cyrilzakka/clinical-trials huggingface dataset:
Achilles Tendinopathy Treated With Training and Injections

The purpose of this study is to compare in a randomized double blinded controlled trial the effect of heavy slow resistance exercises combined with ultrasound guided injections with local anesthetic with or without glucocorticosteroid in patients with achilles tendinopathy.

Achilles tendinopathy is a common and often longlasting condition especially in a sports population. The highest incidence is seen in sports involving running and jumping.

As the primary treatment eccentric exercises is recommended and 60-90% will benefit by that. Other studies have shown equal effect of stretching exercises. In a new study heavy slow resistance exercises has proven effective in achilles tendinopathy and the best treatment in lig.patellae tendinopathy.

Injection with glucocorticosteroid is often used in the daily clinic, though inflammation is rarely found. Fredberg 2004 found a good short term effect of glucocorticosteroid injection in an RCT, but no effect in the long term, which the investigators explained by an aggressive rehabilitation with running after a few days. Even though 60-90% will benefit from exercises in efficacy studies, a recent pragmatic effectiveness study by Weetke 2015 found that only 26% did benefit from training alone, but if supplemented by need with 1-3 injections of glucocorticosteroid 76% achieved excellent or good result.

To our knowledge no randomized clinical trials have investigated the combined effect of training and injections. The hypothesis of this study is, that training and slowly progressive rehabilitation combined with glucocorticosteroid injections will have better effect than the same training and rehabilitation combined with injections of local anesthetic.

Eligibility Criteria:
Inclusion Criteria:

* Midsubstance pain in the achilles tendon
* Symptoms for at least 3 months
* Ultrasound scanning at the first visit shows thickness of the achilles tendon above 7 mm or 20% thicker than the contralateral.
* Patient can read and understand danish

Exclusion Criteria:

* Earlier operations in the foot and leg, that is judged to complicate training
* known arthritis.
* known diabetes
* Leg ulcerations or infections in the foot.
* Judged unable to comply with the training protocol.
* Daily use of pain killers
* Glucocorticosteroid injection to the diseased achilles tendon within the last 6 months.
* Earlier allergic reactions to glucocorticosteroid or local anesthetic.
* Pregnancy or planning to become pregnant
* BMI above 30.
Reintegration: The Role of Spouse Telephone BATTLEMIND Pilot Study

This study will expand the Department of Defense (DoD) one time, face-to-face post deployment BATTLEMIND training for spouses of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Guard/Reserve service members into year-long, telephone groups focusing on education, skills building and support. The goal is to build spouses' resilience to cope with reintegration, help them serve as a support system for returning service members, and ease the transition for families post-deployment.


Eligibility Criteria:
Inclusion Criteria:

1. have a spouse who participated in OEF/OIF and is at least 1 month post-deployment;
2. if not married, must have lived as married for at least one year;
3. live with the service member when not deployed;
4. have been a spouse/significant other throughout the service member's deployment period;
5. and have a telephone.

Exclusion Criteria:

1. current diagnosis of schizophrenia or other major mental illness;
2. auditory impairment that would make telephone use difficult; or
3. service member refusal of assent for spouse to participate.
A Phase 1b Study Assessing the PK, PD, Safety & Tolerability of SB414 in Atopic Dermatitis

This is a Phase 1b, 2-week study assessing the pharmacokinetics, pharmacodynamics, safety and tolerability of SB414 in subjects with mild to moderate AD.

This is a phase 1b, multi-center, randomized, double-blind, vehicle-controlled study to be conducted in approximately 48 non-immunocompromised adult subjects with mild to moderate AD. Subjects will be randomized to 2 active and 1 vehicle treatment arms. Subjects will apply the study drug (SB414 or Vehicle) to affected areas twice daily for 2 weeks (14 days).

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age and older, and in good general health;
* EASI score \>1 and ≤21, involving ≥5% body surface area (BSA).
* Two target lesions at least 5 cm2 with a TLSS ≥5. Target lesions can not be located on the groin, hands, elbows, feet, ankles, knees, face or scalp.
* Willing to not use any other products for AD during the study;
* Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) prior to randomization and must agree to use an effective method of birth control during the study and for 30 days after their final study visit.

Exclusion Criteria:

* Concurrent or recent use of topical or systemic medications without a sufficient washout period;
* Immunocompromised subjects including those who are known HIV positive or receiving current immunosuppressive treatment,
* Female subjects who are pregnant, nursing mothers, or planning to become pregnant during the study;
* Active acute bacterial, fungal, or viral skin infection within 1 week before the baseline visit.
Partners in Care Diabetes Self-management Intervention

Type 2 diabetes is common among Native Hawaiians and Pacific Peoples. Diabetes related complications decrease quality of life and can result in early morbidity. The purpose of the Partners in Care diabetes self-management educational intervention is to teach participants how to manage their diabetes to avoid or delay diabetes-related complications and how to better work with their health care team.

This is a feasibility study using a randomized controlled trial (RCT) design in which 100 Native Hawaiians (NHs) and other Pacific Islanders (PPs) will be randomized to either a 3-month diabetes self-management group (DSMG; N=50) or a delayed intervention control group (CG; N=50). Participants in the DSMG will receive culturally-tailored, group diabetes self-management education delivered in a community setting by trained community peer educators. To meet this objective, we have partnered with four community-based organizations: 1) Hawai'i Maoli Association of Hawaiian Civic Clubs, 2) Ke Ola Mamo Native Hawaiian Health Care System, 3) Kokua Kalihi Valley Comprehensive Family Services, and 4) Kula No Nā Po'e Hawai'i. These four organizations provide services to a large number of Pacific People to include, but not limited to, Native Hawaiians, Samoans, Filipinos, and Chuukese. They already have intervention research experience as members of the PILI 'Ohana CBPR Project. The 3-month face-to-face intervention will be community-based and community-led by trained community peer educators from these four partnering community organizations. Individuals with a hemoglobin A1c (HbA1c; average blood sugar levels) \>=8% will be recruited for the study because they represent the most at-risk for diabetes-related complications.

Over a 1-year accrual period, the community partners will recruit and enroll 100 eligible NHs and PPs (25 participants per a participating community), as well as deliver and evaluate the intervention in their respective community settings. The primary outcomes of our study are hemoglobin A1c and self-reported diabetes specific quality of life. Secondary outcomes are cholesterol levels (including HDL, LDL, total cholesterol, and triglycerides), blood pressure, body mass index, and psychosocial adaptation.

Eligibility Criteria:
Inclusion Criteria:

1. Self-reported Native Hawaiian, Filipino, or other Pacific Islander ethnic background,
2. Adults age \>=18 years,
3. English-speaking,
4. Physician-diagnosed type 2 diabetes, and
5. Baseline hemoglobin A1c \>=8%

Exclusion Criteria:

1. Survival less than 6 months,
2. Planning to move off island or out of state during the study period,
3. Pregnancy,
4. Any co-morbid condition (physical and mental disabilities) that would prevent the individual from participating in the intervention protocol (i.e., major psychiatric illness).
Investigating the Structural and Functional Changes to the Retina Following PRP in Diabetic Retinopathy Patients

Laser therapy is an established method to stabilize and control proliferative diabetic eye disease. Questions on the long-term effect on the retina from these treatments remain to be answered. The purpose of the study was to evaluate changes in the retina following panretinal photocoagulation (PRP) over time, using structural and functional diagnostic tests.

Diabetic retinopathy is the most common cause of adult-acquired retinal vascular disease. Diabetic retinopathy is estimated to affect more than 100 million adults, and is the leading cause of blindness worldwide.

Over the past 30 years, epidemiological studies and clinical trials have shown that early detection through annual eye exams, intensive glucose and blood pressure control, and timely laser photocoagulation could prevent visual loss. More recently, a variety of newer ocular treatments and medications have been introduced, such as the use of the PASCAL photocoagulation laser system, and various anti-vascular endothelial growth factor therapies. While these treatments have revolutionized how diabetic retinopathy patients are managed clinically, questions on appropriate patient selection and the long-term efficacy and safety of these treatments remain to be answered.

The purpose of this study is to focus on studying the nature and the time course over 2 years of structural and functional changes to the retina following PASCAL photocoagulation in severe preproliferative or proliferative diabetic retinopathy patients.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient's greater than 18 years of age who have signed an informed consent.
* Patients with type 1 or type 2 diabetes mellitus (according to ADA or WHO guidelines) that have severe preproliferative or proliferative diabetic retinopathy and require PRP surgery in at least one eye.
* Adequate pupil dilation and clear media to perform laser photocoagulation, HRT, OCT and visual field testing.

Exclusion Criteria:

* Advanced lens opacity (Lens opacity that excludes the ability to capture data)
* Prior PRP within the past year
* Focal laser within one year of study entry
Effect of Esketamine on Abdominal Pain During TACE-HAIC in Patients With Hepatocellular Carcinoma

Previous studies have confirmed that limb pain caused by oxaliplatin chemotherapy is related to spinal cord central sensitization - induced hyperalgesia through oxaliplatin activating spinal cord NMDA receptor(N-methyl-D-aspartic acid receptor). The investigators speculate that this may be the same as the mechanism of severe abdominal pain caused by HAIC(Hepatic Artery Infusion Chemotherapy) during oxaliplatin infusion. The analgesic effect of Esketamine is mainly related to its inhibition of NMDA receptor in spinal cord. Therefore, this study hypothesized that Esketamine can inhibit the sensitization of spinal cord center by inhibiting NMDA receptor, so as to alleviate severe abdominal pain during HAIC perfusion, and reduce abdominal pain caused by ischemia and inflammation by TACE(transcatheter arterial chemoembolization) by improving organ perfusion and anti-inflammatory effect, Therefore, it is expected that Esketamine can better alleviate acute severe abdominal pain caused by TACE-HAIC (transcatheter arterial chemoembolization combined with Hepatic Artery Infusion Chemotherapy )treatment than sufentanil, decrease the dosage of opioids, and reduce the incidence and degree of chronic abdominal pain after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Participate in this study and sign informed consent
* Voluntarily receive postoperative intravenous controlled analgesia
* Patients receiving TACE-HAIC treatment
* HCC (hepatocellular carcinoma)patients with primary liver cancer BCLC(Barcelona Clinic Liver Cancer) stage B and C, liver function A
* Age 18 to 80

Exclusion Criteria:

* Patients who were unable to cooperate or refused to participate in the trial
* Pregnant women
* Patients with sensory abnormalities such as diabetes neuropathy
* Patients with or having a history of serious mental disorders
* Patients with poorly controlled or untreated hypertension (arterial hypertension, resting systolic / diastolic blood pressure more than 180/100mg)
* Patients with unstable angina pectoris or myocardial infarction within 6 months or congestive heart failure
* Patients with intracranial hypertension or glaucoma
* Patients with hyperthyroidism without treatment or insufficient treatment
* Patients with severe respiratory dysfunction
* Allergy or existing contraindication to chemotherapeutic drugs, opioids or ketamine drugs
* Can not follow with the study procedure
Effectiveness of Powerball System in People With Multiple Sclerosis

There is a high percentage of impairment in the upper limbs (UL) in patients with multiple sclerosis (MS), being muscle strength and hand dexterity a determining factor for the preservation of functional activities, constituting the basis of independence and quality of life. The aim of this study is to determine the effects of a training protocol on UL muscle strength, through the NDS-Powerball® system, in combination with conventional physiotherapy, during 8 weeks in terms of muscle strength, coordination, fatigue, functionality and quality of life in people with MS.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 60 years
* Diagnosed with MS according to McDonald criteria with an evolution time of more than two years
* Evaluation in the Kurtzke Disability Status Scale in Multiple Sclerosis (EDSS) with a score between 3.5 and 6
* Score less than or equal to 4 on the "Pyramidal Function" section of the EDSS functional scale
* Stable medical treatment for at least six months prior to surgery
* Muscle tone in the upper extremities no greater than 2 points on the modified Ashworth scale.
* Muscle balance equal to or greater than 3 in the upper extremity
* Absence of cognitive impairment with ability to understand instructions and score equal to or greater than 4 on the Minimental Test.

Exclusion Criteria:

* Diagnosis of another neurological disease or musculoskeletal alteration other than MS
* Diagnosis of any cardiovascular, respiratory or metabolic disease or other conditions that may interfere with this study
* Having suffered an exacerbation or hospitalization in the last three months before starting the assessment protocol, or during the therapeutic intervention process.
* Having received treatment with botulinum toxin in the six months prior to the start of the study
* Presence of visual alterations not corrected by means of ocular devices.
Assessment of the Effects of Different Implant Abutment Occluding Materials on Dental Implant Health Parameters and Microbiology

The primary purpose of this study is to determine what effect, if any, do different dental materials used to seal the prosthetic screw channels of implant supported restorations have on dental implant health parameters and microbiology.


Eligibility Criteria:
Inclusion Criteria:

* Fully edentulous patient
* Patient has at least one arch restored with a full-arch dental supported prosthesis

Exclusion Criteria:

* poor oral hygiene and motivation (as determined with prosthesis in place)
* uncontrolled diabetes
* pregnant or lactating
* substance abusers
* current smokers
* psychiatric problems or unrealistic expectations
* acute infection in the area intended for implant sealing
* positive to HIV and hepatitis B and C
* affected by autoimmune diseases
* under chronic treatment with steroids or non-steroidal anti-inflammatory drugs.
Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®

PR5I, a hexavalent pediatric combination vaccine is being developed to reduce the number of injections during the first 2 years of life while providing a complete course of immunization against infection caused by H. influenzae type b, hepatitis B virus, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, and poliovirus types 1, 2, and 3.

Primary Objective: To evaluate immunogenicity of PR5I with the adjuvant composition enhancement to the hepatitis B component when administered concomitantly with Prevnar®

Secondary Objectives: To assess the safety and immunogenicity of PR5I when administered concomitantly, or one month apart with Prevnar® or separately with licensed vaccines used for routine infant vaccination in Canada.


Eligibility Criteria:
Inclusion Criteria:

* Infants aged 42 to 89 days inclusive on the day of inclusion.
* Born at full term of pregnancy (\>37 weeks).
* Informed consent form signed by the parent(s) or legally authorized representative.
* Able to attend all scheduled visits and to comply with the study procedures.
* Parent or legally authorized representative has access to a telephone.
* Parent or legally authorized representative able to read and write in English or French.

Exclusion Criteria:

* Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
* Planned participation in another clinical trial during the present trial period.
* Personal or immediate family history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy.
* Known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s).
* Chronic illness that could interfere with trial conduct or completion.
* Received blood or blood-derived products since birth.
* Any vaccination preceding the first trial vaccination or planned in the 4 weeks after any trial vaccination (flu vaccine may be given a minimum of 4 weeks prior to the first study vaccination).
* Previous vaccination with any acellular pertussis- (DTaP) or whole cell pertussis- (DTwP) based combination vaccines, Haemophilus influenzae type b (Hib)-conjugate, poliovirus, hepatitis B, or pneumococcal conjugate vaccines.
* Coagulation disorder contraindicating IM vaccination.
* Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion).
* Developmental delay or neurological disorder.
* Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
* Documented Hepatitis B surface Antigen (HBsAg) seropositivity in the child or his/her mother.
* History of Hib, hepatitis B, diphtheria, tetanus, pertussis or poliovirus disease.
Geko Venous Leg Ulcer Study

This study is designed to look at the effect of the geko device on the circulation in lower limbs of participants with venous leg ulcers.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Intact healthy skin at the site of device application
3. Able to understand the Patient Information Sheet
4. Willing to give informed consent
5. Willing to follow the requirements of the protocol
6. Subjects who had a chronic venous leg ulcer (i.e. CEAP classification of C6 1) greater than 2 cm2 and less than 10 cm in maximum diameter,
7. ABPI of 0.8 or greater

Exclusion Criteria:

1. History of significant haematological disorders or DVT with the preceding six months
2. Pregnant
3. Pacemakers or implantable defibrillators
4. Use of any other neuro-modulation device
5. Current use of TENS in pelvic region, back or legs
6. Use of investigational drug or device within the past 4 weeks that may interfere with this study
7. Recent surgery (such as abdominal, gynaecological, hip or knee replacement)
8. Recent trauma to the lower limbs
9. Size of leg incompatible with the geko™ device.
10. Chronic obesity (BMI \> 34)
11. Any medication deemed to be significant by the Investigator
12. Subjects who had an index venous leg ulcer greater in maximum diameter than 10cm in any one dimension
13. Diabetic subjects with advanced small vessel disease
Chronic Care Management With Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy (mPAP) Trial

The goal of this clinical trial in adults with obstructive sleep apnea prescribed positive airway pressure therapy is to test the effects of a new patient-facing consumer wearable-based program (that involves provision of a consumer wearable that measures oxygen levels during sleep plus customized weekly reports to participants). The main question is to learn whether participants' use of positive airway pressure therapy will differ between the participants who receive the new program immediately versus delayed. Participants assigned to the delayed program will receive usual care while waiting for the program to begin.

After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening to determine eligibility for study entry. Patients who meet the eligibility requirements will be randomized to immediate versus waitlist control in a 1:1 ratio.

Our project is at the forefront of consumer wearable research, leveraging the recent capabilities of consumer wearables to provide pulse oximetry data during sleep, to uncover new ways to promote PAP usage among patients with obstructive sleep apnea.

Eligibility Criteria:
Inclusion Criteria:

* Prescribed PAP therapy from the sleep center for \> 1 week
* Have an active profile in our Center's ResMed AirView or Respironics Care Orchestrator accounts for \> 1 week
* Non-adherent with PAP therapy
* Willing to continue using current PAP device for 28 days continuously
* Have an electronic device compatible with the wearable app

Exclusion Criteria:

* Diagnosis of heart failure, chronic lung disease, dementia, active substance use disorder
* Use home oxygen
* Unstable medical or psychiatric illness
* Planned non-use of PAP therapy (e.g., waiting for replacement of recalled PAP device)
* Planned surgery or hospitalization during study period
* Planned extensive travel during study period
* History of repeated non-attendance at clinic visits