cyrilzakka/clinical-trials huggingface dataset:
Compex Use With Delayed Onset Muscle Soreness: A Comparison to Other Methods

The purpose of this research study is to determine if the application of ice, control group, or a muscle stimulation program from the Compex® series can help reduce or eliminate delayed muscle soreness from performing leg extension and flexion. Individuals will complete a health history questionnaire to determine if they qualify for this study. We will measure your leg girth with a measuring tape and take a pain measurement of your hamstrings by using a spring to press down on your leg. Individuals will then warm-up on a bike without resistance for 5 minutes followed by 10 regular leg extension and flexion exercises. Individuals will then perform 6 sets of 10 leg extension and flexion exercises on a biodex machine (similar to leg curl machines in the gym). Individuals will perform each set to the maximum effort of their capables. After each set of 10 individuals will have a 2 minute rest. We will ask you to rank your leg soreness on a scale from 1-10.

Individuals will then be assigned to a modality of either ice, control group or compex. Individuals will perform the modality (ice, control, compex) we assign you to until you are no longer sore.

Over the next five days individuals will return to measure their level of soreness, leg girth and pain pressure.

This study will examine the following hypotheses:

H1: There will be no difference in pressure pain threshold after using the Compex compared to other groups.

H2: There will be no difference in perceived soreness after using the Compex compared to other groups.

H3: There will be no difference in muscular strength after using the Compex compared to other groups.

H4: There will be no difference in active range of motion after using the Compex compared to other groups.


Eligibility Criteria:
Inclusion Criteria:

* The studied population will be composed of 45 physically active college students between the ages of 18-30 years old.
* Inclusionary criteria will be participation in a physical activity as defined by the ACSM, which can be a mixture of moderate (i.e., sufficient to raise the heart rate and begin to sweat) and vigorous (i.e., breathing hard and fast with a rapidly rising heart rate) intensity aerobic activity and muscle strengthening (i.e., weights lifted to the point where anther repetition cannot be completed without help) activities two or more time per week (ACSM, 2011.)

Exclusion Criteria:

* Exclusionary criteria will be surgery within the last six months requiring immobilization for more than four weeks, discomfort performing intense physical activity, diseases like muscular dystrophy that predispose muscular damage beyond reasonable levels resulting from physical activity, and current injury of the knees or hips.
Cytomegalovirus (CMV) Perilymphatic Fluid

In France, children cochlear implantation (CI) is performed 400 times per year. Causes of profound sensorineural hearing loss (SNHL) are represented by congenital malformation of the inner ear for 50 to 60%. Most of the remaining cases of CI in children are caused by congenital CMV infection. The proportion of CMV inducing SNHL with a CI in children is not clearly defined. During CI, we aim to collect a very small sample of perilymphatic fluid and to analyse it with a CMV polymerised-chain-reaction to evaluate the involvement of CMV in SNHL.

Data on etiology of hearing loss and CMV status are collected. Perilymphatic liquid is collected after cochleostomy using a 1ml seringue. The drop of liquid is deposited on a Guthrie card; on another card, a drop of blood is deposited on another card. CMV PCR (polymerised chain reaction) is then performed in order to assess for the presence of CMV. The sensibility, specificity, positive and negative positive values are then calculated.

Eligibility Criteria:
Inclusion Criteria:

* Children (under 18-year-old) presenting with a Sensorineural Hearing Loss with an indication of cochlear implantation

Exclusion Criteria:

-
Comparison of Antibiotic Protocols in Spine Patients With Postoperative Drains

In spine surgery, postoperative spinal drains are often utilized to prevent fluid buildup around the spinal cord. The purpose of this study is to determine whether postoperative antibiotic treatment continued for the duration of time a drain is in place results in a lower infection rate than antibiotics given for only 24 hours postoperatively.

Patients likely to receive postoperative spinal drains were enrolled and randomized preoperatively to receive one of two postoperative antibiotic treatments, either for 24 hours after surgery or for the duration of time the spinal drain was in place. If patients did not receive at least one spinal drain during surgery, they were excluded from the infection analysis and received the institutional standard of 24 hours of postoperative antibiotics. Patients that did receive drains were treated according to their randomization and followed for a minimum of one year for the incidence of surgical site infection. The diagnosis of surgical site infection was determined using the definition provided for the Center for Disease Control (CDC). All patients that developed surgical site infections were treated as appropriate by the attending physician.

Eligibility Criteria:
Inclusion Criteria:

* Must be scheduled to undergo spine surgery with likely drain placement (3 or more vertebral levels, dependent upon attending surgeon)
* Must be over the age of 18
* Must consent to randomized postoperative antibiotic treatment

Exclusion Criteria:

* Does not receive a drain at the time of surgery
* Surgery is cancelled
* Infection is present at the time of initial surgery
Longitudinal Prospective Study in a Mixed ICU Population

Longitudinal prospective observational multicenter study in a mixed population of intensive care unit (ICU) patients (n=650). The overall purpose of this research proposal is to increase the knowledge in how pre-morbid condition, symptoms during treatment, and selected clinical variables affect self-reported functional status during first year after an ICU admission.

For this study data will be collected using self-report questionnaires for the long-term outcome (e.g functional status) and several covariates (e.g., cognition, anxiety and depression, PTSD, QOL, general symptoms, frailty). To retrieve baseline data from prior ICU admission, family members will be used as proxy reporters at inclusion. During treatment in the ICU, patients will be mapped for 5 pre-selected symptoms every day for 7 days, or until death or ICU discharge. Several clinical variables (e.g., SOFA score, pain score, level of sedation, mobilization, medication, mouth care) will be collected daily until maximum 7 days. Follow-up data will be collected at 3, 6 and 12 months after ICU admission using self-report questionnaires.

The predictive value of pre-morbid condition prior to ICU admission on functional status during the first year after an ICU admission will be investigated, when controlled for various clinical and demographic variables. As a secondary analyses, the present study will identify both the occurrence of symptoms as well as the severity and distress of each symptom, while in the ICU. Another secondary outcome that will be measured in this longitudinal study is the association between cognitive function one year after an ICU admission and various mental health variables (PTSD, anxiety and depression).

Eligibility Criteria:
Inclusion Criteria

* Patients that are \> 18 years and
* Meet the criteria of Norwegian Intensive Register (NIR) for being an intensive care patient. The criteria include any on the following criteria:
* The need of mechanical ventilation, or
* The need of continuous inotropi, or
* 24 hours or more on an ICU, when continuous monitoring is needed, or
* Dies at the ICU within the first 24 hours, or
* Transferred to another ICU within the first 24 hours

Exclusion Criteria:

* Re-admissions to the ICU (within 72 hours from last ICU discharge)
* Pre-defined cognitive deficit (e.g. dementia)
* Homeless
* Unable to read and Write Norwegian
* Not included in the study within the first 48 hours since admission to the ICU
Family Planning Through Dairy Cooperatives

This observational study will assess a model for providing family planning through quarterly events organized by dairy cooperatives supported by Land O'Lakes in Kenya.

Access to family planning and other reproductive health services remains difficult in much of rural Kenya. One option for improving rural access to family planning is to use existing community events outside of the health sector as platforms for delivering information and services. This study will assess a model for providing family planning through quarterly events organized by dairy cooperatives supported by Land O'Lakes in Kenya. During these events, known as Field Days, a healthcare provider will have a tent in which Field Day attendees can receive basic family health services free of charge. The services offered will be: family planning counseling and methods, immunizations, antenatal care, screening and treatment for sexually transmitted infections, and HIV counseling and testing. Since the services are no different than those that could be obtained at Ministry of Health or some private facilities, the service provision is not considered to be part of the research.

Women receiving any service from the health care provider will be recruited for an interview that will measure their demand for family planning and attitudes about receiving services during the field day. In addition, the study will track the number of different types of services provided, the total number of Field Day attendees, and the cost of the service model. The study will be carried out at five Field Days in Rift Valley and Central provinces.

Participants will not be tested for STI/HIV as part of this research; however, at their request, they may have received a test from the provider prior to the research interview. At the time of consent, they will have already received the test, so the consent form will not include anything specific to testing. In Kenya, all STI/HIV test results are reported to the national public health authorities. These reports are not used for contacting patients but for planning purposes.

Eligibility Criteria:
Inclusion Criteria:females aged 18-49 receiving health services at a field day event -

Exclusion Criteria:

-
Patient Control Epidural Versus Conventional Epidural.

As one of the complications of THR is post operative pain, which usually requires epidural catheter insertion.

We are comparing the effect of patient control epidural versus conventional epidural for patient's satisfaction.

More than 20 years of successful usage of epidural analgesia for post operative pain treatment include intermittent provider-administer bolus, patient control analgesia and continuous epidural infusion with or without patient control epidural analgesia. The main drawback of conventional epidural infusion is that it does not allow for individual variation in management of pain. As a result, patient control epidural analgesia has replaced it in recent years.3. It has been demonstrated that continuous epidural infusion with patient control epidural analgesia is highly effective at providing consistent analgesia, improving patient satisfaction, and reducing the workload of anesthesia provider but it is linked to higher local anesthetic consumption4 In patient undergoing THR, patient control epidural analgesia may be considered as an appropriate alternative for managing post operative pain.

Eligibility Criteria:
Inclusion Criteria:

Age \>18 years. ASA 1-2 on pre anesthesia evaluation. Spontaneous breathing. Spo2 \>95% Informed consent for participation.

Exclusion Criteria:

A history of long-term opioid therapy (use of opioid analgesic at doses higher than codeine 120mg/day, hydrocodone 40mg/day, tramadol 200mg/day or oxycodone 40mg/day 0-4 days before surgery).

Indication of revision surgery during immediate post operative care. Acute skin disease. Patients' refusal. ASA 3 and 4. Hypersensitivity to study drugs.
DNA Methylation and Urothelial Carcinoma

Many studies previously showed the significant association between urinary arsenic profiles and urothelial carcinoma (UC) risk and observed the increased UC risk in people with lower plasma folate and higher homocysteine than those with higher plasma folate and lower homocysteine. The investigators would expect to explore the interactions among global DNA methylation, one-carbon metabolic pathway factors, urinary arsenic profiles and UC.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of urothelial carcinoma
* The voluntary of participating the study

Exclusion Criteria:

* Age smaller than 20 years
* Pregnant women
* Not willing to participate the study because of their personal reasons
IP3R Modulation by Cancer Genes in Mesothelioma

Obtaining pleural biopsies in cases of malignant mesothelioma to detect molecular mechnisms and signal transduction


Eligibility Criteria:
Inclusion Criteria:

* suspicion of mesothelioma
* referral for diagnostic thoracoscopy

Exclusion Criteria:

* contra-indication for thoracoscopy
A Prospective Randomized Controlled Trial on the Use of Bone Morphogenetic 7 (BMP-7) (OP-1®) and Demineralized Bone Matrix in Tibial Non-union

The researchers propose a prospective, randomised partially-blinded study to investigate the clinical and radiological outcome, effect on quality of life and socio-economic impact of non-union of diaphysary tibial fractures treated with BMP-7 in adjunct to fresh frozen allograft, in comparison to treatment with allograft together with DBM (demineralised bone matrix).


Eligibility Criteria:
Inclusion Criteria:

* Diaphysary tibial non-unions will be included (9 months after first surgery)
* Major surgery includes exchange nailing, bone grafting, internal fixation, amputation and soft-tissue coverage procedures, such as delayed primary closure and free flaps
* Surgery is classified as minor for removal of external fixator pins for local infection and removal of a static locking screw from intramedullary nails, a procedure known as dynamization
* ASA 1 and ASA 2
* Gap length/bone contact detected (1-5 cm): largest cortical gap in any radiographic incidence
* Subject or legal guardian is willing and able to understand, sign and date the study specific Patient Informed Consent, which has been approved by the Institutional Review Board
* Agrees to participate in post-operative evaluations and required rehabilitation regimen

Exclusion Criteria:

* Patients with known hypersensitivity to the active substance or collagen
* Gap more than 5 cm
* Immature skeleton
* Known auto-immune disease, including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome and dermatomyositis/polymyositis
* Active infection on unhealed site or active systemic infection
* Non-healing resulting from pathological fractures, tumours or metabolic bone diseases
* Presence of tumour in vicinity of non-union
* Patients receiving chemotherapy, radiotherapy or immunosuppressant treatment or excessive steroids
* Patients with severely compromised soft tissue coverage or vascularisation at the non-union site, sufficient to impair bone healing
* Patients with congenital non-union
* Pregnancy and lactation
* Non-union of multiple bones interfering with walking
* Patients with neuromuscular diseases or conditions interfering normal weight bearing
* Patients who, judged by the surgeon, are candidates for just internal fixation alone
Vitamin D Deficiency in Chronic Kidney Disease (CKD) Patients

This is an open label, single center, randomized, active comparator controlled study, comparing the effects of vitamin D replacement using oral ergocalciferol versus paricalcitol on parathyroid hormone (PTH) levels in patients with stage 3 and 4 CKD and vitamin D deficiency or insufficiency. The purpose of this study is to determine which of these two approaches is more successful.

This study will enroll chronic kidney disease patients, stage 3 and 4, who have low serum vitamin D levels as defined by K DOQI Guidelines. Patients will be randomized to receive oral daily ergocalciferol or paricalcitol. A total of 80 patients will be enrolled, 40 in the cholecalciferol group and 40 in the paricalcitol group. Outcomes will be assessed as proportion of patients achieving pre-defined changes from baseline and as absolute changes from baseline values. Baseline values will be determined from averaging two consecutive measurements of the variables of interest prior to randomization.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female chronic kidney disease patients at least 18 years of age.
2. Patients should be able and willing to provide written informed consent and HIPAA Authorization.
3. Chronic kidney disease stage 3 or 4.
4. Plasma intactPTH level above 75pg/ml.
5. Serum 25 OHD level below 30ng/ml.
6. Negative pregnancy test unless 2 years postmenopausal or with a documented tubal ligation or total hysterectomy.
7. Patients need to be off of any Vitamin analogues or preparations for 4 weeks prior to screening.

Exclusion Criteria:

1. Women who are breast feeding, pregnant, capable of becoming pregnant, and not participating in an acceptable form of birth control.
2. Patients currently participating in a clinical trial with another investigational drug or device or who have receive an investigational drug or device within 30 days of enrollment in this study.
3. Major surgery within one month prior to enrollment or planned surgery while patient is in study (other than dialysis vascular access surgery).
4. Patients who have had a malignancy unless they have received curative treatment and have been disease free for 2 years.
5. Patients with a medical status that the PI decides would preclude participation.
6. Patients on hemodialysis or peritoneal dialysis.
7. Patients with a functional renal transplant.
8. Patients with allergies to study drugs.
9. Patients with acute renal failure with the past 12 weeks.
10. Patients with clinically significant gastrointestinal or liver disease.
11. Patients with active granulomatous disease.
12. Patients with urine calcium:creatinine ratio of more than 0.2.
13. Patients who received vitamin D analogs, calcimimetics, or biphosphonates within 4 weeks before screening. Treatment with any one of these medicines during the study is not permitted.
Diet and Migraine Study

The purpose of this study is to look at two different diets (a low carbohydrate diet and a low fat diet) for migraine prevention in overweight or obese persons with migraine. The overall aim is to test the theory that diet will improve migraine frequency and that such improvements will be associated with favorable changes in body weight, inflammation, and heart health.

Obesity is a risk factor for migraine. Further, in the past decade multiple lines of research have substantiated the presence of migraine headaches as a risk factor for CVD (eg. stroke). Migraineurs have also been demonstrated to have abnormal insulin responses, higher lipids and endothelial dysfunction. Limited data suggests a low fat diet may be of benefit in reducing migraine frequency; no studies have examined the efficacy of a low carbohydrate (ie. low glycemic) diet for migraine prevention in adults.. None of these studies examined the effects and potential mechanisms of such diet programs on CV health, body composition, and the inflammatory cascade in migraineurs. This 3 -month study addresses the efficacy and potential mechanisms of two different diets, (a low carbohydrate diet and a low fat diet) for migraine prevention in a clinical cohort of overweight or obese persons with migraine. The overall aim is to test the hypothesis that each behavioral intervention will improve migraine frequency and that such improvements will be associated with favorable changes in body composition, inflammation, and CV parameters.

Hypothesis 1.1 The mean monthly migraine frequency will be decreased in those who maintain a low-fat diet or low-carbohydrate diet for 3 months as compared to controls.

Hypothesis 1.2 Participants randomized to the diets will demonstrate favorable changes in body composition (eg. decrease in adipose tissue volume on magnetic resonance imaging (MRI) and body fat on DEXA), inflammatory markers (eg. decrease in adipocytokine levels), and CV parameters (eg. improved cholesterol panel, glucose levels and markers of arterial stiffness) as compared to controls.

Eligibility Criteria:
Inclusion Criteria:

* overweight or obese (BMI between 25 and 42)
* women
* \>18 years and \< 50 years old
* Migraine meeting ICHD criteria for at least 6 months prior to screening
* headache frequency documented \> 2 and \< 10 headache days per month
* BP inclusion criteria are SBP \<160 or DBP \<100 mm Hg

Exclusion Criteria:

* hypocaloric diet (must be weight stable for prior 3 months)
* Self-report of alcohol or substance abuse in the past year or current treatment
* Type 1 or 2 diabetes
Non-Mesh Versus Mesh Method for Inguinal Hernia Repair

The study aims at establishing the effectiveness of the non-mesh (Desarda) technique for the treatment of primary inguinal hernias at Mulago Hospital in Uganda. First developed and used in India, the Desarda method is reported to offer superior outcomes such as minimal postoperative groin pain and near zero recurrence rates. In comparison to the mesh-based repairs, it is a simple and affordable technique suitable for the resource-constrained communities. It is devoid of complications associated with foreign body implants. Early clinical outcomes which include acute groin pain, time to resumption of normal gait, operative time and complications will be assessed. Participants will be followed at 2 hours, 3 days, 7 days and 14 days postoperatively.

The investigators hypothesize that the mean postoperative acute groin pain score, or the mean postoperative day of return to normal gait is different in adult patients who undergo the non-mesh (Desarda) repair from what it is in those who undergo the mesh (Lichtenstein) technique of hernia repair.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and above;
* with a primary, reducible inguinal or inguino-scrotal hernia;
* who consent to participate in the study;
* who have a telephone contact.

Exclusion Criteria:

* Giant inguino-scrotal hernias;
* Obstructive uropathy or chronic obstructive pulmonary disease;
* Impaired mental state and are unable to give an accurate assessment of the key outcomes of the operation.