cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Results of Two Different Methods in Management of Antero-lateral Instability of the Knee

This randomized clinical study will be conducted to compare the results of anterior cruciate ligament reconstruction (ACLR) combined with either anterolateral ligament reconstruction using peroneus longus autograft or extra-articular tenodesis (Modified Lemaire) in management of antero-lateral instability of the knee

Patients will undergo an anatomic ACLR in a standardized fashion by the same team of surgeons. They are randomly divided into 2 groups either ACLR plus ALL reconstruction or ACLR combined with LET in a 1:1 ratio. There are multiple graft options for ACL-R, but here for the study, the hamstring autograft is harvested following the traditional technique. The graft is measured and bony tunnels are drilled. An anatomical reconstruction technique is used in all cases.

In group A: the surgeon will harvest peroneus longus graft, then sutured to the double bundle hamstring graft. The graft diameters are measured and recorded. The graft is pulled through the femoral tunnel and passed through the tibial tunnel. The single portion of the graft is passed freely through the tibial and femoral tunnels until the quintuple graft portion occupies both tunnels. The graft is then pulled, and an interference screw (Smith \& Nephew Endoscopy) is fixed to the femur. The next step is to fix the inferior end of the quintuple graft to the tibia after pre-tensioning. After tibial fixation, the remaining PL is passed through the subcutaneous and ALL tunnels. The ligament is fixed under traction, mild valgus stress, and 30' of flexion 1.5 cm from the joint line into a midpoint between Gerdy's tubercle and the fibular head.

In group B: the surgeon will use a triple STG hamstring (6- strands) tendon graft. The graft diameters are measured and recorded.

Then, LET is performed in a standardized fashion as described in the modified Lemaire technique. LET is fixed with interference screws (Smith \& Nephew Endoscopy). Femoral and tibial fixations are performed with bio-absorbable interference screws (Smith \& Nephew Endoscopy).

Eligibility Criteria:
Inclusion Criteria:

1. The ACL deficient knee was clinically manifested by physical examination and confirmed by MRI.
2. Age 18-45 years, skeletally mature patient.
3. A positive pivot shift test of at least grade II is required (significant anterolateral instability).

Exclusion Criteria:

1. Multiple ligament injuries or a polytraumatized patient
2. Revision cases.
3. Generalized laxity.
4. Symptomatic articular cartilage defect requiring treatment; Outerbridge \> grade II.
5. More than three degrees of varus or valgus malalignment
Study of Transbronchial Cryobiopsy in Monitoring Complications of Lung Transplantation

The goal of this randomized controlled trial is to compare the diagnostic efficacy and safety of transbronchial cryobiopsy (TBCB) and traditional transbronchial lung biopsy for diagnosing the lung transplantation rejection , so as to establish the evidence-based medical basis for the effectiveness and safety of TBCB for monitoring after lung transplantation, It is expected to provide a better auxiliary examination method for lung transplantation.

The main questions it aims to answer are: (1) Histopathological evaluability of specimens; (2) Safety of TBCB; (3) Size and quality of specimen, and number of attempts to obtain five samples.

Participants will undergo TBCB with 1.1 mm flexible cryoprobe or traditional transbronchial lung biopsy with biopsy forceps.


Eligibility Criteria:
Inclusion Criteria:

* Age among 18-65 years old
* After unilateral or bilateral lung transplantation, patient with unexplained pulmonary function decline, acute/chronic clinical lung injury or new pulmonary infiltrates
* or patients requiring monitoring of rejection after lung transplantation
* The patient should undertake routine preoperative examinations for lung cryobiopsy, including routine blood test, coagulation function, electrocardiogram, and chest CT, and the patients have no contraindications to cryobiopsy

Exclusion Criteria:

* patients intolerable to undertake lung biopsy due to severe cardiopulmonary insufficiency or being weak
* The patient is allergic to lidocaine and midazolam
* The patient has recent active massive hemoptysis, or the proposed biopsy site has a high risk of bleeding, such as bronchial artery penetration or suspected renal cancer lung metastasis
* Unstable angina, congestive heart failure, severe bronchial asthma or multiple bullae
* Severe hypertension and arrhythmia, hemodynamic instability and severe respiratory failure (PaO2\<60mmHg after oxygen therapy or mechanical ventilation)
* The patient has coagulation disorder and unable to stop taking anticoagulants, antiplatelet drugs, aspirin or non-steroidal anti-inflammatory drugs before lung biopsy
* Suspected aortic aneurysm
* The patient does not agree to participate in this study
* Participating in other studies within three months and not withdrawing or ending
* The researchers think that the patient are not suitable for inclusion
Integrative Cognitive-Affective Therapy for Binge Eating Disorder

The purpose of the study is to test a newly developed individual psychotherapy treatment for binge eating disorder in adults. This treatment is a type of individual psychotherapy called Integrative Cognitive-Affective Therapy (ICAT) that focuses on helping people change their behaviors, feelings, thoughts about themselves, and relationships. This new treatment is being compared to an existing treatment called Cognitive-Behavior Therapy-Guided Self Help (CBTgsh), which focuses on changing behavior patterns through the use of reading and homework assignments along with sessions with a therapist. The primary hypothesis of this investigation is that ICAT will be associated with greater reductions in binge eating at end of treatment and follow-up compared to CBTgsh.


Eligibility Criteria:
Inclusion Criteria:

* Binge eating disorder (DSM-5)

Exclusion Criteria:

* History of gastric bypass surgery
* Medical condition acutely affecting eating and/or weight
* Current medical and/or psychiatric instability (e.g., acute suicidality)
* Psychosis and/or bipolar disorder
* Severe cognitive impairment or developmental disability
* Inability to read English
* Current substance use disorder
* Current participation in psychotherapy and/or commercial weight loss program
* Change in dosage and/or frequency of psychotropic medication in the past 6 weeks
* Pregnant or breast feeding
* BMI \< 21
Effect of Adiponectin Genetic Polymorphism on Rosiglitazone Response

The aims of the present study were to investigate the association between adiponectin gene polymorphisms and the response to rosiglitazone monotherapy in T2D patients.

A total of 255 T2D patients and 120 health volunteers were enrolled in this study. 42 T2D patients with -11377(C/G) or +45(T/G) genotypes were selected to administrate orally 4mg rosiglitazone daily for 12 consecutive weeks.

The aims of the present study were to investigate the association between adiponectin allele +45(T/G) and -11377(C/G) polymorphisms and the response to rosiglitazone monotherapy in T2D patients.

A total of 255 T2D patients (138 males, 117 females) aged from 25 to 70 years (mean 48.6 ± 10.7 years) and 120 healthy controls (53 females, 67 males) aged from 25 to 70 years(mean 47.1 ± 11.0 years) were enrolled to participate in this study. Physical examination, medical history and serum biochemical tests were performed to identify healthy or T2D subjects. The diagnosis criteria of T2D patients were made according to the World Health Organization in 1997 by fasting plasma glucose (FPG  7.0 mmol/L) and/or postprandial plasma glucose test (PPG  11.1 mmol/L). The inclusion criteria of all subjects were that subjects had the range of body mass index (BMI) from 18.5 to 30 kg/m2 and did not administrate any PPAR agonists in the last 3 months. Patients who were receiving insulin treatment, pregnant or lactating women, or with serious diseases such as acute myocardial infarction, cerebral vascular accident, trauma, and kidney disease or liver disease were excluded from this study. Table 1 showed the characteristic profiles of T2D patients and healthy controls. There were no statistical differences in the age, height, weight, and BMI value between T2D patients and healthy controls. All subjects were recruited from local residents in Changsha city, Hunan Province, P. R. China. The study protocol was approved by the Ethics Committee of Xiangya School of Medicine, Central South University and written informed consents were obtained before the start of this study. A total of 42 T2D patients (23 male, 19 female) were randomly selected to be only treated with 4mg rosiglitazone daily for 12 consecutive weeks without change in previous medications.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis criteria of T2D patients were made according to the World Health Organization in 1997 by fasting plasma glucose (FPG  7.0 mmol/L) and/or postprandial plasma glucose test (PPG  11.1 mmol/L)
* The inclusion criteria of all subjects were that subjects had the range of body mass index (BMI) from 18.5 to 30 kg/square meter and did not administrate any PPAR agonists in the last 3 months.

Exclusion Criteria:

* Patients who were receiving insulin treatment, pregnant or lactating women, or with serious diseases such as acute myocardial infarction, cerebral vascular accident, trauma, and kidney disease or liver disease were excluded from this study.
Positive End-expiratory Pressure-induced Increase in Central Venous Pressure as a Predictor of Fluid Responsiveness in Robot-assisted Laparoscopic Surgery

In urologic robotic surgery with steep Trendelenburg position, maintenance of cardiac preload and cardiac output is important for clinical prognosis. Previous studies reported the positive end-expiratory pressure (PEEP)-induced increase in central venous pressure (CVP) could be a accurate predictor of fluid responsiveness in cardiac surgical patients. The authors attempt to evaluate the predictability of PEEP-induced increase in CVP as well as stroke volume variation in urologic robotic surgery with Steep Trendelenburg position.

In urologic robotic surgery with steep Trendelenburg position, maintenance of cardiac preload and cardiac output is important for clinical prognosis. As a preload index, the predictability of central venous pressure, pulse pressure variation and stroke volume variations may be impaired due to the impaired hemodynamics that result from the effect of increased abdominal pressure and decreased venous return. Previous studies reported the positive end-expiratory pressure (PEEP)-induced increase in central venous pressure (CVP) could be a accurate predictor of fluid responsiveness in cardiac surgical patients. Therefore, the authors attempt to evaluate the predictability of PEEP-induced increase in CVP as well as stroke volume variation in urologic robotic surgery with Steep Trendelenburg position.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient undergoing robot-assisted laparoscopic radical prostatectomy or cystectomy.
* American Society of Anesthesiologist Physical Status Classification of 1, 2 or 3.

Exclusion Criteria:

* Medical history of arrhythmia or new-onset arrhythmia after anesthesia induction.
* Valvular or ischemic heart disease or left ventricular ejection fraction less than 40%.
* Any significant pulmonary disease or history of chronic obstructive pulmonary disease
* End-stage renal disease or preoperative creatinine \> 1.4 mg/dl
Pharmacokinetics of Mitiglinide and Metformin in Free Combination and Fixed-dose Combination in Healthy Male Subjects.

To investigate safety and pharmacokinetics of mitiglinide and metformin in a fixed-dose combination of mitiglinide/metformin, compared with free combination of mitiglinide and metformin in healthy male subjects.

The Korean clinical practice guidelines on DM recommend that a second oral agent with a different mechanism of action be combined to the regimen when adequate glycemic control is difficult to achieve with an oral hypoglycemic agent accompanied dietary therapy. Therefore, a concurrent administration of metformin, a inhibitor of gluconeogenesis, and mitiglinide, an insulin secretagogue, could be an effective and ideal regimen for management of diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* Subject with adequate clinical laboratory test results (hematology, blood chemistry, serology, drug abuse, urinalysis etc.)
* Subject with normal results in blood pressure, pulse, body temperature and ECG test
* Subject with body mass index (BMI) between 18.5 kg/m2 and to 25 kg/m2

Exclusion Criteria:

* Clinically significant functional disorder or acute disease
* Chronic disease affecting the absorption, metabolism or excretion of drug
* Any study drug administration within 90 days before the first drug administration
* Use of medicine affecting drug metabolism (inhibition, induction) such as barbital, within 30 days before the first drug administration
Effects of Dietary Interventions on the Aging Brain

The researchers will investigate whether caloric restriction or dietary supplementation could provide positive effects on general brain functions in healthy elderly people.

The age-related degradation of cognitive functions even to the point of neurodegenerative disorders such as Alzheimer's disease are a growing public-health concern with devastating effects.

Referring to animal data, empirical studies, and pilot human trials, a healthy diet rich in unsaturated fatty acids and low in calories should improve cognitive functions such as learning and memory. To test this hypothesis, the researchers study general brain functions in healthy elderly subjects (50-80 years old) during a short term diet.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects
* 50-80 years old
* moderate to heavy weight (BMI 25-30)
* must be able to change diet/take supplements at home

Exclusion Criteria:

* diabetes
* younger than 50 years
* BMI \< 25
* psychiatric medication
* severe disease
* MMSE \< 26
* eating disorders
Response to Booster Doses of Hepatitis B Vaccine in Children and Adolescents

The purpose of this study is to determine the immune response to an additional (booster) dose of hepatitis B vaccine 5-14 years after a three dose series was given

Routine hepatitis B vaccination beginning at birth was provided to Alaska Natives several years before other areas of the United States began routine infant hepatitis B vaccination programs. Follow up studies of hepatitis B immunity among Alaska Native children provide an early opportunity to assess long term protection against hepatitis B virus (HBV) infection for children vaccinated at birth with the currently used recombinant vaccine. This protocol describes an evaluation of long-term protection against HBV infection among children who received the recombinant hepatitis B vaccine beginning at birth, and who currently receive medical care at the Alaska Native Medical Center (ANMC) in Anchorage, Alaska.

The specific objective of this study is to evaluate the immune response to a five microgram dose of recombinant hepatitis B vaccine among 5-6 year old and 10-14 year old children who received the primary recombinant hepatitis B vaccine series beginning at birth. The concentration of antibodies to hepatitis B surface antigen (anti-HBs) will be measured immediately before administering the vaccine, and compared with levels in serum drawn 1, 2 and 4 weeks afterwards. A rapid antibody response (anamnestic response) indicates that immune memory, and therefore immunity to HBV infection, is preserved. The frequency and magnitude of the anamnestic response for the group of older children will be compared to that of the younger group.

Currently, there is no recommendation for a routine booster dose of vaccine after receiving three doses at birth. This study will provide valuable information regarding the need for and response to an additional dose (booster dose) of hepatitis B vaccine among children entering primary school or adolescence. If evidence of waning immune memory (as measured by a delayed or diminished response to the additional dose of vaccine) is found, these two age groups would be the most easily accessible for routine delivery of a booster dose.

Eligibility Criteria:
Inclusion Criteria:

Received 3 doses of hepatitis B vaccine during infancy, beginning at birth

Exclusion Criteria:

Mother HBsAg-positive immunosuppressed
Dexmedetomidine Versus Placebo in Endoscopic Retrograde Cholangiopancreatography (ERCP) Sedation

In this pilot prospective non-commercial clinical trial the investigators will study the use of dexmedetomidine as an adjuvant to the patient-controlled propofol sedation in a placebo-controlled and randomized manner in patients with drug addiction during Endoscopic Retrograde Cholangiopancreatography (ERCP). Dexmedetomidine is a sedative medication used mostly in intensive care units,and is marketed under the brand name Precedex. Dexmedetomidine has sedative, analgesic, sympatholytic, and anxiolytic properties. It produces sedation without causing significant respiratory depression. Recent research has suggested dexmedetomidine to be effective in treatment of alcohol withdrawal signs. In previous studies dexmedetomidine was insufficient as an only sedative agent in ERCP and colonoscopy, but it has not been assessed for sedation in patients with chronic pancreatitis. The main objective of this trial is to evaluate if dexmedetomidine can reduce propofol and opioid consumption and facilitate the performance of ERCP in patients with chronic pancreatitis due to drug addiction.Secondary objectives of the trial are the stability of vital signs and safety, patients´ satisfaction plus recovery time from sedation.

50 elective ERCP patients with chronic pancreatitis after written informed consent and randomisation will be recruited to the study. Exclusion criteria are:allergy to propofol, opioid or dexmedetomidine, ASA class greater than 3. All the patients will receive patient-controlled propofol sedation. In dexmedetomidine group dexmedetomidine infusion will be started before sedation beginning and in placebo group placebo-solution (NaCl0,9%) will be administered in the similar manner.Standard monitoring for vital signs will be applied,also sedation degrees will be evaluated with sedation scores. At the end of procedure total amount of propofol and opioid will be calculated,patients and endoscopists satisfaction and the difficulty of ERCP will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Elective ERCP-patients with chronic alcohol pancreatitis

Exclusion Criteria:

* Allergy to the dexmedetomidine, propofol or any opioid, ASA(American Society of Anaesthesiology)class grater when 3
Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus

This study will evaluate the effectiveness and safety of an investigational drug, IV ganaxolone, as adjunctive therapy to standard of care to treat subjects with status epilepticus.

This is a double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, and efficacy of adjunctive IV ganaxolone in subjects with SE.

Study drug will be added to standard of care before IV anesthetic during the treatment of SE.

Subjects will be screened for inclusion/exclusion criteria prior to receiving study drug as adjunctive therapy by continuous IV. Subject's will be followed up for 3 weeks post-treatment.

Subjects who are known to be at risk for SE may be consented and/or assented prior to an SE event.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 12 years of age and older
* Clinical and/or electrographic seizures

Exclusion Criteria:

* Life expectancy of less than 24 hours
* Anoxic brain injury as primary cause of SE
* Recent (\<24 hour) traumatic brain injury as the primary cause of SE
* Administered anesthesia for the treatment of SE
Patient Satisfaction After Eyelid Lesion Excision

eyelid lesion excision is a common eyelid procedure. It associated with visual, aesthetic and functional changes .Investigator will evaluate patient satisfaction.

A baseline and 3 months full ophthalmic examination was done. Procedure is eyelid lesion excision. Satisfaction questionnaire concerning the functional and psychosocial impact of their eyelids was applied.

Eligibility Criteria:
Inclusion Criteria:

* eyelid lesion

Exclusion Criteria:

* previous eyelid surgery
Bowen Therapy and Foam Rolling in Patients With Text Neck Syndrome

This study aims to compare the effects of both the therapies on postural changes, pain, decreased ROM, and functional disability among students suffering from Text Neck Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* neck-head trauma
* history of surgical intervention in the neck area
* neurological deficit
* severe neck pain which required medical treatment
* cervical disc disease with radiculopathy
* inflammatory or malignant type of pain
* systematic disease
* scoliosis
* kyphosis.

Exclusion Criteria:

* neck-head trauma
* history of surgical intervention in the neck area
* neurological deficit
* severe neck pain which required medical treatment
* cervical disc disease with radiculopathy
* inflammatory or malignant type of pain
* systematic disease
* scoliosis
* kyphosis.