cyrilzakka/clinical-trials huggingface dataset:
The Orange-III Trial: Optimised Recovery With Movicol® Preoperatively Within an Enhanced Recovery Programme

The aim of this study is to accelerate recovery after liver surgery by enhancing intestinal passage through the preoperative use of Movicol.

Hypothesis The use of Movicol® during one week prior to partial liver resection combined with the Enhanced Recovery After Surgery (ERAS®) programme accelerates functional recovery by promoting early return of gastro-intestinal function, defined as the passage of stools and early oral intake.

Rationale:

The routine use of laxatives after liver surgery as part of an Enhanced Recovery After Surgery (ERAS®) programme enhances recovery of gastro-intestinal function and early tolerance of oral nutrition. The use of Macrogol (Movicol®) as laxative during one week prior to partial liver resection will further enhance early return of gastro-intestinal function and accelerate functional recovery.

Objective:

The aim of this study is to accelerate recovery after liver surgery by enhancing intestinal passage through the preoperative use of Movicol®

Study design:

The Orange-III trial is a multicentre randomised controlled trial to aim whether the administration of 1 sachet of Movicol® during one week preoperatively and 2 sachets of Movicol® postoperatively will further enhance early recovery compared to the administration of 2 sachets of Movicol® postoperatively only, following liver surgery. All patients will be managed within an ERAS® programme of perioperative care.

Study population:

Patients requiring a partial liver resection (two or more segments), 18-80 yr old.

Main study parameters/endpoints:

The main objective of the Orange-III trial is to provide evidence on early recovery of gastro-intestinal function defined as time to first intake of solid food continued for more than 24 hours after the use of Movicol® during one week prior to partial liver resection within an enhanced recovery programme. Secondary objectives are recovery of gastro-intestinal function defined as time to first stools and time to continuous intake of clear fluids for more than 24 hours, functional recovery, hospital length of stay and patient activity level.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a partial liver resection
* Able to understand the nature of the study and what will be required of them
* Men and non-pregnant, non-lactating women between age 18-80
* BMI between 18-35
* Patients with ASA I-III

Exclusion Criteria:

* Inability to give written informed consent
* Patients requiring bile duct reconstruction
* Patients with ASA IV-V
* Superextended hepatectomy
* Underlying symptomatic liver disease such as cirrhosis
* Underlying gastro-intestinal disease such as motility disorders
* Need for procedures additive to partial liver resection
EVI-01-IT Safety Study

Prospective, single arm, pilot study to assess the safety and tolerability of a single intra-articular injection of EVI-01 for the treatment of symptomatic knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Eighteen (18) years old or above;
* Patient signed informed consent form;
* Patients with stable symptoms related to knee osteoarthritis for at least 3 months prior to screening;
* Failure, inadequate response or intolerance to analgesics and/or NSAIDs or low-grade opioids;
* Kellgren-Lawrence radiographic stage: II-III diagnosed in the previous 12 months;
* WOMAC average pain index score \> 40 mm and \< 90 (on a VAS 0-100 mm) on the knee to be treated;
* Difference ≥ 10 mm between the WOMAC average pain score of the knee to be treated and WOMAC average pain score of the contralateral knee at screening;
* Body Mass Index (BMI) inferior to 35 kg/m2 (weight/height).

Exclusion Criteria:

* Concomitant inflammatory joint disorder;
* Had received previous visco-supplementation treatment in the study knee within 6 months or intra articular corticosteroids within 3 months\* prior to inclusion;
* Infection in or around the study knee;
* Relevant skin disease in the area of injection site;
* Documented presence of injury or trauma of the study knee at screening, including evidence of a subchondral fracture, meniscal lesion, presence of bone or cartilage fragments in the study knee;
* History of allergy or intolerance to sodium hyaluronate;
* Documented presence of osteonecrosis in one or both knees;
* Inability to understand the study procedure;
* Participation in another clinical trial within 30 days prior to screening;
* Ongoing therapy with daily dosage \> 101 mg of acetylsalicylic acid as part of cardiovascular preventive treatment. If dose \< 101 mg, it must be maintained during the study;
* Pregnant or breast-feeding at inclusion.

  * 1 month = 30 days
Sublingual Immunotherapy in Patients With Atopic Dermatitis

To assess the effect and safety of sublingual Dermatophagoides Farinae Drops in adult patients with atopic dermatitis and allergic sensitization to house dust mites.240 adults age 18 to 60 years with atopic dermatitis(Objective Scoring Atopic Dermatitis, Objective SCORAD from 10 to 40) are going to be enrolled in a randomized,double-blind,placebo-controlled study.Sublingual Dermatophagoides Farinae Drops or placebo is given for 9 months in addition to standard therapy.SCORAD,average anesis interval,rescue medicine and DLQI will be recorded.

SCORAD is composed of skin rash area,severity and subjective symptom including pruritus and sleeping quality.Skin rash area and severity score are objective SCORAD(range from 0 to 83).Subjective SCORAD range from 0 to 20 and total SCORAD range from 0 to 103.

Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex ,aged from 18 to 60 years. Diagnosed of atopic dermatitis.
* Mild to moderate AD ( \[SCORAD\] 1O-40)
* The results of skin prick tests with dermatophagoides farinae allergen extracts preparation is positive(≥2+)
* Written informed consent by the subject or legal guardian.
* Female patients of child-bearing potential must be negative pregnant test on screening and use an appropriate method of contraception.

Exclusion Criteria:

* Dust mites are not the primary allergens.
* Pregnant, breastfeeding women or women planned to pregnant within 1 year.
* Have concurrent skin disease that it could interfere with the study evaluation.
* Were treated with antihistamines or topical therapy within 7 days of randomization.
* Have received systemic corticosteroids,leukotriene receptor antagonists or immunosuppressants within 4 weeks of randomization.
* Have received phototherapy (e.g. UVA, UVB) within 4 weeks of randomization.
* Have a history of immune suppressed diseases(malignant tumor or infection of HIV), autoimmune disease or tuberculosis.
* Patients with impaired liver function (aspartate aminotransferase and/ or alanine aminotransferase levels 1.5 times the upper limit of normal), impaired renal function(serum creatinine\>normal value) or other severe diseases.
* Bronchial asthma patients who need treatments with corticosteroids and or β agonists(including injection, oral administration or inhalation) regularly.
* Patients who need to take β-blockers during research.
* Have received investigational drugs within 3 months prior to randomization or planned use of other investigational drugs during participation in this study.
* Have received immunotherapy with dust mite preparation within 3 years prior to randomization.
* Patients with severe mental disorders.
Massage, Oxidative and Antioxidant Enzymes in Hemodialysis Patients With Restless Legs Syndrome(RLS)

This study; It will be done to evaluate the presence of oxidative stress and its effects on lipid peroxidation products and antioxidant parameters after massage application and the possible effects of the appropriate massage protocol applied to the patients on oxidative stress in hemodialysis patients with restless legs syndrome.

In this study, the following research hypotheses will be tested. H0a: Individuals with restless legs syndrome receiving hemodialysis treatment; In the second hour of hemodialysis, massage applied to both calf muscles for 10 minutes three times a week for one month is not affect the oxidative and antioxidant enzymes of the patients.

H1a: Individuals with restless legs syndrome receiving hemodialysis treatment; In the second hour of hemodialysis, massage applied to both calf muscles for 10 minutes three times a week for one month is effective on the oxidative and antioxidant enzymes of the patients.

Eligibility Criteria:
Inclusion Criteria:

1. Receiving hemodialysis treatment for at least 6 months, 3 days a week for 4 hours,
2. Patients with RLS according to the diagnostic criteria of the International RLS study group,
3. No psychiatric problems,
4. No neurological deficit,
5. Exercise and physical therapy modalities have not been applied in the last year,
6. In the laboratory examinations, the kinetic indicators of dialysis adequacy are within the desired target range (Kt/V: 1.2-1.3; URR: 60-65%), and there are no pathological findings (fracture, dislocation, tumor, infection) in the radiological examinations. .

Exclusion Criteria:

1. Hemiplegic patients
2. Patients with heart failure
3. Individuals with chronic obstructive pulmonary diseases
Suxiao Jiuxin Pills in Microvascular Obstruction in Patients With Acute Coronary Syndrome

Microvascular obstruction is the severe complication of percutaneous coronary intervention (PCI) in patients with acute coronary syndrome. Microvascular obstruction after PCI is often association with poor prognosis. Current treatments do not show improvement in prognosis of microvascular obstruction. Suxiao Jiuxin Pills (SXJX) was shown associated with a reduction in MACE, and an improvement of heart function and quality of life in acute coronary syndrome (ACS) patients with early PCI. To evaluate the effectiveness and safety of SXJX in microvascular obstruction after PCI, the investigators designed this study.


Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnosis of AMI, prepare for PCI reperfusion therapy;
* Between the ages of 18-75;
* Volunteer to participate in this study and have signed an informed consent form;
* Have a correct understanding of the significance of drug research, and have a good compliance with the observation and evaluation.

Exclusion Criteria:

* Not suitable for coronary intervention;
* With unstable hemodynamics;
* Platelet count\<100×109;
* Suspected aortic dissection or acute pulmonary embolism;
* With mechanical complications;
* With uncontrolled acute left heart failure and pulmonary edema;
* With known bleeding history, active bleeding, bleeding constitution, or severe hemostatic and coagulation dysfunction;
* Meantain anticoagulants (such as warfarin or new anticoagulants);
* Severe liver and kidney insufficiency (Child-Pugh B and above, Cr\>177μmol/L (2mg/dl) or eGFR\<45ml/min/1.73m2);
* CTO, stent stenosis, or severe left main disease;
* History of coronary artery bypass graft surgery;
* Other pathophysiological conditions whose expected survival period is less than 1 year;
* Allergic history to Suxiao Jiuxin Pills;
* Pregnant or lactating women;
* Participating in other clinical studies;
* With other diseases that are not suitable for participating in clinical research.
U-clip Pilot Study in Plastic Surgery

This study will assess the nitinol U-clip as an alternative to conventional microsurgical suture for arterial anastomoses in free tissue transfer.

Within Scott \& White, a total of 25 free flaps will be performed using U-clips for microvascular anastomoses in lieu of traditional suturing techniques. Each of these free flaps may be in individual patients or two anastomoses may be included in one patient. Historical controls will be used for comparison of complication rates of U-clip versus sutured anastomoses. Postoperatively, the study participants will be evaluated at 2 weeks (+/- 1 week) and at 3 months (+/- 1 month) follow up.

Eligibility Criteria:
Inclusion Criteria:

* either gender
* any ethnicity
* patient requiring free tissue transfer for complex wound coverage or reconstruction
* patient having arterial anastomotic diameter of at least 2 mm
* patient capable of giving informed consent

Exclusion Criteria:

* less than 18 years of age
* allergy to nitinol or any of its components (nickel or titanium)
* pregnancy
* known coagulopathy
Glycemic And Blood Pressure Control In Type 2 Diabetes, In A Primary Care Unit: A Staged Management Strategy

The aim of this study is to to analyze if it is possible to reach the goals of HbA1c \<7.0% and blood pressure \<= 130/80 mm Hg in a cohort of patients with type 2 diabetes attending a primary care unit, using ony those resources available at the unit, and provided by the Brazilian National Health System. It is an open label, observational study, with a duration of 4-6 years. Patients attending a primary care outpatient facility will be sequentially included in the study provided they give consent. They will be followed on a monthly basis by a team of physicians and nurses. Glucose, A1c, Blood PRessure will be the outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus (WHO)

Exclusion Criteria:

* Terminal disease (renal, cancer, heart failure)
Comparing the Effectiveness of mCIMT and Bimanual Training

This study aimed to compare the effects of Modified Constraint-Induced Movement Therapy (mCIMT) and Bimanual Training (BIT) based on the International Classification of Functioning, Disability, and Health, Children \&Youth (ICF-CY) conceptual framework. Our assumptions were that (1) mCIMT is more effective on outcomes representing all subdomains of ICF and (2) the possible improvements in the body structure and function, activity, and participation subdomains of ICF are intimately related to each other.

Thirty-two children with spastic hemiplegic cerebral palsy (mean age 10.43 years \[SD 2.9 years\]; 15 females, 17 males) whose functional profiles associated with Manual Ability Classification System, Gross Motor Function Classification System, and Communication Function Classification System changed between level I-III were randomly distributed to one of the mCIMT or BIT groups with equivalent dosing frequency and intensity (10 weeks/3 days per week/2.5 hours per day). Outcome measures categorized according to the domains of International Classification of Functioning, Disability, and Health, Children \&Youth (ICF-CY) framework were used to document body functions, activity, and participation outcomes. Assessments were carried out before (T1) and after treatment (T2), and at 16 weeks post-intervention (T3) by a physical therapist blinded to group allocation. Before the study entry, informed consent was obtained from the parents. General and specific contents related to each intervention were delivered as individual sessions at the school (one session per week) or group sessions with two participants at rehabilitation centers (two sessions per week).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of spastic hemiplegic cerebral palsy
* Must be able to attend primary or secondary school

Exclusion Criteria:

* Family-dependent problems interfering with participation in study sessions
* The presence of behavioral problems interfering with the assessment periods or intervention sessions
Cosmetic Effects of Topical Acetyl Zingerone

Cosmeceuticals are an emerging market within dermatology and the growth of natural products and derivatives of natural products has accelerated in use within the field. Here the investigators aimed to study the microbial and cosmetic effects of Synoxyl AZ, the trade name for topical acetyl zingerone (AZ), a novel compound designed based on Zingerone and curcumin.

Cosmeceuticals are an emerging market within dermatology and the growth of natural products and derivatives of natural products has accelerated in use within the field. Here the investigators aim to study Synoxyl AZ, the trade name for topical acetyl zingerone (AZ), a novel compound designed based on Zingerone and curcumin.

Both curcumin and Zingerone are from the Zingiberacea family of plants (also known as the ginger family). Both have been widely studied and noted to have antibacterial effects and promote skin health effects. Curcumin has been studied widely in recent years due to various microbial effects. AZ is a derivative that is similar to both Zingerone and curcumin and has been noted to have many different activities including anti-inflammatory, antimicrobial, and antioxidant functions. However, there are no studies looking at how it modulates the skin cosmetically or the superficial microbiome.

The aim of this study was to compare the cosmetic effects of AZ to a vehicle over an 8-week period.

Eligibility Criteria:
Inclusion criteria:

* Individuals aged 30-60
* Healthy subjects

Exclusion Criteria:

* Those that have had topical antibiotics within the past 4 weeks
* Those that have had oral antibiotics within past 4 weeks
* Those who have used systemic isotretinoin in the last 6 months
* Those with a known allergy to members of the ginger family
* Current smokers OR 20 pack-year history of smoking OR Have smoked within the past 3 years
* Pregnant women
* Prisoners
* Those who have had any change to their hormonal birth control regimen in the last 4 weeks.
* Those with visible signs in the area of application of or on active treatment for cystic acne, eczema, seborrheic dermatitis, papulopustular rosacea at investigator discretion
* Those who have had a recent surgical or cosmetic procedure in the last 3 months that can affect facial wrinkles or facial hyperpigmentation, such as botulinum toxin injections, chemical peels, laser based therapies to the face, or face lift surgeries at investigator discretion
6MW3511 in Patients With Advanced Solid Tumor

This is a phase I/II , open-label, multicenter single arm study designed to evaluate the safety, tolerability, pharmacokinetic (PK), and immunogenicity of 6MW3511.

This is a Phase I/II, open-label, dose-escalation trial with consecutive parallel-group expansion in selected solid tumor indications. The study consists of a dose escalation phase to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for 6MW3511, and a dose expansion phase which will characterize treatment of 6MW3511 at the RP2D.

Eligibility Criteria:
Inclusion Criteria:

1. In dose-escalation cohorts, histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy.In the dose-expansion cohorts , histologically or cytologically confirmed selected advanced solid tumors (to be determined).
2. Male or female subjects aged over 18 years old (inclusive) and not more than 80 years old (inclusive).
3. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.

Exclusion Criteria:

1. History of other malignant tumors within 3 years, except for the tumors that had been cured.
2. Symptomatic or active central nervous system metastasis.
3. Patients with active autoimmune disease.
4. History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
5. Patients previously treated with PD-（L）1/ TGF-β antibody or combined PD-（L）1 with TGF-β antibody.
6. Pregnant or breast feeding.
Peri-operative Oral Triiodothyronine Replacement Therapy to Decrease the Risk of Transient Atrial Fibrillation After Off-pump Coronary Artery Bypass Surgery

This study is planned to medicate oral T3(Liothyronine)to the patients who are planned to have OPCAB(off- pump coronary bypass graft surgery. The aim of this study was to assess the effects of oral triiodothyronine (T3) therapy on postoperative thyroid hormone concentrations, hemodynamic variables and outcomes in patients undergoing OPCAB in a randomized, controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are undergoing Off-pump coronary artery bypass graft

Exclusion Criteria:

* No normal sinus rhythm,
* History of thyroid disease
* Abnormal thyroid hormone
* Renal dysfunction
* Hepatic dysfunction
* LVEF \<30%
* Recent MI
* Active infection 1\~15
Risk of Aspergillus Infection in Patients With Chronic Lung Disease

Large doses of systemic corticosteroids ，severe lung tissue damage and longer COPD diagnosis may increase the risk of IPA in patients with chronic structural lung disease. By comparing the risk factors of aspergillus colonization group and aspergillus infection group, the main risk factors of aspergillus pneumonia were determined.

Patients with chronic lung disease were identified as positive for Aspergillus fumigatus through sputum microscopy. According to diagnostic criteria, patients diagnosed with IPA and CPA and were assigned to the Aspergillosis pneumonia group, while the remaining patients were included in the Aspergillus colonization group. Then,Risk factors for aspergillus pneumonia, invasive pulmonary aspergillus disease, and chronic pulmonary aspergillus disease, such as the use of high-dose corticosteroids, inhaled corticosteroids, and the extent of damage to basic lung structures, were identified by comparing the aspergillus colonization group with the aspergillus infection group.

Eligibility Criteria:
Inclusion Criteria:

1. Age : at least 18 years old ;
2. Imageological examination : Patients who complete high-resolution computed tomography (HRCT) images of the chest;
3. Serological examination : Patients who complete serological test results, including serum aspergillus specific IgG antibody, serum aspergillus IgM antibody and GM antigen detection.

Exclusion Criteria:

1. immunodeficiency conditions : Patients diagnosed with HIV infection, hematological malignancies, and autoimmune diseases.
2. Critically ill patients : Those who require mechanical ventilation in the ICU and have established various types of cardiopulmonary bypass.
3. Inadequate Clinical Data: Inability to provide reliable diagnostic measurements or insufficient clinical information.
A Study of Adult Participants With BRAF V600 Mutation-Positive Advanced Melanoma Treated With Cobimetinib (Cotellic®) During the French Early Access Program (Temporary Authorization for Use [TAU])

This is a multicentre, ambispective (both retrospective and prospective), and non-interventional study conducted in France in adult participants with BRAF V600 mutation-positive unresectable or metastatic melanoma treated with cobimetinib in combination with vemurafenib (Zelboraf®).

Concomitantly to the marketing authorization applications for cobimetinib and vemurafenib to European Medicines Agency (EMA) and United States Food and Drug Administration (USFDA) in 2014, a French TAU program was initiated in February 2015. This study will enroll participants under this program.

Eligibility Criteria:
Inclusion Criteria:

* Participants included in the TAU from 26 February 2015
* Participants with BRAF V600 mutation-positive unresectable or metastatic melanoma treated with cobimetinib in combination with vemurafenib
* For alive participants: participants who have been informed verbally and in writing about this study who do not object to their data being electronically processed or subjected to data quality control
* For participants who died before the inclusion period: participants who did not express their opposition when they were alive

Exclusion Criteria:

- Alive participants unable to give informed consent