cyrilzakka/clinical-trials huggingface dataset:
Shift Work, Heredity, Insulin, and Food Timing Study

The purpose of this study is to determine whether night time eating that coincides with elevated endogenous melatonin impairs glucose tolerance, particularly in carriers of the MTNR1B risk allele.

Preliminary observations suggest that food intake coincident with high melatonin levels leads to impaired glucose tolerance-particularly in MTNR1B risk allele carriers. Our objectives are to determine the effect of concurrent food intake and melatonin on glucose tolerance; and to assess the role of MTNR1B single nucleotide polymorphism (SNP)\*melatonin interaction in this deleterious effect. Our central hypothesis is that concurrent high melatonin levels and food intake, commonly experienced in night shift workers, cause long-term impairment of glucose tolerance and that this effect is worse in carriers of the MTNR1B type 2 diabetes (T2D) risk SNP than in non-carriers. The results of this proposal will help to clarify an ongoing controversy about the role of melatonin in glucose tolerance, and will help to develop novel strategies in the prevention and treatment of T2D, especially in shift workers, night eaters, and MTNR1B risk allele carriers.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female
* 18-60 years
* Currently employed (night shift workers and day workers), graduate students, part-time workers, or unemployed
* Able and willing to give consent relevant to genetic investigation

Exclusion Criteria:

* Currently taking any medications for the treatment of diabetes
* Currently taking medications known to affect glycemic parameters, such as glucocorticoids, growth hormone or fluoroquinolones
* Pregnant, nursing or at risk of becoming pregnant
* Chronic renal failure, hepatic diseases, or cancer diagnoses
* Bulimia diagnosis, prone to binge eating
* Eating disorder diagnosis such as anorexia, binge eating, or bulimia
* With psychiatric illness, such as schizophrenia or bipolar affective disorder
* Blind
* History of bariatric surgery
Acute Pain Memory Among Former Burned: Exploration of fMRI.

Pain is complex phenomenon misunderstood in spite of medical progress and neurosciences. That's why the relief of chronic pain is only partial for a lot of infection as arthrosis, chronic back pain, headaches or neuropathic pain. Certain situations bring to relive pain sensation. Investigators were interested to former burned. They wonder about somatic memory and unconscious of acute.

It is a comparative and monocentric study. There are two groups. On the one hand, there is the former burned and, on the other hand, healthy volunteers. While they thought to painful memory or not, functional Magnetic Resonance Imaging (fMRI) will be performed. Then, investigators compare two functional Magnetic Resonance Imaging (fMRI).

Main objective of this study is link up between brain activity by functional Magnetic Resonance Imaging (fMRI) and acute pain memory.

Eligibility Criteria:
Inclusion Criteria:

For control group:

* Affiliated or entitled to a social security
* Have signed consent before their participation in the study
* Adult women and men french and is right handed
* Vision and hearing normal or corrected

For former burned:

* Affiliated or entitled to a social security
* Have signed consent before their participation in the study
* Adult women and men french and is right handed
* Vision and hearing normal or corrected
* Localized burn at the hand or feet onset between 12 and 24 years
* Not sequelae painful at the inclusion
* Scope and depth of the burn according to classifications CIM 10

Exclusion Criteria:

For control group:

* Any contraindications to pass an fMRI test
* Neuropathic pains and psychiatric disorders
* Medical history of head injuries
* Burn presence

For former burned:

* Any contraindications to pass an fMRI test
* Neuropathic pains and psychiatric disorders
* Medical history of head injuries
Sequential Compression Devices for Treatment of Restless Legs Syndrome

The purpose of this study is to determine if sequential compression devices (SCD) when worn for an hour per day by patients suffering from Restless Legs Syndrome (RLS) are helpful for the improvement of the RLS symptoms and sleep.

Restless legs syndrome (RLS) is a highly vexing problem manifested by sensory and motor symptoms that disrupt sleep onset or sleep maintenance. RLS is the second most common sleep disorder and occurs with an estimated prevalence of 10% in the general population. The sleep disruption results in daytime symptoms such as excessive daytime sleepiness (EDS) and mood changes. There are no consistently reliable treatment alternatives. There is an urgent need for new, innovative treatment strategies because available pharmacological treatments often stop working over time or are associated with unacceptable side effects. An effective nonpharmacological treatment would be a highly attractive alternative.

Anecdotally, patients have reported that use of sequential compression devices (SCD) prescribed for prophylaxis of deep vein thrombosis can have a positive effect on RLS symptoms. Because this nonpharmacological alternative is available, safe, and affordable, further investigation is warranted.

Simply stated, the null hypothesis is that SCD therapy does not have an impact on RLS symptoms.

Patients will be randomized to wearing SCDs or sham SCDs for an hour each day prior to the usual onset of the RLS symptoms. At baseline and at monthly follow-ups for 3 to 4 months, participants will complete questionnaires to assess the severity of the RLS symptoms, their daytime sleepiness, and the impact of the RLS on quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 17 years with a reliable diagnosis of RLS in accordance with the International Classification of Sleep Disorders, Revised Diagnostic and Coding Manual of the American Academy of Sleep Medicine.

Exclusion Criteria:

* Age less than 18 years
* Unstable medical conditions that may interfere with the requirements of the study (for example uncontrolled diabetes mellitus, symptomatic asthma, congestive heart failure with symptoms of pulmonary edema), and mental or physical limitations (including dementia) that would preclude data collection on questionnaires or wearing the SCD.
* Other medical conditions that would serve as exclusion criteria are those where increased venous or lymphatic return is undesirable. These specific conditions are known or suspected acute deep vein thrombosis, thrombophlebitis, severe congestive heart failure, pulmonary edema, severe arteriosclerosis, active infection such as gangrene, recent vein ligation or skin graft, or extreme deformity of the legs.
Intraperitoneal Bupivacaine for Pelvic Organ Prolapse

The purpose of this study is to evaluate the effects of 30 mL intraperitoneal Bupivacaine without epinephrine 0.25% on postoperative pain control in patients undergoing pelvic organ prolapse repair. The investigators hypothesize that use of intraperitoneal Bupivacaine will decrease postoperative pain scores and opiate consumption in the postoperative period, following pelvic organ prolapse repair.


Eligibility Criteria:
4.1 Inclusion Criteria

List the criteria:

* Age \>= 18 years
* Access to cell phone with text messaging capabilities (for same day surgery discharge)
* Patients undergoing pelvic organ prolapse repair with peritoneal access 4.2 Exclusion Criteria

List the criteria:

* Bupivacaine allergy
* History of epilepsy or other seizure disorder
* EKG demonstrating asymptomatic sinus bradycardia \<40 bpm, symptomatic sinus bradycardia \<60 bpm, first degree AV block, second degree AV block, third degree AV block, prolonged QT, atrial fibrillation, supraventricular tachycardia, or myocardial infarction
* Chronic liver disease proved by any ALT or AST elevation greater than 2x upper limit of normal
* Serum bilirubin elevation in excess of 5 mg/dL
* G6PD deficiency
* Weight less than 100 lbs
* Chronic opiate use
Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A

Sobi.BIVV001-003 is an open-label, 2-period, fixed sequence study for intra-participant comparison of the PK profiles of efanesoctocog alfa and the extended half-life rFVIII products damactocog alfa pegol or turoctocog alfa pegol after a single i.v. injection in previously treated males, 18-65 years of age, with severe haemophilia A.

Participants who are receiving treatment with damoctocog alfa pegol (n\~12) or turoctocog alfa pegol (n\~12) will be enrolled in the study. The study will start with a screening period (up to 28 days), including a wash-out period prior to start of the actual study period.

During the the first visit, a single dose of damactocog alfa pegol or turoctocog alfa pegol (corresponding to the participant's pre-study treatment) will be administered. A PK sampling period will follow over 7 visits. Following completion of the PK sampling of the original treatment regimen, the patients will be given a single dose of efanesoctocog alfa at visit 8, after which a new PK sampling period will follow (visit 8-15).

The primary objective for the study is to compare the half-life of efanesoctocog alfa with that of the two comparator drugs after a single iv. injections.

Secondary objectives include comparison of area under the curve for efanesoctocog alfa vs. the two comparator drugs, characterization of PK parameters for all three drugs as well as well as to evaluate safety and tolerability of a single iv. injection of efanesoctocog alfa.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be male, 18 to 65 years of age, inclusive, at the time of signing the informed consent form (ICF).
* Severe haemophilia A, defined as \<1 IU/dL (\<1%) endogenous FVIII activity, as documented in historical medical records from a clinical laboratory demonstrating \<1% FVIII coagulant activitiy or a documented genotype known to produce severe haemophilia A.
* Previous treatment for haemophilia A with any marketed recombinant and/or plasma derived FVIII for at least 150 exposure days.
* Currently receiving treatment with damoctocog alfa pegol or turoctocog alfa pegol at Screening.

Exclusion Criteria:

* Any history of a positive inhibitor test, defined as \>0.6 Bethesda units (BU)/mL in at least two consecutive Bethesda inhibitor assays, or any value greated than or equal to the lower sensitivity cut-off for laboratories with cut-offs for inhibitor detection between 0.7 and 1.0 BU/mL. Family history of inhibitors will not exclude the participant.
* Positive FVIII inhibitor result (assessed by central laboratory), defined as ≥0.6 BU/mL at Screening.
An Analgesia Protocol for Acute Renal Colic in the Emergency Department

An analgesia protocol for acute renal colic will lead to faster significant reductions in pain than prior practice.

A retrospective study was performed that assessed the time to significant analgesia and medications used to achieve analgesia in the DHMC ED. Based upon this a prospective pain management protocol was designed and we will track the difference in time to significant pain relief between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Kidney stone on stone protocol CT scan
* Acute pain from a kidney stone

Exclusion Criteria:

* Age \< 18 or \> 65
* Pregnant women
* Contraindications to NSAID's or opiates
Evaluation of the Effects of A-Prf and Oral Dexamethasone Use in Third Molar Extraction

Impacted third molar tooth extraction is one of the most frequently performed procedures in oral surgery. Complications such as pain, swelling and trismus, which are frequently seen after this operation, affect the patient's quality of life in the postoperative period. Today, there are many methods used to prevent or treat these complications. Corticosteroid use and A-PRF biomaterial obtained from the patient's own blood are some of these methods. In patients with bilaterally impacted lower wisdom teeth, A-PRF was applied to one side after extraction and postoperative oral dexamethasone was used to the other side. Intra-group and inter-group evaluations were made by collecting the patients' pain, edema, trismus and analgesic use data.

Impacted third molar tooth extraction is one of the most commonly performed procedures in oral surgery. Complications such as pain, swelling and trismus, which are frequently seen after this operation, affect the quality of life of the patient in the postoperative period and may cause patients to avoid this procedure. Today, there are many methods used to prevent or treat these complications. The use of corticosteroids and the A-PRF biomaterial obtained from the patient's own blood are some of these methods. No study has been found in the literature comparing the effects of oral use of dexamethasone, a corticosteroid drug, with A-PRF on pain, edema, trismus and analgesic use. In patients with bilateral impacted lower wisdom teeth, A-PRF was applied to the extraction site after extraction on one side and postoperative oral dexamethasone was used on the other side. Pain, edema, trismus and analgesic use data of the patients were collected and in-group and intergroup evaluations were made.

Eligibility Criteria:
Inclusion Criteria:

* Not having any systemic disease,
* Being over 18 years of age,
* Bilateral teeth being in similar positions and being completely impacted,
* Not having any allergies to the drugs to be used in the study.

Exclusion Criteria:

* Infection in the area where the extraction will be performed,
* Pregnancy or breastfeeding,
* Using medication up to 2 weeks before tooth extraction,
* Not using prescribed medications regularly,
* Not coming to regular check-ups.
Triple Combination Therapy in High Risk Crohn's Disease (CD)

The purpose of this study is to determine the effect of triple combination therapy with an anti-integrin (vedolizumab intravenous \[IV\]), a tumor necrosis factor (TNF) antagonist (adalimumab subcutaneously \[SC\]), and an immunomodulator (oral methotrexate) on endoscopic remission in participants with newly-diagnosed CD stratified at higher risk for complications.

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have CD. This study will look at the endoscopic remission and mucosal healing of gastrointestinal tract of people who take vedolizumab as triple combination therapy with adalimumab and methotrexate.

The study will enroll approximately 60 participants. Participants will receive triple combination therapy which includes:

* Vedolizumab 300 mg (intravenous)
* Adalimumab 160/80/40 mg (subcutaneous)
* Methotrexate 15 mg (oral)

All participants will receive vedolizumab intravenous infusion on Weeks 0, 2, 6, 14 and 22 along with adalimumab 160 mg, subcutaneous injection at Week 0, 80 mg at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with methotrexate tablets orally, once weekly from Weeks 0 up to Week 34. In monotherapy phase, all participants will receive vedolizumab intravenous infusion once at Weeks 30, 38, 46, 54, 62, 70, 78, 86, 94 and 102.

This multi-center trial will be conducted in the United States and Canada. The overall time to participate in this study is 128 weeks. Participants will make multiple visits to the clinic, plus a final visit 18 weeks after last dose of study drug for a safety follow-up assessment. Participants will also participate in a long-term safety questionnaire, by phone, at 26 weeks (6 months) from the last dose of study drug.

Eligibility Criteria:
Inclusion Criteria:

1. Has an initial diagnosis of CD established within 24 months prior to screening with involvement of the ileum and/or colon that can be assessed by ileocolonoscopy.
2. Has moderate to severely active CD during Screening defined by a centrally assessed simple endoscopic score for Crohn disease (SES-CD) score \>=7 (or \>=4 if isolated ileal disease).

Exclusion Criteria:

Gastrointestinal (GI) Exclusion Criteria

1. Has a diagnosis of ulcerative colitis (UC) or indeterminate colitis.
2. Has clinical evidence of a current abdominal abscess or a history of prior abdominal abscess.
3. Has a known perianal fistula with abscess. (The participant may have a perianal fistula without abscess.)
4. Has a known fistula (other than perianal fistula).
Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)

This study will compare the safety, tolerability, and immunogenicity of measles, mumps, rubella, and varicella (MMRV) vaccine made with an alternative manufacturing process with those of the 2006 process


Eligibility Criteria:
Inclusion Criteria:

* Negative clinical history for measles, mumps, rubella, varicella, and zoster

Exclusion Criteria:

* Received any measles, mumps, rubella, or varicella vaccine, either alone or in any combination at any time prior to the study, or is anticipated to receive any of these vaccines outside of study protocol, either alone or in any combination, during the study
* Received immune globulin, a blood transfusion or blood-derived products (does not include autologous blood/blood products) within 5 months (150 days) prior to any dose of the study vaccines or plans to receive these products while enrolled in this study
* Exposed to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the study vaccination
* Any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity, including that resulting from steroid use or other immunosuppressive therapy
* Received 1) systemic immunomodulatory steroids \[greater than the

equivalent of 2 mg/kg total daily dose of prednisone\] within 3 months prior to

entering the study, or 2) any dose of systemic immunomodulatory steroids within

7 days prior to entering study, or 3) is expected to require systemic immunomodulatory steroids through the course of the study

* History of allergy or anaphylactoid reaction to gelatin, sorbitol, neomycin, egg proteins (eggs or egg products), chicken proteins, or any component of the study vaccines
* Received salicylates (eg, aspirin or aspirin-containing products) within 14 days prior to study vaccination
* Diagnosis of an active neurological disorder. Enrollment may be considered

when the disease process has been stabilized

* History of seizure disorder, including single febrile seizure
* Diagnosis of active untreated tuberculosis
* History of thrombocytopenia
* Born to a human immunodeficiency virus (HIV) infected mother
Improving Child Mental Health Service Utilization in Ibadan

The investigators will develop and evaluate a community-based participatory intervention that will be principally guided by the model we test and confirm in Aim 1. To meet this second aim, ten guardian consultants will co-develop and co-implement a group intervention whose goal is to increase 100 guardians' recognition and knowledge of CAMH problems, perceived need for CAMH services, and willingness to use accessible services at UCH. The investigators will also evaluate the process of developing, planning, and administering a CBP intervention in Nigeria and draw broader implications for CBP programming in other LMICs.

One hundred participants will be randomly recruited from the cohort of guardians who completed the interview in Phase 1 and expressed interest in participating in an intervention. The investigators will use a switching replication design in which fifty guardians will be randomly assigned using a lottery to receive the intervention and fifty will be assigned to a group who will receive the intervention at a later time point.127 The latter group will serve as a control in the first part of the intervention plan, and the roles will be switched in the second part. The investigators will initially propose 4 intervention sessions, each comprised of 2 meetings, lasting 1.5 hours each for 25 guardians. Two sessions will be conducted concurrently for Group 1 (n=50) followed by 2 sessions concurrently conducted for Group 2 (n=50). The program outcomes - guardian recognition and knowledge of CAMH problems, the perceived need for CAMH services, and willingness to use accessible CAMH services - will be measured with the same instruments administered in Aim 1

Eligibility Criteria:
Inclusion Criteria:

* Participated in Phase 1 of student (participated in structured interview)

Exclusion Criteria:

-
Physiotherapy Investigation in Patient With Temporomandibular Joint Dysfunction

Knowing the associated factors for people suffering from TMD may help to develop preventive, therapeutic and health strategies. The aim of this study was to present the assessments of audiovestibular symptoms in people with TMD. The main question it aims to answer is the questions are as follows:

1. Is there a relationship between TMJ symptoms and audiovestibular assessment in people with TMD?

Participants will:

Participants diagnosed with TMD will be informed about the study and informed consent will be obtained. Data obtained after the TMJ and vestibular system evaluation of the participants will be analyzed.

Temporomandibular dysfunction (TMD) is a health condition affecting the temporomandibular joint (TMJ) and related structures. The prevalence of TMD in adults affects a very large portion of the world's population. TMD is complex and multifactorial due to its etiology with neuromuscular, traumatic, degenerative and sociodemographic aspects. The aim of this study is to reveal audiovestibular assessments in individuals with TMD. After obtaining voluntary consent forms, participants are subjected to assessments. The "Statistical Package for Social Sciences (SPSS) Statistics 23.0 (SPSS Inc, Chicago, USA) program will be used in the analysis of the study data. Before starting the analysis of the data, the Kolmogorv Smirnov test will be used to check whether the data is suitable for normal distribution. Data that are suitable for normal distribution will be analyzed with parametric tests, and those that are not suitable for normal distribution will be analyzed with non-parametric tests. Descriptive statistics for quantitative variables will be shown as mean and standard deviation, and for qualitative variables determined by counting, descriptive statistics will be shown as numbers and percentages. T-test/chi square/Mann Whitney U will be used in two-group comparisons, and one-way variance analysis/Kruskal Wallis test will be used in three-group comparisons.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in the study between the ages of 18-35
* Diagnosed with unilateral TMJ disorder at least 1 month ago according to the - Research Diagnostic Criteria of Temporomandibular Disorders (RDC/TMD) classification (Dworkin et al., 1992)
* Having muscle tenderness and pain in the temporomandibular joint region

Exclusion Criteria:

* Traumatic injuries in the same area other than TMD
* Ear diseases that cause hearing loss
* Dentofacial Anomalies
* Receiving orthodontic treatment
* Neurological diseases, vestibular or visual problems