cyrilzakka/clinical-trials huggingface dataset:
Resistance Training in Patients With Morbid Obesity

The researchers will conduct a study for avoiding the metabolic syndrome in morbid obese patients. Thus, the aim of the present will be determine the effects of a resistance training programme (RT) in preventing or attenuating metabolic syndrome (MetS) in patients with morbid obesity. A second aim will be report the prevalence of non-responders in terms of improvements in MetS markers and other co-variables considered.

The prevalence of metabolic syndrome (MetS) and cardiovascular disease is expected to rise along with the global obesity epidemic. MetS is a cluster of clinical risk factors, including abdominal (visceral) obesity, hypertension, elevated serum triglycerides, low serum high-density lipoprotein (HDL) and hyperglycaemia.The MetS for example, significantly decreases the life expectancy of individuals with morbid obesity and increases the disease burden and economic costs associated with healthcare. In this sense, more recently, there was reported that body mass index (BMI) and fat distribution showed higher associations with inflammation, fat indices, and more prevalence of MetS in morbidly obese subjects, claiming for an early prevention of the MetS in the morbid obese state.

Exercise training has proven to be effective in inducing a clinically significant weight loss and reducing cardiovascular risk. Exercise have reported to be associated with increased muscle mass, decreased body fat, and improved metabolic profile (i.e., improved glucose control and lipid levels). In addition, supervised RT improved muscle strength and functional capacity in patients with obesity undergoing bariatric surgery. However, although RT has been widely studied in obesity, there is little information in the morbid obesity. On the other hand, there is poor knowledge similarly, about the interindividual variability to exercise training in terms of responders and non-responders (NR). Thus, considering the poor knowledge about the MetS prevention in morbid obese patients, as well as the little information about Responders and Non-Responders for improving MetS outcomes, the aim of this study will be determine the effects of a RT program on cardio-metabolic outcomes of MetS in patients with morbid obesity. A second aim will be report the prevalence of non-responders in terms of the effects of resistance training on MetS markers and other health-related variables.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

* Older than 18 and younger and ≤65 years of age.
* With risk factors to Metabolic syndrome
* With obesity and morbid obesity condition
* Medical authorization by a physician.

Exclusion Criteria:

* Physical limitations (e.g., restricting injuries of the musculoskeletal system, or dependent of a third person).
* Exercise-related dyspnoea or respiratory alterations.
* Chronic heart disease with any worsening in the last month.
* Adherence rate of less than 80% of the total interventions.
Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics

The purpose of the study is to evaluate effect of benralizumab on structural and lung function changes in severe eosinophilic asthmatics.

Changes will be assessed over 48 week treatment period in patients with persistent symptoms despite standard therapy of inhaled corticosteroids (ICS) plus long acting B2-agonist (LABA) with or without additional controller medication.

Patients who complete treatment will enter 4 weeks follow-up period.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18 through 70 years.
2. Physician-diagnosed asthma requiring continuous treatment with medium- or high-dose ICS plus LABA with or without additional controller medication for at least 12 months prior to Visit 1, and current treatment with high-dose ICS plus LABA for at least 3 months prior to Visit 1 with or without additional asthma maintenance medication.
3. Morning pre-BD FEV1 ≥50 to \<80% of predicted normal value (PNV) and ≥1 liter (L) or morning pre-BD FEV1 ≥ 50 to \< 90% of PNV, if historical pre-BD FEV1 value (within 12 months prior to screening visit) was \< 80% of PNV.
4. A blood eosinophil count meeting any of 3 criteria: ≥300 cells/µL during screening or ≥ 220 to \< 300 cells/μL during screening and documented eosinophil count of ≥ 300 cells/μL in the past 12 months, or ≥150 to \<300 cells/µL during screening plus one of the following: presence of nasal polyps or pre-BD FVC \<65% predicted at Visit 2
5. Negative pregnancy test.
6. Asthma control questionnaire (ACQ-6) \>1.5.
7. Fewer than 12 exacerbations within the 6 months prior to Visit 3.

Exclusion Criteria:

1. Any disease or concomitant medication which could affect study results or safety of study participants, including:

   * current smokers
   * history of cancer
   * life-threatening asthma
   * clinically important pulmonary disease other than asthma
2. Use of chronic immunosuppressive medication or receipt of immunoglobulin (or blood products) within 30 days prior to the date informed consent is obtained.
3. Previously received:

   * benralizumab
   * live attenuated vaccines 30 days prior to the date of randomization.
   * bronchial thermoplasty in the last 24 months prior to Visit 1
   * any investigational non-biologic within 30 days (or 5 half-lives) prior to the date informed consent is obtained, whichever is longer.
   * any marketed or investigational biologic for the treatment of asthma within 4 months (or 5 half-lives) prior to the date informed consent is obtained, whichever is longer.
4. Currently pregnant, breastfeeding or lactating women.
Long-term Follow-up of Patients With Alcoholic Liver Cirrhosis Who Had Administered Cellgram-LC in PMC-P-07 Study

This Long-term follow-up is designed to evaluate the safety of patient with Alcoholic Liver Cirrhosis who had administered Cellgram-LC in PMC-P-07 study.

To evaluate the safety for 60 months after a single dose of Cellgram-LC in patients with alcoholic liver cirrhosis.

Eligibility Criteria:
Inclusion Criteria:

1. Those who participated in PMC-P-07 clinical trials and received Cellgram-LC
2. Those who voluntarily agreed in writing to participate in this investigation

Exclusion Criteria:

-
Dexmedetomidine Versus Fentanyl Plus Bupivacaine for Epidural Analgesia With General Anesthesia for Lumbar Disc Operations

The purpose of this study is to compare addition of dexmedetomidine or fentanyl to bupivacaine for epidural analgesia in combination with general anesthesia in elective lumbar spine operations as regard hemodynamic stability, postoperative pain control and adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* Physical status American Society of Anesthesiologist (ASA) I or II.
* First time elective lumbar dicsectomy or laminectomy

Exclusion Criteria:

* Patients who refuse to participate
* Body mass index (BMI) \> 30
* Need an emergency lumbar disc operation
* ASA physical status \> II
* Major illnesses (e.g. cardiac, respiratory, renal, liver)
* Coagulation abnormalities
* Hypovolemia
* History of increased intracranial pressure
* Convulsions
* Spinal stenosis
* Infection at needle insertion site
* Other contraindications to epidural procedure
* Allergy or contraindications to the drugs used in the study
* History of addiction or alcohol abuse
* Psychiatric illness or mental retardation
Gefitinib 500mg Versus 250mg in Patients With NSCLC With Stable Disease After a Month Treatment of Gefitinib 250mg

This is a multi-center phase II randomized controlled study to assess the efficacy of Gefitinib 500mg in patients with IIIB/IV staged non-small cell lung cancer(NSCLC) with stable disease after a month treatment of 250mg Gefitinib by DCR,also PFS and OS.The side effect is evaluated as well.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)
2. received at least one chemotherapy regimen
3. with stable disease after a month treatment of gefitinib(CT scan)
4. the radiotherapy focus is not the measurable disease within 4 weeks.the patients received palliative therapy can be included.
5. Age \>18 years, either sex
6. with a measurable disease(longest diameters \>=10mm with Spiral computed tomography (CT)and \>=20mm with conventional CT) at least according to RECIST Criteria
7. WHO performance status(PS)\<= 2 ( Patients Whit PS=2 Should not get worsen within 2 weeks Before Included)
8. N\>=1.5×109/L, Plt\>=1.5×109/L,Hb\>=10g/dL
9. ALP\<2.5×ULN.If ALP\>=2.5ULN, AST\&ALT should \<1.5ULN(without liver metastasis) or \<5ULN(with liver metastasis).TBIL\<=1.5ULN，AST\&ALT\<2.5ULN(without liver metastasis) or \<5ULN (with liver metastasis).
10. Signed and dated informed consent before the start of specific protocol procedures.
11. recruiting and receiving treatment in 5 days after last CT scan
12. Patients able to taken oral drug

Exclusion Criteria:

1. Life expectancy \<= 12 weeks.Patients with metastatic brain tumors without symptoms or had been treated can be included.
2. experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as erlotinib or Cetuximab.
3. can not take drug orally, have active peptic ulcer,half upper gastrointestinal or have dyspepsia.
4. allergic to gefitinib
5. Prior exposure to drugs without approval from this research or other study drugs within 21days before the 1st day taken Gefitinib 500mg or 250mg.
6. Pregnant or breast-feeding women
7. Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
8. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except of cervical carcinoma in situ,basal cell carcinoma within 5 years prior to study entry.
Neural Compensation, Visual Function and Visual Quality After Monofocal or Multifocal Intraocular Lens Implantation

Multifocal intraocular lenses (MIOLs) provide enhanced far and near visual acuity, but they can bring about halos and glare, which are caused by design deficiencies of the IOLs. Compared to monofocal intraocular lens, pseudo accommodation in nonphysiological state may increase the difficulty of neural compensation reconstruction in patients with multifocal intraocular lens implantation. Patients enrolled into the study will be followed for 1 year and will have study visits preoperatively, at 1 week, 3 months, 6 months, 12 months postoperatively.In this trial, we aimed to specify the time of neural compensation reconstruction in patients and to explore the changes of visual function in senile patients with monofocal or multifocal intraocular lens implantation.

Cataract extraction and intraocular lens (IOL) implantation are the current standard treatments for age-related cataract (ARC). Cataract surgery increases visual acuity but may lead to complaints after surgery. Multifocal intraocular lenses (MIOLs) provide enhanced far and near visual acuity, but they can bring about halos and glare, which are caused by design deficiencies of the IOLs. Fortunately, most of the halos and glare diminish with time. Niels et al noted that neural adaptation (NA) may explain the lower incidence of glare and halos in their study. Compared to monofocal intraocular lens, pseudo accommodation in nonphysiological state may increase the difficulty of neural compensation reconstruction in patients with multifocal intraocular lens implantation.

In the present study, the investigators evaluated the activity of neurons in the visual cortex using fMRI both preoperatively and postoperatively. In addition, the investigators evaluated postoperative changes in VF, including visual acuity (VA), contrast sensitivity (CS), straylight values (SVs), and pattern visual evoked potential (PVEP), stereoscopic vision, wavefront aberrations at 1 week, 3 months, 6 months, 12 months postoperatively.In this trial, the investigators aimed to specify the time of neural compensation reconstruction in patients and to explore the changes of visual function in senile patients with monofocal or multifocal intraocular lens implantation.

Eligibility Criteria:
Inclusion Criteria:

* visual acuity less than 0.3
* Cataracts in both eyes classified by the Lens Opacity Classification System III
* Corneal astigmatism less than 1.5 diopters (D)
* Capability of understanding and signing the informed consent

Exclusion Criteria:

* Corneal astigmatism ≥ 1.5D.
* History of neurological or psychiatric disorders; systemic disease such as severe hypertension or diabetes mellitus that might interfere with the visual outcomes.
* Associated ocular disease that could interfere with final results
* Previous anterior and posterior segment surgery and intraoperative or postoperative complications
* Driving at night frequently; excessive expectations for visual outcomes
Fractional Micro-Needle Radiofrequency and I Botulinum Toxin A for Primary Axillary Hyperhidrosis

Because of the limiting data about an efficacy and safety of fractional radiofrequency for the treatment of hyperhidrosis, this study aim to compare clinical efficacy by Hyperhidrosis Disease Severity Score (HDSS) between Fractional Microneedle Radiofrequency device and intradermal Botulinum toxin type A injection for the treatment of primary axillary hyperhidrosis. The secondary objectives to determine the improvement change of iodine starch test, total amount of sweat production by trans-epidermal water loss (TEWL), patient's satisfaction and their quality of life by Dermatology Life Quality Index and side effect between the groups.


Eligibility Criteria:
Inclusion Criteria:

Male or female subjects, age between 18-60 years

* Healthy volunteers
* Subjects who have experienced with excessive sweating on both sides of axillary areas and have a positive result for iodine starch test on the screening day
* Willing to participant into the study and voluntary to sign in the informed consent form

Exclusion Criteria:

Active bacterial or fungal infection over tested area / axillae

* Pregnancy and breast feeding
* Previously underwent the surgical treatment such as radical resection of sweat glands for primary axillary hyperhidrosis
* Currently being treated with intradermal botulinum toxin type A injection at axillary area for less than 12 months
* Currently being inserted the cardiac pace maker or any other internal electronic devices
* Secondary hyperhidrosis caused by hyperthyroidism, drug induced, abnormal autonomic or neurological disorder that affect sweat gland
* Allergy to botulinum toxin type A
* Known contact allergy to iodine
* Unable to follow and comply to the study protocol
Colon Capsule Versus Virtual Colonoscopy for Colorectal Cancer Screening

France is among the countries with a high incidence of colorectal cancer. The prognosis associated with colorectal cancer is related to the development stage of the disease at diagnosis. Thus, when the cancer is detected and treated at an early stage, the survival rate at 5 years was 90%. It is therefore a major issue of screening is widespread in France since the end of 2008.

This screening is based on a two step strategy: 1) the occult blood in the stool (FOBT) and if positive 2) the realization of an optical colonoscopy examination currently regarded as the evaluation procedure colon reference. But as part of this organized screening, 13% of those with a positive FOBT ultimately refuse to have an optical colonoscopy. Under the refusal, virtual colonoscopy may be proposed as an alternative according to the recommendations of the National Health Authority in 2010. But it has never been assessed as part of organized screening. Similarly another alternative is recently developed colic capsule that benefits of development in recent years of the capsule for the small intestine which has become the gold standard for diagnosis of most diseases of the small intestine (bleeding occult, diagnosis of unknown colitis...).

Therefore the study proposes virtual colonoscopy or colon capsule for people with a positive FOBT as part of organized screening and did not realize optical colonoscopy after the usual procedure and complete recovery. This study aims to answer the question of the place of colic capsule as part of organized screening. An economic component is integrated to assess, in terms of health insurance, the cost associated with these two exams, and compare them to the cost of optical colonoscopy.

The proposed study is an observational study of impact of an alternative screening strategy for colorectal cancer whose primary objective is to compare the rate of acceptance of virtual colonoscopy and colon capsule in patients refusing optical colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a positive FOBT at screening organized colorectal cancer, patients who have not achieved optical colonoscopy and who received the usual procedure and complete recovery

Exclusion Criteria:

* None
Effectiveness of Focused Tele-education in Reducing Diabetes Complications During Ramadan

Introduction Diabetes is a global emergency with detrimental clinical and financial consequences. Poorly managed diabetes leads to a myriad of serious complications, especially cardiovascular and infectious complications, with consequent increased cost and mortality rate. For Muslims in particular, the annual fasting month of Ramadan is one such period when diabetes control is essential. Adequate adjustments in diabetes management need to be made in line with the allowed mealtimes to avoid the risk of diabetes complications during Ramadan.

Objective Investigators aim to investigate the effectiveness of Ramadan-focused structured diabetes tele-education to reduce diabetes complications during Ramadan fasting for Muslims with diabetes in South East Asia.

Methodology In a parallel group randomized controlled trial, investigators aim to recruit 300 adults with diabetes who are able to fast at least 15 days in Ramadan. You will be randomized to the intervention group comprising of a Ramadan-focused structured diabetes tele-education and control group receiving standard care. You will be reviewed again after Ramadan. The primary outcome is the incidence of hypoglycemia in Ramadan. The secondary outcomes are incidence of other diabetes complications in Ramadan episodes including hyperglycemia, episodes of acute infections, attendances in clinic and emergency department, hospital admissions, and compliance to recommendations for diabetes management during Ramadan.

Clinical Significance The study enables investigators to evaluate Ramadan-focused structured diabetes tele-education to reduce the risk of diabetes complications for a large population during the fasting month.


Eligibility Criteria:
Inclusion Criteria:

* Adults with diabetes planning to fast in Ramadan,

  1. Adults with type 2 diabetes aged at least 21 years old,
  2. Able to fast at least 15 days in Ramadan based on experience of fasting in previous year's Ramadan,
  3. Underlying type 2 diabetes treated with basal insulin and one or more doses of prandial insulin, or at least twice-daily premixed insulin
  4. Performed laboratory tests as per standard care - glycated haemoglobin (HbA1c), serum Low Density Lipoprotein- cholesterol, serum triglycerides, serum High Density Lipoprotein- cholesterol, serum Total cholesterol and serum creatinine
  5. Ability to give informed consent,
  6. Ability to perform self-monitoring blood glucose
  7. Have had diabetes-related clinic visits or hospitalization in the past 10 months.
  8. Have the capacity for video conferencing (internet connection with mobile phone or computer)

Exclusion Criteria:

1. Severe diabetes complications including end-stage renal failure
2. Severe hypoglycemia and hyperglycemic crises within the last 3 months
3. Advanced comorbidities negating the ability to fast
4. Pregnancy
5. Patients on oral medications alone or oral medications plus basal insulin alone
6. Patients on sulfonylureas
Study to Investigate Effect of a New Drug (PF-00446687) in Males Suffering From Erectile Dysfunction

The purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on erectile activity in males suffering from erectile dysfunction as well as examining the safety and toleration of the drug.


Eligibility Criteria:
Inclusion Criteria:

* Males aged 18-65 years who has given written informed consent to participate in the study and who suffers moderate to severe erectile dysfunction who has a current or recent successful response to treatment with phosphodiesterase type 5 inhibitors

Exclusion Criteria:

* Males with a history of significant cardiac disease; unstable angina or recent myocardial infarction.
* Males suffering from treated or untreated hypo- or hypertension
* Males currently receiving vasoactive medication
* Males taking medications contraindicated, or cautioned with sildenafil or MC4 agonists
Comparison of 2 Extracts of Saw Palmetto Versus Placebo on Lower Urinary Tract Symptoms (LUTS) and Urinary Frequency

A randomized, double-blind, placebo-controlled, parallel group study to compare 2 extracts of saw palmetto versus placebo on lower urinary tract symptoms and urinary frequency in 120 generally healthy participants, 45 - 80 years.


Eligibility Criteria:
Inclusion Criteria:

* Male aged between 45-80
* Mild to moderate in the IPSS
* Generally healthy
* Able to provide informed consent
* Agree not to participate in another clinical trial while enrolled in this trial
* Agree not the change their diet or exercise while enrolled in this trial

Exclusion Criteria:

* Serious illness e.g., mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions (A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments)
* Unstable illness e.g., diabetes and thyroid gland dysfunction (An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity)
* Have used a drug/natural therapy for LUTS or other urological symptoms within the last 30 days?
* Have had a urinary infection in the last 30 days or have, chronic urinary tract infections, or diagnosed chronic prostatitis
* Have had urogenital surgery within the last 6 months.
* Have had a bladder biopsy and/or cystoscopy and biopsy within the past 30 days.
* Have been diagnosed with chronic persistent local pathology (e.g. interstitial cystitis, bladder stones)
* Receiving/ prescribed Coumadin (Warfarin) or other anticoagulation therapy
* Diagnosed genital anatomical deformities, uncontrolled diabetes mellitus, and history of spinal cord injury, uncontrolled psychiatric disorder, and/or abnormal secondary sexual characteristics.
* Diagnosed cancer including prostatic cancer; if suspected by the investigator, refer for medical assessment
* Active smokers and/or nicotine or drug abuse
* Chronic alcohol use (\>14 alcoholic drinks week)
* Allergic to any of the ingredients in investigational, comparator or placebo formula
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
* Participated in any other clinical trial during the past 1 month