cyrilzakka/clinical-trials huggingface dataset:
Clinical Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine

A prospective cohort study was performed in patients with angina pectoris who were treated with oral Chinese patent medicine and Western medicine.Collect primary and secondary efficacy indicators such as the incidence of cardiovascular events, using clinical samples to detect genomics, proteomics, metabolomics, intestinal flora and sclerotia.To explore the clinical efficacy of Chinese patent medicine in the treatment of coronary heart disease with angina pectoris, and provide reliable data support for its clinical application.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily participate, understand and sign the informed consent form;
2. Age 35-75 years old, gender is not limited;
3. Patients with coronary heart disease and angina pectoris in the Department of Cardiology or Outpatient Department, the diagnosis of angina pectoris meets the diagnostic criteria of Western medicine and the standard of TCM syndrome differentiation;
4. Patients who met the criteria for drug treatment, the exposed group was treated with traditional Chinese medicine combined with Western medicine, and the non-exposed group was treated with Western medicine alone.

Exclusion Criteria:

1. Combined with other heart diseases, neurosis, menopausal syndrome, hyperthyroidism, cervical or vertebral artery type cervical spondylosis, gastro-oesophageal reflux disease or esophageal hiatus hernia may cause chest pain;
2. Patients with severe symptoms and uncontrollable angina pectoris, with acute myocardial infarction, heart failure, myocarditis, cardiomyopathy, severe heart valve disease, liver failure or renal failure, malignant tumors and serious metabolic diseases;
3. Pregnant women, lactating women or women of childbearing age who have birth requirements;
4. Mental patients, or cognitive dysfunction;
5. Participated in other clinical trials in the last 3 months;
6. Allergic persons, or those known to be allergic to therapeutic drugs;
7. It is expected that the compliance is poor and it is not possible to visit regularly;
8. Patients who do not have a current address or whose current address is incomplete and have no contact number;
9. The investigator believes that there are other situations that are not suitable for the trial.
Efficacy and Safety of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

To evaluate the efficacy and safety of brexpiprazole as adjunctive treatment in elderly patients with Major Depressive Disorder (MDD)


Eligibility Criteria:
Inclusion Criteria:

* The patient is an outpatient consulting a psychiatrist.
* The patient has a recurrent Major Depressive Disorder diagnosed according to DSM-IV-TR™. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI).
* The patient had at least one previous MDE before the age of 60 years.
* The patient has a moderate to severe depression and an insufficient response to at least one and no more than three adequate antidepressants treatments.
* The patient, if a woman, must have had her last natural menstruation ≥24 months prior to the Screening Visit.
* The patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential.

Exclusion Criteria:

* The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than MDD.
* The patient has a current Axis II (DSM-IV-TR™) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypical or histrionic personality disorder.
* The patient has experienced/experiences hallucinations, delusions or any psychotic symptomatology in the current MDE.
* The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
* The patient, in the opinion of the investigator, or according to Columbia Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
* The patient has had neuroleptic malignant syndrome.
* The patient has any relevant medical history or current presence of systemic disease.
* The patient has a neurodegenerative disorder.
* The patient has, at the Screening Visit an abnormal ECG that is, in the investigator's opinion, clinically significant.
* The patient has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, that has not been in remission for \>5 years prior to the first dose of IMP.
* The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.
Observational Study to Evaluate the Efficacy and Safety of Bortezomib, Melphalan, Prednisone (VMP) in Participants With Multiple Myeloma

The purpose of this study is to assess the 2-year progression-free survival rate.

This was a prospective, open-label, multicenter, observational study. Participants who received bortezomib, Melphalan, Prednisone(VMP) therapy for Multiple myeloma (MM) that was not eligible for autologous stem cell transplantation will be enrolled in the study. The study will consist of Screening phase; VMP therapy phase (9cycles); Follow-up phase (2 years from the day when the first cycle was started). Participants visited each institution for evaluation for 2 years from the date of baseline evaluation and first VMP administration (duration of treatment, 9 cycles; follow-up visits, every 3 months after the end of the treatment). Participants receiving VMP therapy will be primarily evaluated for 2-year progression-free survival rate. Participants safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are naïve to chemotherapy for multiple myeloma and not eligible for autologous stem cell transplantation
* Participants with symptomatic multiple myeloma: a) Intramedullary monoclonal plasma cells greater than or equal to (\>=) 10% or histologically confirmed plasmacytoma; b) Presence of monoclonal protein in the serum or urine; c) Myeloma-related organ impairment as defined in protocol
* Participants with presence of an illness that is detectable by definitions as defined in protocol
* Postmenopausal, sterilized or sexually inactive women, including women of childbearing potential who exercise effective contraceptive measures before and during the clinical trial

Exclusion Criteria:

* Participants with previous experience of receiving a therapy for multiple myeloma (excluding radiotherapy and dexamethasone \< 160mg in total)
* Participants with severe peripheral neuropathy (Grade \>= 2 by NCI CTC version 4.0)
* Pregnant or breastfeeding mothers
* Participants with mental illness that can interfere with his/her cooperation with the therapy or the monitoring conditions of the clinical trial
* Participants with other serious medical conditions (such as uncontrolled hypertension, diabetes mellitus and active infections)
Improving Muscle Assessment in Older Adults - The "Can We Build a Better Mouse Trap?" Study

The primary aim of this study is to compare traditional muscle function tests with computerized versions using body-worn motion sensors and video motion analysis of the same tests. The investigators selected the Timed Up and Go (TUG) test as the investigators primary variable for this aim with several other function tests (e.g., repeated chair rise, 6-meter walk, 2-minute walk, Romberg stance, semi-tandem / tandem stance) as secondary variables. The investigators primary hypothesis is that the computerized versions of the TUG test are highly correlated (\>0.9) with the traditional method, but with comparable or better reproducibility. Secondary analyses will correlate other function tests with their computerized version, again with the hypothesis that they are highly correlated and that computerized versions are of similar or better reproducibility. This analysis will also compare traditional assessments of balance with a computerized balance method, computerized dynamic posturography.


Eligibility Criteria:
Inclusion Criteria:

1. Ambulatory, community dwelling men and women age ≥ 70 years
2. Able and willing to sign informed consent
3. Able to stand without assistance

Exclusion Criteria:

1. History of myocardial infarction within the prior six months or ongoing angina
2. History of injury or surgery within the prior six months which limits the ability to ambulate
3. History of malignancy with metastasis to the musculoskeletal system
4. Neuromuscular disease or severe end organ disease impairing balance or muscle function to the degree that completion of all study tests is unlikely.
CHO-loading Before and High Intermittent CHO-intake During Physical Exercise in T1D

Prolonged physical exercise (PE) is a challenge in type 1 diabetes with an increased incidence of both hypoglycemia and hyperglycemia.

The purpose was to evaluate the impact of two consecutive days of carbohydrate (CHO) loading, followed by high intermittent CHO-intake during prolonged PE, facilitated by a proactive use of Real-Time Continuous Glucose Monitoring (rtCGM), on glucose control in individuals with type 1 diabetes.

Ten physically active individuals with type 1 diabetes were invited to participate in a 3-day long sports camp with the objective to evaluate CHO-loading and high intermittent CHO-intake during prolonged PE. 1.5 months later the same procedure was evaluated during a 90 km cross-country skiing race. Participants were instructed to act proactively using rtCGM with predictive alerts set for high and low glucose values to maintain sensor glucose values within target range, defined as 72-180 mg/dl (4-10 mmol/l).

This is a descriptive, single arm, non-randomized interventional study. The intervention consisted of carbohydrate loading prior to and intermittent high carbohydrate intake during physical exercise and a proactive use of Real-Time Continuous Glucose Monitoring (rtCGM) to achieve and maintain glucose control.

Central Contact Person Stig A Mattsson, dietician PhD student Phone: +46702047759 E-mail: stigmattsson@live.com

IPD Sharing Statement No: There is not a plan to make IPD available.

Eligibility Criteria:
Inclusion criteria:

* age 18-50 years
* type 1 diabetes
* diabetes duration \>1 year
* exercising regularly ≥3 workout/week
* previous experience from cross-country skiing

Exclusion Criteria:

* A1c 8.6% NGSP (70 mmol/mol IFCC)
* proliferative retinopathy
* known nephropathy
* cardiac failure
* following a low-carbohydrate diet.
Post Market Clinical Follow Up Study for Evaluation of Agluna® METS

The Agluna® (antimicrobial ionic silver surface technology) is used to treat the surface of the METS (Modular Endoprosthetic Tumour System) medical devices, in order to reduce the risk of post surgical infections after orthopaedic endoprosthetic replacement surgery.

This Post Market Clinical Follow up study is designed to retrospectively establish the infection rate of a cohort patients who have received an Agluna® Treated METS implant and compare the clinical data to patients that have received an untreated METS implant; in order to provide evidence to support the investigators' clinical claims.

This post-market clinical follow-up study will be a retrospective data comparison study of a series of Agluna® treated and untreated METS™ modular prostheses conducted at the Royal National Orthopaedic Hospital, Stanmore. The expected sample size will be 106, with 53 patients in each treatment arm (Agluna® treated vs untreated). However there will be an initial pilot of 20 subjects to evaluate the feasibility of the study conduct and to identify if any further study design modification are required.

The primary outcome is the estimation of the infection rate over 12 months following an Agluna (silver) treated METS™ endoprosthetic surgery. This will be compared to the infection rate of non-Agluna Treated devices in a similar population. Incidence of infection will be measured according to the accepted definition of periprosthetic joint infection from the American Academy of Orthopedic Surgeons. The study follow up period is 12 months after implantation. Secondary objectives are to examine the health economic impacts of using the Agluna® Treated METS™ Modular Tumour System in comparison to the untreated METS™ Modular Tumour System and to establish clinically relevant superiority of the Agluna® Treated METS™ Modular Tumour System in comparison to untreated METS™ Modular Tumour System.

Eligibility Criteria:
Inclusion Criteria:

1. Implanted with a METS™ modular implant at the Royal National Orthopaedic Hospital, Stanmore.
2. Patient was between 18 years old and 70 years old at the time of implantation.
3. Patient has been followed up for at least 12 months following implant surgery

Exclusion Criteria:

1. Patient is obese
2. Patient is currently or has been involved in pending litigation or worker's compensation
3. Patient has participated in another clinical investigation or study with an investigational medical device within the last 60 days
Injury Prevention Model For K-1 Students

There is no educational injury prevention model uniquely suited for kindergarten and first grade (K-1) students. The Teddy Bear Injury Clinic (TBIC) is a unique modification of the teddy bear clinic to facilitate classroom injury prevention teaching

The TBIC will be administered to K-1 students, aged 5-7 years. Initial analysis will be descriptive and qualitative. Subsequent randomization of students to test and control groups followed by statistical analysis will be done to evaluate for effectiveness of the educational model

The TBIC is a 40minute educational intervention divided into two sections with the first section consisting of classroom teaching with two safety messages each for four safety topics and the second section being that of students acting as caregivers for their teddy bears, using role-play for the messages taught.

Qualitative data collection will be initially done in an inductive manner and qualitative content analysis done using the directed method to analyze effectiveness and appropriateness of the TBIC for a pilot group.

Controlled trial will consist of randomizing students to either the TBIC group or the control group which will receive an alternate teddy bear clinic for non trauma related hospital education. Pre and post questionnaires will be administered to evaluate the efficacy of the TBIC.

Statistical analysis will be done using the Wilcoxon signed test rank score for the Likert scale based evaluations generated.

Eligibility Criteria:
Inclusion Criteria:

* K-1 elementary school students in the catchment area of the hospital for educational sessions

Exclusion Criteria:

* No consent/assent for study
Genetics of Periodontal Diseases in Chinese

(A retrospective case control study to validate the association between Interleukin-1 gene variations and adult chronic periodontal disease in Chinese (Shanghai))


Eligibility Criteria:
Inclusion Criteria:

- To be included in this study, an individual needs to be Han Chinese of 35 years of age or older at time of enrollment.

Exclusion Criteria:

- 1) Age younger than 35 years old. 2) Patients with diagnosis of rheumatoid arthritis, psoriasis, inflammatory bowel disease, glomerulonephritis/kidney disease, cancer, or Sjogren's syndrome.

3) Organ transplant recipients.
Single Cell Genomics of Psoriatic Skin

The purpose of this study is to understand how genetics play a role in psoriasis. Specifically, a genetic allele HLA-Cw6 is known to be associated with psoriasis, and this study aims to find out how it affects genetic and protein expression in patients with psoriasis, compared to healthy people, at a single-cell level using a novel flow cytometry and RNA-sequencing protocol.


Eligibility Criteria:
Inclusion Criteria:

For subjects in the psoriasis group:

1. Ability to provide written consent and comply with the protocol
2. At least 18 years of age
3. Diagnosis of plaque psoriasis for at least 6 months prior to enrollment
4. BSA \> 5% and at least one target plaque on trunk or extremities greater than 10cm2

For control subjects:

1. Ability to provide written consent and comply with the protocol
2. At least 18 years of age
3. No previous diagnosis of psoriasis or other inflammatory skin conditions

Exclusion Criteria:

For subjects in the psoriasis group:

1. Subject has non-plaque form of psoriasis.
2. Subject has drug-induced psoriasis.
3. Pregnancy at any point during the study period.
4. Known allergy to lidocaine, other local anesthetics, or any component of local anesthetic agents.
5. Known HIV positive status.
6. Evidence of abnormality of any immune cell population from a drug-induced or genetic cause.
7. Known coagulopathy.

For control subjects:

1. Any physical examination findings by the investigators consistent with psoriasis or other inflammatory skin conditions.
2. Pregnancy at any point during the study period.
3. Known allergy to lidocaine, other local anesthetics, or any component of local anesthetic agents.
4. Known HIV positive status.
5. Evidence of abnormality of any immune cell population from a drug-induced or genetic cause.
6. Known coagulopathy.
7. Use of any immunosuppressant or immunomodulating therapies within 6 months.
GLP-1 and Oxyntomodulin Release in Relation to Diet in Type 2 Diabetes Patients.

The aim of this trial was to assess glycemic control and incretin release in subjects affected by type-2 diabetes, a condition in which GLP-1 release is impaired. It is known that nutrition affects a variety of factors in overall quality of life in diabetes and we hypothesized incretin secretion may improve in acute. As little is known regarding oxyntomodulin secretion in relation to diet, we explored this gut-derived hormone behavior as well.

Hence, the administration of two meals was carried out; these were equal in terms of calories but different for macronutrients composition. Appetite rating was assessed as well through a 100-mm horizontal Visual Analogue Scale, either at fasting and for 4 hours once the meal was completed.

Type-2 diabetes (T2D) is a multifactorial metabolic burden whose metabolic features include alterations in GLP-1 secretion and ultimately hunger/satiety circuit derangement. Manipulating the composition of the diet in order to promote GLP-1 secretion may represent a promising lifestyle strategy for obesity and T2D management.

The objective of this study was to assess the post-prandial profile of appetite- regulating hormones and assessing the post-prandial appetite ratings using a Visual Analogue Scale (VAS), as well as measuring the fasting and postprandial glucose/insulin responses in overweight and/or obese, well controlled patients with T2D.

Twelve T2D patients (M:F = 7:5) aged 63.1±8.5 years were enrolled in a randomized, controlled, crossover trial. Subjects consumed on two different days, at one-week interval, an experimental High Fiber Vegetarian meal (HFV) rich in dietary carbohydrate and fiber in comparison with a standard, Mediterranean-like meal (MED). The two meals were isocaloric. Appetite ratings, glucose/insulin and gastrointestinal hormone responses were assessed either at fasting and every 30' until 210' for GLP-1 and Oxyntomodulin and 240' for glucose and insulin after the ingestion of the meal.

Eligibility Criteria:
Inclusion Criteria:

* Type-2 diabetes history of at least 2 years, age above 18 years, body mass index (BMI) between 25 and 35 kg/m2, and drug naïve and/or with metformin treatment.

Exclusion Criteria:

* clinically significant neurological, endocrinological, or other systemic diseases, as well as those with acute illness and chronic inflammatory or infective disease.
Combined Use of BCG and Interferon Alpha in Bladder Cancer

To compare the toxicity and efficacy of the combination of BCG and interferon alpha to standard dose and low dose BCG alone in high risk superficial bladder cancer

140 eligible patients with high risk superifical bladder cancer would be randomised to receive standard dose BCG, low dose BCG or the combination of low dose BCG and interferon alpha in a schedule of "6+3" weekly intravesical instillations. Patients would be closely monitored with cystoscopy and urine cytology and intravenous urograms when indicated. Pre-and post-instillation urine samples would be collected for cytokine analysis.

Eligibility Criteria:
Inclusion Criteria:

(1) Patients must have completely resected, histologically?proven urothelial carcinoma of the urinary bladder, stage Ta or Tl 1 ? 16 weeks prior to registration, and/or carcinoma-in-situ on bladder biopsy. Central pathology review was mandatory. (2) Patients with Stage Ta urothelial carcinoma must be judged to be at increased risk of tumor recurrence by virtue of any one of the following: (a) Tumor recurrence during the 56 weeks prior to registration, (b) Two or more initial tumors within 28 weeks, (c) Grade III urothelial carcinoma during the 16 weeks prior to registration, (d) Dysplasia or carcinoma-in-situ on random biopsy or (e) Positive urinary cytology post tumor resection. "Suspicious" or "suggestive" cytology is insufficient for this criterion. (3) Patients who have received prior intravesical therapy other than BCG were eligible provided they had not undergone a course of any other intravesical agent within two months prior to entry. (4) There was no age restriction; however, all patients registered had to be willing to be available for 5?year follow up and to have a life expectancy of at least two years. (5) Patients had a Karnofsky score \>50. (6) Women of child?bearing age were using effective contraceptive methods. (7) Patients agreed not to take vitamin supplements (except for those prescribed in the study) for the duration of the trial. (8) Pretreatment laboratory tests and radiological examinations must have been obtained during the 16 weeks prior to patient registration. (9) All patients had to be informed of the investigational nature of this study, and had to sign a written informed consent in accordance with institutional guidelines.

Exclusion Criteria:

* (1) Patients with medical illness or mental status, which would preclude cooperation with the study. (2) Patients who were immunodeficient, or had received immunosuppressive radiation therapy or chemotherapy. (3) Patients with urothelial carcinoma of stage T2 or higher. (4) Patients who had evidence of urothelial carcinoma of the upper urinary tract at the time of recruitment. (5) Patients who had received radiation therapy for bladder cancer within one year prior to registration. (6) Patients who had been previously treated with intravesical BCG. (7) Patients with active tuberculosis.