cyrilzakka/clinical-trials huggingface dataset:
The Effects of Exogenous Ketones on Exercise Performance in Young Healthy Adults

The ketone body beta-hydroxybutyrate is produced during prolonged fasting or exercise and can be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a ketone salt, is proposed to have ergogenic potential for high-intensity exercise performance but this has not been adequately studied. The purpose of this study is to determine whether supplementing with an acute dose of ketone salts can alter fuel use during exercise and improve exercise performance.


Eligibility Criteria:
Inclusion Criteria:

* Males aged 18-40
* Ability to understand and communicate in English to answer questionnaires and interact with the research assistant
* Physically active (defined by engaging in moderate-to-vigorous exercise at least 3 times per week, determined via validated questionnaire)

Exclusion Criteria:

* Diagnosed with diabetes or any other medical conditions that could affect metabolism.
* Diagnosed with heart disease or taking anti-hypertensive medications.
* Competitive endurance athlete (self-identified as engaged in specific endurance training in triathlon, cycling, or distance running and competing in races or competition)
* Recent (last 3 months) or current consumption of a low-carbohydrate ketogenic diet
* Current consumption of ketone supplements
* Any other contraindication to vigorous exercise (identified via physical activity readiness questionnaire \[PAR-Q\])
The Achilles Tendon Length Measure (ATLM) - Development and Validation

The purpose of this study is 1) to develop and validate a new measurement to assess the length of the Achilles tendon after rupture, and 2) to examine if goniometer measurement of the ankle joint is a better method.

It has been shown that an Achilles tendon elongation compared to the un-injured leg is negatively associated with the clinical outcome and strength of the gastrocnemius muscle. Despite this knowledge, there is a lack of a valid score system that can measure the length of the Achilles tendon in daily clinical practice. Patients, who follow a rehabilitation program at the Department of Physiotherapy, also have their Achilles tendon examined for lengthening by physiotherapists, to evaluate if the heeling progresses as planned. Of concern, this examination is based on measures, which have not been thoroughly validated.

The ATLM test use the same test position of the lower limb as being used in Matles test. Besides observing the foot's position, we will measure the distance from a point of reference on the foot to the examination coach. Reproducibility and responsiveness of the ATLM will be examined, while concurrent validity will be examined against ultrasound and a goniometry measure. The ultrasound is considered the most precise, secure and objective measure.

The ATLM and goniometer measures will be conducted at 8 and 16 weeks after the injury. At 8 weeks there will be two physiotherapists conducting these measures (to investigate inter-tester reliability). The ruler and goniometer will have the numbers hidden. A third physiotherapist will read the results at 8 and 16 weeks, so that the physiotherapists will be blinded towards the results. A person blinded to these results will conduct the ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-60.
* Patients who are being referred to the rehabilitation program for patients with an AATR, at Hvidovre Hospital.
* The patients have to speak and understand Danish.
* The patients have to be able to sign the written informed consent.

Exclusion Criteria:

* Patients who earlier have had a rupture of one or both AT.
* Patients who have had an operation one of the achilles tendons before.
* Patients who have been diagnosed with arterial insufficiency in legs.
* Patients with a terminal disease or who suffers from a critical medical illness.
* Patients where the distance from rupture to calcaneus is less than 1 cm (examined by palpation or in doubt, measured with an ultrasound)
* Fluoroquinolone treatment within the last 6 months.
* Tendinosis treated with corticosteroids (tablets or injections) within the last 6 months.
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis

The primary objective of this study is to evaluate the long-term safety of apremilast in participants 2 years of age or older with oral ulcers associated with Behçets disease or 5 years of age or older with active juvenile psoriatic arthritis that have completed Study 20190530 or Study 20190529.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent / assent obtained
* Must have completed Week 52 on treatment on core study
* Age and sex specific body mass index (BMI) no lower in range than the 5th percentile on Centers for Disease Control (CDC growth chart)
* Willing to adhere to study visit schedule and protocol requirements
* Must have acceptable benefit/risk for continued treatment with apremilast

Exclusion Criteria:

* Answer "yes" to any question on C-SSRS at Week 52 visit of core study
* Scheduled surgery or other interventions that would interrupt study participation
* Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for 30 days after last dose
* Female participants planning to become pregnant while on study through 30 days after last dose
* Female participants of childbearing potential with positive pregnancy test at Week 0
* Known sensitivity to any products to be administered during dosing
* Not likely to be available to complete all protocol-required study visits
Ovulation Inhibition of Two 4-phasic Oral Contraceptive Regimens

The aim of the study is to investigate the ovulation inhibition of two 4-phasic oral contraceptive regimens.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women willing to use non-hormonal methods of contraception

Exclusion Criteria:

* Women with any contraindication for oral contraceptive use, for example but not limited to: presence or history of venous or arterial thrombotic / thrombembolic events, hypertension, presence or history of severe hepatic disease
Dysregulation of FSH in Obesity: Functional and Statistical Analysis

Excess maternal weight, especially obesity, influences almost every aspect of fertility, from conception to problems during pregnancy. The investigators will use novel statistical methods to clarify the hormonal changes behind reproductive health conditions. A better understanding of reproductive hormonal changes in obese women may offer a way to identify new treatments.

Hypothesis. Insufficient FSH (Follicle-stimulating hormone) pulsatility, as seen in obesity, results in inadequate folliculogenesis and reduced ovarian steroid and protein production.

AIM: To test the hypothesis that insufficient FSH pulsatility, as seen in obesity, results in inadequate folliculogenesis and reduced ovarian steroid and protein production. The investigators will determine if exogenous FSH administered in a pulsatile fashion results in a significant increase of ovarian hormones in obese women. Serial inhibin B and E2 levels will be measured in obese and normal weight women undergoing frequent blood sampling studies before and after GnRH (Gonadotropin-releasing hormone) antagonist blockade.

Eligibility Criteria:
Inclusion Criteria:

* Age between 21 to 39 years old with regular menstrual cycles every 25-40 days
* Body mass of 18.5 kg/m2-24.9kg/m2 (normal weight controls) or greater than 30.0 kg/m2 (obese group)
* Prolactin and thyroid-stimulating hormone (TSH) within normal laboratory ranges at screening
* Baseline hemoglobin \>11 gm/dl.

Exclusion Criteria:

* Diagnosis of polycystic ovary syndrome (PCOS), defined by the 2003 Rotterdam criteria as suggested by 2012 NIH Workshop
* History of chronic disease affecting hormone production, metabolism or clearance or use of thiazolidinediones or metformin (known to interact with reproductive hormones)
* Use of hormones affecting hypothalamic-pituitary-gonadal (HPO) axis (such as hormonal contraceptives) within 3 months of entry
* Strenuous exercise (\>4 hours of intense physical activity per week)
* Pregnancy
* Breast-feeding
* Current attempts to conceive
* Significant recent weight loss or gain
Postoperative Bladder Testing After Total Laparoscopic Hysterectomy

The objective of this study is to determine if backfilling the bladder immediately post-operatively, prior to removal of the foley catheter, in patients undergoing same-day total laparoscopic hysterectomy will hasten time to first spontaneous void and time to discharge

In recent years, a paradigm shift from traditional perioperative care models to "Enhanced Recovery After Surgery (ERAS)" has taken place across a wide range of surgical subspecialties including minimally-invasive gynecologic surgery. Many gynecologic procedures that once required hospital admission are now being performed as outpatient procedures. To optimize same-day discharge through the ERAS pathways, protocols call for early removal of urinary catheters following gynecologic surgery. Studies in urogynecologic literature have shown that a backfill-assisted voiding trial is superior to a spontaneous voiding trial in patients undergoing transvaginal surgery. However, there are limited studies published in literature focusing on minimally invasive gynecologic procedures, specifically laparoscopic hysterectomies. A successful spontaneous voiding trial is usually a postoperative criteria prior to discharge after same-day total laparoscopic hysterectomy. Through this randomized controlled trial, the investigators aim to compare two techniques of postoperative bladder testing for patients undergoing same-day total laparoscopic hysterectomy. This study would provide valuable data on improved measures for predicting voiding efficiency, time to first void, and time to discharge for patients undergoing same-day total laparoscopic hysterectomies. Ultimately, the investigators predict that backfilling the bladder immediately postoperatively, prior to removal of the foley catheter, will hasten time to first spontaneous void and reduce the amount of time spent in the recovery room.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-75 years of age
* Ability to comprehend English
* Women undergoing same-day laparoscopic hysterectomy through the Enhanced Recovery after Surgery (ERAS) protocol at Magee-Womens Hospital (includes total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy, laparoscopic-assisted vaginal hysterectomy)

Exclusion Criteria:

* Women who are unable to give informed consent
* History of prior or concurrent urogynecologic procedures performed including mid-urethral sling, rectocele/cystocele repairs, burch urethropexy, sacrospinous ligament fixation, uterosacral vaginal vault suspension, sacrocolpopexy
* History of multiple sclerosis
* Known malignancy of the bladder
* Bladder or ureteral injury that occurred intra-operatively
* Women who are being treated for an active urinary tract infection at the time of surgery
* Women admitted overnight who fail to go home the same day after total laparoscopic hysterectomy
A Mediation Analysis Investigating Dry Needling Treatment Mechanisms in a Chronic Low Back Pain Population

Low back pain is a common problem that many adults experience at some point in their lives. One treatment being studied is dry needling, a technique where a small needle is inserted into a specific area of muscle to help relieve pain. So far, the research on dry needling for low back pain hasn't been clear, and it's hard to know when and for whom it will work best. This study aims to figure out how dry needling works to help people with chronic low back pain by looking at the underlying factors. By understanding how dry needling helps people, we can develop a more targeted approach to treatment, which could lead to better outcomes for people with chronic low back pain. The goal of this study is to identify the factors that make dry needling effective for people with chronic low back pain, so that this this information can be used to provide more personalized and effective care.

Eligible participants will attend 5 research sessions lasting approximately 1 hour and complete 2 online surveys. At 3 of those sessions, participants will receive dry needling to their low back.

As part of the research, participants will complete questionnaires related to how pain effects their life. Participants will also undergo testing for muscle stiffness, low back mobility and strength, and pain sensitivity.

To be included in this study participants must:

* Be 18-65 years of age
* Have low back pain for at least 3 months


Eligibility Criteria:
Inclusion Criteria:

1. Ages 18 - 65,
2. Currently experiencing pain in the space between the twelfth rib and the horizontal gluteal fold with or without radiating leg pain

b) Low back pain symptoms that are chronic, in that symptoms, have persisted for at least 3 months with pain experienced on most or every day in the past 3 months c) Not currently receiving treatment for their low back

Exclusion Criteria:

1. Non-English speaker
2. presence of a medical condition known to affect sensation
3. history of surgery to the low back
4. history of blood clotting disorders or medical conditions associated with bleeding disorders
5. Current use of the medication causing difficulty with clotting (such as blood thinners)
6. Contraindication to the application of needles including, but not limited to, diabetes, local infection, epilepsy, fear of needles or metal allergy
7. women who are pregnant or currently attempting to become pregnant
8. diagnosis of active cancer
9. inability to obtain the testing position (laying prone).
The Effect of Emotional Resilience Training on Fear of Birth and Depression in Primiparous Pregnant Women

Although birth has a great place in a woman's life, factors such as the woman's education level, personal experiences, social support status, whether the pregnancy is planned or not, the family's attitude towards pregnancy, and socioeconomic status increase the burden of pregnancy and can create a stressful situation for the woman. While the pain that may be experienced during birth, thoughts about the baby's health and postpartum baby care further increase this fear, primiparous women who will give birth for the first time experience many emotions that they cannot define and cannot predict the situations they will encounter during birth. The most important situation that will cause pain during birth is fear. So much so that fear of birth may cause women to avoid pregnancy and increase optional abortions.In particular, fear of birth may increase cesarean delivery rates and also lead to negative maternal outcomes such as poor mental health after birth. Fear experienced during the antenatal period can lead to difficult births, mother-baby attachment problems, and depression. While fear of birth causes depression and anxiety disorders in the postpartum period, it is stated that depression experienced during pregnancy may increase the fear of birth, or fear of birth may be a hidden symptom of depression. It is noted that emotional regulation skills and resilience in pregnant women can be effective strategies in minimizing and managing fear, anxiety, stress, and anxiety. Emotional resilience is defined as the style of coping with stress, the ability to repair oneself, the ability to recover from adverse events quickly, and the state of adapting to a new environment. In particular, individuals with high emotional resilience can protect their physical and mental health and increase their life satisfaction by reducing the negative consequences they experience. With the emotional resilience training given during pregnancy, pregnant women's stress, fear, and anxiety will be reduced, and they will be able to cope better with the difficulties they experience. This research will be conducted to examine the effect of emotional resilience training given to primiparous pregnant women on fear of childbirth and depression.


Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years of age,
* Volunteering to participate in the research,
* 32-34. Being at the gestational age,
* Knowing Turkish,
* Being at least a primary school graduate,
* Having a single and healthy fetus,
* Having a WBDRS-A score of 38 and above,
* Being at least a primary school graduate.
* Depression score above 12/13,

Exclusion Criteria:

* Pregnant women with any risky pregnancy history (Preeclampsia, placenta previa, gestational diabetes mellitus, oligohydramnios and polyhydroamnios, etc.),
* Those who do not attend at least one of the sessions of the training program,
* Chronic and/or psychiatric health Pregnant women with problems (based on self-report and clinical diagnosis status) will be excluded from the study.
Understanding Loss of Muscle Mass and Function

Sarcopenia is a loss of muscle mass and function that develops during aging. But sarcopenia is also observed in several other conditions: chronic diseases, cancers, viral infections, renal / respiratory insufficiency, immobility, obesity with low physical activity. This sarcopenia is named secondary sarcopenia to distinguish it from the age-associated primary sarcopenia. During prolonged hospitalizations in intensive care, a significant loss of muscular mass and function is also observed. This acute sarcopenia or Intensive Care Unit-Acquired Weakness (ICU-AW) may persist for several months after discharge from hospital. In addition to the loss of autonomy, the reduction of muscle mass has important metabolic implications, ranging from insulin resistance to modification of myokines production. Sarcopenia greatly increases the morbidity and mortality of patients regardless of its cause. The aim of our project is to identify the molecular mechanisms implicated in sarcopenia from different origin. We will particularly focus our work on the metabolic properties, the proliferation/ differentiation and regeneration capacities of the satellite cells (adult muscle stem cells). These satellite cells will be purified from quadriceps biopsies of human volunteers recruited at CHU Montpellier. These satellite cells will also be used to test the ability of some wild aromatic plants from south of France to improve cell survival and differentiation. This will allow us to identify the molecular mechanisms involved in sarcopenia development and identify potential therapeutic molecules.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing quadriceps muscle biopsy as part of the treatment.
* Patient having given their agreement of conservation within the framework of the care of the biological sample (biopsy and blood sample)

Exclusion Criteria:

* Subject refusing the detection of anti-HIV, anti-hepatitis C antibodies, HBS antigen
* Subject treated with anticoagulant, beta blocker, lipid-lowering agent (statin or fibrate), anti-inflammatory, ACE inhibitors, angiotensin 2 receptor antagonist or corticosteroids, including locally.
* Allergic subject to local anesthetics
* History or presence of psychoactive substance abuse
* History of recent abdominal surgery (less than 3 months)
* Subject deprived of liberty by judicial or administrative decision
* Major subject protected by law
* Inability to understand the nature and purpose of the study and / or communication difficulties with the investigator
Post-ICU Consultation : a Time to Discuss Advance Directives (CoPRADA)

The aim of this study is to assess the possibility of discussing advance directives during post-intensive care consultation.

After a stay in intensive care units (ICU), patients can experience physical, psychological and cognitive impairments. To assess this post intensive care syndrom (PICS), post-ICU consultation have been developed.

Since 5 year mortality is higher in ICU survivors, it might be interesting to address those patients' views relating to illness and end of life through a discussion on advance directives (AD), during post-ICU consultation.

However, the development of these consultations being recent, it has not yet been assessed whether this consultations might be a suitable time to discuss AD and the intensivit a suitable interlocutor.

Eligibility Criteria:
Inclusion Criteria:

* Patients with 48 hours of mechanical ventilation
* Patients with a 5 days stay in ICU

Exclusion Criteria:

* Patients with therapeutic limitation discussed during their ICU stay
* Geographical remotness to come to the post-ICU consultation
* Minor patients
* Patient not affiliated to the social security scheme
Surgical Treatment of Pancreatic RCC Metastases

Data from 26 patients undergoing resection of Pancreatic Metastases and extra-Pancreatic Metastases from RCC were retrospectively analysed. Clinical data were collected from a digital database and QoL was assessed through patient's interview and Karnofsky performance scale.

Retrospective data was analysed from 26 patients that were submitted to pancreatic resection between August 2002 and November 2015. Inclusion criteria were: single or multiple metastases in pancreas or extra pancreatic; primary RCC; never received chemotherapic treatment; patients that already received a previous pancreatic resection were also included.

Cases were collected from two high-volume centres: Surgical Department "Pietro Valdoni" in Policlinico Umberto I and the Division of Transplantation and General Surgery at University of Pisa.

Different kind of surgical approaches were taken into account in this study: duodenal-pancreatectomy, total-pancreatectomy and distal-pancreatectomy associated or not with other metastatic site resections. Surgery was performed either with classical open approach and modern robotic surgical approach, with the robot "Da Vinci". Aim of surgical interventions were to remove all metastases in association to radical lymphadenectomy thus to achieve R0 result. All postoperative events occurring within 90 days of surgery were considered. Postoperative complications were graded according to Clavien-Dindo classification.

Patients were followed-up 3 months after discharge and every 6 months thereafter.

Patients had blood chemistries and CT scans at least every year. A database was used to record all patients' data. Results were analysed in terms of Operative Mortality and Morbidity, Actuarial Survival, Actuarial Disease-Free Survival and Quality of Life.

Protocols were approved by the bioethical review committee and meet the guidelines of both University Sapienza of Rome and University of Pisa.

QoL was measured by Karnofsky performance scale and through Activities of Daily Living scale (ADL), Instrumental Activities of Daily living scale (IADL), BMI evaluation, serum albumin and hemoglobin, also depression was evaluated as a parameter. QoL was defined by combination of these parameters as: excellent, good, fair, poor or very poor.

A low Karnofsky scale index with inadequate social and environmental situations, a reduction in functional capacity with depression and severe weight-loss were identified as a decline in QoL.

Data was analysed via Chi-square test, as well as Student's paired and unpaired t-tests.

Actuarial relative survival and actuarial relative disease-free survival were described by Kaplan-Meier analysis. A log-rank test was used to compare continuous variables and was expressed by Kaplan-Meier curves. Homogeneity of the different groups to be compared was tested by chi-square test. Statistical significance was set at p ≤ 0,05.

Eligibility Criteria:
Inclusion Criteria:

* metastases from RCC
* surgically manageable lesions

Exclusion Criteria:

* metastases from different malignancies
* other malignancies
* surgically unmanageable