cyrilzakka/clinical-trials huggingface dataset:
Semi-Recumbent Vibration Therapy in Older Adults

This proposed prospective study will evaluate whether a novel exercise approach, seated vibration therapy, can improve function in the target population of older adults. Therefore, the primary aim of this pilot is to examine the effect of vibration therapy on muscle function (balance, muscle power and strength) and muscle mass.

There are four study visits; screening/baseline followed by eight weeks of training three times a week, visit 1 at eight weeks followed by 4 weeks of washout, Visit 2 at 12 weeks followed by eight weeks of training three times a week, and a final Visit 3 at 20 weeks.

At the screening visit, volunteers will be asked to perform tests included in the short physical performance battery (SPPB) (gait speed, chair rise, balance). If the participants score is ≤ 9 or ≤ 2 in any of the three tests included in the SPPB they will be eligible for the intervention phase. At the baseline visit several questionnaires will be obtained and participants then will proceed with muscle function tests (SPPB, jumping mechanography, grip strength, timed-up-and-go test).

Participants will then be randomized into one of two groups. The first group will receive vibration + loading treatment for the first 8 weeks, the second group will receive sham treatment (loading only). After 8 weeks both groups will go through a 4 week wash-out period and then crossover will occur. The first group will now receive sham treatment (loading only) while the second group will receive vibration + loading treatment. The participants will train for 10 minutes, 3 times a week, during the active 16 total weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women age ≥ 70 years
2. Able and willing to sign informed consent
3. Able to stand without assistance
4. Able and willing to train for 10 minutes, 3 times per week
5. Total SPPB score of ≤ 9 or ≤ 2 in any of the three tests included in the SPPB

Exclusion Criteria:

1. Cognitive impairment to the degree that it limits the ability of signing informed consent
2. Unable to sit upright for 10 minutes
3. History of injury or surgery within the prior six months which limits the ability to ambulate
4. Major illness that might cause missed training sessions or visits.
Modified Brostrӧm Procedure With and Without Possible Arthroscopy for Lateral Ankle Instability

This study is to show that the investigators believe the Modified Brostrӧm Procedure (MBP) can be completed without a routine ankle arthroscopy. Routine ankle arthroscopy, if determined not to be necessary in all cases, is a waste of resources in terms of operating room, surgeon, and staff time as well causing an increase in hospital financial expenses. Most importantly, this procedure is morbid. Ankle arthroscopy forces a patient's foot into distraction for up to one hour, exposes the patient to potentially longer anesthesia exposure that is unnecessary, increases infectious risks, and requires exposure at the portal sites near superficial nerves.

The purpose of this investigation is to determine if ankle arthroscopy is necessary in the treatment of routine ankle instability without evidence of intra-articular pathology on MRI. Our study population will include those individuals whose ankle MRI is inconclusive or negative for intra-articular pathologies, and intra-articular ankle pain is not a predominant presenting symptom. Although it is our current practice at WBAMC not to conduct an ankle arthroscopy on this group of patients, there is a debate in the literature on whether the arthroscopy should be conducted. Thus, the purpose of this study is to examine the MBP with and without ankle arthroscopy.

Eligibility Criteria:
Inclusion Criteria:

1. Able to independently consent for surgery
2. Able to demonstrate an understanding of study procedures
3. Adult patient 18 years of age or older
4. All active duty soldiers, Veterans, dependents
5. Ability to comply with study procedures for the entire length of the study
6. Presence of lateral ankle instability meeting operative criteria listed in 6.2.1 with documented failed conservative measures such as: physical therapy, ankle braces, and rest

Exclusion Criteria:

1. Unable to obtain medical clearance for surgery
2. Recent (1 month) febrile illness that precludes or delays participation
3. History of or suspected of drug/alcohol abuse, as these patients may not be compliant with physical therapy. All patients are required to be immobilized for 6 weeks after surgery
4. Pregnant women, this is an elective procedure and a MBP or ankle arthroscopy is not typically offered to pregnant women. Screening for pregnancy is done as part of standard of care
TRI-V Heart Failure (HF) Implanted Cardioverter Defibrillator (ICD) Study

It's the aim of this study to investigate the impact of Right Ventricular (RV) lead position (RV-apex, His bundle area, RV-apex+His bundle area) in combination with individually optimized Left Ventricular (LV) lead placement and CRT timing on the outcome of cardiac resynchronization therapy (CRT).


Eligibility Criteria:
Inclusion Criteria:

* Patient with indication for CRT-D: NYHA III-IV congestive heart failure, in spite of optimal medical treatment for their congestive heart failure
* LVEDD \> 55 mm or \> 30 mm/m² BSA
* EF \< 35%
* Sinus rhythm and one of the following criteria:
* QRS \>= 120 ms and PQ \>= 200ms
* or
* 2nd / 3rd degree AV block
* Written informed consent

Exclusion Criteria:

* pacemaker indication (without ICD indication)
* tricuspidal valve and/or aortic valve replacement
* Indication for revascularization.
* less than 3 month after heart surgery or myocardial infarction
* hypertrophic obstructive cardiomyopathy
* intravenous catecholamine treatment
* uncorrected thyroid function
* severe kidney disorder (creatinin \>2,5mg%)
* no written patient consent
* insufficient patient compliance
* participating in another study
* life expectancy \< 1 year due to other severe disease
* age \< 18 years
* no contraception (young women) or pregnancy
BELux Children OutcoME During A(@)Dulthood With GHD

Our objective is to evaluate the outcome in adulthood of Belgian and Luxembourgish patients treated with rhGH during childhood for CO-GHD. The primary goal is to determine the proportion of adult CO-GHD patients who continue to receive regular medical follow-up and those still undergoing rhGH therapy using a questionnaire. Secondary objectives include assessing the regularity of follow-up and compliance with treatment in adulthood, evaluating possible comorbidities, health issues, lifestyle, living environment, and quality of life. Additionally, we aim to assess the metabolic profile in adulthood, particularly focusing on BMI, glycemic, and lipid data, for patients who consent to share their current clinical and biological data. Data will be described according to treatment adherence and CO-GHD etiology/phenotypes (e.g., idiopathic vs. organic GHD, isolated vs. combined GHD, partial vs. severe GHD).


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years
* Diagnosed with child-hood onset growth hormone deficiency (CO-GHD) (no exclusion criteria: isolated or multiple GHD, idiopathic or organic, severe or partial)
* Registered in the BELGROW registry (informed consent at the time of inclusion in registry)
* Stopped treatment with rhGH for growth after 2011
* Persistent GHD at the end of growth

Exclusion Criteria:

* No exclusion criteria
Mechanism Underlying Beta-cell Failure in Obese African Americans With History of Hyperglycemic Crises

Obesity is common in African American (AA) patients with newly diagnosed diabetes who present with diabetic ketoacidosis (DKA). Despite the presentation with severe symptoms of insulinopenia and ketoacidosis, clinical and immunogenetic observations indicate that most obese AA patients with DKA have type 2 diabetes. In such patients, previous studies reveal that: a) at presentation, obese AA patients with DKA have markedly decreased pancreatic insulin secretion, lower than in obese non-DKA patients admitted with comparable hyperglycemia, but significantly greater than in lean patients with DKA; b) aggressive diabetic management results in significant improvement in beta-cell function and insulin sensitivity sufficient to allow discontinuation of insulin therapy within 3 months of follow-up. Based on these observations the researchers conclude that similar to obese patients with hyperglycemia, most obese AA with DKA have type 2 diabetes, and that although defects in both insulin secretion and insulin action are present, transient b-cell failure is the primary defect in the development of ketoacidosis.

Obese AA patients with a history of DKA who later experience near-normoglycemia remission represent an ideal population in which to define the sequence of events that lead to b-cell dysfunction in type 2 diabetes. The researchers hypothesize that obese AA with DKA will prove particularly susceptible to beta-cells dysfunction due to sustained elevations of plasma glucose (glucose toxicity) and/or free fatty acid levels (lipotoxicity). This study will test beta-cell response by administering a glucose infusion to diabetic African Americans with a history of DKA, diabetic African Americans without a history of DKA, and non-diabetic African Americans.

Eligibility Criteria:
Inclusion Criteria:

* Obese African American subjects (body mass index (BMI) equal or greater than 30)
* Age 18-65
* Patients with a history of diabetic ketoacidosis as defined by the American Diabetes Association (ADA) criteria
* Patients admitted with hyperglycemia but without ketoacidosis (blood glucose greater than 400ml/dl without evidence of ketosis/ketones
* Obese nondiabetic controls (BMI \>30; ruled out for diabetes with a 75g oral glucose tolerance test)

Exclusion Criteria:

* Patients with positive autoimmune markers (islet cell or glutamic acid decarboxylase (GAD) autoantibodies)
* Patients with significant medical or surgical illness, including but not limited to myocardial ischemia, congestive heart failure, chronic renal insufficiency, liver failure, and infectious processes
* Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, such as hypercortisolism, acromegaly, or hyperthyroidism
* Patients with bleeding disorders, thrombocytopenia, or abnormalities in coagulation studies
* Patients with fasting hyperglycemia (blood glucose \> 120 mg/dl) after discontinuation of insulin therapy
* Pregnancy
Mindfulness - Based Intervention in the Treatment of Fatigue in Patients With Primary Biliary Cholangitis

To assess the efficacy of mindfulness-based intervention (MBI) intervention in the treatment of moderate or severe fatigue in patients with primary biliary cholangitis (PBC).

Aim 1: To assess the efficacy of mindfulness-based intervention (MBI) in the treatment of moderate or severe fatigue in patients with primary biliary cholangitis (PBC).

Hypothesis: MBI is feasible in PBC patients with fatigue and will result in improvement in symptoms of fatigue.

Aim 2: To assess the impact of MBI in physical activity levels, daytime somnolence, autonomic symptoms, functional status, cognitive dysfunction and anxiety and depressive symptoms of patients with PBC with moderate or severe fatigue.

Hypothesis: MBI will result in an improvement in physical activity levels, daytime somnolence, autonomic symptoms, functional status, cognitive dysfunction and anxiety and depressive symptoms in patients with PBC who have moderate or severe fatigue.

Aim 3: To evaluate the effects of MBI on candidate markers and/or cytokines of fatigue and physiological stress, including hepatic panel, antimitochondrial (AMA) titers, IL-1β, IL-6, TNFα, cortisol, leptin, CRP, BDNF, MIF, and CD74 levels and other relevant markers.

Hypothesis: MBI will result in a decrease of levels of above mentioned markers of fatigue and physiological stress in patients with PBC who have moderate or severe fatigue.

Eligibility Criteria:
Inclusion Criteria:

* Primary Biliary Cholangitis as defined by previously published criteria
* On stable therapy with UDCA for at least 6 months before enrollment
* Primary Biliary Cholangitis-40 fatigue domain score \> 33
* The ability to provide written consent

Exclusion Criteria:

* A known medical condition or metabolic disorder sufficient to explain fatigue such as anemia, thyroid disease, renal failure, use of beta-blockers and untreated depression
* Active drug or alcohol use or history of drug and/or stimulant abuse
* History of psychosis
* Modification of treatment for underlying PBC in the preceding six months
* Other serious coexistent conditions such as pre-existing advanced malignancy or severe cardiopulmonary disease which would be expected to limit their life expectancy
* Anticipated need for transplantation in one year (Mayo survival model \<80% one-year survival without transplant) or MELD above 15
* Recurrent variceal bleeding, presence of diuretic-resistant ascites, or spontaneous encephalopathy
* Non-proficiency in English
The Study of Psychological Status in Monophthalmic Patients With Ocular Surgery

This study is designed to evaluate the change of psychological status before and after surgery in monophthalmic patients who receive the ocular surgery in eye with better vision.

Monophthalmos means the best corrected visual acuity (BCVA) of the worse eye is less than 0.05 or the central visual field (CFOV) is less than 5°. The ocular surgery of the better eye in monophthalmic patients is of high risk. On the one hand the surgical failure will result in the patient falling into permanent darkness. On the other hand the monophthalmic patient may have the same disease in both two eyes such as high axial myopia, uveitis and glaucoma, which will increase the surgical risk. There is still no consensus on whether it is necessary to take risks to perform this kind of operation. In this study we will evaluate the change of psychological status before and after surgery in monophthalmic patients who receive the ocular surgery in eye with better vision. The necessity of the ocular surgery in monophthalmic patients will be evaluated from the point of social psychology.

Eligibility Criteria:
Inclusion Criteria:

* Intention to receive ocular surgery in one of two eyes.
* Free from prior mental disorders.
* Without general disease and can tolerate the operation.
* Communication without difficulty.

Exclusion Criteria:

* With prior mental disorders.
* Can not tolerate the operation.
* Communication with difficulty.
Postoperative Pain Relief After Cesarean Section: Is There a Role for the Quadratus Lumborum Block?

The Quadratus Lumborum block (QLB) was first described by Blanco in 2007. The main advantage of QLB compared to the Transversus Abdominis Plane block (TAP) is the extension of local anesthetic agent beyond the TAP plane to the thoracic paravertebral space. The wider spread of the local anesthetic agents produces extensive analgesia and prolonged action of the injected local anesthetic solution.

Previous studies showed that TAP block may not be effective in improving postoperative analgesia in patients who had cesarean section under spinal anaesthesia.

The aim of this randomised controlled, double blinded study is to examine the effect of QLB on the postoperative pain management in patients who had cesarean section under spinal anesthesia.

After ethical committee approval, informed written consent will be obtained from all patients. A Sample size of 25 patients per group was calculated based on 15% reduction in morphine consumption with 0.05% significance and a power of 0.8.

Consenting patients scheduled to have elective cesarean section under spinal anesthesia will be randomised to undergo QLB with Bupivacaine versus placebo(saline) after their surgery. Allocation will be done using closed envelope technique.

The study medications/placebo will be prepared and labelled by an anesthetist who is not involved in the study.

All patients will receive a standard spinal anesthetic. At the end of surgery , Quadratus lumborum block group (QL) patients will receive bilateral QLB with 0.125% bupivacaine.

Control group patients will receive a bilateral placebo block using saline. The block will be performed in operation theatre after the end of cesarean section with intravenous access, ECG, BP, oxygen saturation by pulse oximetry monitoring and full resuscitation equipment and medication ready.

The patient will be placed in a lateral position with the side to be blocked facing upwards. The ultrasound probe will be properly sterilized and with sterile covers.

A 22 Gauge, two inch Pajunk Sonoplex needle is advanced under ultrasound guidance on the posterior aspect of the Quadratus Lumborum. Following negative aspiration, 0.2 ml/kg of 0.125% bupivacaine, or placebo(saline) is injected in each side with intermittent aspiration and the spread of injectate followed on ultrasound.

All patients will receive the routine postoperative analgesia, comprising patient-controlled IV morphine analgesia and regular diclofenac and paracetamol.

All patients will be assessed postoperatively by a blinded investigator: in the postanesthesia care unit and at 2, 4, 6, 12, 24, 36, and 48 h postoperatively

Eligibility Criteria:
Inclusion Criteria:

* Elective caesarean sections
* ASA 1 to 3
* Written informed consent.

Exclusion Criteria:

* Patient refusal
* Local infection at the site of injection
* Allergy to study medications
* Sepsis
* Anatomic abnormalities
* Systemic anticoagulation or coagulopathy
* Inability to comprehend or participate in pain scoring system
* Inability to use intravenous patient controlled analgesia
Screening for HPV and Cervical Cancer in Young Women With Perinatally Acquired HIV

This is a cross-sectional, observational study of high-risk HPV status, cervical cytology and HPV vaccine uptake and response in young women with perinatally acquired HIV.

This is an observational study of cervical cytology assessment, high risk human papilloma virus (hr-HPV) status, and HPV antibody titres amongst adult women living with perinatally acquired HIV infection (PaHIV). Eligible consenting participants will have two samples taken; firstly, a cervical sample tested for cytology and Hr-HPV with the Cepheid GeneXpert HPV; secondly serum will be assessed for hr-HPV serology. All women with PaHIV, vaccinated and unvaccinated for HPV, over the age of 18 years will be eligible and will be recruited into one of two cohorts: (1) sexually active women: full study, cervical and blood sampling or (2) non-sexually active women, blood sampling only (total n=80). Follow up for abnormal smear results or hr-HPV positivity will be arranged through colposcopy.

Eligibility Criteria:
Inclusion Criteria - Cohort 1:

* Perinatally acquired HIV aged 18+
* Sexually active
* Able to give informed consent

Inclusion Criteria - Cohort 2:

* Perinatally acquired HIV aged 18+
* Able to give informed consent

Exclusion Criteria - Cohort 1:

* Pregnancy
* Not sexually active
* Previous total abdominal hysterectomy
* Unable to give informed consent

Exclusion Criteria - Cohort 2:

* Unable to give informed consent
Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia

The purpose of this study is to determine the long-term safety of a fixed-dose, daily regimen of PCI-32765 PO in subjects with B cell lymphoma or chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL).


Eligibility Criteria:
Inclusion Criteria:

* Men and women with recurrent surface immunoglobulin positive B cell non-Hodgkin's lymphoma (NHL) according to WHO classification (including, but not limited to, CLL/SLL, Waldenström's macroglobulinemia \[WM\], mantle cell lymphoma \[MCL\], and diffuse large B cell lymphoma \[DLBCL) who have met requirements for roll over from their parent protocol and want to continue study drug.
* Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 3 days of the first dose of study drug and agree to use dual methods of contraception during the study and for 1 month following the last dose with study drug. Post menopausal females (\>45 years old and without menses for \>1 year) and surgically sterilized females are exempt from this criterion.
* Male subjects must use an effective barrier method of contraception during the study and for 3 months following the last dose if sexually active with a female of childbearing potential.
* Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).

Exclusion Criteria:

* A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue risk
* Known history of Human Immunodeficiency Virus (HIV) or active infection with Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any uncontrolled active systemic infection.
* Lactating or pregnant
Haloperidol vs. Valproate in Agitation

The aim of this study is to compare the efficacy of haloperidol and valproate in management of people with agitation in emergency department


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of psychomotor agitation
* aged 18 to 65 years

Exclusion Criteria:

* Pregnant patients
* Severe liver disease
* History of drug (haloperidol/valproate) allergy
* Readily amendable causes for the agitation (hypoxemia or hypoglycemia)
* Hypotension (systolic blood pressure (SBP) ≤ 90 mm Hg)
* Known history of liver disease or uncontrolled diabetes
* Noticeable or suspected head trauma
* Previous history of neuroleptic malignant syndrome
* Receiving psychotropic medication, neuroleptic agents or cholinesterase inhibitors at the time of enrollment
Association of Acne Vulgaris With Oral Hygiene and Gingivitis

The goal of this observational study is to learn about in the relationship between acne vulgaris and oral hygiene and gingivitis. The main questions it aims to answer are:

* Is there a relationship between the severity of acne vulgaris lesions and the severity of plaque-related gingivitis?
* Could oral hygiene or the severity of plaque-related gingivitis have an impact on the treatment of acne lesions?

Participants will;

* First be examined at the dermatology clinic.
* Then be examined at the periodontology clinic.
* Participants with severe acne vulgaris lesions will be examined a second time at the dermatology clinic. (1.5 months after the first examination)
* Regularly use the antibiotic containing 100 mg doxycycline prescribed in the dermatology clinic for acne treatment. (Patients deemed suitable by the dermatologist)


Eligibility Criteria:
Inclusion Criteria:

* Being systemically healthy
* Not using any medication regularly
* Not having received acne treatment before
* Not having a known allergy to Doxycycline/Tetracycline antibiotics
* Not having received periodontal disease treatment in the last 6 months
* Not having taken antibiotics or anti-inflammatory drugs in the last month
* Not having used antiseptic mouthwash in the last month
* Being between the ages of 13-18
* No radiographic bone loss or clinical attachment loss
* Absence of any diagnosed psychiatric disease

Exclusion Criteria:

* Smoking
* Using antibiotics and anti-inflammatory drugs
* Having significant psychological problems
* Mouth breathing