cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation and Study of the Efficacy of a Centella Asiatica-Infused Facial Mask on Discosmetic Dermatosis

The purpose of this study was to investigate the efficacy and safety of repairing facial mask containing Asiaticum asiatica in treating disjunctive skin diseases. A multi-center randomized double-blind self-half face control method was used. A computer-generated randomization method was used. Each cheek was randomly assigned to receive the snow glycoside mask and the control group.


Eligibility Criteria:
Inclusion Criteria:

1. Meet mild to moderate rosacea, acne diagnostic criteria; Meet the diagnostic criteria for melasma;
2. Over 18 years of age;
3. Be able to follow the treatment rules of the study and be followed for 8 weeks;
4. Informed consent; 5There were no significant cardiac, liver, kidney, gastrointestinal, neurological, psychiatric, or metabolic disorders

6.No medication was used within 1 month

Exclusion Criteria:

1. Currently pregnant, planning to become pregnant or breastfeeding;
2. Documented hypersensitivity to any active ingredient or excipient included in the study drug, or a history of adverse reactions to cosmetic products;
3. Participate in other clinical studies within 3 months before the start of the study;
4. Frequent use of Chinese medicine, sleeping pills, sedatives, anti-anxiety drugs or potentially addictive substances;
5. Present with concomitant skin conditions that may confuse the clinical assessment of rosacea, melasma, seborrheic dermatitis or pose a risk to participants, or have a history of severe skin conditions;
6. Normal use of relevant treatment (including intense pulsed light, pulsed fuel laser, oral and topical tranexamic acid, oral tetracycline antibiotics, oral compound glycyrrhizin and other anti-inflammatory drugs)
7. Patients with incomplete observation data, incomplete course of treatment and inability to take drugs as prescribed by doctors were removed
Effects of Head and Neck Cooling and Heating on Fatigue in Multiple Sclerosis and Healthy Men

Local head and neck cooling strategies can help reduce multiple sclerosis-related fatigue, while heating can exacerbate heat-related fatigue. However, no study has detailed the peripheral and central responses to head and neck cooling (at 18°C) and heating (at 43 ± 1°C next to the scalp and neck skin) during fatiguing isometric exercise in non-challenging ambient temperature in multiple sclerosis and healthy male subjects. In addition, there is a lack of data describing the effects of head and neck cooling/heating and strenuous exercise on blood markers, muscle temperature, motor accuracy, and rate of perceived exertion. The investigators hypothesized that: (i) men with multiple sclerosis would be more affected by central and peripheral fatigue compared to healthy subjects; (ii) local cooling will result in greater central fatigue but will be associated with greater peripheral fatigue, whereas heating will result in greater central and peripheral fatigue in multiple sclerosis men; (iv) local cooling and heating will have a greater effect on the release of stress hormones, rate of perceived exertion and motor accuracy compared to the control condition in both multiple sclerosis and healthy groups.


Eligibility Criteria:
Inclusion criteria:

* Relapsing-remitting multiple sclerosis disease course according to McDonald criteria
* Expanded Disability Status Scale less than 4 points and Fatigue Severity Scale score greater than 5 points in participants with multiple sclerosis
* Males
* Age between 18 and 45 years
* Sufficient tolerance to electrical stimulation

Exclusion Criteria:

* Physical limitations that would impair the ability to perform neuromuscular testing
* Mental disorders, such as depression or anxiety, due to their recognized association with fatigue
* Involvement in temperature manipulation program for ≥ 3 months
* Attending any excessive physical exercise or sports programs
* With blood/needle phobia
Effectiveness Study of Integrative Treatment for Pediatric Pneumonia

The purpose of this study is to evaluate the effectiveness of traditional Chinese medicine for treatment of pediatric pneumonia. It is a multicenter randomized controlled trial.

The retrospective case study has been finished at the National clinical research base of traditional Chinese medicine for major disease pediatric pneumonia, and the research center organized the field training of prospective-study to coordinated units. Based on the primary statistical outcomes of retrospective case study and the discussion around prospective-study during the training, investigators found it difficult to include simplex viral infection, therefore, investigators revised the inclusion criteria and treatment protocol of the pragmatic randomized controlled trial.

The block randomization is used in this trial. Random numbers are generated by SPSS software. Statistical analysis staff and those who perform the follow-up are blinded. Sample size calculation was performed, which was 369, and considering drop-out or withdrawal, investigators plan to enroll 450 patients (300 in experimental group, 150 in control).

Eligibility Criteria:
Inclusion Criteria:

* children, aged 6 months to 59 months old, diagnosed as pneumonia according to western medicine diagnostic criteria;
* diagnosed as TCM pneumonia with gasp-cough, meeting wind-heat blocking lungs pattern (feng re bi fei zheng), and phlegm-heat blocking lungs pattern (tan re bi fei zheng);
* disease progression within 72 hours;
* those whose guardians understood and assigned the informed consent;

Exclusion Criteria:

* emergency pneumonia;
* complicated with other Pulmonary Disorders attack other than pneumonia;
* complicated with primary disease of heart (congenital heart disease, myocarditis, et al), liver (ALT, and AST ≥ 1.5 times of normal value ceiling), kidney (BUN \> 8.2mmol/L, or serum CR \> 104 µmol/L, et al) and blood system (anemia), and those with psychopathy;
* allergic to interventional medications;
* those who are participating or have participated in other clinical trials in 3 months.
Diabetes Outcomes and Unmet Resources

This study will refine and test the effectiveness of CareAvenue, an automated e-health tool that informs and activates patients with uncontrolled diabetes to take steps in accessing resources and engaging in self-care. Our central hypothesis is that activating patients with uncontrolled diabetes and linking them to resources to address financial burden and unmet social risk factors will improve both intermediate outcomes and measures of disease control above and beyond existing services, especially for high need patients.


Eligibility Criteria:
Inclusion Criteria:

* Be 18-75 years of age
* Be diagnosed with type 1 or type 2 diabetes with prescribed anti-hyperglycemic medication
* Have a most recent hemoglobin A1c(HbA1c) level within the past 6 months of ≥7.5% for individuals ≤70 years and \>8.0% for individuals between 70-75 years in age
* Have access to a telephone that can receive and send text messages
* Not participating in another diabetes intervention research study

Exclusion Criteria:

* Significant cognitive impairment precluding individuals from completing the study as evidenced by ability to complete study intake procedures.
AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens)

Study purpose: to explore the entire spectrum of proteomic and genomic changes (amongst others) involved in diseases and in healthy/control populations. The Study is designed to discover biomarkers, develop and validate diagnostic assays, instruments and therapeutics as well as other medical research. Specifically, researchers may analyze proteins, RNA, DNA copy number changes, including large and small (1,000-100,000 kb) scale rearrangements, transcription profiles, epigenetic modifications, sequence variation, and sequence in both diseased tissue and case-matched germline DNA from Subjects.

The primary objective of this Study is to collect high-quality tissue, whole teeth, and biofluid Specimens, and associated Clinical Data from consented Subjects.

The secondary objective of this Study is to test Specimens and associated Clinical Data to confirm pathology diagnosis and correlation of microscopic evaluation with the provided information, to assess RNA and DNA integrity or degradation, and provide overall quality control evaluations.

Eligibility Criteria:
Inclusion Criteria:

1. Subject shall be at least 18 years of age, or higher if required by Applicable Law.
2. Subject's Clinical Data shall be relevant to the Study in which he/she is participating.
3. Subject shall understand and voluntarily sign the ICF prior to the Study participation. If the Subject is illiterate, the witness must sign the ICF (see 5.6. for details). If the Subject is incapable of consenting himself/herself, the legally authorized representative must sign the ICF (see 5.6. for details).
4. Subject shall meet any other additional inclusion criteria specified in Appendices to this Protocol, or in additional written instructions of the Sponsor.
5. Subject shall be able to donate the requested Specimen(s) without compromising his/her current health status.

Exclusion Criteria:

1. Younger than 18 years of age, or higher if required by Applicable Law.
2. The individual is incapable of understanding the items listed in the ICF and the consent process unless consented by the legally authorized representative.
3. Prisoner
Use-Results Surveillance Study of Harvoni® in Japanese Patients With Chronic Genotype 1 Hepatitis C Virus Infection

This study will evaluate the safety and efficacy of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC)) treatment under real world use in Japan. Among adult patients with chronic genotype 1 hepatitis C virus (HCV) infection and treated with Harvoni in routine clinical use, the primary objective of this study is to evaluate the incidence of adverse drug reactions (ADRs) under real world settings.


Eligibility Criteria:
Key Inclusion Criteria:

* Adult patients with chronic genotype 1 HCV infection with or without compensated cirrhosis
* Patients who are prescribed Harvoni

Key Exclusion Criteria:

* None

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Effects of Atorvastatin Versus Probucol on Small Dense LDL

Small dense low-density lipoprotein (LDL) plays an important role in causing glomerular injury through conversion to an oxidatively modified form of LDL. However, few studies evaluated the effects of antilipidemic agents on the LDL particle size and renoprotective actions in hyperlipidemic patients with non-diabetic nephropathy.

The study is a randomized crossover trial comparing the effect of atorvastatin (10 mg/day) and probucol (500 mg/day) for 24 weeks in 30 patients (urinary albumin excretion 0.3-2.0 g/day, and creatinine clearance \> 30 ml/min/1.73 m2 or serum creatinine concentration \< 2 mg/L). Lipid parameters, mean LDL particle diameter, creatinine clearance, and urinary albumin to creatinine excretion ratio are measured before and during treatment periods. It will be evaluated that, first, whether atorvastatin and probucol significantly reduce serum total cholesterol and LDL cholesterol concentrations, second, whether atorvastatin and probucol significantly increase the LDL particle size, third, whether significant differences in urinary albumin/creatinine excretion ratio and creatinine clearance are observed in both groups during treatment.

Eligibility Criteria:
Inclusion Criteria:

* Hyperlipidemic patients with non-diabetic nephropathy

Exclusion Criteria:

* Endocrinological, hematological or hepatic disease
* Cerebral infarction or hemorrhage
* Homozygous familial hypercholesterolemia
* Uncontrolled hypertension
* Myocardial infarction occurring within the previous 6 months
* Unstable angina
* Diabetic nephropathy
* Abnormal thyroid function
* Receiving steroids or immunosuppressive agents
Traumatic Spinal Cord Injury: Effects of Corporal Suspension and Pendulum Exercises

The purpose of this study was to evaluate the effects of an exercise program proposed by the CHORDATA® Method on the functionality, maximal isometric torque, muscle activity and muscle thickness of trunk muscles in patients with traumatic spinal cord injury.

The hypothesis is that the CHORDATA® Method could reduce the deleterious effects of the traumatic spinal cord injury.

Participants were allocated into one of two groups (rehabilitation or control). Rehabilitation group (8 weeks of rehabilitation; CHORDATA® Method) Control group (patients with up to three years of traumatic spinal cord injury): Participants maintained their daily-life activities routine during the same eight weeks period and were tested before and after this control period. At the end of the control period, patients interested at participating on the training program were included in the intervention group

Eligibility Criteria:
Inclusion Criteria:

- Patients that suffered traumatic spinal cord injury in the last 42 months, capable of transporting themselves for rehabilitation at the physical therapy clinic and for the neuromuscular tests at the laboratory where measurements were performed.

Exclusion Criteria:

* Body weight above 95kg
* Physical and functional limitations impeding them of performing physical activity
* Physically incapacitating diseases (e.g severe cardiovascular and respiratory diseases, neurodegenerative diseases, oncologic diseases, systemic arterial hypertension)
* Visual deficit that impeded reading
* Recurrent vertigo or hypotension to exercise
* Engaged in other treatments that could constitute a confounding effect
* Changed their daily life activities during the study
Effectiveness of Using Calligraphic Activity to People With Schizophrenia

To examine the effects of calligraphy activity on symptoms, attention, emotion, and quality of life in people with schizophrenia. We hypothesized that through a six-month intervention using calligraphy activity, people with schizophrenia will have their symptoms decreased, attention improved, emotion enhanced, and quality of life increased. This study will adopt single-blind, randomized controlled trial, and 160 people with schizophrenia will be recruited in this study. They will be randomly assigned to either a calligraphy activity group (treatment group; n=80) or an occupational activity group (control group; n=80). Participants will complete assessments at pretest, posttest, and 3-month follow-up using the following instruments: Positive and Negative Syndrome Scale (PANSS), Chu's Attention Test, The Taiwanese version of Montreal Cognitive Assessment (MoCA-T), WHO questionnaire on the Quality of Life, Brief Form (WHOQOL-BREF), and Chinese Depression Anxiety Stress Scales(DASS21).


Eligibility Criteria:
Inclusion Criteria:

* Inpatients
* With diagnosis of schizophrenia or schizoaffective disorder
* Not in acute stage
* Voluntarily participate

Exclusion Criteria:

* Severe cognition level or intellectual disability that prevent from participation
* Severe behavioral problems and symptoms that prevent from participation
* People with blindness
A Prospective, Multi-center Trial for Reinforced Staple During Distal Pancreatectomy

The aim of this study is to evaluate if the Endo GIA Reinforced Reload with Tri-Staple Technology reduce incidence of pancreatic fistula (ISGPF grade B and C) after distal pancreatectomy by a prospective, multi-center trial.

Reducing the incidence of pancreatic fistula is the most important issue in pancreatectomy. There is no certain view on the pancreatic resection method to reduce pancreatic fistula in distal pancreatectomy.This study will be conducted to scientifically investigate the impact of Endo GIA Reinforced Reload with Tri-Staple Technology in distal pancreatectomy. The aim of this study is to evaluate if the Endo GIA Reinforced Reload with Tri-Staple Technology reduce incidence of pancreatic fistula (ISGPF grade B and C) after distal pancreatectomy by a prospective, multi-center trial.

Eligibility Criteria:
Inclusion Criteria:

1. disease of pancreatic body and tail
2. PS (ECOG Performance Status Scale)0-1
3. Age: 20 years or older
4. distant metastases are not diagnosed preoperatively. Eligible for this clinical study when only distal pancreatectomy contributes to the favorable prognosis even if patients with pancreatic neuroendocrine cancer have the liver metastasis
5. Patients who can provide written informed consent

Exclusion Criteria:

1. Patients with severe ischemic cardiac disease
2. Patients with severe liver cirrhosis or active hepatitis
3. Patients with respiratory illness that requires oxygen administration
4. Patients with chronic renal failure requiring dialysis
5. Patients requiring other organ resection
6. Patients who are unfit for the study as determined by the attending physician
Comparison of Postoperative Outcome After Sevoflurane and Propofol Anaesthesia

As the investigators know, postoperative cognitive dysfunction (POCD) is a fairly well-documented clinical phenomenon, which affect patients' short-term and long-term outcome. Most patients will receive general anesthesia and cardiopulmonary bypass (CPB) during cardiac valvular surgery. Inhalation sevoflurane based and propofol based anesthesia are most commonly used strategy for general anesthesia. At present, it was unknown that which one is better in providing cerebral protection effect for patients undergoing cardiac valvular surgery with CPB. The current study aimed to explore the possible difference.

The investigators hypothesize that the incidence of postoperative cognitive dysfunction (POCD) is not different in patients received intravenous anesthetics propofol or sevoflurane for their cardiac valvular surgery. Two groups of general anesthetics (propofol or sevoflurane) are used to explore the possible difference of the postoperative outcome and the incidence of POCD. After cardiac valvular surgery with CPB, patients' POCD tests at 7 days after the surgery, and postoperative delirium, etc., are evaluated by different questionnaires. Also the blood sample of these patients are collected for detection of some stress hormones.

Eligibility Criteria:
Inclusion Criteria:

* patients who receive cardiac valvular surgery
* 18 to 65 years
* American society of anesthesiologists classification Ⅱto Ⅲ
* education level higher than elementary school

Exclusion Criteria:

* Patients are not expected to be alive for longer than 3 months.
* Mini-mental State Examination (MMSE) score ≤ 23.
* current use of sedatives or antidepressant
* history of dementia, psychiatric illness or any diseases of central nervous system.
* accompanying liver or kidney function deficiency
* history of some endocrine disease
* alcoholism and drug dependence
* patients previously included in this study or currently included in the other clinical study
* patients who have second surgery during the study period
* difficult to follow up or patients with poor compliance
Localized Neuropathic Pain: Topical Treatment Versus Systemic Treatment

Evaluation of topical treatment with lidocaine 5% patch (daily administration) or capsaicin 8% patch (periodic administration - upon reoccurrence of pain symptoms) in adult patients suffering from localized neuropathic pain (LNP) across a wide variety of etiologies, with a duration between 1 and 24 months (subacute to chronic neuropathic pain (NP)).

A multicentre, randomized, open-label comparative trial evaluating topical treatment options versus oral systemic treatment in adult patients suffering from localized neuropathic pain (LNP) syndromes. A wide variety of peripheral neuropathic pain syndromes will be included such as post-herpetic neuralgia (PHN), post-surgical NP/post-traumatic NP/scar pain, post-amputation NP, post-radiation therapy NP, complex regional pain syndrome (CRPS) type 1. In contrast to most (or even all) commercial clinical studies we will not limit the inclusion to one or two distinct neuropathic pain syndromes such as post-herpetic neuralgia (inclusion based on etiology of the neuropathic syndrome). In this pragmatic trial we will however include all patients suffering from a clinical neuropathic syndrome with distinct clinical features such as hyperalgesia/allodynia, presence of spontaneous positive sensory phenomena and lasting for more than 3 months without making any exclusion based on etiology. Initial pain intensity indicates the presence of either moderate or severe pain in these adult patients (NRS 4/10).

Eligibility Criteria:
Patients eligible for inclusion in this study must fulfil all of the following criteria:

* Subjects should be capable of giving their informed consent with sufficient knowledge of the Dutch, French or German language;
* Males and females, 18 years and older;
* Be assessed as suffering from moderate to severe neuropathic pain across the screening process with pain intensity (numeric rating scale - NRS) ≥ 4/10,
* At the time of screening pain symptoms have to be present for at least one (1) month, with a maximum of 24 months;
* Sensory disturbances present in the skin area of maximal pain;
* At the time of screening pain is clearly related to the presence of a localized neuropathic pain syndrome.
* Male or female patients of child producing potential\* must agree to use contraception or take measures to avoid pregnancy during the study and until after the final treatment;
* Women can only be included after negative pregnancy test;

Exclusion Criteria:

* Age \< 18;
* Pregnant and breastfeeding women;
* Infection in the painful skin region;
* Poorly healed or non-healed wound or scar in the painful skin region as well as presence of cutaneous abnormalities (non-intact skin barrier) within the painful skin region related to dermatological conditions;
* Known and/or strong suspicion of allergy to the study medication, known skin disorder (resulting in disruption of the normal skin barrier);
* Previous treatment with any of the three medications included in the study protocol for the same painful area within the last 12 months at the time of screening;
* Risk of heart failure and/or renal failure.
Study Investigating Novoeight®/NovoEight® (Turoctocog Alfa) in Mexican Haemophilia A Patients

The trial is conducted in North America. The aim of the trial is to assess the safety of turoctocog alfa under conditions of routine clinical care in patients with haemophilia A in Mexico


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* Male and female patients with haemophilia A
* Age range is 0 years and above
* The decision to initiate treatment with commercially available turoctocog alfa has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Known or suspected allergy to turoctocog alfa or related products
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Efficacy and Safety of Deoxyspergualin in Renal Transplant Patient With Chronic Rejection

The purpose of this study to examine the efficacy and safety of cycling treatment of deoxyspergualin in renal transplant patients with biopsy-proven chronic rejection.

The primary aim of this study is to investigate the efficacy of deoxyspergualin after the completion of 6 cycles treatment. The efficacy valuables are histological findings in renal grafts, renal function, proteinuria, graft survival, anti-HLA antibody. The safety data are also evaluated in the study.

Eligibility Criteria:
Inclusion Criteria:

* Chronic rejection defined by Banff 2007 criteria

Exclusion Criteria:

* Patients who have recurrent renal diseases and virus-associated renal diseases
* Patients who have initial WBC \< 4,000, neutrophil \< 1,000 , platelet \< 50,000 or Hb \< 8g
* Patients who have acute or chronic infection