cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Potential Vitamin D Effects on Muscle: a Pilot Study

People who do not have adequate amounts of vitamin D develop weakness of leg and arm muscles. This study will determine if vitamin D supplementation benefits muscle functions important for swallowing, bladder and bowel function.


Eligibility Criteria:
Inclusion Criteria:

* Patients who present for evaluation to the UW Geriatric clinic including Dr. Pryzbelski's subspecialty, or Osteoporosis clinics
* Age 70 years or older
* Cognitively intact, as determined by the attending physicians at above mentioned clinics

Exclusion Criteria:

* History of, on ongoing, renal failure
* History of liver failure
* Known malabsorption
* Known disorders of parathyroid function, hyper/hypocalcemia, or other abnormalities of calcium or phosphate metabolism
* Known history of vitamin D intoxication or granulomatous disease
* active seizure disorder
* Pain associated with temporomandibular joint (TMJ)
COLONIC RESECTION FOR CANCER AS DIABETOGENIC RISK FACTOR

Colon cancer (CC) survivors have an increased risk of developing T2D. A recent study revealed that the surgical procedures per se may be causally involved. Hence, left-sided colon resections increased the risk of developing T2D. In addition, treatment with chemotherapy may play a role in the pathogenesis. Given the steadily improving survival rate after a CC diagnosis, prevention of secondary diseases such as T2D is important to improve quality of life in these patients and to reduce socioeconomic expenses. This study aims to elucidate the effect of resection of tumors located in the left part of the colon on pathophysiological intermediates, which may lead to T2D 12 months post-surgery or later. The physiological mechanism might be a changed postprandial secretion of gut hormones including glucagon-like peptide-1 (GLP-1) secreted from L-cells in the left part of the colon. The investigators will evaluate changes in primarily glucose homeostasis as well as in gastrointestinal hormones, microbiota, visceral fat accumulation and markers of low-grade inflammation etc. in CC survivors who underwent a left hemicolectomy or sigmoidectomy.

Material and Methods: 60 patients will be included in this explorative clinical study. Patients will be divided into 4 groups depending on surgical procedure and treatment with chemotherapy. In the group of patients undergoing left hemicolectomy or sigmoidectomy ± treatment with chemotherapy 2 x 15 patients will be included, and in the group of patients scheduled to undergo right hemicolectomy ± treatment with chemotherapy another 2 x 15 patients will be included. During the 3 study visits (before surgery, 3-4 weeks post-surgery and 12 months post-surgery) the following tests will be performed: An oral glucose tolerance test, blood and fecal sampling, a DXA scan and an ad libitum meal test.

Implications: With this study the investigators expect to obtain an insight in the pathogenesis behind the possible development of T2D in CC survivors who underwent a resection of the left part of the colon ± treatment with chemotherapy. This insight may also help scientists develop new ways of treating or preventing T2D in general.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria:

* Adult (\> 18 yrs.)
* ASA score 1-3
* Signed written informed consent
* Hba1c \<48 mmol/mol
* Hemoglobin ≥ 6,5 mmol/L

Exclusion Criteria:

* • Pregnancy

  * Known type 1 or 2 diabetes
  * Inflammatory bowel disease (Ulcerous colitis and Crohns' disease).
  * Prior major abdominal surgery including bariatric surgery or colorectal resections
  * Treatment with agents that may interfere with glucose homeostasis and or appetite or reduce the chance of successful follow-up examination
  * Planned stoma
17-Alpha-Hydroxyprogesterone Caproate in Pregnant Women With Placenta Previa

Purpose to evaluate the effects of intramuscular 17-Alpha-Hydroxyprogesterone Caproate (17-OHPC) for prevention of Emergent Cesarean Delivery in symptomatic Pregnant Women with Placenta Previa

Most authors report an increased risk of bleeding with advancing gestation among women with placenta previa.

The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) both recommend the use of 17-OHPC to prevent recurrent spontaneous preterm birth.

Preterm deliveries account for 75% of perinatal mortality and surviving preterm infants are at risk for neurological, respiratory, and gastrointestinal complications. So, it is therefore very important to try to prolong the pregnancy without increasing the risk of emergent delivery in cases with placenta previa. The authors hypothesized that a pharmacological strategy like 17-alpha-Hydroxyprogesterone caproate may improve pregnancy outcomes and may also allow obstetricians to tailor their approach to save delayed scheduled cesarean section women with a placenta previa.

The aim of this study to evaluate the role of17-alpha-Hydroxyprogesterone caproate in the prevention of preterm cesarean delivery (CD) in cases with symptomatic placenta previa with avoids of an emergent CD which affects the maternal outcome and prevents prematurity which affects the prenatal outcome.

Eligibility Criteria:
Inclusion Criteria:

* Estimated gestational age: between 24 weeks and 37 week's gestation
* Confirmed Placenta previa; either major or minor degrees.
* Placenta previa with preterm uterine contractions or with a history of at least single attack of mild vaginal bleeding

Exclusion Criteria:

* Severe attack of bleeding requiring an immediate intervention.
* Fetal heart rates instability or non-reassuring tracing
* Intrauterine fetal death or major fetal anomalies.
* If associated with abruptio placentae
* Patients with known bleeding disorders or on anticoagulant therapy
* Patients with severe medical disorders
Analyze Previously Collected Biopsy Samples From Participants Who Completed the "SPLASH: Split-Body Randomized Clinical Trial of Poly-L-Lactic Acid for Adipogenesis and Volumization of the Hip Dell" Study

Primary Objective: use immunofluorescence (IF) on previously obtained biopsies to analyze and quantify changes in adipose tissue of subjects injected with poly-L-lactic acid (PLLA) or saline.

Sixteen female adults that participated in SPLASH study will be enrolled in this retrospective study. It aims to analyze previously collected biopsy samples from participants who completed the "SPLASH: Split-Body Randomized Clinical Trial of Poly-L-Lactic Acid for Adipogenesis and Volumization of the Hip Dell" study. The study will use immunohistology to assess changes in adipose tissue associated with treatment with PLLA (poly-L-lactic acid). We hypothesize that specimens treated with PLLA will be found to have more adipocyte-derived stem cells and preadipocytes undergoing mitosis and differentiation compared to control specimens.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who completed all biopsies in the previous SPLASH trial "A Single Center, Double- Blinded, Split-Body, Randomized Clinical Trial of Injectable Poly-L-Lactic Acid for Volumization and Adipogenesis of the Hip Dell - Protocol Number Sculptra-Hip-Dell-2021-12" .

Exclusion Criteria:

* Subjects who had biopsies of poor quality, insufficient tissue, or were otherwise unsuitable for immunofluorescence analysis.
Study of Amiodarone Given Before Lung Surgery to Prevent Atrial Fibrillation After Lung Resection

Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation. We propose a randomized controlled trial to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.

Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation.

We propose a study to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.

Eligibility Criteria:
Inclusion Criteria:

* Resectable lung nodule or mass

Exclusion Criteria:

* Allergy to amiodarone
* Currently taking amiodarone
* Documented atrial fibrillation within past 12 months
* Known pulmonary fibrosis
* Known hepatic dysfunction
* Thyroid disease
* 2nd or 3rd degree heart block
* Severe SA node disease
* Bradycardia-induced syncope
* Pregnancy
Quality of Life After Abdominoperineal Resection for Rectal Cancer, Comparing Two Surgical Techniques

The purpose of the study is to compare self-reported health related quality of life after two different operating techniques for low rectal cancer operated by rectal amputation, using a specific and detailed questionnaire. The population has been operated over a 6 year period in one university hospital.

Low rectal cancer treated by abdominoperineal resection (APR, rectal amputation)has worse prognosis than other rectal cancers, both regarding local recurrence and cancer specific survival. With a view to improve local recurrence rates a more extensive perineal operation (excision of the levator muscle) has been suggested. In our university hospital thie technique was introduced for all surgeons January 2007. A population of all patients operated from 1 January 2007 to 31 December 2009 was compared to all patients operated from 1 January 2004 to 31 December 2006 using the traditional, less extensive method, in all a six year period and 158 patients.

A specific questionnaire was developed after in depth interviews, and was face-validated by patients who had undergone an APR. This questionnaire will be sent out to all patients in our population who are still alive.

The patients will be contacted first by a letter of invitation, later called by telephone to be given more information and asked for permission to send the questionnaire.

The send out of invitation letters will start March 2011.

Eligibility Criteria:
Inclusion Criteria:

* rectal cancer operated by abdominoperineal resection 2004-2009

Exclusion Criteria:

* no informed consent
Educational Programs Based on Healthy Habits to Improve Quality of Life and Psychosocial Profile in Women with Neurodegenerative Diseases: the ADVICE Protocol Study (Phase 2)

This phase of the project aims to compare in-person, supervised educational programs (EP) with online self-guided EPs in individuals with relapsing-remitting multiple sclerosis. A total of 75 participants will be randomly assigned to one of three groups: a supervised and individualized educational program focused on HIIT training, a supervised and individualized educational program focused on strength training, and a non-supervised, self-guided educational program based on resistance band training. Additionally, sessions on the Mediterranean diet (both supervised and non-supervised) and cognitive-behavioral interventions will be included. A control evaluation will be conducted three months after the intervention to assess the effects of the educational programs, followed by another evaluation three months later to analyze residual effects. Women who participated in Phase 1 of the study will be invited to take part in this second phase.


Eligibility Criteria:
Inclusion criteria include:

* Women and men of reproductive age (18-45 years) with MS will be included, with the upper age limit adjusted to reflect the reproductive phase;
* no iron-deficiency anemia;
* stable disease phase;
* independent walking ability for over 10 meters.

Women will be recruited first and later matched with men based on age, EDSS, and lifestyle habits (physical activity, smoking, and alcohol consumption).

Exclusion criteria will include participants with MS who:

* score \<1 or \>6 on the EDSS;
* report a relapse within 12 months before the study begins;
* have taken corticosteroid treatment within the last 2 months;
* have participated in a structured training program in the previous 6 months.

Once all women with MS are recruited, male participants will be recruited following a 1:1 matching methodology based on age, geographic region, and lifestyle habits.
Effect of Delorme Resistance Exercises Versus Treadmill Training in Cerebral Palsy

Cerebral palsy is one of the most important source of disability among children and its incidence is almost 3.6 in thousand live births.Children with Cerebral Palsy presents with ambulatory difficulties.The current study highlights the effect of treadmill training as compared to DeLorme resistance exercises on locomotor activities in cerebral palsy child.The present study would add to the clinical knowledge of physical therapists by promoting the implementation of treadmill training and DeLorme resistance exercises for this prevalent pediatric neurodevelopmental disorder. The study would decrease the burden of disease among community and enhance the social participation of cerebral palsy children. This in turn would improve the quality of living of these disabling diseased children.


Eligibility Criteria:
Inclusion Criteria:

* Children with Gross Motor Functional Scale Level II and III
* Ability to understand commands and directions
* Diplegic type of cerebral palsy
* Children who had undergone bilateral Tendon of Achilles Lengthening procedure 3 to 6 months post-operatively

Exclusion Criteria:

* Children presenting with other types of Cerebral Palsy
* Children with audiovisual impairment that can hinder the treatment
* leg length discrepancy greater than 2 cm,
* Fixed contractures, joint instability and associated cardiovascular condition.
Hip Activation vs. Hip Activation + Core Stabilization

The purpose of this investigation is to compare the effects of a combined hip activation and core stabilization training home exercise program (HEP) versus a hip activation training HEP alone on lower extremity (LE) frontal plane mechanics in healthy individuals.

Specific Aim 1: To determine whether between- and/or within-group differences exist on the Forward Step-Down test (FSDT) when comparing a combined hip activation and core stabilization training HEP as compared to a hip activation training HEP.

Specific Aim 2: To determine whether between- and/or within-group differences exist on the peak external knee abduction moment when comparing a combined hip activation and core stabilization training HEP to a hip activation training HEP.

Specific Aim 3: To determine whether between- and/or within-group differences exist on gluteal and core muscle surface electromyography (sEMG) when comparing a combined hip activation and core stabilization training HEP to a hip activation training HEP.

Specific Aim 4: To determine whether a dose-response relationship exists between HEP compliance and change on the FSDT, peak external knee abduction moment, and sEMG.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be current first- or second-year Doctor of Physical Therapy (DPT) students in the School of Allied Health Professions (SAHP) at Louisiana State University Health Shreveport over the age of 21.

Exclusion Criteria:

* Current pain or pathology in either LE which currently limits their ability to perform the FSDT or drop landing task, a history of low back pain in the last three months, known pregnancy, as pregnancy is a risk factor for diastasis rectus abdominis (DRA) which may be exacerbated by participation in the intervention and could be a confounding variable, and current participation in other clinical trials.
Study to Estimate How Common it is to Have Genetic Variants Associated With NAFLD

The purpose of this study is to estimate the prevalence of genetic variants associated with liver disease in participants who are known, or are likely to have NAFLD.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormality based on medical history, physical exam, and 12-lead electrocardiogram (ECG) collected during Visit 1
* Women must be of non-childbearing potential, defined as either: a.) Postmenopausal or b.) Permanently sterile
* Must be willing to provide a deoxyribonucleic acid (DNA) sample for assessment of genetic variants associated with NAFLD
* Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria:

* History or presence of drug abuse within the 2 years prior to Visit 1
* Excessive use of alcohol within 2 years prior to the study
* Body mass index greater than (\>) 40 kilogram per meter square (kg/m\^2)
* Evidence of other active (acute or chronic) liver disease other than NAFLD/ Nonalcoholic steatohepatitis (NASH)
* History of bariatric surgery or planning to undergo bariatric surgery within the next year
* Inability to undergo magnetic resonance imaging (MRI)
Janus Feasibility Study

The purpose of this feasibility study is to assess whether an alternative transvenous lead location affects respiration and airway physiology during a commercial remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator) implant procedure.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years old
* Subject with moderate to severe central sleep apnea is undergoing a de novo commercial remedē® System implant procedure or other de novo transvenous cardiac implantable device procedure including a pacemaker or an implantable cardiac defibrillator
* Subject is willing and able to give informed consent

Exclusion Criteria:

* Subject is unable or unwilling to participate with study procedures or in the investigator's opinion is medically unstable for the procedure (Medically unstable is defined as when a patient is expected to have worsening health status if additional procedure time is needed)
* Subject is pregnant or planning to become pregnant (all women with childbearing potential must have a negative pregnancy test within 7 days prior to the implant)
* Subject is known to be allergic to radio opaque dye which cannot safely be pre-treated per the investigator
* Subject has body mass index (BMI) \> 40 kg/m2 at the time of implant
* Subject has had prior neck surgery
* Previous or currently implanted upper airway stimulation device
* Subject has had prior oral cavity surgery that may interfere with breathing
* Subject has significant upper airway-related anatomic anomaly
* Subject is enrolled in concurrent study that may confound the results of this study
* Subject is taking muscle relaxant medication unless approved by the site implanter and ZOLL Respicardia clinical staff
* Subject has evidence of nerve weakness/paresis/paralysis or a neurologic disorder that involves the tongue
Safety, Efficacy and Cost-efficacy of Ranibizumab (Monotherapy or Combination With Laser) in the Treatment of Diabetic Macular Edema (DME)

To evaluate, specifically within the Canadian medical environment, the efficacy, safety and cost-efficacy of ranibizumab administered either as combination therapy (ranibizumab plus laser photocoagulation), or as monotherapy in comparison with the current standard of care (laser photocoagulation monotherapy), in patients with visual impairment due to DME.


Eligibility Criteria:
Inclusion Criteria:

* Stable Type 1 or Type 2 diabetes mellitus
* Visual impairment due to focal or diffuse DME in at least one eye

Exclusion Criteria:

* Active conditions in the study eye that could prevent the improvement of visual acuity on study treatment
* Active eye infection or inflammation
* History of stroke, renal failure or uncontrolled hypertension

Other protocol-defined inclusion/exclusion criteria may apply
PulseSelect™ PFA Global Registry

The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-approval study. Subjects will be treated with the PulseSelect™ PFA System and followed according to SOC.

The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-market registry. The purpose of this clinical study is to collect clinical performance and safety data in a broad patient population treated with the PulseSelect™ PFA system. The PulseSelect™ PFA System used in the study is market approved. The ablation procedure will be performed according to routine hospital practice. The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure.

Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years of age or minimum age as required by local regulations.
* Subject has been diagnosed with atrial fibrillation (AF)
* Planned procedure using commercially available PulseSelect™ PFA System.
* Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements.

Exclusion Criteria:

* Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager.
* Subject with exclusion criteria required by local law.