cyrilzakka/clinical-trials huggingface dataset:
Magnesium Sulfate to Prevent Hospitalisation of Acute Exacerbations of Chronic Obstructive Pulmonary Disease

The purpose of this study is to assess whether administration of a bolus dose of MgSO4 (magnesium sulfate) plus standard therapy is superior to standard therapy alone for the management of Acute Exacerbations of Chronic Pulmonary Obstructive Disease (AECOPD) in the emergency department. The investigators hypothesize that MgSO4 causes faster recovery of the bronchospasm, and a reduction of the dead space, translating to the following clinical outcomes : less hospitalisation, lower length of stay (LOS), better composite outcome of hospitalisation + LOS + readmission for AECOPD.

Patients presenting to the participant Emergency Departments (ED) with a diagnosis of AECOPD and who receive at least one dose of albuterol, will be randomized to receive either placebo or one dose of MgSO4 2g IV. Security and efficacy outcomes will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Current or previous smoking for at least 10 pack-years
* Confirmed COPD :

  1. reported by the patient if already diagnosed in the past by a pulmonary disease specialist or on the basis of respiratory function tests; or
  2. new diagnosis in the ED, with confirmatory pulmonary tests showing Forced Expiratory Volume (FEV1) / Forced Vital Capacity (FVC) ratio \< 70% and FEV1\< 80%
* Patient requires at least one dose of albuterol (salbutamol).

Exclusion Criteria:

* Dialysis patients
* Severe kidney disease, known or suspected to have a creatine clearance \< 15.
* Metastatic neoplasm
* Patients who received IV MgSO4 in the last week.
* Hypotension, defined as systolic blood pressure less than 90.
Intermittent Preventive Treatment for Malaria in Infants in Navrongo Ghana

Evaluation of the safety and effectiveness of malaria intermittent chemotherapy and iron supplementation delivered through Expanded Programme on Immunisation vaccination clinics.

Anaemia is one of the main disease burdens of children in developing countries. Severe anaemia is often fatal, while moderate anaemia leads to growth and cognitive disorders. The incidence of anaemia in children is extremely high in malaria endemic areas since episodes of clinical malaria and asymptomatic parasitaemia result in red cell destruction. It has been shown in Tanzania that the incidence of severe anaemia in infants can be reduced by 30% by regular administration of iron supplements, and by 60% if regular malaria chemoprophylaxis is given in addition. One way to operationalise this research finding, with minimal additional cost to governments and communities, is to link the distribution of iron and antimalarial drugs to the EPI programme. We propose a community-randomised trial to study the effectiveness of intermittent iron supplements and malaria chemotherapy in reducing the incidence of anaemia and clinical malaria, and to investigate any possible interactions of iron and antimalarial drugs with EPI vaccines. The study will have two arms: children in both arms will receive monthly supplies of twice weekly iron supplements when they attend EPI and growth monitoring clinics. In addition, children in arm 1 will receive a placebo when they receive Polio/DPT 2, Polio/DPT 3 and measles vaccines, while those in arm 2 will receive sulfadoxine-pyrimethamine (SP). The baseline incidence of anaemia and malaria, and immune response to EPI vaccines, will be estimated in a sample of children from a non-intervention area adjacent to the study area. The immune response to EPI vaccines, drug side-effects, and the incidence of anaemia and malaria will be compared between the two arms of the study and with the non-intervention area. Any possible 'rebound' in malaria incidence due to impairment of immunity will be monitored and treated during the six months after stopping the chemotherapy and supplementation.

Eligibility Criteria:
Inclusion Criteria:

* All infants living in study clusters without a history of allergy to sulfadoxine-pyrimethamine were eligible for enrollment in the study.

Exclusion Criteria:

* History of allergy to sulfadoxine-pyrimethamine.
A Study of a Human Anti-Intercellular Adhesion Molecule-1 Monoclonal Antibody, in Patients With Multiple Myeloma

This is a first in human study which will assess the safety and tolerability of a monoclonal antibody against ICAM-1 in patients with Multiple Myeloma. The tumour response rate will also be measured.


Eligibility Criteria:
Inclusion Criteria:

* Advanced Myeloma with measurable disease after at least 2 previous regimens.
* Life expectancy \> 3 months.
* Performance status ECOG \< 2.

Exclusion Criteria:

* Prior antineoplastic therapy within 4 weeks prior to inclusion.
* No high dose steroids within 7 days prior to screening.
* Severe other conditions.
Reducing HIV: Safer Sex Skill Building in Pregnant Drug Abusing Women

This study will examine safer sex skills building (SSB), a targeted behavioral HIV prevention and risk reduction group intervention in two samples of pregnant drug abusing women.

"Safer Sex Skills Building" in Pregnant Women: Dace Svikis, (Psychology, Ob-Gyn, Psychiatry) PI, Diane Langhorst (Social Work) and Nichole Karjane, (OB-Gyn) Co-Investigators). This study will focus on increasing Safer Sex Skills development among pregnant women at high risk for HIV infection. The "Safer Sex Skill Building" (SSB) program developed by El Bassel and Schilling (1991, 1992), has demonstrated efficacy in national studies in reducing sexual risk for HIV and other STD transmission. This manual-driven, gender-specific intervention has proven effective in reducing sexual risk behaviors in both methadone maintenance and outpatient drug-free patients. To date, however, the intervention has not been tested with pregnant drug abusing women who may actually be at increased risk if they stop using condoms or continue drug use during pregnancy. This study will examine SSB, a targeted behavioral HIV prevention and risk reduction intervention in two samples of pregnant drug abusing women. Using a 2x2 design, a randomized clinical trial will compare the five-session SSB group intervention to a one-session standard group HIV Education intervention (SE). Study findings will provide benchmark data on the efficacy of SSB for HIV and STD prevention in a diverse sample of pregnant drug abusing women.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older, pregnant
* At prenatal care (PCC) site: screen positive for on T-ACE and TWEAK and/or drug CAGE, report drinking 3 or more drinks on at least one occasion and/or using an illicit drug at least once in the 30 days prior to pregnancy awareness, and report at least one incident of unprotected penetrative (vaginal or anal) intercourse with a male partner within the six months prior to baseline assessment.
* At community treatment (RBHA) site, inclusion criteria are the same except post-partum women (i.e., those who gave birth to a child 2 years of age or less) will also be eligible for study enrollment.

Exclusion Criteria:

Both sites:

* Unable to provide informed consent due to cognitive impairment, psychiatric instability, or language barriers
Patient Satisfaction Scales

This study aims to assess differences between 4 types of single satisfaction measures. Secondly, if there is a difference in satisfaction between English speaking and Spanish speaking patients.


Eligibility Criteria:
Inclusion criteria:

* All new or return patients seeing a UE / LE surgeon
* Age 18-89
* Able to provide informed consent
* English speaking
* UT Health Austin Musculoskeletal Institute, Austin Regional Clinic, Seton Institute for Plastic and Reconstructive Surgery, Orthopaedic Specialists of Austin, Texas Orthopedics, and ATX Ortho.

Exclusion criteria:

* Not fluent in English
PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass

To assess the safety of performing a percutaneous fem-pop bypass using the PQ Bypass Guidewire Delivery System and commercially available stent grafts.

Multi-center, single-arm first-in-man study utilizing the PQ Bypass Guide Wire Delivery System to access, deliver guidewires and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent
* Age 18 or older
* Rutherford Classification of 3-5
* Lesions ≥10cm in length considered to be:

  * Chronic total occlusion (100% stenosis)
  * Diffuse stenosis (\>50% stenosis) with moderate to heavy calcification
  * In-stent restenosis (\>50% stenosis)
* Proximal and distal target vessels are 4.8 - 7.5 mm in diameter
* Orifice and proximal 1cm of SFA is patent
* Patent popliteal artery 3cm proximal to tibial plateau
* At least 1 patent tibial artery to the foot
* Patent femoral vein

Exclusion Criteria:

* History of deep vein thrombosis
* Has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated
* Has a known sensitivity or allergy to aspirin, heparin or anti-platelet medications
* Documented in-sensitivity to anti-platelet medication
* Has a known or previous coagulopathy
* Pregnant or lactating
* Untreated flow-limiting aortoiliac occlusive disease
* Has renal failure (GFR \< 30mL/min)
* Major distal amputation (above the transmetatarsal) in the study or non-study limb
* Patient has had a procedure on the target limb within 30 days
* Previous bypass surgery on the target limb
* Bypass length required is greater than 35cm
Effect of Biphasic Insulin Aspart 30 on Blood Glucose Control in Subjects With Type 2 Diabetes

This trial was conducted in Russian Federation. This trial aimed for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different treatment regimens: biphasic insulin aspart 30 thrice daily, biphasic insulin aspart 30 twice daily in combination with metformin and treatment with oral anti-diabetic drugs.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes, currently treated with one or more oral hypoglycemic agent
* HbA1c: At least 8.0%

Exclusion Criteria:

* Impaired hepatic, renal or cardiac function
Anticoagulation Preference by AF Patients Study

The main research question of this patient survey is to assess AF (Atrial Fibrillation) patients' preferences associated with different attributes which describe the different available anticoagulation treatment options (Vitamin K Antagonists \[VKA\] or New Oral Anticoagulants \[NOACs\] and, in case of NOACs, Apixaban, Dabigatran, Edoxaban or Rivaroxaban).

VKAs (Marcoumar®, Sintrom ®) will be grouped together and compared to Rivaroxaban.

The objective of this study is to investigate the following research questions in a cross-sectional survey of German-speaking Swiss AF patients being treated either with a VKA or with a NOAC:

* Which attributes of a medication to prevent stroke do AF patients view as important?
* Do AF patients have a preference regarding the attributes of the medication options VKA or NOAC and, in case of NOACs, with regards to rivaroxaban attributes?
* Are there subgroups of AF patients whose preference for one of the medication options appears above or below average?
* What is the quality of life of Swiss German-speaking AF patients? Are there subgroups with differences in their quality of life (for example: subgroups of patients with different CHA2DS2-VASc scores)?
* Which burden do German-speaking Swiss AF patients experience in association with their anticoagulation therapy? Are there differences in the burden of treatment (ACTS) between patients treated with VKA or with NOACs?

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for AF patients in both the NOAC and the VKA groups:

* Patients with a confirmed diagnosis of nonvalvular atrial fibrillation (persistent, paroxysmal, permanent),
* Age of at least 18 years at time of study inclusion,
* Generally willingness (informed consent) and ability to fill out a survey on satisfaction with treatment and quality of life, and to conduct a structured phone interview (approx. 20 - 30 min) in German language.

Additional inclusion criterion for Group 1 (NOAC):

* Continuous anticoagulation with either Apixaban, or Dabigatran or Rivaroxaban for prevention of Stroke \& systemic embolism for at least the previous 3 months.

Additional inclusion criterion for Group 2 (VKA):

* Continuous anticoagulation with a VKA for prevention of Stroke \& systemic embolism for at least the previous 3 months.

Exclusion Criteria:

Exclusion criteria for both groups:

* Participation in another study (clinical intervention / observational) within the 3 months prior to enrollment,
* Interruption of VKA/NOAC therapy of more than 2 weeks (bridging) within the prior 3 months or planned bridging in 4 weeks after study inclusion.
Efficacy and Mechanism of rTMS in Children With ASD: an Open-label Clinical Trial

This study is a 6-week open-label clinical trial involving 20 children aged 6-10 years with autism spectrum disorder. During the study, subjects received repeated transcranial magnetic stimulation（rTMS）intervention at the left primary motor cortex (M1) 5 times per day for 10 days. From the beginning of intervention to the end of 4 weeks after the completion of intervention, the subjects's clinical symptomatology, cognitive psychology, neuroimaging, and adverse events will be followed up.Our purpose is to explore whether rTMS can improve the clinical symptoms of children with autism spectrum disorder in China, and to explore the neurophysiological mechanism of rTMS for autistic children.

Participants will receive continuous theta burst stimulation (cTBS) for a 10-day period (10 sessions). If feasible for the participant, all stimulation sessions will be held at the same time of the day. During this study，participants' clinical symptomatology, cognitive psychology, neuroimaging, and adverse events will be followed up for four times, specifically，before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6-10 years.
* Meeting the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Edition 5 (DSM-5) .
* Confirmed by the ADOS and/or ADI-R diagnostic tool.
* IQ ≥70.
* Informed consent.

Exclusion Criteria:

* Patients with metal implants .
* Patients with neurological diseases such as epilepsy .
* Patients requiring surgical treatment due to structural abnormalities indicated by brain MRI .
* Genetic or chromosomal abnormalities .
* Suffering from mental disorders (such as mood disorders, etc.)
* Suffering from serious heart disease .
* Hearing-impaired .
* Intracranial hypertension .
* Participating in other clinical trials.
* Participants who received other interventions within 4 weeks prior to enrollment.
Efficacy of Aponeurectomy on the 2-year Recurrence Rate of Dupuytren's Disease

Dupuytren's disease is a frequent hereditary disease in Northern Europe. It is a degenerative disease affecting the palmar aponeurosis of the hand. It develops a progressive contractile fibrosis which cuts the hypodermic fatty tissue, adheres to the skin and the phalanges, gradually bending the affected rays, resulting in significant functional impotence.

Various medical and surgical treatments are available.

Among these treatments, none to date can eliminate recurrences, which are still too frequent.

Open aponeurectomy (consisting of surgical curettage of the fibrotic cords) remains for the moment the reference technique for treating Dupuytren's disease, with recurrences (between 12 and 39%), but less frequent than the needle technique (50 to 85%).

Could the addition of adipose tissue in the resection areas of Dupytren's fibrosis reduce the rate of recurrence (by the inhibitory action of ADCs on myofibroblasts) in addition to reconstructing the hypodermis in the cavity left by the resection of the cords and improving the quality of the scars? The investigators insist on the fact that this is a homotopic and homologous adipose tissue graft, in closed circuit without denaturation or adjuvant products.

Since, to our knowledge, no other team has used "lipofilling" as an adjuvant treatment to the open resection technique of Dupuytren's cords (aponeurectomy), the investigators first conducted a clinical feasibility and safety study on 70 patients between 2012 and 2017 (currently being published by Springer Editions).

The investigators now wish to conduct a prospective comparative study between patients operated by aponeurectomy WITH (experimental group) and WITHOUT (control group) addition of autologous adipose tissue in the resection areas of Dupuytren's cords.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Carrier of Tubiana stage II-IV Dupuytren's disease on at least one or more rays, not previously operated
* Indication of a surgery by aponeurectomy
* Skin pinch of the posterior aspect of the arm of more than 1cm
* Affiliation to a social security system
* Patient informed of the study and having given informed consent

Exclusion Criteria:

* Previous surgery of any kind for Dupuytren's disease
* Involvement on the thumb only
* Need for a total skin graft or a pedicle flap on all the rays to be treated
* Active autoimmune disease
* Previous treatment with collagenase
* Pregnant and breastfeeding women
* Patient under legal protection
* Contraindications to MRI (criteria applicable only for patients from the coordinating center, not applicable for other centers)
Effect of Paracetamol,Pregabalin and Dexamethasone on Pain and Opioid Requirements in Postoperative Patients

Women scheduled for abdominal hysterectomy needs postoperative pain treatment, i.e. morphine. Unfortunately morphine has side-effect: nausea, vomiting, sedation and dizziness, which is unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine.

Combinations of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin + dexamethasone is investigated. Primary outcome is 24 hours morphine usage.

Eligibility Criteria:
Inclusion Criteria:

* Women scheduled for abdominal hysterectomy, between the age of 18 and 75, ASA 1-2
* BMI between 18-32.

Exclusion Criteria:

Patients who:

* Are unable to cooperate
* Has cancer ovarian
* Does not speak Danish
* Has allergy for drugs used in the trial
* Has drug and medicine abuse
* Epilepsy
* Diabetes treated with medicine
* Chronic pain condition
* Daily use of antacids or analgesic
* Known kidney disease
* Use of antidepressive
Child Development and Primary Care in Low Income Families

The objective of this study is to conduct a 12-month pilot longitudinal study of a parent-directed program delivered in a primary care setting serving primarily low-income families. The parent-direction program will be evaluated in a randomized controlled design to determine the feasibility of protocol implementation and to investigate the potential impact on parental outcomes. Process outcomes will include success with recruitment, participant retention, and ability to collect outcome measures. Clinical outcomes will incorporate measures of parental self-efficacy and parenting behaviors, including observational assessments of parent-child interactions.

Enriching parenting behaviors in early childhood promotes child development and offers a promising strategy to reduce future educational disparities. However, current interventions are limited by cost and have not been widely disseminated. Recognized as a target for research to improve early childhood development and subsequent school readiness skills among at-risk families, the primary care setting offers an ideal opportunity to reach the millions of children living in poverty. However, what remains unknown is how to more efficiently leverage the primary care setting to deliver a sustainable and effective preventive program to promote positive parenting behaviors and encourage early childhood development in low-income families. Therefore, the investigators designed Sit Down and Play (SDP) a brief parent-directed program delivered in the primary care setting. Modeled after the widely disseminated literacy program Reach Out and Read and grounded in social cognitive theory, SDP is intended to take place during each pediatric well-child visit occurring in a child's first two years with the goal of promoting positive parenting behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Parent is 18 years or older
* Child is present for a 2 month well-child visit
* Adult present with child at appointment is parent/caregiver of child

Exclusion Criteria:

* Parent is non-English speaking
* Child is acutely sick
Prediction Model for the Recanalization OuTcome Evaluation of Ischemic Stroke Using Multimodal CT

Prediction model for the Recanalization OuTcome Evaluation of ischemic stroke using multimodal CT (PROTECT) study was a multicenter prospective observational study that recruited patients from 13 centers located in 10 provinces across China. The study was to assess the effects of novel imaging biomarkers/ imaging patterns based on multimodel CT for patients selection and outcome prediction in acute ischemic stroke.

Patients Patients with cerebral ischemia symptoms of anterior circulation or posterior circulation onset in 24 hours were included. A neurological evaluation (Modified Rankin Scale and NIHSS); physical examination, including measurement of weight (kg) and vital signs (supine systolic and diastolic blood pressure); time from symptom onset to enrollment were recorded.

Imaging protocols:

CT scan protocols: Non-contrast computed tomography(NCCT) , computed tomography angiography(CTA), computed tomography perfusion(CTP)

Contrast agent:

CTA: Omniscan 40-50ml, 5ml/s; saline solution 50ml, 5ml/s

CTP: Omniscan 50ml, 5ml/s; saline solution 50ml, 5ml/s

Imaging evaluation:

CTA was reviewed and stenosis or occlusive lesions were identified. Parameter maps including cerebral blood flow, cerebral blood volume, mean transit time, the time to the maximum of the residue function derived from CTP were processed by the software Rapid to quantitatively assess infarct core volume and mismatch.

Multiphase CTA was extracted from CTP to evaluate the collateral circulation.

Treatment:

Intravenous recombinant tissue plasminogen activator(rtPA), endovascular therapy, and conventional treatment including neuroprotection, anti-platelet, and statin according to the guideline.

Follow up:

Modified Rankin Scale(mRS) was obtained at 90 days after symptom onset. An imaging follow-up was also recommended within 30 days after symptom onset.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral ischemic sympton with onset in 24 hours
* All CT examination performed according to study protocol
* Signed informed consent obtained from the patient or patient's legally authorized representative

Exclusion Criteria:

* Acute intracranial hemorrhage
* Pre-existing medical, the neurological, or psychiatric disease that would confound the neurological, functional, or imaging evaluations
* Pregnancy
* Known allergy to iodine previously refractory to pretreatment medications
* Renal Failure (serum creatinine \> 2.0 or Glomerular Filtration Rate \< 30)
* History of severe kidney disease as an adult, including tumor or transplant surgery, or family history of kidney failure
* Severe cardiac insufficiency