cyrilzakka/clinical-trials huggingface dataset:
Gene Expression and FDG PET/MRI in Evaluating Treatment Response in Patients With Locally Advanced Rectal Cancer Undergoing Chemotherapy and Radiation Therapy Before Surgery

This pilot clinical trial studies gene expression analysis and fludeoxyglucose F 18 (FDG) positron emission tomography (PET)/magnetic resonance imaging (MRI) in evaluating treatment response in patients with rectal cancer that has spread to nearby tissue or lymph nodes undergoing chemotherapy and radiation therapy before surgery. Studying samples of tissue in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and may also help doctors predict a patient's response to treatment before surgery. PET-MRI is a procedure that combines the pictures from a PET scan and an MRI scan. The combined scans give more detailed pictures of areas inside the body than either scan gives by itself. PET-MRI may help determine how well people respond to pre-surgery chemotherapy and radiation therapy and help the surgeon make the best plan for removal of the tumor.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven adenocarcinoma of the rectum.
* Surgical candidate.
* Candidate for neoadjuvant chemotherapy.
* Clinical evidence of T1-3N1 or T3N0 disease. This can be either by imaging studies or by physical exam findings.
* At least 18 years of age.
* Zubrod performance status of 0-2.
* Able to understand and willing to sign a written informed consent document.
* Patients with distant metastatic disease will be eligible if they satisfy all other conditions.

Exclusion Criteria:

* Pregnant.
* Past history of pelvic radiotherapy.
* Received prior chemotherapy for colorectal cancer.
* Uncontrolled diabetes with a fasting glucose ≥ 200 mg/dl at the time of PET/MRI imaging.
* Claustrophobia or any other contraindication to MRI imaging evaluated by a standardized safety questionnaire.
* Renal insufficiency (defined as glomerular filtration rate (GFR \< 30 mL/min/1.73 m2) measured no more than 60 days before the first research scan) which precludes safe administration of the contrast agent.
* Currently on dialysis.
* Known prior allergic reaction to gadolinium-based MR contrast agents.
A Study of Home-based Pulmonary Rehabilitation and Health Coaching to Treat Bronchiectasis

The purpose of this study is to gather information on the effectiveness on a home-based pulmonary rehabilitation in patients with bronchiectasis.

The purpose of this study is to gather information on the effectiveness on a home-based pulmonary rehabilitation in patients with bronchiectasis. We hope that by participating in home-rehab that patients with bronchiectasis will become more physically active in their daily lives.

Pulmonary Rehabilitation in a medical center has proven to have a positive impact on physical activity and shortness of breath in patients with chronic lung disease. However, travel and access can make going to a center difficult.

Study participation involves completing gentle flexibility exercises and walking practice using a provided computer tablet, pulse oximeter and an activity tracker for 12 weeks. During that time, you will talk to a health coach once a week on the phone. At the end of the 12 weeks, someone will call you and ask you questions about your experience with the home-based rehab. Health Coaching calls will be recorded so that it can later be transcribed. All identifying information will be removed and the answers will be lumped together.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of non-cystic fibrosis bronchiectasis (primary inclusion criteria) ,confirmed by records, that are symptomatic.
* Ability to communicate in English.

Exclusion Criteria:

* Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility).
* Cognitive impairment or inability to understand and follow instructions.
* Traditional PR completed within 3 months of study recruitment.
* Hospice or end-of-life care at the time of screening.
* Acute exacerbation at the time of screening.
Efficacy and Safety of HRS-7535 Tablets in Adults With Type 2 Diabetic Kidney Disease

The study is a 16-week multicenter, randomized, double-blind, placebo-controlled, parallel-designed Phase II clinical study. The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in subjects with type 2 diabetic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects, 18-75 years of age at the time of signing informed consent;
2. Body weight ≥50 kg, 20.0 kg/m2 ≤BMI ≤40.0 kg/m2;
3. Diabetic kidney disease was diagnosed, and the eGFR≥30 mL/min/1.73 m2;
4. Had a history of T2DM at least 3 months, or had diabetic retinopathy as assessed by the investigators;
5. UACR ≥300 and \<3000 mg/g;
6. HbA1c ≥6.5% and ≤10.0%;
7. ACEI/ARB was used for ≥3 months and ACEI/ARB was stabilized at either the maximum recommended dose (reference to the drug label) or the maximum tolerated dose within 4 weeks;
8. Use hypoglycemic drugs for ≥3 months (the dosage of SGLT2i remains stable if used);
9. Able and willing to provide a written informed consent;

Exclusion Criteria:

1. Have type 1 diabetes mellitus or specific type of diabetes;
2. Acute kidney injury or dialysis treatment within 6 months;
3. Kidney transplantation is planned during the trial;
4. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
5. Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix;
6. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
7. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
Efficacy and Safety of Namilumab for Moderate-to-severe Axial Spondyloarthritis

The study will assess the effect of namilumab, a GM-CSF inhibitor, on the clinical response in subjects with axial spondyloarthritis. Subjects will receive treatment with either namilumab or placebo.

A phase 2a proof-of-concept, randomised, double-blind, placebo-controlled study to evaluate the safety/tolerability and efficacy of 4 subcutaneous injections of namilumab (150 mg) given over 10 weeks in subjects with moderate-to-severely active axial spondyloarthritis including those previously exposed to anti- TNF therapy (NAMASTE study).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 75 years of age.
* Diagnosis of axSpA by an appropriately qualified physician and classified using ASAS criteria ≥ 3 months prior to Baseline.
* Bath Ankylosing Spondylitis Disease Activity Index score ≥ 4 and spinal pain score ≥ 40, at screening and Baseline.
* MRI evidence of active axSpA ≤ 6 (ideally ≤ 3) months prior to randomisation using ASAS criteria.
* Stable NSAID use prior to study entry.
* Stable use of MTX, sulfasalazine or leflunomide prior to study entry.
* Stable oral corticosteroid dose prior to study entry.
* Capable of giving signed informed consent.
* Inadequately responded to or experienced intolerance to previous treatment with an anti-TNF agent (some subjects).

Exclusion Criteria:

* Current diagnosis of axSpA with a BASDAI \> 4 but no evidence of inflammation on MRI.
* Discontinued biologic therapy \< 8 weeks prior to Baseline.
* Previous or current use of oral corticosteroid as defined in protocol.
* Received intra-articular or i.v. corticosteroids prior to or during Screening.
* Received anti-IL-17A or anti-IL-12/23 therapy.
* Received cyclosporine, tacrolimus or mycophenolate mofetil prior to Baseline.
* Previously received stem cell transplantation.
* Infection(s) requiring treatment with i.v. anti-infectives or oral anti-infectives prior to Baseline.
* Abnormal screening laboratory and other analyses.
* Receipt of any live vaccine within 2 weeks prior to randomisation, or will require live vaccination during study participation.
* Evidence of current or prior dysplasia or history of malignancy.
* Has had any uncontrolled and/or clinically significant illness, hospitalisation, or any surgical procedure requiring general anaesthesia prior to Screening, or any planned surgical procedure within 6 months after randomisation.
* Known current or previous interstitial lung disease.
* Positive pregnancy test at Screening (serum) or Baseline (urine).
* Female subjects who are breastfeeding or considering becoming pregnant during the study.
* Considered by the Investigator to be an unsuitable candidate for the study.
* Received any investigational agent or procedure within 30 days or 5 half-lives prior to Baseline.
* Related to or a dependent of the site staff, or a member of the site staff.
Environmental Factors to Increase Patient Comfort During Urodynamics Testing

Urodynamics is a comprehensive study of the lower urinary tract. Although the information obtained from urodynamics answers several questions and assists in guiding therapies for patients, the testing environments is unnatural and may be distressing for patients. This may impact the results of the study, as it is not uncommon for patients to be unable to void for the test due to their distress. Often to alleviate the distress, music or soothing noises are used in the background. The study aims to identify simple environmental factors which may improve patient experience with urodynamic testing. The population will include patients with existing appointments for urodynamics testing at the Mayo Urology Clinic. The investigators plan to assess patient satisfaction and comfort during this assessment using a visual analog scale questionnaire. The environmental variables will include music of the patients' preference, the sound of running water, or no background noise at all. By asking patients to complete a questionnaire, The investigators will be able to assess ways to improve patient comfort in a commonly used urologic assessment.


Eligibility Criteria:
Inclusion Criteria:

* All adults undergoing urodynamics
* Must be able to understand and complete questionnaire

Exclusion Criteria:
A Study of TAK-662 for Japanese Patients With Congenital Protein C Deficiency

Pharmacokinetic Part:

This study is for Japanese participants with congenital protein C deficiency. The main aim of this study is to check how much TAK-662 stays in their blood over time. This will help the study sponsor (Takeda) to work out the best dose to give patients in the future.

Participants will receive 1 single infusion of TAK-662.

They will stay at the clinic until 3 days after the infusion. Then, participants will return to their clinic 7 days after the infusion to check side effects from the study treatment.

Extension Part:

Participants who will complete the PK part will be given an opportunity to continue TAK-662 administration as 3 different treatment options (on-demand therapy, short-term prophylaxis, and long-term prophylaxis) in the Extension part, until the commercial protein C concentrate is available at each study site or study termination.


Eligibility Criteria:
Inclusion Criteria:

PK Part:

1. Male and female participants with Japanese nationality.
2. A diagnosis of congenital protein C deficiency (homozygous or compound heterozygous).
3. Asymptomatic participant.
4. Oral anticoagulants allowed to be received.

Extension part:

1. Participants who participated in the PK part of this study (TAK-662-1501).
2. Participant who are; a. Diagnosed with PF, CISN/WISN, and/or other acute thromboembolic episode for on-demand treatment only; b. Requiring treatment with TAK-662 for short-term prophylaxis for surgical procedures; c. Requiring treatment with TAK-662 for long-term prophylaxis.

Exclusion Criteria:

PK Part:

1. Current or recurrent disease that could affect the action, or disposition of the investigational product (IP), or clinical or laboratory assessments.
2. A body weight less than 8 kg.
3. Serious liver dysfunction, judged by the investigator.
4. Any thrombosis within 2 weeks prior to administration of the IP.
5. Other investigational product than TAK-662 received within 60 days prior to the administration of the IP.
6. Current or relevant history of physical or psychiatric illness, or any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the IP or procedures.
7. Current use of any medication (including over-the-counter, herbal, or homeopathic preparations) that could affect (improve or worsen) the condition being studied, or could affect the action or disposition of the IP, or clinical or laboratory assessment.
8. Known or suspected intolerance or hypersensitivity to the IP, closely-related compounds, or any of the stated ingredients.
9. Known history of alcohol or other substance abuse within the last year.
10. Within 30 days prior to the first dose of IP, a participant has been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this sponsored study.

Extension Part:

1. New serious medical conditions which could affect participant's safety or treatment were observed during participation in the PK part of this study (TAK-662-1501).
A Comparison of Different Community Models of ART Delivery Amongst Stable HIV+ Patients in Two Urban Settings in Zambia

The purpose of this study is to compare the virological and clinical outcomes of patients participating in community models of ART delivery to the standard of care in an urban setting in Zambia.

The outcomes of this study will be measured in a prospective cohort of adult patients enrolled into ART care in two urban communities participating in the HPTN 071 (PopART) trial. The two community models are: 1) adherence clubs, groups of 20-25 stable patients who receive ART care in the community every 3 months, and 2) home-based ART delivery in which a community health worker delivers ART care to an individual at home every 3 months. The standard of care is delivery of ART care at the local clinic.

Eligibility Criteria:
Inclusion Criteria:

18 years or older On first-line ART and retained in care for more than 6 months Virologically suppressed World Health Organization (WHO) stage I and II at time of screening Reside within the clinic catchment area Willing to provide written informed consent and accept Community HIV-care Provider (CHiPs) intervention

Exclusion Criteria:

-
Fully Coated, Removable, Self-expanding Oesophageal Stents for Preventing Strictures Following Complete Barretts Excision.

The purpose of this study is to investigate whether preventative placement of a removable oesophageal stent reduces the rate of scar tissue, or stricture formation after removing the precancerous or early cancerous Barrett's mucosa by Endoscopic Mucosal Resection (EMR). The stent will be placed 10-14 days after initial EMR. The stent will then be removed 8 weeks later by repeat Endoscopy. Patients will be followed up weekly following insertion of the oesophageal stent.


Eligibility Criteria:
Inclusion Criteria:

* Patients with short segment Barrett's Oesophagus with high grade dysplasia or early cancer, having circumferential EMR to achieve complete Barrett's excision.
* Aged 18-75 years old
* Biopsy proven to be Barretts with HGD or EAC
* The absence or lymph node involvement
* Short segment \<3cm of Barretts Oesophagus.

Exclusion Criteria:

* Women who are pregnant and the human foetus
* Children and/or young people \<18 years
* People with an intellectual or mental impairment.
Fluselenamyl - Beta Amyloid PET Imaging for Alzheimer Disease

The purpose of this research study is to determine the safety of a radiotracer 18F-Fluselenamyl using positron emission tomography (PET) imaging.

The investigators will first complete whole-body PET dosimetry studies in healthy adult normal volunteers to calculate the actual radiation dose of each human organ and determine the allowable dose for a human subject when receiving a single dose for a PET scan.

Second, imaging of the brain and neck will be completed in a wide range of ages of healthy adult normal control participants and participants with mild cognitive impairment, both male and females to characterize 18F-Fluselenamyl uptake in the brain, its binding to beta-amyloid plaques, and radiolabeled metabolite will be completed. Amyloid is a protein related to dementia of Alzheimer's disease. 11C-PIB PET imaging along with MRI will also be completed in the same participants and the data will be compared with 18F-Fluselenmayl. 11C-PIB and 18F-Fluselenamyl both bind to beta-amyloid plaques.

Finally, a comparison of the normal control participants to patients with Alzheimer's disease will be completed.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female, any race
* Age ≥ 18 years
* Healthy volunteers or volunteers with Alzheimer's disease

Exclusion Criteria:

* Has hypersensitivity to 18F-Fluselenamyl or any of its excipients ;
* Has hypersensitivity to 11C-PIB or any of its excipients ;
* Incapable of providing written informed consent or lacking a legally authorized representative (LAR) to provide informed consent ;
* Unwilling or unable to undergo PET scans tracer injections ;
* Unwilling or unable to undergo MRI (Aim 2 and Aim 3);
* Any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data (e.g., renal or liver failure, advanced cancer);
* Women who are currently pregnant or breast-feeding;
* Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1.
Dyslipidemia and Diabetic Retinopathy

The purpose of this study is to determine if the reparative cells of blood vessels called endothelial progenitor cells(EPC) are defective in people with diabetes.

The purpose of this study is to determine if the reparative cells of blood vessels, called endothelial progenitor cells (EPC's) are defective in people with diabetes. Diabetic retinopathy (DR) is an eye disease related to diabetes. It can cause blurred vision and possible bleeding in the blood vessels in the back of the eye (retina). Damage to the cells of the blood vessels from DR can cause vision loss or blindness. Even with current treatments, the quality of life for people with DR is much reduced.

Eligibility Criteria:
Inclusion Criteria:

* Any man or woman
* Greater than 18 years of age
* Diagnosis of diabetes (applies to the Diabetic Arm only) (N=15 Type 1 and N=15 Type
* The subject must be willing and have the ability to cooperate with the protocol. Children will not be eligible because the investigators need to obtain 150 ml of blood and this is in excess of what can be drawn in children.

Exclusion Criteria:

* Female participants must not be pregnant at the time of the blood draw as evident through a dipstick pregnancy test.
* Have retinal abnormalities other than diabetic retinopathy.
The Feasibility and Advantages of Subxiphoid Uniportal Video-assisted Thoracoscopic Surgery in Pulmonary Lobectomy

Uniportal video-assisted thoracoscopic surgery (VATS) lobectomy has emerged as a promising and exciting approach for minimally invasive thoracic surgery. However, nearly all reported uniportal VATS lobectomies have been performed via the intercostal route, and chest wall trauma has still occurred. Here,the investigators undertook novel uniportal VATS technique involving a subxiphoid route for pulmonary lobectomies to evaluate the feasibility and advantages.


Eligibility Criteria:
Inclusion Criteria:

* Patients with lung cancer can be undertook the subxiphoid uniportal VATS or three-port VATS

Exclusion Criteria:

* Contraindications in patients with lung cancer
Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer

To investigate the non-inferiority of disease-free survival in women who received hypofractionated intensity-modulated whole pelvic radiation therapy (2.5 Gy x 16 fractions) after curative surgery for stage III endometrial cancer.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed endometrioid type endometrial cancer
* completion of hysterectomy and surgical staging
* pathologically confirmed FIGO stage III
* ECOG performance status 0 or 1
* adjuvant chemotherapy was done or planned

Exclusion Criteria:

* presence of distant metastasis
* previous history of pelvic radiotherapy
* severe and unstable medical condition
* previous history of other carcinoma except for thyroid cancer, skin cancer, and endometrial cancer
Efficacy and Safety of DLBS3233 in Subjects With Polycystic Ovary Syndrome (PCOS)

This is a 2-arm, randomized, double-blind, double-dummy, and controlled clinical study, with 6 months of treatment to evaluate the clinical and metabolic efficacy of DLBS3233 in improving reproductive parameters and to evaluate the safety of DLBS3233 in women with polycystic ovary syndrome compared with metformin, as an active control.

There will be 2 groups of treatment; each group will consist of 62 subjects with the treatment regimens :

* Treatment I : 1 capsule of DLBS3233 100 mg (once daily) and 1 placebo caplet of Metformin XR (twice daily)
* Treatment II : 1 caplet of Metformin XR 750 mg (twice daily) and 1 placebo capsule of DLBS3233 (once daily) for 6 months of treatment.

Clinical examination to evaluate the efficacy of the investigational drug will be performed at baseline and every interval of 1 month.

Laboratory examinations to evaluate the metabolic efficacy parameters and ultrasonography (USG) examination will be performed at baseline, Month 3rd, and end of study (Month 6th). In addition to that, USG will also be performed about 2 weeks after Month 3rd (Month 3.5th) and after Month 5th (Month 5.5th).

Laboratory examinations to evaluate the reproductive efficacy parameters (reproductive hormone levels) and safety, at baseline and Month 6th (end of study).

General counseling on lifestyle modification will be provided to the subjects by the assigned Nutritionist. All study subjects should follow a lifestyle modification. Evaluation on subjects' performance on lifestyle modification will be conducted every follow-up visit by Investigator, but particularly at baseline, Month 3rd, and end of study (Month 6th) by the Nutritionist.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects in reproductive age (i.e. 18-40 years)
* Subject with a diagnosis of polycystic ovary syndrome confirmed by two of the Rotterdam Criteria
* Subject with insulin resistance defined by: HOMA-IR of \> 2.00

Exclusion Criteria:

* Pregnant and lactating women
* Subjects known to have Cushing's syndrome, late onset of congenital adrenal hyperplasia, androgen-secreting tumors, uncontrolled thyroid disease, hyperprolactinemia
* Known to have current medical condition, which, is judged by the Investigator could jeopardize subject's health or interfere with the study evaluation, such as diabetes mellitus, uncontrolled hypertension, other cardiovascular diseases, acute or chronic infections, and any known malignancies
* Impaired renal function (serum creatinine level \> 1.5 ULN)
* Impaired liver function (serum ALT level ≥ 2.5 ULN)
* Medically-assisted weight loss with medications or surgical procedures
* Currently having laparoscopic ovarian diathermy (LOD)
* Currently under treatment with in vitro fertilization (IVF) techniques
* Have been regularly taking any medications which affect insulin sensitivity as well as reproductive function (i.e. ovulation, menstrual cycle), within ≤ 3 months prior to screening
* Participating in other clinical trial within 30 days prior to screening