cyrilzakka/clinical-trials huggingface dataset:
MAKO Total Knee Artroplasty

The purpose of this study is to determine the early clinical and radiographic outcomes of robotically assisted total knee arthroplasty with the MAKO surgical robot using the Triathlon knee system. Results of this study will be compared to those of a previously published cohort of patients from this institution who underwent TKA using non-robotic, manual instruments.

MAKO TKA patients will be given Fitbits and the Focus Motion Knee Brace to capture the data listed in attachment section. The results of this data will be compared to the control group to see if there is or there is not a difference in clinical outcomes with patients receiving Total knee surgery using the MAKO surgical robot versus those who got Total knee surgery without the MAKO robot.

Research objectives:

The purpose of this study is to determine the early clinical and radiographic outcomes of robotically assisted total knee arthroplasty with the MAKO surgical robot using the Triathlon knee system. Mean weekly VAS pain score during the first 4 weeks is the primary end point. Results of this study will be compared to prospective cohort of patients in the IRB study 201805014 from this institution who underwent TKA using non-robotic, manual instruments

Primary Hypothesis: Patients receiving robotic TKA will have better early recovery, including lower mean weekly VAS pain score for the first 4 weeks postoperatively and higher functional outcome scores, than the manual TKA historical cohort.

Secondary Hypothesis:

Patients receiving robotic TKA will have more accurate component position and alignment than the manual TKA historical cohort.

Potential Contribution: This study would give us a better understanding of the clinical and radiographic outcomes of patients receiving robotic TKA versus manual TKA. It will identify potential advantages and disadvantages of robotic TKA using the MAKO surgical robot.

Eligibility Criteria:
Inclusion Criteria:

* Planning to undergo Unilateral primary total knee arthroplasty
* 18 and up
* Willing to sign informed consent
* Willing to return for all follow-up visits
* Smartphone or tablet device capable of running the Fitbit andFocusMotion platform

Exclusion Criteria:

* BMI \> 45
* Inflammatory arthritis
* Narcotic use greater than 5 days per week
* Walking aid for musculoskeletal or neurologic issue other than operative joint
* Bilateral total knee arthroplasty
* Patient with an active infection or suspected infection in the operative joint
* The absolute and relative contraindications stated in the FDA cleared labeling for the device
Acute Clinical Evaluation of Multi-purpose Solutions (MPS) in Soft Contact Lens Wearers

The purpose of this study was to clinically evaluate lens care solutions used with soft contact lenses.

This study was conducted as a series of ten smaller studies in three countries using commercially available contact lens solutions per each country, ie, United Kingdom, France, and the Philippines. In each study, participants were assessed after use of up to 5 products (with one always being a control saline/blister pack solution) in randomized order in conjunction with one of the silicone hydrogel contact lenses. A total of 278 participants were enrolled in the 10 studies.

Eligibility Criteria:
Inclusion Criteria:

* Have read, understood, signed, and dated the written Informed Consent.
* Be an adapted and successful soft contact lens wearer on a daily wear basis for at least two weeks.
* Vision correctable to at least 20/30 Snellen.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Topical ocular medication use.
* History of hypersensitivity to any component of the study contact lens care systems.
* Any slit-lamp finding of abnormal nature at the baseline visit assessment of each study period.
* Pregnant, lactating, or planning a pregnancy.
* Other protocol-defined exclusion criteria may apply.
Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature

The present randomized trial was initially intended to study the benefits of a combined treatment with growth hormone (GH) and a gonadotropin-releasing hormone (GnRH) agonist for pubertal children with idiopathic short stature. However, treatments were stopped in January 2012 at the request of the French drug agency. Therefore, a protocol amendment divided the study in two study periods.

Study Period 1 involved combined treatment with somatropin and leuprorelin or treatment with somatropin alone. Participants from France who participated in this Period 1 of the study were asked to participate in a long term safety follow up defined as a Period 2 of the study. Participants from the Netherlands were offered participation in Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS, clinicaltrials.gov Identifier: NCT01088412) for long term safety follow up independent of this study.


Eligibility Criteria:
Inclusion Criteria:

* male or female children with ISS
* age greater than or equal to 8 years and less than or equal to 12 years and 3 months for girls and greater than or equal to 9 years and less than or equal to 14 years and 3 months for boys
* bone age less than or equal to 12.0 years for girls and less than or equal to 14.0 years for boys based on a central reading of an X-ray of the left hand and wrist
* Pubertal stage B2 and B3 for girls based on the Tanner method
* Pubertal stage G2 and G3 for boys based on the Tanner method

Exclusion Criteria:

* Growth hormone deficiency (GHD)
* Insulin-like growth factor-I levels greater than 3 SDS
* Chromosomal abnormality diagnosed locally on a karyotype. For girls, the karyotype to eliminate a Turner syndrome, is mandatory
* Small for gestational age (SGA)
* Has reached menarche (had her first menstrual period)
* Have any significant concomitant disease that is likely to interfere with growth or with the study, or is a known contraindication to Growth Hormone treatment
Study to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics of HIP2101 in Healthy Volunteers

A Phase 1 Study to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics of HIP2101 in Healthy Volunteers

A Randomized, Open-label, Multiple-dose, Crossover Phase 1 Clinical Trial to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics after Oral Administration of HIP2101 in Healthy Adult Volunteers

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers in the age between 19 and 50 years old.
* Body mass index (BMI) in the range of 18 to 30 kg/m2 and weight 50.0kg to 90.0kg.
* After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.
* Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.

Exclusion Criteria:

* Gastrointestinal disorders (Crohn's disease or Acute/chronic pancreatitis) or gastrointestinal surgery (except for simple cecal or hernia surgery) which may affect the safety and pharmacokinetic evaluation of test drug.
* Subjects who have a history of hypersensitivity or clinically significant hypersensitivity to investigational product or the same component or other drugs.
* Aspartate aminotransferase and alanine aminotransferase exceed 2 times the upper limit of normal range from screening laboratory results before randomization.
* Subject who continues to drink (21 units / week, 1 unit = 10 g of pure alcohol) within 6 months before the first administration or who cannot abstain from consent to post-study visit.
* Heavy smoker (\>10 cigarettes/day).
Data Aquisition for Optimization of Coronary Artery Disease Algorithm

The purpose of the study is to optimize an already existing algorithm for diagnosing atherosclerosis of the coronary arteries (CAD, Coronary Artery Disease).

Acoustic information from the heart is obtained from patients suffering from Coronary Artery Disease. The acoustic signals are evaluated as indicators for CAD.

Eligibility Criteria:
Inclusion Criteria:

* Age minimum 18 years
* Referred to CAG on suspicion of CAD
* Stabile angina without ACS
* Signed informed consent

Exclusion Criteria:

* ACS
* Previous bypass operation
* Previous heart transplant(incl. mechanical or artificial)
* Pregnancy
* Damaged skin on examination location
Crossover Bioequivalence Study of Irbesartan HCTZ 300/25 mg Tablets Under Fasted Conditions

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Irbesartan and Hydrochlorothiazide 300 mg / 25 mg Tablets under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects between the ages of 18 and 45 years (inclusive).
2. Voluntary consent to participate in the study.
3. Body Mass Index (BMI) between 18 and 30 (inclusive).
4. Female subjects of childbearing potential - not surgically sterile or at least 2 years postmenopausal - must agree to utilize one of the following forms of contraception from screening through completion of the study: abstinence, hormonal (oral, implant, transdermal, or injection) for at least 3 months prior to the first dose of the study, barrier (condom with spermicide, diaphragm with spermicide), IUD, or vasectomized partner (6 months minimum).
5. No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

1. A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
2. A history of allergic or adverse responses to irbesartan and hydrochlorothiazide, or any comparable or similar product.
3. Subjects who (for whatever reason) have been on an abnormal diet or have had substantial changes in eating habits within 30 days prior to study initiation.
4. Subjects must not have made a blood donation of one pint or more within 30 days prior to study initiation.
5. Subjects must not have made a plasma donation within 14 days of study initiation.
6. Participation in a clinical trial within 30 days prior to study initiation.
7. Use of any over-the-counter (OTC) medication, including vitamins, herbal products, and dietary supplements, within 7 days prior to or during the study.
8. Use of any prescription medication within 7 days prior to or during the study, with the exception of hormonal contraceptives for women of childbearing potential, or hormone replacement therapy.
9. Treatment with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, phenytoin, rifampin, rifabutin, glucocorticoids, diltiazem, ketoconazole, MAOI, antidepressants, neuroleptics, verapamil, quinidine, erythromycin, etc., within 30 days prior to or during the study.
10. Smoking or use of tobacco products within 6 months prior to or during the study.
11. Female subjects who are lactating.
12. Positive serum pregnancy test for female subjects.
13. Positive blood screen for HIV, Hepatitis B or Hepatitis C.
14. Positive screen for alcohol or drugs of abuse, and history or presence of alcoholism or drug abuse within 6 months prior to the study start.
The STRIVE Study: Development of a Blood Test for Early Detection of Multiple Cancer Types

GRAIL is using high-intensity sequencing of circulating cell-free nucleic acids (cfNAs) to develop blood tests to detect cancer early. The purpose of this study is to validate the ability of the pre-specified GRAIL Test to detect breast cancer and other invasive cancers, including hematologic malignancies, that will occur within one year of the first study blood draw.

Detection of early stage cancer may be possible through analysis of circulating cell-free nucleic acids (cfNAs) shed into the blood by tumors. GRAIL is using high-intensity sequencing (based on broad genomic coverage and deep sequencing) of cfNAs, combined with machine learning, to develop blood tests to detect cancer early. The purpose of this prospective, multi-center, observational cohort study is to validate an assay for the early detection of breast cancer and other invasive cancers, including hematologic malignancies. The study will collect blood samples from participants within 28 days of their screening mammogram. Additional blood samples will also be collected for a subset of participants. For participants who receive a cancer diagnosis during the study, archival tissue samples will be collected.

Eligibility Criteria:
Inclusion Criteria:

1. Women undergoing mammography for screening indications or have an appointment for screening mammography.
2. Participant provides informed consent and expresses understanding of the protocol and its requirements, risks, and discomforts.

Exclusion Criteria:

None.
Different Approaches to Thoracic Paravertebral Block

Thoracic paravertebral block (TPB) in thoracic surgery is practiced since the development of minimally invasive surgery. Historically, thoracic epidural analgesia is done in open thoracic surgery. Thoracotomy with rib spacing causes strong post-operative pain that is well controlled with epidural analgesia and allows less use of morphine. However, this method causes frequent side effects. Minimally invasive surgery, when it is possible and recommended, has the main benefit of not spacing the ribs and therefore preventing nerve stretching, rib fractures and less post-operative pain. This less aggressive method has other benefits: less inflammation, better recuperation especially for vulnerable patients (the elderly; limited pulmonary functions), less time of thoracic drainage, less in hospital stay and better quality of life (1). Less invasive surgery has brought us to use less invasive analgesic methods. Thoracic paravertebral block is a good alternative to thoracic epidural analgesia but is unfortunately not done everywhere due to the lack and need of professional training. The objective of our study is to compare two methods of TPB: ultrasound guided method undergone by the anesthesiologist, and intrathoracic method undergone through video assisted surgery (VATS) or robotic assisted surgery (RATS).

A randomized prospective mono-centric non-inferiority controlled and simple blinded study comparing the "surgical" method (experimental group) to the "anesthetic" method (control group) for patients operated in thoracic minimally invasive surgery (VATS or RATS).

Recruitment: Patients undergoing therapeutic or diagnostic surgery in the thoracic ward of the university hospital of Marseille.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age.
* VATS or RATS with lung resection including wedges, segmentectomies or lobectomies.
* Signed consent.
* Scheduled surgeries.

Exclusion Criteria:

* Patient refusing to sign the consent form.
* Minors.
* Patients under any guardianship.
* All surgeries with pleura intervention: talc, pleurectomy, wall resection.
* Non trained anesthesiologist to ultrasound TPB.
* Presence of pain or daily use of painkillers prior to surgery.
* Medical history of homolateral thoracic surgery.
An Evaluation of a Family Counseling Intervention ("Tuko Pamoja") in Kenya

The purpose of this study is to evaluate a family counseling intervention, entitled "Tuko Pamoja" (Translation "We are Together" in Kiswahili). The intervention, delivered by lay counselors and through existing community social structures, is expected to improve family functioning and individual mental health among members. The sample includes families with a child or adolescent (ages 8-17) experiencing problems in family functioning.

The purpose of this study is to evaluate a family counseling intervention, entitled "Tuko Pamoja" (Translation "We are Together" in Kiswahili), using a pilot randomized control trial design.

The intervention, delivered by lay counselors and through existing community social structures, focuses on improving family relationships and mental health with content derived from evidence-based practices; these include family systems and solution-focused family therapies and cognitive behavioral strategies. It is components based, with modules delivered based on need. The content and structure has been adapted in both content and implementation model based on formative research in this context. Primary hypotheses include achieving improvements in outcomes related to:

1. Family functioning, including elements such as communication, emotional closeness, structure and organization, and satisfaction for the overall family; this also includes indicators of functioning at dyadic levels (i.e., parent-child and couples functioning)
2. Mental health of both children and caregivers.

The investigators also hypothesize feasibility and acceptability, including high fidelity and adequate clinical competency by the non-specialist counselors, based on a previous evaluation of the program.

The study will follow a randomized controlled design with a target sample size of 60 families, including up to 2 caregivers per family (who hold primary responsibility for the child whether biological or non-biological) and a target child identified either through caregiver-report of the child about whom they are most concerned or randomly, if there is no child with particular concerns. Families will be recruited in two rounds of 30 families due to logistical limitations of enrolling all 60 at the same time.

Eligibility Criteria:
Inclusion Criteria:

* Family with self-reported elevated distress (e.g., high levels of conflict) that also has a child/adolescent (ages 8-17) with caregiver-reported emotional or behavioral concerns

Exclusion Criteria:

* Families without reported distress and/or without reported adolescent distress.
* Families with children older than 17 or younger than 8 years of age.
* Families in which primary caregivers or children are living too far outside of the community to participate in treatment.
Preliminary Establishment of the Medical Reference Range of Serum Vitamin K2 in Chinese Healthy Adults

Osteocalcin is a type of vitamin K2-dependent protein, and many studies have confirmed that vitamin K2 has anti-osteoporosis effects, and has preventive and therapeutic effects on a variety of diseases such as nervous system, cardiovascular disease, immune disease, and glucose metabolism. However, as a pleiotropic vitamin and nutrient, vitamin K2 does not have an exact normal range like other vitamins, when it needs to be supplemented, and in what regimen. Different organizations have different opinions on the recommended intake of vitamin K. Thus, this study intends to preliminarily obtain the reference interval of serum vitamin K2 by conducting clinical research in healthy people in the Beijing-Tianjin-Hebei region, and analyzes different factors, such as gender, age, and place of residence, to compare their level differences and changing trends, and to provide data reference for the recommended intake of vitamin K2 for people with vitamin K2 deficiency.


Eligibility Criteria:
Inclusion Criteria:

* People aged over 18.
* People with normal routine blood test.
* Willing to participate in this study.

Exclusion Criteria:

* Subjects with congenital metabolic problems and endocrine diseases.
* Treatment with any investigational drug within the past 3 months.
Health-eBrain Study

The purposes of this study are to (1) track dementia caregiver health indicators over 12 weeks, both with and without the Mindoula plus DANA intervention (case manager and mobile messaging and assessment applications) to determine if the intervention improves caregiver health and (2) obtain feedback from caregivers to inform on the design of future interventions.

This study will track the mental status and cognition of caregivers with and without the Mindoula and DANA intervention and use subject feedback to aid in designing future interventions for caregivers.

This is a remotely administered, virtual study targeting dementia caregivers who are mild to moderately depressed. Screening calls for online administration of four surveys to determine inclusion in the study arms. These surveys will be taken on the Health-eBrain website, both at baseline/screening and throughout participation. All other participation will be completed on the participant's mobile phone, and all psychological and cognitive tests will be self-administered.

This study has a between-group design. Participants will be screened for eligibility and then randomized into each arm. The intervention arm will receive the Mindoula plus DANA intervention. The wait list control arm will take the psychological surveys at regular intervals then, after 12 weeks, be enrolled in the DANA-only observation group. The DANA-only group will take DANA and a usability questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Females and males who regularly provide care for a person with Alzheimer's Disease
* Between the ages of 45-75
* Self-reported ability to speak and read English
* Providing care for at least a year

Participants in the Intervention and Waitlist Control Arms must meet the following additional inclusion criteria:

* Zarit Burden Inventory (ZBI) Score of 9+
* Overall M3 score of 33+
* M3 Depression score of 7+
* Female Only
* Minimum hours of caregiving a week must be equal to or greater than 20 hours

Exclusion Criteria:

* Anyone with a known cognitive diagnosis
* Anyone with color blindness
* Overall score of high risk on the M3 and/or high risk on the PTSD or Bipolar subsection of the M3
* Failure to meet all inclusion criteria per arm
Antithrombotic Activities of a Novel Yoghurt Drink: a Postprandial Study

The project aims to investigate the antithrombotic activity of the novel yoghurt drink enriched with polar lipids derived from ovine milk. The health claims the formulated novel or functional food on EFSA guidelines "The scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health" and in a particular paragraph 5.4, "Claims on reduced platelet aggregation" "Platelet hyperactivity and hypercoagulability states are more commonly observed in subjects with cardiovascular (CV) risk factors. Healthy subjects or participants at very low risk of CV disease normally have non-activated circulating platelets. Reducing platelet aggregation in subjects with platelet activation during sustained exposure to the food/constituent (e.g., four weeks) would be a beneficial physiological effect".

Within this investigation, the postprandial effects of this novel yoghurt drink against platelet aggregation are going to be studied ex vivo in blood from healthy human subjects as described in previously established procedures.


Eligibility Criteria:
Inclusion Criteria:

* • Healthy subjects need to have their dietary and dairy intake within the range \[1-2 serves per week\]

Exclusion Criteria:

* Subjects will be excluded from the study if they are

  * Under medication and intake of dietary supplements
  * Treatment for blood clotting disorders or dyslipidaemia
Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes

The investigators hypothesis is that a carbohydrate-free diet, ingested for 3 days, results in a change in blood glucose that is similar to the change observed after 3 days of fasting.

In addition to plasma glucose concentrations, other hormones and metabolites known to be affected by fasting will be measured. These include insulin and glucagon, which are hormones that have an important role in regulating fuel use in the body.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* C-peptide \> 1.5 ng/ml

Exclusion Criteria:

* Body mass index \> 40
* hematological abnormalities
* liver disease
* kidney disease
* congestive heart failure
* life threatening malignancies