cyrilzakka/clinical-trials huggingface dataset:
CD38-targeted Chimeric Antigen Receptor T Cell (CART) in Relapesd or Refractory Acute Myeloid Leukemia

This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of targeted CD38 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD38 positive relapsed or refractory acute myeloid leukemia.

The patients will receive infusion of CAR T-cells targeting CD38 to confirm the safety and efficacy of CD38 CAR T-Cells in relapsed or refractory acute myeloid leukemia.

Eligibility Criteria:
Inclusion Criteria:

* CD38 positive relapsed/refractory acute myeloid leukemia
* age 6-65 years.
* left ventricular ejection fractions ≥ 0.5 by echocardiography
* creatinine \< 1.6 mg/dL
* aspartate aminotransferase/aspartate aminotransferase \< 3x upper limit of normal
* Total bilirubin \<2.0 mg/dL
* karnofsky performance status ≥ 60
* expected survival time ≥ 3 months (according to investigator's judgement)

Exclusion Criteria:

* patients are pregnant or lactating
* uncontrolled active infection
* class III/IV cardiovascular disability according to the New York Heart Association Classification
* active hepatitis B or hepatitis C infection
* patients with HIV infection
* patients with history of seizure
* active central nervous system leukemia
Establishment and Application of Digital Diagnosis and Treatment System for Sarcopenia

The goal of this observational study is to establish a digital diagnosis and treatment system for sarcopenia, integrating research outcomes into a unified approach encompassing a digital vaccine (early warning screening model), digital drug (intervention model associated with pathogenesis), and digital rehabilitation (preventive system combining early warning and treatment). This aims to create a digital visual tertiary prevention network for sarcopenia.

Research aims:

Evaluate the effectiveness of the digital vaccine through a cross-sectional epidemiological survey.

Establish a specialized cohort for sarcopenia through a longitudinal investigation, implementing the digital drug and digital rehabilitation interventions.

Participants will:

Engage in screening and assessment based on inclusion and exclusion criteria.

Be monitored longitudinally, with tailored interventions for those with muscle atrophy and regular follow-ups for at-risk individuals.

Key outcomes will focus on sarcopenia indicators, serum biomarkers, and clinical endpoints such as fracture rates, weakness classification, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥45 years;
* meeting sarcopenia diagnostic criteria;
* consent to participate in this study

Exclusion Criteria:

* Age \<45 years;
* patients in acute phase of chronic illness;
* infectious disease patients;
* people who lack of independent mobility;
* people who lack of communication or cognitive skills;
* people who refusal to participate in this study
Supplemental Oxygen in Vascular Surgery

The purpose of this study was to test the hypothesis that supplemental postoperative oxygen reduces the risk of surgical wound infection in patients following lower limb vascular surgery.


Eligibility Criteria:
Inclusion Criteria:

* lower limb vascular surgery

Exclusion Criteria:

* COPD
* sPO2 less than 90%
Head to Head Study of Anti-VEGF Treatment.

An exploratory single site, open label, randomized, controlled study evaluated plasma vascular endothelial growth factor levels after intravitreal injection of ranibizumab (Lucentis) and conbercept (Langmu) for neovascular age-related macular degeneration

This prospective, randomized, open label study enrolled patients with neovascular AMD who were naïve to anti-VEGF therapy or have not received intravitreal anti-VEGF therapy for the previous 3 months. Patients were randomized in two treatment arms for 3 months:

* Study arm 1: Three monthly injections of 0.5mg Ranibizumab
* Study arm 2: Three monthly injections of 0.5mg Conbercept Blood sample (plasma/serum) was collected at baseline (pre-dose), 3h post-injections and days 1, 3, 7 and 28, following doses 1 and 3 for PK and systemic VEGF analysis. The lab staff was blinded for treatment allocation.

Plasma VEGF concentration was measured by a blinded laboratory using Quantikine® ELISA kits. Serum ranibizumab and conbercept concentration will be determined using validated ELISA assay.

The study was divided into 2 stages: the 1st initial feasibility stage with 6 patients per arm (12 patients in total) to verify SD for sample size justification and 2nd stage to confirm the findings with justified sample size.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed.
2. Male or female patient ≥ 50 years of age.
3. Subfoveal CNV secondary to nAMD.
4. BCVA score must be between 73 and 24 letters as measured by ETDRS chart

Exclusion Criteria:

For both eyes

1. Any active periocular or ocular infection or inflammation
2. Uncontrolled glaucoma
3. Neovascularization of the iris or neovascular glaucoma. For study eye
4. Choroidal neovascularization of any other cause than wet AMD
5. Ocular disorders present that may confound interpretation of study results,
6. Previous treatment with verteporfin PDT (Visudyne®), external-beam radiation therapy, focal laser photocoagulation, vitrectomy, submacular surgery, or transpupillary thermotherapy.
7. Structural damage within 0.5 disc diameter of the center of the macula
8. Atrophy or fibrosis involving the center of the fovea.
9. Inability of obtaining required lab report. Ocular medical history
10. History of intravitreal injection with any anti-VEGF drugs within 3 months. Exclusion criteria for systemic medical conditions and treatment
11. Any type of systemic disease or its treatment
12. Any patients diagnosed with tumor.
13. Stroke or myocardial infarction less than 3 months.
14. Known hypersensitivity to indocyanine green, fluorescein, or any component of the investigational drug formulation.
15. Use of any systemic anti-VEGF drugs within 6 months. Exclusion criteria for patient
16. Patients who have participated in other investigational drug study within 60 days.
17. Pregnant or nursing (lactating) women.
18. Inability to comply with study or follow-up procedures.
Modifying Treatment Expectations in Depression: the Role of Social Learning

Research has shown that treatment expectations play a major role in the course of mental disorders and that positive expectations have a beneficial impact on treatment outcomes. Expectations can develop in different ways, whereby an emerging body of research has shown that social learning plays a significant role in this process. To date, most studies have investigated the impact of social learning on treatment expectations in the context of pain relief. Little is known about the impact of social learning in the psychotherapeutic treatment of depression. Therefore, this study investigates whether treatment expectations regarding the treatment of depression can be modulated via social learning, i.e., showing positive treatment testimonials.

Hypotheses:

H1: The investigators predict that individuals who are provided with treatment testimonials (experimental groups) show a greater change toward positive treatment expectations compared to individuals who do not view such testimonials (control groups).

H2: The investigators predict that individuals provided with treatment testimonials will, compared to the control groups, show a greater change in secondary outcome variables in the following ways: a greater decrease in perceived uncertainty/ barriers; a greater decrease in stigma/ negative attitudes toward psychotherapy; a greater increase in intentions to seek therapy; a greater willingness to try the specific technique described in the videos.

H3: Inter-individual differences in the effect of provided testimonials are associated with pre-existing factors: level of depressive symptoms; intolerance of uncertainty; treatment experience; locus of control; general self-efficacy; dispositional optimism and cognitive immunization tendencies.

Exploratory questions:

1. An exploratory aim of this study is to assess whether viewing different types of testimonials (clinician delivered; patient-delivered; combination of both) has differential effects on treatment expectation change.
2. Furthermore, the investigators want to assess whether implicit treatment expectations change in a similar pattern as explicit treatment expectations.
3. Based on the results of H1 and H2, the investigators aim to assess possible mechanisms of change: e.g. assess whether a change in treatment expectations is mediated by a decrease in perceived uncertainty or a change in stigma/ attitudes toward therapy.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* be able understand German (at least B1 level)
* have access to a computer device with internet access

Exclusion Criteria:

* age below 18 years old
* non correctable hearing or visual impairment
Implementing Technology Enhanced Real Time Action Observation Therapy in Persons With Chronic Stroke

This is a feasibility study to alter the Microsoft Kinect software to be used as a rehabilitation tool. The prototype used is still in the early developing stage. The purpose of this research study is to develop a prototype of altered Microsoft Kinect Software and determine its use in improving the function of the study subjects' weaker extremities. The altered software will allow a viewing of the mirror image of the involved limb as it is moved. However, the image that is viewed will reflect normal movement even if the limb cannot move normally. By viewing normal movement of the weaker limbs the "mirror neuron" network in the brain will become activated and will ultimately improve the function of the weaker side.


Eligibility Criteria:
Inclusion Criteria:

* - Adults 40 years of age and older having had a stroke greater than 6-months post onset
* Able to follow commands in English
* Medically stable and without acute illness, such as infection, inflammation, ongoing chest pain, or short of breath with walking and light activities
* Able to stand up off of a standard height chair (16-18 inches)

Exclusion Criteria:

* - Cognitive impairment as measured by a score below 24/30 on Mini Mental State Examination
* A diagnoses of cancer involving the nervous or musculoskeletal system
* Severe pain in arms, legs, or spine measured by \>6/10 using Verbal Numerical Pain Rating Scale that prevents them from standing or walking independently
* Diagnoses of other neurological diseases except for stroke, such as spinal cord injury or Parkinson's disease etc.
* Individuals at the advanced stage of a disease and with less than 12 months to live.
Effectiveness of a Safety App to Respond to Dating Violence for College Women and Their Friends

Intimate partner violence (IPV), including violence in dating relationships (dating violence, DV) is a widespread and serious public health problem. Among U.S. female IPV survivors, 47.1% report their first abusive relationship occurred at college age (age 18-24). Similarly, in national surveys, adults respondents 18-24 years of age report the highest rate of stalking victimization, most commonly by a former intimate partner. Safety planning is the most widely used intervention to prevent and respond to IPV, yet the vast majority of abused women never access safety planning services. Our challenge is to increase college women's access to safety planning, with the opportunity to consider their unique safety priorities and level of danger during and when ending an abusive relationship. In addition, while "bystander" interventions that train peers to safely intervene have been shown to be effective in sexual assault prevention on campus, and college women in abusive relationships most frequently disclose IPV to a friend, no similar interventions have been tested with friends for IPV response on campuses. Therefore, the objective of the study is to evaluate the:

1. effectiveness of an interactive, personalized smart phone and web based safety application ("App") intervention in Maryland and Oregon with: 1) college women (age 18-24) who experience IPV and 2) friends (age 18-24) of women experiencing IPV. The safety decision App allows the user to enter information on: a) relationship health; b) safety priorities; and c) severity of violence/danger in relationship. The App then uses the information to provide the user with a personalized safety planning information and resources; and
2. dissemination of the App nationally to determine the reach, adoption, implementation and maintenance of App use among university/college students.


Eligibility Criteria:
Inclusion Criteria:

* Females who report current physical violence, sexual violence, psychological abuse or stalking by a dating/intimate/ex-intimate partner, or who have a female friend currently experiencing abuse from dating/intimate/ex-intimate partner.
* Males who have a female friend currently experiencing physical violence, sexual violence, psychological abuse or stalking by a dating/intimate/ex-intimate partner
* English speaking
* Between the ages of 18-24 years old
* Attend a college in Maryland or Oregon
* Enrolled in college or university (at least part time)
* Have access to a safe smart-phone or computer with internet and are comfortable downloading an app or using the internet
* Have a safe email address

Exclusion Criteria:

* Younger than 18 years of age
* Older than 24 years of age
* Cannot read/speak English
* Live outside targeted states
* No access to safe smart phone or computer with internet
* Uncomfortable with downloading an app
* No access to a safe email address
* Does not report current violence from an intimate partner or having a female friend that has experienced intimate partner violence
N-Care Project: Enhancing Asian-Pacific Collaboration

Through Asian-Pacific multinational collaboration, we aim to utilize third-generation genome sequencing to rapidly diagnose genetic diseases in critically ill infants and young children, achieving the goal of early diagnosis for targeted treatment.

A group of individuals with specific characteristics was selected. Genetic studies were arranged for participants who provided their consent.

Eligibility Criteria:
Inclusion Criteria:

1. Age: infant/newborn less than 18 months
2. Admitted to intensive care unit
3. At least one of the following conditions A. Specific anomaly highly suggestive of a genetic etiology

   * Multiple birth defects
   * Single major malformation that required intervention (surgery or medication)
   * Significantly abnormal EKG
   * Significant hypotonia

B. Children with high-risk stratification on assessment of a Brief Resolved Unexplained Event (BRUE) with any of the following:

* Recurrent severe infection events
* Recurrent or prolonged seizures
* Unexplained cardiopulmonary resuscitation (CPR)
* Suspect inborn error of metabolism

Exclusion Criteria:

1. Infants with a definitive non-genetic diagnosis: ex as below A. An infection with normal response to therapy B. Isolated prematurity C. Transient hypoglycemia D. Isolated unconjugated hyperbilirubinemia E. Isolated Transient Neonatal Tachypnea F. Those where the clinical course can be explained without genetic testing
2. Confirmed genetic diagnosis explains illness
3. Lack of consent: Families who do not consent to genetic testing or data sharing.
4. Infants without sufficient DNA sample quality/quantity: Where the quality or quantity of the DNA sample is inadequate for sequencing.
Study of the Effect of Mometasone Furoate/Formoterol (MF/F), Montelukast and Beclomethasone Dipropionate (BDP) on Plasma Cortisol Levels of Children 5-11 Years Old With Persistent Asthma (P05574)

The purpose of this study is to assess the effect of one of five possible study medications used in the treatment of asthma on blood plasma cortisol levels in children aged 5-11 years with persistent asthma.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of persistent asthma of ≥6 months duration
* body weight ≥18 kg
* able to discontinue prescribed inhaled corticosteroid (ICS) or ICS combined with long-acting beta-agonist (LABA) before starting study medication
* use of a low or medium daily dose of ICS (either alone or in combination with a LABA) with no use of oral corticosteroids within 3 months prior to Screening Visit
* stable asthma regimen (daily dose unchanged) for ≥2 weeks prior to Screening Visit
* documented positive responsiveness to bronchodilators
* ability to use a peak flow meter correctly and to perform spirometry and PEF measurements
* ability to use an inhaler correctly
* consent/assent for the trial and for pharmacogenetic testing (Note: If unwilling to consent/assent for pharmacogenetic testing, inclusion in the study is still allowed, but no pharmacogenetic samples will be obtained.)

Exclusion Criteria:

* use of a high dose of ICS for ≥30 days within 6 months prior to Screening Visit
* treatment in the emergency room (for a severe asthma exacerbation requiring systemic corticosteroid treatment) or hospitalization for management of airway obstruction within 3 months prior to Screening Visit
* ever required ventilator support for respiratory failure secondary to asthma
* upper or lower respiratory tract infection (viral or bacterial) within 2 weeks prior to Screening Visit
* clinically significant abnormal vital sign
* evidence of oropharyngeal candidiasis
* history of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular, or other significant medical illness or disorder that may interfere with study participation. Specific examples include but are not limited to insulin-dependent diabetes, active hepatitis, cardiovascular disease including hypertension, or conditions that may interfere with respiratory function such as, bronchiectasis, and cystic fibrosis
* allergy to or intolerance of corticoids, beta-2 agonists, montelukast or any of the inactive ingredients in the medications used in this study
* participation in this same study at another study site
* previous randomization into this study
* participation in another investigational study for the duration of this study
* use of any investigational drug within one month prior to Screening Visit
* previous participation in a study with MF/F or montelukast
* direct association with or family member of one of the investigators or study staff
* sibling of a participant in this study
Patient Satisfaction After Silicone Metacarpophalangeal Arthroplasty

The primary objective of this study is to identify determinants of long-term patient satisfaction after hand reconstruction using silicone metacarpophalangeal arthroplasty (SMPA). The investigators hypothesize that appearance of the hand, ulnar drift, range of motion, pain, hand function and intake of the newer antirheumatic drugs (i.e. biologicals) influence patient satisfaction.

This is an ambidirectional, monocenter research project consisting of a retrospective chart review and a prospective cohort project.

Participants fulfilling all of the following inclusion criteria are eligible for the project:

* Patients with rheumatoid Arthritis (RA) / Psoriasisarthritis / Lupus erythomatodes who had a SMPA between Jan 2007 and one year before the project examination
* Informed Consent as documented by signature

The presence of any one of the following exclusion criteria will lead to exclusion of the participant:

* Major surgery at another joint at the hand (e.g. proximal interphalangeal (PIP) joint arthroplasty, thumb trapeziectomy) less than 6 months ago
* Legal incompetence
* German language barrier to complete the questionnaires

Eligibility Criteria:
Inclusion Criteria:

* Patients with RA / Psoriasisarthritis / Lupus erythomatodes who had a SMPA between Jan 2007 and one year before the project examination
* Informed Consent as documented by signature

Exclusion Criteria:

* Major surgery at another joint at the hand (e.g. PIP arthroplasty, thumb trapeziectomy) less than 6 months ago
* Legal incompetence
* German language barrier to complete the questionnaires
Effectiveness of Bupropion for Treating Nicotine Dependence in Young People

Little is known about the best ways to help young people stop smoking. Bupropion (a medication marketed as Wellbutrin or Zyban) has proved helpful in treating adult smokers. The purpose of this study is to determine if bupropion is also effective in treating smokers between the ages of 12 and 25 years old. This study also compares the effectiveness of bupropion used as a supplement to behavioral treatment versus behavioral treatment used alone. In addition, the study evaluates whether hormonal response to stress measured prior to the start of treatment predicts whether individuals respond well to treatment with medication.

Cigarette smoking and other forms of tobacco exposure are one of the leading preventable causes of morbidity and mortality in the United States. Most smokers begin smoking during adolescence, and though they seem motivated to quit smoking, they frequently fail. Although behavioral treatments are available, they have not been very successful in past studies.

Depressed adults may have more difficulty quitting smoking than non depressed adults; this finding may also apply to depressed youth. The purpose of this study is to determine the effectiveness of bupropion in combination with standard behavioral treatment in helping young smokers quit, as compared to behavioral treatment alone. Finally, the study examines whether hormonal response to stress measured prior to treatment initiation predicts whether individuals respond well to treatment with bupropion.

Participants in this double-blind study will be randomly assigned to receive either bupropion or placebo. Both groups will receive behavioral treatment. The trial will last for 9 weeks, with weekly study visits. Study visits will last 30 minutes to 1 hour and will include medication monitoring, self-reported and biological measures of smoking, and behavioral treatment. Participants will have follow-up visits six months after completion of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Has smoked at least 10 cigarettes each day for 3 or more months
* Weighs at least 90 lbs
* Motivated to quit smoking and has had at least one previous failed attempt
* Speaks, reads, and writes English
* Either diagnosed as depressed OR no history of a psychiatric disorder

Exclusion Criteria:

* History of bipolar disorder, eating disorder, schizophrenia, schizoaffective disorder, autism, or non-nicotine substance use disorder in the 6 months prior to study entry
* Currently suicidal or with a history of a suicide attempt in the 6 months prior to study entry
* Psychotic symptoms
* Use of psychotropic medication(s)
* Serious medical condition
* Prior use of bupropion for smoking cessation
* Currently using other smoking cessation treatments