cyrilzakka/clinical-trials huggingface dataset:
An Analysis of the Symptomatic Domains Most Relevant to Charcot Marie Tooth Neuropathy (CMT) Patients

The purpose of this study is to identify the issues that have greatest impact on QOL for patients with Charcot Marie Tooth (CMT) Disease. Patients who have -registered in the Inherited Neuropathies Consortium Contact Registry will be invited to participate.

The protocol consists of two anonymous surveys. The first large scale survey is designed to identify items that best reflect the issues and symptoms with high impact upon QOL in CMT. A second brief survey focuses on the frequency and impact of muscle cramps on QOL in adult CMT. The surveys will be distributed via an online link to all adult CMT patients self-registered with the RDCRN contact registry. Those who complete the first two surveys will be requested to complete only the second brief survey on muscle cramps again 3 weeks after completing it the first time. Those who complete the brief muscle cramps survey a second time will be requested to complete it again 5 weeks later to assess variability in occurrence of muscle cramps.

The first large scale survey to identify items that best reflect the issues and symptoms with high impact upon QOL in CMT will be sent out in a second wave. This second wave will only contain the QOL survey and not the muscle cramp survey. The QOL survey will be distributed via an online link to three populations: adult CMT patients self-registered with the INC (RDCRN) Contact Registry who had not been registered at the time of the first enrollment period, adult patients who had been registered at the time of the first enrollment period and had received the survey, but had not returned it, and patients who were registered, but were under age 18 at the time of the first enrollment period and have turned 18 by the time of the second enrollment period.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CMT that are 18 years or older and have joined the INC RDCRN Contact Registry.

Exclusion Criteria:

* Does not have CMT.
* Does not read or speak English.
Minimal Invasive Anterior Approach Versus Trans-gluteal Approach for Hemi-arthroplasty in Femoral Neck Fractures

The aim of the study is to test the hypothesis that patients older than 60 years with a femoral neck fracture eligible for hemi-arthroplasty (HA) operated by an anterior minimal-invasive approach as compared to a standard lateral Hardinge approach show better functional recovery postoperatively as measured by the "Timed up and go"-test (TUG).

HA via various well established approaches is the typical treatment for displaced femoral neck fractures in elderly patients. In the last decade, so called minimal-invasive surgery (MIS) for the implantation of total hip arthroplasty (THA) has become popular and studies have demonstrated that MIS is as safe as conventional approaches. Our hypothesis is that femoral neck fracture patients may especially benefit from MIS. To date, no published data exist comparing a Hueter minimal-invasive anterior (AMIS) with a conventional trans-gluteal Hardinge approach (CLAS) for HA.

Geriatric patients presenting at the University hospital Basel (UHBS) with a femoral neck fracture eligible for HA are randomly assigned to the minimal-invasive or conventional group. In both groups HA will be performed using the same implants. Postoperatively patients will be followed-up continuously until discharge from our hospital (with 7 days as expected average duration of postoperative hospital stay) with a first functional status assessment on day 5. Further follow-up is planned at week 3 and 6, 3 months and one year postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Age of 60 years or more, ambulatory with/without walking aids before trauma
* Femoral neck fracture eligible for hemi-arthroplasty in accordance with the algorithm for femoral neck fracture patients used at the University hospital Basel
* Informed consent

Exclusion Criteria:

* Refusal of consent by the patient or legal representatives to participate in the study
* More than one fracture
* Suspicion of a pathological fracture in the context of known or unknown malignancy
* Previous surgery of the proximal femur on the same side
* Follow-up not possible (Tourist etc.)
Antioxidative Effect of Plantago Asiatica L. Extract

The purpose of this study is to evaluate the antioxidant effect of Plantago asiatica L. extract in subjects with mild hyperlipidemia.

The purpose of this study is to evaluate an acute effect of Plantago asiatica L. extract consumption on antioxidative biomarkers in subjects with mild hyperlipidemia. Subjects will intake Plantago asiatica L. extract with a high fat meal for oxidative stress loading. Antioxidative biomarkers will be measured after single-dose administration of Plantago asiatica L. extract.

Eligibility Criteria:
Inclusion Criteria:

* Adults age over 30
* BMI(Body mass index) between 25 and 33 kg/m2
* Total cholesterol between 200mg/dL and 250mg/dL OR Triglyceride between 150mg/dL and 220mg/dL OR LDL-cholesterol between 130mg/dL and 165mg/dL

Exclusion Criteria:

* Subject who has taken part in other clinical trials within 30 days of screening visit
* Subject who has taken medicines, Chinese medicines and Health/Functional Foods which can affect antioxidative biomarkers within 30days of screening visit
* Subject who is pregnant or breast feeding
* Subject who lost body weight over 4kg within 30days of screening visit
* Alcoholic
* Smoker
* Subject who takes excessive exercise (over 7hours/week)
* Subject who has hypertension(≥140/90mmHg), diabetes(fasting blood glucose ≥126mg/dL), kidney disease, hepatic disease or hyperthyroidism within 2years
* Subject who has an allergy to the ingredients of study product
A Pedometer-based Intervention With and Without Email Counselling in General Practice

A two-arm parallel randomised controlled trial comparing pedometer-based intervention with and without email counselling in a primary care setting. Physically inactive patients from four general practices will be randomised to the pedometer-plus-email group or to the pedometer-alone group. All patients will be instructed to gradually increase the daily number of steps to at least 10,000. Patients in the pedometer-plus-email group will receive 8 counselling emails based on behavioural techniques. The primary outcome will be change in average daily steps measured during 7-day period at baseline and at 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* physically inactive, i.e. takes less than 8,000 steps per day at baseline
* registered at the participating general practice,
* over 18 years of age,
* regular email user, and willing to use email for the purpose of the study,
* has a home computer with access to the Internet.

Exclusion Criteria:

* medical or psychiatric condition which the general practitioner considers as inappropriate for participating in the intervention (e.g., terminal illness, psychotic illness, chronic disorders or diseases that seriously influence the ability to be physically active, dementia or significant cognitive impairment, unable to move about independently),
* medical, personal of family condition which the general practitioner considers temporarily affects mean daily step count at baseline (e.g., acute illness, holiday or business trip),
* pregnant woman,
* currently engaging in regular sports or exercise (at least twice a week),
* failure to upload pedometer data to a website at baseline assessment,
* failure to give informed consent with the study.
Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma

The outcome of patients with metastatic Ewings Sarcoma is poor with current standard of care chemotherapy, with less than 30% survival. Based on recent encouraging pediatric literature we have designed this trial to improve the outcome of patients with metastatic Ewings sarcoma using Irinotecan and Temozolomide in addition to standard chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of metastatic Ewing's sarcoma.
* Patients must have measurable disease defined as lesions that can be measured by medical imaging techniques such as CT or MRI. Ascites, pleural fluid, bone marrow disease, lesions seen on scan will not be considered measurable.
* Patients must have metastatic disease.
* Age 13 years or older
* Life expectancy of at least 3 months.
* ECOG performance status of \<= 3.
* Normal hepatic function (Direct bilirubin \<1.5mg/dl, SGOT or SGPT \<3x upper limit of normal).
* Left Ventricular Ejection fraction of at least 50%.
* Adequate renal function: Creatinine clearance \>= 50 ml/min or Serum creatinine \< 1.5 x ULN for age.
* Adequate bone marrow reserve (defined as an absolute peripheral granulocyte count of \>=1500/mm3, platelet count of \>=75,000/mm3); unless bone marrow infiltrated with metastatic Ewing's sarcoma; ANC \>= 500 and Platelet \>= 50,000 mm3.
* Ability to understand and willing to sign a written informed consent document.
* Patients of childbearing potential must agree to use an effective method of contraception.

Exclusion Criteria:

* No prior chemotherapy for Ewing's sarcoma; No prior doxorubicin, temozolomide or irinotecan.
* Known hypersensitivity to any of the components of the protocol drugs.
* Clinically significant unrelated systemic illness (such as serious infections requiring active systemic intravenous antibiotic therapy; cardiovascular disease \[congestive heart failure, recent myocardial infarction, unstable angina, inadequately controlled hypertension\].
* No prior history of chronic diarrhea, bowel obstruction, Crohn's disease or ulcerative colitis.
* Pregnant or nursing woman are not included in the study.
* HIV-positive patients will be excluded from the study due to risk of infection or other serious side effects.
* Other medical, psychiatric or social condition incompatible with study treatment.
Clinical Evaluation of Instrumented Wheel as Biomedical Device Quantifying the Displacement Efficiency

The purpose of this study is to validate an instrumented wheel such as a new biomedical device. The physicians will compare this instrumented wheel with another instrumentation "Ergometer roller", each patient will try the both instrumentations, physical and physiological parameters will be measured.

The increase rate of radial power during the cardiac stress test may be more important when the physicians use the instrumented wheel.

\* The manual wheelchair is used by people for whom walking is difficult or impossible due to spinal cord lesions, neurological and muscular diseases, lower limb trauma, age ...etc.

Although the wheelchair help to regain mobility, this made of displacement is nor natural nor well-to-do.

* The CIC-IT and TSR (Transmissions Services Roulements, Mérignac, France) improved the instrumented wheel, adaptable with all wheelchairs, with information wireless transmission.
* The primary objective of study is to validate the instrumented wheel of manual wheelchair such as a new device of evaluation of capacities of displacement in ecologic situation.
* The primary criteria is to compare the mechanical power calculated using instrumented wheel versus the power calculated using ergometer roller during protocol of standard cardio-respiratory stress test.

This study is interventional, mono-centric, controlled and crossover. The population concerned is patients with spinal cord injury (SCI) and users of manual wheelchair.

Number of subjects projected for the entire study: 62 patients The total duration of participation of each patient: 7 days ±2days

Eligibility Criteria:
Inclusion Criteria:

* Age : 18-70 years.
* Spinal cord injured patient.
* User of manual wheelchair for daily locomotion (having at least 30/100 at displacement items of WST questionnaire) .
* Affiliation to a social security scheme or entitled.
* Informed consent dated and signed by subject or subject's legally acceptable representative (and investigator).

Exclusion Criteria:

* Cognitive troubles.
* Progressive diseases: Tumoral, infectious, inflammatory and associated pathologies: brain injury, amputation.
A Study to Test How Food Influences the Amount of BI 1323495 in the Blood of Healthy Men

The main objective of this trial is to assess the effect of food on the pharmacokinetics of an oral tablet formulation of BI 1323495 by investigating the relative bioavailability following single dose administration under fed and fasted conditions.


Eligibility Criteria:
Inclusion criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 45 years (inclusive)
* Body Mass Index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion criteria:

* Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Chronic or relevant acute infections
* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
* Use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)
* Intake of an investigational drug in another clinical trial within 60 days of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
* Further exclusion criteria apply
NC Enhanced WISEWOMAN Project

The overall aim of the study was to test the feasibility and effectiveness of a cardiovascular disease risk reduction intervention program for midlife, low-income women. We enhanced an existing nutrition and physical activity intervention tool, A New Leaf...Choices for Healthy Living, which was designed specifically for this demographic group as part of the CDC's WISEWOMAN Program. The enhanced intervention was tested in a randomized controlled trial in a community health center setting.

We conducted a 2 year study to test the feasibility and effectiveness of a CVD risk reduction intervention program for older, under or uninsured women. We used an existing nutrition and physical activity (PA) intervention tool (New Leaf...Choices for Healthy Living) designed specifically for this demographic group as part of the WISEWOMAN program (A CDC-funded CVD risk factor screening and intervention program for older, low-income women). We enhanced this already tested intervention to include: 1) the latest recommendations regarding dietary fat and carbohydrate intake, 2) group education sessions and follow-up telephone contacts from lay health advisors (LHAs); and 3) a community resource linkage component delivered primarily by LHAs. We tested the enhanced intervention in a randomized controlled trial in a community health center setting.

A total of 240 women aged 40-64 were randomized to the enhanced New Leaf intervention or minimum intervention groups. Women in the enhanced New Leaf group received a 6 month intensive intervention consisting of 2 individual counseling sessions at the CHC, postcard mailings, 3 group sessions, and lay health advisor (LHA) guided linkages to community resources for diet and PA. This was followed by a 6 month maintenance period led by the LHA and including 6 phone contacts, and 3 tailored mailings along with continued community resource linkages. Primary outcome measures at 6 and 12 months included 1) PA measured by CSA accelerometer and 2) fruit, vegetable, and fat intake. Secondary outcomes included biomarkers of dietary intake (red blood cell membrane fatty acids, carotenoids), CVD risk factors (total and HDL cholesterol, blood pressure), and psychosocial variables.

Eligibility Criteria:
Inclusion Criteria:

* Women 40-64 years old
* Patient at participating site who is considered an appropriate candidate by the primary care clinician
* Ability and willingness to provide informed consent
* Availability for follow-up--plan to reside within 50 miles of study site for 1 year
* Home phone or easy access to phone

Exclusion Criteria:

* Medical condition for which intervention may not be appropriate
* Pregnancy/lactation
* Severe chronic medical conditions such that interventions to improve diet and physical activity are not appropriate
To Compare the Pharmacokinetic Characteristics of the Fixed-dose Combination Compared to the Loose Combination

To compare the safety and pharmacokinetic properties between the administration of DWP16001 and DWC202213 as an individual drug, and the administration of DWJ1563 as a combination drug.


Eligibility Criteria:
Inclusion Criteria:

1. Before participating in the clinical trial, a person who fully explained the purpose, content, and characteristics of the clinical trial drug and signed a written consent form approved by the IRB of Chungbuk University Hospital to participate in this study according to his free will.
2. Healthy adults aged 19 or older at the time of screening.
3. Those who weigh more than 50.0 kg in men and women, and have a body mass index (BMI) of 18.0 kg/m2 or more and less than 30.0 kg/m2 or less in women.

   * Body mass index (BMI) = Weight (kg) / \[Height (m)\] 2.

Exclusion Criteria:

1. A person with a clinically significant history in liver, kidney, neuropsychiatric system, respiratory system, endocrine system, blood and tumor system, cardiovascular system (including orthostatic hypotension), digestive system, musculoskeletal system, etc.
2. A history of gastrointestinal diseases (e.g., esophageal diseases such as Crohn's disease, esophageal achalasia, or esophageal stenosis) or surgery (except appendectomy, hernia).
3. Those who are hypersensitive to other drugs (DPP-4 inhibitors, etc.) or have a history of clinically significant hypersensitivity reactions, including DWP16001, DWC202213 and homogeneous (SGLT2 inhibitors)
4. A person who shows the following results in the inspection items conducted during screening.

   * Blood ALT, AST, Total bilirubin \> twice the upper limit of the normal range.
   * The glomerular filtration rate (e-GFR) \<90 mL/min/1.73 m2 (using the CKD-EPI method)
5. After more than 3 minutes of rest, systolic blood pressure \> 150 mmHg or \<90 mmHg, or diastolic blood pressure \> 100 mmHg or \<60 mmHg, or pulse ≤ 40 bpm or ≥ 100 bpm in vital signs measured at the seat
A Proof-of-Concept Study of Danicopan for 6 Months of Treatment in Participants With C3 Glomerulopathy (C3G)

The primary purpose of this proof-of-concept clinical study was to evaluate the efficacy and safety of the study drug, ACH-0144471 (also known as danicopan and ALXN2040), in participants with C3G who also had significant proteinuria attributable to C3G.


Eligibility Criteria:
Key Inclusion Criteria:

* Had biopsy-confirmed primary C3G
* Had clinical evidence of ongoing disease based on significant proteinuria, attributable to C3G disease in the opinion of the Principal Investigator (PI), and present prior to study entry and confirmed during Screening
* Was willing to comply with vaccination requirements.

Key Exclusion Criteria:

* Had a history or presence of any clinically relevant co-morbidities that would make the participant inappropriate for the study
* Had ever received danicopan
* Had more than 50% fibrosis or more than 50% of glomeruli with cellular crescents on the pre-treatment renal biopsy
* Had an estimated glomerular filtration rate \<30 milliliters/minute/1.73 meters squared at the time of screening or at any time over the preceding 4 weeks
* Was a renal transplant recipient or receiving renal replacement therapy
* Had a history of a major organ transplant or hematopoietic stem cell/marrow transplant
* Had evidence of monoclonal gammopathy of unclear significance, infections, malignancy, autoimmune diseases, or other conditions to which C3G is secondary
* Had other renal diseases that would interfere with interpretation of the study
* Had been diagnosed with or showed evidence of hepatobiliary cholestasis
* Females who were pregnant, nursing, or planning to become pregnant during the study or within 90 days of study drug administration
* Had a history of febrile illness, a body temperature \>38°Celsius, or other evidence of a clinically significant active infection, within 14 days prior to study drug administration
* Had evidence of human immunodeficiency virus, hepatitis B infection, or active hepatitis C infection at Screening
* Had laboratory abnormalities at screening that, in the opinion of the PI, would make the participant inappropriate for the study