cyrilzakka/clinical-trials huggingface dataset:
Diagnostic of Rotator Cuff Calcific Tendinosis Using MRI With ZTE Sequence

Conventional radiographs are still considered the reference for identifying rotator cuff calcific tendinosis.

MRI is widely performed for rotator cuff disorders evaluation but has a moderate accuracy in rotator cuff calcific tendinosis diagnosis and calcific deposits identification (sensitivity and specificity around 60%), even though it helps in determining acuity of the finding by adjacent soft tissue edema depiction and differential diagnosis identification (i.e. adhesive capsulitis, sub-acromial bursitis...).

Zero echo time (ZTE) MRI provides enhanced bone contrast by enabling the acquisition of signals from tissues exhibiting the shortest T2 values on a single sequence with a spatial resolution of 0.8-1.2 mm isotropic and can therefore provide images similar to those obtained with radiographs.

We hypothesize that ZTE images could also depict rotator cuff calcific tendinosis, but to our knowledge, no study compared this technique to radiographs and/or standard MRI.


Eligibility Criteria:
Inclusion Criteria:

* patient referred to the imaging department for a MRI scan in case of suspicion of rotator cuff tendinosis

Exclusion Criteria:

* incomplete data sets
A Study of ARRY-334543 and Capecitabine in Patients With Advanced Cancer

This is a Phase 1 study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and capecitabine. Patients will receive increasing doses of study drug in combination with capecitabine in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 30 patients from the US and Canada will be enrolled in this study.


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of any advanced/metastatic cancer suitable for treatment with capecitabine. Pancreatic cancer is not allowed and patients with gastric or gastroesophageal junction (GEJ) cancer are only eligible if prior treatment did not include a total gastrectomy.
* Target lesions may be in a previously irradiated field only if progression of the lesion has been clearly documented.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
* Must be able to take and retain oral medications.
* Additional criteria exist.

Key Exclusion Criteria:

* Active concomitant malignancies.
* Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days).
* Known dihydropyrimidine dehydrogenase (DPD) deficiency.
* Requiring intravenous (IV) alimentation.
* Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
* Pregnancy or lactation.
* Chemotherapy, anticancer immunotherapy, monoclonal antibodies or biologics within 21 days prior to first dose of study drug.
* Anti-EGFR and/or ErbB2 small molecule targeted therapy or hormonal anticancer therapy within 14 days prior to first dose of study drug.
* History of any hypersensitivity to or intolerance of capecitabine or any of its components, or to fluorouracil or any fluoropyrimidine therapy.
* Additional criteria exist.
Pharmacokinetics, Safety and Tolerability of Single Doses of BIIB033 (Opicinumab) Produced by 2 Manufacturing Processes

The primary objective of the study is to characterize the pharmacokinetics (PK) of BIIB033-B and to compare the PK profile with that of BIIB033-A in healthy volunteers. Secondary objectives are: To assess the safety and tolerability of BIIB033-A and BIIB033-B; To assess the secondary PK parameters of BIIB033-A and BIIB033-B; To assess the immunogenicity of BIIB033-A and BIIB033-B.


Eligibility Criteria:
Key Inclusion Criteria:

* - Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
* - Must have a body mass index of 18 to 32 kg/m2, inclusive.
* - All male participants and all female participants of childbearing potential must practice highly effective methods of contraception during the study and be willing and able to continue contraception for 6 months after being dosed with study treatment. Male participants must not have unprotected sexual intercourse with a female who is pregnant or breastfeeding during the study. Male participants must also be willing to refrain from sperm donation for at least 6 months after dosing with study treatment.
* - Must be in good health as determined by the Investigator (or designee), based on medical history and screening evaluations.

Key Exclusion Criteria:

* - History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or other major disease, as determined by the Investigator.
* - History of or ongoing malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 12 months prior to Day -1).
* - Serious infection (e.g., pneumonia, septicemia) as determined by the Investigator, within the 3 months prior to Day -1.
* - Fever or bacterial or viral infection (including upper respiratory tract infection) within 2 weeks prior to Day -1.
* - History of severe allergic or anaphylactic reactions, or history of any allergic reaction that in the opinion of the Investigator is likely to be exacerbated by any component of the study treatment.
* - Prior exposure to BIIB033.
* - Female participants who are breastfeeding or pregnant at Screening or Day -1, or plan to become pregnant during the study or during the 6 months following study drug administration.
* - History of, or positive test result at Screening for, human immunodeficiency virus.
* - History of, or positive test result at Screening for, hepatitis C virus antibody or hepatitis B virus (defined as positive for hepatitis B surface antigen or hepatitis B core antibody).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin

A double-blinded randomised control trial conducted in the Department of Obstetrics and Gynaecology of a tertiary hospital, Universiti Kebangsaan Malaysia Medical Centre (UKMMC) for two years duration from January 1st, 2012 till December 31st, 2013.

The aim of the study is to compare the haemodynamic and cardiovascular effects between intravenous carbetocin 100 μg and intravenous oxytocin 5 IU in women undergoing elective Lower Segment Caesarean Section (EL LSCS).

Study hypothesis: A single injection of carbetocin is haemodynamically and cardiovascularly safe and has similar efficacy in comparison to a single injection of oxytocin.

OUTCOME MEASURES systolic blood pressure (SBP), diastolic blood pressure (DBP), Heart Rate (HR), saturation of oxygen (SpO2) in certain time after drug injection.

The presence of myocardial ischemia symptoms and side effects of both drugs, ECG changes such as ST depression and changes in T-waves.

Hemoglobin and troponin-T level

The need for additional oxytocin infusion and estimated blood loss

The time interval between initial drug administration, type of additional oxytocic intervention that used and complication that happened.

Eligibility Criteria:
Inclusion Criteria:

1. Viable, singleton pregnancy ≥ 37 weeks gestation undergoing EL LSCS.
2. Low risk for post-partum hemorrhage, such as no proven abruptio placentae, placenta previa, multiple pregnancy, pre-eclampsia / gestational hypertension, previous PPH, obesity (based on BMI pre pregnancy which is ≥ 30 kg/m2), big baby.
3. Ability to provide informed consent.

Exclusion Criteria:

1. Emergency caesarean section
2. Preterm Labour
3. Grandmultipara
4. Multiple Pregnancy
5. Placenta Previa
6. Previous PPH
7. Maternal Obesity ( BMI pre pregnancy ≥ 30 kg/m2))
8. Have co-morbidity illness such as hypertension/pre-eclampsia, established cardiac diseases, history or evidence of liver, renal, vascular, or endocrine disease and bleeding disorder.
9. Contraindication to carbetocin and oxytocin
10. Language Barrier
11. Women undergoing general anaesthesia
12. Women who has abnormal baseline ECG that suggestive myocardial ischemia
Study of Efficacy of PEAR-004 in Schizophrenia

The purpose of the study was to determine in patients currently being administered antipsychotic pharmacotherapy whether PEAR-004 could further reduce symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS).

The overall rationale for the study was to assess the first prescription digital therapeutic (PDT) in schizophrenia using a form of proven psychosocial intervention, cognitive behavioral therapy (CBT), to supplement standard of care with antipsychotic medications.

This was a randomized, sham-controlled, rater-blinded, parallel group trial. Overall, 112 subjects were randomized 1:1 in to the following groups:

* Group A: Clinician-directed pharmacotherapy + PEAR-004
* Group B: Clinician-directed pharmacotherapy + sham app An up to 28-day screening period included standard screening assessments as defined in the assessment schedule. Eligible subjects were randomized on Day 1 into one of the treatment groups.

Subjects in both groups continued to receive their clinician-directed standard-of-care treatment for schizophrenia, including pharmacotherapy. Subjects in Group A used PEAR 004 and subjects in Group B used a sham for a period of 12 weeks. Subjects returned to the clinic for outpatient visits at Week 4 (day 29), Week 8 (day 57), and Week 12 (day 85). At each visit, standard assessments were performed according to the assessment schedule, including PANSS, ISST-Plus, CGI, BMQ, MAP-SR, WHOQOL-BREF, BDI-II, ISI, and adverse events (AEs). A final follow-up visit was performed at Week 16 (day 115),

Eligibility Criteria:
Key Inclusion Criteria:

* Signed informed consent must be obtained prior to participation in the study.
* Healthy male and female subjects 18 to 65 years of age, inclusive, and in good health as determined by medical history, physical examination, and vital signs at screening
* SCID-based DSM-5 diagnosis of schizophrenia and a total PANSS score \> 60
* Proficient in English at 5th grade reading level or higher, in the judgement of the investigator
* Capable of using a mobile device (compatible with PEAR-004) and using common applications, in the judgement of the investigator

Key Exclusion Criteria:

* Major change in primary antipsychotic medication in the prior 4 weeks before screening (e.g., switching to a new agent or a dose adjustment within two weeks of randomization)
* Planning to move out of the geographic area within 3 months
* Unable to use English to participate in the consent process, the interventions or assessments
* Inability to comply with study procedures, due to severe medical conditions or otherwise
* Meet DSM-5 diagnosis for a current episode of major depression, mania, or hypomania in the past month
* Meet DSM-5 diagnosis for a current moderate or severe alcohol or cannabis use disorder in the past 2 months
* Meet DSM-5 diagnosis for a current substance use disorder (other than alcohol or cannabis) in the past 2 months
* Considered high risk for suicidal behavior based on ISST-Plus score at screening, or in the judgement of the investigator
* Previously participated in a clinical study involving PEAR-004
G-CSF and Autologous Cord Blood Infusion in Cerebral Palsy

This study is performed to reveal the safety and feasibility of combination therapy with autologous cord blood mononuclear cells (CB) and G-CSF as well as repeated administration of G-CSF for children with cerebral palsy. The evaluation tools are as follows: (1) Developmental tests (DDST, PEDI, GMFM, GMFCS, MACS, QUEST), (2) Neurocognitive function test (WPPSI-IV), (3) Brain MRI-DTI, (4) Peripheral blood CD34+ cell counts, (5) Neurotrophic factors/anti-inflammatory cytokines.


Eligibility Criteria:
Inclusion Criteria:

* Ages from 2 years to 10 years at the time of enrollment
* Non-severe type of cerebral palsy
* Willing to comply with all study procedures

Exclusion Criteria:

* Previous participation within 1 year in a clinical study with stem cell therapy including cord blood, G-CSF, and erythropoietin
* Presence of chromosomal abnormalities
* Unwillingness to participate clinical trial
* Presence of hypersensitivity reaction to G-CSF
* Evidence of hepatic, renal, cardiac dysfunctions
Patient Reported Outcomes With LASIK: PROWL-2

This study evaluates a questionaire designed to measure satisfaction and ophthalmic-related quality of life (QoL) of 300 civilian participants prior to and three months following state-of-the-art laser in situ keratomileusis (LASIK).

The LASIK Quality of Life Collaboration Project (LQOLCP) is a government partnership among the FDA's Center for Devices and Radiological Health (CDRH), the Department of Defense, and the National Eye Institute (NEI). This project examines patient-reported outcomes (PROs) following LASIK surgery. This three-phased project is part of FDA's ongoing effort to better monitor and improve the safety and effectiveness of lasers used in LASIK surgery. PROWL-2 is the third phase of the larger LQOLCP project. The primary objective of PROWL-2 is to explore the psychometric properties of a computer-based questionnaire assessing the patient-reported outcomes of satisfaction and ophthalmic-related quality of life before and over a period of 3 months following LASIK. This questionnaire initially developed and examined in PROWL-1 (a military population) will be examined psychometrically in a civilian population. PROWL-2 is a prospective, multi-center, observational study in which a participant's pre-operative status will serve as the baseline for one-month and three-month post-surgical comparisons. Three hundred (300) participants planning to undergo refractive surgery using LASIK for myopia, hyperopia, or astigmatism will be enrolled in this study from five (5) clinical sites across the United States. Additionally, routine clinical data will be collected pre- and post-operatively (e.g., best corrected visual acuity, manifest refraction, wavefront aberrometry, conreal topography, and other clinical assessments) and questionnaires will be independently administered pre-operatively and at the one-month and three-month post-operative visits.

Eligibility Criteria:
Inclusion Criteria:

* Investigators will be instructed to base subject eligibility on the Professional Use Information for their specific laser and keratome system, including but not limited to subjects who:
* Are aged 21 years or older.
* Have the ability to give informed consent.
* Speak and read English fluently.
* Have not previously had any form of refractive surgery, including prior LASIK or cataract surgery.
* May benefit from increased spectacle independence.
* Have been determined to be a good candidate for the LASIK procedure based on the investigator's assessment of medical and ophthalmic health, general cognitive function, and physical and social limitations.
* Have a treatment target of bilateral emmetropia. Of note, an eye must be treated within 7 days of the fellow eye.
* Express willingness and potential ability to return for all follow-up examinations through the 3-month follow-up exam under the care of the treating investigator.
* Have access to a computer with internet service.
PEEK Bar Versus Titanium Bar Fabricated by CAD-CAM in Mandibular Hybrid Prostheses: A Comparative Study

CAD/CAM-fabricated PEEK bar exhibited greater dimensional deviation in comparison to its titanium counterpart. Nevertheless, patients with PEEK bars reported higher satisfaction levels and lower marginal bone loss when compared to those with titanium bars.

Fourteen patients with completely edentulous mandibular arch opposing natural dentition were selected and divided into two groups, seven patients in each. All patients received implant-supported hybrid prostheses with a bar fabricated by CAD/CAM milling technique. In group I (control), bar was fabricated from titanium, while in group ӀӀ, the bar was fabricated from PEEK. The evaluation of the study was done at 6 and 12 follow-up periods according to the following: 1- Experimentally by Geomagic (Geomagic, Japan) to detect any dimensional deviation of PEEK bars compared to titanium bars. 2-Clinically by questionnaire to evaluate the patient satisfaction. 3- Radiographically (digital periapical) to measure marginal bone loss around the implants.

Eligibility Criteria:
Inclusion Criteria:

* Completely edentulous mandibular arch for at least six months have almost of the natural teeth in the maxillary arch with a ranged of age from 40- 60 years old.

and normal class Ӏ maxilla-mandibular relationship with a minimum 12-15 mm inter-arch space

Exclusion Criteria:

* All patient had systemic disorders that may influence soft or hard tissue healing were excluded as:

  * History of radiation therapy in the head and neck region.
  * Active infection or inflammation or flabby tissue in the mandibular arch
  * Bone diseases as osteoporosis.
  * Clenching or bruxism, temporomandibular joint troubles
  * Neurological or psychiatric handicap conditions that could interfere with good oral hygiene.
  * Heavy smoking and drug abusing
Prospective Study on the Role of Intravenous Unfractionated Heparin Following Digital Replantation and Revascularization

The purpose of this study is to determine the effectiveness of therapeutic dose intravenous heparin at improving replantation/revascularization success and its indications (if any) in participants who have suffered traumatic digital amputation. Digital replantation/revascularization success will be assessed in participants who receive continuous intravenous drip of thromboprophylactic heparin at a therapeutic dose (i.e. modifies INR to the desired range) contrasted to those who do not receive therapeutic dose heparin (i.e. does not modify INR to the desired range). In the study, replantation/revascularization success is defined as a clearly viable digit at the time of discharge. Secondary objectives include assessing postoperative complications associated with heparin use, such as bleeding, hematoma or heparin induced thrombocytopenia. The investigators would also assess the impact of categorical variables such as smoking status, mechanism of injury and comorbidities, on digital survival.


Eligibility Criteria:
Inclusion Criteria:

* All replantation and revascularization patients who are accepted into the CEVARMU program at the Centre hospitalier de l'Université de Montréal

Exclusion Criteria:

* Patients on anticoagulants, other than ASA, prior to admission (i.e. Coumadin, Eliquis, Pradaxa, Plavix, or similar medications)
* Patients with a contraindication for heparin (e.g. coagulopathy, acute ulcers, thrombocytopenia, severe liver damage, shock)
* Patients who suffered an amputation in the level of the carpal tunnel and proximal to it
* Patients who experienced a degloving injury
Identification of Phenotypic Factors That Predict Success for Weight Loss and Long-term Weight Maintenance

The Investigational Weight Management Clinic now entitled the Weight Management Program at the University of Michigan was created to identify strategies that will result in cost-effective, long term weight management for overweight and obese individuals. The driving hypothesis of the clinic is that the 'one size fits all' philosophy is untenable with a complex disease such as obesity. The clinic will serve as a portal for patients to choose standard clinical care or to explore alternatives from a variety of clinical studies offered through the clinic. These studies will include further investigations into nutrition, the biological basis of weight and weight management and protocols using approved and experimental pharmaceuticals as well as technologies that aid in self-management of weight.


Eligibility Criteria:
Inclusion Criteria:

* Obese males and females: age \>20 years; Obese population defined as BMI \> or = 27 kg/m2
* Lean population BMI \< 27 but \> 17 kg/m2
* Able and willing to provide written informed consent for the trial

Exclusion Criteria:

* Evidence of inherited disorders of lipid metabolism.
* History of Cancer within the last 5 years
* Human immunodeficiency virus (HIV) antibody positive.
* Patients with solid organ transplants.
* Participation in any other clinical trial within 90 days of entry into this trial.
* Pregnant or lactating females.
* Uncontrolled thyroid disease
* Unstable angina or NY heart association class II failure or above
* Gastrointestinal disease specifically GI motility disorders
* Unstable neuropsychiatric disease including major depression/anxiety, eating disorder such as binge eating, bulimia or anorexia
* End stage renal or hepatic disease
* Autoimmune disorders (e.g. SLE)
* Body weight fluctuation of more than 5 kg in the previous 3 months
* Prior bariatric surgery
* A history or current alcohol/substance abuse and change in smoking habits or cessation in the past 6 months.
* Women of childbearing age must use a reliable form of contraception.
* Any medical condition, which in the opinion of the investigator would make the patient unsuitable for recruitment, or could interfere with the patient participating in or completing the protocol.
* Unwilling or unable to consent for the study.