cyrilzakka/clinical-trials huggingface dataset:
Musculoskeletal Pathologies of the Upper Extremity in Surgical Device Mechanics

Work-related upper extremity musculoskeletal disorders (WRUEMSDs) have shown to be related to many occupational situations and specific industries. However, there is conflicting information about monotonous and repetitive activities. In this context, the profession of surgical device mechanics has not been analyzed so far.

The objective of this study is to examine surgical device mechanics at different workplaces with varying work contents and to compare them with a control group without the repetitive workload exposition as described above. The headquarters and main production site of Aesculap are located in Tuttlingen/Germany. Aesculap is the world leading manufacturer of surgical devices.

After statistical power analysis, the investigators plan to randomize and include a total of 90 voluntary test persons in 3 groups (30 persons each). The study will include standardized questionnaires and a physical examination as well as an industry test (Purdue Pegboard Test).

Primary and secondary endpoints were defined to show if significant difference between surgical device mechanics and a control group is present.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* work ability without absence \> 2 weeks within the last 3 months
* \>5 years on workplace or similar workplace when in group of surgical device mechanics

Exclusion Criteria:

* spinal syndrome in history
* chronic shoulder pain in history
* congenital malformation of the upper extremity/hand
* rheumatoid arthritis or fibromyalgia in history
* actual hand therapy as conservative therapy or therapy after operation due to upper extremity musculoskeletal pathology
* previous operation(s) due to nerve entrapment syndrome or chronic musculoskeletal pathology of the upper extremity
Real Life Second-Line Nivolumab in Advanced Non-Small Cell Lung Cancer

Data regarding nivolumab as second line treatment in advanced non-small cell lung cancer (NSCLC) are based on selected populations and might not reflect daily practice. Investigators aimed at assessing efficacy and safety of nivolumab in a real-life setting and determining a subtype of NSCLC patients that are more likely to benefit from immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

* advanced NSCLC (stage IIIB-IV)
* failure of at least one line of chemotherapy.
* age ≥18 years,
* initiation of nivolumab between 01/09/2015 and 30/09/2016.

Exclusion Criteria:

* nivolumab initiation after October 2016
* prior involvement in an immunotherapy trial
* refusal to participate.
Game Changers for Family Planning Peer Advocacy Program

This study will adapt the Game Changers peer advocacy training model for family planning context and pilot test the feasibility, acceptability and preliminary efficacy of the intervention to empower female contraception users to advocate for contraception use among women in their social networks who have unmet need for contraception.

The investigators will conduct a pilot RCT of Game Changers for Family Planning (GC-FP) with 40 female modern contraceptive (MC) users (index participants) at one rural public clinic, with 20 randomly assigned to receive the intervention (in 2 groups of 10) and 20 to the wait-list control; enrollment and randomization will be stratified by age and relationship status. Each index will recruit up to 3 social network members (alters) with unmet need for MC (max. total=120). Data will be collected at baseline and month 6 from all participants; primary outcome is alter MC use at month 6.

Eligibility Criteria:
Index participants:

Inclusion Criteria:

* MC user for past year

Social network member participant:

Inclusion Criteria:

* Not using MC, but reports trying to prevent pregnancy
* Know about the MC use of their referring index participant
Compassionate Use of Concizumab if You Have Haemophilia

The compassionate use programme will give participants concizumab for free, even though it is not yet approved by health authorities. This is because participants need this medicine to treat their haemophilia properly. The programme will check that participants are safe and that the medicine works for them. The programme may last for years. Participants will take one injection under their skin every day. Participants will have 4-5 visits with the study doctor for the first half year. After that they will have 1 visit every half year. At all clinic visits participants will have blood samples taken. Participants will fill in a diary between the visits.

A patient is considered to have completed the programme when any of the following criteria occurred first: 1) when the patient is included in a clinical trial with concizumab or 2) up to 6 months after concizumab is commercially available in the patient's country and approved for the patient (The time span of 6 months should provide ample time for the patient to obtain concizumab commercially) or 3) the sponsor decides to discontinue concizumab clinical development for the patient's population.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any programme-related activities. Programme-related activities are any procedures that are carried out as part of the programme.
* Patients with congenital haemophilia:

  1. severe haemophilia A (coagulation factor VIII (FVIII) less than 1%) or moderate/severe haemophilia B (coagulation factor IX (FIX) less than or equal to 2%) without inhibitors or
  2. any haemophilia severity with documented history of inhibitors (more than or equal to 0.6 bethesda unit (BU)) who cannot be treated satisfactorily with authorised and marketed medicines (example: due to inhibitors or allergic reactions to factor-containing products, or due to poor venous access), and who are not able to enrol in clinical trials designed to support the development and registration of concizumab medicines (example: due to inhibitors or allergic reactions to factor-containing products, or due to poor venous access) as per investigator and Novo Nordisk assessment.
* The potential benefit for the individual patient justifies the potential risks of treatment.

Exclusion Criteria:

* Known or suspected hypersensitivity to investigational medicinal product or related products.
* Any condition (current or medical history), which in the investigator's or Novo Nordisk's opinion might jeopardise patient's safety or compliance with the protocol.
Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis

The primary purpose of this study is to identify an appropriate dose of study medication.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Diagnosis of active Rheumatoid Arthritis (RA) by standard criteria (American Rheumatism association (ARA) \[1987\] or American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) \[2010\]) at least 16 weeks prior to screening
* ACR global functional status class of 1 to 3
* Documented evidence of inadequate response tumor necrosis factor (TNF) inhibitors
* All subjects must have been receiving treatment with a minimum dose of 15 mg per week of Methotrexate for at least 12 weeks and at a stable dose for 28 days prior to screening. A dose as low as 10 mg Methotrexate is permitted if 15 mg could not be reached, due to toxicity. In Japan, Korea and Taiwan, a minimum dose of 7.5 mg per week is permitted. Additional treatment with Hydroxychloroquine or Chloroquine is permitted, if it is at a dose approved for the treatment of RA and the dose has been stable for at least 28 days prior to screening
* Minimum of 6 swollen and 6 tender joints on a 66/68 joint count at screening and at baseline (Day 1)
* Elevated High-sensitivity (hs) CRP and/or ESR

Exclusion Criteria:

* Active serious infection
* History of or active tuberculosis (TB)
* Elevated liver function tests (LFTs)
Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20)

The study is a 2 arm, multi-center, randomized, open-labeled clinical trial designed to assess the effects of varying doses and schedules of oral insulin on immunological and metabolic markers in relatives at risk for type 1 diabetes (T1D).

A minimum of 40 eligible participants will be identified for study participation from the TrialNet Pathway to Prevention study. Participants must have a relative with type 1 diabetes and be positive for insulin autoantibodies and at least one other autoantibody. All participants will receive active treatment of recombinant insulin treatment in capsules of either 67.5 mg daily or 500mg every other week. Participants will need to visit the study site up to eleven times over one year for blood tests and other study procedures. During the beginning treatment phase there are two visits one month apart for those given the 67.5 mg dose, and three visits two weeks apart to titrate the dose for those in the 500mg treatment group. There are three additional treatment visits at months 2, 3, and 6 and 4 additional visits for follow-up at months 7, 8, 9 and 12. The primary outcome is the change in immune function as assessed by change in level or quality of T lymphocyte or autoantibody biomarkers measured between 13 and 26 weeks compared to baseline. .

Eligibility Criteria:
Inclusion Criteria:

* Participants in TrialNet Natural History/Pathway to Prevention Study (TN01); is relative of proband with type 1 diabetes
* Between ages 3-45 with normal Oral Glucose Tolerance Test (OGTT) or between ages 3-7 with an abnormal OGTT
* Confirmed positive for insulin autoantibodies within previous six months
* Confirmed positive for one or more other autoantibodies on two separate occasions within the past six months

Exclusion Criteria:

* Diagnosed with type 1 diabetes
* History of treatment with insulin or oral hypoglycemic agent
* History of therapy with immunosuppressive drugs or non-physiologic glucocorticoids within the past two years for a period of more than three months
* Ongoing use of medications known to influence glucose tolerance
* Pregnant or intending to become pregnant while on study or lactating
Nutrition as a Determinant of Labor Outcome

This is a randomized, double-blind trial looking at how nutrition intake is associated with labor progress and complications.

Insufficient intake of energy during labor may result in poor labor progress. The study investigates the effect of an energy supplement during labor.

Eligibility Criteria:
Inclusion Criteria:

* Women at gestational age \> 36 weeks, parity 0

Exclusion Criteria:

* Gestational age \< 36 weeks
* Signs of fetal pathology:

  * Different or abnormal (pathological) CTG test performed just before start of the test
  * Abnormal Doppler registrations (PI in the arteria umbilicae \> 2SD for the gestational age)
  * Established notch in the arteria uterinae or notch bilaterally or PI \> 2SD \> 24 weeks
  * Diverging in the weight of the fetus \> - 22% or diverging in the growth of the fetus - 10% or more, and established structural pathology in the fetus, oligohydramnion (amniotic fluid index \< 6)
* Maternal diseases and pregnancy complications

  * diabetes in pregnancy
  * high blood pressure
  * cardiovascular diseases
  * rheumatic disease
  * epilepsia
  * lung disease, etc.

CTG test: cardiotocographic test (a measure of fetal activity)

PI: pulsatory index (velocity pattern)

SD: standard deviation
Conservative Treatment of Trigger Finger

This study is to analyze the effectiveness of a nighttime extension orthosis after receiving a cortisone injection for the treatment of trigger finger to improve pain and restore functional outcomes. The investigators hypothesize that the extension orthosis will improve pain and functional outcomes compared to those without a digital night extension orthosis in those with trigger finger at 12 weeks from the injection.

The purpose of the research is to analyze the effectiveness of a proximal interphalangeal joint (PIPJ) extension night orthosis status-post cortisone injection of the first annular pulley for the treatment of trigger finger to improve pain and restore functional outcomes. The investigators hypothesize that the extension orthosis will improve pain and functional outcomes (Quick Dash score) compared to those without a digital night extension orthosis in those with trigger finger at 12 weeks from the injection.

Eligibility Criteria:
Inclusion Criteria:

* Individuals 18 years old or older are included
* Patients with trigger finger, aka stenosing flexor tenosynovitis
* Status post receiving cortisone injection of the affected digit(s)

Exclusion Criteria:

* Any records flagged with break the glass or research opt out
* Patients with rheumatoid arthritis
* Patients with a history of traumatic injury to the hand
* Cognitive or behavioral problems which would preclude informed consent
* Unable to speak and understand English
Significance of Immunohistochemical Expression of Survivin in Renal Cell Carcinoma

detection of Survivin expression in renal cell carcinoma and correlate this expression to tumor grade and stage.

renal cell carcinoma is the third most prevalent malignant tumor of the genitourinary system. deregulation of apoptosis is involved in carcinogenesis by abnormally prolonged cell survival, facilitating accumulations of multiple mutations and augment resistance to immune-surveillance. Survivin is a member of inhibitor of Apoptosis Protein family (IAPs). it play a role in cell cycle regulation by inhibiting apiptosis. Survivin is over-expressed in many human neoplasms.

Eligibility Criteria:
Inclusion Criteria:

* patients suffer from renal cell carcinomas

Exclusion Criteria:

* patients received pre-operative chemotherapy or radiotherapy. patients with insufficient clinical data.
Mothers in Motion Program to Prevent Weight Gain in WIC Mothers (MIM)

Mothers in Motion will draw on the successes of the pilot intervention of the same name and will promote healthy lifestyle behavior changes (eating more fruits and vegetables, increasing physical activity, dealing with stress) in low-income WIC mothers of young children. The intervention group's weight change (difference between the initial enrollment and 3 months post intervention) will differ from the control group's weight change by an average of at least 2.8 pounds.

Mothers in Motion will draw on the successes of the pilot intervention of the same name and will promote healthy lifestyle behavior changes (eating more fruits and vegetables, increasing physical activity, dealing with stress) in low-income WIC mothers of young children. Both treatment groups will receive usual WIC care (nutrition counseling and similar services). The control group will receive generic printed health and nutrition materials to read at their own pace if they wish. The intervention group will watch the culturally sensitive DVD chapters according to a study calendar, complete action plan worksheets, and call in to peer support group teleconferences to discuss the DVD chapter contents. The teleconferences will be led by moderators trained in motivational interviewing (MI) and group facilitation. Participants will complete phone interviews and provide body weight measurements at baseline (T1), immediately after (T2) and 3 months after (T3) the intervention time period. T3 body weight will be the primary outcome.

Eligibility Criteria:
Inclusion Criteria:

* African American or White
* Fluent in English
* 18-39 years old
* At least 6 weeks postpartum
* Body Mass Index (BMI) between 25.0 and 39.9
* Willing to provide address and up to 3 working phone numbers
* Willing to update their contact information monthly
* Willing to participate in the project for 9 months
* Willing to make 3 additional trips to WIC clinics for weight measures
* Working DVD player at home and access to a working phone.

Exclusion Criteria:

* Pregnant
* MIM Pilot study participation
* Plan to become pregnant or relocate to a location outside of study area during the trial
* Self-reported type 1 or 2 Diabetes
* Unable to walk more than 1 block without resting or shortness of breath.
Follow-Up Study for Exubera

In studies of Exubera in persons with diabetes, lung cancer occurred in a few more people who were taking Exubera than in people who were taking other diabetes medicines. All subjects diagnosed with lung cancer had a history of smoking and the number of lung cancer cases observed fell within the expected range based on population-based data. There is currently not enough information to determine if any of the observed lung cancer cases were related to Exubera use, therefore, the study is being conducted to further investigate whether Exubera use makes the appearance of lung cancer more likely.

Both retrospective and prospective components All subjects who participated in one of the 17 included Exubera clinical trials will be invited to participate in the current study.

Eligibility Criteria:
Inclusion Criteria:

* Previously participated in an eligible Exubera clinical trial
* Willing to provide study doctor with at least one alternate contact person

Exclusion Criteria:

* Participated in an investigational study of an unapproved drug since completing the Exubera trial
* Ever used an other (non-Exubera) inhaled insulin
Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M In BCG Refractory NMIBC

The purpose of this study is to determine whether Nanoxel®M is effective in the treatment of patients with recurrent Ta and T1 who experienced treatment failure with at least one prior BCG intravesical treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of superficial transitional cell carcinoma of the bladder (Ta, T1)
* Recurrent superficial bladder cancer refractory to Bacillus Calmette-Guerin (BCG)
* No previous intravesical therapy for 6 weeks
* No history of prior radiation to the pelvis
* Peripheral neuropathy ≤ grade 1
* Eastern Cooperative Oncology Group (ECOG) performance status 0 t0 2
* Adequate hematopoietic and hepatic parameters

Exclusion Criteria:

* Muscle invasive disease (T2-T4)
* Any other malignancy diagnosed within 2 years of study entry (Except basal or squamous cell skin cancers or noninvasive cancer of the cervix)
* Participation in any other research protocol involving administration of an investigational agent within 3 months before study entry
* History of sensitivity reaction to docetaxel
* Prescribed immunosuppressive medications because of a confounding medical condition
* Female patients who were pregnant or lactating
Clinical Characteristics and Medication Satisfaction of Kanarb Tablet in Korean Hypertensive Patient(Kanarb-Hypertension Epidemiology Medication Satisfaction Study)

1. Investigate the clinical characteristics, medication satisfaction and quality of life of anti-hypertensive drugs in Korean hypertensive patients
2. Observe the changes of medication satisfaction and compliance in patients after switchting to Fimasartan


Eligibility Criteria:
Inclusion Criteria:

Step1

* Over 20 years old
* Essential hypertensive patients who taking anti-hypertensive drugs during previous 1 month

Step2

* Patients does not taking Fimasartan
* Patient's medication satisfaction score under 4

Exclusion Criteria:

* Patients with secondary hypertension
* Patients with orthostatic hypotension who has sign and symptom
* Patients with known severe or malignancy retinopathy
* Patients with significant investigations; abnormal renal function
* Childbearing and breast-feeding women
* Patients with history of allergic reaction to any angiotensin II antagonist
Eribulin Use for the Treatment of Advanced Breast Cancer: A Prospective Observational Registry

The purpose of this prospective observational registry is to monitor safety of eribulin in routine clinical practice. Additionally, this study will also assess the effectiveness of eribulin in real-life settings.


Eligibility Criteria:
Inclusion Criteria

The participants have to meet all of the following criteria to be eligible to enter into the prospective registry:

1. Participants older than 18 years of age
2. Willing and able to provide informed consent
3. Diagnosis of locally advanced or metastatic breast cancer
4. Progression after up to two previous chemotherapy regimens for advanced disease. Prior therapy should have included an anthracycline and a taxanes in either the adjuvant or advanced setting unless not suitable
5. Adequate bone marrow, liver, and renal function
6. Life expectancy greater than 12 weeks

Exclusion Criteria

Participants meeting the following criteria will not be permitted to enter the study:

1. Prior treatment with eribulin
2. Participants who have received more than two prior chemotherapeutic regimens for advanced disease
Pharmacogenetic Supported Prescribing in Kids

Implementation of pharmacogenetic testing for children and adolescents aged 6-24 who are starting or changing psychiatric medication.

Children with moderate to severe mental health conditions (e.g. depression, anxiety, OCD) or neurodevelopmental disorders (e.g., autism spectrum disorders, ADHD) are frequently prescribed medications as either the sole form of treatment or in combination with psychotherapy. However, up to 50% of these children will not respond or experience burdensome adverse drug reactions to these medications. Current use of mental health-related medications (e.g., antidepressants, antipsychotics) in children can be best described as a trial-and-error process that can impact the well-being of those taking the medications and their families at a considerable economic cost. However, this trial-and-error process could, in part, be avoided through the application of pharmacogenetic testing, a specific type of genetic testing that has the potential to improve drug efficacy and reduce the morbidity, mortality and cost associated with adverse drug reactions. The aim of this project is to implement and evaluate an evidence-based pharmacogenetic testing service to improve drug treatment outcomes in children receiving mental health care.

Our objectives are to:

1. Implement Canada's first pharmacogenetics testing service to improve drug treatment outcomes in children receiving mental health care.
2. Collect performance, outcome, and economic indicators related to the pharmacogenetics testing service.
3. Establish a research platform for the discovery of new genetic and non-genetic markers of drug treatment outcomes relevant to mental health care in children.

Eligibility Criteria:
Inclusion Criteria:

* Medical records available
* The initiation, change, dose adjustment, or augmentation of psychiatric medication(s) is indicated
* Treating psychiatrist, family physician, or pediatrician licensed in Alberta, British Columbia, Saskatchewan, or Manitoba requests pharmacogenetic testing

Exclusion Criteria:

* Medically unstable or lacking capacity to provided informed consent
* Unwillingness of child to provide saliva sample for genetic analysis
* History of liver or bone marrow (hematopoietic cell) transplant