cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)

This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of TNX-601 ER monotherapy versus placebo in patients with Major Depressive Disorder (MDD).


Eligibility Criteria:
Inclusion Criteria:

* Female or male aged 18 to 65 years (inclusive).
* Have a primary DSM-5 diagnosis of current MDD.

  1. The duration of the current MDE must be at least 12 weeks.
  2. Without psychotic or catatonic features.

Exclusion Criteria:

* Psychiatric History:

  1. Diagnosis of DSM-5-defined lifetime bipolar disorder (I, II, or unspecified), schizophrenia, schizoaffective disorder, MDD with psychotic features, other psychotic disorder, or antisocial personality disorder; current (past month) obsessive-compulsive disorder; current (past month) posttraumatic stress disorder; current (past 3 months) anorexia nervosa; lifetime opioid or lifetime sedative-hypnotic use disorders, as confirmed by the MINI 7.0.2.
  2. Diagnosis of borderline personality disorder
  3. Patients with comorbid generalized anxiety disorder (GAD), social anxiety disorder (SAD), or panic disorder are excluded only if the GAD, SAD, or panic disorder is considered the primary psychiatric diagnosis, rather than MDD. (If MDD is the primary diagnosis, patients with comorbid GAD, SAD, and panic disorder are allowed for randomization).
* Patients with treatment refractory MDD, ie, previously having in their lifetime failed ≥2 treatments with at least 2 different classes of antidepressants of adequate dose, duration, and treatment adherence
Multicenter Prospective Registry Study of Diffuse Large B Cell Lymphoma

This study was designed to review clincal outcomes of Diffuse Large B Cell Lymphoma (DLBCL) treated with R-CHOP chemotherapy in the era of pegylated-filgrastim. The investigators will prospectively collect clinical data and treatment outcome of patients with DLBCL who use prophylactic pegylated-filgrastim.

* Newly diagnosed DLBCL patients treated with R-CHOP chemotherapy
* Prphylactic peg-filgrastim on the day after chemotherapy

Eligibility Criteria:
Inclusion Criteria:

* 19 or older
* newly diagnosed with DLBCL
* R-CHOP chemotherapy
* offer informed consent

Exclusion Criteria:

* other subtype of NHL
* concomitant other cancer
* previous chemotherapy or radiotherapy
A Real-world Study of Adjuvant Therapy in Early Stage NSCLC With EGFR Mutation-Positive in China

This study is a prospective, national, multi-center, non-interventional study. The main purpose is to explore the initial adjuvant treatment pattern after radical resection for early-stage NSCLC patients with EGFR Mutation-Positive in the real world. The secondary purpose was to observe the postoperative follow-up treatment pattern and its subgroups (based on different EGFR mutation status and different clinical stages).

About 2,000 eNSCLC patients who received radical resection from about 50 research centers across the country will be included in this study, and will be followed up to 2 years after enrollment according to the actual clinical situation. The analysis method of this study is mainly based on descriptive statistics. The information about the human genetic resources of the subjects to be collected includes: demography, physical examination, WHO fitness status, medical history, smoking history, disease characteristics, surgical information, initial and follow-up adjuvant treatment pattern, laboratory tests, survival status, and adverse events related to gefitinib/osimertinib, serious adverse events/non-severe ADR, measures taken for adverse events, outcome of adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent signed;
2. Newly confirmed EGFR Mutation-Positive NSCLC confirmed by histopathology except for cytology;
3. Receiving or not receiving neoadjuvant treatment before surgery;
4. Patients with stage I-III NSCLC undergo confirmed radical R0 resection;

Exclusion Criteria:

1. Patients who currently or have previously participated in any other anti-tumor clinical studies;
2. Patients with NSCLC who have received any systemic anti-cancer therapy as the main treatment in the past. Cytotoxic therapy, targeted therapy (tyrosine kinase inhibitors or monoclonal antibodies) and immunotherapy included except for the use of neoadjuvant therapy;
3. Patients who have received adjuvant therapy before enrollment.
4. Patients with stage I-III NSCLC whose surgical resection cannot be confirmed.
5. Patients assessed by the investigator as unfit for enrollment, such as neurological disorders or metabolic disorders, physical examination or laboratory examination suspected that the patient has a possible disease, or has contraindications to the use of study drugs, or has treatment-related complications High risk etc.
TeLIPro Health Program - Active With Diabetes

In a randomized-controlled trial the hypothesis should be tested that the Telemedical Lifestyle Intervention Program TeLIPro could significantly improve HbA1c (primary outcome), body weight and composition, cardiovascular risk factors, quality of life, eating behavior, and medication demand (secondary outcomes) in type 2 diabetes mellitus (T2DM) patients.

T2DM patients, assured at the health insurance AOK Rhineland / Hamburg will be randomized into two parallel groups. In addition to routine care both groups will be provided a scale as well as a step counter and access to a secured online portal. The TeLIPro group will additionally got a glucose meter with test stripes fpr self-monitoring of blood glucose and telemedical coaching.

Participants of both groups will enter their anthropometric and metabolic data into a database on quarterly basis. In addition, the costs for diabetes-specific treatment, inpatient and outpatient treatment costs and drug costs will be analyzed on the basis of the routine data of the AOK Rhineland / Hamburg.

Patient preference for type 2 diabetes intervention will be recorded using Discrete Choice Experiment (DCE) questionnaires at the beginning of the program and at the end of the intervention. As part of the development and validation of the DCE, focus groups are used to determine the DCE attributes. In addition, focus groups should also be used during the data collection in order to obtain additional information on patient preferences by means of qualitative analysis.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* body mass index of et least 27 kg/m2

Exclusion Criteria:

* acute infections
* chronic diseases other than type 2 diabetes and hypertension (e.g., cancer, chronic obstructive pulmonary disease, asthma, dementia, chronic gut diseases, psychoses, liver cirrhosis, macronephropathy/nephropathy, kidney insufficiency with glomerular filtration rate \<30 ml/min/1.73 m2)
* acute chemotherapy or chronic cortisol treatment
* smoking cessation for \<3 months and/or planned smoking cessation during study
* pregnancy or breast-feeding
APRiCOT-P: Study of Apricoxib With Gemcitabine and Erlotinib to Treat Advanced Pancreatic Cancer

This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib in patients with advanced pancreatic cancer.

This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib as measured by progression-free survival to test the hypothesis that down regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumors will have a clinical benefit compared with Gemcitabine/Erlotinib only.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed adenocarcinoma of the pancreas that is locally advanced or metastatic.
2. Life expectancy greater than or equal to 3 months.
3. Patients must have measurable disease by RECIST.
4. ECOG PS of 0, 1, or 2.
5. Negative serum pregnancy test at the time of first dose for women of childbearing potential.

Exclusion Criteria:

1. Previous chemotherapy as primary treatment for locally advanced or metastatic pancreatic cancer(stage 3 T3 and T4, and all stage 4).
2. RT within 2 weeks or chemotherapy within 3 weeks or noncytotoxic investigational agents within 4 weeks of initiating study treatment.
3. Evidence of New York Heart Association class III or greater cardiac disease.
4. History of myocardial infarction, stroke, ventricular arrhythmia.
5. Symptomatic central nervous system metastases.
6. Pregnant or nursing women.
7. Hypersensitivity or intolerance to apricoxib, erlotinib, gemcitabine, sulfonamides, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs).
8. History of upper gastrointestinal bleeding, ulceration or perforation. History of lower GI bleeding, ulceration, or perforation within 12 months.
9. Previous anti-EGFR kinase therapy.
Variation in Sulphonylurea Response in Type 2 Diabetes

The study hypothesis is that people who respond well to sulphonylureas have a different underlying cause for their diabetes than people who respond poorly to this medication. We are using two approaches to study this. In one approach we look at people who have previously responded well or poorly, confirm this by rechallenging them with a sulphonylurea drug, and then looking at how well they produce insulin in response to glucose and an intravenous sulphonylurea called tolbutamide. The second approach identifies people with a certain genetic predisposition to diabetes (due to changes in the TCF7L2 gene) and then looks at how well they respond to sulphonylurea medication.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Age \>35 and \< 70
* Age of diabetes diagnosis \>35 and \<70
* White European
* Pre-SU HbA1c \<=10%
* HbA1c (on treatment) \<= 9%
* No myocardial infarction or Acute coronary syndrome in previous year
* No stroke or transient ischaemic attack in previous year
* No or stable (background) retinopathy (no unscheduled laser treatment in the last 6 months)
* eGFR \> 60mls/min
* No Proteinuria \>30mg/dl on multistix 10SG
* No active foot ulceration or infection
* Liver ALT ≤ twice the upper limit of the reference range
* Contactable by telephone

Exclusion Criteria:

* Type 1 diabetes
* HbA1c \>10% prior to commencing SU
* HbA1c\>9% on SU treatment
* Recent MI or Stroke within last 12 months
* Pre-proliferative or proliferative retinopathy
* eGFR\<60 ml/min
* Proteinuria \>30mg/dl on multistix 10SG
* Active foot ulceration or infection
* Liver ALT \> twice the upper limit of the reference range
* Female planning to conceive within the study period
* Any other significant medical reason for exclusion as determined by the investigator
Paracetamol Absorption Technique as a Method for Measuring Gastric Tube Outlet

Retention of the gastric tube after esophagectomy is a clinically important problem, and there is a need of a simple method to evaluate emptying rate from the gastric tube after esophagectomy. Scintigraphy is the golden standard of measuring emptying rate from the gastric tube. In non-operated patients, paracetamol clearance technique have been widely used for measuring gastric emptying rate. There is no validation however if paracetamol clearance technique can be used for measuring emptying rate of the gastric tube. The investigators aim of this pilot- study is to validate paracetamol clearance technique to scintigraphy for measuring emptying rate from the gastric tube and to evaluate if there is a correlation between symptoms of retention and quality of life with the emptying rate.


Eligibility Criteria:
Inclusion Criteria:

* Patients where it had past at least two years since they had underwent an Ivor Lewis esophagectomy with gastric pull-up reconstruction.
* no signs of recurrence
* \>18 years of age

Exclusion Criteria:

-
Phase I Drug-drug Interaction of Omega-3 and Atorvastatin

This study evaluates the safety and pharmacokinetic drug-drug interactions of omega-3 and atorvastatin in healthy male volunteers. Half of the participants will receive omega-3 for 16 days to be steady state of omega-3 and followed by omega-3 and atorvastatin in combination for 7 days. The other half will receive Atorvastatin for 7 days to be steady state of Atorvastatin, and followed by Atorvastatin and Omega-3 in combination for 16 days.


Eligibility Criteria:
Inclusion Criteria:

* 50kg or less of body weight and body mass index of 18 \~ 30kg/m²
* No congenital or chronic disease requiring treatment, and no pathological symptoms or findings as a result of medical examination
* Eligible for the clinical trial as a result of a clinical laboratory test, 12-lead ECG, V/S test at the screening

Exclusion Criteria:

-
The Church as a Bridge to Deliver Health Resources Via Telehealth

The proposed Church Bridge intervention project will provide an innovative, evidence-based and technology supported, health intervention model for Southern, African American, and rural populations who continue to be disparately burdened by obesity and associated co-morbidities (i.e., hypertension, diabetes, cardiovascular disease). By targeting young adults (21-50 years of age) with families, the project will contribute to the long-term reduction of preventable chronic disease and related health care costs for the public.


Eligibility Criteria:
Inclusion Criteria:

* BMI \>/=30
* Must have elementary aged child (5-11 years) in household

Exclusion Criteria:

* Any health condition where weight loss is contraindicated
* Complicated disease states (ie., advanced renal disease or heart failure)
Safety and Efficacy of the SurVeil™ Drug-Coated Balloon (AVess FIH)

The purpose of this study is to evaluate the safety and performance of the SurVeil DCB in subjects with obstructive lesions of arteriovenous fistulae for hemodialysis.

AVess FIH is a prospective, multi-center, single arm, first-in-man feasibility study evaluating up to 15 subjects

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be ≥18 years of age.
2. Native AV fistula has been created ≥60 days prior to the index procedure.
3. AV fistula, located in the arm, has undergone one or more successful hemodialysis sessions.
4. Target de novo or non-stented restenotic lesion consisting of a ≥50% stenosis by operator visual estimate.
5. Fistula vessel diameter ≥5 mm and ≤7 mm by operator visual estimate.
6. Target lesion or tandem lesion ≤120 mm in total length by operator visual estimate.
7. Successful pre-dilatation of the target lesion. Defined as crossing of the guide wire AND pre-dilatation with a PTA balloon resulting in: residual stenosis of ≤30% and dissection ≤ Grade B
8. Subject has provided written informed consent and is willing to comply with study follow-up requirements.
9. Subject has a life expectancy of ≥1 year

Exclusion Criteria:

1. Subject has a synthetic AV graft.
2. Determined by operator to have a lesion that prevents complete inflation of an angioplasty balloon.
3. Presence of pseudoaneurysm or aneurysm requiring treatment at the lesion site.
4. Target lesion is located \<30 mm from any stent.
5. Thrombosis of the access site 30 days prior to procedure.
6. Surgical revision of the access site planned within 30 days of procedure.
7. Blood coagulative disorder, sepsis, or current AV access infection (white blood count ≥12,000).
8. Known contraindication (including allergic reaction) or sensitivity to antiplatelet therapy, anticoagulation therapy or paclitaxel (mild to severe cases), that cannot be adequately managed with pre-and post-procedure medication.
9. Subjects who are taking immunosuppressive therapy or are routinely taking ≥10mg of prednisone per day.
10. Scheduled for kidney transplant or peritoneal dialysis within the next 6 months post procedure.
11. Myocardial infarction 30 days prior to procedure.
12. Stroke or TIA 90 days prior to procedure.
13. Women who are pregnant, breast-feeding or intend to become pregnant or men who intend to father children during the time of the study.
14. Subject is participating in any other investigational study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoint from this study.
Facilitation of Corneal Re-epithelialization After Photorefractive Keratectomy

Photorefractive keratectomy (PRK) or surface ablation is one of the most commonly used surgical procedures to correct refractive errors, which was proved to be safe and effective. In PRK, the corneal epithelium is removed by various techniques such as diluted alcohol, manual debridement, brush, or excimer laser, before the refractive excimer laser ablation of the corneal stroma. Compared to laser in situ keratomileusis (LASIK), the two main drawbacks for PRK are slower visual recovery and discomfort in the immediate postoperative period, due to the epithelial removal.

Corneal healing is a complex process involving cellular interaction and reaction with various molecules (proteases, growth factors, and epithelial and stromal cytokines). Enhanced corneal re-epithelialization may reduce the risk for corneal infection and stromal scarring or melting. Over the past few years, a new type of matrix therapy by ReGeneraTing Agent (RGTA) has provided encouraging results, accelerating the healing of chronic skin ulcers in diabetes or vascular origin. RGTAs mimic the action of heparin sulfate molecules, breaking the negative repair-destruction cycle occurring in chronic lesions and inhibit proteolytic enzymes in vitro. In the domain of ophthalmology, RGTA has been reported to show encouraging results in the treatment of corneal ulcer and dystrophies of various etiologies.

The Cacicol20 is an RGTA that binds to matrix proteins to protect them from proteolysis; the extracellular matrix microenvironment protection improves the production of signals and growth factors needed for tissue healing. It is supplied as a sterile single-dose solution of alpha 1-6 poly-carboxymethyl glucose sulfate described and synthesized as in US Patent Number 6689741, with dextran T40 and 0.9% sodium chloride as excipients. It contains no component of animal or biological origin, and penetrates into the cornea without crossing Descemet´s membrane (no intraocular penetration). The Cacicol20 has been reported to be effective in treatment of neurotrophic ulcers and persistent epithelial defects which were unresponsive to the common treatment approaches. Therefore, we expect that the Cacicol20 may facilitate the corneal re-epithelialization after PRK.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing bilateral PRK surgeries for treatment of refractive error
* Age over 18 years
* Refractive stability for at least 2 years

Exclusion Criteria:

* Ocular pathology, including keratoconus or suspected keratoconus, glaucoma, and epithelial defects
* Previous corneal surgery
* Systemic disease that might affect corneal wound healing.
Head-to-head Comparison of [18F]F-PSMA-N5 With [68Ga]Ga-PSMA-11 PET/CT in PCa Diagnosis, Recurrence, and Metastasis

To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent \[18F\]F-PSMA-N5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with \[68Ga\]Ga-PSMA-11.

\[18F\]F-PSMA-N5 PET/CT was used for initial assessment of prostate cancer or detection of recurrence. The maximum standardized uptake value (SUVmax) was used to evaluate tumor uptake. The sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of \[68Ga\]Ga-PSMA-11 PET/CT.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 90 years old;
* Complete MRI images and clinical data (such as PSA level, Gleason grade, etc.);
* Prostate cancer detected by PSA or imaging examination, or clinically suspected recurrence after standardized treatment;
* simultaneous \[18F\]F-PSMA-N5 and \[68Ga\]Ga-PSMA-11 examinations within two weeks;
* Willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment;
* Sign informed consent.

Exclusion Criteria:

* Patients who cannot cooperate with the examination;
* Concurrent malignant tumors;
* Previous alcohol allergy;
* Patients with liver and kidney dysfunction;
* Other circumstances deemed by the investigator to be inappropriate for trial participation.
A Study of Ramucirumab or Icrucumab in Colorectal Cancer

The purpose of this study is to determine if participants with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus ramucirumab, or standard chemotherapy plus icrucumab.

The purpose of this study is to evaluate the progression-free survival (PFS) in participants with metastatic colorectal cancer when treated with 1 of 3 modified FOLFOX-6 (folinic acid \[FA\] + fluorouracil \[5-FU\] + oxaliplatin \[mFOLFOX-6\])-based regimens, as second-line therapy.

During 2010, there has been an identified shortage of injectable folinic acid (FA) in the United States. Levo-folinic acid (LFA) will be allowed as a substitute for FA in the mFOLFOX-6 chemotherapy regimen in circumstances in which FA is not available, to facilitate continuity of participant care.

Eligibility Criteria:
Inclusion Criteria:

* Disease progression on an irinotecan-based first-line chemotherapy regimen (ie FOLFIRI or CAPIRI \[capecitabine + irinotecan\], with or without bevacizumab)
* Age ≥ 18 years
* Life expectancy of ≥ 6 months
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 at study entry
* Agrees to adequate contraception during the study period and for 12 weeks after the last dose of study medication
* Provided signed informed consent

Exclusion Criteria:

* Has received prior oxaliplatin-based chemotherapy for locally advanced unresectable or metastatic Colorectal Cancer (CRC) (Prior oxaliplatin-based adjuvant chemotherapy is allowed if the last dose of oxaliplatin was administered \> 12 months prior to randomization)
* Has documented and/or symptomatic brain or leptomeningeal metastases
* Has an ongoing or active infection, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders
* On chronic non-topical corticosteroid treatment. A participant discontinuing such treatment \> 3 months prior to randomization is eligible
* Has uncontrolled or poorly controlled hypertension on a standard regimen of antihypertensive therapy
* Has a concurrent active malignancy. A participant with previous history of malignancy is eligible, provided that he/she has been disease free for \> 3 years
* If female, is pregnant (confirmed by serum beta human chorionic gonadotropin \[βHCG\] test) or lactating
* Has received a prior autologous or allogeneic organ or tissue transplantation
* Has undergone major surgery within 28 days prior to randomization
* Has had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization
* Has an elective or planned major surgery to be performed during the course of the trial
* Has a history of inflammatory bowel disease requiring pharmacological and/or surgical intervention in the 12 months prior to randomization