cyrilzakka/clinical-trials huggingface dataset:
Image-derived Prediction of Response to Chemo-radiation in Glioblastoma

This study seeks to investigate if advanced image-analysis of diagnostic scans, can be used to predict how aggressive brain tumors (glioblastoma) respond to standard chemo- and radiation treatment.

Generally, response prediction models seeks to predict time to an event, e.g. time-to-progression and/or overall survival. The aim of this study is to explore the feasibility of establishing an individualized response model, that, based on several morphologic, physiologic and metabolic parameters extracted from computed tomography (CT), positron emission tomography (PET) and magnetic resonance imaging (MRI), is able to predict the tumor response at the level of an imaging voxel, using machine learning techniques.

Imaging modalities include MRI, PET/CT with 18F-fluroethyltyrosine (18F-FET), and PET/MRI with 64Cu-diacetyl-bis(N4-methylthiosemicarbazone) (64Cu-ATSM).

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, primary supratentorial glioblastoma (WHO grade IV).

Exclusion Criteria:

* No informed consent can be obtained
* Inability to undergo MRI examination, due to metal implants, pacemaker etc.
* Not eligible for Stupp-regimen
Hepatitis C Testing in VA Community-Based Outpatient Clinics

The VISN1 VA Hepatitis C Testing and Linkage to Care Quality Improvement project aims to increase the proportion of Veterans tested for HCV in those born between 1945-1965 and in vulnerable, high-risk groups.

The VISN1 VA Hepatitis C Testing and Linkage to Care Quality Improvement project aims to: (1) increase the proportion of Veterans tested for HCV in those born between 1945-1965 and in vulnerable, high-risk groups, (2) Increase linkage to specialized HCV care among VISN 1 VA Veterans diagnosed with HCV infection, and (3) Evaluate whether race, ethnicity, gender, or other markers of social disparity influence completion of HCV testing and linkage to specialty care, and whether disparities are reduced by the planned VISN 1 VA HCV Quality Improvement (QI) program. The central focus is to reduce delays in diagnosis and linkage to treatment evaluation, management of comorbidities and contraindications, and subsequent initiation.

Eligibility Criteria:
Inclusion Criteria:

* Veterans
* Born in the period of 1945-1965 ("birth cohort")
* With an outpatient visit in primary care at a VISN1 facility in FY 2016

Exclusion Criteria:

* N/A
Barriers to Eye Screening for People With Diabetes in India

Brief Summary: Diabetic retinopathy (DR) is a leading cause of visual impairment and has major public health implications globally and especially in countries such as India where the prevalence of diabetes is high. With timely screening and intervention, the disease progression to blindness can be prevented but several barriers exist to the provision of care. The long term aim is to identify the barriers to DR screening and to plan potential interventional strategies. From the qualitative study, the reasons such as lack of awareness or knowledge, distance to travel, lack of reminder system were identified as a reason for poor follow-up. This lead to the development of interventional strategies.

This was a randomized, investigator-masked clinical trial that was conducted in a tertiary eye care centre in South India. Consecutive patients with diabetes who were residents in Chennai and its vicinity of approximately 100 km radius and who were undergoing repeated intravitreal injections for DME were recruited into the trial. The aim of the study is to investigate the effect of SMS informational reminders among patients with Diabetic macular edema for the follow-up. They study consists of 2 groups, SMS reminder group receives the reminders 1 week and 2 days prior to the scheduled appointments with the concerned doctor on a particular date and time, whereas other group does not receive any reminders for the appointment schedule. After the follow-up, the patients will be screened for the attendance at the review visit.


Eligibility Criteria:
Inclusion Criteria:

* Adults with \> 40 years of age
* Diagnosed as centre involving Diabetic macular edema (DME)
* Patients who received intravitreal injections for DME
* Ability to give informed consent

Exclusion Criteria:

* Patients from outside the area of residence who stayed more than 100 km from the hospital
* Patients with ocular co-morbidities other than DME
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Adults With Atopic Dermatitis

This is a phase 2 study to investigate the safety and efficacy of PAC-14028 cream in Atopic Dermatitis patients.

PAC-14028 Cream (0.1%, 0.3%, 1.0%) or placebo will be treated to Mild to Moderate Atopic Dermatitis patients twice daily for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 19 - 70 years.
* Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria.
* Whose affected BSA is over 5% and IGA score is 2 (mild) to 3 (moderate).
* Who voluntarily agreed to participate in the study and signed an informed consent form.

Exclusion Criteria:

* Who has skin diseases other than atopic dermatitis or scar in the affected area which can affect the study, determined by the study investigators.
* Who has clinically significant medical history or diseases involving liver, kidney, neurological system, psychical disorder that can affect study results.
* Who has used systemic steroids, antibiotics, immunosuppressants, or received photochemical therapy within 28 days before study drug administration.
* Who has used topical steroids, immunosuppressants or antibiotics to treat atopic dermatitis within 14 days before study drug administration.
* Who has used or is expected to inevitably use prohibited concomitant medications during the study.
* Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives.
* Who has dosed other study medications within 30 days before screening.
* Who is determined ineligible for study participation by investigators for any other reasons.
Plasma Glucagon-like Peptide-1 Levels and Acute Myocardial Infarction

GLP-1(9-36) amide and (9-37), which was previously thought to be the inactive metabolite of GLP-1, also exerts cardioprotective effects. Direct administration of GLP-1(9-36) during reperfusion reduced ischaemic damage in isolated hearts and increased cGMP release, vasodilatation and coronary flow in AMI mouse model, one may speculate that total GLP-1 level may associate with adverse cardiovascular events in AMI patients, the hypothesis is therefore tested in this study.


Eligibility Criteria:
Inclusion Criteria:

* consecutive patients of acute AMI come to our department,absent of cardiogenic shock, and survival for at least 24 h after PCI treatment.

Exclusion Criteria:

* patients with cancer, and patients who were taking a DPP4 inhibitor or a glucagon-like peptide-1 (GLP-1) analogue
Breast Cancer Risk Reduction: A Patient Doctor Intervention

The proposed research combines the scientific advances in breast cancer research with health information technology (IT) to design a personalized intervention that assesses breast cancer risk for women, disseminates important breast health information, and facilitates discussion of breast cancer risk reduction practices. Our goal is to implement a tablet-PC (personal computer) based breast cancer risk education (BreastCare) intervention in the primary care setting that estimates a woman's individual risk for breast cancer and provides her and her physician with personalized breast cancer risk information and recommendations for action.


Eligibility Criteria:
Inclusion Criteria:

1. Patient component:

   * Women who visit the General Internal Medicine (GIM) practices at SFGH and UCSF during the study period
   * Between the ages of 40 and 74
   * Self-identify as Asian American, Spanish- and English-speaking Latinas, African American, or White
   * Have no history of breast cancer are eligible to participate.
2. Physician component: Primary care physicians currently practicing at the GIM clinics at SFGH and UCSF

Exclusion Criteria:

1. Patient component: Women whose physicians object to their participation in the study
2. Physician component: No exclusion criteria for physicians
The Efficacy and Safety of Nab-paclitaxel Plus S-1 in First-line Treatment of Advanced Biliary Tract Adenocarcinoma

Advanced biliary tract adenocarcinoma has a poor prognosis with limited therapeutic options. Nab-paclitaxel plus S-1 chemotherapy will be given to untreated patients with advanced biliary tract adenocarcinoma for the first-line treatment.

Gemcitabine/Nab-paclitaxel has become a standard therapy in advanced pancreatic cancer. Given the morphologic and histologic similarities between pancreatic cancer and biliary tract adenocarcinoma, nab-Paclitaxel may be a promising regimen, and S-1 has been approved for biliary tract cancer in Japan. Untreated patients with advanced biliary tract adenocarcinoma will receive Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) and S-1 (40mg BID for body surface area\<1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area\>1.5 m2; D1-14, q3w) as the first-line treatment. The investigators will investigate the efficacy and safety of the combination treatment, and expect to provide a more effective treatment plan for patients with advanced biliary tract cancer in China.The primary endpoint is objective response rate(ORR), and the secondary endpoints are progression-free survival(PFS), overall survival(OS) and the safety.

Eligibility Criteria:
Inclusion Criteria:

* Age, years: 18-70
* Histologically and cytologically confirmed advanced biliary tract adenocarcinoma, unresectable, measurable lesions according to RECIST criteria; ECOG score of 0-1; life expectancy ≥12 weeks;
* Untreated; more than 6 months after the last adjuvant chemotherapy (does not include taxanes and S1);
* Laboratory examination within 14 days before entering the study should meet following requirements:

ANC ≥ 1.5 x 10\^9/L; PLT ≥ 100 x 10\^9/L; Hb ≥ 90g/L (9g/dL); AST, ALT ≤ 2.5 x ULN (with no liver metastasis), ≤ 5 x ULN（with liver metastasis); creatinine ≤ 1.5 x ULN; TBIL ≤ 1.5 x ULN

* Both male and female subjects of potential fertility have to agree effective birth control during the entire study
* Informed consent

Exclusion Criteria:

* Concurrent other effective treatment (including radiotherapy)
* Resectable patients
* Allergy history to other drugs in the same class patients with pregnancy or lactation
* Known severe internal medical diseases
* Abnormal heart function or relevant history of myocardial infarction and severe arrhythmia
* Immunocompromised patients, such as HIV positive
* Uncontrollable mental illness
* Other conditions the researchers considered ineligible for the study
Autologous Platelet-rich Plasma for Clomiphene Citrate-induced Thin Endometrium

This is a prospective self-controlled clinical study. Women with clomiphene Citrate failure with thin endometrium less than 7 millimeters for at least 3 cycles will be selected (N = 30). Patients will receive 2 ovarian stimulation cycles with Clomiphene citrate (CC) 100 mg/ day for 5 days from cycle day 3. A control cycle (CC only cycle) woman will continue on CC alone plus cervical irrigation of cervix with 1 ml of 0.9% normal saline at cycle day 8 and 10 to assure patient-blinded method. The study group, the same will be done plus the intrauterine infusion of Autologous platelet-rich plasma (PRP) in 8th and 10th days of the cycle. In both groups, the endometrial thickness and Power Doppler evaluation of their endometrial and sub-endometrial blood flow will be measured on the day of Human Chorionic Gonadotropin (HCG) administration.

This is a pilot prospective self-controlled clinical trial. Women with Clomiphene Citrate failure with documented thin endometrium less than 7 millimeters for at least 3 stimulation cycles will be chosen (N = 30). Patients will experience 2 ovarian stimulation cycles with Clomiphene citrate (CC) in a dose of 100 mg/ day for 5 days starting from cycle day 3. A control cycle (CC only cycle) woman will continue on Clomiphene Citrate alone plus cervical irrigation of cervix with 1 ml of 0.9% normal saline at cycle day 8 and 10 to confirm patient-blinded process.

The study group, the same will be done in addition to the intrauterine infusion of with Autologous platelet-rich plasma (PRP) in 8th and 10th days of the cycle.

In both groups, the endometrial thickness and Power Doppler evaluation of their endometrial and sub-endometrial blood flow will be measured on the day of HCG administration.

Eligibility Criteria:
Inclusion Criteria:

* Women with clomiphene citrate failure (defined as at least previous 3 ovulatory cycles with clomiphene citrate, with no pregnancy),
* persistently thin endometrium (less than 7 millimeters in at least 3 cycles).
* normal baseline Follicle Stimulating Hormone, Luteinizing Hormone, and free testosterone levels, patent tubes by hysterosalpingography, and satisfactory male semen analysis

Exclusion Criteria:

* previous ovarian surgery;
* endocrine disorders ;
* pelvic pathologies;
* chronic hepatic, cardiovascular, or renal disease;
* other factors of infertility and
* use of gonadotropins or hormonal contraception through the latest 6 months.
Capecitabine and Gemcitabine in Patients With Metastatic Colorectal Cancer

This study is for patients with colorectal cancer that has spread and has increased in size after standard treatments. This study is being done to find out how long it takes their tumors to grow after treatment with the chemotherapy drugs capecitabine and gemcitabine. Capecitabine is a chemotherapy drug that has been approved by the FDA for the treatment of colorectal cancer. We are adding another drug (called gemcitabine), which is approved by the FDA for the treatment of cancer of the pancreas to see if the ability of capecitabine to shrink tumors can be improved by adding gemcitabine. The side effects of the combination will also be evaluated. Another purpose of this study is to measure the levels of certain substances that affect how the body reacts to the chemotherapy agents in cancer cells (in the tumor). In addition, the genes (which are the cell's blueprint for these substances) will also be evaluated in the blood.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic adenocarcinoma of the colon or rectum, with measurable disease. The primary histologic diagnosis is sufficient if there is clear evidence by imaging and/or markers of metastatic disease sites.
* Patients must have failed CPT-11 and oxaliplatin based therapies.
* Patients must have received at least two prior chemotherapy regimens for advanced disease (completed \> 4 weeks prior to enrollment).
* Tumor must be accessible for biopsy or paraffin embedded tissue must be available for review.
* SWOG performance status 0-2.
* AGC \>1000, platelets \>100,000.
* Total bilirubin \< 3 x upper limit of normal. Transaminase (AST and/or ALT) \< 2 x upper limit of normal or \< 5 x upper limit of normal in patients with liver metastasis.
* Patients must have a measured or calculated creatinine clearance greater than 35 mL/min obtained within 28 days prior to registration.
* Age greater than or equal to 18 years
* Patients should have hemoglobin \> 9 g/dL; patients may be transfused to achieve this level of hemoglobin.
* Except for cancer-related abnormalities, patients should not have unstable or pre-existing major medical conditions.

Exclusion Criteria:

* History of a malignancy other than colon or rectal cancer, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years.
* Patients with brain metastasis.
* History of recent (within one year) myocardial infarction or evidence of congestive heart failure.
* Patients that have psychological, familial, sociological, or geographical conditions that do not permit medical follow-up and compliance with the study protocol.
* Patients should not have any immediate life-threatening complications of their malignancies.
The Effect of Walking on Fatigue After Chemotherapy in Patients 65 and Older

This study will look at the impact of a self-directed walking program on post-chemotherapy survivors experiencing fatigue. It is hypothesized that the walking program will help lessen fatigue.

The investiagors propose to evaluate the impact of a home-based self-directed walking program on post-chemotherapy fatigue among 150 cancer survivors age 65 and older -- Senior Physical Activity after Chemotherapy (S-PACT). Participants must have potentially curable cancer, moderate to severe fatigue (score of 4 or higher on the Brief Fatigue Inventory), currently exercise less than 120 minutes per week and have completed chemotherapy treatment (radiation treatment must also be completed if it is part of the patient's treatment plan) within the last 6 weeks. The design is a randomized controlled trial, with participants randomized to a 3-month physical activity program (intervention group) or to wait-list control (this group begins the walking program at 3 months post-randomization). The primary objective is to compare the change in fatigue scores from baseline to 3 months between the intervention and wait-list control groups.

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 65 years and older
* Histologically or cytologically confirmed cancer (hematologic or solid) at stage considered amenable to cure as assessed by the treating MD
* Within 6 weeks of end of chemotherapy (all participants must have had chemotherapy treatment)

  * Any radiation received must also be completed prior to randomization (if radiation treatment follows adjuvant chemotherapy, then the patient must be recruited within 6 weeks of end of radiation)
  * Maintenance hormonal therapy in women with breast cancer is allowed; see exclusion criteria regarding hormonal therapy in males with prostate cancer
* Moderate to severe fatigue (\>4 on BFI)
* Less than 120 minutes/week of physical activity
* English speaking
* Signed IRB approved written informed consent
* Approval from their treating physician to engage in moderate-intensity physical activity
* Patient-assessed ability to walk and engage in moderate physical activity
* Willing and able to meet all study requirements.

Exclusion Criteria:

* Receiving hormonal therapy for prostate cancer
* Unable to walk or engage in moderate-intensity physical activity
* Have BFI≤3.
* Report more than 120 minutes/week of physical activity
Virtual Reality in Burn Pain Management

To examine the safety and efficacy of Virtual Reality (VR) distraction therapy in burn patients experiencing severe procedural pain during wound care.

This is a prospective, randomized cross-over study of the safety and effectiveness of the use of a virtual reality distraction intervention to management procedural pain during burn wound care. Up to 20 subjects will be enrolled until 12 complete the study.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or oler with thermal injury
* Understands English
* patient perception of previous wound care procedural pain is greater than 6 on a numeric pain scal of 0-10 where 0= no pain and 10=worst pain ever experienced
* ability to use a computer mouse or hit the space bar on a computer keyboard

Exclusion Criteria:

* unhealed burned wounds on face, neck or head
* history of severe susceptibility to motion sickness
* presence of open woun ds to the hands that cannot be covered with a dressing while operating the control button
* patients who report a feeling of anxiety or discomfort while viewing the Snow World software on a computer without the helmet
Hexvix Photodynamic Therapy in Patients With Bladder Cancer

The purpose of the study is to investigate the safety and feasibility of Hexaminolevulinate based photodynamic therapy in patients with intermediate or high-risk transitional cell carcinoma of the bladder.

Non-muscle invasive bladder cancer is currently treated by transurethral resection (TURB) and/or fulguration. However, recurrence and progression rates following endoscopic treatment of visible lesions are significant. To prevent recurrent and progressive disease, adjuvant intravesical chemotherapy and immunotherapy are applied. There is also increasing interest in new therapeutic strategies such as photodynamic therapy.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or above who have given written informed consent.
* Patients with intermediate or high-risk superficial bladder cancer, defined as low-grade early recurrence within 6 months after local chemotherapy or BCG, primary or recurrent high-grade disease (TaG3, TaG3 with CIS or CIS alone) or patients with primary T1G3 who are tumour free at second resection.

Exclusion Criteria:

* Patients with muscle invasive tumour
* Patients with bladder shrinkage
* Patients who have received prior PDT for bladder cancer
* History of T1G3 disease or other indications for cystectomy
* Patient with porphyria
* Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with PDT)
* Patients who have received BCG or chemotherapy within three months prior to Hexvix instillation, except for a single dose of chemotherapy for prevention of seeding after resection
* Known allergy to hexaminolevulinate or a similar compound
* Participation in other clinical studies either concurrently or within the last 30 days
* Women of child-bearing potential.
* Conditions associated with a risk of poor protocol compliance
The Efficacy and Safety Study of Rikkunshito in Patients With Functional Dyspepsia

The purpose of this study is to assess the efficacy and safety of Rikkunshito compared to placebo in Japanese subjects with Functional Dyspepsia (FD).


Eligibility Criteria:
Inclusion Criteria:

* -Patients diagnosed with FD according to the ROME III criteria i) Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to obtaining informed consent ii) Have not received upper endoscopy within the last 6 months prior to enrollment and do not have evidence of structural/organic disease iii) Must have one or more of the following symptoms:

  1. Bothersome postprandial fullness
  2. Early satiation
  3. Epigastric pain
  4. Epigastric burning
* At least one of the FD-related symptoms on the Global Overall Symptom (GOS) scale (bothersome postprandial fullness, early satiation, epigastric pain, epigastric burning) is ≥4, whereas heartburn is ≤3.
* Total score of depression-related symptoms on Hospital Anxiety and Depression Score (HAD) is ≤10.
* Type of visit: Outpatient
* Provides voluntary informed consent after receiving adequate explanation and demonstrates thorough understanding of the nature of the study.

Exclusion Criteria:

* Confirmed ulcer (excluding scars) or malignant tumor in the upper GI
* Suspected organic lesions in the hepato-biliary-pancreatic regions such as cholelithiasis, hepatitis, pancreatitis
* History of upper GI resection
* Serious complications (liver, kidney, heart, or blood disease or metabolic disease)
* Less than a year since testing positive for H. pylori or have undergone a successful eradication therapy
* Use of prohibited medications
* Neuropsychiatric disorders
* Use of or planned use of any investigational drugs
* Unable to take drugs orally
* History of allergic reactions to Kampo medicines
* Pregnant or lactating women or those who are planning to conceive during the study period
* Deemed ineligible by principal investigator or sub-investigator