cyrilzakka/clinical-trials huggingface dataset:
Acquired Immunodeficiency Syndrome(AIDS) and Tuberculosis(Tb) Co-infection Treatment Strategies Study of China.

To determine the best time to begin anti-HIV(Acquired Immunodeficiency Syndrome) treatment in individuals who co-infected with HIV and tuberculosis (Tb). This prospective, randomized study is being conducted on HIV/Tb co-infected patients in China to evaluate and compare the efficacy of antiretroviral therapy after 2 weeks TB treatment versus deferred ART initiated 8 weeks after initiation of TB treatment.

Anti-Tb Therapy: 2HREZ-4HRifb(H:Isoniazid，R:Rifampicin，E:Ethambutol，Z：pyrazinamide，Rifb:Rifabutin) HAART: The first line was Zidovudine(AZT)+Lamivudine(3TC)+Efavirenz(EFV) and the second line is Stavudine(D4T)+3TC+EFV Study group one: after anti-TB therapy 2 weeks begin with High Active Antiretroviral Therapy(HAART); study group two: after anti-TB therapy 8 weeks begin with HAART. If begin with HAART and the H change with Rifb.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of AIDS co-infected with TB CD4 T cell count lower than 350/ul Must be able to swallow tablets and finish the follow-up Sign the information consent form Chinese

Exclusion Criteria:

* Can not tolerance the therapy estimated by the doctor.
Glofitamab in Chinese Patients With R/R DLBCL

This study will evaluate the safety and efficacy of glofitamab as a single agent in Chinese patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have failed two or more lines of systemic therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically-confirmed DLBCL
2. Participants must have relapsed or failed to respond to at least two lines of prior systemic therapy
3. Participants must have measurable disease

Exclusion Criteria:

1. Pregnancy or breastfeeding
2. Patient with known active infection, or reactivation of a latent infection
3. Patient with active autoimmune disease or immune deficiency
4. severe organ failure：LVEF\<40%；DLCO\<40%；eGFR\<30ml/min；Bilirubin≥3ULN
5. Patients who are dependent on the sponsor, the investigator or the trial site
Validation of a Historical Physical Activity Survey

To compare long-term recall of physical activity up to 15 years in the past with physical activity reports and physical fitness levels assessed at the baseline examination.

BACKGROUND:

Sedentary habits in middle-aged individuals are associated with increased risk for cardiovascular disease. Studies examining this association typically have assessed physical activity participation in a narrow window, (for example, 1 week or 1 month) relative to probable disease etiology and progression. When the study was initiated, the possible relation of long-term physical activity patterns over decades or a lifetime to disease risk was not known because there existed no validated method of determining such exposure, but such studies were needed. It was hypothesized that validation of long-term recall of activity could lead to the application of lifetime physical activity patterns questionnaires. Data on lifetime activity patterns might be useful in case-comparison and prospective studies of cardiovascular disease.

DESIGN NARRATIVE:

Data analyzed for this project were from a cohort that had been under observation in the Aerobics Center Longitudinal Study. Baseline preventive medical examinations were given to 6,902 men and women during the interval from 1971-1982. Current physical activity and physical fitness levels (maximal exercise treadmill test) were assessed at baseline. Participants also completed a lifetime physical activity pattern questionnaire as part of a mail survey done in 1986. Self-reported physical activity from the 1986 questionnaire was used to categorize participants' physical activity levels for the years 1971-1985. These recalled levels of activity were compared to physical activity and physical fitness levels assessed during those same years at the baseline examinations (measure of truth). For example, participants who reported in the 1986 survey that they engaged in relatively high levels of physical activity in 1976 were expected to have recorded higher levels of physical fitness at the 1976 examination than participants who reported in 1986 that they were relatively sedentary in 1976. The study design permitted evaluation of how accurately participants recalled their physical activity up to 15 years in the past and allowed quantification of the errors investigators might expect from such assessments.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Mobile Health Cognitive Stimulation in Heroin Users

Heroin use has been related to brain dysfunction particularly in the prefrontal cortex. These effects are evident in neuropsychological impairments in attention, memory and executive functioning of heroin users. To assess these deficits and the application of a novel approach of cognitive stimulation to heroin users in treatment for opioid dependence, we have carried out a neuropsychological intervention program with mobile health technology. Patients diagnosed with opioid dependence were submitted to cognitive stimulation during four weeks in a three-day/week basis.


Eligibility Criteria:
Inclusion Criteria:

* Only patients that scored higher than the cutoff values for their age on the Mini Mental Examination Test and with no clinical scores on the Symptoms Checklist Revised will be included in the study.

Exclusion Criteria:

* Patients with alcohol dependence or with history of previous neurological disorders will be excluded from the study. Patients will be also screened for minimal computer literacy.
Safety and Efficacy of Remote Ischemic Conditioning in Patients with Severe Stenosis or Occlusion of Anterior Intracranial Circulation Vessels

The primary purpose of this study is to examine whether remote ischemic treatment can better the 90 - day neurological outcomes in acute ischemic stroke patients having severe stenosis or occlusion of anterior intracranial circulation vessels.


Eligibility Criteria:
Inclusion Criteria:

1. Age is 18 years old or above.
2. Severe stenosis (70% - 99%) or occlusion of anterior intracranial circulation vessels, mainly including the intracranial segment of the internal carotid artery, middle cerebral artery (M1, M2) and anterior cerebral artery (A1, A2), which is confirmed by digital subtraction angiography (DSA), computed tomography angiography (CTA) or magnetic resonance angiography (MRA).
3. Patients with clinically diagnosed acute ischemic stroke who received remote ischemic treatment within 72 hours after the onset.
4. The NIHSS score ranges from 4 to 24.
5. The mRS score before stroke is less than or equal to 1.
6. informed consent.

Exclusion Criteria:

1. Patients with vessel recanalization after mechanical thrombectomy (TICI grade ≥ 2b).
2. Patients planning to receive intracranial endovascular treatment within 3 months.
3. Patients with cardiogenic embolism considered as the cause, such as rheumatic mitral or aortic valve stenosis, artificial heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, left ventricular wall thrombus or valvular vegetations, congestive heart failure, bacterial endocarditis, etc.
4. Patients diagnosed with acute posterior circulation cerebral infarction.
5. Symptoms caused by non - culprit vessels.
6. Ipsilateral extracranial vessel stenosis ≥ 70%.
7. Systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110 mmHg, and uncontrollable by antihypertensive drugs.
8. Intracranial tumors, arteriovenous malformations or aneurysms.
9. Cerebral venous thrombosis or stenosis.
10. Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) within 90 days before enrollment.
11. Severe coagulation abnormalities.
12. Any contraindications to remote ischemic conditioning: severe soft tissue injury, fracture or vascular injury of the upper limb, perivascular lesions of the distal upper limb, etc.
13. Patients with any serious diseases and a life expectancy of less than 1 year.
14. Patients who participated in other clinical trials within 3 months before enrollment or are currently participating in other clinical trials.
15. Patients who cannot be followed up (such as those without a fixed residence, overseas patients, etc.).
16. Pregnant or lactating women.
17. Patients who have previously received remote ischemic treatment or similar treatments.
18. Patients whom the researchers consider unsuitable for this clinical study.
Does the Suture-spanning Augmentation of Single-row Repair in Massive Rotator Cuff Tear Reduce the Retear Rate?

There are several associated structural changes when dealing with massive rotator cuff repair, which include tendon retraction and fragility, muscle atrophy and fatty infiltration, as well as osteoporosis over the tendon insertion. Those changes may lead to difficult in applying double-row repair, suture cutting through the tendon, too much tension over the repair and loosening or pull-out of anchors, which may results in poor tendon-bone healing and subsequent high re-tear rate. Therefore decreasing the tension over the repair site may increase the healing over tendon bone junction as well as decrease the risk of anchors loosening. A suture-spanning augmentation with two set of suture loops passing over musculotendinous junction medially and fixed with anchor at the lateral cortical wall may solve the problem. In order to define the clinical benefit of this adjuvant procedure, a prospective randomized control study is designed to compare the adjunctive reinforce suture with the single-row simple suture repair in massive rotator cuff tear.

Around sixty patients were randomized divided into two groups. The study group was used adjunctive reinforce suture repair technique, which was one lateral cortical anchor holding 2 separated set of transverse looping sutures over the medial musculotendinous junction in addition to single row repair, while the control group was used single row repair technique in simple stitch fashion. All patients will have clinical evaluation in pain (VAS score) and functional recovery (ASES and UCLA score) as well as MRI image for the tendon integrity.

If the suture-spanning augmentation of single-row repair can yield an improved healing rate and fewer complications, massive rotator cuff tear should be repaired earlier in order to prevent the late development of irreparable tear.


Eligibility Criteria:
Inclusion Criteria:

* the pre-operative image (MRI) showing the massive rotator cuff tear (fulfilling one of the following definition a tear with a diameter of 5 cm or more; a complete tear of two or more tendons; one with a coronal length and sagittal width greater than or equal to 2 cm)
* patient was willing and able to provide scores for the study

Exclusion Criteria:

* irreparable rotator cuff tear which was identified pre-operatively or intra-operatively
* glenohumeral or acromioclavicular joint osteoarthritis
* stage III or more of the fatty degenerative of supraspinatus in Goutallier classification
* revision surgery
* patients with bacteremia, a systemic infection, or an infection at the surgical site
* patients who previously attempted or failed a treatment program
A Prospective Trial to Study the Evolution of Clonal Architecture of Tumors From Patients Treated With Molecular Targeted Agents

This is a prospective study to identify molecular mechanisms of acquired resistance to targeted therapies in patients with unresectable or metastatic cancer.

This is a protocol to study clinical characteristics and biopsy tissue of patients with oncogene-driven cancer who have had previous clinical response to targeted therapy and subsequently experience progression of disease. The tissues and other specimens will be used to carry out laboratory studies to explore the molecular basis of acquired resistance to targeted therapies.


Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with confirmed cancer and who fulfill the following eligibility criteria will be considered eligible for this study:

1. Patient affiliated to a social security regimen
2. Patients scheduled to receive anticancer agents or currently receiving anticancer agents
3. Tumor lesion accessible to core biopsies (malignant effusions can represent an alternative)
4. Patient who is fully informed, able to comply with the protocol and who signed the informed consent.
5. Availability of initial tumor material (ideally frozen, or non-Bouin fixed paraffin embedded material) acquired before exposure to the targeted therapy Note: Patients may have received other treatments since treatment with targeted therapies including radiation or chemotherapy, before undergoing the study biopsy.

Exclusion Criteria:

1. Coagulation abnormality prohibiting a biopsy
Asthma and Atopic Dermatitis Validation of PROMIS Pediatric Instruments

This is designated to validate patient-reported outcomes (PRO) measures in itch-specific pediatric skin conditions, such as atopic dermatitis, and examine the ability of a modified stigma instrument to assess the severity and type of stigma experienced in atopic dermatitis and other potentially stigmatizing conditions.

This study involves a series of research and development projects targeted at two of the most common chronic diseases affecting children: asthma and atopic dermatitis (AD, or eczema). The Investigators propose to directly validate patient-reported outcomes (PRO) measures in a large cohort of itch-specific pediatric skin conditions, with a primary focus on AD. The Investigators propose to examine the ability of PROMIS (Patient-Reported Outcomes Measurement Information Systems) instruments to detect meaningful and clinically significant change in disease status, as well as to create a pediatric itch item pool and PRO model for signs and symptoms of skin disease. The Investigators will also examine the ability of a modified Neuro-QOL stigma instrument to assess the severity and type of stigma experienced in AD and across various dermatologic or other potentially stigmatizing conditions. Lurie Children's Hospital will only be involved in the AD and stigma portions of this project

Eligibility Criteria:
Inclusion Criteria:

* Affected children must have moderate to severe AD or another skin condition that causes itch, experience itch, understand English, and be able to complete an English-based survey
* Any child with a potentially disfiguring skin condition or change in appearance related to disease/intervention will be considered eligible. Parents of children with such conditions will also be asked to participate. Children and parents must also understand English and be able to complete an English-based survey

Sub-study Inclusion Criteria:

1. Patients ages 8 years-17 years with a diagnosis of mild AD
2. Patients ages 6 months to 8 years with a diagnosis of AD (any severity)
3. English speaking
4. Families must be able to access the internet (e.g., Skype or Facetime) for follow-up, or be able to come for follow-up within five days of an AD flare and again when improved.
5. Patients with developmental delay and/or a behavioral disorder that would preclude participation in form completion will not be eligible for this study.
A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)

Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be males or non-pregnant, non-lactating females.
* Subjects must be at least 15 years of age, of either sex, and any race.
* Subjects (and/or the parent or guardian for subjects under the age of legal consent or who otherwise are unable to provide independent consent) must demonstrate willingness to participate in the study and to adhere to dose and visit schedules.
* Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria(18) for opioid dependence.
* Subjects must have been receiving maintenance treatment with Subutex at doses ranging from 4 mg to the maximum dose permitted by country labeling requirements, but not to exceed 24 mg/day, for at least 1 month prior to screening.
* Subjects must not, according to self-report, have injected opioids more than four times in the month prior to screening.
* Subjects must have an opioid-negative urine drug screening (UDS) result prior to randomization.
* Each subject must confirm that he or she is practicing adequate contraception.
* Female subjects of childbearing potential must have a negative urine beta-human chorionic gonadotropin (β-hCG) test prior to enrollment in the study.

Exclusion Criteria:

* Subjects for whom treatment with either Subutex or Suboxone as required in the protocol would be inconsistent with national labeling.
* Subjects who are unwilling or unable to comply with the requirements of the protocol (eg, pending incarceration) or are in a situation or condition that, in the opinion of the investigator, may interfere with participation in the study.
* Subjects who are participating in any other clinical study in which medication(s) are being delivered.
* Subjects with known allergy or sensitivity to naloxone.
* Subjects who are on the staff, affiliated with, or a family member of the staff personnel directly involved with this study.
* Subjects must not have serious untreated Axis I DSM-IV-TR psychiatric comorbidity (eg, those who are actively suicidal or homicidal, have untreated schizophrenia, etc). Polysubstance abuse or dependence will not exclude subjects except in the case of unauthorized and significant benzodiazepine use requiring medical detoxification or alcohol dependence requiring medical detoxification.
* Human immunodeficiency virus (HIV)-positive subjects with clinical acquired immunodeficiency syndrome (AIDS).
* Subjects treated with generic buprenorphine.
The Effect of Sequential Feeding for Circadian Rhythm and Gut Flora Rhythm in Critically Ill Patients

Circadian rhythms plays an important role for healthy. And critical illness contributes to the disruption of circadian rhythms. Not only right but also feeding can affect the circadian clock gene expression. In a investigators' previous study, some metabolic indicators (the albumin level, total cholesterol level and total bile acid level) and the increases in lymphocyte counts in the sequential feeding group were different from those in the continuous feeding group. Investigators think sequential feeding may adjust circadian clock gene expression for its effect on metabolism and immunity. Moreover, sequential feeding did alter the abundances of some gut microbes to some degree in the investigators' previous study. Investigators think sequential feeding may adjust gut flora rhythms.


Eligibility Criteria:
Inclusion Criteria:

* Patients newly admitted to ICU were eligible for inclusion.

Exclusion Criteria:

* An estimated feeding time of less than 10 days in ICU;
* Diabetes;
* Gastrointestinal disease (gastrointestinal surgery, gastrointestinal bleeding, pancreatitis, Crohn's disease, ulcerative colitis, irritable bowel syndrome);
* Inability to tolerate ≥80% of the nutrition target calories (25-30 kcal/kg/d) with enteral feeding through gastric tube;
* The ability to eat orally at admission.
Detecting Absence Seizures Using Eye Tracking

The goal of this study is to develop a comfortable system that uses a wearable eye-tracker similar to eyeglasses to assist people with epilepsy in counting and measuring the severity of seizures. Participants will wear an eye-tracker during a routine EEG.

Seizures can be difficult to detect outside of the hospital even with careful observation by a caregiver. EEG is the best method that we have to detect seizures- but it is uncomfortable for long term use outside of the hospital. The goal of this study is to develop a comfortable system that uses a wearable eye-tracker similar to eyeglasses to assist people with epilepsy in counting and measuring the severity of seizures. People participating in this study will have a routine EEG performed while an eye tracker measures eye movements. After the EEG is complete the researchers will compare the eye movements to the EEG to develop a software program that can detect seizures from eye movements.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form- per local IRB
2. Stated willingness to comply with all study procedures including the clicker test and availability for the duration of the study
3. Male or female, aged 4-100
4. Experience known typical absence seizures as defined by the ILAE 2017 classification or referred to EEG lab for staring spell or concern for absence seizure

   a. This will allow for inclusion of children and adults across the entire spectrum of disease states including new diagnosis (medication naive), medication responsive and non-medication responsive
5. Scheduled for clinical EEG observation

Exclusion Criteria:

1. Intolerant of wearing or unable to wear the eyeglasses
2. Autism or other developmental disorder that the PI thinks will interfere with data collection
3. History of aggression that the PI thinks will interfere with data collection
4. History of not tolerating EEG that the PI thinks will interfere with data collection
5. Unable to give consent (for individuals ≥ 18 years old) unless they have an adult with power of attorney to consent
A Study of Retrovir in the Treatment of Psoriasis in HIV-Positive Patients

To evaluate the feasibility of Retrovir (AZT) in the treatment of psoriasis in HIV antibody positive patients. Retrovir has been shown to be effective in the treatment of AIDS. In addition, the administration of AZT appears to have induced a remission of psoriasis in one case study. In light of AZT's antiviral activity and potential effectiveness as an agent for the treatment of psoriasis, this would be the most likely treatment for HIV positive, psoriatic patients whose disease progresses quickly.


Eligibility Criteria:
Inclusion Criteria

Study participants must have biopsy-proven psoriasis with 3 distinct psoriatic lesions. (Biopsy-proven Reiter's syndrome patients with 3 distinct cutaneous lesions may be included.) Documented HIV antibody (by federally licensed ELISA test) positive patients.

Prior Medication:

Allowed:

* Zidovudine (AZT).

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Presence of any active opportunistic infection.
* Presence of any AIDS-defining neoplasms (excluding Kaposi's sarcoma) such as central nervous system (CNS) lymphoma.
* Known hypersensitivity to zidovudine (AZT).
* Impaired renal function.
* Significant hepatic dysfunction.

Concurrent Medication:

Excluded:

- Topical steroid, anthralin, or tar preparations. Etretinate, methotrexate, or psoralen ultraviolet A (PUVA) therapy. Psoriatic treatment such as systemic agents or topical steroids (emollients used distal to the control lesions and antipruritic shampoos are admissible).

Patients with the following are excluded:

* Presence of any active opportunistic infection.
* Presence of any AIDS-defining neoplasms (excluding Kaposi's sarcoma) such as central nervous system (CNS) lymphoma.
* Known hypersensitivity to zidovudine (AZT).
* Impaired renal function.
* Significant hepatic dysfunction.

Prior Medication:

Excluded:

* Other antiretroviral agents (e.g., suramin, ribavirin, HPA-23, dideoxycytidine).
* Excluded within 2 weeks of study entry:
* Topical steroid, anthralin, or tar preparations.
* Any other experimental therapy drugs which cause significant bone marrow suppression such as antifolates or pyrimethamine.
* Cytolytic chemotherapy.
* Drugs which cause significant nephrotoxicity or hepatotoxicity.
* Rifampin or rifampin derivatives.
* Excluded within 4 weeks of study entry:
* Etretinate, methotrexate, or psoralen ultraviolet A (PUVA) therapy.
* Excluded within 8 weeks of study entry:
* Immunomodulating agents, including steroids, interferon, Isoprinosine, and interleukin 2.