cyrilzakka/clinical-trials huggingface dataset:
Adductor Canal Block In Anterior Cruciate Ligament (ACL) Repair

Adductor canal block will provide adequate analgesia to patients undergoing arthroscopic ACL reconstruction surgery, yet result in less motor blockade than a femoral block.

This study is designed to demonstrate that postoperative analgesia produced by the adductor canal block is not inferior to that produced by femoral nerve block in patients undergoing arthroscopic ACL reconstruction surgery. The study will also compare the degree of motor blockade of the adductor canal block to that of the femoral nerve block.

Eligibility Criteria:
Inclusion Criteria:

American Society of Anesthesiologists(ASA)classification I-III, Patients 18 to 50 years of age, BMI 18 - 40. Patients scheduled for anterior cruciate ligament reconstruction surgery under general anesthesia and nerve blocks.

Exclusion Criteria:

Refusal or inability to provide informed consent. Any contraindication to regional anesthesia including coagulopathy or bleeding diathesis, allergy to local anesthetics, infection, nerve injury or malignancy at the site of the block.

History of alcohol/drug dependence. History of long term opioid intake or chronic pain disorder. History of preexisting neuropathy in the operative leg History of significant psychiatric conditions that may affect patient assessment.

Inability to understand the informed consent and demands of the study. Allergy to any of the components of the multimodal analgesic regimen.
Study of Topical Superoxide Dismutase to Treat Radiation Induced Fibrosis

The purpose of this study is to determine if topical superoxide dismutase is an effective treatment of radiation related neck fibrosis, and to determine the quality of life impact from radiation related fibrosis in the head and neck cancer patients at Sanford Health.

The primary goal of this study is to evaluate the effect of topical Superoxide Dismutase (SOD) on the radiation induced fibrosis in head and neck cancer patients. A prospective, blinded, two group control design will be used with pretest and post test quality of life as well as objective fibrosis assessment. Patients will be randomized to alternatively receive topical SOD or placebo as instructed on twice daily use for 3 months. Pre and post treatment quality of life surveys and objective assessment will determine if the topical SOD improves neck fibrosis/function and global quality of life.

This study will increase clinical trial awareness and participation while potentially improving the long term functional outcomes of head and neck cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* must have evidence of neck fibrosis
* previous radiation treatment to the neck for cancer
* age greater than or equal to 18 years
* life expectancy of greater than 12 weeks
* ability to understand the purpose of the study and the willingness to sign a written informed consent document.

Exclusion Criteria:

* History of allergic reactions attributed to compounds of similar chemical or biologic composition to SOD or Cetaphil cram.
* any psychological, familial, sociological or geographical conditions that do not permit medical follow-up and compliance with the study protocol.
Effects of Robotic-assisted Gait Training In Non-Ambulatory Patients After Guillain-Barré Syndrome

This study investigates the effects of Robotic-assisted gait training in non-ambulatory patients after Guillain-Barré syndrome.The participants are randomly divided into two groups.Patients of the treatment group receive robotic-assisted gait training,while the contorls receive conventional rehabilitation.

Guillain-Barré syndrome (GBS) is an acute autoimmune disease of the peripheral nervous system, which may lead to rapidly developing motor deficits, sensory deficits, autonomic dysfunction and respiratory failure. Approximately, 20.3% of patients cannot walk unaided at 4 weeks of symptom onset and 18.0% at 6 months. So, restoration and improvement of independent walk are one of major goals of GBS rehabilitation. For severely affected neurological patients, gait training using conventional therapy is technically difficult due to their motor weakness and balance problems. Robotic-assisted gait training （RAGT）is an effective alternative to treadmill therapy with partial body weight in intense gait rehabilitation after some neuropathy. And the proven reliability and safety of RAGT suggest that it may be effective for treating non-ambulatory patients after some neuropathy. In our study, we investigated the anti-inflammatory effects of RAGT in non-ambulatory patients of GBS.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of GBS;
* Age between 18 and 65 years;
* Period of GBS is between 4 and 8 weeks;
* severe walking disabilities, defined as a GBS disability score of 2-4;

Exclusion Criteria:

* An unstable phase of disease;
* Disorders preventing RAGT(eg, unstable cardiovascular, respiratory disease ,orthopedic, or neurological condition, unhealed decubitus, orthostatic hypotension etc.) ;
* Severe cognitive impairment preventing meaningful communication;
* Body weight more than 100 kg;
* Pregnancy;
Growth Response in Short Children Suffering From a Disease With Growth Retardation and Treated With Somatropin

Growth hormone therapy will improve the height of short statured children with pathological conditions that lead to growth retardation. Growth hormone therapy will show an increase in height velocity \>1 SD compared to pretreatment height velocity. and the therapy will be safe.

Growth hormone (GH, Somatropin, e.g. Genotropin®) is approved in the treatment of children in specific indications. However, besides the benefit in approved indications, a benefit can also be achieved in other pathological conditions that lead to growth retardation. However, because of their relative low frequency and the long duration of GH studies in children, few data or only case reports on GH treatment are available in these conditions. Nevertheless, published data have suggested a benefit of GH treatment in children suffering from some of those diseases and pediatric endocrinologists sometimes request GH treatment for those children to improve growth rate. This protocol is designed to allow such children with severe growth retardation to be treated with GH and will allow those children to be carefully followed-up and finally evaluated at the end of the GH treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Severe growth retardation (\< -2,5 height SDS and annual growth velocity (HV SDS) \< 0 SD according to Reinken (1992) and parental adjusted target height \< -1 SD according to Tanner (1986)
* Chronological age \> 4 and \< 10 years, prepubertal children; for girls: Tanner breast stage B = 1, for boys: testis volume ≤ 3 ml
* Any disease which is NOT part of the registered indications for GH treatment in Germany
* Written informed consent from both parents and from the patients if she/he is able to receive and understand the information
* GH treatment requested by an expert in pediatric endocrinology

Exclusion Criteria:

* Participation in any other clinical study
* Unable to follow the and/or comprehend the protocol ( e.g. severe mental retardation)
* Previous history of intolerance or hypersensitivity to the study drug
* History of malignancy
* Chromosomal anomalies with increased risk for malignancy
The Use of Neuromuscular Electrical Stimulation to Reverse Muscle Atrophy in Patients With Rheumatoid Arthritis

This study will be a small randomized clinical trial to test the effectiveness of neuromuscular electrical stimulation (NMES) to improve physical function and reverse muscle atrophy in patients with rheumatoid arthritis (RA). The investigators will also determine the mechanism by which NMES affects muscle hypertrophy and physical function. The proposed study will be the first step in demonstrating that NMES training is an effective alternative to highly intense volitional exercises (VE) in individuals with RA. After baseline testing, 60 individuals with RA will be randomly assigned to a 16-week NMES program or highly intense VE program. Both programs will be applied based on the best current clinical evidence. Subjects will be re-assessed after intervention. Groups will be compared for differences in performance-based and self-reported lower extremity function, muscle volume, muscle strength, proportion and area of type I and II muscle fibers, fat content, and muscle oxidative capacity from pre- to post-intervention. Changes in physical function, muscle volume, and muscle strength will be correlated with proportion and area of type I and II muscle fibers, fat content, and markers of muscle oxidative capacity.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Age 21 or older
* Diagnosed with RA for at least 5 years according to the criteria of the American College of Rheumatology
* Independent ambulator

Exclusion Criteria:

* History of cardiovascular disease or uncontrolled hypertension (above 140/90 mmHg);
* History of a quadriceps tendon or patellar tendon rupture;
* History of previous adverse reaction associated with electrical stimulation treatment;
* Surgery to the dominant lower extremities within the past 6 months.
* History of a neurological disorder that may affect lower extremity function, such as cerebrovascular accident or neuropathy, parkinson's disease, multiple sclerosis, etc.;
* History of muscle disease such as muscular dystrophy;
* Change in medication regimen (excluding NSAID change) during the month prior to treatment;
* Current use of cholesterol-lowering medication;
* History of malignancy during the last 5 years, excluding skin cancers other than melanoma;
* Current or anticipated pregnancy;
* Less than 70º of passive knee flexion;
* Are not willing to undergo needle biopsy.
* Participated in progressive resistance training or NMES training in the prior year;
* Prior adverse effects with local anesthesia.
Effects of Different Concentric and Eccentric Muscle Fatigue Protocols on the Knee Joint Position Sense

The aim of this study was to investigate the effects of different concentric and eccentric muscle fatigue protocols on the knee joint position sense of healthy individuals.

A randomized controlled crossover trial will be conducted at a biomechanics laboratory with healthy males. All participants will perform with a washout period of 1 week: a control condition (5-minute rest) and 4 local muscle fatigue protocols (concentric of quadriceps; concentric of hamstrings; eccentric of quadriceps; eccentric of hamstrings) in an isokinetic dynamometer at 30º/s. Three maximum voluntary isometric contractions (MVIC) of quadriceps and hamstrings will also be assessed in the beginning of all conditions.

Knee joint position sense will be assessed before and immediately after the fatigue protocols/control condition, through active concentric and eccentric positionings/repositionings, in sitting and prone positions, to a target range of 45º of knee flexion in an isokinetic dynamometer. Surface electromyography electrodes will also be placed on the vastus lateralis and biceps femoris during all procedures.

Eligibility Criteria:
Inclusion Criteria:

* males aged between 18 and 30 years;
* without current or previous knee pathology or surgery;
* with a low or moderate physical activity level, according to the International Physical Activity Questionnaire;
* normal Body Mass Index (under 24.9 kg/m2), according to the World Health Organization.

Exclusion Criteria:

* those with cardiorespiratory, neurological or vestibular pathologies;
* with positive knee integrity tests (anterior drawer, Lachman's test, posterior drawer; valgus and varus stress testes); and
* those taking any medication that can affect motor control (sedatives, anxiolytics, antibiotics, analgesics, NSAIDs or myorelaxants).
Muscle Capillarization and Sarcopenia

Aging is associated with a loss of muscle mass, termed sarcopenia, that reduces mobility, decreases physical function and accelerates progression of other age-related disorders. This study is designed to determine whether increasing skeletal muscle capillarization through aerobic exercise will enhance muscular adaptations to strength training in older adults with sarcopenia.

Sarcopenia, or the aging-related loss of muscle mass, affects a large number of older adults. The presence of sarcopenia is associated with physical disability, poor quality of life, and all-cause mortality, in part because sarcopenic adults have low muscle skeletal muscle capillarization and may lack the adequate perfusion needed to maintain muscle mass and function. This study will test the effects of increasing skeletal muscle capillarization through aerobic exercise training on responses to resistance training in older adults. Eligible participants will be randomized to one of two groups, resistance training preceded by aerobic exercise training (AEX-RT), or resistance training followed by aerobic exercise training (RT-AEX). Participants in the AEX-RT group will undergo 3 months of aerobic exercise training to increase skeletal muscle capillarization, followed by 3 months of resistance training. Participants in the RT-AEX group will undergo 3 months of resistance training, followed by 3 months of aerobic exercise training. Before and after the interventions, participants will undergo assessments of muscle size, strength, and capillarization, as well as assessments of physical function.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index = 18-32.5 kg/m2
* Non-smoker
* Presence of at least moderate sarcopenia (low muscle mass per unit body height)

Exclusion Criteria:

* Diagnosis of diabetes, cancer, pulmonary or renal disease
* Physical impairment preventing exercise
* Recent history of exercise training
Genetics Study of In-stent Restenosis

The investigators hypothesized that genetic variants of G protein influence the development of restenosis and clinical outcome of patients receiving drug-eluting stents (DES).

Although drug-eluting stents (DES) have reduced restenosis rates compared with bare-metal stents, the restenosis rate is still high in the high-risk group. G protein plays important roles in the signal transduction leading to vascular smooth muscle proliferation. The initial and subsequent studies suggest that the T allele of C825T polymorphism is associated with enhanced transmembrane signaling via Gi proteins.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent follow-up angiography. All the patients must had been implanted with DES during the last two years.

Exclusion Criteria:

* For the non-ISR group, the patients underwent follow-up angiography less than 6 months away from stent implanting.
HFNC During Awake Craniotomy - Impact on Patient Comfort

Background: Patients undergoing awake brain surgery are exposed to non-humidified, non-warmed oxygen/air mix flow through a face mask for a prolonged duration. This causes increased discomfort, inadequate breathing with the risk for hypoxia perioperatively. Humidified high flow nasal cannula (HFNC) oxygen therapy potentially improves patient comfort, oxygen/air exchange, improves surgical conditions and prevents atelectasis of the lung, compared to traditional oxygen administration using a face mask in patients undergoing awake brain surgery.

Results of this trial will be used to initiate a more extensive, multicenter trial to further characterize the potential impact of HFNC.

Background: Patients undergoing awake brain surgery are exposed to non-humidified, non-warmed oxygen/air mix flow through a face mask for a prolonged duration. This causes increased discomfort, inadequate breathing with the risk for hypoxia perioperatively.

Hypothesis: Humidified high flow nasal cannula (HFNC) oxygen therapy improves patient comfort, oxygen/air exchange, improves surgical conditions and prevents atelectasis of the lung, compared to traditional oxygen administration using a face mask in patients undergoing awake brain surgery.

Methods: After obtaining ethics approval and written informed patient consent, 20 patients undergoing scheduled awake brain surgery will be randomized to either HFNC therapy or standard face mask. Evaluation of patient satisfaction, pain / dry upper airway along with drawing of arterial blood gases to measure oxygen/carbon dioxide content of the blood will be performed during and after the procedure. Lung ultrasound will be performed in the recovery room to determine the presence of atelectasis.

Expected results and Significance: We expect that HFNC improves patient comfort as well as breathing / arterial oxygen content in long-duration awake brain surgery. This could result in higher patient satisfaction, shorter times in PACU, a shorter requirement for oxygen therapy, decreased risk for hypoxia during surgery and better elimination of carbon dioxide - which could lead to better surgical conditions due to softer brain tissue and therefore shorter time for the surgical procedure. Potential positive results of this trial will be used to initiate a more extensive, multicenter trial to further characterize the potential impact of HFNC.

Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing elective awake craniotomy

Exclusion Criteria:

* ASA \> 4
* pregnant females
* Body Mass Index (BMI) \> 40
* elective postoperative mechanical ventilation/conversion to general anesthesia
* denial of consent
* obstructive sleep apnea requiring CPAP
* severe COPD requiring home oxygen therapy
Prevalence of Frailty in Patients With a Cardiovascular Disease and Correlations With Markers of Exercise

In the first part of this study the prevalence of frailty in patients with cardiovascular disease will be examined. Frailty is defined as a progressive age-related decline in physiological systems that results in decreased reserves of intrinsic capacity, which confers extreme vulnerability to stressors. Patients (≥65 years, men and women) suffering from heart failure or undergoing a coronary artery bypass grafing (CABG) or percutaneous coronary intervention (PCI) will be included. Based on the phenotype of Fried, frailty will be examined in the physical domain. Moreover, the nutritional, social, psychological and cognitive domain of frailty will be examined. This will result in a total score of 0 (no frailty) to 24 (severe frailty), divided into four categories: no frailty (score 0-6), minor frailty (score 7-12), moderate frailty (score 13-18) or severe frailty (score 18-24).

Besides this frailty protocol, a few other measurements will be completed to collect additional information about the functioning of the patient.

At discharge from the hospital, some of these patients will start with a cardiac rehabilitation program. To define the exercise intensity of this program, patients will perform a maximal exercise test (CPET). In the second part of this study, correlations will be examined between markers of frailty and markers of exercise from the CPET (e.g. maximal heart rate, maximal oxygen uptake).


Eligibility Criteria:
Inclusion Criteria:

Men and women with an age of at least 65 years at the start of the study; Staying in Jessa Hospital for PCI, CABG or heart failure

Exclusion Criteria:

A persistently unstable clinical condition at baseline visit (angina, advanced conduction disturbances, threatening ventricular arrhythmias, acute heart failure, clinical condition requiring interventions such as acute renal failure, Hb \<9,0 mg/dl, presence of end-stage disease or the lack of informed consent to study participation)
Efficacy and Safety of Gemigliptin 50mg qd Added in Patients With Type 2 Diabetes Inadequately Controlled on Glimepiride and Metformin

After a screening, a 2-week, single-blind placebo run-in, 174 patients will be randomized in a 1 : 1 ratio to the addition of either once-daily Gemigliptin 50 mg or placebo to ongoing stable doses of glimepiride in combination with metformin for 24 weeks.

Subjects will visit the center on Week 6, 12, 18 and 24 during the entire 24-week treatment period. Total study duration will be approximately 26weeks and the subjects will be to practice exercise/diet control together.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with Type 2 Diabetes Mellitus
2. Adults aged ≥ 19 years old
3. Patients with HbA1c 7%\~11% at Visit 1
Identification of Genetic Factors Implicated in Orofacial Cleft Using Whole Exome Sequencing

Despite significant progress made in identification on numerous genes and gene pathways critical for craniofacial development, several approaches, ie mutation screening of specific candidates, association studies and even genome-wide scans have largely failed to reveal the molecular basis of NS human clefting

Despite significant progress made in identification on numerous genes and gene pathways critical for craniofacial development, several approaches, ie mutation screening of specific candidates, association studies and even genome-wide scans have largely failed to reveal the molecular basis of NS human clefting. Moreover, the efficiency of Whole Exome Sequencing -WES- was proven. The efficiency of WES was proven by the identification of the genes causing Freeman Sheldon and Miller's syndrome, followed by several others. In the Picardy region, management and follow-up of orofacial cleft patients are well-organised by a multidisciplinary team in the university hospital of Amiens. The investigators therefore decided to perform whole exome sequencing (WES) on precisely phenotyped non-syndromic CL/P patients followed in our center.

Eligibility Criteria:
Inclusion Criteria:

* Subject with a NSCL/P or CL/P of unknown etiology,
* national health care insurance holders

Exclusion Criteria:

* Subject with a CL/P of known etiology,
* Subject with a NSCL/P and an IRF6 mutation