cyrilzakka/clinical-trials huggingface dataset:
The Effect of Variety on Physical Activity

Increasing physical activity continues to be a challenge among many individuals, particularly those who are overweight. Recent data from the National Health and Nutrition Examination Survey (NHANES) showed that individuals who reported engaging in a variety of activities were more likely to meet national physical activity recommendations compared to those who reported no variety. Incorporating a variety of activities into a physical activity program may be a way to increase physical increase physical activity levels.

One method to increase variety in physical activities is to use active videogames. Videogames that use motion sensors allow a gamer to physically perform a variety of activities. Thus, the purpose ot this laboratory-based investigation is to conduct a study to examine the effect of engaging in a greater variety of active videogames on energy expenditure in 30 non-obese, regularly active adults.

Thirty men and women, aged 18- to 35- years, recruited from the local area, with a normal body mass index (BMI) between 18.5 and 29.9 kg/m, will participate in two experimental sessions, VARIETY and NON-VARIETY, with order of experimental sessions counterbalanced across participants. Participants will be assessed on liking of the active videogames, energy, tiredness, motivation, to succeed, interest in the games, and energy expenditure during the experimental sessions.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages 18-25 years are eligible to participate. They will be recruited from flyers posted around campus and in local gyms, and must be willing to participate. They must have a body mass index (BMI) between 18.5 and 29.9 kg/m2.

Exclusion Criteria:

* Participants who have never played an active videogame or are unable to play an active videogame. If the participant dislikes (scoring \<50 on a 100 mm visual analogue scale \[VAS\]) playing the active videogames used in the investigation. Or if the participant engages in less than 150 minutes/week of moderate- to vigorous-intensity physical activity over the previous month.
A Study of Pegylated rhG-CSF as Support to Advanced Non-Small-Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy Receiving Chemotherapy

Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with ﬁlgrastim. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with advanced NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Investigator diagnosis of staged III or IV NSCLC
* Age 18 to 70 years
* ECOG performance status ≤ 1
* Chemotherapy naïve
* Body weight ≥ 45kg
* Hemoglobin ≥ 100g/L; white blood cell ≥ 4.0×109/L; absolute neutrophil count ≥1.5 × 109/L; platelet count ≥ 100 × 109/L
* Alanine transarninase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine ≤1.5×ULN; total bilirubin ≤1.5×ULN

Exclusion Criteria:

* History of systematic chemotherapy or radical radiation therapy
* Prior bone marrow or stem cell transplantation
* Received systemic antibiotics treatment within 72 h of chemotherapy
* Pregnancy or lactation
Flare Photometry in Uveitis Patients

This is a cross sectional study of a novel non-invasive optical flare photometer (OFAM). Patients meeting the inclusion/exclusion criteria will receive a standard eye examination including a slit lamp examination to collect ocular flare data. In addition to the standard eye examination, subjects will receive flare measurements using the OFAM device.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Ability to understand and willingness to sign a written informed consent document.
* To be eligible for the uveitis arm of the study subjects must have active anterior chamber uveitis in one or both eyes as determined by a physician
* To be eligible for the non-inflammatory arm of the study the study subjects must have no ocular inflammation in either eye as determined by a physician.

Exclusion Criteria:

* Inability to give informed consent
* Exclusion criteria for the uveitis arm: no active disease
* Exclusion criteria for the non-inflammatory arm: Signs of uveitis
Carpal Tunnel Release in Diabetic Patients

The aim of this study is to extend a previously reported 1 year follow-up on carpal tunnel release, in matched diabetic and non-diabetic patients,to compare outcomes 5 years after surgery.

The Follow-up investigation includes:

1. Clinical examination of sensory and motor function
2. Generic and disease specific self-administered questionnaires
3. Nerve conduction study
4. Vibration threshold testing

Eligibility Criteria:
Inclusion Criteria:

* diabetic and non-diabetic patients operated for carpal tunnel syndrome 5 years ago.

Exclusion Criteria:

* previous carpal tunnel release in the hand under study
* clinical signs of nerve entrapment other than CTS
* cervical radiculopathy, inflammatory joint disease
* renal failure
* thyroid disorders
* previous wrist fracture on the affected side
* daily long-term exposure to vibrating tools
* pregnancy
Comparison of Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment of Needle Hole Bleeding in Vascular Surgery

Present trial is the third study that in combination with two completed studies (one being a trial in hepatic resection surgery also comparing TachoSil® and Surgicel® Original) targeted toward providing clinical safety and efficacy data to support extending the current label of TachoSil® to a general hemostasis indication across several surgical procedures and organ systems in the USA.

The drug being tested in this study is called TachoSil®. TachoSil® was used to treat people undergoing scheduled subacute vascular surgery. This study looked at how well TachoSil® patches stopped bleeding at the surgical site compared to Surgicel® Original patches.

The study enrolled 150 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two open label treatment groups in a 2:1 ratio:

* TachoSil®
* Surgicel® Original

This multi-center trial was conducted in the United States. The overall time to participate in this study was approximately 6 months. Participants made multiple visits to the clinic, including safety follow-up visits at 1, 3 and 6 months after surgery.

Eligibility Criteria:
Main Inclusion Criteria:

* Planned elective and subacute procedures with a polytetrafluoroethylene (PTFE) graft including at least one expected end-to-side anastomosis of a PTFE graft to the femoral artery (e.g. femoral-femoral cross-over, aorto-(bi)femoral, axillo-(bi)femoral, femoro-popliteal, femoro-crural bypass grafting), a PTFE patch angioplasty of the femoral artery, or an end-to-side anastomosis of a PTFE graft to an upper extremity artery in connection with arteriovenous bypass grafting for dialysis access.
* The evaluation site for the planned femoral anastomosis must be a de novo site.
* The participant must be heparinized during surgery.

Intra-operatively (before randomization)

* The participant has a need for secondary hemostatic treatment
* Verification of the evaluation site being a de novo site
* Verification of the surgical procedure performed as being either an end-to-side or PTFE patch angioplasty.

Main Exclusion Criteria:

* Thrombolytic therapy administered within 12 hours before surgery (e.g. the recombinant tissue plasminogen activator (rt-PA) Alteplase).
* Liver cirrhosis.

Intra-operatively (before randomization)

* Severe bleeding at the anastomosis of the arterial bypass using PTFE graft prosthesis or the PTFE patch angioplasty
* No bleeding (dry surgical field) at the targeted application area
* Disseminated intravascular coagulopathy (DIC)
* Application of topical hemostatic material including fibrin sealant/glue on the evaluation site.
Sagittal Spinopelvic Parameters in Patients With Lower Extremity Amputation

The aim of this study is to investigate the relationship between sagittal spinopelvic parameters and low back pain and quality of life in individuals with lower extremity amputation.

Low back pain is one of the secondary health problems that negatively affect functionality, independence and quality of life in individuals with lower extremity amputation. The prevalence of low back pain was reported to be higher in individuals with lower extremity amputation (52-89%) than in the non-amputee population (12-45%). Although the etiology of low back pain is multifactorial, changing anatomy and biomechanics after lower extremity amputation and maintaining daily activities are often associated with the development of low back pain. Postural imbalance, which is one of the musculoskeletal disorders of the spine that contributes to low back pain, is considered to cause additional load on the spinal structures.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 and ≤ 65 years
* Patients followed for at least 12 months with lower extremity amputation
* Patients who have been using prosthesis for at least 3 months
* Patients with stable medical and psychological status
* Patients willing to participate in the study

Exclusion Criteria:

* Patients with serious cardiovascular, pulmonary, neurological disease or other musculoskeletal problems (inflammatory rheumatic disease, active synovitis, severe low back pain, hip/knee joint replacement or other hip/knee-related trauma, fracture, or surgery) that impair walking
* Patients with severe vision, hearing and language problems
Number of Necessary Paints of Preoperative Skin Disinfection to Prevent Surgical Site Infections

This observational study investigates whether 3 paints are superior compared to 2 paints in reducing microbial skin counts in the disinfection area of cardiac and abdominal surgery patients.

Surgical site infection (SSI) remain the most common nosocomial infection in surgical departments. Preparation of the skin with disinfectants belongs to the standard of care prior to any surgical intervention but disinfection practices are heterogeneous across different hospitals and countries. Although the efficacy and effectiveness of preoperative surgical site preparation is dependent on both the antiseptic agent used and the application method, it is unclear how many paints of an antiseptic are needed to ensure adequate infection protection.

An adequately powered study including different standard antiseptic agents (i.e. chlorhexidine in alcohol (CHX) and povidone iodine in alcohol (PI)) is therefore required to compare the protective effect of different numbers of paints.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing elective cardiac surgery at the study site
* Adult patients undergoing elective abdominal surgery at the study site
* Provision of informed consent

Exclusion Criteria:

* Pregnancy reported by patient
* Emergency (non-elective) surgical interventions
* Contraindications to the use of either one of the compounds: Alcoholic CHX; Alcoholic PI
* Skin or other hypersensitivity reactions during the disinfection process
EnteroCT With Enteroclysis Versus Enterography-MRI for the Diagnosis of Tumors of the Small Intestine: a Pilot Study

Early diagnosis of tumors of the small intestine is a challenge for clinicians and for radiologists. The detection of tumors of the small intestine is a field in which the video capsule endoscopy has the lowest performance.

The entero-CT with enteroclysis is the imaging technique used primarily to explore patients with a strong suspicion of small intestine tumors. However the entero-CT with enteroclysis has disadvantages : it is irradiating, the nasojejunal tube implies a discomfort to the patient and it is a complicated examination in terms of logistics with necessity of specific equipment to insert the nasojejunal tube.

MRI has been proposed as an alternative imaging technique and satisfactory results have been reported with the MRI enteroclysis. However, this technique has several disadvantages related to nasojejunal tube insertion and the necessity of equipment compatible with the high magnetic fields. The enterography-MRI without enteroclysis, whose principle is to distend the small intestine by ingestion of large quantities of a liquid, has a major and undisputed role in the exploration of Crohn's disease of the small bowel. However, its capacity for distension of the small intestine for optimal tumor detection is questioned and its role in tumor detection is largely unknown.

Evaluate the diagnostic performances of enteroCT with enteroclysis and enterography-MRI without enteroclysis, for the diagnosis of tumor of the small intestine, among patients with suspicion of small intestine tumors.

Eligibility Criteria:
Inclusion Criteria:

* patient clinically suspected of having a tumor of the small intestine
* patient consenting to participate to the study
* patient enrolled in the national healthcare insurance program
* patient older than 18 years

Exclusion Criteria:

* patient with inflammatory bowel disease
* patient with contraindication for MRI
The Comparison of Three Different Immunosuppressant Regimens in Kidney Transplant Recipients.

The study is being done to compare the safety and effects (good and bad) of three different combinations of immunosuppression drugs used by kidney transplant recipients while also looking at their kidney function.

This is an open-label, randomized, comparative, multinational study. The study will be looking at the kidney function of kidney transplant recipients, while also comparing the safety and the effects (good and bad) of three different combinations of immunosuppression drugs in combination with prednisone, following treatment with Daclizumab (Zenapax). The three combinations are; (1) sirolimus and tacrolimus followed by the withdrawal of tacrolimus after three months; (2) sirolimus and mycophenolate mofetil (MMF); and (3) tacrolimus and MMF. The participants will be required to return to throughout the next 24 months following their transplant for physical exams, chest x-ray, blood, and urine tests. Participants will be put into one of three groups, and receive the study drugs starting on the day of transplant. Due to some drugs affecting the drug levels of sirolimus, participants need to agree not to take any new drugs during the study unless approved by the study doctor.

Eligibility Criteria:
Participants must be at least between the ages of 18 and 75, and will be receiving their first or second kidney transplant.
A Randomized Cross-over Trial of the Postprandial Effects of Three Different Diets in Patients With Type 2 Diabetes

The trial will study the acute metabolic effects of three different types of diet: low-fat diet, low-carbohydrate diet and Mediterranean diet. About 20 patients with diabetes mellitus type 2 will be recruited and each of them will be given each type of diet on three different days. Menus with the same energy content but with different content of fat, carbohydrate and protein are designed. Breakfast and lunch are served for the patients each day of testing. Laboratory samplings are performed six times during the day. The order of the dietary intervention is randomized for each patient.

The investigators suppose to find different reaction in plasma glucose and lipids depending on the type of diet.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus type 2

Exclusion Criteria:

* Treatment with insulin or sulfonylurea
Evaluating the Impact of Telehealth-Based ASD Assessments and Supports on Child and Caregiver Outcomes

The overall goal of this study is to evaluate telehealth and internet-based approaches to meet accessibility challenges for families with concerns about ASD in their infants. In this study, we will gather exploratory data related to the potential of two telehealth tools: 1) The Telehealth Evaluation of Development for Infants (TEDI); and 2) "Help is in Your Hands" (HIIYH), a set of video materials and information on interactive strategies parents can use to support their child's communication development. We will recruit families participating in an ongoing study using the TEDI (R21 HD100372, PI: Talbott) to evaluate infants' behavioral development. As families exit the parent TEDI study and enter the current study, we will ask parents to complete online questionnaires, and randomize them to either receive immediate access to additional online materials (HIIYH) for parents or no additional materials. After 12 weeks, parents will complete online questionnaires and all families will then be given access to the online materials. When children reach 30 months, we will collect additional questionnaires, complete a live telehealth behavioral session with toddlers and their caregivers, and conduct an exit interview with parents to gather feedback about their experience.


Eligibility Criteria:
Inclusion Criteria:

Previous enrollment in the parent R21 project (R21 HD100372, PI: Talbott).

Exclusion Criteria:

No previous enrollment in the parent R21 project (R21 HD100372, PI: Talbott).
The Efficacy Tretinoin Cream in the Treatment of Axillary Hyperpigmentation Associated With Acanthosis Nigricans

The goal of this randomized intra-individual design with a split-side axillary approach is to comparing the efficacy of 0.025% tretinoin cream against a cream-based formulation in the treatment of axillary hyperpigmentation associated with acanthosis nigricans.

The main questions it aims to answer are:

* The efficacy of 0.025% tretinoin cream and cream based in the treatment of axillary hyperpigmentation associated with acanthosis nigricans.
* The safety of 0.025% tretinoin cream and cream based in the treatment of axillary hyperpigmentation associated with acanthosis nigricans.

Participants were randomly assigned to apply both 0.025% tretinoin cream and the cream-based product on opposing sides of the axillary region.

This study employed a randomized intra-individual design with a split-side axillary approach, comparing the efficacy of 0.025% tretinoin cream against a cream-based formulation. Participants were randomly assigned to apply both 0.025% tretinoin cream and the cream-based product on opposing sides of the axillary region. The efficacy of treatment was assessed by Mexameter (melanin index). The investigator's global evaluation (IGE) and parent's global evaluation (PGE) were also used to evaluate the overall success rate. The local safety was conducted for assessment of any cutaneous irritation. At each visit, the investigator graded the degrees of erythema, dryness, peeling, burning, and itching using a scale of 0 to 4. This study was followed for 4 visits, at the baseline, at week 2, 4 and 8.

Eligibility Criteria:
Inclusion Criteria:

* The participants aged over 18 years with BMI more than 25 kg/m2, axillary hyperpigmentation associated with acanthosis nigricans

Exclusion Criteria:

* Vulnerable skin diseases
* Infectious skin diseases
* Other recent diseases involving the axillary
* Other serious medical disorders e.g. liver disease
* Any patients having received other therapies for up to 4 weeks prior to enrollment
* Photosensitive skin
* Immunocompromised host
* Pregnancy and lactation
* Receiving oral retinoids
* Axillary tattoo
Pediatric Frontal and Nasal Bispectral Index

To compare the accuracy of frontal versus nasal BIS monitoring in pediatric patients under general anesthesia.

Standard position of frontal bispectral index (BIS) may not be available in some operations that frontal area is occupied by surgical field. This prospective cohort study aims to compare the accuracy of the BIS between an alternative position across the nasal area with the standard frontal BIS position in pediatric patients undergoing general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients undergoing general anesthesia
* American Society of Anesthesiologists physical status 1-3

Exclusion Criteria:

* Patients with neurological diseases
* Patients who are using anticonvulsant drugs
* Patients who is expected to be intubated and return to the pediatric intensive care unit
* Patients undergoing head and face surgery
* Patients undergoing surgery in the prone position
* Patients who have contraindications to sevoflurane, thiopental, fentanyl, and cisatracurium
To Evaluate the Efficacy and Safety of Injection With HARA as Compared to Restylane® Lidocaine in Temporary Correction of Nasolabial Folds

* Investigational Device : HARA (Hyaluronic Acid Filler)
* Title : A Single center, Randomized, Subject \& Evaluator-blind, Matched pairs, Active-controlled design Pivotal study to Evaluate the Efficacy and Safety of Injection with HARA as Compared to Restylane® Lidocaine in temporary Correction of Nasolabial folds
* Sites and investigators : Chung-ang University Hospital(Seoul), Beom-Joon Kim, M.D, Ph.D
* Objective : To compare the non-inferiority of HARA with Restylane® Lidocaine for evaluation of the efficacy and safety on Nasolabial Folds


Eligibility Criteria:
Inclusion Criteria:

1. Those who agreed to this treatment and signed the Informed Consent Form
2. Those who are 19 years old or more and desire to take correction of nasolabial folds
3. Those who have an intention of refraining from other cosmetic treatment(other filler injection, laser or chemical peeling, Botox injection or wrinkle reduction) during the clinical study period
4. Those whose Wrinkle Severity Rating Scale (WSRS) is more than 2 points at least

Exclusion Criteria:

1. Those who are sensitive to lidocaine or other amide anesthesia
2. Those who are sensitive to control device
3. Those who are pregnant or lactating, or expect pregnancy
4. Those who are judged by the subinvestigator to be improper for this study
Effect of Agonist GLP1 on Adipose Tissue in Patients Undergoing Bariatric Surgery

Normalizing weight gain and preventing the redistribution of body fat is a major health issue, and could help prevent the onset of various symptoms of metabolic syndrome. Above all, it is important to understand the mechanisms by which these different treatments affect adipose tissue. To this end, the investigators will first study the impact of GLP-1 analogues on adipose tissue. The main objective is to show that subjects treated with a GLP-1 agonist have a significant change in their oxytocin levels compared with subjects not treated with a GLP-1 agonist.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age.
* Patient able to read and understand the information/consent leaflet.
* Patient with BMI \> 35 with at least one comorbidity. Or BMI \> 40
* Indication for digestive surgery validated in a multidisciplinary consultation meeting and prior agreement accepted by the CPAM.
* Membership of a social security scheme
* Patient's signed informed consent
* For subjects in the GLP-1 analogue group: GLP-1 analogue taken for at least 3 months.
* For non-GLP-1 analogue group: never taken GLP-1 analogues.

Exclusion Criteria:

* Pregnant or breast-feeding women.
* Vulnerable patients (under guardianship)
* Patients deprived of liberty