cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Flortaucipir PET Signal and Cognitive Change in Early Alzheimer's Disease

This study will evaluate whether visual interpretation of flortaucipir-PET (positron emission tomography) scans, examining patterns of tracer uptake at baseline, can predict the rate of clinically-meaningful cognitive decline due to AD after 18 months. All scans are acquired from cohorts of a previously completed study, I8D-MC-AZES (NCT02245737, lanabecestat, Eli Lilly and Company sponsor).


Eligibility Criteria:
Scan Reader Criteria (5 total readers):

* Board-certified in radiology or nuclear medicine
* Professional experience interpreting PET scans

Scan Criteria (205 total scans):

* Former enrollment in AZES Study
* Flortaucipir scan at baseline
* clinical dementia rating - sum of boxes (CDR-SB) assessment at 18 months

Scan Study Population (AZES Study):

* 55 to 85 years
* MCI due to AD or probable AD by National Institute on Aging-Alzheimer's Association criteria (Albert 2011
* mini-mental status exam (MMSE) of 20 to 30 inclusive
* CDR global score of 0.5 (MCI), or 0.5 or 1 (AD) with a memory box score ≥ 0.5, and a score of ≤85 on the Delayed Memory Index of the Repeatable Battery for the Assessment of Neuropsychological Status.
* Amyloid positive status confirmed by florbetapir PET or lumbar puncture
Study of Recombinant Factor VIIa Fusion Protein (rVIIa-FP, CSL689) for On-demand Treatment of Bleeding Episodes in Patients With Hemophilia A or B With Inhibitors

The purpose of this study is to investigate the pharmacokinetics (PK), efficacy, and safety of rVIIa-FP (CSL689). The study will enroll approximately 54 male subjects, 12 to 65 years of age, with hemophilia types A or B who have developed inhibitors to FVIII or FIX. The study consists of 3 sequential parts (Parts 1, 2, 3): The purpose of Part 1 (PK part) is to evaluate the PK of a single treatment of CSL689 (low dose or high dose) and compare with the PK of a single treatment of Eptacog alfa (low dose or high dose). In Part 1, CSL689 and Eptacog alfa will be given by the doctor at the study center. The purpose of Part 2 (Dose-evaluation part) is to identify which of the 2 tested dose levels of CSL689 shows the best efficacy and safety in stopping acute bleeding events (this dose will be called the "population best dose"). The purpose of the final Part 3 (Repeated-dose part) is to confirm the efficacy and safety of the "population best dose" identified in Part 2. In Parts 2 and 3, subjects will self-administer a specified number of CSL689 infusions at home on-demand (ie, when a bleeding event occurs), will keep an electronic diary, and will visit the center at monthly intervals. This study is expected to last for up to 16 months for the subjects participating in all 3 parts, and up to 9 months for the subjects participating in Part 3 only.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects with hemophilia A or B and inhibitors.
* Age ≥ 12 and ≤ 65 years.
* High responding inhibitor with documented historical inhibitor titer \> 5 Bethesda Units/mL.

Exclusion Criteria:

* Congenital or acquired coagulation disorders other than hemophilia A or B.
* Ongoing immune tolerance induction therapy or planned during study.
* Known or suspected hypersensitivity to activated recombinant human FVII or to any excipient of CSL689.
* Body mass index \> 30 kg/m².
* Major surgery within 28 days before screening or scheduled major and / or orthopedic surgery during the study.
* Advanced atherosclerotic disease (ie, known history of ischemic heart disease, or ischemic stroke).
* Any clinical signs or known history of thromboembolic events, including known deep vein thrombosis.
* Human immunodeficiency virus (HIV)-positive subjects who have low cluster of differentiation 4 (CD4)+ lymphocyte count (200/μL or less) at screening.
* Use of the following within the screening period or planned during study: a) plasma or coagulation factor concentrates other than rescue therapy or therapy during Part 1, b) other platelet inhibitors, c) desmopressin, and d) fibrinolysis inhibitors, except if used as local treatment (eg, for oral bleeds).
Clinical Research on Dynamic Monitoring MRD Via Plasma ctDNA After Systemic Therapy of Hepatocellular Carcinoma

This study aims to combine biomarker characteristic atlas and ctDNA detection technology to establish a precise standard scheme for minimal residual diagnosis of liver cancer after surgery and systemic treatment.

This study is a prospective, single-blind, randomized, controlled, single-center study. The patients with liver cancer are recruited after surgery or systemic treatment. Intraoperative cancer and para-cancer tissues of surgical patients are collected, and peripheral blood of all patients after multiple follow-up visits before and after treatment are also collected. The established detection method and model are used to detect blood ctDNA of patients with liver cancer after treatment, and the follow-up data are collected to observe the correlation between the genomic characteristics of plasma at multiple follow-up points after treatment and the recurrence or progression after treatment. The sensitivity and specificity of ctDNA detection method is calculated to predict the risk of relapse or progression after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 years old (including 80 years old), gender is not limited;
2. Patients diagnosed with primary HCC;
3. ECOG score ≤1;
4. no previous malignant tumors, including liver cancer;
5. Before blood collection, the patient had not received any treatment related to liver cancer, including surgery, transplantation, radiotherapy, chemotherapy, etc.;
6. Survival period of ≥3 years as initially assessed by researchers;
7. Those who are fully aware of this study and voluntarily sign the informed consent.

Exclusion Criteria:

1. Patients diagnosed with esophageal cancer, gastric cancer, colorectal cancer, lung cancer, pancreatic cancer, breast cancer and other malignant tumors;
2. Patients who have received major surgical treatment such as blood transfusion or transplantation within 3 months;
3. Participate in other interventional clinical investigators within 3 months;
4. Pregnant or lactating women;
5. Patients with autoimmune diseases, genetic diseases, mental disorders/disabilities, substance abuse and other diseases deemed unsuitable for participation in the study by the researchers;
6. Poor compliance, according to the judgment of the researcher can not complete the study.
Study of the Predictors of the Course and Early Outcome of Patients With Systemic Lupus Erythematosus: Nature Versus Nurture

OBJECTIVES: I. Continue yearly ascertainment visits of all patients of the established Lupus in Minority Populations: Nature vs Nurture (LUMINA) study cohort.

II. Recruit into the LUMINA cohort newly diagnosed patients with systemic lupus erythematosus (SLE).

III. Determine the impact of additional major histocompatibility complex (MHC) and non-MHC genetic factors not previously examined, specifically tumor necrosis factor, mannose binding protein, interleukin-1 receptor antagonist, and bcl-2, on the course and outcome of SLE.

IV. Refine the assessment of those clinical and behavioral-cultural factors found to be important predictors of disease activity, damage, and functioning, thus far in these patients.

V. Determine the relationships among disease activity, disease damage, and physical and mental functioning in these patients as the SLE progresses and the factors that predict them.

PROTOCOL OUTLINE: This is a parallel, follow up study of a natural history study. Patients are stratified according to ethnicity (Caucasian vs African-American vs Hispanic).

Patients are examined at baseline and then every 6 months thereafter in order to determine the relative impact of genetic, sociodemographic, and behavioral-cultural factors on disease outcome. Patients are assessed for the following outcome variables: disease activity by the Systemic Lupus Activity Measure (SLAM), disease damage by the Systemic Lupus International Collaborative Clinics Damage Index (SDI), and physical and mental functioning by the Medical Outcomes Study 36 Item Short-Form Health Survey (SF-36). Patients are also assessed for independent variables belonging to the following domains: socioeconomic-demographic, clinical, immunogenetic, and behavioral-cultural. Patients undergo genetic analysis utilizing polymerase chain reaction and electrophoresis to further study the immunogenetic domain and genetic markers that may be related to disease. Specifically, patients' blood is analyzed for tumor necrosis factor alpha, tumor necrosis factor beta, mannose binding protein, interleukin-1 receptor antagonist, and bcl-2.

Eligibility Criteria:
* All systemic lupus erythematosus (SLE) patients currently constituting the established Lupus in Minority Populations: Nature vs Nurture (LUMINA) cohort OR New recruits meeting at least 4 of the 1997 American College of Rheumatology criteria for the classification of SLE
* Disease onset within the past 5 years
* African-American, Hispanic, or Caucasian Self stated, plus the same for all 4 grandparents
* No concurrent participation in any intervention studies
* Not pregnant
* Not mentally retarded
* No prisoners
* No other concurrent disability that would preclude study
A Study of Pharmacokinetic Drug Interaction Study of the Hedgehog Pathway Inhibitor GDC-0449 in Combination With Rosiglitazone or Combined Oral Contraceptive in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists

This is a single-arm, multicenter, Phase Ib study designed to describe the effect of GDC-0449 on the pharmacokinetics of rosiglitazone and oral contraceptives in patients with advanced solid tumors who are refractory to treatment or for whom no standard therapy exists.


Eligibility Criteria:
Inclusion Criteria:

* Histologic documentation of incurable, locally advanced, or metastatic solid malignancy that has failed to respond to at least one prior regimen or for which there is no standard therapy
* Documented negative serum pregnancy test for women of childbearing potential and use of two forms of contraception. Contraception must be used while the patient is enrolled in the study and for 12 months after the patient discontinues from the study.
* For men with female partners of childbearing potential, agreement to use a latex condom and to advise their female partner to use an additional method of contraception during the study and for 3 months after their last dose of GDC-0449.
* Agreement not to donate blood or blood products during the study and for at least 12 months after their last dose of GDC-0449
* For male patients, agreement not to donate sperm during the study and for at least 3 months after their last dose of GDC-0449
* Adequate hematopoietic capacity
* Adequate renal function
* Adequate hepatic function
* At least 3 weeks since the patient's last chemotherapy, investigational agent, radiation therapy, or major surgical procedure and recovery to pre-treatment baseline or stabilization of all treatment-related toxicities

Exclusion Criteria:

* Active infection requiring intravenous (IV) antibiotics
* Clinically important history of liver disease significantly impairing hepatic function, including active viral or other hepatitis, current alcohol abuse, or cirrhosis
* Any medical condition or diagnosis that would likely impair absorption of an orally administered drug
* Pregnant or lactating
* Treatment with excluded medications, including strong CYP450 inhibitors and inducers, within 2 weeks of study entry
* Male patients already receiving rosiglitazone
* Male patients with a known contraindication to rosiglitazone
* Female patients already receiving oral contraception \< 14 days prior to Day 1
* Female patients with known contraindication to oral contraceptions
Profiling the Skin Microbiome in Response to Altreno in Acne Patients

The study objective is to characterize the shift in the diversity and abundance of the skin microbial community at baseline and in response to Altreno monotherapy as compared to benzoyl peroxide (BPO) 2.5% leave-on gel monotherapy in acne patients.

With the advent of 16S rRNA sequencing, scientific community is beginning to understand the critical importance of the microbiome in human health. In dermatology, researchers have begun to lead the effort to not only better understand how the microbiome contributes to the pathogenesis of skin disease, but also harness its power to develop novel therapies. Acne is a common inflammatory skin disorder. P. acnes on the skin has been traditionally thought of as the culprit bacteria in the pathogenesis of acne.

Recent studies demonstrate that the skin microbial composition dynamically changes in response to systemic acne therapy. Using 16 rRNA gene sequencing, a prior study has confirmed that systemic antibiotic treatment decreased the abundance of P. acnes, which returned to baseline after discontinuation of the therapy. In contrast, the systemic therapy increased the abundance of Pseudomonas species, which returned to baseline after therapy cessation. Based on the opposing response to the therapy, it can be speculated that these two species compete for the same microenvironment within the skin microbiome. Interestingly, the same systemic therapy decreased the abundance of lactobacillus genus, the "good bacteria" that is protective against skin infection, and that decrease was sustained even after cessation of the therapy. Similarly, another study has demonstrated that systemic isotretinoin therapy disturbed the skin microbiome in acne patients with increased bacterial diversity on the cheeks. It is unclear the potential therapeutic role of the increased bacterial diversity in the management of acne patients.

The study aims to characterize the shift in the diversity and abundance of the skin microbial community in response to Altreno in acne patients. Understanding the role of the skin microbiome in response to therapy can help clinicians to develop tailored, targeted treatment options, including reconstitution of "good bacteria." Furthermore, it can lead to development of novel topical pre and probiotics.

Eligibility Criteria:
Inclusion Criteria:

* A confirmed diagnosis of acne that warrants initiating topical medications.
* Denies use of any prescribed systemic acne treatments in the past 30 days.
* Denies use of any prescribed topical medications in the past 30 days.
* Denies use of any OTC topical acne medications in the past 14 days.
* Denies use of any emollients in the past 24 hours (if feasible).
* Denies bathing or facial washing in the past 12 hours (if feasible).
* Willingness to adhere to the recommended topical regimen during the duration of the study.

Exclusion Criteria:

* Women who are pregnant, breastfeeding, or planning to get pregnant during the study.
* Use of any investigational drug(s) in the past 3 months.
Immersive Virtual Reality Based Exersice in Post-mastectomy Lymphedema Patients

To determine the effect of immersive virtual reality on shoulder proprioception and ROM of post-mastectomy lymphedema patients.

RESEARCH QUESTION:

Does Immersive virtual reality based exercise effective in improving shoulder proprioception and ROM for post-mastectomy patients?

Assessment:

The digital goniometer will be used in measuring shoulder extension, flexion, adduction, abduction, internal rotation and external rotation before the sessions and after one month of sessions. Also, shoulder proprioception will be assessed by the digital goniometer.The measurement will be taken for both the edematous side and the non-affected side.

Treatment:

Study group: the patients will receive eight sessions of Immersive virtual reality based exercise, 2 sessions per week for 4 weeks besides the traditional physical therapy.

Control group: the patients will receive eight sessions of the traditional physical therapy, 2 sessions per week for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* All the patients will be females.
* Patients with lymph node dissection.
* start at least 2 weeks after operation.

Exclusion Criteria:

* Vision problems.
* Medically instable patients.
* Balance disorders.
* Other musculoskeletal condition of shoulders.
Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease (IBD)

This is a randomized, double-blind placebo controlled study to assess for safety, tolerability and nutritional impact of oral serum bovine immunoglobulin (SBI) on pediatric patients and young adults with inflammatory bowel disease (IBD) as assessed by an increase in serum albumin and other nutritional markers including vitamin D level, pre-albumin, transferrin and iron saturation; and improvement in weight and body mass index. SBI is an animal derived protein isolate from the serum of cows containing \>50% IgG. It has been used for patients suffering from irritable bowel syndrome, human immunodeficiency virus enteropathy and antibiotic-associated diarrhea for symptomatic relief of diarrhea with good results and minimal side effects. However its role in IBD has not yet been investigated. The investigators hypothesize that the study product will have a positive nutritional impact along with symptom improvement for pediatric and young adult patients with IBD. The volunteers for our study will have established Crohn's disease or ulcerative colitis and will be treated with a daily powder (SBI or placebo) added to their breakfast food (egg, yogurt, or peanut butter are best) for total of 60 days followed by 30 day monitoring period after completion of treatment. The volunteers will be followed by clinic visits and labs on day 0, day 15, day 60 and day 90. There is the potential for the treatment to alter disease activity, a secondary outcome, as assessed by measurement of serum markers of inflammation (ESR, CRP), fecal calprotectin (validated marker of intestinal inflammation), and clinical indices like short pediatric Crohn's disease activity index (shPDCAI) or pediatric ulcerative colitis activity index (PUCAI) for children and Harvey Bradshaw Index or SCCAI for adults. Stool samples will be collected on day 0 and day 60 for 16S RNA sequencing to assess for changes in microbiota of the participants while on the study product/placebo. We plan to enroll 43 patients in the study to allow for data analysis of atleast 30 patients. The study will take place over 1 year and will be conducted at University of Texas-Children's Memorial Hermann Hospital, where we follow \> 125 children with inflammatory bowel disease.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients, ages 6-30 years diagnosed with inflammatory bowel disease (UC/Crohn's disease) based on the pediatric ulcerative colitis activity index/ short pediatric Crohn's disease activity index for children and Harvey Bradshaw Index/SCCAI for young adults

Exclusion Criteria:

* Patients with severe illness requiring inpatient admission
* Patients with known allergy to beef or beef products, sunflower lecithin and dextrose
* Patients with liver function tests elevated to more than 3 times the upper limit of normal
* Pregnancy or breastfeeding
A Study Evaluating Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy

The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of VX-993 in treating acute pain after a bunionectomy.


Eligibility Criteria:
Key Inclusion Criteria:

Before Surgery:

* Participant scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo block)

After Surgery:

* Participant is lucid and able to follow commands
* All analgesic guidelines were followed during and after the bunionectomy

Key Exclusion Criteria:

Before Surgery:

* Prior history of bunionectomy or other foot surgery on the index foot
* History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) within the last 2 years
* A known or clinically suspected active infection with human immunodeficiency virus or hepatitis B or C viruses

After Surgery:

* Participant had a Type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair, or had medical complications during the bunionectomy

Other protocol defined inclusion/exclusion criteria may apply.
Bleeding Rate After EGD and Colonoscopy in Patients Who Continue to Take Antithrombotic Agents

The bleeding rate of both EGD (including biopsy) and colonoscopy (including biopsy, cold or hot snare polypectomy, or EMR) in patients who continue to take various antithrombotic drugs is studied prospectively. The immediate or delayed bleeding that requires hemostatic clipping or other endoscopic treatments is defined as the bleeding. Immediate bleeding requiring hemostatic clipping is defined as spurting or oozing which continued for more than 30 seconds. Delayed bleeding is defined as bleeding that requires the endoscopic treatment within 2 weeks after endoscopy. Prophylactic clipping is not performed after taking biopsy and doing polypectomy. Additionally, investigators evaluate the rate of injured submucosal arteries of the excised specimen when the bleeding occurs.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria is all patients who continue to take antithrombotic drugs and undergo EGD or colonoscopy

Exclusion Criteria:

* Patients who take prophylactic clipping after biopsy or polypectomy American Society of Anesthesiologists physical status of class IV or V
Mega-CHOEP: Conventional Chemo Vs HD Chemo Followed by Auto SCT in Younger Pts With Aggressive Non-Hodgkin's Lymphoma

According to amendment 3 this study addresses the question if intensification of administration of rituximab in standard treatment for patients with newly diagnosed aggressive B-Non Hodgkin Lymphoma (B-NHL) and high risk (aaIPI 2 or 3) results in a better time to treatment failure (TTTF)

This study was primarily designed to compare aggressive conventional chemotherapy with a repetitive high-dose (HD) therapy program using identical, effective drugs at highest possible dose and dose intensity with/without addition of rituximab (initially 4 treatment arms). In 2004 the first amendment had to be added in order to close two treatment arms without rituximab due to recent data revealing a significant advantage for rituximab-treated patients with CD20+lymphoma.

A planned interim analysis in 2010 revealed inferiority of the high-dose treatment thus in the 2nd amendment the high-dose arm was closed and additionally the rituximab frequency was raised from 6 to 12 administrations as recent publications gave hint for advantage. The last amendment was added in 2010 to adjust for delayed recruitment mainly due to organisation problems.

As the high-dose arm was closed only CD20+ B-lymphoma were included past amendment 2.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years of age
* Risk group International Prognostic Index (IPI) 2 and 3 (age adjusted)
* Performance status: Eastern Cooperative Oncology Group (ECOG) 0-3
* Patient's written informed consent
* Aggressive non-Hodgkin's lymphoma with CD20+ histology

Exclusion Criteria:

* Already initiated lymphoma therapy
* Serious accompanying disorder or impaired organ function
* Bone marrow involvement \> 25%
* Known hypersensibility to the medications to be used
* Known HIV-positivity
* Active hepatitis infection
* Suspicion that patient compliance will be poor
* Simultaneous participation in other trials
* Prior chemo- or radiotherapy for previous disorder
* Other concomitant tumour disease