cyrilzakka/clinical-trials huggingface dataset:
Caffeine Supplementation, Resistance Training and Blood Antioxidant Status

The purpose of this study is to verify the effect of acute caffeine intake on resistance training volume and blood antioxidant status, in a randomised, double-blind, placebo-controlled crossover trial.

Caffeine is one of the most commonly consumed psychoactive substances in the world. Several previous studies confirmed that caffeine improves several aspects of exercise performance, including resistance training outcomes. Interestingly, caffeine and its catabolic products, theobromine and xanthine, exhibit antioxidant and prooxidant properties. Additionally, resistance training promotes the generation of reactive oxygen species, which are important for the cellular adaptation process.

Hovewer, to the best of our knowledge, there is no information as to how caffeine combined with resistance training affects blood antioxidant status. Therefore, the aim of this study was to examine acute effects of caffeine supplementation on resistance training volume and blood antioxidant status in resistance trained men.

Eligibility Criteria:
Inclusion Criteria:

* written consent to participate,
* medical permission by physician
* "resistance-trained," defined as having a minimum of two years of resistance training experience
* minimum of 2 workout sessions per week in the last 6 months

Exclusion Criteria:

* neuromuscular or musculoskeletal disorders
* current injury
* using any medications, dietary supplements or ergogenic aids which could potentially affect the study outcomes
* a positive smoking status
* potential allergy to caffeine
Efficacy of Combined Pharmacotherapy Versus Solifenacin with Vaginal Estrogen Cream for Women with Detrusor Overactivity

To investigates the effects of combined pharmacotherapy with solifenacin and mirabegron versus solifenacin with vaginal estrogen cream in women with detrusor overactivity.

Women with detrusor overactivity who were refractory to anti-muscarinics were enrolled for prospective study. Patients were divided into two groups: one receive combined pharmacotherapy with solifenacin and mirabegron, and the other received solifenacin and vaginal estrogen cream. Incontinence-related symptoms distress and impact on quality of life were evaluated by short form of Urinary Distress Inventory, (UDI-6), Incontinence Impact Questionnaire (IIQ-7) and Overactive Bladder Symptom Score (OABSS). Objective outcomes include changes from baseline in episodes of daily micturition, urgency, urinary incontinence and nocturia.

Eligibility Criteria:
Inclusion Criteria:

* Patients with detrusor overactivity which defined as a urodynamic observation characterized by involuntary detrusor contractions during the filling phase. Those who were refractory to monotherapy with anti-muscarinics were enrolled for prospective study.

Exclusion Criteria:

* Postvoid urine retention before treatment
* Women who had medical illness and contraindication for using solifenacin and mirabegron, such as narrow-angle glaucoma and hypertension
* Concerns for using estrogen include: Women with history of cerebrovascular disease; thromboembolic disorders; gallbladder disease; known or suspected breast carcinoma; estrogen-dependent neoplasm or undiagnosed abnormal genital bleeding.
* Women who were on hormone replacement therapy within 3 months were also excluded from the study
Safety and Efficacy Study in the Treatment of Pediatric Crohn's Disease

The purpose of this study is to observe pediatric Crohn's Disease response to sargramostim in patients with or without steroid therapy at two possible dosage levels.

On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.

Eligibility Criteria:
Inclusion Criteria:

* Have a parent or guardian able to provide written informed consent
* Be able to provide verbal or written assent depending on age
* Age 6 to 16 years
* Have confirmed diagnosis of Crohn's Disease at study time of study entry based on radiologic, endoscopic, or histologic evaluations
* Have a PCDAI score \>/= 30 points
* Have a negative serum pregnancy test within 7 days prior to receiving the first dose of sargramostim in female patients who, in the opinion of the investigator, are sexually active and of childbearing potential
* Be able to self-inject sargramostim or have a designee who can do so
* Available documentations of weight from 4 to 6 months prior to study entry

Exclusion Criteria:

* Existing colostomy or ileostomy
* Immediate need of GI surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal or perianal abscess requiring surgical drainage
* GI surgery within 3 month prior to receiving the first dose of sargramostim
* Symptoms of bowel obstruction or confirmed evidence of a clinically significant stricture within the last 6 month that has not been surgically corrected
* Use of any of the following medications within 4 weeks prior to receiving the first dose of study drug: 6 mercaptopurine, azathioprine, cyclophosphamide, methotrexate, mycophenolate mofetil, tacrolimus, cyclosporine, or thalidomide
* Use of licensed/registered and/or experimental anti-tumor necrosis factor (TNF) therapy such as infliximab or adalimumab within 8 weeks prior to first dose of sargramostim
* Use of any investigational drug within 4 weeks or 5 half-lives (whichever is greater) prior to receiving the first dose of sargramostim
* Concurrent use of corticosteroid therapy for Crohn's Disease, which exceeds a dose of 60 mg/day (or equivalent) of prednisone
* Inability to comply with protocol requirements or provide informed consent
* Presence of clinically important comorbid condition(s) unrelated to Crohn's Disease
* Prior use of recombinant human GM-CSF (sargramostim or molgramostim) or granulocyte colony-stimulating factor (G-CSF; filgrastim or pegfilgrastim)
* Current use of nutritional therapy (i.e., tube feeding or elemental/polymeric diet) which provides \> 50% of daily caloric intake
Efficacy of Core Strengthening and Intensive Dynamic Back Exercises in Patient With Low Back Pain

The study aimed to investigate the efficacy of core strengthening and intensive dynamic back exercises on pain, muscle strength, endurance, and functional disability in patients with chronic non-specific low back pain.

The study will be based on a three-arm parallel group randomized control design. Forty-five participants with chronic non-specific low back pain will be recruited from the Physiotherapy department, at Integral University, India. Study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study. All the participants will be randomly divided into three groups A, B, and C. Experimental group A will be receiving the hot pack, active Stretching, isometric exercise intervention, and core strengthening exercises while group B will receive the hot pack, active Stretching, isometric exercise intervention, and intensive dynamic back exercises, control group C will receive the hot pack, active Stretching, isometric exercise intervention.

Eligibility Criteria:
Inclusion Criteria:

* age 20-50 years
* chronic low back pain (\>3 months),

Exclusion Criteria:

* Participants with low back pain related to cancer,
* infection,
* inflammatory arthropathy,
* high-velocity trauma,
* fracture
* low back pain associated with severe or progressive neurological deficits trauma
* pregnancy.
Accuracy of Pulse Oximeter With Hypoxemic Measurements

A study about accuracy of pulse oximeter with hypoxemic measurements (Blue sensor, Masimo, Irvine, CA, USA) in children with cyanotic congenital heart disease


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of cyanotic congenital heart disease
* weight 2.5kg to 30kg
* undergoing general anesthesia
* preoperative SpO2\<97%

Exclusion Criteria:

* none
The Effects of Oculomotor Training on Pain, Cervical Range of Motion, Joint Position Sense, Endurance, and Balance in Individuals with Mechanical Neck Pain

The aim of this study was to investigate the effects of oculomotor training on pain, cervical range of motion, joint position sense, endurance and balance in individuals with mechanical neck pain.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with mechanical neck pain
* Neck pain lasting longer than 3 weeks
* Individuals aged 18-50 years
* Score of 5 or higher on the Neck Disability Index

Exclusion Criteria:

* Having received physical therapy in the last 6 months
* Presence of congenital anomaly on cervical radiography
* Neurological deficit detected in physical examination
* Diagnosis of vertebrobasilar artery insufficiency
* Diagnosis of vestibular disease
* Presence of a rheumatic disease
* Presence of structural scoliosis
* History of spinal surgery
* Pregnancy
* Malignancy
* Eye disease/strabismus other than refractive errors
* Active use of anti-inflammatory medication
* Any mental condition that may prevent adherence to exercises
Cluster Headache Cortivazol Injection (CHCI)

the aim of tis study is to demonstrate the efficacy of cortivazol injections at the level of the greater occipital nerve to diminish the frequency of cluster headache (episodic or chronic) attacks during an active period. Injections will be used in adjunct with oral verapamil.

Cluster headache is characterized by unilateral attacks of severe periorbital pain accompanied by autonomic symptoms and restlessness. Though patients may respond to the standard prophylactic treatment of verapamil, some are refractory and continue to suffer from numerous attacks, with a limit of two doses of subcutaneous sumatriptan per day. Some patients also have contra-indications to standard prophylactic or acute treatments. Other preventive treatments like systemic steroids, lithium and methysergide may cause significant side effects. We intend to show the efficacy of occipital nerve injections with cortivazol, in adjunct to verapamil, in cluster headache patients. We expect a diminution of attack frequency over two weeks, with a protocol of three injections separated by two or three days each. Tolerance and safety will be examined.

Eligibility Criteria:
Inclusion Criteria:

* patient age, man or woman whose age is between 18 and 65 included
* patient who signed a free express and informed consent
* patient with cluster headache, episodic or chronic according to the criteria of International Headache Society (ICHD-II)
* patient with more than two episodes of CH per day
* patient with a normal medical examination

Exclusion Criteria:

* patient not affiliated with a social security scheme (or beneficiary entitled)
* patient with another diagnosis ICHD-II,and being unable to differentiate CH attacks from its other cranial pain
* patient of CH having started his episodic active period more than 30 days ago
* patient with a contra-indication to verapamil
* patient with a known allergy to cortivazol
* patient with anticoagulant therapy or having a bleeding disorder
* patient unable to complete the schedule crisis
* patient non-compliant or unable to follow the research protocol
* women without contraception, pregnant, or nursing
PROPHESSOR: AmBisome in Antifungal Primary Prophylaxis Treatment of High Risk Patients Undergoing Allogeneic Stem Cell Transplantation

This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome® loading dose regimen, in a weekly administration schedule during the initial phase of allogeneic stem-cell transplant and in case of occurrence of graft versus host disease (GvHD), which are both high risk periods as far as severe fungal infection development is concerned.

This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome® loading dose regimen, in a weekly administration schedule during the initial phase of allogeneic stem-cell transplant and in case of occurrence of GvHD, which are both high risk periods as far as severe fungal infection development is concerned.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged more than 18 years
* Patients with hematological malignancies undergoing allogeneic stem cell transplantation from donors other than human leukocyte antigen (HLA) identical sibling; source of stem cell includes either peripheral blood or bone marrow
* No evidence of fungal infection at chest computed tomography (CT) scan and at sinus X-ray at baseline
* Patients with no sign or symptoms of fungal infection and no previous proven or probable invasive fungal infection (IFI)
* Females of childbearing potential must be surgically incapable of pregnancy, or practising a method of birth control, or agree to abstain from heterosexual intercourse while participating in the study, and with a negative pregnancy test (blood or urine) at baseline
* An understanding of the study and agreement of the patient to give written informed consent
* Ability and agreement to comply with all study requirements
* Patient willing to attend hospital appointments for each injection (infusions will be performed in the hospital, under strict medical supervision). All patients will be hospitalised prior to, and remain in the hospital for at least one day, after the first infusion.

Exclusion Criteria:

* Known hypersensitivity to amphotericin B, in particular known history of anaphylactic reaction to amphotericin B
* Patients undergoing cord transplantation
* Creatinine \> 2.0 mg/dL
* Patient with moderate or severe liver disease as defined by AST or ALT \> 5 times the upper limit of normal (ULN)
* Patients who are unlikely to survive more than 1 month
* Patients who have received systemic antifungal therapy within 15 days prior to the inclusion
* Any severe cardiovascular disease (such as arrhythmias, in particular) which may constitute a contra-indication to AmBisome® administration
* Any severe disease other than the hematological diseases described at the second point of inclusion criteria, which in the investigator's judgement may interfere with study evaluations or affect the patient's safety
* Pregnant or nursing females
* Patients previously included in this study
* Patients who have taken any investigational drug in the last 30 days prior to the inclusion.
Evaluation of Influenza H1N1 Vaccine in Adults With Lymphoid Malignancies on Chemotherapy

The purpose of this study is to determine whether adults with hematologic malignancies on active systemic therapy or shortly after bone marrow transplantation need one or two doses of adjuvanted vaccine to achieve best possible rates of protection. An additional research question is whether baseline biomarkers of the cellular and humoral immune systems are associated with an antibody response to vaccination.

The novel influenza H1N1 virus responsible for a world-wide pandemic throughout 2009 (H1N1(2009)) is expected to cause a second wave of infection during the 2009/10 winter season. Vaccines against H1N1(2009) will be available in early November, 2009. Adults with hematologic disorders are at high risk of influenza-related complications, including death. Given that the vaccination dosing for the pandemic vaccine has been developed on healthy individuals, it is unknown whether this subgroup of patients will respond similarly. We will evaluate the safety and efficacy of the pandemic vaccine in patients with lymphoid malignancies receiving active systemic treatment, or who have recently undergone stem cell transplantation. Patients will be randomized to one or two doses of the approved adjuvanted vaccine; immune responses will be measured to identify the optimal regimen. Also, we will look for an association between biomarkers of the immune system and a response to the vaccine; this will be done by measuring baseline CD3, 4, 8, 19, and 56 cells by flow cytometry.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, ages 20-65
* Diagnosis of lymphoproliferative disorder
* One of the following types of systemic treatment: active chemo/immunotherapy at enrollment or completed within the last 3 months, OR auto/allo stem cell transplant recipient within the past 12 months
* Able to provide consent and comply with trial requirements

Exclusion Criteria:

* Systemic hypersensitivity to hen's eggs, thimerosal, gentamicin
* History of life-threatening reaction to prior influenza vaccination
* Thrombocytopenia or bleeding disorder contraindicating IM injection
* Pregnancy
* Laboratory-confirmed infection with H1N1(2009)
* IVIG infusion within the last three months
Minimum Effective Intrathecal Dose of Local Anaesthetic With Fentanyl for Fractured Neck of Femur(Dose Finding Study).

Fractured neck of femur (FNF) is a common cause of admission to hospital in elderly patients with multiple comorbidities. Anaesthetic management of this patient group is extremely challenging.Neuraxial anaesthesia with minimum doses of local anaesthetic agents administered via a spinal catheter leads to better cardiovascular stability.The minimum dose of local anaesthetic with intrathecal fentanyl was not established yet.We propose to study and determine the initial minimum local anaesthetic dose (MLAD) of 0.5% bupivacaine with 20 mcg of fentanyl administered via a spinal catheter to achieve a sensory block up to T10 for the operative fixation of FNF.We will use a previously well established Dixon and Massey "up-and-down method" to calculate initial MLAD in this prospective, observational trial.

Objectives: We would like to determine the initial MLAD of 0.5% bupivacaine with 20mcg of fentanyl administered via a spinal catheter required to achieve a sensory block up to T10 on the side of FNF.

Outcomes

Primary outcome:

1. Initial MLAD of 0.5% bupivacaine with 20mcg of fentanyl required for a sensory block up to T10 on the side of FNF.

   Secondary outcomes:
2. Total dose of 0.5% bupivacaine with 20mcg of fentanyl required for the operative fixation of fractured neck of femur.
3. The effect on haemodynamic variables (blood pressure, heart rate).
4. Incidence of side effects
5. The length of postoperative analgesia (the time from the last dose of local anaesthetic administered intrathecally to VAS\>3).
6. The time to first rescue analgesic requirement

Study Design Prospective, observational trial.

Study Size Based on the previously well established Dixon and Massey "up-and-down method"(10), we will recruit patients until a successful spinal block has been achieved in six consecutive patients who received a specific dose. This is the requirement to calculate the initial MLAD.


Eligibility Criteria:
Inclusion Criteria:

* fractured neck of femur
* Above 60 years
* American Society of Anesthetists(ASA) I to III

Exclusion Criteria:

* Patient refusal
* Outside Age Range
* Contraindications to spinal anaesthesia
* Head injury or other associated injuries
* Loss of consciousness and signs of acute coronary syndrome
* Mini-Mental Score \< 25 (Appendix 2)
* Allergy to bupivacaine, lignocaine or fentanyl
A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients

The purpose of this study is to assess the efficacy and safety of rabeprazole 10mg once and twice daily in maintenance therapy for PPI resistant gastroesophageal reflux disease patients.

This is randomized, multicenter, parallel-group, double-blind trial that investigates the efficacy and safety of rabeprazole 10mg twice daily over a period of 52 weeks. The 8-week Treatment Period (unblinded) was followed by a 52-week Maintenance Period (blinded). Participants with cure (modified Los Angeles Classification Grade N or Grade M) at the final endoscopy of the Treatment Period were entered into the Maintenance Period. Participants without cure were discontinued from the study. The participants in the Treatment Period were randomized to take Arm C or Arm D at a ratio of 1:1. The non-recurrence rate as endoscopically confirmed at 52 weeks shall be the primary end point, and this shall be examined through a randomized, multicenter, parallel-group, double-blind trial that investigates the efficacy and safety of rabeprazole 10mg twice daily over a period of 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

Subjects fulfilling all of the below criteria shall be eligible for the study:

1. Patients diagnosed with gastroesophageal reflux disease who are shown through endoscopic examination to have mucosal lesions (erosions, ulcers)
2. Patients shown through endoscopy not to have recovered despite administration of PPI once daily for eight weeks.
3. Patients over 20 years of age who have freely given their informed consent in writing to participation in the study.
4. Patients who, having received a full explanation of the matters that must be adhered to during the study, intend to adhere to their requirements, and are capable of doing so.

Exclusion Criteria:

Subjects fulfilling any of the following criteria shall be excluded from the study:

1. Patients considered candidates for surgical treatment of the upper gastrointestinal tract due to perforation, esophageal stricture, pyloric stenosis, esophageal varices, etc.
2. Patients with Zollinger-Ellison syndrome.
3. Patients with gastrointestinal hemorrhage.
4. Patients with serious cardiovascular disease, cerebrovascular disease, hematological disorders, renal disease, liver disease, malignant tumors, etc.
5. Patients with long segment Barrett's esophagus.
6. Patients with open gastric or duodenal ulcers.
7. Patients with drug allergies or a past history of drug allergies to PPI.
8. Patients who are taking other drugs under development, or have done so within 12 weeks prior to enrollment.
9. Patients who are, or may be pregnant, patients who wish to become pregnant during the study period, patients who are breastfeeding, and patients or their partners who do not wish to use reliable contraceptive measures.
10. Patients with a history of dependence on or abuse of drugs or alcohol within the past two years.
11. Other patients deemed unsuitable for inclusion in the study by the principal investigator or sub-investigators.
Increased Ketorolac Administration After Cesarean Section and Its Effect on Opioid Use: a Randomized Control Trial

To evaluate the efficacy of increased ketorolac in reducing opioid use after cesarean section.

This was a single-center, randomized, double-blind, parallel-group trial to assess pain management following cesarean section with increased ketorolac versus placebo. All patients undergoing cesarean section with neuraxial anesthesia received two doses of 30mg IV ketorolac postoperatively per hospital protocol and were then randomized to receive an additional four doses of 30 mg of IV ketorolac or placebo every 6 hours. The primary outcome was the total morphine milligram equivalents (MME) used in the first 72 postoperative hours. Secondary outcomes included the number of patients that used no opioid postoperatively, postoperative pain scores, postoperative change in hematocrit and creatinine, and postoperative satisfaction with inpatient care and pain management. A sample size of 74 per group (n=148) was planned.

Eligibility Criteria:
Inclusion Criteria:

* Women presenting for care at Tufts Medical Center as an outpatient in obstetrics clinic or on Labor and Delivery.
* The subject must have had a cesarean section for any indication at Tufts Medical Center to be randomized to the study
* The subject is willing to have a phone call follow up conversation 2 weeks after their surgery.

Exclusion Criteria:

* Patients with allergy to ketorolac, NSAIDS or aspirin
* Patients with peptic ulcer disease, preexisting kidney or liver disease.
* Duramorph is not used as the anesthetic for the spinal/epidural during the cesarean section.
* Patient is hemodynamically unstable due to hemorrhage.
* Patient requires therapeutic anticoagulation in the post-operative period
* Patients with peripartum cardiomyopathy
* Provider decision to exclude patient.
* Patient diagnosis of chronic hypertension, gestational hypertension, preeclampsia, HELLP syndrome, or eclampsia
* A study subject may participate in another research study while participating in this research study.