood pressure in both hypertensive and normotensive patients with obstructive sleep apnoea hypopnoea syndrome.

Scientific data about the causal role of obstructive sleep apnoea hypopnoea syndrome (OSAHS) in the development of systemic hypertension and the effects of positive airway pressure (PAP) treatment on blood pressure (BP) control are continuously increasing; however they are controversial. We aimed to determine the long term effects of compliance with PAP therapy on BP in both hypertensive and normotensive patients with OSAHS.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed OSAHS by polysomnography according to standard criteria
* no history of previous PAP therapy
* normotensive and hypertensive patients
* an above-elementary school education.

Exclusion Criteria:

* refusal to participate
* refusal of PAP therapy
* secondary hypertension
* central sleep apnea syndromes
* obesity hypoventilation syndrome
* restrictive ventilator syndromes
* history of established cardiovascular disease
* severe congestive heart failure
* a history of life-threatening arrhythmias
* severe cardiomyopathy
* significant chronic kidney disease
* long-term oxygen therapy
* family or personal history of mental illness
* drug or alcohol abuse
* severe cognitive impairment
* concurrent oncological diseases
* need for chronic use of medication that may affect BP levels
* pregnancy
* history of narcolepsy or restless leg syndrome
SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer

This study is a multicentre, open-label, dose-finding/efficacy-expanding phase Ib/II clinical trial to evaluate the tolerability, safety, pharmacokinetic profile and immunogenicity of SHR-A1811 combination regimen in the treatment of recurrent or metastatic cervical cancer and to preliminarily evaluate the efficacy of SHR-A1811 combination regimen for recurrent or metastatic cervical cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must voluntarily join this study, sign the informed consent form, have good compliance and be able to cooperate with the follow-up.
2. Female, aged 18-75 years old.
3. Expected survival ≥ 12 weeks.
4. Normal function of vital organs.
5. Female subjects of childbearing potential must have a negative serum HCG test within 7 days prior to the first dose and must be non-lactating.
6. Female subjects must agree to comply with contraceptive requirements from signing the informed consent form to 7 months after the last dose of the investigational drug.

Exclusion Criteria:

1. Previous or concomitant other malignancies.
2. Severe bone damage caused by bone metastasis from tumours.
3. Presence of active autoimmune disease or history of autoimmune disease with possible recurrence.
4. Those with active tuberculosis.
5. Concomitant poorly controlled or severe cardiovascular disease.
6. Occurrence of arteriovenous thrombotic events within 6 months prior to the first dose.
7. Presence of gastrointestinal obstruction or presence of symptoms and signs of gastrointestinal obstruction within 6 months prior to the first dose.
8. Subjects who have had a serious infection within 1 month before the first dose.
9. Subjects who have a history of immunodeficiency.
10. As judged by the investigator, there are other factors that may affect the results of the study or cause the study to be forced to terminate halfway.
Prevention of Postpartum Weight Retention in Low Income WIC Women

This study will examine the effects of an online behavioral intervention to promote weight loss in low income postpartum women in the WIC program.

This program is designed to reduce postpartum weight retention in low income women in the WIC program. The weight loss program will be delivered over the internet and will use behavioral weight loss techniques.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Age 18-40 years.
* Delivery within 6-52 weeks
* Exceed pre-pregnancy weight by at least 4.5 kg (10 pounds) or current body mass index (BMI) \>/= 25
* Current BMI \> 22
* English or Spanish speaking
* Has internet access at home or a landline
* Literacy of at least 5th grade reading level
* Has a cell phone

Exclusion Criteria:

* Pregnant or planning to become pregnant
* Relocating in the next year
* Serious psychological problems (untreated depression, schizophrenia, bipolar disorder) or medical problem (i.e. heart disease, cancer, renal disease and diabetes), for which physician supervision of diet and exercise prescription is needed.
Feasibility Study Of Ambulatory Monitoring System

This is a clinical, data collection study conducted at one site. This study will collect open comments, user feedback and parameter raw data to support patient monitoring product development. Subjects participating in this study will be monitored with the site's standard of care primary monitor and the investigational device as the secondary monitor while enrolled in this study. No subject care decisions or diagnoses will be made based on information obtained from the investigational secondary monitor.

This is a pre-market, open label, prospective, non-randomized, data collection clinical research study conducted at one investigational site. This study will collect open comments, user feedback and parameter raw data to support product development. Raw parameter data will be collected from electrocardiogram (ECG), Pulse Rate (PR), respiratory rate (RR), peripheral capillary oxygen saturation (SpO2), non-invasive blood pressure (NIBP), and temperature. Subjects participating in this study will be monitored with the site's standard of care primary monitor and the investigational device as the secondary monitor while enrolled in this study. No subject care decisions or diagnoses will be made based on information obtained from the investigational secondary monitor.

Participation is expected to last no more than 72 hours.

Eligibility Criteria:
Inclusion Criteria:

1. Are able to provide written informed consent or have a legally designated representative provide written informed consent;
2. Are being cared for in a hospital unit and are expected to remain in the unit for the duration of the study procedure; AND
3. Are an adult 18 years or older, or pediatric or neonate subject.

Exclusion Criteria:

1. Are known to be pregnant;
2. Are breastfeeding; OR
3. Are suffering from infections that require isolation.
Effect of Live Combined Bifidobacterium and Lactobacillus on Glycemic Control and Other Outcomes in Type 1 Diabetes

Aim Evidence of a possible connection between gut microbiota and several physiological processes linked to type 1 diabetes is increasing. However, the effect of multistrain probiotics in people with type 1 diabetes remains unclear. This study investigated the effect of live combined Bifidobacterium and Lactobacillus preparation on glycemic control and other diabetes-related outcomes in people with type 1 diabetes.

Design A randomized, single-blind, parallel-group, controlled clinical trial. Setting Diabetes clinic of a teaching hospital in Shenzhen China Participants A total of 30 participants with type 1 diabetes, aged 18-60 years, will be recruited and randomly assigned to receive either probiotics (n = 15) or placebo (n = 15) for 12 weeks.

Outcomes Primary outcomes were glycemic control related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity C-reactive protein. The gut microbiota profile will be analyzed before and after intervention and between groups.

Eligibility Criteria:
Inclusion Criteria:

type 1 diabetes patients ,age 18-60years old,18 Kg/m2≤BMI≤30Kg/m2, 7.0mmol/L\<fasting blood glucose \<13.0mmol/L；HbA1c≤10%，ketonuria (-)；

Exclusion Criteria:

pregnancy, lactation, having other severe chronic illnesses.taking other anti-diabetic drugs
Dentist-Patient Communication on Dental Anxiety Using the Social Media and Timing in Communication

Scales application one week before and one week after impacted tooth extraction.

The purpose of the present study was to assess the effects of dentist-patient communication via social media on dental anxiety, and second, to evaluate the appropriate timing of such communications.

Instagram's quick replies system was used to answer patients' questions to alleviate dental anxiety for patients undergoing impacted mandibular third-molar extraction under local anesthesia. Patients were assigned randomly into four groups according to timing of such communications: Communication before operation (n=36), Communication after operation (n=35), Communication before and after operation (n=36), and a control group who received no communication on social media (n=36). Dental anxiety was evaluated one week before and after the surgical operation using recognized assessment scales-the Spielberger's State-Trait Anxiety Inventory, Modified Dental Anxiety Scale and a visual analog scale.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to use the Instagram platform. I
* Clinicial diagnosis of mesioangular impacted lower third molar according to the classification of Winter and the Pell and Gregory classification (2 or 3/B).

Exclusion Criteria:

* Patients who previously obtained information from social media
* Bad dental history
* Systemic disease
* Pregnant
Stanford Coronary Risk Intervention Project (SCRIP)

To determine whether modification of risk factors altered the rate of progression of coronary artery disease in arteries with mild atherosclerosis and no mechanical intervention in patients who had coronary bypass surgery or percutaneous transluminal coronary angioplasty (PTCA).

BACKGROUND:

Because of difficulties with quantitative measurement and with feasibility of follow-up, few controlled studies prior to SCRIP had been completed to determine the impact of risk factor modification directly on the progression of coronary atherosclerosis in humans. Suggestive evidence existed from animal studies, especially in primates, that diet and exercise altered atherosclerosis as a result of risk modification. But these animal models did not accurately represent the potential for modifying the coronary atherosclerotic process in humans. Some indirect evidence had been developed in humans by studying arteries more accessible than the coronaries. In the several preliminary studies reported using coronary arteriography to study the impact of risk modification on atherosclerosis, the results had been encouraging but far from definitive. One angiographic follow-up study of vein bypass grafts and severely atherosclerotic coronary arteries reported improvement with lipid lowering therapy. None of these studies had included randomization of patients to systematic, intense, long-term risk reduction versus usual care with prospectively identified coronary artery segments with mild disease.

DESIGN NARRATIVE:

Randomized, fixed-sample. A total of 300 patients were randomized, 155 to usual care (UC) in the community and 145 to special intervention (SI). The SI group received intensive efforts directed at reducing or eliminating risk factors, including lowering LDL-cholesterol and increasing HDL-cholesterol, reducing blood pressure, eliminating cigarette smoking and obesity, increasing exercise, and decreasing stressful life experience. The major endpoint was the rate of coronary artery disease progression as measured by angiography, at baseline and at forty-eight months. Follow-up was for four years.

Eligibility Criteria:
Men and women, up to 75 years of age. Patients with coronary artery disease but no mechanical intervention on all major vessels.
Clinical Trial on Frozen Shoulder Using Bilateral Shoulder Radiography in Different Position

This study on frozen shoulder addressed the null hypothesis that there is no difference in the motion of scapula against the thoracic wall between affected and non-affected shoulder.

Adult patients with unilateral shoulder pain lasted for more than one month, accompanied by passive and active limitation of range of motion in all directions will be included. Patients with bilateral involvement, history of trauma, history of surgery on the affected shoulder, history of fracture, shoulder osteoarthritis, symptoms less than one month and any signs of rotator cuff tear will be excluded. MR imaging will be done to exclude other pathologies and frank rotator cuff tear.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with unilateral shoulder pain lasted for more than one month, accompanied by passive and active limitation of range of motion in all directions

Exclusion Criteria:

* bilateral involvement, history of trauma, history of surgery on the affected shoulder, history of fracture, shoulder osteoarthritis, symptoms less than one month and any signs of rotator cuff tear. MRI will be done to rull out the rotator cuff tear.
Anakinra for COVID-19 Respiratory Symptoms

The main objective of the ANACONDA-COVID-19 trial is to assess the efficacy of Anakinra + optimized Standard of Care (oSOC) as compared to oSOC alone on the condition of patients with COVID-19 infection and worsening respiratory symptoms. Success defined as patient alive and free of invasive mechanical ventilation (IMV) and free of Extracorporeal Membrane Oxygenation (ECMO) at Day 14.


Eligibility Criteria:
Inclusion criteria:

* Male or female≥ 18 years of age
* Written informed consent of the patient or a proxy
* Ability for participant to comply with the requirements of the study
* Hospitalized patient with COVID-19 defined as

  * Positive SARS-CoV2 RT-PCR
  * Or typical COVID-19 Radiographic infiltrates on the CT scan (peripheral ground glass without lung cavitation, lymphadenopathy, or pulmonary nodules) other non COVID-19 diagnosis ruled out.
* Patient with respiratory symptoms and requirement of oxygen therapy as defined:

  * Oxygen therapy \>= 4L/min to maintain Sp02\>92% and respiratory rate \>=24/min.
  * Or patients under oxygen \>= 1L/min and presenting worsening of oxygen requirement defined by an increase of oxygen therapy \>= 2L/min to maintain Sp02\>92%.
* Inflammatory component C-Reactive Protein ≥ 50mg/L.
* Patients within the first 20 days from the onset of the first COVID-19 symptoms
* Probabilistic antibiotics therapy according to local practice

Non-inclusion criteria:

* Respiratory failure related to other cause than COVID-19
* Patients requiring mechanical ventilation at inclusion or requiring oxygen therapy equal or more than 11 liters per min to maintain Sp02\>92%
* Infectious diseases such as severe bacterial infections, aspergillosis, HIV, active HCV, active HBV, active tuberculosis
* Contra indication to anti-IL1 receptor

  * Known hypersensitivity to Anakinra
  * Absolute neutrophil count (ANC)\< 1500/mm3
  * Liver cirrhosis Child-Pugh Score C
  * Live or attenuated vaccine in the past 8 weeks
  * Pregnant or breast-feeding women
* Patients with either legally protected status or who have been deprived of their freedom
* Patient included in other interventional therapeutic research (e.g. = concurrent participation in French CoVID-19 is accepted)
* Patients who have received previous treatment by anti-IL6R, anti-IL-6, anti-IL1R, anti-IL1 or anti-TNFα within 21 days preceding inclusion
* Absence of Health Insurance
* Existence of any life-threatening co-morbidity or any other medical condition which,in the opinion of the investigator, makes the patient unsuitable for inclusion.