cyrilzakka/clinical-trials huggingface dataset:
Skin Tape Transcriptome Methods in Children

This pilot study will evaluate new methods for the collection, storage, shipment, and RNA extraction of skin tape specimens from children with atopic dermatitis (AD) that will facilitate the multi-center SunBeam Birth Cohort study. Additionally, this pilot study will test new methods for the generation of whole transcriptome sequencing data from skin tape RNA and whether these data reflect the transcriptional state of the skin in health and disease.


Eligibility Criteria:
Inclusion Criteria:

1. Able to provide informed consent/assent.
2. Male or female, 4-12 years of age (prepuberty) inclusive at the time of consenting
3. Participant must be either:

   1. Active atopic dermatitis with two areas of non-lesional AD within 5 cm of the measured lesional area within the same region.

      OR
   2. .No personal history or current manifestations of AD, food allergy, asthma, allergic rhinitis, and no positive prick or blood testing for allergen (based on self-report); and no evidence of dry skin or other skin condition

Exclusion Criteria:

1. Unable to provide consent or comply with the protocol
2. Presence of any skin condition that might compromise the stratum corneum barrier in infants and young children (e.g., ichthyosis, psoriasis, extensive seborrheic dermatitis, scabies)
3. History of any skin reaction to tape, or adhesives
4. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
5. Use of any topical product (e.g., emollient, topical corticosteroids, topical immunomodulatory agents, topical antibiotics) on the area(s) to be tested within 24 hours before the study visit.
Effect of Repeated tDCS Sessions on Cognitive Improvement in Patients With Disorders of Consciousness

In this study, researchers will show to caregivers of patients how to use a tDCS device (this device was designed to be easy to use, with fixed parameters and only one button to press to run the stimulation). They will be asked to apply a stimulation every day, 5 days per week during for 4 weeks, in chronic patients in minimally conscious state (MCS).

2 sessions of 4 weeks of stimulations will be realized, one anodal and one sham in a randomized order. Before and after each session, behavioral improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done 8 weeks after the end of the sessions to assess the long term effect of tDCS.

A single session of tDCS showed positive effects on patients in MCS (study published in Neurology, 2014). Nevertheless, the effects went down after 1 or 2 hours. In a second study (Protocol ID: 2009/201/B) we have found that 5 days of tDCS increase the lasting of the effects up to one week.

To know if tDCS could be use in clinical daily practice, a new study will evaluate the effects of 20 minutes of tDCS over the left prefrontal dorsolateral cortex for 4 weeks, 5 days per week, in chronic patients in MCS.

2 sessions of 4 weeks of stimulation (total=20 stimulations per session) will be performed, one session will be real (anodal stimulation) and one placebo (sham stimulation).

Firstly, the patient will be seen at the hospital for a behavioral assessment (CRS-R) with one of his/her caregiver. The investigator will explain to the caregiver how to perform the stimulation. In addition, he/she will receive a folder and a video. The caregiver will take an exam to be sure he/she performs the tDCS properly.

Before and after each stimulation session, behavioral improvement will be assessed with the CRS-R by a trained neuropsychologist, at the hospital. A final assessment will be done 8 weeks after the end of the session to assess the long term effect of tDCS.

The compliance will be recorded by the deice to be sure that the caregiver performs the stimulation every day as expected.

Researchers expect to see (a) an improvement of the CRS-R total score at the end of the anodal session and (b) this improvement persists for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* be in an minimally conscious state
* be chronic (more then 3 months post insult)
* stable condition

Exclusion Criteria:

* NMDA receptor inhibitor drugs
* modification of the treatment during the protocol
* illness or infection during the protocol
* pacemaker
* metallic cerebral implant
* prior neurological disorder
* tDCS or other non-invasive brain stimulation treatment less than 3months before the inclusion in the present study
Pediatric Catheter-related Thrombosis Imaging Study

This protocol will serve as a pilot study to determine the validity and feasibility of contrast enhanced magnetic resonance imaging (MRI) without and with contrast and/or ultrasound (US) for detection of catheter related deep vein thrombosis (DVT) in children


Eligibility Criteria:
Inclusion Criteria:

* Functioning central venous catheter in the upper or lower venous system
* Cohort A: Asymptomatic patients having placement of a new central venous catheter in the last 40±20 days
* Cohort B: Subjects who have experienced symptoms for a CVC-related DVT with a CVC in place or subjects who have been incidentally identified by radiographic imaging (imaging modalities to diagnose an incidental CVC-related DVT may include, but is not exclusive of Echocardiogram, CT scan, MRI, or Ultrasound) performed for other clinical reasons, as having a CVC-related DVT in the veins where the current catheter is placed
* Males and females from full-term newborns to \< 18 years

Exclusion Criteria:

* For Cohort A subjects only, present therapeutic dosing of a systematic anticoagulant, systemic thromboprophylaxis or antiplatelet therapy. Local thromboprophylaxis \[flushes, low dose infusions of heparin of up to 5 u/kg/hr or locks with heparin, urokinase, t-plasminogen activator\] according to standard-of-care at the respective center will be allowed
* Patients unable to undergo contrast enhanced magnetic resonance imaging
* Renal function \< 50% of normal for age and size
Infliximab in Treating Cancer-Related Fatigue in Postmenopausal Women Who Have Undergone Treatment for Breast Cancer

RATIONALE: Infliximab may help improve energy levels in patients who have undergone treatment for breast cancer.

PURPOSE: This phase II trial is studying how well infliximab works in treating cancer-related fatigue in postmenopausal women who have undergone treatment for stage 0, stage I, or stage II breast cancer.

OBJECTIVES:

* Determine the association between the body's immune system and energy, sleep, mood, and other symptoms in postmenopausal women who have undergone treatment for stage 0-II breast cancer.
* Determine whether treatment with infliximab affects energy and immune function in these patients.

OUTLINE: Patients receive infliximab IV over 2 hours.

Patients complete a diary twice daily for 14 days before and for 14 days after infliximab administration to assess fatigue and other symptoms, including mood, pain, and sleep.

After completion of study treatment, patients are followed at 2 weeks and then monthly for 3 months.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Women who report elevated fatigue following cancer diagnosis and treatment

Exclusion Criteria:

* Women who have medical conditions that may affect the immune system or are associated with baseline fatigue syndrome, and/or who use medications that affect the immune system or fatigue.
* Women with major affective disorders and those with sleep or pain disorders.
* Presence of medical conditions that may but subject at undue risk for experimental procedures.
* Chronic or recurring infections, symptoms of chronic heart failure, demyelinating disorders, and those taking immunosuppressive medications.
* Neoplastic disease other than primary breast cancer
* Compromised cardiovascular function
* Insulin-dependent diabetes
* Neurological disorder
* Peripheral neuropathy
* Pregnancy
* Use of psychotropic medications within 2 weeks of screening
* Abnormal screening laboratory findings (i.e., creatinine \> 1.4mg%; anemia; abnormal thyroid hormone; hematuria; elevated liver function tests, low protein or albumin; fasting glucose \>120mg%; elevated FTI or TSH; positive TB screening, HIV screening or hepatitis C).
* Smokers
A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of a Monovalent Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18-40 Years of Age

The goals of the proposed study are to evaluate the safety, tolerability and immunogenicity of a GBS vaccine. Previous studies suggest that immune responses against GBS can protect humans from infection.


Eligibility Criteria:
Inclusion Criteria:

* healthy females 18 through 40 years of age;
* have provided written informed consent after the nature of the study has been explained;
* are available for all visits scheduled for the study (i.e. are not planning to leave the area before the end of the study period);
* are in good health as determined by: medical history, physical assessment, clinical judgment of the investigator

Exclusion Criteria:

* unwilling or unable to give written informed consent to participate in the study;
* pregnant (serum pregnancy test)
* unwilling to use acceptable birth control from screening and until at least 3 months after the final immunization
* nursing (breastfeeding) mothers
Gallbladder Cholesterolosis, Body Mass Index and Serum Cholesterol and Triglycerides

Cholesterolosis is a common finding in biopsy specimens of gallbladders surgically removed for cholelithiasis.

To the best of the investigators knowledge no study has analyzed the relationships of Body Mass Index, serum Cholesterol and Triglycerides and gallbladder cholesterolosis.

The purpose of this study is to analyze and find relations between gallbladder cholesterolosis, Body Mass Index, serum cholesterol and triglycerides.

A prospective database including the following variables was filled out:

* Age
* Gender
* Diagnosis
* Weight
* Height
* Body Mass Index
* Histopathological results (Biopsy)
* Serum cholesterol
* Serum triglycerides

All elective patients older than 15 years of age submitted to cholecystectomy for symptomatic gallstones were included. Plasma cholesterol and triglycerides levels were measured 5 to 7 days before surgery. Only patients with chronic cholecystitis and with cholesterolosis according to the histology of the surgical specimen were included, we did not include any patient with acute cholecystitis or gallbladder cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients submitted to elective cholecystectomy
* Histopathological report of gallbladder cholesterolosis
* Histopathological report of chronic cholecystitis
* Patients older than 15 years of age

Exclusion Criteria:

* Patients younger than 15 years of age
* Pathological report missing from the hospital records
Quick Start Approach to Birth Control Pills

Women who choose to take birth control pills are currently instructed to begin taking the pills at the end of a menstrual cycle. This creates a window of time between when the woman is given the pills and when she begins taking them. Some women fail to begin taking the pills, placing them at increased risk of pregnancy. This study will evaluate a new approach to beginning birth control pills. Women will take the first pill in the doctor's office rather than waiting until the next menstrual cycle.

Despite the effectiveness of oral contraceptives, pregnancy rates are high among women who choose this method of birth control. These pregnancies occur due to incorrect use, premature discontinuation, and failure to begin taking oral contraceptives after they have been prescribed. As many as 25% of adolescents who seek oral contraceptives from family planning clinics never take the first pill. Failure to begin oral contraceptives may occur due to ambivalence, confusion about starting instructions, or intervening pregnancy. Conventional starting instructions for oral contraceptives require waiting until the next menstrual period; this may leave the woman at high risk of pregnancy. This trial will evaluate a "quick start" approach in which the woman swallows the first pill during the clinic visit under direct observation and then continues daily pill use without waiting for her next menses. The trial will determine whether immediate oral contraceptive initiation offers benefits compared to conventional starting approaches.

Participants in this study will be randomized to receive either the quick start or the standard starting approach. Participants will complete a questionnaire at study entry and Months 3 and 6. The main outcomes are 6-month oral contraceptive continuation rates and pregnancy rates.

Eligibility Criteria:
Inclusion Criteria

* Requests hormonal contraceptives as primary method of contraception
* Sexually active (intercourse within 30 days prior to study entry) or anticipating sexual activity within 30 days following study entry
Long Term Follow-Up of HIV Infected Patients Who Have Previously Participated in HIV Clinical Trials

The purpose of this study is to monitor the progression of HIV infection and HIV-related disease processes in patients who have previously participated in HIV clinical trials.

Since 1982, the National Institute of Allergy and Infectious Diseases (NIAID) has been conducting numerous clinical trials on patients infected with HIV-1. Unfortunately, once clinical studies have closed or participants have reached a study endpoint, no additional follow-up data are collected regarding progression of HIV infection and development of HIV-related complications in these study participants. This study will collect long-term data for participants of previous NIAID-sponsored clinical trials to study HIV-related disease processes and complications, benefits and toxicities of investigational medications and vaccines, and medical management of participants with known or suspected HIV infection.

Study visits will occur every 6 months. A physical exam, blood collection, and medical history will occur at all visits. Depending on the need of participants, additional laboratory and diagnostic tests will be performed, and standard medical care will be provided.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected
* Previously participated in a NIAID-funded clinical trial studying HIV disease
Motor Function and Activity of Daily Life in Spinal Muscular Atrophy

This study will incorporate patients/ caregivers' perspectives to investigate the performance in daily activities of individuals with SMA and how it relates to their motor function abilities.

Spinal muscular atrophy (SMA) is an autosomal recessive neuromuscular disease that causes progressive muscle weakness and atrophy and eventually leads to loss of function. Despite recent advances in disease-modifying treatments, SMA can still significantly impact an individual's functioning in daily living and quality of life. This study will incorporate patients/ caregivers' perspectives to investigate the performance in daily activities of individuals with SMA and how it relates to their motor function abilities.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of SMA with genetics confirmed as 5q SMA.
* Above 3 years of age (capable of performing motor assessments).

Exclusion Criteria:

* Having severe respiratory and other medical conditions precluding safe participation in standardized motor function tests.
* Having any orthopedic surgery during the past 6 months.
* Women who are pregnant.
Influence of Bovine Milk Consumption on Hormonal Profile in Males

50 men will be recruited to this study. Participants will be asked to ingest commercially available bovine milk. Hormonal profile will be analyzed before and after consumption.


Eligibility Criteria:
Inclusion Criteria:

* healthy, non infertile males

Exclusion Criteria:

* lactose intolerance
Breakthrough Anxiety and Sleep Evaluation Using Linked Devices and Smartphone Application Onar (BASEL)

Sleep is not simply the absence of wakefulness. Sleep is an active procedure, normally happening every night, and is absolutely vital. Good sleep is essential for our well-being. Survival without food can be further than without sleep. Work time and commuting time seem to affect total sleep time and night bedtime. Social and work obligation can, therefore, suppress sleep time. Sleep deprived individuals may be facing anxiety and depression symptoms.

The aim of this study is to investigate the presence of anxiety and depression symptoms among adults with the use of the smartphone application Onar. Onar app will be used to gather information from wearable devices of the users including total sleep time, sleep efficiency, wake after sleep onset time. An established questionnaire (Hospital Anxiety Depression Scale/ HADS) will be used to quantify and detect the presence of anxiety and depression in the study population.


Eligibility Criteria:
Inclusion Criteria:

* Acceptance of terms of use of the application must be done prior to participation in the study.
* Male and female adults aged ≥18 years old and ≤60 years old.
* Subjects using the application on a daily basis for at least 1 week prior to participation.

Exclusion Criteria:

* History of alcohol or other substance abuse.
MAPS Group Therapy Model for Bipolar Disorder

This study aims to develop the MAPS(M,Monitoring;A,Assessing;P,Preventing or Reducing Relapse;S,Smart goal setting) group therapy model for bipolar disorder patients as other adjuvant clinical treatment and develop the instruments for evaluating the severity of bipolar symptoms. The investigators insist to provide the psychosocial intervention for bipolar patients in the general hospital and offer appropriative adjuvant intervention except current psychiatric biological treatment.

This study is a one-year project. First, the investigators like to translate the Depression, Anxiety and Stress Scale (DASS) and the Altman Self-Rating Scale for Mania (ASRM) to Chinese and finish the reliability and validity study. Second, the investigators would like to develop the MAPS group therapy to enhance bipolar patients' insight, increased life quality and decrease suicidal ideation. This study is a case control study. All cases recruit from the psychiatric outpatient department of one medical center. The inclusion criteria are diagnosed as bipolar disorder, age from 18 to 65 and agree to sign the inform consent. The excluded criteria are hard to communicate, with acute psychiatric feature and severe physical illness. The investigators plan to hold the MAPS group three times and predetermine to recruit totally 30 patients as the case group. As to the control group, the investigators also recruit from the psychiatric outpatient department and those who treat as usual by control their gender, age and the same diagnosis as bipolar disorder. The only one different factor between the case group and the control group was attending the MAPS group therapy or not. In MAPS group therapy, two facilitators work with ten clients with twelve weekly sessions and three monthly booster sessions. Self-report rating scales (DASS and ASRM) are completed at the beginning of each session. The investigators use DASS and ASRM to evaluate the severity of bipolar symptoms; BSS for suicidal ideation; SF-36 for life quality. The hypothesis is "patients attended to MAPS group therapy have better symptoms control, lower suicidal ideation, better life quality and less use emergency department or admissions than those who didn't attend the group therapy".


Eligibility Criteria:
Inclusion Criteria:

* bipolar disorder outpatients in remission, defined as Young Mania Rating Scale score \< 6, Hamiltone Depression Rating Scale-17 \< 8
* age 18 to 65 years old
* speaking Mandarin
* agree to sign the inform consent

Exclusion Criteria:

* Those who were hard to communicate such as mental retardation, hearing impairment and etc
* with acute psychotic feature
* with severe physical illness
Extracorporeal Shock Wave Therapy for Pain-Relief After Arthroscopy for Osteochondral Lesions of the Talus

Arthroscopic surgery is effective in treating osteochondral lesions of the talus. However, there are still some patients with postoperative ankle pain. This study aims to investigate the clinical efficacy of shock wave adjuvant therapy in the treatment of postoperative pain caused by cartilage injury of talus after arthroscopy and to provide basis for further popularization and application.

Arthroscopic surgery is effective in treating osteochondral lesions of the talus. However, there are still some patients with postoperative ankle pain. This study was conducted to investigate the clinical efficacy of shock wave therapy in the treatment of postoperative pain caused by cartilage injury of talus after arthroscopy.

Patients with osteochondral lesions of the talus treated by arthroscopic microfracture surgery and still complained ankle pain three months after surgery were enrolled. Radial extracorporeal shock wave therapy was used to give energy to the injured region of the talus and the adjacent area.Treatment was done once a week for 5 consecutive weeks. After shock wave therapy,the patients were followed by Visual Analogue Scale (VAS), the American Orthopaedic Foot and Ankle Society ankle-hindfoot scale(AOFAS-AHFS) , and followed finally by Magnetic Resonance Imaging(MRI) of the ankle.

Eligibility Criteria:
Inclusion Criteria:

1. For arthroscopy:

   * Ankle pain, aggravated after exercise or weight-bearing activity, accompanied by lameness, joint stiffness and dysfunction for at least 3 months
   * No talar collapse
   * Talar cartilage injury cases before stage Ⅳ of Hepple classification
2. For shock wave therapy:

   * Patients with micro-fractures treated with arthroscopic treatment of talar cartilage injury and were treated with routine rehabilitation training after arthroscopy
   * Patients who till complained obvious ankle pain 3 months after surgery

Exclusion Criteria:

* Severe cardiovascular and cerebrovascular diseases
* Hemorrhagic diseases, coagulation disorders
* Bone immaturity
* Thrombosis
* Use of anti-immune agents
* Various types of tumor patients
* Pregnant women
* History of mental illness
* Patients who could not be followed
* Patients with other lower extremity injuries after surgery and were unwilling to participate in the study