cyrilzakka/clinical-trials huggingface dataset:
Gut Microbiome and p-Inulin in CKD - TarGut CKD Study

The purpose of this Phase 1, 3-period crossover with repeated measures feasibility study is to characterize the gut microbiome of individuals with chronic kidney disease, and to explore effects of p-inulin on the gut microbiome. The nature of the study will provide information about the feasibility of stool sample collection for future multicenter studies of the gut microbiome.

The overarching hypothesis motivating this exploratory study of variability is that treatment with oligofructose-enriched inulin (p-inulin) will alter the composition and/or function of the gut microbiome, and thereby reduce the generation of gut-derived uremic toxins, improve gut barrier function and attenuate systemic inflammation in CKD patients. In order to design a future clinical trial the following parameters from CKD subjects are needed:

1. Intra-patient variability in the composition and function of the gut microbiome
2. Inter-patient variability in the composition and function of the gut microbiome
3. Impact of p-inulin on the composition and function of the gut microbiome
4. Tolerability of p-inulin administration
5. Feasibility of collecting stool samples in this patient population

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with eGFR 15.0 to 50.0 ml/min/1.73 m2 as estimated by the CKD-EPI equation
2. Albuminuria greater than 300 mg/g creatinine (by spot urine test) if eGFR is ≥45 ml/min/1.73 m2
3. Age ≥ 18 years
4. For women of childbearing potential, willingness to use a highly effective method of birth control for up to 4 weeks after the last dose to study drug. See Section 4.2.1 for definition of childbearing potential and acceptable methods of birth control
5. Ability to provide informed consent

Exclusion Criteria:

1. Use of pre- or pro-biotics during the past 2 months
2. Consumption of probiotic yogurt during the past 2 weeks
3. Use of antibiotics within the past 3 months if the patient received a single course of antibiotic. If the patient received more than one course of antibiotic treatment, we will wait for 6 months prior to inclusion.
4. Presence of HIV infection, chronic wound infection and osteomyelitis
5. Presence of or treatment for periodontal infection
6. Inflammatory bowel disease, chronic diarrhea, current C. difficile infection
7. Cirrhosis or chronic active hepatitis
8. Treatment with immunosuppressive medications in the past 6 months or more than a week of treatment with prednisone \>10 mg in the last 3 months
9. Treatment with proton pump inhibitors within the last one month
10. Anticipated initiation of dialysis or kidney transplant within 9 months
11. Acute on chronic kidney disease
12. Expected survival \< 9 months Do not disclose or use except as authorized by the Pilot Clinical Trials in CKD Consortium.
13. Pregnancy, anticipated pregnancy, or breastfeeding
14. Incarceration
15. Participation in another intervention study
16. Severe anemia defined as hemoglobin \<9.0 g/dl any time during the last 3 months
17. Patients in whom frequent blood sampling may be difficult
AMPLATZER™ Cardiac Plug Observational Post-Approval Study

The purpose of this study is to observe the safety and effectiveness of the AMPLATZER™ Cardiac Plug (ACP) device in Chinese population indicated for use of AMPLATZER™ Cardiac Plug after its market approval by China FDA (CFDA). This is a prospective, multi-centre, single arm, post approval, observational study. The clinical study will be conducted at up to 35 sites in China. Approximately 343 subjects will be enrolled in this study.

The total study duration is expected to be approximately 7 years. The study population included patients who have non-valvular atrial fibrillation (NVAF) and are contraindicated to long-term oral anticoagulant; or patients who experience stroke or other thromboembolic event despite taking warfarin.

Scheduled office visits occur at 45 days (+45 days), 6M (+/- 3 weeks) 12M (+/- 6 weeks) and 24 M(+/- 6 weeks) post procedure; Phone contact follow up visits occur at, 36 M (+/- 6 weeks), 48M (+/- 6 weeks) and 60 M (+/- 6 weeks) post procedures.


Eligibility Criteria:
Inclusion Criteria:

1. Patient who meets the current indications and per physician discretion for ACP implant
2. Patient who is ≥ 18 years of age at the time of enrolment
3. Patient who is able to provide written Informed Consent prior to any study related procedures

Exclusion Criteria:

1. Patient who is unable to comply with the follow-up schedule
2. Patient with the presence of intracardiac thrombus
3. Patient with active endocarditis or other infections producing bacteraemia
4. Patient who has low risk of stroke (CHA2DS2-VASC score is 0 or 1) or low risk of bleeding (HAS-BLED score\<3)
5. Patient where placement of the device would interfere with any intracardiac or intravascular structures
6. Patient who is under medical conditions not appropriate to participate in the study in the opinion of the investigator
7. Patient with LAA anatomy that does not accommodate a device per the sizing guidelines
8. Patient who has a life expectancy of less than 2 years due to any condition
9. Patient who are currently participating in a clinical investigation that includes an active treatment arm
10. Patient who already had a left atrial appendage closure device implanted prior to the study
Patient Derived Breast Cancer Xenografts

This study will use tissue or body fluid acquired during standard procedures that are part of the patient's care for their cancer, such as surgery to remove tumor tissue or needle withdrawal of body fluid containing cancer cells. The tissue or cells will be injected into immune compromised mice and the tissue will be allowed to grow to a tumor 1-1.5 cm size. The tissue will then be extracted and either frozen, embedded in paraffin, or used for engraftment into another generation of mice. The second generation mice will be separated into groups and given various treatments.

Tissue from the participants and from the mouse established tumors, in which the mice have either received treatment or have not received treatment, will be used to evaluate the levels of various genes that assist in regulating cell growth and cell death. The tumor tissue from participants and mice will also be tested for random changes in the genetic material and compared to the participant's blood to determine if any of the changes in the genetic material correlate with better engraftment of the patient tissue in the mice. It is anticipated that 10-30% will have successful engraftment of tumor tissue


Eligibility Criteria:
* Women \> age 18. with a history of ER+. HER-2 negative breast cancer previously treated with adjuvant anti-estrogen therapy (tamoxifen or aromatase inhibitor? for at least 1 year after surgical resection of primary tumor.
* ER+ status requires positive staining in \> 10% of malignant cells in biopsy specimen.
* HER-2 Negative status requires Immunohistochemistry 0-1+, or with a FISH ratio of \< 2.0 if IHC is 2+ or if IHC has not been done.
* Patient must have: A. newly diagnosed recurrent, locally advanced or metastatic breast cancer. B. existing advanced or metastatic breast cancer.
* Patient must be having clinically indicated: A. diagnostic tumor biopsy via core-or needle incision or B. surgical removal of tumor or C. collection of pleural or ascetic fluid in order to obtain fresh tumor tissue for research (transplant into mice).
* For subjects having a diagnostic tumor biopsy, excess fresh tumor tissue must be available from the biopsy for research for immediate transplantation into mice.
* For subjects having a surgical resection of the primary tumor, the tumor must have a clinical size of 1 cm or greater, and and excess fresh tumor tissue must be available from the surgical specimen for research for immediate transplantation into mice.
* Ability to give signed informed consent
Adenosine vs AF Termination for Paroxysmal AF Ablation

This study investigates impact of adenosine versus AF inducibility and subsequent termination on the acute and long-term outcome of paroxysmal AF ablation.

Despite intensive efforts to increase single procedure success rates of pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (AF), an arrhythmia-free surveillance has not raised beyond 80%. This prospective, randomized study investigates the efficacy of two different procedural endpoints in terms of single-procedure arrhythmia-free outcome.

A total number of 152 patients undergoing de-novo catheter ablation for paroxysmal AF will be randomized to two different treatment arms. In group-A patients, PVI will be performed with the patient either in spontaneous or induced AF. If AF will not terminate with PVI, ablation will be continued by targeting extra-PV AF sources with the desired endpoint of termination to sinus rhythm (SR). The ablation procedure in group-B patients consists of PVI exclusively, regardless to the underlying rhythm. In this group, all isolated PVs will be challenged to adenosine administration in the attempt to reveal and ablate dormant conduction. The primary endpoint is arrhythmia-free survival during a follow-up of 1 year.

Eligibility Criteria:
Inclusion Criteria:

* patients with paroxysmal AF
* de-novo AF ablation
* age \> 18 years

Exclusion Criteria:

* persistent AF
* previous cardioversion
Percutaneous Electrical Nerve Stimulation and Exercise for Shoulder Pain

Based on the available literature, application of percutaneous electrical nerve stimulation interventions targeting peripheral nerves (also called percutaneous neuromodulation) has shown positive effects for improving pain-related and functional outcomes in musculoskeletal chronic pain. Studies investigating the use of this intervention for the shoulder are lacking.

Based on the available literature, application of percutaneous electrical nerve stimulation interventions targeting peripheral nerves (also called percutaneous neuromodulation) has shown positive effects for improving pain-related and functional outcomes in musculoskeletal chronic pain. Studies investigating the use of this intervention for the shoulder are lacking.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral non-traumatic shoulder pain (positive painful arc during shoulder abduction and a positive Hawkins test on clinical examination)
* Shoulder pain from at least 3 months
* Shoulder pain of more than 3/10 points on a NPRS

Exclusion Criteria:

* Bilateral shoulder symptoms
* Younger than 18 or older than 65 years
* History of shoulder traumatisms, fractures or dislocation
* Diagnosis of cervical radiculopathy or myelopathy
* Previous interventions with steroid injections in the shoulder area
* Comorbid medical conditions, e.g., fibromyalgia syndrome
* Previous history of shoulder or neck surgery
* Any type of intervention for the neck-shoulder area during the previous year
* Fear to needles
Fetal Orbital Measurements by 3D Ultrasound

The investigators will measure fetal orbital transverse and anterior-posterior diameter by 2D ultrasound and orbital volume by 3D ultrasound in women visiting our unit for other examinations during pregnancy. The investigators will examine 5-10 women in each gestational age in order to create a normal values curve throughout pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* well dated singleton pregnancies

Exclusion Criteria:

* multiple pregnancy
* pregnancies with known malformations,
* chromosomal abnormalities or
* intrauterine infections
Three Dimensional Ultrasonographic Detection of Human Ovulation

The research aims to compare diagnosis of ovulation and anovulation in 2D and 3D ultrasonography.

Thirty healthy participants will be enrolled. When their dominant ovarian follicle has a diameter of 16 mm or more, an anti-prostaglandin medication, indomethacin 30 mg, will be administered three times daily for 1-7 days. Anti-prostaglandins are known to cause anovulation. Daily 2D and 3D ultrasound scans, and urine and finger prick blood tests for reproductive hormonal assays will be performed. The medication will be discontinued once ultrasound features of anovulation are observed. These study procedures will also be carried out on days 1, 3 and 7 after anovulation.

A second cohort of 30 participants who had 2D and 3D ultrasound scans and hormonal assays in a natural cycle in a previous study (Bio 2080; NCT05531357) will also be evaluated.

These two groups represent the anovulatory and ovulatory groups, respectively, and their 2D and 3D ultrasound features will be compared. With 2D ultrasonography as a gold standard, the study aims to determine if 3D ultrasonography improves ovulation assessment and improves the recognition of anovulatory follicles in infertility treatment

Eligibility Criteria:
Inclusion Criteria:

* Healthy biological females
* Regular menstrual cycles (21-35 days)

Exclusion Criteria:

* BMI \<18 or \>30
* Pregnancy
* Breastfeeding mothers
* History of infertility
* History of hysterectomy or oophorectomy
* Reproductive health issues that can interfere with study outcomes
* Smoking
* Not on any hormonal medication that affects reproduction (including hormonal contraception)
* History of metabolic syndrome or untreated thyroid disease
* Contra-indication to non-steroidal anti-inflammatory drug (NSAID) use. These include:
* Gastric ulcers or gastro-intestinal bleeding
* History of myocardial infarction or a coronary artery bypass
* Cerebrovascular disease
* Hypertension
* Chronic or acute renal failure
* Severe liver disease
* Nasal polyp syndrome
Comparison Between Cisatracurium and Rocuronium in Terms of Recovery of the Muscular Strength in the Postoperative Phase After Surgery and General Anaesthesia

The purpose of this study is to determine the incidence of post-operative residual curarization in our patients and to determine if Cisatracurium and Rocuronium behave differently from each other in terms of residual curarization.


Eligibility Criteria:
Inclusion Criteria:

* general anaesthesia with need to use of neuromuscular-blocking agents
* awakening and extubation of the patient in the operating room and permanence in the PACU for at least 60 minutes
* age 18-80
* surgical operations lasting at least 1 hour
* ASA class I-III
* possibility to apply TOF-monitoring with thumb-acceleromyography
* women of childbearing age not using contraceptives
* women of childbearing age using contraceptives

Exclusion Criteria:

* subjects unable to give a valid consent
* patients in emergency situations
* patients not awakened and not extubated in the operating room
* age above 80 years or under 18 years
* surgical operations lasting less than an hour
* ASA class IV
* impossibility to apply and/or perform TOF-monitoring
* neuromuscular diseases
* intake of therapies interfering with the neuromuscular function
* patients having contraindications for either studied drug
* pregnant women
* women who are breast-feeding
In Market Utilisation of Liraglutide Used for Weight Management in the UK: a Study in the CPRD Primary Care Database

This study is conducted in Europe. The aim of this study is to investigate the usage of liraglutide for weight management in clinical practice using the CPRD (Clinical Practice Research Datalink) primary care database.


Eligibility Criteria:
Inclusion Criteria:

-New initiators of liraglutide (unbranded, or branded prescription, i.e. Saxenda® or Victoza®), who have no liraglutide prescriptions in the twelve months prior to index date (time of first prescription). Patients must be research standard (registered as "acceptable" in the database) with at least one year of up-to-standard registration prior to their index date

Exclusion Criteria:

-Not applicable
Pulmonary Rehabilitation in Patients With Sarcoidosis

The primary objective of the study is to assess the improvement of daily activity in subjects with Stage IV Pulmonary Sarcoidosis one year after the conduct of a pulmonary rehabilitation program.

The secondary objectives are the following:

* assess the improvement of daily activity at several times : 2, 6 and 12 months after the beginning of a pulmonary rehabilitation program
* assess the improvement of exercise capacity by tests used in medical practice
* assess the correlation between daily activity and exercise capacity
* assess the improvement of dyspnea
* assess the improvement of quality of life and psychological state

The primary objective of the study is to assess the improvement of daily activity in subjects with Stage IV Pulmonary Sarcoidosis one year after the conduct of a pulmonary rehabilitation program

The secondary objectives are the following :

* assess the improvement of daily activity at several times : 2, 6 and 12 months after the beginning of a pulmonary rehabilitation program
* assess the improvement of exercise capacity by tests used in medical practice
* assess the correlation between daily activity and exercise capacity
* assess the improvement of dyspnea
* assess the improvement of quality of life and psychological state

Eligibility Criteria:
Inclusion Criteria:

* Stage IV Sarcoidosis
* No hospitalization for respiratory distress in the 3 months preceding the inclusion
* Dyspnea on exertion
* Age over 18 years

Exclusion Criteria:

* Physical disability does not allow the creation of a rehabilitation program
* Inability to give written consent to the study
* Refusal of contraception in women of childbearing age
* Inability to participate in the entire study
* No cover by the social security system
* Inability to perform self-questionnaires etude

The trial does not include special populations include:

* Pregnant women
* Breastfeeding women
* People in emergencies
* Persons unable to consent
* Persons deprived of liberty
Comparison of SPECT/CT Perfusion and Volumetric CT Volume

The main aim of this study is to show that single photon emission tomography/Computer tomography (SPECT/CT) is a reliable examination to predict postoperative pulmonary function after segmentectomy, by comparing this predicted function to that measured at 1 and 6 months.

Lung cancer has a high prevalence, incidence and mortality in France and worldwide. Surgical treatment, possible only at an early stage, improves the prognosis of patients. In addition, the increasing accessibility of chest CT scans allows early detection and monitoring of small pulmonary nodules. As a result, more conservative surgical techniques are becoming increasingly important, including segmentectomy.

Among patients for whom it is indicated, the preoperative assessment involves the evaluation of pulmonary function and the prediction of postoperative pulmonary function in order to validate the feasibility of surgery. To do this, several methods have been described: anatomical methods (segment counting), radiological imaging methods (CT, DECT, perfusion MRI), and nuclear imaging methods (planar perfusion and/or ventilation pulmonary scintigraphy, SPECT pulmonary perfusion scintigraphy), some of which are hybrid (SPECT/CT). The use of SPECT/CT to predict postoperative pulmonary function is routinely practiced, and its reliability, accuracy, and concordance with measured postoperative pulmonary function are well demonstrated for pneumectomy and lobectomy. For more conservative surgeries, the data in the literature remain uncertain. However, being able to predict pulmonary function is essential, both to justify the feasibility of the intervention, but also to target the most fragile patients and intensify their postoperative respiratory rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Person having received full information on the organization of the research and not having opposed the exploitation of this data
* Patients having benefited from a single or multiple segmentectomy within the thoracic surgery department of the CHRU of Nancy during the period April 2021 to June 2023
* Patients having a complete pre-operative assessment (SPECT/CT, volumetric CT and EFR)
* Patients having 2 post-operative assessments (respiratory functional exploration (EFR) at approximately 1 month post-operatively and 6 months post-operatively).

Exclusion Criteria:

* Patients who underwent more extensive surgery (lobectomy, pneumectomy) or less extensive surgery (wedge).
* Patient who did not have a complete preoperative assessment (SPECT/CT or volumetric CT or missing respiratory functional exploration EFR).
* Patient who did not have a complete postoperative assessment (missing respiratory functional exploration EFR at 6 months).

NB: the absence of respiratory functional exploration EFR at 1 month postoperatively is not an exclusion criterion
Noninvasive Hemoglobin Testing, Prospective Blood Donors

The objective of this clinical investigation is to evaluate the pulse oximeter devices for screening prospective blood donors. The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer in a blood donation setting.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Weight at least 110 pounds
* Subjects with the intention of being screened for eligibility to donate blood
* The subject has given written informed consent to participate in the study

Exclusion Criteria:

* Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, infections, abnormalities, etc.
* Subjects unwilling and/or unable to remove nail polish or acrylic nails
* Subjects with blood cancers such as leukemia
* Subjects with hemoglobin disorders such as sickle-cell anemia and thalassemia
* Subjects with known history of infectious diseases such as HIV/AIDS, syphilis, hepatitis, etc.
* Subjects with self-disclosed/known pregnancy at the time of enrollment
* Subjects deemed not suitable for the study at the discretion of the investigator
* Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
Carboplatin-gemcitabine Versus Cisplatin- Gemcitabine as Neoadjuvant Chemotherapy for Treatment of Muscle Invasive Urinary Bladder Cancer

Patients will be randomized in 1:1 ratio to two treatment groups first group will receive 3-4 cycles of neoadjuvant Carboplatin(AUC4)-Gemcitabine (treatment group) and second group will receive 3-4 cycles of neoadjuvant Cisplatin(75mg/m2 Day1)-Gemcitabine (Control group). Patients will undergo radiological assessment, full laboratory work up, and cystoscopy before undergoing either radical cystectomy or Definitive Radiotherapy concurrent with chemotherapy

Patients will be randomized in 1:1 ratio to two treatment groups first group will receive 3-4 cycles of neoadjuvant Carboplatin(AUC4)-Gemcitabine (treatment group) and second group will receive 3-4 cycles of neoadjuvant Cisplatin(75mg/m2 Day1)-Gemcitabine (Control group). Patients will undergo radiological assessment, full laboratory work up, and cystoscopy before undergoing either radical cystectomy or Definitive Radiotherapy concurrent with chemotherapy. After finishing treatment, all patients should undergo follow up every 3 months for two years then six monthly thereafter .Follow up will include History, physical examination, full laboratory works (CBC, renal function testing and liver function testing). Imaging by CT or MRI abdomen and pelvis for all patients and cystoscopy in bladder preservation protocol

Eligibility Criteria:
Inclusion Criteria:All patients diagnosed with muscle invasive urinary bladder cancer that can receive chemotherapy are included the criteria are

* • Age above 18 years,

  * Pathologically proven urinary bladder cancer,
  * Patients with clinical stages T2-4a N0-3 M0,
  * Patients with good renal and liver functions
  * patients with no distant metastases,
  * no other malignancy (double malignancy).
  * Performance status 0-1 according to ECOG performance status scale.
  * Patients with no contraindications for radiotherapy.

Exclusion Criteria:

* • performance status 2-4 according to ECOG performance status scale.

  * patients refuse to receive chemotherapy,
  * patients not eligible to receive chemotherapy due to liver or renal impairment or thrombocytopenia,
  * patients with M1 disease.