cyrilzakka/clinical-trials huggingface dataset:
A Registry Study of Runzaozhiyang Capsule Used in Clinical Real World

The purpose of this study is get to know what and how Runzaozhiyang capsule in hospital results in drug-induced liver injury or adverse drug reactions from a cohort event monitoring as registration research.

In order to improving monitoring drug-induced liver injury or adverse drug reactions of Chinese medicine containing Radix Polygoni Multiflori in clinical real world, registry study is suitable method in this area. Otherwise, nested case control study is used to find out the mechanism of drug-induced liver injury. Calculate the incidence of drug-induced liver injury or adverse drug reactions is one of the main aims for this study. Safety surveillance on Chinese medicine containing Radix Polygoni Multiflori is an important problem that needs to be sorted out through large sample observational study. According to the relevant regulations of the CFDA, 3000 cases need to be registered at least. The aim population is who using Runzaozhiyang capsule 's with abnormal liver function before medication from June 2017 to June 2019.

Eligibility Criteria:
Inclusion Criteria:

Patients using Runzaozhiyang capsule 's with abnormal liver function before medication from June 2017 to June 2019.

Exclusion Criteria:

none
Stroke and CPAP Outcome Study: A Sham-controlled Trial of CPAP Among Stroke Rehabilitation Patients

The purpose of this study is to assess the effect of continuous positive airway pressure (CPAP) on functional outcome in patients with acute stroke, the investigators conducted a sham-controlled, double-blind pilot trial during inpatient rehabilitation.

Patients with acute stroke were recruited and randomly assigned to auto-titrating or sham-CPAP during their rehabilitation stay.

All acute stroke patients admitted to the inpatient rehabilitation service at the University of Washington were invited to participate in the study. Given the high prevalence of obstructive sleep apnea (OSA) in this population, no screen for OSA was performed. Enrolled patients were assigned randomly to active-CPAP with auto-titrating pressures or to sham-CPAP with an otherwise identical device but with pressures ≤ 1 cm water. Subjects used active or sham-CPAP for the duration of inpatient rehabilitation, but no longer than 28 days. CPAP compliance was assessed by memory card that recorded mask-on time. Other information on download, such as apnea-hypopnea index, was only available on active-CPAP and not assessed by investigators in real time. In this study, the investigators defined tolerance as any continued use of CPAP at night and adherence as mean hours of CPAP use per night in those who were CPAP tolerant.

Eligibility Criteria:
Inclusion Criteria:

* greater than 18 years of age
* admitted to an inpatient rehabilitation unit at the University of Washington
* head CT or brain MRI demonstrating an ischemic or hemorrhagic stroke
* enrolled in another research study

Exclusion Criteria:

* stroke was a subarachnoid hemorrhage or due to a secondary cause (vascular malformation, vasculitis, brain tumor, head trauma, or predisposition to bleeding)
* history of CPAP use, advanced chronic lung disease requiring supplemental oxygen, heart failure (NYHA class III or IV)
* require a nasogastric feeding tube.
A Study to Compare to the Pharmacokinetic Profile of Two Paracetamol Formulations

A repeat dose pharmacokinetic study investigating two paracetamol formulations


Eligibility Criteria:
Inclusion Criteria:

* Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.

Exclusion Criteria:

* Subject does not agree to refrain from alcohol consumption for the 10-day period prior to visit 2 and throughout the study.
* Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
* Current (within 14 days of screening) or regular use of any prescription, over-the-counter drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing (e.g. barbiturates, theophylline, cimetidine, or erythromycin), excluding prescription birth control, if applicable.
Laparoscopic Adrenalectomy for Large Adrenal Tumors.

Laparoscopic adrenalectomy is the treatment of choice for the benign tumor of less than 6 cm. However, this is an ongoing debate that exact cut-off value of tumor size for LA. The aim of this study was to assess whether the size of the adrenal tumor affects preoperative and postoperative outcomes in patients undergoing laparoscopic transperitoneal adrenalectomy as well as to evaluate the learning curve.

From April 2010 to October 2018, preoperative and postoperative data of 107 patients who underwent LTA with adrenal mass were recorded prospectively and analyzed retrospectively.

The inclusion criteria were all hormonally active adrenal lesions, detection of increases in size in \< 4 cm adrenal tumors on serial imaging, solitary adrenal metastases without evidence of local invasion, tumors size ≥ 4 cm, patients between the age of 18 and 80, and American Society of Anesthesiologists score (ASA) ≤ 3. The patients with adrenal masses that specified suspicion of malignancy on imaging such as local invasion, irregular tumor margins were evaluated as ineligible for LTA, and excluded in this study, were addressed to open surgery. Retroperitoneoscopic and laparoscopic partial adrenalectomies were also excluded from the study.

Totally 102 patients were included in the study. The patients were allocated according to adrenal tumor size as \<6cm (group 1:76) and ≥ 6 cm (group 2: 26). The variables such as demographics, tumor size, and laterality, operation time, blood loss, per-operative and postoperative complications, length of hospital stay, final pathology result were compared between the two groups. In order to evaluate the learning curve, the patients were also classified into three consecutive groups including group A (1-25), group B (25-50), group C (51-75) and group D (76-102) according to the chronological order of their surgery. Variables including operation time, tumor size, blood loss, and hospital stay, and overall complications were used to investigate the learning curve.

Eligibility Criteria:
Inclusion Criteria:

1. all hormonally active adrenal lesions,
2. detection of increases in size in \< 4 cm adrenal tumors on serial imaging,
3. solitary adrenal metastases without evidence of local invasion,
4. tumors size ≥ 4 cm,
5. patients between the age of 18 and 80
6. American Society of Anesthesiologists score (ASA) ≤ 3.

Exclusion Criteria:

1. suspicion of malignancy on imaging such as local invasion, irregular tumor margins
2. Retroperitoneoscopic adrenalectomies
3. laparoscopic partial adrenalectomies
Study of Autologous Tumor Lysate-pulsed D-CIK Combined With Chemotherapy for Gastric Cancer

The purpose of this study is to evaluate the safety and efficacy of chemotherapy combined with autologous tumor Lysate-pulsed dendritic with cytokine-induced killer cell (Ag-D-CIK) for gastric cancer.

40 patients with stage Ⅰ～Ⅲ Gastric Cancer,who had received surgery and kept their tumor tissue,will be randomly divided into group A（receive Ag-D-CIK treatment and chemotherapy) or group B（just receive chemotherapy),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of Ag-D-CIK treatment (every 1 months) and 4 cycles of chemotherapy (every 2 weeks).Patients in group B will receive only 4 cycles chemotherapy（every 2 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Patients who can accept curative operations
* 18\~80 years old
* Histologically confirmed with gastric cancer at stage Ⅰ\~Ⅲ
* Patients who can accept radical gastrectomy;
* Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.

Exclusion Criteria:

* Hemoglobin\<8.0 g/dL,White blood cell \<3 x 10\^9/L;Platelet count \<75 x 10\^9/L; ALT, AST, BUN and Cr more than normal limits on 3.0 times
* Known or suspected allergy to the investigational agent or any agent given in association with this trial
* Pregnant or lactating patients
* Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection
* Patients who are suffering from serious autoimmune disease
* Patients who had used long time or are using immunosuppressant
* Patients who had active infection
* Patients who are suffering from serious organ dysfunction
* Patients who are suffering from other cancer
* Other situations that the researchers considered unsuitable for this study.
In Vivo Kinematics of Scapolunate Interosseous Ligament Injuries

The investigators hypothesize that there is no relationship between in vivo kinematic abnormalities and patient-rated outcomes for scapholunate interosseous ligament injuries (SLIL)

The secondary null hypotheses are that: There are no kinematic differences between subjects with unilateral, symptomatic, full thickness scapholunate ligament tears in comparison to the contralateral wrist without scapholunate ligament injury.

The investigators aim to answer to the below questions:

* What are baseline validated outcomes for subjects with SLIL injury?
* What are baseline physical measures (range of motion, Jamar Dynamometry)?

In vivo kinematics of the normal wrist has been studied previously, but few studies have characterized the wrist with a SLIL injury. There are few studies evaluating validated patient-rated outcomes for patients with SLIL injury. The goal of this study would be to evaluate to what degree kinematic abnormalities affect patient-rated outcomes.

Eligibility Criteria:
Inclusion Criteria:

* All patients with a unilateral full thickness scapholunate ligament tear diagnosed by radiographs or advanced imaging

Exclusion Criteria:

* Patients with a partial thickness scapholunate ligament tear
* Patients with radiographic arthrosis
* Patients with prior wrist injury
* Pregnant women
Whole-Body MRA at 3T - A Comparison Between Two Different Scan Protocols

To compare to different approaches in whole-body magnetic resonance angiography of patients suffering peripheral arterial disease.

Our hypothesis is that use of a new protocol improves the diagnostic quality of the WB-MRA procedure.

Patients suffering peripheral arterial disease must undergo imaging procedures before endovascular or surgical procedures.

WB-MRA is an imaging procedure that can visualise the arterial system. WB-MRA can be performed in different manners. On option is to start the scan in the head region and continue down the body to the feet (standard protocol). Another option is to use a hybrid protocol that first examines the head and lower leg followed by examination of the pelvic and upper leg region.

A comparison between the standard and hybrid protocols has not been performed in a 3T high magnetic field system, therefore we will perform such a study.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic lower extremity ischemia (claudication, ischemic wounds)
* Referred to digital subtraction angiography (DSA)

Exclusion Criteria:

* Renal insufficiency (GFR \< 30 ml/min)
* Contra-indications for MRI-examination (claustrophobia, metal-implants, pacemaker)
* Dementia
* Pregnancy/lactation
* Allergy to gadolinium based MRI contrast agents
* Acute disease
Effect of Kidney Replacement Therapy with Polymethylmethacrylate Membranes on Pruritus-related Quality of Life in Patients Receiving Maintenance Haemodialysis

This randomized controlled trial aims to evaluate the effect of polymethylmethacrylate dialysis membranes use on the intensity of pruritus in patients with CKD stage 5D receiving maintenance hemodialysis.

The main question it aims to answer is: Does the use of polymethylmethacrylate (PMMA) membranes reduce the intensity of pruritus in dialysis patients?

Researchers will compare PMMA membranes to standard polysulfone-based membranes to see if PMMA works to reduce moderate-to-severe pruritis and pruritis-related quality of life.

Participants will:

* receive maintenance hemodialysis with PMMA or polysulfone membranes for 2 months;
* fill in questionnaires about intensity of pruritis and its impact on daily life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CKD stage 5D, maintenance hemodialysis not less than 3 months prior screening;
* Moderate-to-severe pruritis (WI-NRS score ≥ 4);
* Adequate dialysis dose (spKt/V≥1,4 and/or eKt/V≥1,2);
* Dialysis treatment regimen: three sessions per week of at least 4 hours duration;
* Signed informed consent.

Exclusion Criteria:

* Presence of active skin disease, cholestasis, severe secondary hyperparathyroidism and other conditions that, in the investigator's opinion, may be responsible for pruritus.
* Noncompliance of the patient with the protocol (in the investigator's opinion).
* Use of haemodiafiltration.
Copper Use as Protection Against Antimicrobial Resistance in the ICU

CUPRIC is an investigator initiated and conducted, prospective, quasi-experimental study to determine whether the combined use of copper-alloyed objects plus copper-enriched textiles reduce the burden of MDRO colonization and HAIs incidence in the critically ill population.

BACKGROUND: Healthcare-associated infections (HAI) are among the leading causes of preventable death and are associated with significant financial costs. Treatment of HAI has been complicated by the rise of antimicrobial resistance (AMR). AMR limits the number of effective antibiotics available to treat HAI. Therefore, the prevention of these infections is increasingly important. Current evidence indicates that patients' colonization with multidrug-resistant organisms (MDRO) is a critical issue with the potential of causing serious harm. Fortunately, newer strategies such as copper usage in the healthcare environment are under development and these approaches may decrease the burden of MDRO without disrupting gastrointestinal colonization resistance. This project will explore a cutting-edge strategy to decrease HAIs through the reduction of environmental reservoirs by replacement of high-touch surfaces and textiles in an intensive care unit (ICU) setting using the inherent antimicrobial properties of copper alloys. By studying the incidence of MDRO colonization of patients and rates of HAIs in patients exposed and unexposed to copper-based surfaces and textiles, the aim is to expand knowledge, to help optimize the practice of the application of antimicrobial surfaces in the ICU setting.

AIM: To establish the efficacy of the combined use of copper alloy-surfaced objects and copper-enriched textiles to reduce the burden of patients' MDRO colonization in the ICU.

METHODS: The investigators will conduct a prospective, quasi-experimental study in the ICU at the Hospital Regional de Iquique. During the first stage of the study (6 months), the investigators will determine the cumulative incidence of MDRO acquisition (primary outcome) and the incidence rate of HAIs in patients admitted to the ICU before installation of the antimicrobial copper products. During the second stage (6 months), the investigator will assess study outcomes after the installation of copper surfaces over highly touched surfaces within the patient unit.

EXPECTED RESULTS: It is expected a 30% reduction of the cumulative incidence of MDRO acquisition with respect to the control group. The investigators also expect this reduction to translate into a decrease of HAIs in the treatment versus the control group.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (age ≥18 years)
2. ≥ 72 h in the ICU
3. Provide informed consent (or via an appropriate proxy, according to local requirements).

Exclusion Criteria:

(a) Patients with conditions that preclude rectal or nasal sampling, such as total colectomy with a colostomy bag, facial surgery/trauma with nasal involvement, among others.
Nutritional Metabolomics: the Search for Dietary Exposure Variables

In the post-genomic era, a major challenge for health research is to understand the complex interactions among genetic, environmental and lifestyle factors including dietary intake. Unfortunately, such initiatives are hampered by the lack of accurate dietary intake assessment methods for large studies. The newly emerging field of metabolomics offers unique possibilities to characterize individual food intake, dietary patterns and effects of dietary intervention in large studies. The investigators propose to develop a platform to detect broad metabolomic responses to food intake in controlled trials as well as to use targeted metabolomics approaches to characterize dietary intake in longitudinal studies. Our laboratory has a long history of developing methodology for assessing nutritional status and effects of diet on metabolism. Here, the investigators team up with the Sahlgrenska Academy Core Facility and the Swedish NMR Centre at the University of Gothenburg, that offer modern metabolomics equipment and competence in bioinformatics, and use this in the context of nutrition research. To their knowledge, the investigators are among the first groups in the country to develop skills in metabolomics to assess dietary intake and effects of nutrition on metabolism, and probably the first to use two complementary platforms with both mass-spectrometry and nuclear magnetic spectroscopy. Hence, our methodological results should be useful to nutritional scientists nationally as well as internationally.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index 18.5-30.0
* Age 18-65 years old

Exclusion Criteria:

* Medications or tobacco use
Effect of Moringa Oleifera Leaves on Glycemic Control of Women With Type 2 Diabetes

The objective of this clinical trial was to understand whether supplementation of Moringa oleifera leaf powder improved glycemic management in Sahrawi women with type 2 diabetes living in refugee camps. The main question sought to be answered was:

- Does daily supplementation of Moringa oleifera leaf powder, in addition to oral hypoglycemic therapy, improve glycosylated hemoglobin and fasting blood glucose?

Researchers compared Moringa supplementation with no Moringa consumption to see if Moringa oleifera worked to improve glycemic control.

Participants had to:

* Take Moringa oleifera leaves daily or abstain from consuming Moringa for 3 months.
* Consistently take prescribed oral hypoglycemic agents
* Undergo clinical examinations and measurement of biochemical, metabolic and body composition parameters at the time of recruitment and at the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes for at least 1 year
* Absence of advanced retinopathy, terminal renal failure, active diabetic ulcers, amputations, and heart failure
* Treatment with only oral hypoglycemic drugs.

Exclusion Criteria:

* Diagnosis of type 1 diabetes
* Pregnancy or lactation
* Treatment with insulin.
Clarksdale Diabetes and Metabolism Clinic CHEC Study

This study will involve established clinic patients. The Rapid Estimate of Adult Literacy in Medicine will be administered during patients' regular clinic visits. Patients will then be referred to the Consumer Health Education Center (CHEC)by healthcare providers who will fill out a referral form. The form will be given the the CHEC health educator who will assist patients in finding literacy-appropriate health information. BMI and Hgb A1c values will be compared after 3 months and 6 months to baseline values. It is hypothesized that objective assessment of patient use of literacy-appropriate, health information from the Clarksdale Diabetes and Metabolism Clinic CHEC will improve Hgb A1c and BMI values among patients.


Eligibility Criteria:
Inclusion Criteria:

* Established patients of the Clarksdale Diabetes and Metabolism Clinic between the ages of 18 and 64.

Exclusion Criteria:

* Individuals who are not established patients of the clinic and are not between the ages of 18 and 64.
A Study to Evaluate the Mass Balance, Metabolism, Elimination, and Drug Levels of [14C]-BMS-986504 (MRTX1719) in Participants With Advanced Solid Tumors With Homozygous Methylthioadenosine Phosphorylase Deletion

The purpose of this study is to evaluate the mass balance, metabolism, elimination, and drug levels of \[14C\]-BMS-986504 (MRTX1719) in participants with advanced solid tumors with homozygous methylthioadenosine phosphorylase deletion.


Eligibility Criteria:
Inclusion Criteria

* Participants must have an advanced, unresectable, or metastatic solid tumor malignancy with a deletion of the methylthioadenosine phosphorylase (MTAP) gene.
* Participants must have received, be refractory to, be ineligible for, or be intolerant of available standard care for their cancer.

Exclusion Criteria

* Participants must not have a history of any surgical or medical conditions possibly affecting how the study drug is distributed, broken down (metabolized) and removed (excreted or eliminated) from the body.
* Participants must not have participated in a clinical study involving a radiolabeled study drug within 12 months prior to admission to the research center.
* Participants must not have a current or recent (within 3 months of study drug administration) gastrointestinal disease.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Effect of the Release of the Tongue Muscles in the Treatment of Chronic Non-specific Neck Pain

Background The mechanisms behind non-specific neck pain (NS-NP) have not yet been fully clarified. The anatomic relation between the tongue and structures that attach to the cervical spine suggests a possible clinical relation with a NS-NP.

This study protocol describes a randomized, double-blind, clinical trial, the aim of which is to determine the influence of the release of the tongue muscles on pain intensity, cervical range of motion and neck function in individuals with NS-NP.

Methods/Design Forty patients with NS-NP will be enrolled in a randomized, double-blind, clinical trial. The participants will be randomly allocated to two groups of 20 patients each. The experimental group (EG) will be submitted to a clinical method considered the gold standard for the treatment of neck pain together with a tongue muscle release protocol. The control group (CG) will only receive the gold standard method for the treatment of neck pain. All patients will receive six sessions of treatment at a frequency of twice per week and will be evaluated before and one week after the end of treatment. The primary outcome will be pain intensity measured using a numerical pain rating scale (range: 0 \[no pain\] to 10 \[maximum pain\]). The secondary outcomes will be the Pain Catastrophizing Scale, Patient-Specific Functional Scale, Neck Disability Index and cervical range of motion. Comparisons between groups before and after treatment will demonstrate whether the tongue muscle release technique exerts an effect on pain intensity, cervical range of motion and neck function in individuals with NS-NP.

Discussion The purpose of this randomized clinical trial is to evaluate the effect of a tongue muscle release technique on pain intensity, cervical range of motion and neck function in patients with NS-NP. The data will be published after the study is completed. The study will support the practice of evidence-based physical therapy for individuals with nonspecific neck pain.


Eligibility Criteria:
Inclusion Criteria:

* History of neck pain for a period of more than three months; score of 10 to 24 on the Neck Disability Index (adapted and validated for the Brazilian population); score of 3 to 6 points on numerical rating scale (NRS) for perceived pain intensity.

Exclusion Criteria:

* History of neurological disorders (irradiated pain) or neck surgery; chronic neck pain resulting from a traumatic incident (whiplash); chronic musculoskeletal condition (such as muscular disorder or polyarthritis); fibromyalgia; systemic disease; current pregnancy; having undergone physical therapy, massage or acupuncture in the previous two weeks; or use of analgesic, muscle relaxant, psychotropic agent or anti-inflammatory agent in the previous three days.