cyrilzakka/clinical-trials huggingface dataset:
Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer

M-Trap is an implantable medical device designed to capture disseminated tumor cells (DTCs). It is intended for use in advanced-stage ovarian cancer patients. The study objective is to assess the safety and the performance of the M-Trap device.


Eligibility Criteria:
Inclusion Criteria:

1. Is a female ≥18 years old.
2. Presents with a diagnosis of Stage IIIC ovarian cancer.
3. Presents with high-grade serous carcinoma.
4. Has one of the following:

   1. Visible residual tumor ≤1 cm after primary tumor debulking surgery.
   2. Three cycles of neoadjuvant chemotherapy and complete resection after interval tumor debulking surgery.
   3. Three cycles of neoadjuvant chemotherapy and visible residual tumor ≤1 cm after interval tumor debulking surgery.
5. ECOG performance status of 0 or 1.
6. Is willing to comply with required follow-up study visits.
7. Is willing and able to provide written informed consent.

Exclusion Criteria:

1. Has a life expectancy of \<3 months.
2. Is pregnant, as confirmed through a blood test prior to any study procedure, planning on becoming pregnant during the study, or is lactating.
3. Will be receiving intraperitoneal chemotherapy.
4. Has undergone prior treatment with abdominal and/or pelvic radiotherapy.
5. Has significant active concurrent medical illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
6. Presence of central nervous system or cerebral metastases.
7. Recurrent ovarian cancer.
8. Complete resection with no residual tumor after primary tumor debulking surgery.
9. Suboptimal resection with \>1 cm residual tumor after primary or interval tumor debulking surgery.
10. Is simultaneously enrolled in another investigational study.
11. Has a history of cancer within 5 years other than in-situ uterine cervix cancer or non-melanoma skin cancer.
12. Has a known hypersensitivity to carboplatin or paclitaxel.
13. Is concurrently using other antineoplastic agents.
Effect of Walker vs Wheeled Device on Mobility After Total Knee Arthroplasty

Maneuverability is currently under appreciated by patients who are seeking mobility. This pilot study is examining how patients maneuverability and mobility will change with this novel mobility tool - A-Linker compared to the standard of care walker.

Patients who are using a walker is randomized into two groups:

1. 12 patients get an A-linker 3 months before surgery (knee arthroplasty)
2. 12 patients use a walker 3 months before surgery (knee arthroplasty)

All 24 patients will undergo a total knee Arthroplasty surgery.

Questionnaires at:

0 week from randomization into two groups 6 weeks 12 weeks (surgery) 18 weeks

Eligibility Criteria:
Inclusion Criteria:

* Receiving total knee arthroplasty

Exclusion Criteria:

* Not receiving total knee arthroplasty
A Phase I Clinical Trial to Evaluate the Effect of Renal Impairment on Pharmacokinetics of NOX-E36

This is a multi center, open label, parallel group, single administration, phase I trial, in subjects with mild, moderate or severe renal impairment and a control group with normal renal function.

Current diabetes therapy does not stop progression of the disease and the development of diabetes mellitus (DM)-associated complications. A major concern in DM-patients is renal impairment due to nephropathy leading to a reduced glomerular filtration rate (GFR). It has been established that chronic (sub)clinical inflammation is crucial for the onset and progression of DM.

CCL2, also known as Monocyte chemoattractant protein 1 (MCP 1) is a chemokine from the cysteine-cysteine family, secreted by leukocytes or tissue cells. CCL2 promotes monocyte emigration from the bone marrow, activates monocytes and macrophages and directs their migration to sites of inflammation. Recent animal studies and clinical trials indicate a critical involvement of CCL2 in DM and diabetic nephropathy, suggesting that CCL2 may be a potential target for therapeutic intervention in DM. Finally, protein overload and oxidative challenge of the diseased kidney was suggested to stimulate CCL2 expression in renal tubuli, thereby accelerating the progression of diabetic nephropathy.

As NOX E36 is designed to specifically target human MCP-1/CCL2. This study is performed to evaluate the role of renal impairment for adequate dosing recommendations in the planned target population.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects (age 18-75 years, both inclusive)
2. Male subjects who agree to sexual abstinence and/or use a highly effective method of birth control. Female partners of male subjects must be of non-child bearing potential or must practice an adequate non-hormonal contraceptive method to prevent pregnancies.
3. Subjects will be categorized as follows based on creatinine clearance(mL/min/1.73m2): Normal renal function: CrCl \> 80; mild renal impairment: 50 ≤ CrCl ≤ 80; moderate renal impairment: 30 ≤ CrCl ≤ 50; severe renal impairment: CrCl \< 30
4. Body Mass Index (BMI) between 22 and 40 kg/m², both inclusive.

Exclusion Criteria:

1. Women of childbearing potential
2. Patients who have received kidney transplantation.
3. Patients receiving hemodialysis to control their disease.
4. Any clinically significant abnormality other than related to the renal impairment following the investigator's review of the physical examination, ECG and clinical laboratory tests at screening.
5. Not able to communicate meaningfully with the investigator and staff.
Efficacy and Safety of Fermented Cinnamon Vine Powder on Decrement of Body Fat

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Fermented Cinnamon Vine Powde on decrement of body fat. The investigators measured decrement of body fat parameters , including abdominal fat, Body Fat Mass, LDL-C, HDL-C, Total Cholesterol and triglyceride, and monitored their blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 19-55 years old
* BMI(body mass index) ≥ 25 kg/m\^2 or WC(Waist Circumference) ≥ 90(men), WC ≥ 85(women)
* Able to give informed consent

Exclusion Criteria:

* Significant variation in weight(more 10%) in the past 3 months
* Allergic or hypersensitive to any of the ingredients in the test products
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnant or lactating women etc.
Open-Label Study of AB-729, Nucleos(t)ide Analogue and Pegylated Interferon Alfa-2a in Subjects with Chronic Hepatitis B Infection

This is a randomized, open label, multicenter Phase 2 study investigating the safety and antiviral activity of AB-729 in combination with ongoing NA therapy and short courses of Peg-IFNα-2a in subjects with CHB.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis B virus infection with documentation at least 6 months prior to screening
* Subjects must have been receiving either TAF, TDF (or equivalent), or ETV consistently for ≥12 months prior to dosing Day 1
* HBV DNA \<LLOQ at Screening
* HBsAg between 100 and 5,000 IU/mL at Screening
* Subjects must be HBeAg-negative at Screening
* Fibroscan® result of ≤8.5 kPa within 6 months prior to dosing Day 1
* Medically stable based on physical examination, medical history, vital signs, laboratory values, and 12-lead Electrocardiogram (ECG) at screening

Exclusion Criteria:

* Evidence of co-infection with hepatitis A, C, D or E virus or human immunodeficiency virus (HIV) at screening
* History of any clinically significant medical condition associated with chronic liver disease, cirrhosis, evidence of decompensated liver disease, or findings suggestive of hepatocellular carcinoma (HCC) at any time
* Contraindications to the use of Peg-IFNα-2a or incapable of self-administration or assisted administration of Peg-IFNα-2a
* Previous treatment with an experimental HBV-directed RNA-interference or antisense oligonucleotide product.
Treatment of Patients With Skin Burns Using Keratinocytes and Skin Fibroblasts

Treatment of patients with burns of the skin of the 2nd degree using: autologous keratinocytes and skin fibroblasts mixed with collagen gel 7% (tissue equivalent of the skin)

Treatment of patients with burns of the skin of the 2nd degree by applying a wound covering with layer-by-layer cultured autologous keratinocytes and fibroblasts in collagen gel

Eligibility Criteria:
Inclusion Criteria:

* skin burns of the 2nd degree

Exclusion Criteria:

* acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
* mental disorders
* pregnancy
Safety and Efficacy of Inhaled Insulin in Patients With Diabetes and Asthma or COPD

Phase 3 , open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected insulin in type 1 and type 2 diabetes patients with asthma or COPD. Patients will be treated for 12 months with a 2 month follow up period.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetes
* asthma or COPD

Exclusion Criteria:

* Current smoking habit
Search for New Genetic Causes of Hypercalcemia by Massively Parallel Sequencing of a Genes Panel

Hypercalcemia, whether chronic or acute, exposes the patient to potentially serious complications (arrhythmias, nephrolithiasis, nephrocalcinosis, ...). Prevention relies primarily on effective etiological necessary for taking matched load. Under the French reference center for rare disorders of calcium and phosphorus, the investigators looked for mutations in the coding sequence of the CYP24A1 gene (encoding the enzyme responsible for the breakdown of vitamin D), among patients with hypercalcemia without hyperparathyroidism with hypersensitivity to vitamin D. However, only 25% of these patients have a genetic anomaly suggesting the involvement of other genes (Molin et al. 2015). Recently our team, combined with Kaufmann et al. (2014 JCEM) validated the interest of the determination of metabolites of vitamin D by liquid chromatography-tandem mass spectrometry (LC-MS / MS), as biological pre-screening stage for patients with hypercalcemia.

The objective of this project is to complement the molecular and biochemical studies of patients without mutation of the coding sequence of CYP24A1, in a gene candidate approach using massively parallel sequencing (MPS) which allows to study a panel of gene potentially involved in disorder of metabolism of calcium and phosphorus. Highlighted variations will be tested in silico, and if possible in vitro. The investigators will also use LC-MS / MS to evaluate in vivo the effects of these variations on the metabolism of vitamin D, to develop a genotype / phenotype correlation.

The work carried out within the Genetics Department Caen University Hospital in collaboration with physicians of the rare disease reference center of the metabolism of calcium and phosphorus should identify new genetic mechanisms underlying hypercalcemia. At the time of development of personalized medicine, it will adapt the therapy in patients at risk for metabolic complications and / or kidney following administration of vitamin D and finally to offer genetic counseling.


Eligibility Criteria:
Inclusion criteria

* Chronic hypercalcemia or at least one episode of acute hypercalcemia not linked to hyperparathyroidism
* Consent to the realization of a genetic analysis for medical purposes Non-inclusion criteria
* Another genetic disorder identified with hypercalcemia (eg Williams-Beuren syndrome)
* Primary hyperparathyroidism (high PTH)
* neoplasia
* granulomatosis
Treatment of Gastric Peritoneal Carcinomatosis by Association of Complete Surgical Resection of the Lesions and Intraperitoneal Immunotherapy Using Catumaxomab

Treatment by association of complete surgical excision of the lesions and intraperitoneal immunotherapy using Catumaxomab for patients with gastric peritoneal carcinomatosis


Eligibility Criteria:
Inclusion Criteria:

* consent form signed
* Age \>= 18
* Carcinomatosis pre operative known or discivered in intraoperative
* Patients uin good general condition who may have extent surgery associated to specific inflammatory syndrom of immunotherapy
* Patients in good general condition
* Patient insured to social care

Inclusion Criteria (intraoperative):

* Gastric adenocarcinoma with macroscopic peritoneal carcinomatosis (PC) confirmed by extemporaneous histological examination
* CP extension minimal or moderate (peritoneal index ≤ 12).
* Resection of the entire macroscopic lesions detectable (primary tumor, lymph nodes and CP). cleaning D2 lymph node (or D1.5).

Exclusion Criteria:

* Presence of metastasis in reach
* Previous treatment with a non-humanized monoclonal AC- (mice or rat)
* Hypersensitivity to any type of antibody.
* History of cancer within 5 years preceding the entry in the trial other than basal cell skin carcinoma or in situ of the cervix,
* Patients already included in another clinical trial with experimental molecule
* Pregnant, or likely to be or breastfeeding, (Women of childbearing potential should have a pregnancy test (blood) negative 15 days before the date of the surgery) Using of a suitable method of contraception for patients of childbearing age during treatment. adequate contraception Methods includeare: an intrauterine device, hormonal contraception, condom use combined with a spermicide
* Persons deprived of liberty or Trust (including curatorship)
* Unable to undergo medical test for geographical, social or psychological.

Exclusion Criteria (intraoperative):

* Persistent peritoneal lesions visible to the end of the surgery
* Resection of the tail of the pancreas or pancreatic break (because no drainage post-op); break pleural (for K cardia)
* Presence of metastasis in reach during surgery (except for ovarian metastasis
Risk Communication in African American Smokers

The study aims to understand the effects of learning about one's genetic risk for lung cancer that is specific to their ancestry. Participants will be given hypothetical personalized genetic risk results and ask to think about how they might respond to such information if they actually received such results.

The study aims to understand the effects of learning about one's genetic risk for lung cancer that is specific to their ancestry. Smokers will be randomized to receive hypothetical information about their genetic status and consider how they think they would respond if such results were actually presented to them. They will be randomly assigned to receive one of four sets of hypothetical genetic results: 1) High risk of lung cancer and high genetic African ancestry, 2) High risk of lung cancer and low genetic African ancestry, 3) Low risk of lung cancer and high genetic African ancestry, or 4) Low risk of lung cancer and low genetic African ancestry. After being given this hypothetical information, participants will complete brief questionnaires assessing perceived risk of lung cancer, worry about cancer, psychological distress, and motivation to quit smoking.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age minimum
* Self-report African American
* Report smoking at least 100 lifetime cigarettes

Exclusion Criteria:

* Report history of cancer
Retrospective Evaluation of Commercial Spacers in Prostate Cancer Patients

Assessment of efficacy and safety of implantable spacers when used to reduce the radiation dose delivered to the organs at risk in prostate cancer patients undergoing radiotherapy.

Multi-center, retrospective, observational study for assessment of rectal dose reduction following implantation of the BioProtect Balloon Implant System

Eligibility Criteria:
Inclusion Criteria:

- Males at least 18 years of age, who have undergone radiation therapy with implantable spacers

Exclusion Criteria:

* Patients whose clinical and pathological data are not available.
* Patients have been histologically diagnosed with invasive adenocarcinoma that is extracapsular with posterior extension
Cessation of Dialysis Treatment in Reinbek and Geesthacht

Currently, approximately 80.000 patients with end stage renal disease (ESRD) in Germany undergo chronic renal replacement therapy, either as hemodialysis or peritonealdialysis. Since the nationwide registry for chronic dialysis patients (QuasiNiere) was terminated in 2006, no data exist from that time on regarding alterations in morbidity and mortality of patients with end stage renal disease in Germany.

With this study we start a single center prospective registry of all patients undergoing hemodialysis or peritonealdialysis therapy in our two nephrology departments Reinbek and Geesthacht. In these centers we perform approximately 34.000 hemodialysis sessions and supervise about 10.000 peritoneal treatment days of about 300 ESRD patients annually.

The aim of the study is to analyze all patients who stopped dialysis treatment in our centers due to death, kidney transplantation, recovery of renal function or other causes. Patients characteristics such as underlying renal diseases, duration of dialysis, co-morbidities as well as laboratory parameters will be recorded.

The data is collected with an Microsoft Access Database and analyzed by a statistician of the University of Luebeck (Germany). Power calculations revealed, that at least 200 patients were necessary to detect differences in particular interesting variables such as vascular access or the need of palliative care. During the last years at least 50 patients stopped chronic renal replacement therapy at out centers annually. Thus, the first interims evaluation is expected after 4 years.

The results of our study are important to estimate the development of patient age and renal diseases responsible for dialysis therapy in our centers. Moreover, the results may add important information to our internal quality assurance.


Eligibility Criteria:
Inclusion Criteria:

* Patients with end stage renal disease and hemodialyis or peritonealdialysis
* Renal replacement therapy performed in our centers Reinbek or Geesthacht
* at least 4 weeks of dialysis treatment in any of our two treatment sites

Exclusion Criteria:

* dialysis treatment period in our centers shorten than 4 weeks
Efficacy Study of Leflunomide to Treat Juvenile Idiopathic Arthritis

A randomized double blind clinical trial to assess efficacy of leflunomide in treatment of refractory juvenile idiopathic arthritis.

Patients are randomly divided into two groups. In group 1 leflunomide and in group 2 placebos will be added to conventional treatment for three months. therapeutic responses will be evaluated by ACRpedi (American College of Rheumatology Pediatric) scores every 4 weeks.

30 Patients(2-19 y) are randomly divided into two groups. In group 1 leflunomide will be added to conventional treatment, 5-20 mg daily based on weight.

In group 2 placebo will be prescribed as same as leflunomide. The course of treatment is 3 months. Every 4 weeks ACRped 30, 50, 70 should be determined to evaluate therapeutic response. Side effects of treatment will be assessed by physical examination and lab tests every 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* JIA based on ACR criteria
* age between 2- 19 y
* polyarticular, oligoarticular(\> or = 3 active joints) or extended oligoarticular subtypes
* resistance to conventional treatment

Exclusion Criteria:

* pregnancy
* malignancy
* severe active infection
* other rheumatic diseases or overlap
* ALT(Alanine transaminase) or bilirubin \> 3 folds
* IVIG (Intravenous immunoglobulin) treatment during last 2 weeks
* biologic agents during last 3 months
Acupressure for Cancer-Related Fatigue

This study develops and pilot tests the efficacy of a home-based, self-administered acupressure intervention in improving cancer-related fatigue (proximal outcome), and physical functioning and other quality of life outcomes (distal outcomes) of Chinese immigrant breast cancer survivors (versus usual care control group).

We will enroll 124 foreign-born, Chinese-speaking women from Southern California and Maryland areas with moderate to severe levels of fatigue, diagnosed with stage 0-IV breast cancer, aged 21-74, and 1-5 years post-primary treatment. Using an adaptive treatment strategy design, participants will be randomized to either the acupressure intervention or control groups. The acupressure group will learn how to press three chief energy acupoints on each side of the body through de novo 11-minute Chinese-language video and practice acupressure every day (one minute per acupoint; a total of 6 minutes per day) for an 8-week intervention period. Participants will be telephone interviewed twice: at baseline and 8-weeks post-intervention follow-up.

Eligibility Criteria:
Inclusion Criteria:

* 1) be between ages 21 to 74
* 2) be first-generation immigrants
* 3) speak Chinese (Mandarin and/or Cantonese)
* 4) be diagnosed with breast cancer at stage 0, I, II III or IV
* 5) have completed primary treatments (including surgery, radiation, and chemotherapy) 1-5 years prior to recruitment
* 6) have not had recurrence
* 7) have moderate to severe levels of fatigue.

Exclusion Criteria:

* have hypothyroidism and anemia
* being using acupuncture
A Vignette-based Randomized Controlled Trial to Evaluate the Impact of Supervisor's Role on Research Practices of Doctoral Students

This study aims to evaluate the influence of supervisors on PhD students' research practice (i.e., an environment where there is a lack of opposition to detrimental research practice from the supervisor)

PhD students are the next generation of researchers and will present the field in the future. However, several environmental factors might influence their research practice. In this study, we will evaluate the influence of supervisors on PhD students' research practice (an environment where there is a lack of opposition to detrimental research practice from the supervisor).

Objective: To evaluate the influence of supervisors on PhD students' research practice

Design: A randomized controlled trial

1. Intervention: Participants will be shown two case vignettes describing dilemma situations in research reported with and without the role of the supervisor.
2. Participants: The participants will be PhD students in all biomedical disciplines.
3. Sample size will be 300 participants
4. Primary outcome: In each vignette, participants will have to indicate which solution they prefer on a semantic differential scale, rated from - 5 to -1 (preference for solution A) and from 1 to 5 (preference for solution B). Participants will be forced to make a choice between the 2 solutions. The primary outcome will be the mean preference score.
5. This study is approved by ethics review regulations by INSERM (CEEI-IRB): IRB00003888

Eligibility Criteria:
Inclusion Criteria:

* PhD students in biomedical sciences

Exclusion Criteria:

* NA