cyrilzakka/clinical-trials huggingface dataset:
Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis

Nordic walking is currently offered by a number of health care practitioners as a form of exercise therapy for older adults at risk of fracture. These include older individuals with osteoporosis, previous vertebral fracture, or hyperkyphosis. To the investigators knowledge, this practice is not evidence-based and thus potentially problematic as benefits and safety of Nordic walking for individuals with osteoporosis, fractures, or hyperkyphosis are unknown. The proposed study will answer the following principal question: Does Nordic walking improve mobility, physical function, posture, and quality of life for ambulant community dwelling individuals who have osteoporosis, a history of osteoporotic fracture, or hyperkyphosis? Participants will be randomized into either the Nordic walking intervention group, or the waiting-list control group. Participants will initially train 3 times per week for 3 months, led by peer- and/or student-instructors. The Nordic walking training will depend on the participant's skill and comfort level and will consist of walking with poles over a distance set individually for each participant. The control group will receive the same 3-month Nordic walking intervention after their control follow-up measurements are completed.

The investigators will include 160 individuals who have been diagnosed with osteoporosis, have history of osteoporotic fracture or hyperkyphosis (hunched-back posture). Participants will be randomized to either a Nordic walking intervention group or a waiting-list control group (the latter group will receive same intervention after the trial is completed). The pole-walking intervention will be 12 weeks in duration, including 3 weekly Nordic walking sessions (warm up, Nordic walking with posture and leg strengthening exercises and stretches) tailored to each participants. The investigators will define osteoporosis status at baseline (via DXA scans). The investigators will compare between group changes in dynamic balance, posture, quality of life, mobility, muscle strength, size and composition (using low radiation CT scans) after 3 months of Nordic walking intervention.

Eligibility Criteria:
Eligibility criteria for study participants:

* diagnosis of osteoporosis, past vertebral fracture or hyperkyphosis
* ambulatory (without the use of assistive devices)
* not currently involved in moderate-vigorous exercise training, including Nordic walking, more than once per week
* must not be diagnosed with Parkinson's disease
Bowel, Urinary and Sexual Function After Laparoscopic Colorectal Surgery

Research Populations: Male patients scheduled for laparoscopic colorectal surgery

Study Method: Questionnaire and function tests

Hypothesis: A laparoscopic nerve-sparing operation is not inferior to reported open surgery in preserving urinary and sexual function.

There have been some reports that laparoscopically assisted rectal resection is associated with a higher rate of male sexual dysfunction compared with the open approach. But these reports are studied retrospectively.

We examine the frequency of bowel, urinary and sexual dysfunction prospectively in patients who received laparoscopic colorectal surgery.

We examine before operation, 7 days after, 3 months after, 6 months after and 12 months after operation, by questionnaires (International Index of Erectile Function (IIEF) 、Short Form-8 (SF8)、International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF)、International Prostate Symptom Score(IPSS)、Gastro-Intestinal Functional Outcome(GIFO)) and function tests (uroflowmetry and US).

Eligibility Criteria:
Inclusion Criteria:

* Male
* Laparoscopic right colon resection/laparoscopic rectal surgery
* 20-80 years old
* ECOG performance status (PS) 0-2

Exclusion Criteria:

* Emergent operation
* Previous proctectomy
* Severe urinary dysfunction
Short-term Starvation vs. Normal Diet Before Chemotherapy of Solid Tumors

Recent pre-clinical data provide strong evidence that short-term starvation before the administration of cytostatic drugs for the chemotherapy of solid tumors leads to significantly higher efficacy and lower toxicity levels. However, these findings have so far not been validated in patients. The aim of this trial is to provide first clinical evidence regarding the impact of pre-chemotherapeutic short-term starvation on response to therapy (primary endpoint). Additionally, progression-free survival, adverse events, and overall survival will be monitored (secondary endpoints). In perspective, short-term starvation before chemotherapy could represent a simple and secure way to improve both efficacy and tolerance of chemotherapies at low cost.


Eligibility Criteria:
Inclusion Criteria:

1. Patient (male/female) ≥ 18 years of age
2. Written informed consent obtained prior to any trial specific procedure
3. Patient suffering from gastrointestinal tumors: Cholangiocarcinoma (CC), Pancreatic ductal adenocarcinoma (PDAC), Colorectal Cancer (CRC), Gastric Cancer (GC)/ Adenocarcinoma of the Esophagogastreal Junction (AEG) / Esophagus cancer (EC).
4. Planned to receive palliative chemotherapy
5. No prior palliative chemotherapy
6. ECOG performance status of 0 or 1
7. Life expectancy of 12 weeks or more
8. Adequate hematological parameters, as demonstrated by:

   * Hemoglobin \> 9.0 g/dl (5.6 mmol/l)
   * WBC ≥ 3.0 x 109/l
   * ANC ≥ 1500/mm³
   * Platelets ≥ 75 x 109/l
   * S-creatinine ≤ 1.5 mg/dl (132 µmol/l)

Exclusion Criteria:

1. Underweight (BMI \< 18.5)
2. Dysphagia
3. Insulin-dependent diabetes mellitus
4. Renal failure requiring hemo- or peritoneal dialysis
5. Pregnant or breast-feeding women
6. Drug/alcohol abuse
Ultrasound Guided Fascia Iliaca Block for Pain Control After Elective Hip Replacement Surgery

The purpose of this study is to determine whether ultrasound guided fascia iliaca blocks performed before surgery help to reduce pain after elective total hip replacements.

Total hip arthroplasty is associated with moderate to severe pain in the acute postoperative period, which can increase the risk of postoperative complications such as thromboembolism, myocardial ischemia/infarction, pneumonia, poor wound healing, insomnia, and delirium.

Sensory innervation of the hip joint comes from a combination of peripheral nerves, including femoral, obturator, sciatic, superior gluteal, and nerve for the quadratus femoris muscle. Superficial innervation of the skin involved in incision for hip arthroplasty comes from the lateral femoral cutaneous nerve (LFCN).

The fascia iliaca block (FIB) was originally described in 1989 using a landmark technique. The ultrasound guided FIB was introduced in recent years, and has been shown to produce a better quality of block than the landmark technique. It appears to consistently block the femoral and LFCN, while being less successful in achieving consistent obturator blockade.

The FIB is effective for analgesia for hip fracture injuries in the emergency department. Thus far, there has been limited exploration into the potential use of this block as a tool for postoperative analgesia after elective hip arthroplasty. The potential benefits of this regional block, as with other regional techniques, include better analgesia, less opioid use and associated side effects, and an improved overall patient satisfaction with postoperative recovery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists' (ASA) score I, II or III
* Scheduled for elective total hip arthroplasty

Exclusion Criteria:

* Contraindication to regional anesthesia (allergy to local anesthetic, coagulopathy, infection or malignancy in the area)
* Neurologic disorder affecting the ability to sense pain
* Long term opioid use or chronic pain disorder
* History of drug or alcohol abuse
* Patient refusal
* Pregnancy
* Revision procedures
* General anesthetic
* Psychiatric or mental conditions that may affect assessment of outcomes
Mid-term Outcomes of First MTP Arthroplasty With Primus™ FGT Implant.

Foot silicone implants suffer from bad reputation on the market, due to poor results obtained with the first generations of implants. Allergies to silicone, infections due to silicone and implants breakage used to be common with previous generations of silicone implants. Publications relative to those implants showed that the survival rates after 5 years of follow-up were unsatisfactory.

Since 1998, Tornier has been selling a new generation of silicone implants made of Ultrasil™. The use of this new material in its manufacturing process together with its innovative geometry, make the Primus™ FGT a much more resistant, anatomic and long lasting implant.

The main objective of this study is to evaluate the clinical outcomes of the implantation of Primus™ FGT implant in great toe arthroplasty. The study will capture long term outcomes in terms of functional metrics from documented clinical data. Other objectives are to evaluate the outcomes in terms of radiological evaluation and of safety during all the follow-up.

This is an observational post-marketing surveillance study, performed by 1 (one) investigator in 1 (one) Italian site.

* Preoperative and peroperative data were collected retrospectively.
* Postoperative data (minimum 5 years follow-up or until implant revision) were collected prospectively.

Eligibility Criteria:
Inclusion Criteria:

* patient has had a Primus™ FGT implantation for one of the following indications: hallux limitus, hallux rigidus, hallux abducto valgus associated with severe arthritis, unstable or painful joint from previous surgery on the great toe,
* patient having all necessary clinical and radiographical data available.,
* patient has been informed about this scientific study and has provided their Consent to participate.

Exclusion Criteria:

* patient does not have clinical and radiographic follow-up data available.
A Psoriasis Plaque Test With LEO 29102 Cream and Its Combination Products

The purpose of this trial is to evaluate the anti-psoriatic effect of LEO 29102 cream and its combination with calcipotriol and betamethasone using a psoriasis plaque test method.


Eligibility Criteria:
Inclusion Criteria: (in summary)

* Subjects having understood and signed an informed consent form
* All skin types
* Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk. The lesions must have a total size suitable for application. The subjects should be asked if their lesions have been stable
* Subjects willing and able to follow all the study procedures and complete the whole study
* Subjects affiliated to social security system

Exclusion Criteria: (in summary)

* Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding
* Subjects using biological therapies (marketed or not marketed) with a possible effect on psoriasis (e.g. alefacept, efalizumab, etanercept, infliximab, adalimumab) within 12 weeks prior to study drug administration
* Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D-analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation
* Subjects using one of the following topical drugs for the treatment of psoriasis within four (4) weeks prior to study drug administration: - Potent or very potent (WHO group III-IV) corticosteroids - PUVA or Grenz ray therapy
* Subjects using one of the following topical drugs for the treatment of psoriasis within two (2) weeks prior to study drug administration: - WHO group I-II corticosteroids - Topical retinoids - Vitamin D-analogues - Topical immunomodulators (e.g. macrolides) - Anthracen derivatives - Tar - Salicylic acid - UVB therapy
* Subjects with skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds within the plaque test areas
Study of Association Between Peripheral Immune Cells and Recurrence in Stage II/III Colorectal Cancer

The purpose of this study is to determine association between Peripheral Immune Cells(PIC) and recurrence in stage II/III colorectal cancer

The investigators hypothesize differentiation of Peripheral Immune Cells(PIC) would result in resistance of chemotherapy and tumor local of metastatic recurrence.

The primary endpoint of this study is Disease Free Survival and the secondary endpoint is 5-year Overall Survival.

5ml peripheral blood will be sorted and counted through flow cytometry at the point of before primary treatment(surgery for colon cancers, neoadjuvant therapy for rectal cancers) , before the first chemotherapy postoperatively and 1 month after last chemotherapy.

Patients will be followed up with 3 monthly assessments in the first two years and 6 monthly assessments in the rest three years. Stratification factors include age , BMI , gender , tumor location , rectal or colon cancer stage,the chemotherapy (FOLFOX, XELOX, DeGramont or Capecitabine ),laparoscopic or laprotomy, anastomosis, concomitant medications and complications.

Eligibility Criteria:
Inclusion Criteria:

* Clinically /Pahohistologically diagnosed as stageII/III CRC
* ECOG 0-2
* Age 18-90
* Gender both

Exclusion Criteria:

* Distant metastases noticed before or during surgery
* History of malignant tumor disease
* History of autoimmune diseases or immunodeficiencies
* History of hematological disease
* History of hepatic cirrhosis or Splenomegaly
* History of chronic kidney disease
* History of organ transplant
* History of chronic inflammatory disease
* Use of hematological drugs within 1 year prior to surgery
* Use of immunodulatory drugs within 1 year prior to surgery
* Use of chemotherapeutic drugs within 1 year prior to surgery
* Long term Use of non-steroid anti-inflammatory drugs(\>6 months)
* Unable or Unwilling to undergo all the standard treatment
Noninvasive Ventilation Breathing Test Guiding Weaning in Patients With Acute Hypoxic Respiratory Failure

SBT, as a routine extubation strategy for invasive mechanical ventilation, has been widely recognized. However, in recent years, studies have found that SBT may lead to delayed extubation, which has been confirmed in COPD patients but has not yet been widely accepted in patients with acute hypoxic respiratory failure. Both invasive mechanical ventilation and non-invasive mechanical ventilation are positive pressure ventilation, with the essential difference being the human-machine interface. The safe inspiratory pressure for non-invasive mechanical ventilation should not exceed 20cmH2O (1cmH2O=0.098 kPa). If the cause of respiratory failure is relieved or removed, respiratory function improves, and the patient has good airway protection ability and can tolerate non-invasive ventilation, the endotracheal tube can be removed as soon as possible to switch to non-invasive mechanical ventilation, thereby shortening the time of invasive mechanical ventilation and reducing the risk of complications. This study trial aims to identify the timing of early extubation sequential non-invasive mechanical ventilation in patients with acute hypoxic respiratory failure through non-invasive ventilation breathing tests, providing a basis for updating the process of invasive mechanical ventilation extubation.

All the patients included will be randomly assigned to receive Non Invasive Ventilation Breathing Test protocol or SBT protocol.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who have been admitted to the intensive care unit (ICU) with Acute Hypoxic Respiratory Failure. Oxygenation index less than 300mmHg, have undergone tracheal intubation, and are anticipated received invasive mechanical ventilation for more than 24 hours.

Exclusion Criteria:

* • Age over 80 years,

  * Pregnancy,
  * Consciousness disorders or intracranial hypertension caused by various reasons,
  * Neuromuscular disorders,
  * Severe cardiac dysfunction (New York Heart Association Class III or IV, acute coronary syndrome or persistent ventricular tachycardia),
  * Cardiogenic shock or after major cardiac surgery,
  * Severe liver and kidney failure,
  * Severe malnutrition,
  * Injury to the upper airway or nose and face, making it impossible to wear a nose (face) mask,
  * Severe agitation, Severe agitation, expected to be unable to cooperate with non-invasive mechanical ventilation.
NeuroCognitive Bases of Tool Use

Tool use is considered to be the hallmark of complex cognitive adaptations that humans have achieved trough evolution, that provides an adaptive advantage to the human species. Even if nonhuman species do use tools too, human tool use is much more complex and sophisticated. If humans have special abilities for tool use, it has to be grounded in a specific neuroanatomical substrate. Humans and nonhumans share a similar prehension system located within the superior parietal lobe and the intraparietal sulcus. However, there is a human specificity: the supramarginal gyrus within the left inferior parietal lobe is unique to humans, and could play a central role in tool use. This project aims to study the neurocognitive bases of human tool use with functional Magnetic Resonance Imaging (fMRI), to precise the cognitive mechanisms through which humans are able to use tools.


Eligibility Criteria:
Inclusion Criteria:

* To be between the ages of 18 and 65 years old
* Having given an informed consent for the study

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Persons under curators or deprived of civil rights or deprived of their freedom
* Not being registered with the French Social Security System
* Not able to read/write the French
* Neurologic or psychiatric illness, known or revealed during the inclusion visit
* Substance intake ( taking psychoactive medications or recreational drugs) on the day of the experiment
* Noise intolerance
* Unable to fill a questionnaire (severe cognitive troubles)
* Not willing that their personal doctor to be informed in case of a MRI anomaly.
* Not willing to be informed in case of MRI anomaly
* Subjects must not have metallic or electronic implants in the body : pacemakers or pacemaker wires, open heart surgery, artificial heart valve, brain aneurysm surgery, middle ear implant, hearing aid, braces or extensive dental work, cataract surgery or lens implant, implanted mechanical or electrical device, or artificial limb or joint o foreign metallic objects in the body (bullets, pellets, shrapnel, or metalwork fragments) or current or past employment as machinists, welders or metal workers, tattoos near the head or neck regions, permanent makeup
* Not willing to complete the study
* Appearance of a exclusion criterion during the protocol
* Appearance of an undesirable event preventing the completion of the protocol
* Too great head movements (\>4mm for the session)
* Detection of artifacts in the brain images collected
Percutaneous Electrical Nerve Stimulation for Carpal Tunnel Syndrome

There is evidence supporting that physical therapy interventions can be effective for the management of patients with CTS. No consensus on the best approach exist. It seems clear that the median nerve is affected in several ways (compression, inflammation, excursion) in carpal tunnel syndrome. Percutaneous Electrical Nerve Stimulation is a treatment approach consisting of the application of an electrical current throughout needling filaments placed close to the nerve, in this case the median nerve. The purpose of this clinical trial is to compare changes in function, symptom severity and the intensity of pain after the application of Percutaneous Electrical Nerve Stimulation vs. endoscopic surgery in women with CTS at short- and long-term follow-up periods.


Eligibility Criteria:
Inclusion Criteria:

* pain and paresthesia in the median nerve distribution
* positive Tinel sign,
* positive Phalen sign,
* symptoms had to have persisted for at least 6 months
* deficits of sensory and motor median nerve conduction according to guidelines of the American Association of Electrodiagnosis, American Academy of Neurology, and the American Physical Medicine and Rehabilitation Academy

Exclusion Criteria:

* any sensory/motor deficit related to the ulnar or radial nerve;
* older than 65 years of age;
* previous surgical intervention, steroid injections or physical therapy intervention
* multiple diagnoses of the upper extremity (eg, cervical radiculopathy);
* history of neck, shoulder, or upper limb trauma (whiplash);
* history of any systemic disease causing CTS (eg, diabetes mellitus, thyroid disease);
* history of other systemic conditions (eg, rheumatoid arthritis, fibromyalgia);
* pregnancy;
Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm

The planned study is a prospective analysis of non-psychoactive Cannabidiol (without THC) as an adjunctive therapy for blepharospasm in a masked double cross-over study. This prospective study is a follow-up to a retrospective study completed by the researchers using over-the-counter, self purchased CBD. This study will use FDA approved Cannabidiol medication, Epidiolex, directly from GW pharmaceuticals, rather than self-purchased CBD from the internet. Patients will undergo videorecording with a high resolution videocamera system at days 0, 45, 90, 135, and 180 using a novel blink analysis to gather objective data measurements of changes induced by CBD in Blepharospasm patients. This study will attempt to codify the data and quantify if adjunctive CBD therapy improves those areas compared to botulinum injection alone.


Eligibility Criteria:
Inclusion Criteria:

* Patients in the private practice of the principal investigator with an ICD code of "blepharospasm" and:
* undergoing routine maximal botulinum therapy
* experiencing break through symptoms of spasm
* marijuana naïve

Exclusion Criteria:

* concomitant diagnosis of epilepsy
* patients whom are not marijuana naive
* patients on concurrent anti-epileptics
* patients who are pregnant or wishing to become pregnant
* patients not wishing to participate in the study.
Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor

The purpose of this study is to assess the safety and efficacy of rhRlx for cervical ripening, when compared to a placebo.

A multicenter, randomized, double-blind, placebo-controlled, dose escalation study of healthy female subjects at ≥ 40 weeks gestation and who are scheduled for induction. A dose-escalation portion of the study is followed by a randomized, double-blind, placebo-controlled portion of the study. The endpoints include cervical ripening, as well as progression to labor and delivery.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 40 years
* Normal pregnancy
* At least 40 weeks of gestation
* Otherwise healthy

Exclusion Criteria:

* Anemia or hypertension
* Presence of chronic disease
* Endometriosis
* Known fetal anomaly
* Substance abuse
* History of cancer
Pubourethral Ligament Plication for the Surgical Treatment of Stress Urinary Incontinence

To test efficacy and safety at six months of the proposed Pubourethral Plication Procedure (PPP) for cure of stress urinary incontinence - reinforcing pubourethral ligaments (PUL) with large diameter polyester sutures.

Full thickness vaginal incisions will be made in the suburethral sulci extending from bladder neck to urethral meatus. The operation space is 2.5cm2 space. A No2 or 3 polyester suture will be inserted into PUL, immediately lateral to midurethra, into PUL origin, external urethral ligament, laterally into m.pubococcygeus, then will be tied, but not tightly. The vaginal incisions will be closed with vicryl sutures. All women will be discharged on day of surgery. During the regular follow ups the healing at stress urinary incontinence will be evaluated

Eligibility Criteria:
Inclusion Criteria:

* Urine loss on coughing controlled by hemostat behind symphysis

Exclusion Criteria:

* No exclusion criteria