cyrilzakka/clinical-trials huggingface dataset:
Maximal Exercise Capacity at 2500 m of High Altitude

The impact of hypoxia on maximal work rate during incremental ramp exercise within 3-6 hours after arriving at 2500m of high altitude in patients with precapillary pulmonary hypertension


Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature (Appendix Informed Consent Form)
* PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure \>20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization

Exclusion Criteria:

* resting partial pressure of oxygen \<8 kilopascal at Zurich at 490 m low altitude
* exposure to an altitude \>1000 m for ≥3 nights during the last 2 weeks before the study
* inability to follow the procedures of the study
* other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
The Subvastus Approach in Total Knee Arthroplasty

The purpose of this study is to determine if the observed benefits of minimally invasive total knee arthroplasty, namely decreased hospital stay and increased range of motion, can be achieved with standard knee arthroplasty using the subvastus approach.


Eligibility Criteria:
Inclusion Criteria:

* You are willing to take part in the study, including signing this form after carefully reading it.
* You are available for follow-up for a minimum of 24 months (2 years).
* You have no medical conditions that prevent you from having surgery.
* This is the primary (first) knee replacement for this knee
* You are fluent in English and are able to understand your responsibilities in this study.

Exclusion Criteria:

* Active, local or systemic infection
* Fibromyalgia or other chronic pain syndrome
* Inability to follow the study requirements
* Had this knee replaced before
* Had a previous surgery on this knee that would interfere with the MIS approach (examples are femoral-femoral bypass, femoral-popliteal bypass, and quadricepsplasty)
* Body Mass Index (BMI) \> 35, as you would not be eligible for the MIS approach.
SpyGlass™ Discover Percutaneous

To document the clinical utility of percutaneous cholangiopancreatoscopy using a thin, disposable, flexible endoscope for evaluation and treatment of complex pancreaticobiliary disease in a prospective, multi-center case series

This case series aims to illustrate the clinical utility of percutaneous transhepatic cholangiopancreatoscopy using a thin, disposable, flexible endoscope performed by gastroenterological endoscopists and/or interventional radiologists in procedures including but not limited to:

* PTCS for tissue diagnosis in cases of surgically or pathologically-altered anatomy,
* PTCS for stone removal after surgically or pathologically-altered anatomy,
* Percutaneous rendezvous to aid ERCP after failed endoscopic cannulation,
* Percutaneous delivery of palliative intraluminal brachytherapy,
* Intra-procedural percutaneous salvage procedures when an initial route of access fails

Eligibility Criteria:
Inclusion Criteria:

1. Scheduled for a percutaneous transhepatic procedure to access the pancreaticobiliary anatomy that will accommodate passage of SpyGlass™ Discover Digital Catheter per local standard of practice
2. Written informed consent from patient or legally authorized representative of the patient

Exclusion Criteria:

1. Contraindication for cholangiopancreatoscopy
2. Subjects with unresolved adverse event(s) associated with prior percutaneous pancreaticobiliary ductal access
3. \<18 years of age
4. Potentially vulnerable subjects, including, but not limited to pregnant women
A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy

The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, oral cavity, or larynx with no evidence of metastatic disease (i.e. M0).
* Confirmed unresected Stage III, Stage IVA or IVB according to the eighth edition of the American Joint Committee on Cancer (AJCC) staging manual (tumor, node, metastasis (TNM) staging system).
* Participants will have completed definitive concurrent chemoradiotherapy (cCRT) with curative intent within 12 weeks prior to randomization.

Exclusion Criteria:

* Histologically/cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including participants with squamous cell carcinoma of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland). Participants with \>1 primary tumors are not eligible for the study.
* Participants with any of the following:

  1. Residual disease that needs further treatment with curative intent after definitive cCRT administration;
  2. LA-HNSCC that was resected before definitive cCRT
  3. LA-HNSCC that was treated and is recurrent at the time of screening
* Participants who have received radiotherapy (RT) alone as definitive local therapy for LA-HNSCC.
* Receipt of the last dose of anticancer therapy (chemotherapy and/or RT) \> 12 weeks (84 days) prior to randomization.
Validation of 18F-MISO-PET and 18F-FLT-PET

Hypoxia and tumor cell proliferation are important mechanisms contributing to resistance to radiotherapy in human head and neck tumor cells. Currently, assessment of these two tumor characteristics is performed in biopsies using immunohistochemical staining and subsequent analysis. A promising non-invasive method of characterizing a tumor is the use of positron-emission tomography (PET). Specific tracers can be used to detect hypoxia and proliferative activity. 18F-misonidazole is a tracer for hypoxia and 18F-thymidine is a tracer for proliferation.

Patients suffering from head and neck cancer and who will undergo surgery will be included in this study.

One week before the surgery the patients will undergo a CT-scan and a PET-scan with either of the tracers. Shortly before the surgery they will be given immunohistochemically detectable marker substances enabling the characterization of the tumor samples gathered from the resection specimen. These markers are pimonidazole for detection of hypoxia and iododeoxyuridine for detection of tumor cell proliferation.

The data collected by PET-scan will be analysed and compared to the results acquired by immunohistochemistry.


Eligibility Criteria:
Inclusion Criteria:

* Stage II-IV squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx, planned for curative resection.
* Age \>18 years.
* Written informed consent.

Exclusion Criteria:

* Pregnancy.
* Prior treatment for this tumor
* Women breast feeding
Electric Impedance Tomography Before and After Dilatative Tracheotomy

The changes of local pulmonary ventilation should be registered with an electric impedance tomography (EIT) before and after a dilatative tracheotomy. The hypothesis is that the EIT cannot show changes in local ventilation due to the tracheotomy.


Eligibility Criteria:
Inclusion Criteria:

* treatment on ICU
* indication for tracheotomy
* age between 18 and 85 years
* written to consent

Exclusion Criteria:

* severe chronic pulmonary disease
* cardio pulmonary unstable situation
A Pilot Evaluation of Adhesives and How They Are Impacted by Output

This study investigates the impact of real output on the adhesion of two adhesives.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had an ileostomy for more than one year
4. Have intact skin on the area used in the evaluation
5. Has an ileostomy with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist) -

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
5. Participating in other interventional clinical investigations or have previously participated in this evaluation
Electromagnetic Stimulation of the Phrenic Nerve of Intubated Patients

Ventilator-induced diaphragmatic dysfunction is a common issue in critically ill patients. Muscle stimulation has shown to have beneficial effects in muscle groups on the extremities. A non-invasive way to stimulate the diaphragm would be the electromagnetic stimulation but it is currently unclear if that is feasible.

In this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction leading to an inspiration with a sufficient tidal volume via an external electromagnetic stimulation of the phrenic nerve.

During the time of first spontaneous breathing trial 60% of mechanically ventilated patients present with diaphragmatic weakness or also know as ventilator-induced diaphragmatic dysfunction (VIDD). The damage to the diaphragm in terms of muscle atrophy has been shown as early as 12 hours after initiation of mechanical ventilation. Recently, a correlation between diaphragmatic atrophy and mortality could be established.

Induction of diaphragmatic contractions via stimulation of the phrenic nerve would be a possible method to prevent or treat VIDD. A possible modality would be the non-invasive electromagnetic stimulation but feasibility has not been established.

In this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction leading to an inspiration with a sufficient tidal volume via an external electromagnetic stimulation of the phrenic nerve.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* American Society of Anaesthesiologists Classification I or II

Exclusion Criteria:

* Chronic lung disease
* Preexisting diaphragmatic weakness
* Neurologic disease with known motor weakness
* Paralysis of the phrenic nerve
* Contraindication for any movement in the cervical vertebrae
* Conditions that limit the movement of the diaphragm e.g. ascites, increased intraabdominal pressure, adipositas.
* Inability to communicate in the official language
* Infections, lesions or stricture in the neck area
* Implanted cardiac devices e.g. pace maker, defibrillator, event recorder
* Implanted medical pumps e.g. left ventricular assist device
* Metal implants in the upper body
* Preganancy
Prospective Randomised Study for Use of CHG Dressing at Entry Site of EVD's to Reduce EVD-associated Infections

The objective of this study is to assess the efficacy of 3M™ Tegaderm™ CHG I.V. Securement Dressing at the entry-site of a EVD in reducing quantity of microorganisms (CFU/cm2) after a time period of 5 days as a surrogate marker for EVD-associated infections \[1, 2\], compared to a nonantimicrobial polyurethane 3M Tegaderm™ Transparent Film Dressing. We aim to investigate, if the adjunct of an additional CHG-impregnated device on a routinely basis for the daily care is as a valuable and effective option to reduce contamination of the EVD entry-site and consecutive colonization of the catheter.

Randomised, parallel group, single-centre Phase IV trial comparing the change in the quantity of microorganisms (CFU/cm2) after a time period of 5 days (primary endpoint) as surrogate marker for EVD-associated infections \[1, 2\], in patients undergoing EVD with dressing at the entry site with 3M™ Tegaderm™ CHG I.V. Securement Dressing (study arm) versus 3M™ Tegaderm™ I.V. Advanced Dressing (standard arm). Secondary objectives are the comparison of regrowth (CFU/cm2) every 5th day before routine change of the device, cerebrospinal fluid (CSF) cultures every 2nd day and sonication of the catheter tip after explantation (secondary endpoints).

We hypothesize that bacterial contamination (CFU/cm2) of the EVD entry-site after 5 days compared to baseline (bacterial regrowth since baseline) in subjects treated with the 3M™ Tegaderm™ CHG I.V. Securement Dressing is significantly lower compared to subjects treated with 3M™ Tegaderm™ I.V. Advanced Dressing. Quantitative microbiology of the catheter tip (sonication) might be reduced by this external intervention, as well as CSF cultures.

We will use an internal pilot study design \[3\]. The three step procedure includes:

* initial sample size calculation
* sample size review
* final analysis.

Eligibility Criteria:
Inclusion Criteria:

- Patients following the criteria cited below are included: Patients undergoing implantation of an external ventricular drain (EVD), frontal or occipital, due to a given underlying pathology.

* Written informed consent (IC) by patients and/or independent physician \[according 5.1\]
* Age ≥ 18 years

Exclusion Criteria:

* Patients presenting one of the criteria cited below are excluded:
* Presence of clinical signs or laboratory findings suspicious infection
* Presence of antibiotic intake
* Traumatic Brain Injury (TBI) with evident or suspected dural breach (including skull base)
* Decision for Rifampin impregnated ventricular catheter (Bactiseal©)
* Known hypersensitivity to chlorhexidine (people from Japanese origin)
* Age \< 18 years
* Participation in another study involving External Ventricular Drains
* Pregnancy or breastfeeding
A Clinical Study To Investigate The Effectiveness And Safety Of Tanezumab In Treating Pain Associated With Endometriosis

The purpose of this study is to determine whether tanezumab is effective and safe in the treatment of pain associated with endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* Pre-menstrual women with moderate to severe endometriosis. The diagnosis of endometriosis must have been confirmed surgically within the last 8 years.
* Subjects should have regular menstrual cycle (21 - 35 days) and must be willing to use adequate contraception (2 forms of birth control, one of which must be a barrier method). Contraception is required throughout the study (screening to 16 weeks post treatment), even if subjects discontinue prematurely.

Exclusion Criteria:

* Previous hysterectomy
* Surgical treatment for endometriosis within last 6 months.
* Medical treatment for endometriosis other than combined oral contraceptive pill within the last 3 months
* Current use of the coil or progesterone only contraceptive (the combined oral contraceptive pill is allowed).
* Any history of malignant disease (cancer)
Meropenem Pharmacokinetics in Spontaneous Bacterial Peritonitis

The emergence of multidrug-resistant bacteria has increased the use of meropenem in spontaneous bacterial peritonitis (SBP). Additionally, recent studies suggested female gender as an independent risk factor for mortality in SBP. Studies regarding possible sex dependent differences in meropenem pharmacokinetics in SBP are scarce. The aim of this study is to determine the pharmacokinetics of meropenem during SBP in female and male patients with liver cirrhosis to investigate whether pharmacodynamics therapy goals are met.

Spontaneous bacterial Peritonitis (SBP) in liver cirrhosis is a severe and increasingly common disease, which is associated with high morbidity, mortality and high costs for the investigator's health care system. In addition to age and severity of comorbidities, female sex is associated with detrimental outcome. Delayed diagnosis and therapy of SBP may lead to a higher mortality in this patient population. Therefore, an early diagnosis and adequate anti-infective therapy is essential. Due to the accumulation of antimicrobial-resistant (AMR) pathogens, especially in nosocomial SBP, empirical application of broad-spectrum antibiotics is recommended in the therapy of SBP.During the use of antibiotic drugs in general, pharmacokinetic/pharmacodynamic (PK/PD) targets, as the achieved time period over the minimal inhibitory concentration (MIC), should be evaluated to increase drug efficacy and reduce AMR development. Pharmacokinetic studies of meropenem concentrations at the infection site in this particular group of patients are rare in the literature. Recent studies in critically ill patients showed highly variable meropenem concentrations in peritoneal fluid after iv administration. The aim of this study is to determine the pharmacokinetics of meropenem during SBP in female and male patients with liver cirrhosis to investigate whether pharmacodynamics therapy goals are met.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 75 years
* Administration of meropenem
* Diagnosis of liver cirrhosis
* Diagnosis of spontaneous bacterial Peritonitis
* Indication for peritoneal drainage catheter

Exclusion Criteria:

* Incapacity to give informed consent
* Participation in other studies
* Pregnancy
Cladribine Combined With G-CSF and Cytarabine as a Salvage Treatment in R/R ALL

To explore the efficiency and safety of CLAG regimen in R/R ALL

R/R Acute Lymphoblastic Leukemia has poor response to second-line chemotherapy.Here,we want to explore efficiency and safety of CLAG regimen in R/R ALL.

Eligibility Criteria:
Inclusion Criteria:

The patients meet the diagnostic criteria for Relapsed/Refractroy B-ALL. ECOG score is 0-3. Expecting life span is more than 6 weeks.

Exclusion Criteria:

Patients are combined with severe organ dysfunction or organ failure: Cardiac failure, Liver and kidney insufficiency.

Patients are combined with severe infection or other complications that can not tolerate chemotherapy.

Patients are considered as other tumor progression. Patients have used cladribine. Pregnant and lactating women will not be included.
Development of Organoids From Primary Colorectal Tumors and Synchronous Liver Metastases

Pilot feasibility study for the development of organoids from primary colorectal tumors and synchronous liver metastases, to prepare organoids from primary colorectal tumors and synchronous liver metastases. The organoids will allow us to study the function of genes targeted by the activity of the NF-Y/p53 complex.

Organoids will allow us to study the function of genes that are targets of the NF-Y/p53 complex activity. In these organoids, we will perform overexpression and/or silencing of these genes and assays of proliferation, invasion and motility. We will also perform functional assays in cocultures of the organoids with PBMCs from the same patients. This could allow the discovery of new pathways that could be targeted by targeted therapy and/or immunotherapy. Organoid preparation will be performed from fresh colorectal cancer tissue and liver metastasis following enzymatic digestion. Organoid culture medium and specific organic matrix will be used

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years
* Histological and cytological diagnosis of colorectal cancer neoplasia that has developed a liver metastasis
* Patients who are candidates for surgery for colorectal cancer with liver metastasis
* Signing of the relevant informed consent form.

Exclusion Criteria:

* All exclusion criteria adopted in surgical protocols will be applied to the study
Effect of Recombinant Human Growth Hormone Injection on the Clinical Outcome of POR in Patients Undergoing IVF/ET

Observe the clinical efficacy and safety of Recombinant Human Growth Hormone Injection assisted in the treatment of the patients with poor ovarian response in vitro fertilization and embryo transfer.


Eligibility Criteria:
Inclusion Criteria:

* Female, age 30-42 years old.
* Diagnosis of POR (2011 ESHRE Bologna Standard).
* At least two previous IVF failure history.
* Voluntarily to sign the "informed consent".

Exclusion Criteria:

* Severe acute and chronic liver and kidney disease，Such as liver cirrhosis, acute and chronic renal failure, hepatitis B virus activity period, etc.；Liver and kidney dysfunction.
* Endocrine and metabolic diseases，eg, diabetes、Thyroid function hyperthyroidism, Thyroid dysfunction, cushing's syndrome, hyperprolactinemia，hyperandrogenism.
* Related diseases affecting outcome of IVF pregnancy，eg, hydrosalpinx, hysteromyoma≥4cm, adenomyosis, stage III and IV endometriosis, untreated endometrial lesions, uterine malformation, genital tuberculosis, malignant tumor of reproductive system （include endometrial carcinoma, cervical carcinoma, ovarian cancer, fallopian tube carcinoma）.
* Allergic to E. coli expression product and its excipients.
* Subjects who participated in the past three months or are participating in other drug clinical researchers.
* IVF failure history≥3.
* The researchers consider who is not suitable for enrolling the group.
Quantitative Evaluation of the Breast's Morphological Variations During Radiotherapy: MorphoBreast3D

Quantitative evaluation of the breast's morphological variations during radiotherapy consisting in performing three-dimensional surface acquisitions of the breast in order to study its shape and volume. Evaluation of the dosimetric impact of these variations.


Eligibility Criteria:
Inclusion Criteria:

* Women
* In situ or invasive breast carcinoma
* Treated by conservative breast surgery
* Pre-treatment with authorized chemotherapy
* Eligible for conventional breast irradiation in 25 sessions of 2 Gy with or without irradiation of the tumor bed and lymph nodes area
* Conventional 3D radiotherapy technique
* Bra cup size from A to D included
* Speaking and understanding french
* Having given written consent
* Patient with health insurance

Exclusion Criteria:

* Surgical treatment by mastectomy
* No indication for breast radiotherapy
* Local or diffuse inflammatory state of the breast at inclusion
* History of epilepsy or anticonvulsive treatment for preventive or curative purposes
* BMI\> 30kg / m2
* T4 stage tumor
* Bilateral breast tumor
* Use of a ventilatory control to treat the patient
* Minor patient or major incompetent
* Patient deprived of liberty
* Patient under safeguard of justice