cyrilzakka/clinical-trials huggingface dataset:
Electroacupuncture for Relieving Pain in Ankylosing Spondylitis

Background: Ankylosing spondylitis imposes burdens on individuals and society that AS costs 3 times higher than general population. Conventional approaches for AS have their limitation. Previous studies demonstrated acupuncture has significant therapeutic effects for AS in diminishing joint pain, enhancing functional disorders and modifying spinal deformity. Although acupuncture is effective in relieving pain in AS patients, the evidence is very limited due to methodological flaws.

Design This study will be a single-arm pilot study in patients with AS. Eligible subjects will receive electroacupuncture treatment twice per week for at least 6 weeks (12 sessions in total). The length of treatment can be extended to a maximum of 10 weeks (20 sessions in total) if participants request a prolonged treatment. The acupuncturist, who is a registered Chinese medicine practitioner, of this trial will not participate in data collection and data entry.

Objective: To explore the treatment effect of electroacupuncture for relieving pain in ankylosing spondylitis.

Setting: Hong Kong

Participants: 20 subjects with a diagnosis of ankylosing spondylitis

Main Measures: Pain Severity Numerical Rating Scale (NRS), Adverse events

Data analysis All data will be double-entered and checked for consistency before conducting the analysis. Binomial test will be used to analyze the percentage of responders to treatment compared with a reference value of 10%. Wilcoxon signed rank test will be used to compare the values of all continuous variables between baseline and post treatment. The population for safety analyses will include all subjects who receive at least one acupuncture treatment. Adverse events will be coded using the WHO Adverse Reaction Terminology Dictionary. Special attention will be given to those subjects who have discontinued treatment due to adverse events or who experience serious adverse events.


Eligibility Criteria:
Inclusion Criteria:

1. with a diagnosis of AS and fulfilled either ASAS criteria or Modified New York criteria,
2. Bath Ankylosing Spondylitis Disease Activity Index, BASDAI ≥4,
3. currently taking analgesic or NSAIDs for pain control,
4. spinal pain assessment score≥4 on a numerical rating scale (NRS; 0-10 scale)

Exclusion Criteria:

1. having active skin lesion or open wound over the needle placement areas;
2. having heart disease, bleeding disorder or taking anticoagulant drugs
3. have previous acupuncture experience 12 months before the baseline,
4. are pregnant, breast-feeding or of childbearing potential but not using adequate contraception;
5. having psoriasis, rheumatoid arthritis, osteoarthritis, psoriatic arthritis or reactive arthritis;
6. having unstable medical condition such as liver and/or kidney failure or cancers.;
7. concurrently taking or injecting steroid.
Ultrasound Assessment of BC in the NICU

The overall objective of the proposal is to evaluate the ability of ultrasound to predict and routinely (weekly) monitor changes in the body composition of healthy preterm infants in the neonatal intensive care unit (NICU) in response to nutritional intake. The investigators hypothesize that ultrasound is an accurate method to routinely monitor the quality of weight gain and assess the adequacy of nutritional provision for premature infants in the neonatal intensive care unit.

The investigators will address the hypothesis in the following Specific Aims:

Specific Aim 1: Validate ultrasound as a method to measure whole body fat mass and fat free mass in healthy, premature infants. Body composition will be assessed using ultrasound measurements and the validated method of air displacement plethysmography (ADP). Stable isotope dilution techniques will be used in a subset of our population as a secondary source of validation.

Specific Aim 2: Determine whether ultrasound measurements can detect clinically relevant (weekly) changes in body composition in healthy premature infants. Ultrasound will be used to obtain serial (weekly) measurements of muscle and adipose tissue thickness (triceps, abdomen, quadriceps) until discharge in healthy, premature infants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, premature infants 25-34+6 weeks gestational age at birth
* Admitted to the University of Minnesota Masonic Children's Hospital NICU
* Stable on room air or can be removed from respiratory support for 5 minutes
* Written or verbal (telephone) informed consent can be secured from a parent within 1 week of admission to the NICU

Exclusion Criteria:

-Require medical support preventing ADP measurements
Observation of the Effect of Chemotherapy Combined With Tyrosinase Inhibitor on the Reactivation of CMV and EBV in Patients With Acute Lymphoblastic Leukemia

Philadelphia-chromosome-positive or partial ph-like acute lymphoblastic leukemia (ALL) preferred chemotherapy combined with tyrosine kinase inhibitors (TKIS) therapy. Recently we found that there were cytomegalovirus reactivation and even cytomegalovirus infection in three ALL patients treated with chemotherapy combined with TKIs. However, the cytomegalovirus risk after dasatinib use in patients with philadelphia-chromosome-positive ALL is still unknown. It is reported that dasatinib can be observed in the treatment of philadelphia-chromosome-positive leukemia patients with significant increase in large granular lymphocytes, the cytomegalovirus is often positive, and this part of the patient's prognosis is relatively good. Dasatinib can inhibit SRC and TEC kinase, and induce immune function inhibition,and in vitro experiments have confirmed that it inhibits the immune function of T cells and NK cells. In this study, we examined the potential association between cytomegalovirus AND EBV reactivation the treatment of chemotherapy combined with TKIs, and the numbers of large granular cells and NK cell activity.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with acute lymphoblastic leukemia who had not previously received chemotherapy (except for hormone preconditioning) or started with chemotherapy but not more than 3 days, and CMV and EBV quantitative negative;
2. Age Limits:\>or= 14 years old.

Exclusion Criteria:

1. Patients who had previously received chemotherapy and hematopoietic stem cell transplantation;
2. Patients with CMV and EBV infection before treatment and not to turn yin;
3. The researchers considered unsuitable patients.
Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status

The overall goal of this study is to address the question of whether progressively lowering nicotine content in cigarettes can reduce or eliminate nicotine dependence in smokers of low socioeconomic status

To address the question of whether progressively lowering nicotine content in cigarettes can reduce or eliminate nicotine dependence in low socioeconomic smokers, we will randomize smokers to either an Reduced Nicotine Content group with a gradual step-wise reduction in nicotine from 11 mg to 0.2 mg per cigarette in five 3-wk stages, or a control group with nicotine content similar to their preferred usual brand of cigarettes.

Overall, we hypothesize that low socioeconomic smokers who switch to progressively lower nicotine cigarettes will initially alter their smoking behavior to compensate for lower nicotine until cigarette nicotine yields become so low that complete compensation becomes too difficult. At that point, smokers will either drop-out or continue to smoke the reduced nicotine content cigarettes but with incomplete compensatory behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Less than 16 years of education
* Able to understand, and sign consent
* Smoke \>4 cigarettes/day for at least a year
* No quit attempt in prior 1 month and not planning to quit smoking within next 6 months
* Plan to live in local area for next 8 months
* Able to read and write in English
* Women not pregnant and taking steps to avoid pregnancy

Exclusion Criteria:

* College graduate
* Use of psychotropic drugs
* Significant medical condition, or immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data
* Use of any non-cigarette nicotine delivery product in the past week or smoking cessation medicine in prior 3 months
* Currently pregnant or nursing
* Uncontrolled serious psychotic illness or substance abuse
* History of difficulties providing blood samples-fainting, poor veins, anxiety
Long-Term Survival With HIV: Psychological and Behavioral Factors Associated With the Transition From Adolescence to Young Adulthood

This study will examine the emotional and behavioral aspects of long-term survival of HIV/AIDS among adolescents and young adults with HIV infection.

HIV-infected individuals between 13 and 23 years of age may be eligible for this study. They must be aware of their HIV diagnosis, have been infected for at least 13 years and have been on an active NIH protocol during the past 5 years.

In addition to the usual stresses of growing up, children with HIV infection may have spent much of their time in hospitals and may have lost parents, friends and other loved ones. This study will explore psychological aspects of growing up with HIV, including self esteem, possible risk behaviors, how disclosure to others changes over time, the commonness of anxiety and depression, and the impact that losses have had on the adolescents' emotional health. To gather this information, participants will be interviewed and asked to fill out a set of forms. Caregivers will also fill out forms.

Patients who are not currently on an active NIH protocol will have the option of having a physical examination and routine blood work. The results will be sent to their home care provider.

Children and adolescents with HIV/AIDS are living well beyond the life expectancy that was projected for them in the past. As the number of survivors of vertically or transfusion associated pediatric HIV disease increases, attention to the psychosocial adjustment of these adolescents and young adults becomes increasingly important. Studies in the late 1990s described child and adolescent survivors as generally well adjusted, though difficulties become more apparent as the child approached the age of 18. Nothing is known about these HIV positive youngsters as they enter late adolescence and young adulthood. This study will examine psychosocial factors associated with long-term survival of HIV/AIDS, including the prevalence of psychiatric diagnoses, risk behaviors, evaluation of self competence, and the impact that multiple losses has on the adolescents' emotional well-being. In addition, data will be collected from the primary caregivers on the prevalence of parenting stress compared to national norms. Subjects will include children who have been infected (either perinatally or through transfusion) for at least eight years and who are aware of their diagnosis.

Eligibility Criteria:
INCLUSION CRITERIA

HIV-infected adolescents 13-24 years of age with documented HIV infection for greater than or equal to 13 years.

On active protocol at NIH during the past 5 years.

Willingness to sign informed consent.

Ability to understand and read English.

EXCLUSION CRITERIA

Presence of psychotic symptoms.

Cognitive impairment or full scale IQ less than or equal to 75.

Not aware of HIV diagnosis.
Silicone Gel to Improve Scar in Microtia Patients

Effort to reduce post-surgical scar is especially important for microtia patients. Even the scar lies posterior to ear auricle, but hypertrophic scar contracture may limit the ear auricle projection. If the scar is hypertrophic and conspicuous, this stigmata will accompanies the child for many years.The main objective aim of this study is to examine whether post-operative use of silicone gel can improve scar formation for microtia reconstruction scars.

Background:

A scar represents dermal fibrous replacement tissue and results from a wound that has healed by resolution rather than regeneration. Undesirable scars, such as hypertrophic or keloid scars, occur most frequently over the anterior chest, shoulders, scapular area, lower abdomen and suprapubic region. Many of the investigators' microtia patients complained postsurgical hypertrophic scar. The incidence of hypertrophic scars after microtia reconstruction could be 6.29%.

Effort to reduce post-surgical scar is especially important for microtia patients. Even the scar lies posterior to ear auricle, but hypertrophic scar contracture may limit the ear auricle projection. If the scar is hypertrophic and conspicuous, this stigmata will accompanies the child for many years. The micropore tapes is very useful for facial scars. However, because of retroauricular contour and hairline, micropore tapes is difficult to retained over it place. Self-dry silicone gel is effective in both treatment and prevention of hypertrophic scar. It is consider first line for hypertrophic prevention in last update of facial scar care.

The main objective aim of this study is to examine whether post-operative use of silicone gel can improve scar formation for microtia reconstruction scars.

Patients and Methods:

This is a prospective randomize clinical trial primarily designed to compare the scarring after second stage of microtia repair with post-operative use of self-drying silicone gel. The control group did not use self-drying silicone gel for their scar care. The study group will receive application of self-dry silicone gel (Dermatix Ultra Gel - Invida, Hanson Medical Inc, USA) twice a day.

Six months after surgery, Vancouver scar sale and Visual analogue scale will be used for subjective scar measurement. Standard craniofacial photograph will be taken at the same time. A surgical ruler will be placed underneath the op wound. The scar width will be measured using with commercial software.

Eligibility Criteria:
Inclusion Criteria:

* Patients with microtia.
* Written informed consent given by parent/guardian.

Exclusion Criteria:

* Combined other craniofacial anomalies
* Without permission of parent/guardian, without signed informed consent by parent/guardian.
Patient Participation Beliefs and Post-Traumatic Stress Disorder (PTSD)

This is an exploratory qualitative interview study being conducted with a primary objective of examining perceptions held by active military and veterans regarding help-seeking attitudes and mental health beliefs which influence the decision to consent or decline participation in Post-Traumatic Stress Disorder (PTSD) or Traumatic Brain Injury (TBI) clinical trials. Active duty military and/or veterans aged 18 years and older who consent to participate (N = 50), or have recently declined participation (N = 50), in an INTRuST affiliated outpatient clinical trial for deployment-related PTSD or TBI will be recruited. Participants who consent to participate in an INTRuST clinical trial (Group 1) will be interviewed once at the beginning the of the clinical trial, and again following participation in the trial. Participants who decline participation in an INTRuST affiliated outpatient clinical trial (Group 2) will be interviewed once. For participants in both groups, study participation will initiate within 1 month of referral to study. Total duration of study participation is based on the specific clinical trial that the participant is recruitment from; the longest trial is estimated to be 24 weeks or less. Semi-structured qualitative individual interviews will be conducted to carry out a thematic analysis of the data exploring familial, social and institution-level constructs which may influence the subjective experience of the research treatment process.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and over
2. Active duty and/or veteran
3. Referred to participate in INTRuST-affiliated outpatient clinical trials for PTSD or TBI
4. Ability to provide written informed consent
University Hospital Cardiac Device MR Registry: The Safety of MR Imaging in Patients With Implanted Cardiac Devices

A single-center registry to prospectively evaluate the safety of non-cardiac/non-thoracic magnetic resonance imaging (MRI) in patients with implanted cardiac devices (pacemakers and implantable cardioverter defibrillators).

Evaluation of safety of MR scanning of patients with implanted cardiac devices. Device parameters pre and post MR imaging will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years or older
* Informed consent can be provided by patient or medical power of attorney
* Presence of implanted pacemaker or ICD
* MRI is the diagnostic modality of choice for a specific clinical scenario without acceptable alternative imaging technology as determined by ordering physician
* Non-cardiac/non-thoracic MRI ordered

Exclusion Criteria:

* Presence of metallic objects that represent a contraindication to MR imaging
* Morbid obesity which results in body contact with the magnet façade
* Pacemaker or ICD generator implanted prior to 2002
* ICD patients who are pacing dependent
* Pregnancy
* Device generator at ERI (elective replacement interval)
* Presence of other active implanted medical device
* Presence of abandoned leads (with the exception of post CABG temporary epicardial pacing wires)
* Presence of implanted cardiac device in the abdominal position
* Pacemaker or ICD that is labeled as MRI-Conditional by the FDA
* Pacemaker or ICD implanted less than 6 weeks prior to MRI scan
An Integrated Approach to Treating Recurrent Thoracic Carcinomas Resistant to Tyrosine Kinase Inhibitors

Patients are asked to participate in this study if they have been diagnosed with a thoracic carcinoma which includes lung cancer and have a gene mutation (alteration in the body's genetic instructions) and after undergoing treatment the cancer has come back, progressed, or shown a partial response on standard treatment.

In order to improve the treatment outcome for thoracic carcinomas after they become resistant to targeted therapy, the investigator is using tumor biopsies at the time of recurrence for genomic analysis to identify novel somatic changes in critical genes and gene pathways that can potentially be targeted with therapy. The study team is also creating patient-derived xenografts to test drug efficacy and optimize personalized therapy for each patient.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Thoracic carcinoma tumors are positive for any targetable genetic alterations
* Have shown partial or no response, progression or recurrence while on or after gene targeted therapy by CT/PET scan
* Tumor is accessible for biopsy or surgery
* Expected life is 6 months or longer.

Exclusion Criteria:

* \< 18 years
* Not able to communicate in English
Adaptive Therapy for Resected Stage ⅠB-Ⅱ NSCLC Patients With Undetectable MRD

It is a prospective, multicenter, randomized controlled trial to investigate the predictive value of MRD on adjuvant therapy. Stage IB-II resected EGFR/ALK negative NSCLC patients will undergo two-round MRD tests after surgery, first in 3-7 days and second in 1 month after surgery. And patients who confirm two-round landmark undetectable MRD will be enrolled and randomly assigned to the conventional treatment group or the adaptive therapy group . Patients in the the adaptive therapy group will undergo closely MRD and imaging monitoring without adjuvant therapy if the MRD was negative.


Eligibility Criteria:
Inclusion Criteria:

* Stage IB-II non-small cell cancer patients who after complete resection.
* EGFR/ALK negative
* Two-round MRD tests confirm landmark undetectable MRD
* Expected survival ≥24 months
* ECOG PS 0-1
* Willing to accept MRD monitoring every 3 months for a total of 2 years after surgery

Exclusion Criteria:

* Patients who had previously undergone radiotherapy or chemotherapy or any other anti-tumor therapy
* Patients with a history of other malignancies in the past 5 years
* Any unstable systemic disease (eg, active infection, high-risk hypertension, unstable angina, congestive heart failure, etc.) or other conditions that investigators considered would limit the ability of the patient to participate in the study
REstart or STop Antithrombotic Randomised Trial in France

RESTART- fr is a randomised controlled trial for adults surviving spontaneous intracerebral haemorrhage who had taken an antithrombotic drug (i.e. anticoagulant or antiplatelet medication) for the prevention of vaso-occlusive disease before the ICH.

RESTART- fr is testing whether a policy of starting antiplatelet drugs (one or more of aspirin, clopidogrel, or dipyridamole, chosen at investigator's discretion) results in a beneficial net reduction of all serious vascular events over two years compared with a policy of avoiding antiplatelet drugs.

More than one third of the adults with a stroke due to bleeding into the brain - known as brain haemorrhage - are taking drugs to prevent clotting when they have a brain haemorrhage.

These patients had previously suffered illnesses like angina, heart attack, or stroke due to blood vessel blockage, which is why they are treated with drugs to prevent further clots occurring. These drugs are usually stopped when the brain haemorrhage occurs.

But when patients recover from brain haemorrhage, they and their doctors are often uncertain about whether to restart these drugs to prevent further clots occurring, or whether to avoid them in case they increase the risk of brain haemorrhage happening again.

In this preliminary study of 292 such people who survive a brain haemorrhage, we will study the potentially beneficial effects of three antiplatelet drugs (one or more of aspirin, clopidogrel, or dipyridamole, chosen by the patient's physician) on the risks of heart attack, stroke and other clotting problems as well as their effect on the risk of a brain haemorrhage happening again.

Eligibility Criteria:
Inclusion Criteria:

* Patient age ≥18 years.
* Spontaneous intracerebral hemorrhage confirmed by imaging
* Patient had been taken antithrombotic drug(s) for the prevention of vaso-occlusive disease for at least 1 week before ICH onset
* Randomisation more than 24 hours after ICH onset.
* Patient and their doctor are uncertain about whether to start or avoid antiplatelet drugs.
* Brain imaging that first diagnosed the ICH is available. Participant or representative consent.

Exclusion Criteria:

* intracerebral hemorrhage associated with : a vascular malformation (AVM, arterial aneurysm, cavernoma); a secondary hemorrhagic infarction; a cerebral venous thrombosis; a tumor
* Patients with a formal indication of restarting oral anticoagulants despite the ICH (eg mechanical heart valves or pulmonary embolism under 6 months)
Capecitabine and Interferon-Alpha in Metastatic Renal Cell Carcinoma Patients With Failure on Interleukin-2 Based Regimens

The aim of this study is to determine preliminary efficacy of capecitabine and interferon-alpha in second-line after interleukin-2 based regimens in patients with MRCC


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed renal carcinoma
* CT-confirmed metastatic sites
* Must have measurable disease, defined as ≥ 1 unidimensionally measurable lesion measured as ≥ 20 mm with conventional techniques OR as ≥ 10 mm with spiral CT scan
* Disease progression after IL-2
* Age 18 or older
* ECOG performance status 1-3
* Life expectancy ≥ 2 months
* WBC ≥ 3,000/mm3
* Platelet count ≥ 100,000/mm3
* Hemoglobin ≥ 7.5 g/dL
* Creatinine ≤ 1.5 mg/dL (2.0 mg/dL in post-nephrectomy patients)
* Total bilirubin ≤ 1.5 mg/dL
* AST ≤ 3.0 times normal
* Alkaline phosphatase ≤ 2.5 times normal (10 times ULN in presence of bone metastases)
* Not pregnant or nursing
* No history of autoimmune
* No history of serious cardiac arrhythmia, congestive heart failure, angina pectoris, or other severe cardiovascular disease (i.e., New York Heart Association class III or IV)
* No CNS metastases by neurologic exam and/or MRI
* No history of seizure disorders
* No local and/or systemic infections requiring antibiotics within 28 days prior to study entry
* No other malignancy
* Written informed consent