cyrilzakka/clinical-trials huggingface dataset:
Use of Extended Release Triamcinolone in the Treatment of Rotator Cuff Disease

The primary objective of this study is to assess the overall safety and general tolerability of extended release triamcinolone acetate (TA-ER/FX006) in patient with rotator cuff disease. The study will enroll 65 patients, aged 40-75 years old, in a longitudinal case series level IV study using extended release triamcinolone to treat shoulder pain from rotator cuff disease. Inclusion criteria will be shoulder pain without a history of trauma and physical exam consistent with rotator cuff tendinitis, impingement syndrome or rotator cuff tear.

The purpose of this study is to assess the safety and efficacy of TA-ER in the treatment of rotator cuff disease. The study will enroll 65 patients in a longitudinal case series level IV study using extended release triamcinolone to treat shoulder pain from rotator cuff disease. Inclusion criteria will be shoulder pain without a history of trauma and physical exam consistent with rotator cuff tendinitis, impingement syndrome or rotator cuff tear. Patients will have normal Xrays or Xrays indicative of chronic cuff tearing and a musculoskeletal ultrasound indicating an intact rotator cuff, partial cuff tearing or cuff tear. Patients will undergo an ultrasound guided injection of TA-ER into the subacromial space from a lateral access point at the time of the examination. They will be monitored for any immediate adverse effects. Patient reported outcomes measures will be recorded with online questionnaires which include a Visual Analog Scale (VAS), Single assessment numeric evaluation (SANE), Veteran's Rand 12 (VR-12) and American Shoulder and Elbow Scale (ASES) and will be recorder pre-treatment and at 2, 4, 8 and 12 and 24 weeks post treatment. Patients will be asked to follow up for an in person evaluation at 4 weeks, 12 weeks and 24 weeks post injection.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female between the ages of 40-75 years old.
2. Able and willing to give written informed consent in accordance with the IRB.
3. Read and Speak English.
4. History indicative of rotator cuff disease.
5. Physical exam consistent with rotator cuff disease.
6. All patients will have AP and Outlet X ray views.
7. X rays will be normal or indicative of chronic RTC tearing
8. Musculoskeletal Ultrasound indicating intact RTC, full thickness tears, or large and massive cuff tears in older, sedentary individuals.
9. Willing to abstain from use of NSAIDs

Exclusion Criteria:

1. Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to conceive during the study; or unwilling to practice birth control during participation in the study.
2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
3. Known or suspected hypersensitivity to FX006 (or component of FX006), triamcinolone acetonide.
Study of ABT-333 in Both Healthy Volunteers and Hepatitis C Virus (HCV) + Genotype 1 Infected Subjects

The purpose of this study is to assess the safety, tolerability, pharmacokinetics of ABT-333 in healthy volunteers and the antiviral activity in HCV infected subjects.

Phase 1, double-blind, randomized, placebo-controlled clinical trial in healthy and HCV genotype 1 infected adults to evaluate safety, tolerability, antiviral activity and pharmacokinetics of ABT-333.

Eligibility Criteria:
Inclusion Criteria:

* Main Selection Criteria for Healthy Volunteers:

  * Subject has provided written consent.
  * Subject is in general good health.
  * If female, subject is postmenopausal.
  * If female, subject is not pregnant and is not breast-feeding.
* Main Selection Criteria for HCV+ Subjects:

  * Subject is HAV-IgM, HBsAg or HIV Ab negative.
  * Subject is HCV genotype 1 with HCV RNA of \> 50,000 IU/mL.
  * Subject is excluded if they have previously received antiviral therapy for HCV infection
  * Subjects must demonstrate chronic hepatitis C infection for at least 6 months prior to study enrollment
  * Subjects must have a prior liver biopsy with histology consistent with HCV induced liver damage, and with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV.

Exclusion Criteria:

See above for main selection criteria
Multi-Center Study of ShuntCheck

Multi-Center Study of ShuntCheck


Eligibility Criteria:
Inclusion Criteria:

Exclusion Criteria:
A Comparison of Stryker Hybrid Arch Bars

Patients who sustain a fracture of the lower jaw are typically treated by wiring the teeth together or using small titanium plates and screws to fix the fracture. With either technique the upper and lower teeth are held together to ensure that the fracture is held in the correct position during healing (for closed reduction) or while the plate and screws are applied (for open reduction).

The teeth can be held together using Erich arch bars which are a type of braces that are temporarily wired to the existing teeth. These stay in place for 6 weeks until the fracture has healed even though the patient is able to open his mouth immediately after the surgery is complete. The alternative to the traditional Erich arch bars is a relatively new type of arch bar (Stryker Hybrid) that is screwed to the jaw bone rather than wired to the teeth. The purpose of this study is to compare the two types of arch bars in terms of the speed with which they can be applied as well as any difference in fracture healing


Eligibility Criteria:
Inclusion Criteria:

1. Mandible fracture involving subcondyle, ramus, angle, body, parasymphysis and symphysis
2. Age 18 years - 90 years
3. Ability to give informed consent
4. Minimum 6 weeks follow-up
5. Pre and post-operative panoramic xrays

Exclusion Criteria:

1. Comminuted fractures
2. Infected fractures
3. Previously treated fractures
4. Complete edentulism
5. Gun shot wounds
6. Pregnancy or breast feeding
Evaluating the Effects of Community Delivery of Malaria Intermittent Preventive Treatment on Pregnant Women and Babies

This study evaluates the effectiveness of community delivery of sulfadoxine-pyrimetamine (SP) for intermittent preventive treatment of malaria in pregnancy (IPTp) in increasing the coverage of IPTp among pregnant women in selected districts in Democratic Republic of Congo (DRC), Madagascar, Mozambique and Nigeria, compared to comparison districts where SP for IPTp is distributed as usual in facilities through routine antenatal care (ANC).

The specific objectives of this study are to determine the change in the following indicators during the course of the TIPTOP project: 1) Proportion of women who have had a pregnancy that ended in the past 12 months and have received 1 or more, 2 or more and 3 or more doses of IPTp-SP; proportion of women with pregnancy in the past 12 months who attended ANC clinics at least once, and who attended at least four times; proportion of pregnant women attending the first ANC visit before or at week 14; proportion of women who have had a pregnancy that ended in the past 12 months who know about the IPTp service provided by CHWs; and acceptability of C-IPTp for community delivery of IPTp (note: results will be disaggregated by provider type, age, gravidity and distance from facility). To assess these changes, the study will implement structured household surveys targeting potential beneficiaries of the project (pregnant women) in the intervention and comparison areas, implemented at three time points: baseline, mid- and end-points. In each country an initial implementation area (Phase I) and two expansion areas (Phase II) have been selected for the project. This study will establish if community deliver of IPTp is effective and feasible and whether it influences antenatal care service coverage rates. It is expected that the study will provide information to scale up the approach the 4 study countries for the prevention of malaria in pregnancy. This information is also meant to inform global guidelines on community IPTp delivery and may also be used by other countries.

Eligibility Criteria:
Inclusion Criteria:

* Women who had a pregnancy that ended in the 12 months preceding the survey
* Being resident in the study area during for at least 4 months before the end of the pregnancy
* Willing to participate in the household survey (signing informed consent/assent, in line with country guidelines)

Exclusion Criteria:

* Anyone considered to be a minor in their country.
* Not willing to provide informed consent
The Effect of Yoga on Labour and Neonatal Outcomes in Pregnant Women

The aim of this study was to determine the effect of yoga on mode of delivery preference, labour satisfaction and neonatal outcomes. This study was planned as a randomised controlled experimental study. The population of the study will consist of pregnant women who apply to the childbirth preparation classes of the institutions affiliated to the Bucak District Health Directorate, who meet the inclusion criteria and accept to participate in the study. The sample of the study; It will consist of pregnant women who apply for pregnancy follow-up to the birth preparation class determined between the dates of the study (15.01.2025 - 30.04.2025), who meet the criteria for admission to the study and who accept the study. The sample number was calculated by performing power analysis with the G power programme (19) and taking a study as a reference (20). According to the power analysis, the sample size was determined as 80 people (40 experimental, 40 control) to reach 95% power with an effect size of 0.8 and a 5% margin of error.


Eligibility Criteria:
Inclusion Criteria:

* being a woman
* who had a gestational week over than 26-28

Exclusion Criteria:

* who did not accept to participate in the study,
* who were diagnosed with risky pregnancy,
* who were illiterate,
* who had systemic disease and mental problems requiring treatment, who had a gestational week less than 26-28, and
* who had communication and language problems.
Evaluation of the Awakening Capability by a Vibrating Bracelet (BRASSARD)

As part of developing a relay alarm project, the aim of the study is to test a sleeper's capability to wake up via a vibrating alarm around the wrist (vibrating bracelet).


Eligibility Criteria:
Inclusion Criteria:

* speak french
* with social security For healthy volunteers : no sleep disorder, known neurological or respiratory pathology For patients : congenital central hypoventilation syndrome or ventilatory assistance whatever the indication, able to act on their ventilator, and in stable state on the respiratory level for at least 3 months.

Exclusion Criteria:

* subjects taking treatment that may interfere with sleep patterns
* intake of alcohol or any substance (alcohol, drugs) that may interfere with sleep patterns the day before the polysomnography
PROMASTER - PROspective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes

This study will examine extreme responders to second- and third-line Type 2 diabetes therapy using a prospective approach, and patients with slow or fast diabetes progression using a retrospective approach.

PILOT Phase (March 2013 - Dec 2014) Participants will be recruited initially from 4 centres. Patients due to start second- and third-line Type 2 diabetes treatments, and patients progressing to insulin either particularly quickly or particularly slowly, will be recruited from primary care, secondary care, or community settings. Fasting blood and urine samples will be collected, together with standard biomeasures and information about medical history and prescribing history. Participants in Responders Arm will be contacted by telephone approximately 3 months after starting their new second/third-line agent to review their current medication and blood glucose level. If a 3 month HbA1c has not been collected as part of routine clinical care, the research team will arrange this. Participants will be asked to return for a blood and urine test approximately 6 months after their new treatment was started. This visit will be brought forward should the participant advise they are about to further change their treatment, to enable their samples to be collected in advance of their proposed treatment change.

All study documentation and sample materials will be distributed to sites from the Coordinating Centre. Sites will be expected to process and freeze samples and send them to the Chief Investigator's Central Laboratory where they will be analysed for genetic factors, glycaemic markers and other markers related to drug response.

POST-PILOT Phase (Jan 2015 - Oct 2017) Subject to feasibility, interim analysis and continuation of funding from Medical Research Council (MRC), this study will continue for another 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Demographics: Age 18-90 inclusive
* Ethnicity: Reflective of local demographic
* Medical History: Clinical diagnosis of Type 2 diabetes
* Mental Capacity: Capacity to Consent

Exclusion Criteria:

* Age less than 18 years old and greater than 90 years old
* Incapacity to consent
* Type 1 diabetes.
Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients

The Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST) is a pilot randomized, controlled, singled-blinded (participant) trial in major orthopedic joint surgery patients that will build on a previously clinically tested cognitive behavioral therapy for insomnia (CBT-I) mobile application paired with a wearable device (wrist actigraphy).

CBT-I is the frontline treatment for insomnia but is not considered for preoperative care of older surgical patients with insomnia who are at risk of perioperative neurocognitive disorders associated with sleep/circadian dysfunction. We propose to determine if digital CBT-I (dCBT-I) is feasible for treating older surgical patients with insomnia symptoms and to examine the effects of dCBT-I on sleep, cognitive trajectory, mood, pain, activity, and function after surgery. The Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST) is a pilot randomized, controlled, singled-blinded (participant) trial in major orthopedic joint surgery patients that will build on a previously clinically tested CBT-I mobile application paired with a wearable device (wrist actigraphy).

Eligibility Criteria:
Inclusion Criteria:

1. Adults ≥ 65 years old
2. Scheduled for an elective orthopedic total joint replacement procedure (knee/hip) with an anticipated stay of ≥48 hours
3. At least mild insomnia (ISI score of ≥10 on telephone screening)
4. Stable sleep-affecting medications in the prior month (by clinical review)
5. Own a smart phone
6. Willingness to use the dCBT-I app and actigraphy.

Exclusion Criteria:

1. Current or previous CBT-I
2. Rapidly progressive illnesses/life expectancy \<6 months
3. Active psychosis/suicidal ideation
4. Irregular shift work/sleep patterns
5. Moderate-severe sleep apnea (apnea/hypopnea index ≥15) per chart review
6. Sleep disorders other than insomnia or apnea
7. Cognitive impairment (diagnosis of dementia)
Repeated Infusions of Mesenchymal Stromal Cells in Children With Osteogenesis Imperfecta

This is a study to evaluate the safety and effectiveness of repeated Mesenchymal Stromal Cells (MSC) infusions to patients with Type II or III osteogenesis imperfecta (OI).

Participants will receive MSC infusions approximately every 4 months to complete a total of 6 infusions over 20 months. Participants will be followed for 4 months post their last MSC infusion.

This is a pilot study to evaluate the safety and efficacy of repeated MSC infusions to subjects with OI. This study will evaluate subjects on two separate strata. Stratum A will include subjects with a diagnosis of Type II or Type III osteogenesis imperfecta who have previously undergone a bone marrow transplant. Stratum A may use previously harvested and cryopreserved bone marrow mononuclear cells from original BMT donor or freshly harvested or cryopreserved bone marrow mononuclear cells obtained from a haploidentical healthy parent or sibling. Stratum B will include subjects with Type II or III osteogenesis imperfecta who have not undergone a bone marrow transplant. Stratum B will only receive freshly harvested or cryopreserved bone marrow mononuclear cells from a haploidentical healthy parent or sibling.

Participants will receive MSC infusions approximately every 4 months to complete a total of 6 infusions over 20 months. Participants will be followed for 12 months post their last MSC infusion.

Eligibility Criteria:
Inclusion Criteria:

* Subjects less than or equal to 19 years of age at the time of enrollment
* Children with a diagnosis of severe of Type II or III osteogenesis imperfecta
* Parent or sibling greater than or equal to 18 years of age, donor willing to or has already undergone HLA typing, and willing and able to provide bone marrow
* BMT greater than 5 years ago for Stratum A

Exclusion Criteria:

* Dependent on supplemental oxygen
* Concurrent Infection
Autologous Peripheral Blood Stem Cell Transplantation With In Vivo Purging as an Alternate Stem Cell Transplantation Program for Pts w/AML in 1st & 2nd Complete Remission w/no HLA Matched Related Donor

Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem cell transplantation program for pts w/AML in 1st \& 2nd complete remission w/no HLA matched related donor


Eligibility Criteria:
Inclusion Criteria:

* Patients with AML in 1st \& 2nd complete remission w/no HLA matched related donor
Neoadjuvant Carboplatin in Triple Negative Breast Cancer

Breast cancer is the most frequent neoplasm in women in Brazil and in the world and up to 15% of all cases diagnosed correspond to the triple negative subtype. Triple negative breast cancer affects young women with germline mutations in BRCA 1/2 genes. Giving the lack of target therapies to date, there is no consensus regarding the most effective treatment for this subgroup of tumors. Although evidence shows that triple negative breast cancer is highly sensitive to chemotherapy when compared to other breast tumors, there is no evidence to support the hypothesis that patients with triple negative breast cancer and mutation in BRCA1 / 2 genes have higher chemosensitivity to neoadjuvant therapy. The investigator proposes a prospective, randomized, open-label, phase II study, evaluating the rate of complete pathologic response, disease-free survival, overall survival and prognostic evaluation of BRCA1 / 2 mutation status in women with triple negative breast cancer submitted to sequential neoadjuvant chemotherapy based on anthracycline and taxane, with or without carboplatin.


Eligibility Criteria:
Inclusion Criteria:

* Triple Negative Breast Cancer;
* Stage II or III;
* Performance Status ECOG \<2 or Karnofsky \>50%;
* Hematologic (minimal values):

Absolute neutrophil count \> 1,500/mm3 Hemoglobin \> 10.0 g/dl Platelet count \> 100,000/mm3

Exclusion Criteria:

* Stage I or IV;
* other malignancies.
Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC)

This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and etoposide in first line treatment for patients with newly diagnosed extensive-stage SCLC.

The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 90 patients will be enrolled in the study; 20 patients in the Part 1 and 70 patients in the Part 2 portion.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged ≥18 years
* Unequivocally confirmed diagnosis of SCLC by histology or cytology, preferably including the presence of neuroendocrine features by immunohistochemistry
* At least 1 target lesion that is unirradiated and measurable by RECIST, Version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
* Adequate organ function

Exclusion Criteria:

* Prior chemotherapy for extensive-stage SCLC
* Presence of symptomatic brain metastases requiring immediate treatment with radiation therapy or steroids.
* Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure
* Known history of stroke or cerebrovascular accident within 6 months prior to enrollment
* Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol
* Concurrent radiotherapy to any site or radiotherapy within 2 weeks prior to enrollment or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)
* Receipt of any investigational medication within 4 weeks prior to enrollment
Evaluation of Resilience Skills Enhancement (RISE) Training Among University Students

Background University students experience high levels of stress and this may negatively impact their mental health, coping and academic outcomes. Building resilience has been described as an ability to maintain mental well-being.

Aims This study aims to (1) assess the feasibility of the Resilience Skills Enhancement (RISE) program, (2) evaluate the effects of RISE on undergraduate students' resilience, coping, emotion regulation, positive emotions and stress and (3) explore students' perception of RISE.

Methods This study will be operationalized in three phases.

Phase 1 - Feasibility A single-arm pre-post study will be used. 10 students will be recruited to explore their acceptability, perception, and suggestions for improving RISE. RISE comprises of six weekly sessions delivered via LumiNUS and Zoom. The Wilcoxon signed rank test will be used to analyse the data.

Phase 2 - Randomized controlled trial A prospective, double blind randomized controlled trial and repeated post-tests will be used. A total of 122 students will be recruited from LumiNUS and social media platforms. Participants will receive a series of six, weekly online sessions in both groups. The primary outcome is resilience. The secondary outcomes include, coping, emotion relation, positive emotions, stress. Multivariate analysis of variance with repeated measures will be used to compare the mean difference of scores in the three time points through Wilks's lambda test. The data will be analysed according to the intention-to-treat principle.

Phase 3 - Process evaluation A qualitative study using an individual, semi-structured interviews will be used to explore students' perception of RISE. Approximately 20 students will be recruited, and the final sample size will be determined based on data saturation. Thematic analyses will be used to analyse the data.

Potential contributions This study will contribute by evaluating evidence-based user-friendly RISE that may be effective for enhancing university students' resilience.


Eligibility Criteria:
Inclusion Criteria:

1. Full undergraduate in NUS
2. Above 18 years old
3. Comprehend English language
4. Have access to an electronic device (laptop, smartphone or tablet)

Exclusion Criteria:

1. No self-reported history of mental health disorders
2. Did not participate in any other form of resilience training