cyrilzakka/clinical-trials huggingface dataset:
Personality of Diabetic Patients Will Influence Their Medical compliance-a 5 Years Cohort Follow up With Type D Personality

Diabetes is one of the most common causes of death in Taiwan. With the raising prevalence of diabetes, it became the fourth most common cause of death since 2002. Up to one-tenth of the national health insurance expenditure was used directly in diabetic care. Besides, more expenditure was used in the management of the complications of diabetes, like vascular diseases, renal disease, blindness and neuropathy. Diabetes is a chronic disease, the target treatment is to control HbA1c below 7%, by intensive life style modification, diet control, exercise and medications. Diabetic patient should have a good medical compliance, in order to prevent the tragedy of the complication. A good medical compliance is depended on the individual personality. Personality is the major cause of chronic stress, which is one of the most important cause of psychological stress and the risk factors of the vascular disease and hypertension. Recently, Type D personality had shown the close relationship with patients' prognosis, morbidity, mortality and life quality in different vascular diseases. These vascular diseases are the result of the atherosclerotic process, and diabetes is one of the most important risk factors of the atherosclerotic changes. The investigators believed that type D personality may also affect the medical compliance, the severity (in terms of HbA1c), and the prognosis of diabetic patients. The first part of this study is a cross sectional study, the investigators will try to figure out the relationship of the type D personality toward diabetic medical compliance, and their comorbidity. The second part of this study is a cohort study, base on the population in first part of the study, the investigators will like to construct the correlation of type D personality and diabetic patients' 5-years complication and mortality. The investigators want to establish a more complete vascular care system, improve the medical compliance, lower the complication rates, and improved the quality of life.


Eligibility Criteria:
Inclusion Criteria:

* T2DM patients for OPD
* Age 18-80 y/o
* Inform consent
Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid Tumors

This is an open-label Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0919, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and help the human immune system attack solid tumor cells more effectively.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed solid tumor that is relapsed/refractory to standard therapies or for which no approved or curative therapy exists
* Age \> or = 18
* Eastern Cooperative Oncology Group (ECOG) performance status \< 2
* Life expectancy \> or = 12 weeks
* Adequate hematologic and organ function before initiation of GDC-0919
* For some patients only: Accessible lesions amenable to paired fresh tumor biopsies

Exclusion Criteria:

* Some prior cancer immunotherapies
* Untreated brain metastases
* Active or history of autoimmune disease
Effects of Pelvic Floor Training in Male Chronic Pelvic Pain, Correlation Between Subjective and Objective Outcomes

The goal of this randomized controlled study is to establish the long-term effect of pelvic floor re-education using biofeedback and home training for men with chronic pelvic pain. The main questions it aims to answer are if pelvic floor re-education using bio-feedback and home training will give a long-lasting improvement in symptoms, assessed with a validated symptom score (the National Institute of Health - Chronic Prostatitis Symptom Index) and if an improvement in symptoms can be correlated to objective measurements of pelvic floor function. Participants will be asked to do pelvic floor exercises daily during six months with additional sessions of bio-feedback training. The control group will have no changes in their on-going treatment for their chronic pelvic pain and will be offered to enter the treatment group after six months.

At baseline all included study subjects will fill in a validated symptom score, the National Institute of Health - Chronic Prostatitis Symptom Index (NIH-CPSI) and have an assessment of their pelvic floor muscles and undergo a urodynamic evaluation.

The intervention group will perform short daily session of pelvic floor muscle training at home during six months in combination with four bio-feedback sessions during the first months. The study subjects will receive an individual instruction based on the pelvic floor assessment from the baseline visit. The study subjects will report their training in a digital diary.

A reevaluation will be done at three, six and twelve months. At six and 12 months repeating the baseline tests. At three months a renewed assessment of muscle function and the NIH-CPSI questionnaire.

The control group will be instructed not to engage in any new treatment for their chronic pelvic pain during the study period. After the six months evaluation all participants in the control group will be offered to be enrolled in the treatment group, with the same set-up and follow-up as the treatment group.

Eligibility Criteria:
Inclusion Criteria:

* Men over the age of 18, residents in Sweden, diagnosed with Chronic Primary Pelvic Pain Syndrome (CPPPS) according to the International Statistical Classification of Diseases and Related Health Problems (ICD-10) (N41.1 (chronic prostatitis), N41.9 (Inflammatory disease of prostate, unspecified), N50.8F (Chronic Pelvic Pain Syndrome in men)

Exclusion Criteria:

* Cancer in the abdomen or pelvic organs (current or previous)
* Congenital anomalies affecting the pelvic region (Bladder exstrophy, Myelomeningocele etc.)
* Transsexual male, (i.e. at birth biologically female)
* Diseases affecting the nerve function to the pelvic and/or lower extremities, other disease or ongoing treatment that could have an impact on the outcome of the study.
* Incapability to participate in testing or follow training instructions due to mental incapacity, language difficulties etc.
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)

Background:

The HIV research program is part of the National Institute of Allergy and Infectious Diseases. The program aims to learn more about HIV. It also aims to improve the health of people with HIV and create HIV vaccines. People enrolled in prior HIV studies provided samples or data. They consented for their samples or data to be used for future research. Researchers want to keep studying the stored samples and data.

Objective:

To give approved researchers access to stored samples and data after the study of sample origin is over. To do this with human subjects protection oversight by the NIH institutional review board (IRB).

Eligibility:

The study populations were defined by the protocols under which the samples or data were obtained: 11-I-0259, 13-I-0081, and 14-I-0011.

Design:

All participants consented to provide blood or other samples. Their consent included future use of the samples.

Researchers will not contact participants without prior approval of the IRB or the original study protocol.

Samples will be labeled with a code. They will not be labeled with information that identifies the participants.

Participants data will be stored in computers. The computers will be protected with passwords.

This protocol will be kept open as long as the samples or data can be used for future research. When there is no longer a need, the samples may be moved if the IRB approves this. Otherwise they will be destroyed.

...

The HIV intramural research program of NIAID conducts clinical investigations to increase our

knowledge of the biology, pathogenesis and immunology of HIV infection and vaccine

development. After all study-related interventions, follow-up, and primary specimen and data

analyses are complete for an IRB-approved protocol, some human specimens may remain in

storage, and data may continue to be analyzed to meet secondary and exploratory objectives. This protocol will allow for additional laboratory and data analyses to be continued to complete the analyses described under closed NIAID protocol #14-I-0011, Phase 1 Study of Safety and Immunogenicity of Ad4-HIV Vaccine Vectors in Healthy Volunteers.

Eligibility Criteria:
* The study populations were defined by the original protocols under which the stored specimens and/or data were collected. The total population included on this omnibus protocol comprises the

populations of other protocols.
Chronic Obstructive Pulmonary Disease Case Finding in Community-pharmacies by Spirometry

Chronic Obstructive Pulmonary Disease (COPD) is a prevalent disease. In the investigators country, underdiagnosis has been estimated in around 80% of subjects. Early detection is done mainly in primary care but due to actual situation new alternatives have been proposed to decrease underdiagnosis.

This present study promote by a multidisciplinary research team (respiratory medicine, primary care, nurse and pharmacist) raise the objective of evaluate the effect of a COPD case finding program guide by spirometry in community-pharmacies.

From the results of a pilot-study conducted in 13 community-pharmacies in Barcelona, in which the investigators showed the feasibility of spirometry in community-pharmacies for the early detection of COPD, the investigators have design a second phase to evaluate the effect of this strategy. 100 Barcelona's community-pharmacies during 6 months will select high risk customers and will conduct a spirometry in agreement with the design protocol. 3600 spirometries is the establish objective. Participants hospitals will train pharmacist in spirometry and also control spirometry quality daily by a telematic pathway. Spirometry results will be evaluate in terms of effect and costs. The investigators will also evaluate the impact of this program in the health system by numbers of subjects diagnosed and follow up in primary care.


Eligibility Criteria:
Inclusion Criteria:

* Age over 40 years.
* Current or former smoker
* Chronic respiratory symptoms(cough, shortness of breath, expectoration)

Exclusion Criteria:

* Previous diagnosed chronic lung disease
* Use of inhalers
Opportunities and Limits to Deprescribing in Nursing Homes:Quality Circle Deprescribing Module

Older people residing in nursing homes (NH) are frequently polymedicated and often prescribed potentially inappropriate medications. Deprescribing has been proposed as a way to reduce the number of drugs they receive and their exposure to harmful treatments.

The objectives of this study are 1) To evaluate the effect of a deprescribing-specific interdisciplinary quality circle module on the use of potentially inappropriate medication in nursing-home residents. 2) To determine the effective strategies to reach and implement deprescribing consensus resulting of said quality circle module.


Eligibility Criteria:
Inclusion Criteria:

Nursing homes taking part in the study must have

* a geriatric of psycho-geriatric mission;
* been part of their cantonal pharmaceutical assistance program for at least a year.

Exclusion Criteria:

* None
Genetic Predictors of Analgesic Efficacy of Propranolol for Treating Postoperative Pain

This study is a randomized, double-blind, placebo controlled clinical trial. The main purpose of this study is to determine if postsurgical pain ratings are improved with treatment with oral Propranolol, and if the effectiveness of treatment can be modified by the presence or absence of SNPs (Single Nucleotide Polymorphism) associated with Cathecol-O-MethylTransferase (COMT) and mu-opioid receptor (MOR1) activity. The treatment period will last for three days and the observation period will last for six months. Effectiveness of treatment will be assessed by means of morphine consumption through quantitative evaluation of IV-PCA (Patient Controlled Analgesia) morphine as primary outcome measure.


Eligibility Criteria:
Inclusion Criteria:

* Elective laparoscopic hemicolectomy surgery.
* Self-reported Caucasians.
* ASA (American Society of Anesthesiologists) physical status of I or II.
* Agrees to provide signed and dated informed consent form.
* Willingness to agree with the Biobanking policy.

Exclusion Criteria:

* Uncontrolled medical or psychiatric conditions.
* Severe mental impairment.
* History of major depressive disorder, psychotic disorder or schizophrenia, and/or manic episodes within the past year.
* Active alcoholism within the past 6 months.
* Psychoactive recreational drug abuse within the past 6 months including MDMA, Ketamine, hallucinogens such as LSD and/or sympathomimetics such as Cocaine.
* Inability to comprehend pain assessment.
* Pregnancy and/or breast-feeding.
* Known hypersensitivity to Beta Blockers or Opioids.
* Currently taking Propranolol.
* Currently taking other hypotensive treatments.
* Currently taking Opioids.
* Patients with asthma or reactive airway disease.
* Patients with cardiac arrhythmia, coronary artery disease, congestive heart failure.
* Patients with renal failure or dialysis.
* Patients with liver insufficiency.
* Heart rate less than 60bpm or diastolic blood pressure \<50 mmHg during the preoperative visit.
Multiple Dose Study of MPC-6827 in Subjects With Refractory Brain Metastases

Phase 1, Multiple dose Study of MPC-6827 in Subjects with Refractory Brain Metastases.


Eligibility Criteria:
Inclusion Criteria:

* Refractory Brain Metastases
* At least 1 measurable intracranial lesion as defined by RECIST
* ECOG less than or equal to 1
* Adequate hematology/organ function
* No baseline peripheral or central neuropathy above grade 1

Exclusion Criteria:

* Hypersensitivity to Cremophor EL
* Pregnant or Lactating
* Spinal Cord Compression
* Pre-existing dementia/cognitive disfunction
* Require Neupogen or Neulasta to Maintain Neutrophil Count
* Have Primary Brain Cancer
* Have History of Ischemic Heart Disease
* Have Diabetes
Intervening in Problematic Internet Use

The present study examines the efficacy of a brief intervention for problematic Internet use based on Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT) in a sample of students screened proactively in vocational schools in Northern Germany. Participants will be randomized in an intervention and a control group. It is hypothesized that after 12 months, participants of the intervention group fulfill less DSM-5 criteria for Internet use disorders, spend less time in the Internet, and suffer from less negative consequences caused by the problematic Internet use, compared to the control group.

Problematic Internet use is an increasing problem, especially in younger age groups. A population-based study revealed elevated prevalences in adolescents and young adults. The present study aims to provide an intervention for this vulnerable group to change the problematic Internet use. This is suggested to prevent the development of more severe forms of dependence. Brief interventions using MI and elements of CBT have shown to be an adequate method to change addictive behaviors.

For the recruitment, students of vocational schools in the states of Schleswig-Holstein and Hamburg in Northern Germany are screened proactively in classes. Participants fulfilling at least 21 points on the Compulsive Internet Use Scale (CIUS) receive a diagnostic telephone interview. If fulfilling at least 2 DSM-5 criteria, participants will be randomly allocated to two conditions: (1) Intervention group with up to three telephone counseling sessions based on MI, (2) Control group receiving a booklet on problematic Internet use. Outcome measures are a reduction of DSM-5 criteria for Internet use disorders, a reduction of time spent on the Internet, and a reduction of negative consequences caused by the problematic Internet use. The efficacy of the intervention will be examined after 6 and 12 months in follow-up interviews.

Eligibility Criteria:
Inclusion Criteria:

* CIUS score of 21 and at least 2 DSM-criteria
* At least 16 years old

Exclusion Criteria:

* Current treatment for mental disorders
Early Access to ART for All in Swaziland: Effects on Economic Outcomes

The purpose of this study is to evaluate the impact of offering early antiretroviral therapy to HIV-positive individuals in government-managed health facilities in Swaziland on a range of economic outcomes

The MaxART study is a three-year stepped-wedge randomized trial with open enrollment for all adults 18 years and older across 14 rural health facilities in Swaziland's Hhohho Region. The main trial registration is accessible at: https://clinicaltrials.gov/ct2/show/record/NCT02909218.

This registration is specific to the economic evaluation of the MaxART study which aims to quantify the causal impacts of early ART initiation (compared to national standard care) on a range of key economic outcomes, including healthcare expenditures, productivity, and household wealth.

Eligibility Criteria:
Inclusion Criteria:

* All HIV-positive individuals who are aged 18 years or older, are ART naïve and attend the health facilities included in the study

Exclusion Criteria:

* All HIV-positive individuals who are \<18 years of age
* All HIV-positive pregnant or breastfeeding women
* All HIV-positive individuals who did not consent to participate
Amikacin Penetration Into the Cerebrospinal Fluid

The limited available data precludes establishing an antibiotic regimen in patients suffering from bacterial meningitis after head trauma, or spontaneous bleeding Understanding the disposition of Amikacin administered intrathecally will enable to propose rational treatment of these patients.

The limited available data precludes establishing an antibiotic regimen in patients suffering from bacterial meningitis after head trauma, or spontaneous bleeding Understanding the disposition of Amikacin administered intrathecally will enable to propose rational treatment of these patients.

Eligibility Criteria:
Inclusion Criteria:

1. Culture proved bacterial meningitis where the prescribed therapy includes the use of systemic and intraventricular amikacin therapy.
2. The included patient should have an intraventricular catheter placed for intraventricular pressure measurement and admitted to an intensive care unit.
3. Blood creatinine concentration up to 1.49 mg/dL measured at the inclusion day.

Exclusion Criteria:

1. Patients or legal guardians who refuse to participate in the study.
2. Known allergy to amikacin.
3. Blood creatinine concentration of 1.5 mg/dL or higher.
4. Subjects without intraventricular catheter who will need repeated lumbar punctures for CSF amikacin determinations.
5. Patients suffering from known chronic liver disease.
SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study

The purpose of the study is to evaluate the safety and tolerability of DRG stimulation when placing a neurostimulator during the same procedure as implantation of spinal fixation with or without interbody cage systems in patients with chronic back and/or leg pain requiring single level spinal fusion.


Eligibility Criteria:
Inclusion Criteria:

* Indicated for a single level or two level adjacent spinal fusion having back pain and radiculopathy
* Have been diagnosed with chronic, intractable pain of the lower back and/or leg refractory to conservative therapy for at least 3 of months
* At least 6 months since last surgical procedure on the spine
* Be 21 years of age or older at the time of enrollment
* Be willing and capable of giving informed consent
* Be willing and able to comply with study-related requirements

Exclusion Criteria:

* Any prior spinal fusion at index or adjacent level
* Pregnant
* Have a life expectancy of less than 1 year
* Be concomitantly participating in another clinical study
* Be involved in an injury claim under current litigation
* Baseline narcotic use of ≥ 100 MME per day
* Significant untreated addiction to dependency producing medications
* Current active implantable medical device
* Cancer
* Have osteoporosis
* Active infection
* Allergies to system components
* AGE \> 80
* Expected need to undergo MRI imaging in the future
* Other significant comorbidities
A Phase Ia/Ib Clinical Trial of IBI360 Monotherapy or in Combination With Sintilimab and (or) Chemotherapy in Advanced or Metastatic Solid Tumors

This is an open label Phase Ia/Ib trial to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of IBI360 monotherapy in Advanced or Metastatic Solid Tumors

Phase Ia is dose escalation and dose expansion study of IBI360 monotherapy and IBI360 in combination with sintilimab in advanced or metastatic Solid Tumors; Phase Ib is an multi-cohort trial of pancreatic carcinoma, HER2 negative gastric adenocarcinoma, advanced or metastatic solid tumors to evaluate safety and preliminary efSficacy of IBI360 in combination with sintilimab and (or) chemotherapy or IBI360 monotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Provide signed informed consent;
2. Male or female aged at 18-75 (inclusive) years;
3. Expected survival ≥12 weeks;
4. ECOG PS score 0 or 1;
5. Provide archival or fresh tissues for CLDN18.2 expression analysis;
6. Adequate laboratory parameters;
7. Suffer from advanced or metastatic malignant local solid tumors confirmed by histological diagnosis and meet the criteria of the enrolled group as follows:

Ia: The subjects for whom no standard treatment regimens are available or who is intolerable to standard treatments.

Ib: pancreatic carcinoma, HER2 negative gastric adenocarcinoma, advanced or metastatic solid tumors

Exclusion Criteria:

1. The subjects who received the treatment with CLDN18.2 monoclonal antibody or CLDN-18.2 CART;
2. The subjects who received other anti-tumor medication within 4 weeks prior to the initial dose of the study drug;
3. Any toxicity due to previous anti-tumor therapy that has not yet resolved to NCI CTCAE v5.0 grade 0 or 1 prior to the first dose of study treatment;
4. The subjects with history of hypersensitivity to the study drug;
5. The subjects were not recovery after surgery with history of gastrointestinal perforation or fistula within 6 months prior to the enrollment;
6. The subjects with symptomatic central nervous system (CNS) metastasis or carcinomatous meningitis;
7. The subjects with pyloric obstruction;
8. The subjects with active or poorly controlled serious infections