cyrilzakka/clinical-trials huggingface dataset:
The Effect of Trunk Kinesio Taping on Trunk Strength, Trunk Endurance, Balance and Plantar Pressure

This study perform to investigate the the acute effects of trunk kinesiotaping on trunk strength, trunk endurance, balance and plantar pressure.

Body; It is an integral part of the body for spinal stability, postural control, proprioceptive stimuli, and energy transfer between the upper and lower extremities. Increasing trunk muscle endurance, strength and proprioception; It is of great importance in body function.

In this study, kinesiotape will apply to the trunk flexsor and extensor muscles using the muscle facilitation techniques. Also placebo taping will apply on the same muscles with same kinesiotape without any stretching or positioning. A total of 4 applications including kinesiotaping and placebo taping will perform randomly in 4 consecutive days.

For each subject; A total of 5 separate evaluations will perform on the first day (without taping) and following 4 consecutive days. Between the taping and evaluation of the subjects will wait for 30-45 minutes.

The aim of the study is to determine the effect of kinesio taping (KB) applied to different trunk muscles on various parameters.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form and participated in all stages of the study
2. Being in the age range of 18-30

Exclusion Criteria:

1. Having any physical, mental or psychological illness that may affect participation in the study
2. Having an allergy to kinesio tape
3. Having a history of major surgery in the last six months
Pilot Study of PEnile TRAnsplantation - Vascularized Composite Allografts

Penile transplantation (PT) has recently emerged as an option for penile reconstruction and has shown encouraging outcomes at the international level with two ongoing PT program (US, South Africa). Emergence of such option has been possible thanks to the development of vascularized composite allotransplantation and because of the important limitations of autologous reconstruction (phalloplasty). Feasibility has already been proven, but the surgical management remains in its infancy and has never been tested at a European level. Furthermore, the balance between functional improvement and immunosuppressive risk still needs to be enlightened.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years and ≤ 60 years
* Patient with traumatic penile severe defects (amputation), or congenital penile defects (micropenis)
* ASA ≤ 2
* NYHA ≤ 1
* Creatinine clearance \> 60 mL/min (CKD-EPI)
* Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
* Informed consent signed to participate to the study

Exclusion Criteria:

* Gender incongruence
* Congenital penile defects resulting from exstrophy/epispadias
* Penile malformation due to selh-half/self-amputation
* Amputation for penile cancer
* Other types of malignancy in remission for less than 5 years
* Progressive malignant tumor
* Presenting hepatitis B, hepatitis C, or HIV infection not controlled by appropriate anti-viral therapy
* Uncontrolled arterial hypertension
* Moderate renal failure : glomerular filtration rate of less than 60 mL/min per 1.73 m2
* EBV sero-negative recipient with EBV sero-positive graft, due to the risk of lymphoma
* Non controlled chronic infection
* Malignancy, Connective tissue disease
* Amyloidosis
* Unbalanced diabetes
* Patient with a contraindication to performing an MRI examination
* Contra-indication of Thymoglobuline: Hypersensitivity to rabbit proteins or to any of the excipients of Thymoglobuline, acute or chronic infections that contraindicate any additional immunosuppression,
* Contra-inducation of tacrolimus: Hypersensitivity to tacrolimus or others macrolides, or any of the excipients of PROGRAF,
* Contra-indication of Mycophenolate mofetil: in patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or any of the excipients, Hypersensitivity reactions to mycophenolate mofetil;
* History of major psychiatric disorders \< 3 years (psychotic disorders, severe substance abuse, severe personality disorders) or persons under psychiatric care ;
* Person deprived of their liberty by a judicial or administrative decision ;
* Person admitted to a health or social institution for purposes other than research
* Adult subjects to a legal protection measure (guardianship, curatorship)
* Person not affiliated to a social security scheme of beneficiaries of a similar scheme
Applied Behavior Analysis With Technologies

Applied Behavior Analysis (ABA) is a therapeutic approach for autism that is based on the principles of behavioral theory, learning, and positive reinforcement. Current research shows that early and intensive ABA intervention is effective in reducing dysfunctional behaviors and promoting learning and enactment of socially appropriate behaviors.

In this context, new approaches that attempt to integrate advanced technologies can play a key role. This experimental protocol aims to test whether the use of advanced technologies, such as tablets, as part of an intervention for a group of children with autism spectrum disorder (ASD) is more effective than the traditional approach implemented in a control group of children with ASD. The experimental protocol is aimed at enhancing cognitive skills, increasing new skills and acquiring functional/adaptive behaviors.


Eligibility Criteria:
Inclusion Criteria:

* Children with diagnosis of autism

Exclusion Criteria:

* presence of other medical disorders
An A Study Assessing Subject Satisfaction With A-101 Topical Solution for Seborrheic Keratoses

This study is an open-label study designed to evaluate subject's satisfaction after treatment of seborrheic keratoses with A-101 40%.


Eligibility Criteria:
Inclusion Criteria:

1. Subject can comprehend and is willing to sign an informed consent for participation in this study.
2. Male or female between the ages of 30 and 75 years old.
3. Subject has 3 eligible Seborrheic Keratoses; 2 target SKs must be on the face, and the additional 1 target SK must be on the neck or decolletage.
4. Subjects must have had cryosurgery for SK removal within the last 6 months and prior to first treatment with A-101 Topical Solution.
5. Target and non-target SKs must not have been previously treated.
6. Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair the evaluation of any target or non-target SK or which exposes the subject to an unacceptable risk by study participation

Exclusion Criteria:

1. Subject has clinically atypical and /or rapidly growing Seborrheic Keratoses.
2. Subject has current systemic malignancy.
3. Subject would require the use of any topical treatment (e.g., moisturizers, sunscreens) to any of the target or non-target SKs 12 hours prior to any study visit.
4. Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations
A Study of Tirzepatide (LY3298176) in Pediatric Participants With Obesity

The main purpose of this study is to evaluate the safety and tolerability of tirzepatide (LY3298176) in pediatric participants with obesity. The blood tests will be performed to investigate how the body processes the study drug in these participants. For each participant, the study will last about approximately 13 weeks excluding the screening period.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants with body mass index (BMI) ≥ the 95th percentile for age and sex
* Have failed to achieve adequate weight loss through lifestyle modification in the investigator's opinion
* Female participants only: Determined as prepubertal Tanner Stage 1.

Exclusion Criteria:

* Change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records
* Have obesity induced by other endocrinologic disorders (for example, Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity
* Have acute or chronic pancreatitis or a history of acute idiopathic pancreatitis; or have other GI disorders
* Have a known clinically significant gastric emptying, have undergone weight loss surgery such as gastric bypass (bariatric) surgery or restrictive bariatric surger, or have endoscopic or device-based therapy for obesity or have had device removal within the last 6 months.
* Have confirmed type 1 or type 2 diabetes mellitus
* Have a history or current cerebrovascular, respiratory, hepatic, renal, GI, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the IP; or may interfere with the interpretation of data
Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafer in Patients With Metastatic Brain Cancer

The purpose of this study is to determine the effect of the surgical intervention and insertion of GLIADEL wafers on the neurocognitive functioning in patients with metastatic brain cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Can provide signed/dated Informed Consent, and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization.
2. Are a male or female patient 18 years of age or older.
3. Are willing to a use barrier method of contraception if fertile or of childbearing potential until 30 days after surgical resection. If the patient receives subsequent chemotherapy during study participation (as allowed by the protocol), appropriate contraception will be managed by the principal investigator.
4. Have a primary diagnosis of solid-based tumor cancer (except small cell lung cancer (SCLS), lymphoma, germ cell cancer or anaplastic thyroid cancer) or unknown primary cancer and have 1-3 brain metastasis(es) for which surgical resection is planned for a single metastasis and any remaining metastases are planned for stereotactic radiosurgery (SRS);

   OR

   an intra-operative diagnosis of metastatic brain tumor in a patient with a single brain lesion.
5. Have a life expectancy of ≥12 weeks.
6. Have a Karnofsky Performance Status (KPS) score of 70 or higher.
7. Have Recursive Partitioning Analysis (RPA) status of 1 or 2.
8. Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days of the surgical resection; and
9. Patients must be able to understand English, either orally or in writing, and be able to consent and complete the required assessments and procedures.

Exclusion Criteria:

1. Are unable or unwilling to understand study assessment or to cooperate with the study procedures as determined by the investigator.
2. Have a history of allergic reaction or known hypersensitivity to BCNU (carmustine) or other components of the GLIADEL, such as polifeprosan polymer.
3. Have a history of prior cranial irradiation.
4. Have a prior diagnosis of Central Nervous System (CNS) tumor.
5. Have received prior treatment for brain tumors.
6. Have had prior exposure to GLIADEL or its components, such as polifeprosan polymer.
7. Have any uncontrolled medical or psychiatric conditions which preclude them from participating in or completing the study procedures.
8. Concurrent severe medical conditions include, but are not limited to, active infection, acute hepatitis, cardiac arrhythmia, unstable angina, congestive heart failure, uncontrolled diabetes mellitus, uncontrolled seizures, pulmonary insufficiency, pulmonary fibrosis, pulmonary embolus, etc.
9. Have a diagnosis of tumor in the brain stem or posterior fossa.
10. Have an RPA status of 3.
11. Have a diagnosis of leptomeningeal disease at time of enrollment; or
12. Are currently pregnant or lactating, or plan to become pregnant during the course of the study.
An Open-label Trial With TMC125 in Patients Who Have Virologically Failed in a DUET Trial (TMC125-C206 or TMC125-C216).

The purpose of this trial is to evaluate the long-term safety and tolerability of TMC125 200 mg twice daily as part of an antiretroviral therapy including TMC114/rtv and an investigator selected optimized background in HIV-1 infected patients who have participated in a DUET trial (TMC125-C206 or TMC125 C216) and have met the definition of virologic failure at Week 24 or later in these trials.

This is a Phase III open-label, roll-over trial to evaluate the long term tolerability, safety, antiviral and immunological effect of TMC125 as part of an individually optimized antiretroviral therapy including TMC114/rtv in HIV-1 infected patients who participated in one of the DUET (TMC125-C206 or TMC125-C216) trials. Also the change in HIV-1 resistance over time will be evaluated. This trial offers patients meeting the definition of virologic failure at Week 24 or beyond the option to roll-over to an open-label trial where they will receive TMC125 and TMC114/rtv. Three hundred patients are estimated to enroll into this trial. The withdrawal visit of the DUET trial will be the first visit of this trial. From this visit onward, all patients will receive 200 mg twice daily TMC125 and 600/100 mg twice daily TMC114/rtv until both TMC114 and TMC125 are commercially available or the therapy is no longer of clinical benefit to the patient. Patients will receive an antiretroviral therapy consisting of TMC125 as the only non-nucleoside reverse transcriptase inhibitor (NNRTI), TMC114/rtv as the only protease inhibitor (PI) and an optimized background, which will be selected by the investigator according to the local standard of care, the patient's experience with previous therapies and most recent resistance testing. The most recent HIV-1 genotype-analysis system report results from the DUET trial will be made available. TMC125 will be dosed at 200 mg twice daily, administered orally as 2 tablets twice daily with food.TMC114/rtv will be dosed at 600/100 mg twice daily, administered orally as 2 tablets TMC114 and 1 capsule ritonavir twice daily with food.The optimized background will comprise of at least 1 approved ARV drug: 1 or more NRTI(s), with or without ENF. Administration will continue until both TMC114 and TMC125 are commercially available or therapy is no longer of clinical benefit to the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patient was previously randomized in a DUET (TMC125-C206 or TMC125-C216) trial and completed at least 24 weeks of treatment
* Patient was virologically failing in a DUET trial.

Exclusion Criteria:

* Use of disallowed concomitant therapy
* Any grade 4 toxicity according to the Division of AIDS (DAIDS) grading table
* Patients who had to be withdrawn from the DUET (TMC125-C206 or TMC125-C216) trials because of any of the mandatory withdrawal criteria of that trial.
Surgical Treamtment of Pseudarthrosis of the Humerus (Study of a Series of 53 Cases)

Pseudarthrosis of the humerus is a serious complication of humerus fractures, of particular interest to subjects young working people with pseudoarthrogenic risk factors (tobacco++). It represents a real problem therapeutic given the long period of treatment, its disabling socio-professional repercussions and the cost which resulting.

The aim of our work is to evaluate the anatomical and functional results of different surgical techniques. used.

The management of pseudarthrosis of the humerus remains a subject of controversy. Given our results, the investigators think that osteosynthesis by plate associated with bone grafting and/or decortication remains the most suitable for the treatment of aseptic pseudarthroses of the humeral shaft while treatment with Ilizarov is most appropriate in septic pseudarthrosis.

However, the best treatment for pseudarthrosis of the humerus remains that of treating the initial fracture. and better control of pseudoarthrogenic risk factors (tobacco++).

Eligibility Criteria:
Inclusion Criteria:

* - Adult men and women \&gt; 18 years old with pseudarthrosis of the post-fractured humeral diaphysis treated in the orthopedic surgery and traumatology department.

Exclusion Criteria:

* - Unusable files.
* Patients lost to follow-up.
* Patients who did not accept therapeutic treatment.
Endoscopic-vacuum Assisted Closure of Intrathoracic Postsurgical Leaks

The purpose of this study is to determine the short and long term outcome of endoscopic vacuum assisted closure of intrathoracic postsurgical leaks.

Intrathoracic leakage is a serious complication after esophageal surgery. The reported incidence of esophageal anastomotic leaks after gastrectomy and esophagectomy ranges from 5% to almost 30%. Within the last 10 years endoscopic treatment has changed the approach to intrathoracic anastomotic leakages. Application of metal clips, injection of fibrin glue and placement of self expanding metal or plastic stents (SEMS/SEPS) have been reported to successfully achieve closure of postoperative anastomotic leaks in approximately 66-100%. Alternative endoscopically treatment modalities are welcome especially in cases of failure of the above mentioned endoscopic treatment modalities to prevent the necessity of surgical reintervention which is associated with high mortality or mutilating surgical outcome such as proximal diversion with cervical esophagostomy.

Vacuum-assisted closure (V.A.C.) is an established treatment modality for extensive cutaneous infected wounds. The V.A.C. system device is based on a negative pressure applied to the wound via a vacuum sealed sponge tissue. The sponge results in formation of granulation tissue, while the vacuum removes wound secretions and reduces edema and therefore improves blood flow, all together achieving consecutive wound closure. Since its introduction in the late 1990´s the number of indications for the V.A.C. system has steadily increased. Recently the endoluminal application of a vacuum assisted wound closure system for the closure of rectal anastomotic fistulas has been reported. Our group reported the successful closure of intrathoracic anastomotic leaks in two cases by endoscopic placement of a vacuum assisted closure system. Here we plan to study the efficacy, safety and long term outcome of E-V.A.C. to treat major intrathoracic postsurgical leaks.

Eligibility Criteria:
Inclusion Criteria:

* All patients at the Medical School Hannover that present with intrathoracic postsurgical leakage that can be intubated with a regular 9.2mm diameter endoscope (Olympus GIF-165, Olympus
* Age over 18 years old
* Signed informed consent

Exclusion Criteria:

* Small leakage that can be treated with clips
* Refusal to participate in study
Evaluate the Use of Optical Frequency Domain Imaging (OFDI) for Celiac Disease in Children, Adolescents and Young Adults

The goal of this research is to conduct a pilot clinical study to image Celiac disease characteristic mucosal lesions and compare Optical Frequency Domain Imaging (OFDI) images to histologic evaluation in children, adolescents and young adults with suspected Celiac disease.

The Optical Frequency Domain Imaging(OFDI) catheter will be used in conjunction with a standard pediatric endoscope. The endoscopist will introduce the OFDI imaging catheter through the biopsy channel of the endoscope already in place. The catheter will be passed into the view of the endoscope so that the tip of the catheter can be directly visualized throughout the procedure. The catheter will be placed adjacent to the bowel wall in the vicinity of the target locations. Once the OFDI probe is in place, OFDI imaging will start and data will be continuously collected during helical pullback scanning of the inner catheter drive shaft over a predetermined length of approximately 3 cm.

It is expected that the total experimental procedure including the insertion of the OFDI catheter, OFDI imaging, and removal of the catheter will add approximately 10 minutes to the total length of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Age 7 years and above undergoing upper endoscopy for evaluation of celiac disease
* Clinical history, physical findings, family history, or serologic evaluation suggestive of celiac disease
* Parents/guardian available to sign informed consent

Exclusion Criteria:

* Patients with a history of hemostasis disorders
* Use of Nonsteroidal anti-inflammatory drugs(NSAIDS) within ten days preceding initiation of the study
* Use of any oral anticoagulation medication within one month preceding initiation of the study
* Any known blood coagulation disorder
Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB

Effect of Early management on PAin and DEpression in patients with PancreatoBiliary Cancer, EPADE-PB

Purpose

To determine whether early palliative care integrated with usual oncologic care with automated symptom monitoring can improve depression and pain in patients with cancer


Eligibility Criteria:
Inclusion Criteria:

* Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No
* Pathologic confirmed locally advanced or metastatic pancreatic cancer or biliary tract cancer
* within 8 weeks after diagnosis
* cancer-related pain (Brief Pain Inventory \[BPI\] worst pain score \>3), depression (Center for Epidemiological Studies-Depression Scale \[CES-D\] \>16) or both
* Karnofsky Performance Rating Scale ≥50%

Exclusion Criteria:

* Opioid intolerance
* History of drug or alcohol abuse
* Impaired sensory or cognitive function
* Pregnant or lactating woman
* Women of child bearing potential not using a contraceptive method
* Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential