cyrilzakka/clinical-trials huggingface dataset:
Hypolipidemic and Antioxidant Capacity of Spirulina and Exercise

The purpose of this study is to demonstrate that Spirulina maxima intake and a dosed physical activity program will decrease, both independently and synergistically, cardiovascular risks (Dyslipidemias and oxidative stress) in overweight and obese subjects.

Cardiovascular diseases are the leading cause of death globally, being dyslipidemias, oxidative stress, sedentary lifestyle and obesity primary risk factors. As a way to reduce cardiovascular diseases risk factors, the intake of antioxidants that come from a fruit and vegetable-rich diet or nutritional supplements, have been proposed; in this sense, the cyanobacterium Spirulina maxima is an important source of antioxidants, which is currently associated with cardiovascular protection properties. Furthermore, physical exercise at moderated intensity has protective effect exerted against cardiovascular diseases risks, mainly due to physiological adaptations, including expression of antioxidant enzymes, which stop formation and propagation of radicals, improving redox status of the organism.

There is evidence that Spirulina maxima, in addition to exercise, decreases cardiovascular diseases risks, this was mainly observed in animal models. However, no studies in humans under Spirulina maxima and exercise experimental designs proving these benefits are reported. Therefore this study will analyze the independent and synergistic effect of the intake of Spirulina maxima with a program of physical exercise at moderated intensity on general fitness, plasma lipid profile and antioxidant capacity in overweight and obese subjects.

Methods/design: Through a randomized, double blind, placebo controlled, counterbalanced crossover study design, 80 healthy overweight and obese subjects will be assessed during a 12 week isoenergetic diet, accompanied by 4.5 g/day Spirulina maxima intake and/or a systematic physical exercise program at moderate intensity. Body composition, VO2 consumption, heart rate, blood lactate, plasma concentrations of triacylglycerols, total, low and high-density lipoprotein cholesterol, antioxidant status, lipid oxidation, protein carbonyls, superoxide dismutase, catalase, glutathione, glutathione peroxidase, glutathione reductase, and paraoxonase will be assessed.

Discussion: Spirulina maxima and exercise are good alternatives to improve general fitness, to prevent or lessen dyslipidemia and oxidative stress in subjects with risk factor of chronic or noncommunicable diseases. However the independent and synergistic effect of Spirulina maxima with exercise against dyslipidemias and stress in overweight and obesity is not yet known.

Eligibility Criteria:
Inclusion Criteria:

* Overweight (Body mass index (BMI): 25-29.9 kg/m2) and obese (BMI: \> 30 kg/m2) persons

Exclusion Criteria:

* Taking drugs and/or food or vitamin supplements
* diabetes
* have a physical or electrocardiographic injury that prevents them from engaging in regular physical exercise
From Uncomplicated Alcoholism to Korsakoff's Syndrome

This research project aims to identify factors that contribute to the heterogeneity observed in neuroradiological and neuropsychological signs of chronic alcoholism. The investigators overarching hypothesis is that the heterogeneity of alcoholic consequences on brain structure and metabolism, and cognition is mainly related to individual differences in pattern of alcohol use, gene pool, nutritional status and history of withdrawal symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Completed at least 8 years of education (primary school equivalent)
* Age-normal corrected hearing and visual acuity

Exclusion Criteria:

* documented loss of consciousness of over 30 minutes, documented compound skull fracture, or clear neurological sequelae of head trauma
* history of medical or neurological illness or trauma potentially affecting the CNS, e.g., stroke, multiple sclerosis, epilepsy, psychosurgery, insulin coma.
* active tuberculosis or history of or any malignancy requiring chemotherapy
* history of schizophrenia or bipolar disorder
* metal implantation (e.g., pacemakers) or other factors that preclude MRI scanning for subjects selected for the neuroimaging examination
* meet DSM-IV criteria for current (past 3 months) other Substance Abuse
* met DSM-IV criteria for other Substance Dependence
* Have used other substances more than 5 times in the past month
High-intensity Interval Training Versus Fatmax Training in Diabetic Type 2

The project investigates the effects of two exercise protocols at different intensities, high-intensity interval training and constant load at Fatmax, for 12 weeks in maximal fat oxidation, hormonal regulation of appetite, and insulin sensitivity in persons with obesity and type 2 diabetes mellitus. The participants will be of both sexes with ages between 40 and 55 years, belonging to the Province of Cádiz. Sixty volunteers will be randomly allocated into three groups: High-Intensity Interval TRaining (HIIT), Fatmax, and control groups. The assessments will be at the previous exercise intervention, posterior the exercise intervention, and 12 weeks after the last intervention. The outcome variables will include body composition, oral glucose tolerance test, appetite, plasma glucose, lipids in plasma, hormones, and adipokines.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking
* Non-alcoholic (\<3 standard drinks per day)•Body mass index \>25 kg/m maintaining the habitual dietary patterns without a body mass reduction higher than 2% during the last 6 months
* Not being insulin dependent
* Absence of injury, disease or disability or other known medical condition which could affect the ability to successfully participate in physical exercise tests
* Absence of cardiovascular disease (angina, peripheral or cerebro-vascular disease, etc.).
* Absence of neurologic and psychiatric diseases.
* Absence of respiratory diseases (pulmonary hypertension, chronic obstructive pulmonary disease, etc.).
* Absence of other metabolic diseases (hyper/hypoparathyroidism, hyper/hypothyroidism, Cushing's disease, Type 1 diabetes, etc.)
* Absence of active inflammatory bowel disease
* Absence of kidney disease
* Absence of tumors
* Absence of coagulation dysfunction
* Not under treatment with medications k known to affect glucose metabolism, recent steroid treatment (within 6 months), or hormone replacement therapy
* Be able to understand communication in Spanish or English.

Exclusion Criteria:

* They do not attend more than 2 or 4 consecutive sessions of nutritional counseling or physical training respectively.
* Missing more than 4 or 6 sessions in total of nutritional counseling or physical training respectively.
Study to Evaluate the Efficacy, Safety and Tolerability of N1539

To determine the analgesic efficacy, duration of effect, and safety of single doses of N1539 in subjects undergoing open abdominal hysterectomy


Eligibility Criteria:
Inclusion Criteria:

* moderate to severe pain with VAS of \>/= 45 mm
* undergo open abdominal hysterectomy
* ASA I or II
* signed ICF
* BMI \>18.5 and \< 31.5 kg/m\^2

Exclusion Criteria:

* suspected metastatic cervical or endometrial cancer
* prior abdominal surgery with postoperative complications
* active pancreatitis, obstruction of biliary tree or total bilirubin\> 2.5 mg/dL
* active GI bleeding, or peptic ulcer disease
* unstable medical condition
* HbA1c \>9.5 or uncontrolled diabetes
* SBP \>150 mmHg or DBP \> 95 mmHg
* personal or familial contraindication to undergoing general anesthesia
* Antihypertensive agents or diabetic regimen that is not stable (4 weeks prior to surgery)
* taking CNS agents for pain
* acetaminophen or NSAIDs not discontinued for at least 5 half-lives prior to planned surgery
* currently taking an opioid or has taken an opioid chronically for pain in past 2 years
* corticosteroid or systemic corticosteroids within 6 weeks of planned surgery
* has a known bleeding disorder or taking agents affecting coagulation
* history of intolerance or allergic reactions to NSAIDs, COX-2 inhibitors, aspirin and other salicylates
* receiving lithium or a combination of furosemide with an ACE inhibitor or angiotensin receptor blocker
* Known to have sleep apnea
* History of hepatitis B or C
* AST or ALT \> 2 times the upper limit of normal
* Known or suspected COPD with retention of carbon dioxide
* psychiatric condition that impairs the capability of the subject to report pain
A Multicountry, Multicentre, Non-interventional, Retrospective Study to Determine Real-world Treatment Patterns and Associated Outcomes After First Line Osimertinib in Patients With Advanced and Metastatic NSCLC EGFRm in the GCC Region

A Multicountry, Multicenter, Non-interventional, Retrospective Study to determine Real-world treatment patterns and associated outcomes after FIRST LINE Osimertinib in patients with advanced and Metastatic NSCLC harboring EGFR-activating mutations in the GCC Region

Osimertinib has demonstrated superior PFS compared to firstgeneration EGFR-TKIs (erlotinib and gefitinib) in the first line setting in clinical trials. There remains a need to consider clinical outcomes in the real-world setting and determine the characteristics of long-term survivors in the real world. It will also be important to determine the subsequent treatment pathways of patients who progress on treatment with Osimertinib

Eligibility Criteria:
Inclusion Criteria:

For inclusion in the study, all the following inclusion criteria must be fulfilled:

1. Patients with Stage IIIB-IV NSCLC using either AJCC 7th or 8th edition with EGFR mutation.
2. Age 18 or older at index date (specific age may vary according to country-specific guidelines)
3. Treated in the first line with Osimertinib from (April 1st, 2018, until December 31st, 2021).
4. Medical records available at the participating site reflect at least 9 months of follow-up from the index date (unless the patient died within the first 9 months of diagnosis).

Note: specific databases may have additional inclusion criteria which will be detailed in country-specific protocol adaptations and statistical analysis plans (SAPs).

Exclusion Criteria:

Subjects are not eligible for this study if they fulfil any of the following exclusion criteria:

1. Failure to meet one or more of the inclusion criteria.
2. Patients who received curative CRT within 3 months and/or any first-line systemic anti-cancer therapies (SACT) for advanced/metastatic NSCLC for \>28 days prior to Osimertinib start.
3. Patients who have prior exposure of I/O therapy.
UGYTEX® Mesh Versus Subvesical Plication in the Surgical Treatment of Bladder Prolapse

The main purpose of this study is to evaluate the long-term (5-8 years) functional prolapse recurrence rate of the 147 patients enrolled, randomized and analyzed in the study PRO-CURE I.

Secondary objectives include comparing the following elements between the two randomized groups at a long-term time point (5-8 years):

A. The anatomic failure rate of cystocele (POP-Q stage \> or = 2) B. Late postoperative morbidity C. Residual post-operative pain (visual analog scale (VAS)) D. Patient satisfaction via the PGI-I questionnaire E. Quality of life via the PFDI and PFIQ questionnaires F. Sexual activity via the PISQ-12 questionnaire G. The rate of vaginal erosion H. Displacement and secondary shrinkage of meshs

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* Patient included in, randomized and analysed in the PROCURE study (NCT00153257)

Exclusion Criteria:

* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* Patient not included in the PROCURE study
Influence of Mask on Functional Capacity and Quality of Life During Controlled Endurance Exercise in Sedentary Adults

Subjects had randomly divided into two groups. All will do aerobic exercise in form of treadmill but Group (A) will do while wearing surgical mask and Group (B) without surgical mask. To detect the Influence of surgical mask on functional capacity and quality of life during controlled endurance exercise in sedentary adults

Group (A):

1. Each subject will sign a consent form after receiving a detailed explanation about the procedure.
2. Functional capacity and Quality of life will be evaluated before the start of the training.
3. Subjects in group A will wear surgical mask before starting of the session. 4.3 sessions will be done every week for 3 months.

5.The session will start with warming up for 5 minutes then 25 minutes of aerobic exercise on the treadmill with moderate intensity followed by cooling down for 5 minutes.

6.After finishing the program, the participant will be evaluated to detect the effect of the exercise.

Group (B):

1. Each subject will sign a consent form after receiving a detailed explanation about the procedure.
2. Functional capacity and Quality of life will be evaluated before the start of the training.
3. Subjects in group A will not wear any mask during the session. 4.3 sessions will be done every week for 3 months.

5.The session will start with warming up for 5 minutes then 25 minutes of aerobic exercise on the treadmill with moderate intensity followed by cooling down for 5 minutes.

6.After finishing the program, the participant will be evaluated to detect the effect of the exercise.

Eligibility Criteria:
Inclusion Criteria:

* 100 participants
* 30 to 40 years of age
* both sex

Exclusion Criteria:

* uncontrolled cardiopulmonary conditions,
* sever un treated orthopedic condition
* uncontrolled neurological conditions,)
* uncontrolled diabetes,
* claustrophobia,
* pregnancy
* Recent COVID-19 infection,)
Clinical and Radiographic Evaluation of Advanced Platelet Rich Fibrin in the Preservation of Alveolar Ridge Following Atraumatic Tooth Extraction

compare the effect of application of A-PRF in socket preservation after atraumatic tooth extraction and natural healing regarding to bone remodeling . Null hypotheis, after atraumatic extraction, socket with advanced PRF has no difference with socket with blood clot in primary outcome


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria are as follow :

  * patients with an unremarkable medical history
  * subjects with at least one site bordered by minimum of one tooth.
  * Nonsmoker
  * Teeth with root fracture, teeth with failed endodontic therapy or advanced caries
  * Intact extraction socket with no dehiscence or fenestration.
  * The buccolingual thickness of the buccal plate of bone in surgical area is 1 mm or more

Exclusion Criteria:

* Patients with systemic diseases.
* Patients with presence or history of osteonecrosis of the jaws, with use of bisphosphonates, exposure to head and neck radiation, chemotherapy.
* patients with large distinct pre-apical pathology
Next Generation ORS: Controlled Trial Comparing ORS With Calcium vs Standard ORS in Reducing Severity of Acute Watery Diarrhea

Diarrhea remains a leading killer of children in need of better treatments.

Diarrhea remains a leading killer of children in need of better treatments. Oral Rehydration Solution (ORS) is currently the only oral therapy that is recommended for children with acute diarrhea. Although it is valuable for correcting dehydration and is considered the primary reason for the substantial reduction in mortality from diarrhea in children, ORS does not have the capacity to "halt" intestinal fluid loss and thus, does not offer a rapid relief of a child's diarrhea symptom, and its use by caregivers and medical practitioners has markedly dropped (estimate use in 1/3 of cases who need it). In recognition of its limitations, continuous efforts have been made to modify the composition of ORS. However, none has targeted the central diarrhea-causing pathways and produced a satisfactory outcome in children. New therapeutic approaches and methods are needed. The proposed new ORS is based on recent discovery of the first inclusive antidiarrheal mechanism in the intestine, CaSR (calcium-sensing receptor) that targets all known diarrhea causing pathways. It works in animals. This R21 is the 1st proof-of-concept clinical study in humans and is intended to investigate its safety and efficacy. Two Specific Aims are proposed to determine new ORS safety and efficacy in patients with diarrhea. In the safety study, the investigators propose to enroll 396 diarrheal adults (198 in Intervention New ORS group and 198 in standard WHO ORS). In the efficacy study, the investigators plan to enroll 396 diarrheal adults (198 in Intervention New ORS group and 198 in standard WHO ORS, these will be same patients employed for the safety study). These diarrheal patients will be recruited from the Dhaka area in Bangladesh. At the conclusion of the study, we expect to develop a novel oral rehydrating solution that is inexpensive and practical to use in all the countries. Hypothesis: the volume output Intervention should reduce stool weight/output of diarrhea by 30%.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female patients, age between 18 and 60 years, history of acute watery diarrhea (defined as the passage of ≥3 loose or watery stools in the past 24 hours) for less than 24 h before admission, either signs of severe dehydration and stool positive for Vibrio cholerae, and successful rehydration with intravenous fluids within the first 6 h after admission (cholera group), or signs of some dehydration and stool negative for V. cholera (non-cholera group) , and successful rehydration with intravenous or oral fluids within the first 6 h

Exclusion Criteria:

* Pregnancy as determined by history of last menstrual period, bloody diarrhea, signs of systemic infection that needed intravenous antibiotics, or inability to rehydrate with intravenous fluid therapy in the first 6 h after admission.
Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients

Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients : Clinical Trial, Cross-over Design, Double-blind, Placebo-control, Randomized, Single-center Study

Not provided

Eligibility Criteria:
Inclusion Criteria:

1. Adult(Male or Female) over 19 years who were diagnosed with glaucoma.
2. In the case of participants receiving glaucoma treatment drugs, the investigator judges that the intraocular pressure remains constant for at least 1 year.
3. Intraocular pressure (IOP) \>/= 8mmHg and \< 18mmHg in each eye using Goldmann applanation tonometry prior to the screening visit
4. Adult participants diagnosed and treated for early-moderate glaucoma (VF mean deviation(MD) ≥-12 dB)
5. Have performed a reliable visual field in the last year, with \<33% fixation losses, false positives and false negatives.
6. Written consent voluntarily to participate in this clinical trial.

Exclusion Criteria:

1. Patients with congenital glaucoma and secondary glaucoma caused by steroid drugs, etc.
2. BCVA (best-corrected visual acuity) Snellen equivalent of Snellen 20/80(logMar 0.25) or less.
3. Patients who have medical history of ocular inflammation
4. Patients with any ocular/systemic conditions that may affect electroretinogram parameter, or with visual field defects(Ischemic optic neuropathy, Proliferative diabetic retinopathy, Macular degeneration etc.)
5. Patients who have plans to intraocular surgery within the clinical trial period.
6. Patients with a history of significant ocular trauma within 6 months prior to the screening visit
7. Pregnant or lactating women.
8. A person who disagrees to contraception during a clinical trial period.
9. Patients with a history of malignancy within 5 years prior to the screening visit.
10. Patients that other researchers are determined inadequately.
Do Lower Spine Injections Improve Outcomes for Lower Back Pain Patients

The purpose of this project is to determine the effect of lower back injections on select biomechanical outcomes, walking patterns, lower back flexibility and balance.

The purpose of this project is to determine the effect of lumbar injections on select biomechanics parameters; walking pattern, lumbar flexibility and balance. The surveys will help assess the patient's sense of functional ability and feeling of wellness compared with low back pain scores. The long terms goals of this project will be to elucidate the mechanism of action of injections and to improve identification of patients that are likely to benefit from injection therapy

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of lumbar spine stenosis
* receiving lumbar epidural injection
* age 18-90 years
* BMI \<35kg/m2
* walking unaided

Exclusion Criteria:

* age \<18 or \>90 years
* BMI \>35 kg/m2
* severely impaired intellectual capacity
* medications that could impact balance
* dementia, or other neurodegenerative diseases that would preclude appropriate cognitive or physical ability to perform study protocol
Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery

Adjunct therapy for increasing posterolateral fusion success following single level posterior instrumented lumbar surgery.

The purpose of this study is to determine whether using active low intensity pulsed ultrasound as adjunct therapy following single level posterior instrumented lumbar surgery increases the posterolateral success rate when compared to inactive (placebo) therapy.

Eligibility Criteria:
Inclusion Criteria:

* The subject has a documented diagnosis of degenerative disc disease with up to Grade I spondylolisthesis at the target level
* Requires spinal fusion of a single level disc space (L2 to S1) with the use of local bone graft.
* Requires a posterolateral fusion procedure with or without an interbody fusion procedure using a posterior approach
* The subject has failed non-operative treatment lasting at least 6 months.

Exclusion Criteria:

* Requires spinal fusion at more than one lumbar level.
* Is pregnant, is lactating or plans to become pregnant before discontinuation of study treatment
Evaluate the PK of Multiple Oral Doses of Tegoprazan, Metronidazole, Tetracycline and Bismuth in Healthy Volunteers

This study aims to evaluate the pharmacokinetic interaction between tegoprazan and combination of metronidazole, tetracycline and bismuth in healthy adult volunteers.

A open-label, randomized, multiple dose, two arm, two period, crossover study

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult aged ≥ 19 and \< 55 year-old on the day of obtaining the informed consent.
* Body mass index (BMI) ≥ 17.5 kg/m2 and \< 28.0 kg/m2 with a body weight ≥ 55 kg at screening.
* H. pylori negative.

Exclusion Criteria:

* Medical History

  1. History or evidence of clinically significant disease
  2. History of gastrointestinal disease (e.g., esophageal disease such as esophageal achalasia or stenosis, and Crohn's disease) or surgery that may affect the absorption of a drug.
  3. History or presence of hypersensitivity to IMPs, components of IMPs, benzimidazoles, imidazole derivatives or tetracycline antibiotics
* Laboratory tests(in blood)

  1) Total bilirubin, AST (GOT), ALT (GPT) \> 1.5 X upper limit of normal (ULN) at screening
* History of drug/alcohol abuse
* Participated in other study and received investigational product within 3 months prior to the first study dose.
* taken a medication known to substantially induce or inhibit a drug metabolizing enzyme
* Not able to use a medically acceptable contraceptive method throughout the study.