cyrilzakka/clinical-trials huggingface dataset:
Leveraging the HIV Platform for Hypertension Control in Uganda (INTEGRATED HIV/HTN) STUDY

The INTEGRATED HIV/HTN is a hybrid type-1 effectiveness/implementation cluster randomised trial evaluating the introduction of a multi-component integrated HIV/HTN care model intervention, randomised to 13 districts in the intervention arm compared to 13 districts in the control. Selected health facilities within the 13 intervention districts will receive the intervention while those in the 13 control districts will continue implementing the standard of care as per the Ministry of Health (MoH) guidelines. All the participating facilities will receive blood pressure (BP) machines, and Non- communicable diseases (NCDs) registers as a standard of care.

The investigators propose to evaluate a multi-component integrated HIV/HTN care intervention through a cluster randomised controlled trial. A cluster has been defined at the level of the district which is the randomisation unit. A total of 26 districts will be randomised. Selected health facilities within the 13 intervention districts will receive the multi-component intervention of combined HIV and (hypertension) HTN care which includes; 1) Training and capacity building on the INTEGRATED HIV/HTN model and NCD care; 2) the Integrated HIV/HTN care delivery model by promoting HTN screening and care in HIV clinics; 3) Health management information system (HMIS) enhancements through mentorship and coaching on the use of NCD registers and NCD patient cards and HTN data capture in the EMR system; and 4) Short messaging system (SMS) and/or WhatsApp for data coordination and communication among providers, DHOs and the study team (who acts as mentors). The 13 control districts will continue implementing the current standard of care as per MoH guidelines.

The investigators will test the hypothesis that a multi-component intervention of combined HIV and HTN care, based on the PRECEDE framework, to continuously identify barriers and facilitators leads to better health outcomes including dual control of HIV/HTN among adults in HIV care in the intervention compared to control facilities.

Specific Objectives are as follows;

1. To determine the effectiveness of an integrated HIV/HTN care model on HTN and dual HIV/HTN control among adult patients in HIV clinics.
2. To assess the barriers and facilitators of the integrated HIV/HTN care model for HIV patients at different levels.
3. To determine the cost, cost-effectiveness and incremental gain costs of the integrated HIV/Hypertension care model approach.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years and above with HIV for one category
* Adults 18 years and above with HIV and hypertension for the second category
* Willing to consent

Exclusion Criteria:

* Patients who are very sick
* Patients not willing to continue seeking care from the study health facility
Evaluation of SOMAVAC 100 Sustained Vacuum System

The purpose of this research study is to compare the effectiveness of the Somavac 100 Sustained Vacuum System versus manual section bulbs after immediate breast reconstruction.

Participants will undergo a screening that includes medical history review. Once screening is complete, participants will undergo immediate breast reconstruction per the surgeon's typical protocol. Surgeon will place up to two (2) drain(s) per breast as customary without changing their technique at the end of the surgical procedure. SOMAVAC® 100 Sustained Vacuum System will be attached to the end of the drain(s) on one side of the subject and standard of care manual suction bulbs attached to the other side. Subjects will return to the clinic every 72 hours for visits for the first 1 to 2 weeks, until the drain drops below 25mL, or as instructed by the physician. Each visit will take about 30 minutes. Subjects will have routine phone calls with the clinic to provide their drain output information to help determine when the drains should be removed. This is a study where the standard techniques of closed suction drainage are used for the removal of fluid from a surgical site. Hence, an increased risk related to post-operative care is not anticipated.

Eligibility Criteria:
Inclusion Criteria:

* Aged 21 years or older; undergoing immediate pre-pectoral breast reconstruction after mastectomy (bilateral) with tissue expanders or implant
* Capable of providing informed consent
* Willingness to follow all study requirements including agreeing to attend all required follow-up visits and signs the informed consent.

Exclusion Criteria:

* Reconstruction is not post-mastectomy
* Pregnant or lactating females
* Patients needing more than 2 drains per breast
* Patients on steroids or other immune modulators known to impact healing
* Patients who are likely to not complete the study
* Patient who, in the opinion of the investigator, are unlikely to comply with the protocol
* Patients who have participated in this trial previously and who were withdrawn
* Patients with known allergies to contacting materials (i.e. latex, metal, etc.)
* Patients who received neoadjuvant chemotherapy or radiotherapy within the last 6 months
* Has any medical condition such as obesity (BMI\>40), uncontrolled diabetes (HbA1c\>7%) and/or immunosuppression.
Endovascular Treatment of Wide Neck Intracranial Aneurysms With the LEO + Stent : The LEO + II Cohort Study

This is a prospective, multicenter, single-arm observational study to evaluate the efficacy and the morbi-mortality of LEO + in patients with wide neck intracranial aneurysms (fusiform, saccular or dissecting), ruptured or not ruptured.


Eligibility Criteria:
Inclusion Criteria:

* All patients with ruptured or not ruptured intracranial aneurysms demonstrated by cerebral arteriography treated with LEO + stent
* Patients (or their parents for minors) must be informed and give written consent

Exclusion Criteria:

* Patients (or parents) who refused to give consent.
The Effect of the Non-invasive Brain Stimulation on the Speech Fluency Enhancement

The aim of this study is to determine the effectiveness of concurrent transcranial direct current stimulation (tDCS) and fluency training in adults with developmental stuttering. We examine the severity of stuttering to investigate the effect of treatnment. In the control group the anodal tDCS and DAF will applied on six consecutive days (1 milliampere \[mA\] for 20 mins per day), and the control group will received the sham stimulation and DAF for the same time. The severity of stuttering measured by means of tasks and questionnaires before and after treatment sessions and 6 weeks after intervention.


Eligibility Criteria:
Inclusion Criteria:

* History of developmental stuttering
* Participants diagnosed with moderate to severe stuttering
* Right handed
* Native speaker of Farsi

Exclusion Criteria:

* Speech or language disorders other than stuttering
* Received stuttering treatment within the past year
* Hearing loss
* History of neurological or psychiatric disorders
* History of seizure
* Taking any medication that may affect brain function such as anti-depressants
Compartment Psoas Block Efficacy and Safety

A randomized controlled trial to assess the efficacy and safety of the prolonged compartment psoas block for analgesia and anesthesia for femur surgery in the elderly

A randomized controlled trial was conducted from January 2018 to August 2019 at the Into-Sana Medical Center (Odessa, Ukraine). The study design was approved by the Ethical Committee at Bogomolets National Medical University. Patients who planned osteosynthesis of the proximal femur and who met the inclusion criteria were randomized to 3 study groupsThe aim of our study was to compare the effectiveness and safety of different techniques of perioperative anaesthesia and anaesthesia in patients with fractures of the proximal femur: general anaesthesia and systemic analgesia, neuraxial (spinal) anaesthesia, compartment psoas block in combination with a sciatic nerve block. Patients in group 1 underwent catheterization of the lumbar plexus from the posterior access on admission to the hospital and began analgesia with bupivacaine 0.125% 6-8 ml / h. Intraoperative anesthesia was provided with a bupivacaine bolus of 0.5% 200 mg in a lumbar catheter and a sciatic nerve block with 1.5% 450 mg of lidocaine. Postoperative analgesia was provided with prolonged lumbar plexus block with bupivacaine 0.125% 6-8 ml / h.

Patients in group 2 underwent intraoperative spinal anaesthesia at the level of L3-L4 with hyperbaric bupivacaine 10-15 mg. Patients in groups 1 - 2 receive intraoperative sedation with propofol 1% with a target level of sedation RASS from 0 to -2. Group 3 patients underwent general sevoflurane inhalation anaesthesia with fentanyl infusion for analgesia.

All patients received paracetamol 3g/day and dexketoprofen 75 mg/day during hospitalization. On-demand, nalbuphine 5 mg SC was used for analgesia.

Eligibility Criteria:
Inclusion Criteria:

-proximal femur fracture

Exclusion Criteria:

* pregnancy and lactation
* history of opiate addiction
* traumatic brain injury
* acute cerebrovascular accident
* chronic heart failure (New York Heart Association Functional Classification, NYHA, class III-IV)
* respiratory failure
* renal failure with decreased creatinine clearance less than 30 ml / min / 1.73 m2
* hepatic insufficiency class C according to Child-Pugh).
Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines

An interventional phase 2 study to evaluate safety and efficacy of AbobotulinumtoxinA treatment for glabellar lines


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe glabellar lines at maximum frown as assessed by the Investigator using a photographic scale
* Moderate to severe glabellar lines at maximum frown as assessed by the subject using a static categorical scale

Exclusion Criteria:

* Botulinum toxin treatment in the face within 9 months prior to study treatment
Pilot Study of Autoarterial Remodeling of Bifurcation of the Common Carotid Artery

Comparison of two methods for revascularization of the bifurcation of common carotid artery: carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty compared with new technique of carotid endarterectomy with autoarterial remodeling of bifurcation of the common carotid artery


Eligibility Criteria:
Inclusion Criteria:

* stenotic lesions of the extracranial part of carotid arteries requiring surgical treatment according to national treatment guidelines (asymptomatic ICA stenosis more than 70% symptomatic ICA stenosis more than 65%)
* the length of the atherosclerotic plaques in the ICA than 1 cm
* personally signed Informed consent for participation in the study

Exclusion Criteria:

* Chronic heart failure III-IV functional class NYHA classification
* Chronic decompensated "lung" heart
* Decompensated diseases of endocrine organs (diabetes glycemia more than 10 mmol/l)
* Severe hepatic or renal insufficiency (bilirubin \>80 mmol/l, creatinine \>200 mmol/l)
* Polyvalent drug Allergy;
* Malignant tumor in the terminal stage with life expectancy of up to 6 months;
* Acute disruption of cerebral blood flow
* Extensive occlusion of the internal carotid artery.
* Exacerbation of systemic diseases.
* Pregnancy and lactation.
* The refusal of a patient to sign informed consent for participation in the study
Combination Therapy With Fecal Microbiota Transplantation and Vedolizumab for Induction of Ulcerative Colitis

This is a pilot study of combination therapy using FMT and vedolizumab for induction of UC. The investigators hypothesize that a combination therapy approach which addresses immune trafficking and microbial manipulation simultaneously will lead to superior outcomes than those seen with single agent therapy.

This is a prospective pilot trial involving a single centre (McMaster University Medical Centre) recruiting patients from Hamilton, Ontario Canada and the surrounding regions, to evaluate efficacy and safety outcomes when using fecal microbiota transplantation once weekly for six weeks in UC patients who are initiated on vedolizumab.

A lead in study will be conducted with the first five patients to ensure engraftment of FMT within the colon. Interim analysis will be conducted after these five patients to ensure engraftment within the colon. Data Safety and Monitoring Board will also be informed of the results after the first five patients, including any adverse events. Decision will be made based on these results whether to proceed with the prospective study using FMT weekly for six weeks, or whether to modify the dose/frequency of FMT treatment.

As patients with previous biologic failure tend to have sub-optimal response to vedolizumab monotherapy, this pilot study will focus on recruitment of previous biologic failure patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 or over
2. Active UC defined as total Mayo score of 6 or more points, with endoscopic subscore at \> 2
3. Clinician initiating vedolizumab for patients as per standard of care for UC
4. Patient previously has been exposed to one or more biologic or advanced therapies (anti-TNF, JAK inhibitor, anti-interleukin) and never previously exposed to vedolizumab or other anti-integrin therapy.
5. Females of child bearing potential must be willing and able to use acceptable contraception as per Appendix III. II. b. Toxicity section of the Health Canada Guidance

Exclusion Criteria:

1. Participating in another clinical trial
2. Unable to give informed consent
3. Severe comorbid medical illness
4. Concomitant Clostridium difficile infection
5. Increase in medical therapy for UC in the last 4 weeks. Continued treatment with 5-ASA, azathioprine, or 6-mercaptopurine will be permitted if taken at stable dose for ≥4 weeks prior to study entry. Stable dose (same dose for at least 2 weeks) or a tapering dose of steroids will also be permitted provided the dose of steroid is not increased again. Stable intake of probiotic therapy also permitted.
6. New antibiotic therapy in the last 28 days.
7. Dose of infliximab or golimumab in prior four weeks, adalimumab in prior two weeks, or tofacitinib in prior one week.
8. Pregnant women.
9. Clinically significant lactose intolerance
10. Any condition, in the opinion of the investigator, that the treatment may pose a health risk to the subject, based on lab study results
The Effect of Lower Limb Kinetic Chain Exercise in Shoulder Impingement

The goal of this clinical trial study is to investigate the effect of performing lower limb kinetic chain exercise on muscle activation of scapular muscle strength ratio in patients with shoulder impingement. the main question it aims to answer is:

Does the addition of lower limb kinetic chain exercise to a shoulder exercise program improve scapular muscles strength ratio in patients with shoulder impingement? participants will be devided into two groups to be compared: The first group will be given a rehabilitation program consisting of strengthening exercises (for scapular stabilizers and rotator cuff) and stretching exercises (for pectoralis major, pectoralis minor, latissimus dorsi, levator scapula) The second group will be given the same exercises in addition to lower limb kinetic chain exercise

The term "kinetic chain" (KC) describes the sequential activation of body segments during functional movement patterns (Wilk et al., 2016). An effective KC will produce, summate, and enable effective mechanical energy transmission along the entire chain, which will support function. Any link in the KC that is inefficient has the potential to adversely affect force transfer to nearby segments (Ben kibler et al., 2000 \& Martic et al., 2014). Consequently, therapists usually recommend incorporating trunk and lower extremity movements into shoulder rehabilitation programs in order to maximize efficient energy transfer throughout the entire KC (Sciascia et al., 2012 \& Magarey et al., 2003). Thus, the investigators hypothesize that adding a lower limb (LL) kinetic chain exercise to a shoulder exercise program will improve scapular muscles strength ratio.

Eligibility Criteria:
Inclusion Criteria:

* Age ranges between 20 and 45 years old
* Unilateral shoulder pain lasting more than 6 weeks
* At least one positive finding in each of these categories:

  1. Painful arc of movement during flexion or abduction
  2. Positive Neer or Hawkins-Kennedy impingement signs
  3. Pain on resisted lateral rotation, abduction or Jobe test

Exclusion Criteria:

* History of surgery
* History of fracture or dislocation
* Type III acromion
* Rotator cuff tear
* Long head of biceps tendon tear
* Cervical radiculopathy
Phase I Study in Healthy Male Subjects Comparing QGC001 to Placebo

QGC001/1QG1 is a Phase I "first time in man" study aiming to determine the overall safety and tolerability of single ascending oral doses of QGC001 in healthy male subjects compared to placebo, as well as the pharmacokinetics of QGC001 and its metabolite EC33 and the pharmacodynamic properties of QGC001 (effects on the renin-angiotensin-aldosterone system, blood pressure and heart rate) in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian, male healthy subjects of 18 to 45 years of age.
* Body weight ≥50 kg, with a body mass index calculated as weight in kg/(height in m2) from 18 to 27 kg/m2 at screening.
* Subjects will sign and date an informed consent form before any study-specific screening procedure is performed.
* Healthy, as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12 lead ECG readings.
* Non-smoker or smoker of fewer than 5 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
* Have a high probability for compliance with and completion of the study.

Exclusion Criteria:

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatological, haematological, neurologic, psychiatric disease or history of any clinically important drug allergy.
* Acute disease state within 7 days before study day 1.
* History of drug abuse within 1 year before study day 1.
* History of alcoholism within 1 year before day 1. Consumption of more than 50 g of ethanol per day.
* Positive serologic findings for human immunodeficiency virus antibodies, hepatitis B surface antigen, and/or hepatitis C virus antibodies.
* Positive findings of urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA)
* History of any clinically important drug allergy.
* Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product administration.
* Consumption of any caffeine-containing products in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 hours before study day 1.
* Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen \[paracetamol\], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before investigational medicinal product administration.
* Donation of blood (i.e. 450 ml) within 90 days before study day 1.
Symax International Study

The uncemented Symax hip stem is developed through optimization of the uncemented Omnifit hip stem. The Symax stem design combines an anatomical anteverted proximal geometry with a straight distal section. The proximal part is coated with a biomimetic hydroxyapatite (HA) coating for improved osseointegration to enhance load transfer and to minimize proximal bone loss. The distal part is treated with an anodization surface treatment in order to prevent distal bone apposition, which is expected to prevent distal loading and reduce proximal stress shielding. Aim of this study is to report mid-term clinical performance and evaluate whether the radiographic features are in line with the design principles of the Symax hip in an international clinical study with 5 years of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring uncemented primary total hip arthroplasty (osteoarthritis, avascular necrosis and/or post-traumatic arthritis), age between 18-70 years, BMI less or equal to 35.

Exclusion Criteria:

* Patients with bilateral hip complaints, impaired cognitive function and use of medication or illness influencing bone metabolism.
Peak Impact Forces and Metabolic Cost During Mid-Forefoot Striking in Shod Versus Barefoot Runners

This experimental study will compare impact forces and metabolic cost in runners (N=20; ages 18-45 years, who already use a forefoot strike running gait) in two treadmill running test sessions (shod vs barefoot running)

Specific Aim 1: To identify if differences in metabolic cost exist between barefoot versus cushioned shod FM strikers during an acute bout of running exercise. Hypothesis: The metabolic cost will be higher in the cushioned shod runners with forefoot and midfoot strike compared to the barefoot runners.

Specific Aim 2: To identify if differences in peak impact forces exist between barefoot versus cushioned shod runners in forefoot-midfoot (FM) strikers.

Hypothesis: Peak impact forces will be higher in the barefoot runners with a forefoot and midfoot striking running style compared to the cushioned shod runners with a forefoot and midfoot striking running style.

Eligibility Criteria:
Inclusion Criteria:

* trained runners with a running foot striking style of either initial forefoot or midfoot strike.
* run on average at least 20 miles/week
* be able to run for at least 20 minutes at one session
* free of any orthopedic limitation

Exclusion Criteria:

* history of lower extremity injury within the last 6 months prior to testing
* rear-foot strike running style
* does not run in a cushioned shoe on any occasion
* runs on average \< 20 miles/week
* unable to run for 20 minutes or greater
* presence of any open wound or deformity on the feet which would prevent participant from running barefoot
* neurologic injury that would preclude normal running activity.
Brief Interventions to Improve Behavior Outcomes and Prevent Cavities

The investigators will study brief educational interventions designed to address childhood behavior problems and prevent cavities.

The investigators will study brief educational interventions designed to address childhood behavior problems and prevent cavities. Participants will be parents of children, ages 9 months to 3 years, presenting with their child for a well child visit. Parent/child dyads will be randomized into three different groups: Group 1 will be introduced to an online educational intervention to address childhood behavior problem, Group 2 will be introduced to a printed educational intervention to address childhood behavior problems, and Group 3 will be introduced to an educational intervention to prevent cavities. Study procedures will include 1) the educational intervention in the examination room before the clinic visit, 2) a brief survey immediately after the clinic visit and 3) a brief survey in 2-4 months sent via REDCap, and 4) follow up health and insurance records related to the study interventions.

Eligibility Criteria:
Inclusion Criteria:

* Parents of 9 month to 3 year old children.

Exclusion Criteria:

-