cyrilzakka/clinical-trials huggingface dataset:
Effects of Obesity Surgery on Renal Function

Increasing risk of impaired renal function as a result of obesity is well known. Early data has postulated that weight loss might improve kidney function, but the evidence is rather limited due to the difficulties in measuring glomerular filtration rate(GFR) after weight loss. Cystatin C, GFR measurement using Cockcroft-Gault (CCG) and Modification of Diet in Renal Disease (MDRD) equations, have all yield conflicting results after weight loss surgery.

The study aim to assess:

1. use of 51Cr-EDTA Clearance as the methodological gold standard in evaluating changes in renal function before and after weight loss surgery.
2. the reliability of using MDRD, CCG and Cystatin C in measuring GFR after weight loss surgery
3. the differences in alterations in renal function dependent on the surgical procedures( gastric bypass, gastric band, sleeve gastrectomy).
4. the use of urine albumin/creatinine ratio in detecting alterations in microalbuminuria.

This is a prospective study on obese human subjects undergoing bariatric surgery. Forty-five patients due to undergo gastric bypass (n=15), gastric banding (n=15), and gastric sleeve surgery (n=15) will be recruited.

Subjects will be screened prior to entry into the study with full history, examination, routine bloods (FBC, U+E, liver function tests, and glucose).

1. Blood samples and 24h urine specimens are taken at four time points: preoperatively as well 6 weeks, 6 and 12 months postoperatively.
2. The following methods of GFR assessment will be executed the same time point: measurement of serum creatinine concentration, calculation of the abbreviated and extended MDRD formulae, CCG, creatinine clearance, serum Cystatin C concentration and the 51Chromium-EDTA clearance.

Inclusion criteria

1. Patients with a BMI of \>35kg/m2 approved for obesity surgery based on the NICE criteria.
2. Patients with a GFR \<60 mL/min/1.73

Exclusion criteria

1. Allergy to chromium

Eligibility Criteria:
Inclusion Criteria:

* Patients with a BMI of \>35kg/m2 approved for obesity surgery based on the NICE criteria.
* Patients with a GFR \<60 mL/min/1.73 m2

Exclusion Criteria:

* Allergy to chromium
Framing Messages for Smoking Cessation With Bupropion - 6

This is a randomized study of message framing in individuals beginning a smoking cessation program utilizing bupropion SR and brief counseling, videos, and pamphlets.


Eligibility Criteria:
Exclusion Criteria:

* Pregnant or nursing women, or women of child-bearing potential who are not using an adequate method of contraception
* Psychiatric illnesses requiring psychotropic medications (i.e., psychosis, major depression, mania), or the presence of suicidality or homocidality
* Current use of nicotine replacement therapies (i.e., nicotine patch, gum, or lozenges, nasal spray, or inhaler), bupropion (Zyban, Wellbutrin), or marijuana or current participation in another smoking cessation treatment
* Presence of unstable medical conditions (i.e., cardiac, hepatic, renal disease, diabetes mellitus) that would make a trial of bupropion SR hazardous
* Have taken monoamine oxidase inhibitors or metoprolol succinate within the past six weeks
* History of anorexia nervosa or bulimia
* Previous hypersensitivity to bupropion
* History of alcohol or other drug dependence in the past one year
* History of seizure disorder of any etiology (i.e., brain tumor, traumatic brain injury, substance-induced seizures, etc.)
* Any finding that in the view of the principal investigator would compromise the subject's ability to fulfill the protocol visit schedule and visit requirements or put the subject at risk
* Sharing home or work environment with current or past participant
* No couples or participants who see each other every day
Study on Skin Microbiome of HFS

To skin microecology and breast cancer chemotherapy drug therapy as the breakthrough point, disease prevention and treatment of breast cancer in China, the important scientific problems in basic research, through in-depth study of skin micro ecological changes in advanced breast cancer chemotherapy and its regulatory mechanism, clear skin flora occurred after application of capecitabine and the influence and mechanism of the immune response;Finding markers for the treatment and prognosis of related diseases;Identify and isolate key strains and/or metabolites, and conduct intervention studies to reveal new mechanisms of skin microflora homeostasis and toxic and side effects of breast cancer chemotherapy.

To skin microecology and breast cancer chemotherapy drug therapy as the breakthrough point, disease prevention and treatment of breast cancer in China, the important scientific problems in basic research, through in-depth study of skin micro ecological changes in advanced breast cancer chemotherapy and its regulatory mechanism, clear skin flora occurred after application of capecitabine and the influence and mechanism of the immune response;Finding markers for the treatment and prognosis of related diseases;Identify and isolate key strains and/or metabolites, and conduct intervention studies to reveal new mechanisms of skin microflora homeostasis and toxic and side effects of breast cancer chemotherapy

Eligibility Criteria:
Inclusion Criteria:

* age: 18-65 years old
* advanced breast cancer patients
* healthy volunteers

Exclusion Criteria:

* previous skin disease history, or other skin disease activity at present
* various antibiotics, prebiotics, probiotics or lactic acid products used within three months;
* having a history of alcoholism for more than 2 years and smoking for years;
* pregnancy or lactation;
* have oral, respiratory and gastrointestinal diseases;
* other metabolic diseases, such as obesity, hypertension, diabetes, stones, and liver diseases;
* other autoimmune diseases, such as rheumatoid arthritis, ankylosing spondylitis, inflammatory bowel disease;
* history of gastrointestinal surgery;
* family genetic history, history of mental illness, etc.;
* the subject is participating in other research projects;
* other reasons are not considered suitable for continued clinical trials.
Safety and Efficacy of Body-mapping Tank Top Equipped With Biofeedback System for Adolescent With Early Scoliosis

Adolescent idiopathic scoliosis (AIS) is a prevalent disease that caused a lateral curvature on spine. Spine curvature increases in youths as puberty progresses. The recommended treatment for AIS is different depends on the spine deformity condition. For mild scoliosis (Cobb's angle ≤ 20°), only periodic observation is suggested. For scoliosis cases that the Cobb's angle ≤ 40°, a rigid brace treatment is recommended. A rigid brace that made by rigid plastic material restrict nearly all movements of the wearers, which caused irritation. Flexible brace is an alternative option, however, the efficiency of such treatment is questionable in terms of controlling the spine curvature progression.

Biofeedback has proven to be effective for a number of physical, psychological and psychophysical problems. The basic aim of biofeedback therapy is to support a patient in realizing his/her self-ability to control specific psychophysiological processes.

In this study, a biofeedback embedded tank-top with a specialized design for adolescents as a treatment option for AIS patients by monitoring the daily posture of the wearers.

This project aims to combine the clinical experience with textiles and biofeedback mechanism to research and develop a biofeedback embedded tank-top for AIS. As a result, this will reduce the future likelihood of brace wear or surgery.

In this study, the eligible subjects will be given tailor-made biofeedback tank-top to wear it 8 hours daily. Monitor, observation and additional posture training sessions will be provided during the 6 months wearing period. The effectiveness of the biofeedback tank-top will be evaluated by pre-and post- treatment ultrasonic imaging device (for measuring the angle of the spine), electromyography muscle signal assessment and clinical photographs assessment.

Eligibility Criteria:
Inclusion Criteria:

* Aged 10 to 13 years
* Diagnosis of AIS in early stage
* Primary Cobb angle between 10 -20 degrees
* Pre-menarche or post- menarche by no more than 1 year
* Ability to read and understand English or Chinese
* At high risk for curve progression
* Skeletally immature (Risser grade 0,1 or 2)
* Physical and mental ability to adhere to functional intimate apparel protocol

Exclusion Criteria:

* Contraindications for x-ray exposure
* Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
* History of previous surgical or orthotic treatment for AIS
* Contraindications for pulmonary and/ or exercise tests
* Psychiatric disorders
* Recent trauma
* Recent traumatic (emotional) event
Effect of Conjugated Linoleic Acid Supplement on Body Composition

The purpose of this clinical trial is to examine the effects of a low and high dose of conjugated linoleic acid supplement on body composition in obese humans. Individuals with a body mass index between 30 and 35kg/m2 are randomized to receive either placebo, 3.2gCLA, or 6.4g CLA daily for twelve weeks. Changes in body composition, weight, and clinical laboratory values are compared between the three groups.

Sixty healthy obese adult volunteers will be enrolled and randomized into either: 1) placebo, 2) 3.2 g CLA, or 3) 6.4 g CLA groups and supplemented for 12 weeks. Body fat mass (BFM) and lean body mass will be determined by DEXA at baseline and twelve weeks during the intervention. In addition, indirect calorimetry will be performed at baseline and twelve weeks to measure changes in energy expenditure. The effect of CLA supplementation on weight, waist and hip measurements, and BMI will also be determined at 12 weeks. Plasma CLA and pill counts will be measured as an indication of compliance. Several blood parameters will be monitored throughout the study, and five random 24-hour recall surveys will be used to monitor dietary intake of CLA-rich foods, energy, micronutrients and antioxidants.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 30 and 35 kg/m2

Exclusion Criteria:

* history of chronic disease
* food allergies or intolerances
* drug therapy for diagnosed disease or lipid-lowering
* use of weight-lowering medication or diet
* use of tobacco products
* current or planned pregnancy
* use of CLA supplement in previous 3 months
* current substance abuse
* abnormal clinical laboratory values
A Novel Unidirectional Face Mask During NPPV in COPD Patients

The purpose of this study is to determine the feasibility, safety and efficacy of a unidirectional breathing mask (breathe in through the nose and out through the mouth or breathe in through the mouth and out through the nose) in COPD patients with breathing difficulties requiring noninvasive positive pressure ventilation (NPPV).


Eligibility Criteria:
Inclusion Criteria:

1. Acute hypercapnic respiratory failure as a result of an acute exacerbation of COPD defined as PaCO2 \> 50 mmHg, with or without hypoxia, and a respiratory rate of greater than 25/min with the use of accessory muscles of respiration or abdominal paradox;
2. Requiring NPPV as assessed by the managing care team.

Exclusion Criteria:

1. Patients with facial deformity, heavy beard or moustache which prevents a good seal between the mask and the face;
2. Patients who have claustrophobia and cannot wear the mask;
3. Patients who are hemodynamically unstable;
4. Patients who are disoriented and unable to cooperate with the study procedure;
5. DNI or DNR status or patients in whom intubation is contraindicated;
6. Patients who are currently intubated;
7. Patients who recently (\< 6months) had an MI or stroke;
8. Pregnant woman; There will be no exclusion based on gender, race or ethnicity.
A Feasibility Study of the ReGenerCell™ Autologous Cell Harvesting Device for Diabetic Foot Ulcers

This prospective case series is to gain additional clinical experience in the treatment of diabetic foot ulcers, by documenting and relating patient history (including baseline wound characteristics) and clinical outcomes (incidence of healing, rate of healing, and patient and physician satisfaction) in a group of study participants for whom the ReGenerCell™ Autologous Cell Harvesting Device (ReGenerCell™) is used in combination with conventional therapy for the closure of diabetic foot ulcers (DFUs). Participants will receive ReGenerCell™ treatment in addition to standard care (debridement, cleansing, dressings, offloading).


Eligibility Criteria:
Inclusion Criteria:

* The patient has stable diabetes mellitus according to investigators clinical judgement
* Diabetic foot Ulcer

  * Groups 1 and 2: Ulcer surface area between 3 cm2 and 100 cm2 (inclusive)
  * Group 1: 12-24 weeks in duration, no directly visible tendon or bone (University of Texas Ulcer grade 1A)
  * Group 2: \>3 weeks in duration, University of Texas Ulcer grade 1B, 2A, 2B, 3A, 3B
* No superficial skin infection (of the ulcer area) requiring intervention
* Adequate offloading and compliance must be achievable
* The patient is 18 years of age or older
* The patient is willing to complete all follow-up evaluations required by the study protocol
* The patient is able to abstain from any other non-standard treatment of the ulcer for the duration of the study, unless medically necessary
* The patient agrees to abstain from enrolment in any other interventional clinical trial for the duration of the study
* The patient is able to read and understand instructions and give voluntary written informed consent
* The patient is able and willing to follow the protocol

Exclusion Criteria:

* Patients requiring intervention for Peripheral Arterial Disease (PAD) will be excluded from this study
* Severe Peripheral Arterial Disease that is not reconstructible
* Pregnant/lactating females (self-reported or tested, per institutional requirements
* Use of non-inert dressings (silver, honey etc.) during the past 10 days
* Subjects who have evidence of connective tissue disorders (e.g. vasculitis or rheumatoid arthritis) under active treatment
* The patient is known to have a pre-existing active condition that may interfere with wound healing, e.g. malignancy, autoimmune disease, immunocompromised blood borne diseases, the patient has AIDS, is HIV- or Hepatitis-C positive, or currently has a severe dermatological disorder (e.g. severe psoriasis, epidermolysis bullosa, pyoderma gangrenosum).
* The patient is taking, or has taken in the past 60 days, \>10mg of corticosteroids per day.
* The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives
* The patient has a known hypersensitivity to trypsin or Compound Sodium Lactate solution.
* The patient is a vulnerable or protected adult
* The patient is unable to follow the protocol
* The patient is unable to provide consent
Efficacy and Economic Evaluation of Nonbiological Artificial Liver Therapy in Acute-on-chronic Hepatitis B Liver Failure.

This was a non-blinded, prospective clinical study. From June 2020 to October 2021, 254 patients with HBV-ACLF were treated at the Department of Infectious Diseases, Xiangya Hospital, Central South University (Changsha, China). 186 patients who met the enrollment criteria were included in this study. Inclusion criteria were as follows: (1) aged 18-65 years old; (2) patients with ACLF caused by HBV infection; (3) meeting the diagnostic criteria for ACLF by the Asian Pacific Association for the Study of Liver (APASL).The exclusion criteria were as follows: (1) pregnancy or lactation; (2) previous liver transplantation; (3) hepatocellular carcinoma or other malignancy; (4) human immunodeficiency virus(HIV) infection or other immunocompromised states; (5) complicated with underlying diseases such as severe heart, respiratory, and blood system diseases. Based on the inclusion and exclusion criteria, the investigators randomly matched patients at a 1:1:1 ratio to three groups whose age, sex ratio, complication, and liver function were comparable: comprehensive medical treatment (Control group), PE group, and DPMAS plus half-dose sequential PE (DPMAS + PE group). As a result, 62 subjects per group were recruited into the study. This study was approved by the Clinical Research Ethics Committee of Xiangya Hospital, Central South University with informed content obtained from all participants (No. 202201022). The study protocol followed the principles of the Helsinki Declaration strictly.

All the 186 patients enrolled received comprehensive medical treatment after admission to the hospital, including anti-viral treatment, general supportive treatment, supplementation of blood products, such as albumin and plasma, and symptomatic treatment.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-65 years old
* patients with ACLF caused by HBV infection
* meeting the diagnostic criteria for ACLF by the Asian Pacific Association for the Study of Liver.

Exclusion Criteria:

* pregnancy or lactation
* previous liver transplantation
* hepatocellular carcinoma or other malignancy
* human immunodeficiency virus(HIV) infection or other immunocompromised state
* complicated with underlying diseases such as severe heart, respiratory, and blood system diseases
Effect of Postural Reeducation Versus Pelvic Floor Muscle Training on Stress Urinary Incontinence

The purpose of the study is to evaluate the effects of postural reeducation compared to pelvic floor muscle training on urinary incontinence (UI) symptoms, the impact of UI, and quality of life (QoL) in women experiencing stress urinary incontinence (SUI)

The study is designed as a randomized- controlled trial. It will be carried out on women suffering from stress urinary incontinence referred after urology consultations to the Physiotherapy Clinic in Soad Kafafy hospital.

UI, particularly SUI, affects up to 28% of the population and occurs during activities like coughing or sneezing due to inadequate urethral closure pressure. The pelvic floor muscles play a critical role in supporting pelvic organs and maintaining continence. Pelvic floor dysfunction is a significant contributor to SUI. Postural dysfunction can increase mechanical stress and lead to pelvic floor dysfunction. Postural re-education techniques aim to correct imbalances and improve pelvic floor muscle activity, potentially alleviating SUI symptoms by restoring muscle efficiency and enhancing continence.

Eligibility Criteria:
Inclusion Criteria:

* Fifty females with stress urinary incontinence.
* Age of 30-40 years.
* Body mass index (BMI) \> 30 kg/m2

Exclusion Criteria:

* Genital prolapse grade 3 or 4 based on Pelvic Organ Prolapse Quantification Classification (POP-Q).
* Overactive bladder (OAB)
* Functional impairment (Barthel scale \<85 points).
* Neurological or cognitive impairment (mini mental examination \<24 points).
* Any other type of urinary incontinence.
* Pregnancy.
* History of spinal, hip, knee or foot surgery, pelvic and abdominal surgery (including cesarean section)
* Smoking, chronic cough, history of respiratory diseases, osteoporosis (self-reported).
Docetaxel and Carboplatin Versus Docetaxel as Second Line Treatment in Patients With Non-Small-Cell Lung Carcinoma (NSCLC)

This trial will compare the effectiveness of Docetaxel with or without Carboplatin as second line chemotherapy in patients with Non-Small Cell Lung Cancer, who have not been treated previously with Docetaxel.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed NSCLC.
* ECOG Performance Status 0-2.
* No previous treatment with Docetaxel.
* Measurable Disease.
* Brain metastases that have been treated with radiotherapy should be stable and asymptomatic.
* Adequate liver kidney and bone marrow function.
* Patients must be able to understand the nature of this study and give written informed consent.

Exclusion Criteria:

* Active cardiac disease: unstable angina or onset of angina within last 3 months, myocardial infarction within 6 months, congestive heart failure \> class II, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
* Women who are pregnant or lactating.
* Unknown HIV, chronic hepatitis B or chronic hepatitis C infections.
* Serious neurologic or psychiatric disease.
* Second primary malignancy within the past 5 years, except nonmelanomas skin cancer or in situ carcinoma of the cervix.
* Active uncontrolled infection.
The Effect of Brimonidine

This study will evaluate whether pre-treating patients with Brimonidine 0.2% before and/or after dilating the pupils will help to control the changes in intraocular pressure often seen when using dilating drops. The study will also evaluate the effects of different sequences of administering dilating drops along with Brimonidine on pupil size and reactivity.

Intraocular pressure (IOP) can fluctuate due to various external factors such as exercise, medications, and eye movements. Although it is considered natural for IOP to fluctuate daily, prolonged increases in IOP can be harmful. Sustained elevated IOP has been linked to optic nerve damage and glaucoma. Mydriatic drops routinely given to dilate pupils in patients in need of an eye exam have been known to increase IOP. In practice, a combination of drugs are used to achieve pupil dilation needed for routine eye exams or in perioperative situations. The use of Tropicamide 1% and Phenylephrine 2.5% are known to be safe and effective options for dilating the pupils when used in conjunction with one another, but these drugs can increase IOP. Drugs such as Brimonidine, a selective alpha-2 agonist, are known to reduce IOP through several different methods. This study seeks to understand the effects of Brimonidine used along with Tropicamide and Phenylephrine to control IOP.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals
* Females of childbearing potential must agree to use a reliable method of birth control while participating in the study.

Exclusion Criteria:

* Diabetic
* Have a history of glaucoma
* Have a history of iris trauma
* Have a history of eye surgery except for LASIK or PRK
* Pregnant
* Anisocoria (unequal pupils)
Intravenous Lidocaine and Acute Rehabilitation

Background: Intravenous infusion of lidocaine may decrease postoperative pain and speed return of bowel function. The investigators therefore tested the hypothesis that including perioperative lidocaine infusion improves recovery from laparoscopic colectomy and shortens the duration of hospitalization.

Methods: Forty patients scheduled for laparoscopic colectomy were randomly allocated to receive intravenous lidocaine (bolus injection of 1.5 mg.kg-1 lidocaine at induction of anesthesia, then a continuous infusion of 2 mg.kg-1.h-1 intraoperatively and 1.33 mg.kg-1.h-1 for 24 h postoperatively) or an equal volume of saline. All patients received similar intensive postoperative rehabilitation. Postoperative pain scores, opioid consumption, and fatigue scores were measured. Times to first flatus, defecation, and hospital discharge were recorded. Postoperative endocrine (cortisol and catecholamines) and metabolic (leucocytes, C-reactive protein, and glucose) responses were measured for 48 h. Data (median \[25%-75% interquartile range\] Saline vs Lidocaine groups) were analyzed using Mann-Whitney tests. P\<0.05 was considered statistically significant.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* non-malignant disease

Exclusion Criteria:

* greater than 70 years
* history of gastro-duodenal peptic ulcer or renal failure (contraindications to the use of nonsteroidal anti-inflammatory drug)
* hepatic insufficiency
* psychiatric disorder
* steroid treatment
* chronic treatment with opioid