cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Extremely Low Magnetic Field (ELF) in Fibromyalgic Patients

This is a randomized double-blind crossover study. The investigators applied ELF with a device named "LIMFA Therapy®" to 48 fibromyalgic patients, assigned in two groups (true-sham and sham-true). Fibromyalgia severity was assessed with the Fibromyalgia Impact Questionnaire (FIQ), quality of sleep with the Pittsburgh Sleep Quality Index (PSQI) questionnaire and global quality of life with Short Form-12 of Physical and Mental Health Summary (SF-12) questionnaire.

In the first part of the protocol the group true-sham received 6 twice a week sessions of true ELF therapy of 1 hour, following the antinflammatory, analgesic and biorhythm settings of the device "LIMFA Therapy®". The sham-true group patients received 6 twice a week sessions of sham therapy (no therapy).

During the second part of the protocol, the true-sham group received the sham therapy twice a week for 3 weeks and the sham-true group received the actual true therapy twice a week for 3 weeks.

For the assessment of pain, sleep quality and global quality of life, a set of questionnaires were administrated at specific stages of the protocol. Questionnaires were administrated every three weeks: before the first therapy, after the first course of therapy, after the washout period, after the second course of therapy, and 3 weeks after the end of treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients with an established fibromyalgia diagnosis of at least three months according to American College of Rheumatology 2010 modified criteria and no responsive to their current therapy.
* patients were not responsive to amitryptiline, selective serotonin reuptake inhibitor (SSRI) or duloxetine and pregabalin (with a pain reduction below 50% compared to pre-therapy or intolerant to these drugs)
* patients with a pain level measured with Visual Analogue Scale for Pain (VAS) \> 50/100.
* patients that had been taking other drugs or food supplements for the treatment of fibromyalgia for at least 6 months.

Exclusion Criteria:

* patients that completed either physiotherapy or acupuncture or behavioral treatment in the last 6 months
* patients that were affected by other painful syndromes or potentially painful syndromes other than fibromyalgia.
* pregnant women
* pace-maker carriers
* oncologic patients
* tuberculotic patients.
Interdisciplinary Weight Loss Therapy Associate With the Use of Interactive Digital Technology

Obesity is a complex disease associate to metabolic alterations, which may lead to cardiometabolic risk in women with obesity. The use of interactive digital technology as adjuvante tool to the clinical practices in weight loss therapy emerges as an innovative strategy. However, it was note fully investigated if this kind of approach can contribute to improve inflammatory state and metabolic alterations in obese population.

This study consists in a 12-week clinical interdisciplinary weight loss therapy, with endocrinologist, nutritionist, psychologist and exercise physiologist to evaluate the effects of clinical interdisciplinary therapy associated to use the eletronic means on inflammatory biomarkers and metabolic alterations in women with obesity.

The present study was composed by a sample of obese women (20 to 45 years old), recruited through advertisements in the media (newspapers, magazines, radio, television and social media - Twitter®, Facebook® and Instagram®). The volunteers lived in the city of São Paulo or nearby, so they could attend monthly the University on the days of the clinical, nutritional, psychological and exercise evaluations, counseling, educational sessions and motivational strategies supporting adherence. To complete the Education Behaviors Program the volunteers follow weekly the instructions found in the Platform #12Semanas®. All participants met the inclusion criteria for the obesity profile according to the World Health Organization (WHO), presenting Body Mass Index (BMI) values above 30 kg/m². Patients with any pathology that could compromise the results of the study (heart disease, musculoskeletal deformities, diseases related to the immune system, genetic, metabolic or endocrine diseases, identified by the physician) were not included in the study. Anthropometric measures, body composition by bio-impedance and bood samples were collected to serum analysis.

Eligibility Criteria:
Inclusion Criteria:

* obesity diagnosis;
* body mass index (BMI) values above 30 kg/m²
* adult
* aged 20-45 years

Exclusion Criteria:

* presence of heart diseases
* musculoskeletal deformities
* diseases related to the immune system
Prostate Volume Changes Following Prostate Brachytherapy With Iodine-125 Seeds

The size of the prostate changes due to insertion of the radioactive seeds. We will measure the prostate size, before and after the procedure.

The prostate size will be measured using the TRUS and CT scan on days -1, 0, 1, 9, 30, and 60 days after the brachytherapy procedure.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed diagnosis of prostate cancer
* T1-3 disease
* PSA \<20 ng/ml
* Patient must sign a study-specific informed consent prior to enrollment.

Exclusion Criteria:

* Patients ineligible to brachytherapy
Effect of Celecoxib and Etoricoxib on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol

Tramadol is an opioid analgesic, which is widely used in the treatment of acute and neuropathic pain. After oral administration, tramadol is rapidly and almost completely absorbed. Tramadol is extensively metabolised by O- and N-demethylation, which are catalysed by the liver CYP-450 enzymes. O-desmethyltramadol is an active metabolite and its formation is catalysed by CYP2D6. This study is aimed to investigate the possible interaction of oral tramadol with selecoxib and etoricoxib. Selecoxib is known to inhibit CYP2D6. Twelve healthy male or female adult non-smoking volunteers aged 18-40 years with body weights within ±15% of the ideal weight for height are taken into the study. Primary endpoints of the study are plasma concentrations of tramadol and its metabolites.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Age 18-40
* Body weight within ±15% of the ideal weight for height

Exclusion Criteria:

* A previous history of intolerance to the study drugs or to related compounds and additives
* Concomitant drug therapy of any kind for at least 14 days prior to the study
* Existing or recent significant disease
* History of hematological, endocrine, metabolic or gastrointestinal disease, including gut motility disorders
* History of asthma or any kind of drug allergy
* Previous or present alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements
* A positive test result for urine toxicology
* A "yes" answer to any one of the Abuse Questions
* Pregnancy or nursing
* Donation of blood for 4 weeks prior and during the study
* Special diet or life style conditions which would compromise the conditions of the study or interpretation of the results
* Participation in any other studies involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study
* Smoking for one month before the start of the study and during the whole study period
* Any history of coagulation abnormality, also in first degree relatives
Barbed Suture in Single-port Laparoscopic Myomectomy

The aim of this study is to test our hypothesis that the use of unidirectional knotless barbed suture in single-port laparoscopic myomectomy could facilitate the suture of uterine wall defect after myoma enucleation as multi-port laparoscopic myomectomy did.

The investigators plan to perform a multi-center randomized clinical trial on women scheduled for laparoscopic myomectomy. All women will get the same preoperative and postoperative care. Women will be assigned by chance to one of two groups: one group will receive single-port laparoscopic myomectomy using V-Loc™ suture material (study group). The other group will receive conventional multi-port laparoscopic myomectomy using V-Loc™ suture material (control group). The investigators will collect information on suturing time and complications related to surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 55 years
* Image-confirmed uterine myoma
* Number of myoma ≤2 and largest size ≤10cm
* Women who were scheduled to have laparoscopic myomectomy
* Appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2)

Exclusion Criteria:

* Women with pedunculated subserosal myoma or submucosal myoma
* Women undergoing concomitant complex surgical procedures at the time of laparoscopic myomectomy such as severe adhesiolysis or resection for severe endometriosis
* Women with any suggestion of malignant uterine or adnexal diseases
* Women with diabetics, malignancy, or malnutrition, which can affect wound healing
* Women having major medical comorbidity or psychiatric illness, which could affect follow-up and/or compliance
* Women who refuse to participate or give consent to the procedures
Open-label Adjunctive Zonisamide for Bipolar Disorder

To study the safety and efficacy of zonisamide as adjunctive therapy for children and adolescents with bipolar I or II disorder.


Eligibility Criteria:
* Bipolar I/II
* Average intelligence
* Taking at least one, but no more than two mood stabilizers
Study to Evaluate the Performance of a New 2-piece Ostomy Appliance vs. Flexima® 3S in Patients With Enterostomy

To compare the performance of the comparator Flexima 3S appliance to a new 2-piece appliance in patients with enterostomy.


Eligibility Criteria:
Inclusion Criteria:

* patient having a colostomy or an ileostomy for at least 1 month
* patient currently using a flat appliance
* patient wearing his appliance, on average, at least 5 days
* patient with a stoma's diameter less than 65 mm
* patient who agrees to participate in the evaluation and who have signed the inform consent
* patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)

Exclusion Criteria:

* Patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion)
* Patient receiving or having received, within the last month, chemotherapy or corticotherapy
* Patient already participating in another clinical study or who have previously participated in this investigation
* Pregnant or breast-feeding woman
Intraperitoneal Hyperthermic Chemotherapy in Epithelial Ovarian Carcinoma

Phase II to study results and morbidity of intra peritoneal hyper-thermic chemotherapy as consolidation therapy in patients with FIGO stage IIIC epithelial ovarian carcinoma treated by surgery and a total of 6 cycles of platinum based chemotherapy.

A second look operation is performed after treatment; during this second look secondary cytoreductive surgery is accepted without bowel resection.If none or milimetric peritoneal disease is obseved an intraperitoneal chemotherapy is achieve


Eligibility Criteria:
Inclusion Criteria:

epithelial ovarian carcinoma previous surgery + 6 cycles platinum based chemotherapy

-

Exclusion Criteria:

* Patients ASA 3 patients with no residual tumor at first operation negative microscopic second look
A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults With Type 2 Diabetes

This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. Which treatment participants get is decided by chance. Insulin icodec is the new medicine being tested, while insulin glargine is already approved and can be prescribed by doctors. Participants will get one injection of insulin icodec once a week, or one injection of insulin glargine once a day, depending on the treatment group participants are assigned into. Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh, upper arm or stomach.The study will last for about 9 months, but participants will only be taking the study medicine for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with T2D greater than equal to (≥) 180 days prior to the day of screening.
* HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol), both inclusive, at screening confirmed by central laboratory analysis.
* Treated with once-daily or twice-daily basal insulin (Neutral Protamine Hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 U/mL, or insulin glargine 300 U/mL) ≥ 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses greater than equal to (≥) 90 days prior to screening: metformin, sulfonylureas, meglitinides (glinides), Dipeptidyl peptidase 4 (DPP-4) inhibitors, Sodium-Glucose Transport Protein 2 (SGLT2) inhibitors, thiazolidinediones, alphaglucosidase inhibitors, oral combination products (for the allowed individual oral anti- diabetic drugs), oral or injectable glucagon-like peptide 1 receptor agonists (GLP-1 RAs), injectable glucagon-like peptide 1(GLP-1)/ glucose-dependent insulinotropic polypeptide receptor agonist (GIP RA) combination products.
* Body mass index (BMI) ≤ 40.0 kilogram per square meter (kg/m\^2).

Exclusion Criteria:

* Any episodes of diabetic ketoacidosis within 90 days prior to the day of screening.
* Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
* Chronic heart failure classified as being in New York Heart Association Class IV at screening.
* Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with orlistat, thyroid hormones, or corticosteroids).
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Assessing the Impact of LIve Music in the Intensive Care Unit (ICU) to Improve Care for Critically Ill Patients

Noise in the ICU can worsen patient outcomes through factors such as increased cardiovascular stress, alteration in sleep, and increased discomfort or pain The purpose of this study is to determine the benefit of therapeutic music in the ICU on patients, their families, and ICU staff.

Noise in the ICU can worsen patient outcomes through factors such as increased cardiovascular stress, alteration in sleep, and increased discomfort or pain. The purpose of this study is to determine the benefit of therapeutic music in the ICU on patients, their families, and ICU staff. The results of this study will inform clinicians on best practices for redesigning, implementing and evaluating a patient and family focused therapeutic music program in the ICU.

Eligibility Criteria:
Patient Inclusion Criteria:

* Current hospitalization in adult ICU at Vanderbilt University Medical Center

Patient Exclusion Criteria:

* Airborne or special contact isolation
* Unstable hypotension or bradycardia
* Pregnancy
* Current prisoner status
* The inability to communicate either verbally or in writing in English to complete the therapeutic music evaluations
* Refusal to participate

Family Member Inclusion Criteria

* Family member of ICU patient

Family Member Exclusion Criteria

* The inability to communicate either verbally or in writing English to complete the therapeutic music evaluations
* Refusal to participate

ICU Clinical Staff Inclusion Criteria

* ICU clinical staff who are in the patient's room during the music session

ICU Clinical Staff Exclusion Criteria

* Refusal to participate
Post Market Clinical Follow Up Study for ReliaTack™ Articulating Reloadable Fixation Device With Deep Purchase Tacks

A post-market clinical follow-up study for ReliaTack™ articulating reloadable fixation device with deep purchase tacks

A retrospective, multi-center, chart review of medical records on the use of the device for two (2) surgical procedure indications:

1. inguinal/femoral hernia
2. ventral hernia

A minimum of 4 sites in the United States will perform chart review and enter 116 study records in the database for data collection. The 116 subject records will be comprised of 76 for the inguinal/femoral indication, and 40 for the ventral indication.

Eligibility Criteria:
Inclusion Criteria:

1. Subject underwent ventral or inguinal/femoral hernia repair procedure utilizing ReliaTack™ Articulating Reloadable Fixation Device with Deep Purchase Tacks on or after 510(k) approval.
2. Medical records are available, which document a ventral and/or inguinal/femoral hernia repair surgical procedure.

Exclusion Criteria:

1. Institutional Review Board (IRB) consent requirement cannot be met:

   1. waiver of subject informed consent requirements are not granted by IRB\* and,
   2. an altercation to the consent process is not granted by the IRB and,
   3. subject or subject's parent or legal guardian is unable or unwilling to provide signed informed consent
2. Subject was participating in any investigational drug or device study at the time of surgery or within 30-day (+3 days) study window
3. Subject was pregnant at the time of procedure
4. Subject had a documented allergy at the time of surgery to any of the components of the device or the mesh implant
5. Subject was treated with any other implantable mechanical fixation device, other than sutures

   * A waiver of subject informed consent procedures will be requested from all IRBs of record for this study.
Post-Approval Clinical Trial Comparing the Long Term Safety and Effectiveness Coflex vs. Fusion to Treat Lumbar Spinal Stenosis

Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis

The primary objective of this post-approval study is to examine the long-term survivorship of the coflex®. The coflex® Interlaminar Technology is an interlaminar stabilization device indicated for use in one or two level lumbar stenosis from L1-L5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 months of non-operative treatment. The coflex® is intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. Interlaminar stabilization is performed after decompression of stenosis at the affected level(s).

Eligibility Criteria:
Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

Recurrent pregnancy loss (RPL) defined as 3 or more pregnancy losses affects approximately 3% of couples trying to achieve parenthood. Most cases of RPL are unexplained and have no effective treatment to improve the chance of a live birth. Exciting indications for using Hydroxychloroquine (HCQ) include: Malaria profylaxis and treatment, systemic and discoid lupus erythematosus (SLE) and rheumatoid athritis (RA). HCQ has been reported to have the following properties (anti-thrombotic, vascular-protective, immunomodulatory, improving glucose tolerance, lipid-lowering, and anti-infectious).

There is no data concerning the benefit of HCQ in RPL. Administration for other indications provides extensive safety data during pregnancy.

This study has the potential to establish support for a new treatment option for unexplained RPL.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 4 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained RPL
2. ≥ 3 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained RPL with minimum one second trimester loss.

Exclusion Criteria:

1. Age below 18 years or above 39 at inclusion
2. Abnomal uterine anatomi at hysterosalpingography/hysteroscopy or hydrosonography
3. Chromosomal abnormalities within the couple
4. Menstrual cycle below 23 days or above 35 days
5. Lupusantikoagulans positivity or immunoglobulin (Ig)G/IgM anticardiolipinantibodies (≥10 GPL kU/l at Rigshospitalets Laboratorium) or plasma homocystein ≥25 mikrogr./l at repeated measurement with 12 weeks interval.
6. HIV or Hepatitis B or C positive
7. Psoriasis, retinopathy og serious imparied hearing (Contraindications for HCQ)
8. Chronic disease that lead to intake of immunemodulatory drugs or potentially pregnancy toxic agents
9. Hemoglobin ≤ 6.5 mmol/L, leukocytes \<3.5 E9/L, platelets \<145 E9/L at inclusion
10. Previous treatment with HCQ in pregnancy
11. \>1previous live birth
12. previous participation in this trial
A Retrospective Study to Investigate Prevalence of Capsular Bag Distention Syndrome and Its Influencing Factors

* To Investigate the Prevalence of Capsular Bag Distention Syndrome
* To Analyze Influencing Factors of Capsular Bag Distention Syndrome


Eligibility Criteria:
Inclusion Criteria:

* patients who underwent uneventful phacoemulsification and posterior-chamber IOL implantation at the Eye and ENT Hospital of Fudan University, Xuhui, Shanghai, China, between November 2011 and December 2012

Exclusion Criteria:

* Patients with traumatic cataracts or zonular weakness were excluded from the study, as were eyes with intraoperative complications, such as a posterior capsule opening, radial tearing of the continuous curvilinear capsulorhexis (CCC), or inappropriate IOL implantation.
Multihance at 3 Tesla (3T) in Brain Tumors

Compare the efficacy of MultiHance and Magnevist

The purpose of this study was to evaluate whether Multihance is superior to Magnevist in terms of qualitative and quantitative assessment of unenhanced MRI and contrast-enhanced MRI for the visualization of brain disease.

Eligibility Criteria:
Inclusion Criteria:

* Was 18 years or older
* Provided written informed consent
* Scheduled for MRI
* Confirmed or highly suspected to have brain tumor(s) and willing to undergo two MRI exams within 14 days

Exclusion Criteria:

* Pregnant or lactating females
* Allergy to one or more of the ingredients in the products or hypersensitivity to any metals
* Congestive heart failure, class IV
* Previous stroke in the past year
* Received another contrast agent within 24 hours pre and post each exam
* Investigational product
* Contraindications to MRI
* Severe claustrophobia
* Surgery with 3 weeks prior
* Steroid therapy or radiosurgery between two exams