cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Impact of Ambulatory Epidural on Maternal Satisfaction During Delivery and Postpartum

Childbirth is a special event for women. Maternal satisfaction regarding childbirth is quite important, that is why this factor has to be taken into account. A bad experience related to childbirth could lead to serious psychological and organic consequences such as postpartum depression, mother-baby bond deterioration and chronic pelvic pain. Childbirth image changed over the years to the extent that an increasingly physiological process keeping analgesia and safety is more and more desired. In this perspective, this study aims to investigate an approach so-called ambulatory epidural. Indeed, only a few studies have been conducted and the ones published in 1990s did not involve the current recommended pharmacological protocols.

This is a multi-centre prospective observational analytical before/after-type study.

Practice changes are planned in concerned departments, in particular regarding usual patient care. This observational study aims to quantify the impact of practice changes on patient experience using a Childbirth Assessment Questionnaire (QEVA). During the "before" period, patients will receive a conventional epidural while the others, during the "after" period, will receive an ambulatory epidural. The women involved into this study must fill the QEVA form 2 days after giving birth (at the maternity) then 4 weeks after giving birth in order to get a feedback related to postpartum feelings (phone call).

Eligibility Criteria:
Inclusion Criteria:

* Women older than 18 years old
* with Physiological pregnancy (fetus cephalic position, normal fetal heart rate, spontaneous work between 37 and 41 SA)
* Having benefited from epidural, usual or ambulatory depending on the study period
* who speeks and understand French
* who signed a free and informed consent form

Exclusion Criteria:

* Hearing or comprehension impairment
* Twin pregnancies
* Scarred uterus
* Fetus in non cephalic position
* Imminent delivery
* Women under protective supervision (guardianship, curatorship)
* Women bereaved of a spouse or child during pregnancy
* Hospitalization of child in neonatology after delivery
* Women hospitalized in critical care units after childbirth
Mometasone Furoate Cream Reduces Acute Radiation Dermatitis in Head and Neck Squamous Cell Carcinomas' Patients

Radiation dermatitis is an acute effect of radiation therapy,Especially in the neck skin of head and neck squamous cell carcinomas' patients.The investigators wanted to confirm the benefit of mometasone furoate (MF) in preventing acute radiation reactions, as shown in a previous study.

A randomized,self-comparative controlled trial was undertaken comparing MF cream with no cream administered from the first day of treatment for 5-6 weeks to prevent radiation dermatitis of neck during radiation therapy to the head and neck squamous cell carcinomas' Patients.

One side of patients' neck will begin to use MF cream from the first day of radiation therapy, while the other side accept no preventive measures.

Eligibility Criteria:
Inclusion Criteria:

* pathological diagnosis for head and neck squamous cell carcinomas and
* going to have radiotherapy.

Exclusion Criteria:

* pregnant,
* lactating women,
* infants,
* elderly people with atrophy skin,
* allergic constitution patients,
* the corresponding parts of 5 radiotherapy skin ulceration or infection and
* allergic patients to Mometasone Furoate Cream.
The Inperia Advance Post-Market Retrospective Study

The Inperia Advance Carbostent™ is a CE-marked infra-popliteal stent for treatment of infra-popliteal artery stenosis. The aim of this post-market retrospective study protocl P32203 is to collect clinical data of patients treated with Inperia Advance for the treatment of infra-popliteal artery stenosis in routine clinical practice. In order to obtain long-term follow-up data, the data collection will be limited to patients that have been treated with the device at least 12 months prior to the study start.

The objective of this post-market study is to systematically collect retrospective clinical data on the implantable medical device Inperia Advance in the daily clinical practice in an unselected population treated within the intended use. Data will be collected via medical chart review in anonymous form to assess the safety and efficacy of Inperia Adavance. The Inperia Advance Carbostent™ is a CE-marked infra-popliteal stent for treatment of infra-popliteal artery stenosis.

Eligibility Criteria:
Inclusion Criteria:

* Patient has been implanted with at least one Inperia Advance device according to the indications described in the Instructions for Use (IFU).
* Study device implantation date is at least one year (12 months) prior to the starting date of the retrospective anonymous data collection.

Exclusion Criteria:

* Patients treated less than 12 months prior to study start
Confounder-Corrected Quantitative MRI Biomarker of Hepatic Iron Content

The purpose of this multi-site research is to validate a rapid magnetic resonance based confounder-corrected R-2 mapping method as a quantitative imaging biomarker of liver iron concentrations.

This multi-center, multi-vendor study will validate a rapid magnetic resonance-based confounder-corrected R2\* mapping method as a quantitative imaging biomarker of liver iron concentration (LIC). Excessive accumulation of iron in various organs, including the liver, which affects both adult and pediatric populations, is toxic and requires treatment aimed at reducing body iron stores. Measurement of LIC is critical for detection and staging of iron overload, and for monitoring iron-reducing chelator therapies that are expensive and have side effects. Magnetic Resonance Imaging (MRI) is a widely available, accessible, and safe technology, and it is very sensitive to the presence of iron in tissue. Translation of an MRI biomarker of liver iron concentration into broad clinical use requires that it is clinically feasible, precise, robust to changes in scan parameters, calibrated to a validated reference standard of LIC, and is reproducible across sites and manufacturers. There are currently no available MRI methods that meet these requirements. R2\*-MRI holds the greatest promise to meet these requirements. R2\* mapping can be performed very rapidly with whole-liver 3D coverage in a single 20s breath-hold.

Protocol Modification approved to include additional liver susceptibility measurements for approximately 10 participants (already enrolled at the UW) via recently acquired Superconducting Quantum Interference Device (SQUID). The completion of this additional imaging will depend upon the successful set up and installation of this device.

Per a protocol amendment approved on 10/11/21, the investigators are re-opening the study and increasing enrollment for control subjects. Up to 20 control subjects (changed from 5) will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* know or suspected iron overload
* minimum age: Stanford- 8years , University of Wisconsin - 10 years, John Hopkins follow- 10 years, University of Texas-Southwestern - 18 years

Exclusion Criteria:

* contraindication to magnetic resonance imaging
Efficacy of Empagliflozin or Linagliptin as an Alternative to Metformin for Treatment of Polycystic Ovary Syndrome

The study aims to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).

Patients with polycystic ovary syndrome will be randomized to three arms:

* Metformin (standard care)
* Empagliflozin or Linagliptin Resolution of the syndrome in addition to normalization of sex hormones, metabolic and inflammatory parameters will be tested

Eligibility Criteria:
Inclusion Criteria:

1. Women diagnosed with PCOS according to National Institute of Health criteria.
2. Age: \>18 \<40 years.
3. Infertile women (primary or secondary infertility).

Exclusion Criteria:

1. Patients with history of diabetes mellitus (Type 1 or 2).
2. Patients with liver or renal dysfunction; inflammatory diseases; autoimmune disease; cancer, acute cardiovascular event within last three months and uncontrolled endocrine or metabolic disease.
3. Significantly elevated triglyceride levels (fasting triglyceride \> 400 mg/dL)
4. Untreated or poorly controlled hypertension (sitting blood pressure \> 160/95 mm Hg).
5. Use of hormonal medications, lipid-lowering (statins, etc.), anti-obesity drugs or weight loss medications (prescription or OTC) and medications known to exacerbate glucose tolerance (such as isotretinoin, hormonal contraceptives, glucocorticoids, anabolic steroids) stopped for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors stopped for at least 4 weeks.
6. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.
7. Presence of hypersensitivity to Empagliflozin or other Sodium/glucose cotransporter 2 (SGLT2) inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions).
8. Known hypersensitivity or contraindications to use dipeptidyl peptidase-4 (DPP-4) inhibitors (saxagliptin, linagliptin, sitagliptin...).
9. Use of Metformin, Thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors stopped for at least 4 weeks.
10. Eating disorders (anorexia, bulimia) or gastrointestinal disorders.
11. Having a history of bariatric surgery.
Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes never treated with insulin followed by the extension trial investigating the long-term safety and tolerability in terms of comparing NN1250 with insulin glargine in subjects with type 2 diabetes.

All oral anti-diabetic drug (OAD) treatment will be discontinued when trial participant enters the main trial (NN1250-3579) with the exception of metformin and dipeptidyl peptidase-IV (DPP-IV) inhibitor treatment (only in countries where DPP-IV inhibitor treatment is approved for combination treatment together with insulin, otherwise DPP-IV inhibitor treatment is also discontinued). Subjects who consent to participate in the extension trial will continue the treatment (NN1250 or insulin glargine + oral antidiabetic drugs (OADs)) to which they were randomly allocated in the 52 week main trial.

The main period is registered internally at Novo Nordisk as NN1250-3579 while the extension period is registered as NN1250-3643.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Treatment with oral antidiabetic drugs (OADs) for at least three months before trial start at an unchanged dose
* HbA1c: 7.0-10.0%
* Body Mass Index (BMI) no higher than 40.0 kg/m\^2
* For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3579 (NCT00982644)

Exclusion Criteria:

* Treatment with exenatide or liraglutide within the last 3 months before trial start
* Cardiovascular disease within the last 6 months
* Uncontrolled treated/untreated severe hypertension
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
* Cancer and medical history of cancer
Identification of Predictive Markers for Testis Cancer in a Population of Men With High Risk

Testis cancer with germ cells is the most frequent cancer of young men and its incidence is in constant increase in many industrialized countries, as in France. An increased risk of developing testis cancer has been described in patients with testicular ectopia history and testicular cancer history (controlateral testicular cancer) and more recently suggested in a population of hypofertile men with altered spermatogenesis. To a better understanding of this risk, an attempt of characterization of this group of patients has been proposed in the present work.

The general objective of this project is to characterize morphological and molecular markers of hypofertility which could serve as predictive markers of testis malignant transformation.

In this project conducted in 3 establishments, the investigators propose:

* To select a population of hypofertile patients exhibiting compatible clinical and morphological characters with a high risk of testis tumoral transformation (secretory azoospermia and/or a history of testicular ectopia. To determine the spermatogenic arrests on histological criteria (score of Jonhsen).
* To study the expression of four proteins or family of proteins suspected of being involved in testis tumorogenesis such as: the Placenta Alkaline Phosphatase (PLAPE), cyclin A1, VASA and connexin (Cx) by immunohistochemistry and by real-time quantitative RT-PCR analysis real-time analyses.
* To establish a possible correlation between the clinical data, spermatogenesis arrest and the expression of these biomarkers.

These approaches would allow to identify, in this population of hypofertile patients, subgroups of men who could develop tumours with germ cells, and subsequently to propose potential biomarkers for testis cancer. A more clinical observation of these subgroups will be also proposed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with infertility azoospermia
* Age 18 to 35 years
* Definition of clinical and biological character of azoospermia: testicular volume less than 10 ml and FSH more than 10 IU / l
* Normal karyotype
* Surgical exploration included in a standardized medical aid to procreation
* Testicular biopsy performed by traditional surgery
* Patient informed about the research protocol and having signed consent to conduct a further testicular biopsy included in this study.

Exclusion Criteria:

* adults protected by law, minors
* Individuals who are not affiliated to a social security
* Subjects hospitalized for any reason other than research.
* Patients will be used to support reproductive techniques:
* Positive serology (HIV, hepatitis ...).
* Patients with karyotype anomalies and unfavourable genetic counselling
Longitudinal Oral Microbiome Sampling for BE

This is a longitudinal cohort study to assess the impact of repeated sampling of an oral microbiome signature for Barrett's esophagus (BE). Potential participants will be identified through chart review of patients who have had an endoscopy in the past three years.

Saliva collection is non-invasive and can be performed in clinical and non-clinical settings. As such, saliva testing is a highly attractive method for diagnosing and/or monitoring disease. The investigators previously showed that the bacterial make-up ("microbiome") of saliva is highly distinct in patients with and without Barrett's esophagus (BE), a precursor to esophageal cancer that normally can only be diagnosed by undergoing an upper endoscopy. While the microbiome of saliva is felt to be relatively stable over time, it is unclear whether a microbiome signature for Barrett's esophagus is reproducible within individuals. Also, repeated testing of saliva may improve the ability to diagnose Barrett's esophagus.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for an upper endoscopy or had upper endoscopy within past three years
* Eighteen years of age or older
* Capable of producing a saliva sample
* Able to give informed consent
* For BE patients only: Endoscopic evidence of Barrett's esophagus (at least 1 cm maximal BE length; i.e. Prague classification: any C, M≥1), and intestinal metaplasia present on esophageal biopsies

Exclusion Criteria:

* History of head and neck cancer or esophageal squamous cell or gastric cancer
* History of esophageal or gastric surgery
* Scheduled to undergo colonoscopy on the day of initial saliva collection
* Scheduled only for Endoscopic retrograde cholangiopancreatography (ERCP) or Endoscopy ultrasound (EUS) without accompanying standard upper endoscopy on the day of initial saliva collection
* For BE patients only: History of prior endoscopic therapy for BE except a history of prior Endoscopic mucosal resection (EMR) of focal lesions without subsequent ablative therapy is permitted
Retrospective Study to Determine the Incidence of Bone Fractures in HIV-infected Patients in Spain

Study to determine the incidence of Bone Fractures in HIV infected patients in Spain

Study to know the incidence of bone fractures in HIV patients, determine associate factors to bone fractures, the type of patients with fractures.

Eligibility Criteria:
Inclusion Criteria:

* HIV infection
* Signed ICF
* Patient that fulfill these:

  * Osteroporosis associated fracture
  * Enough information close to the moment of the fracture

Exclusion Criteria:

* patients with cognitive impairment
Neuromuscular Consequences of Knee Arthroscopy

To determine changes in quadriceps muscle function following the application of ice and compression to the knee.

Novel rehabilitation methods, that specifically target decreased muscle activation due to joint pathology prior to strength training, have elicited greater improvements in muscle function and self-reported disability compared to traditional therapies. Preliminary evidence suggests applying cryotherapy to a joint prior to exercise can increase quadriceps activation. It is unknown if applying cryotherapy and intermittent pneumatic compression can also increase quadriceps force output and voluntary activation. The purpose of this study is to determine changes in quadriceps force output and voluntary activation following the application of cryotherapy and compression. The investigators hypothesize there will be an increase in quadriceps force output and voluntary activation following the application of cryotherapy and compression.

Eligibility Criteria:
Inclusion Criteria:

* Age 15-65 years
* BMI \< 30
* Candidate for arthroscopic knee surgery to address meniscus pathology or arthroscopic knee surgery within the past 2 years.

Exclusion Criteria:

* Participants who are outside of age range
* Ligamentous insufficiency or repair
* Participants with traumatic spine or lower extremity injury within past 6 months
* Participants who have had previous adverse reactions to electrical stimulation or cryotherapy (i.e. burns, hypersensitivity)
* Medical conditions which would be contraindications to electrical stimulation or transcranial magnetic stimulation, including cardiac pacemaker, metal implants in the head, current pregnancy, neurological disorders, and history of seizures
* Participants who are unable to give consent or are unable to understand procedures of experiment.
Perception of Nonverbal Acoustic Signals and Resulting Physiological Responses (SINOVE-PER)

Like many other animals, humans produce nonverbal signals including screams, grunts, roars, cries and laughter across a variety of contexts.Due to their acoustic structure, nonverbal vocalizations and valanced speech (e.g., yelling) are also likely to elicit predictable physiological, perceptual or behavioural responses in the receiver of the signal (the listener). This is critical if researchers are to gain a comprehensive understanding of the broad range of mechanisms and the evolved functions of acoustic communication.

Therefore, in this research, investigators will examine specifically how exposure to vocal stimuli affects both the cognitive and biological responses of the listener.

Like many other animals, humans produce nonverbal signals including screams, grunts, roars, cries and laughter across a variety of contexts. Many of these signals (such as cries) are already produced at birth and are likely to serve a number of important biological and social functions. In addition, human speech is characterized by nonlinguistic acoustic parameters (such as pitch, formant frequencies, and nonlinear phenomena) that are known to correlate with biologically important traits of the vocalizer.

Due to their acoustic structure, nonverbal vocalizations and valanced speech (e.g., yelling) are also likely to elicit predictable physiological, perceptual or behavioural responses in the receiver of the signal (the listener).

However, while a number of playback studies have examined behavioural responses (e.g., ratings) of listeners when exposed to various voice stimuli, very few studies have examined whether such behavioural responses are accompanied by an underlying physiological response. This is critical if researchers are to gain a comprehensive understanding of the broad range of mechanisms and the evolved functions of acoustic communication.

Therefore, in this research, investigators will examine specifically how exposure to vocal stimuli affects both the cognitive and biological responses of the listener.

Eligibility Criteria:
Inclusion Criteria:

- Participant should be affiliated or entitled to a social security scheme

Exclusion Criteria:

* Pregnancy
* Hearing impairment, speech production disorders or major health problems.
Motor Performance in Parkinson's Disease After High Intensive Exercise or Deep Brain Stimulation

The purpose of this study is (1) to provide quantitative information of the motor manifestations of Parkinson's disease and (2) to quantify the effect of high intensive antigravity locomotor exercise or Deep Brain Stimulation implantations in Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria (exercise arm):

* Idiopathic Parkinson's disease
* A stable condition the last 6 months
* Hoehn and Yahr 2 - 3

Inclusion Criteria (Deep Brain Stimulation arm):

* Patients referred to Deep Brain Stimulation

Exclusion Criteria:

* Cardiovascular disease
* Conditions that contraindicate physical exercise or the examination
Effect of Age, Weight and Sex on Levothyroxine Pharmacokinetics

This study was a prospective, single-center, open-label, non-randomized, pharmacokinetic study using stable isotope carbon-13 labeled levothyroxine

Setting The study was conducted on the clinical research unit of an academic medical center.

Participants Adults of any age being treated with levothyroxine for hypothyroidism were studied.

Interventions A single dose of 13C- LT4 was administered to hypothyroid subjects taking levothyroxine replacement.

Main Outcomes and Measures Eighteen serial plasma samples were collected. One sample was obtained before the 13C- LT4 dose and the remainder over the 312-hour period post-dosing. 13C- LT4 concentration was quantified using validated liquid chromatography tandem mass spectrometry methods. Pharmacokinetic analysis was conducted using linear log trapezoidal non-compartmental analysis using Phoenix 6.4.

Eligibility Criteria:
Inclusion Criteria:

* age \>21 years at the time of consent
* euthyroidism while undergoing treatment with LT4
* no other serious illness
* ability to give written informed consent.

Exclusion Criteria:

* baseline hematocrit lower than 28.0%
* TSH greater than 4.5 mIU/L
* kidney dysfunction
* concomitant use of drugs that affect thyroidal axis interactions