cyrilzakka/clinical-trials huggingface dataset:
MRI Study of the Structural and Functional Rehabilitation in the Cerebral Infarction Patients With Diabetes

Diabetes mellitus (DM) plays an important role in the occurrence of the cerebral infarction (CI). Clinical studies have demonstrated that the CI patients with DM had a poor prognosis compared with those without DM. Previous magnetic resonance imaging (MRI) studies have shown that patients with DM had abnormalities in cerebral vessels, nerves and functions, similar with the findings in mice models. In this study, with multi-modal MRI technologies, investigators tend to observe structural and functional changes of the brain in both DM and non-DM CI patients and assess their neural rehabilitation using clinical scales in the following 6 months. Investigators also expect to find out dynamic changes of brain structure and function, to reveal the weights of factors including brain blood vessels, nerves and function remodeling related with stroke recovery, as well as the potential mechanism in CI patients with DM.


Eligibility Criteria:
Inclusion Criteria:

1. ﬁrst-ever ischemic stroke;
2. single infarct in the distribution of the middle cerebral artery;
3. no evidence of hemorrhagic infarction;
4. age greater than 18 years;
5. admission between 3 and 7 days after stroke onset;
6. National Institute of Health Stroke Score (NIHSS) score of 4 to 21 on admission and
7. no thrombolytic or recanalization therapies.

Exclusion Criteria:

1. atrial fibrillation;
2. history of neurological or psychiatric disorders;
3. pre-stroke modified Rankin scale (mRS) \> 1;
4. life expectancy \< 1 year.
A Study of PLM60 in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First-Line Chemotherapy

This is an open, multicenter phase II clinical study for PLM60. The primary aim of the study is to observe the initial efficacy of PLM60 in treatment of small cell lung cancer. The secondary aim is to explore the safety and PK characteristics of PLM60


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of SCLC;
2. Must have recurrence or progression after platinum-based first-line chemotherapy or chemoradiation therapy for the treatment of SCLC;
3. ECOG performance status 0\~2;
4. Measurable lesion according to RECIST v1.1;
5. Life expectancy ≥ 12 weeks;
6. Adequate organ function;
7. Signed informed consent from the patient.

Exclusion Criteria:

1. Radical surgical treatment for primary small cell lung cancer;
2. Any anti-tumor treatment received within 4 weeks before the first use of the study drug;
3. Untreated or symptomatic central nervous system (CNS) metastases;
4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
5. History of serious systemic diseases;
6. History of serious autoimmune diseases;
7. Those receiving treatment of adriamycin or other anthracyclines previously, with the total cumulative adriamycin (or adriamycin-equivalent) dose of \>360 mg/m2.
A Comparison of DFD01 Spray Versus Comp01 Lotion, Vehicle Spray and Vehicle Lotion in Subjects With Moderate Psoriasis

The objectives of this study are to compare the safety of DFD01 Spray to Comp01 Lotion for topical treatment of moderate plaque psoriasis and to compare the efficacy of DFD01 Spray to Placebo Spray for topical treatment of moderate plaque psoriasis after 28 days of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
* Subjects with psoriasis involving 10 to 20% BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
* Subjects must have an IGA grade of 3 (moderate) at the Baseline Visit

Exclusion Criteria:

* Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
* Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
* Presence of pigmentation, extensive scarring, or pigmented lesions or sunburn which could interfere with the rating of efficacy parameters.
* History of psoriasis unresponsive to topical treatments.
* History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome

This study randomizes neck and arm pain patients being treated with discectomy and anterior interbody fusion into two groups: one to receive a new ceramic implant and a control group with a more traditional plastic implant. The study will measure and compare pain and disability improvement with the two products over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 75 years
* Radicular signs and symptoms in one or both arms (i.e., pain, paraesthesiae or paresis in a specific nerve root distribution) or symptoms and signs of acute or chronic myelopathy.
* At least 8 weeks prior conservative treatment (i.e., physical therapy, pain medication)
* Radiographic diagnosis of cervical disc herniation and/or osteophyte at 1 level (C3-C4 to C7-T1) in accordance with clinical signs and symptoms
* Ability and willingness to comply with project requirements
* Written informed consent given by the subject or the subject's legally authorised representative

Exclusion Criteria:

* Previous cervical surgery (either anterior or posterior)
* Increased motion on dynamic studies (\> 3 mm)
* Severe segmental kyphosis of the involved disc level (\> 7 degrees)
* Patient cannot be imaged with MRI
* Neck pain only (without radicular or medullary symptoms)
* Infection
* Metabolic and bone diseases (osteoporosis, severe osteopenia)
* Neoplasma or trauma of the cervical spine
* Spinal anomaly (Klippel Feil, Bechterew, OPLL)
* Severe mental or psychiatric disorder
* Inadequate Dutch language
* Planned (e)migration abroad in the year after inclusion
BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris

The purpose of this study is to compare the safety and efficacy of formulation BLI1100 to its vehicle in the treatment of moderate-severe acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Qualifying Investigator's Global Assessment severity score
* Qualifying number of non-inflammatory lesions
* Qualifying number of inflammatory lesions

Exclusion Criteria:

* Facial hair (beard), excessive scarring, sunburn or other disfigurement that may obscure the accurate assessment of acne grade
* Using medications that are reported to exacerbate acne
* Any clinically relevant finding at their baseline physical examination or dermatological medical history such as severe systemic diseases or diseases of the facial skin
* Have a known hypersensitivity or previous allergic reaction to any of the components
* Patients who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
* Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures
Effects of Different Stretching Techniques on Extensibility, Strength and Range of Motion in Football Athletes

To compare the effects dynamic stretching, passive stretching and self-stretching of the quadriceps muscle on muscle extensibility, hip strength and hip range of motion


Eligibility Criteria:
Inclusion Criteria:

* Footbal athletes
* Limited range of motion in ely's test

Exclusion Criteria:

* Previous surgery in the lower limb
* Previous physiotherapy threatment in the thigh
* Stretching contraindications
Study of Blood and Cheek Cell Samples From Patients With Glioma

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at blood and cheek cell samples from patients with glioma.

OBJECTIVES:

Primary

* Determine factors related to glioma survival in patients from two population-based case series collected in the San Francisco Bay Area between August 1991 and April 1994 (series 1) and May 1997 and August 1999 (series 2).

Secondary

* Determine vital status for 879 patients in the two San Francisco Bay Area population-based series through July 2004.
* Determine survival as a function of established, potential, and yet unstudied prognostic indicators.
* Gather data to validate results from this study with information from adult glioma patients enrolled prospectively at the UCSF-Neuro-Oncology clinic and through series 3 of the San Francisco Bay Area Adult Glioma Study; incorporate results from this study and other components of the SPORE into ongoing clinical investigations at the Brain Tumor Research Center and Neuro-Oncology Service at UCSF.
* Using funding from the organization Accelerate Brain Cancer Cure (ABC2), genotype several thousand single nucleotide polymorphisms (SNPs) from some study participants; assess these SNPs for potential relationship to glioma survival.

OUTLINE: Medical records of patients registered to the California Cancer Registry or the Northern California Cancer Center SEER are reviewed for mortality and treatment information related to the brain tumor. Blood and buccal specimens are collected from patients with newly diagnosed disease who are being seen at the UCSF Neuro-Oncology Service. The specimens are used for polymorphism and tumor marker studies and other pertinent data. Tumor specimens and treatment information related to the brain tumor are also collected from the SPORE Tissue Core.

Additional tumor makers are studied, including: chromosome 1p/19q, 7q studies; DNA repair and oxidative metabolism polymorphisms; and up to 2 tumor markers and 2 constitutive genotyping studies.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of glioma
* Meets 1 of the following criteria:

  * Participant in the Survival study of San Francisco Bay Area Adult Glioma Study (SFBAAGS) Series 1 and 2
  * Treated by UCSF Neuro-Oncology Service; diagnosed between Nov. 1, 2001 and June 30, 2006 and seen between Aug. 1, 2002 and June 30, 2006
  * Participant in SFBAAGS Series 3 (not seen at UCSF Neuro-Oncology Service) diagnosed between Nov. 1, 2001 and Oct. 31, 2004

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Compassionate Use of the Becker Expander/Breast Implant

To provide access of the Becker Expander/Breast implant to women who do not meet inclusion/exclusion criteria of the Becker Continued Access Study

Patients' physician will contact Mentor to request use of the device and each request will be reviewed by Mentor, an IRB, and the FDA on a case-by-case basis


Eligibility Criteria:
Inclusion Criteria:

* Women who require a Becker Expander/Breast implant who do not meet inclusion/exclusion criteria of the Becker Continued Access Study
Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.

Pulmonary rehabilitation effectively improves outcomes in patients with chronic respiratory disease, however there is a lack of pulmonary rehabilitation centers. Telehealth technology is one solution to deliver supervised home-based rehabilitation (tele-rehabilitation).

However, the feasibility and the acceptability of using telehealth technology to deliver tele-rehabilitation has not been assessed in a large scale multicenter study.

Therefore, the aim of this study is to assess the feasibility and the acceptability of telemonitoring system during pulmonary rehabilitation in patients with chronic respiratory disease.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years ;
* Referred for pulmonary rehabilitation (every chronic respiratory disease accepted).

Exclusion Criteria:

* Pregnant woman or likely to be ;
* Patient under guardianship ;
* Neuropathic disorder ;
* Contraindication to cardiopulmonary exercise testing or pulmonary rehabilitation.
Trial of Modafinil for Methamphetamine Dependence

The study aims to evaluate the safety and efficacy of modafinil (200 mg/day) over 10 weeks plus a tailored cognitive behavioural therapy program in the treatment of methamphetamine dependence.

Modafinil is a novel wake promoting agent approved in Australia for the treatment of narcolepsy. Preliminary studies have suggested that modafinil may have value in the treatment of psychostimulant dependence through positive effects on mood, sleep patterns, concentration, fatigue and drug craving. It appears to be well tolerated with a low abuse potential. Sixty dependent methamphetamine users will be allocated to 2 equal groups. The experimental group will receive modafinil 200 mg/day for 10 weeks and a tailored cognitive behavioural therapy program. The control group will receive placebo under equivalent conditions. Primary outcome will be a between group comparison of methamphetamine negative urine samples over the 10 week study period. Adverse events, side effects, compliance, retention and self reported health, psychosocial and drug use will also be compared between the study groups.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) amphetamine dependence diagnosis
* Amphetamine positive urine sample at intake
* Regular current amphetamine use (2-3 days per week)
* Aged 18 years or older

Exclusion Criteria:

* Pregnant or nursing females
* Hazardous concurrent uncontrolled physical or mental illness
Preoperative Ionized Magnesium Assessment

The reported incidence of hypomagnesemia is approximately 2% in the general population. Hypomagnesemia is a common problem, occurring in nearly 10%of general hospitalized patients and 17% of hospitalized cancer patients. A higher incidence, up to 60% to 65%, has been found among intensive care unit patients. Hypomagnesemia can potentially cause fatal complications including ventricular arrhythmia, coronary artery spasm, and sudden death. It also associates with increased mortality and prolonged hospitalization.

Magnesium exists in three different forms in the body. In serum, 5-14% of the magnesium is reported to be complexed with anions such as phosphate, bicarbonate, and citrate, 19-33% is reported to be protein-bound (mainly to albumin), and 55-67% is found in the free ionized fraction. Because the amount of bound or complexed Mg can vary significantly, especially in illness, the ionized magnesium can vary in an unpredictable way. Conventional laboratory testing typically only measures total serum magnesium, which is often not reflective of ionized magnesium. Unlike ionized calcium, which is commonly measured and is also readily calculated from the total calcium and albumin levels, ionized magnesium is neither commonly measured nor easily calculated. One study reported that the level of ionized magnesium cannot be predicted by analysis of total magnesium and that the levels of ionized magnesium vary upon different pathophysiological conditions and between individuals. Furthermore, measurement of ionized magnesium in serum might be of great impact in patients for whom magnesium status is required, and the correlation of ionized magnesium and total magnesium is weak in patients for whom magnesium status is required as a whole, and this is the reason why the ionized magnesium should be measured directly.

To date, most of the clinical studies were evaluate the effect of hypomagnesemia on the outcome after surgery using the levels of total serum magnesium. However, the portion of extracellular magnesium that is physiologically active is in the various process is ionized magnesium. So, it is important to evaluate the level of ionized magnesium in surgical patients to predict the outcomes after surgery. Unfortunately, clinical trial regarding the effect of the concentrations of ionized magnesium on the surgical patients is limited.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery
* Aged ≥ 19
* Fasted ≥ 8 hours

Exclusion Criteria:

* Chronic kidney disease
* Aged \< 19
* Fasted \< 8 hours
* Patients who were taking magnesium
Efficacy of PENNSAID® for Pain Management in the Emergency Department

The primary objective of this study is to compare the pain relieving effect and speed of onset of PENNSAID to that of standard oral diclofenac under double blind conditions using a growth curve approach to pain measurement. The investigators will test the hypothesis that PENNSAID will provide more rapid pain relief than oral diclofenac during the ED visit. The secondary goal of the proposed work is to discover and model the onset and course of pain relief during the emergency department (ED) visit.


Eligibility Criteria:
Inclusion:

-We will include ED patients presenting with an acutely painful ankle sprain for which NSAIDs constitute standard of care pain management.

The following will be excluded:

* Those with lacerations, bites, burns
* any head trauma
* pregnant
* anyone with a pre-existing chronic pain condition
* inflammatory intestinal disorders such as Crohn's disease or ulcerative colitis
* anyone regularly using another NSAID or anti-coagulation medication
* anyone who has experienced asthma after NSAID use
* compromised cognitive abilities
* a significant co-morbidity that will compromise participation
* had joint replacements
* known hypersensitivity to diclofenac or allergic responses to NSAIDs as a class
* active stomach and/or duodenal ulceration or gastrointestinal bleeding
* anyone admitted with severe active bleeding
* recent heart surgery
* severe liver or renal insufficiency
* prisoner
* mentally disabled patients
* wards of the state
* cognitive or decisional impairment
Does Increasing the Compression Pause from 3 to 5 Seconds in Mechanical Compression Devices Increase Ventilation Success Rate and Return of Spontaneous Circulation?

To give chest compressions during cardiopulmonary resuscitation (CPR), mechanical chest compression devices can be used. During synchronous 30:2 CPR, the standard setting on these devices leave an automated 3-second chest compression pause after 30 compressions to facilitate caregivers in providing two ventilations. With this standard setting, research has shown that in less than half of ventilation pauses during CPR, those two ventilations are given. Increasing the ventilation pause duration to 5 seconds instead of 3 seconds is also an option following current guideline recommendations, and aligns with measured ventilation pause duration in manual CPR. Increasing pause duration to 5 seconds could result in an increased ventilation success rate. This multicenter randomized controlled trial will randomize LUCAS® mechanical compression devices to a standard setting of 3- or 5-second compression pauses. The main outcome will be the percentage of ventilation pauses in which two ventilations are successfully given. Secondary outcomes include the restoration of spontaneous circulation (ROSC), and the difference in (neurologically intact) survival. No study has been performed to evaluate this effect yet.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥16 years of age)
* OHCA patients with an attempt at cardiopulmonary resuscitation (CPR) by ambulance personnel
* LUCAS® 3.1 has been used during the resuscitation attempt

Exclusion Criteria:

* Missing ambulance run report, missing or unclear impedance signal (measurement of resistance across the thorax), making it impossible to assess the number of ventilation pauses
* Absence of a minimum of 3 assessable pauses intended for ventilation after connecting the LUCAS®
China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-A Quality Control on Right Heart Catheterization

Right heart catheterization(RHC) plays a crucial role in the diagnosis and treatment of pulmonary vascular diseases(PVD). In China, the lack of equipment and technical expertise has historically limited the implementation of RHC, thereby greatly restricting the diagnosis and treatment of RVD. In recent years, with improvements in these issues, more hospitals have acquired the capability to perform RHC. The purpose of this study is to conduct quality control of RHC across multiple pulmonary hypertension(PH) centers in China. The study population consists of patients who underwent RHC for the first time due to dyspnea or suspected PH. This study retrospectively and prospectively collects multicenter RHC data, with the main quality control contents including indications for the procedure, collection and analysis of hemodynamic data, diagnosis and treatment, and long-term management of patients.

Right heart catheterization(RHC) plays a crucial role in the diagnosis and treatment of pulmonary vascular diseases(PVD). In China, the lack of equipment and technical expertise has historically limited the implementation of RHC, thereby greatly restricting the diagnosis and treatment of RVD. In recent years, with improvements in these issues, more hospitals have acquired the capability to perform RHC. The purpose of this study is to conduct quality control of RHC across multiple pulmonary hypertension(PH) centers in China. The study population consists of patients who underwent RHC for the first time due to dyspnea or suspected PH. This study retrospectively and prospectively collects multicenter RHC data, with the main quality control contents including indications for the procedure, collection and analysis of hemodynamic data, diagnosis and treatment, and long-term management of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent right heart catheterization for the first time due to dyspnea or suspected pulmonary hypertension
* Age ≥14 years old

Exclusion Criteria:

* Vital data missing
* Did not sign informed consent or did not agree to follow-up
Developing Metagenomic Approaches to Identify the Causes of Pediatric Infectious Diseases

Infectious diseases remain leading causes of mortality and morbidity in children. Rapid and accurate diagnosis of infectious diseases in children is important for developing an effective treatment and management strategy. However, the current diagnosis of infectious agents mainly depends on culture and molecular testing. Both of the methods either has long turnaround times or narrow detection range. Metagenome next generation sequencing (mNGS) has been applied to the diagnosis of central nervous system infection, lower respiratory tract infection and sepsis, which showed high positive rate, short turnaround time. However, there is currently no assessment of the diagnostic efficacy of mNGS in children infectious diseases. This study used the DNA extraction and library construction technology developed for children's low volume clinical samples to assess the sensitivity and specificity of mNGS in the diagnosis of infectious diseases, and the treatment outcome based on mNGS test results.


Eligibility Criteria:
Inclusion Criteria:

* Patients are highly suspected of sepsis；
* Patients are highly suspected of respiratory infections；
* Patients are highly suspected of central nervous system infection；
* Patients are highly suspected of fever of unknown origin

Exclusion Criteria:

* Congenital malformations；
* Patients requiring surgical intervention;
* Patients with skin barrier dysfunction
Concurrent Oxytocin With Membrane Sweeping Versus Dinoprostone Pessary in Labor Induction of Multiparous Women at Term

The purpose of this study is to compare concurrent oxytocin with membrane sweeping versus dinoprostone pessary in labor induction for multiparas at term with an unfavorable cervix.


Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* Multiparous women
* gestational age \>=37.0 weeks
* Bishop score \<=6
* intact amniotic membrane
* absence of labor
* live fetus with vertex presentation
* no previous uterine surgical procedure

Exclusion Criteria:

* Multiple pregnancy
* Placenta previa