cyrilzakka/clinical-trials huggingface dataset:
Eccentric Exercise Versus Eccentric Exercise and Astym for Insertional Achilles Tendinopathy

The purpose of this research study is to determine if Astym® treatment is an effective treatment for patients with Achilles pain. The usual treatment for this condition is a specific exercise program that has been previously shown to be effective. The research team is trying to determine if combining Astym with the exercise program is more effective than exercise program only.

The main hypothesis for this study is that Astym plus eccentric exercise will be more effective than eccentric exercise alone at improving pain and function in patients with insertional Achilles tendinopathy.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of insertional AT as a primary complaint\*
* symptom duration of at least 6 weeks
* VISA-A score of 78 or lower

  * he presence of insertional AT will be clinically determined by the primary investigator using the following criteria: pain at or within 2 cm of the posterior calcaneal insertion of the Achilles tendon along with localized tenderness and a subjective report of decreased activity levels secondary to Achilles pain.

Exclusion Criteria:

* prior treatment with eccentric exercise or Astym for Achilles tendinopathy
* currently taking anticoagulant medication
* usage of fluoroquinolone antibiotics in the previous six months
* previous Achilles surgery on the involved side
* bilateral symptoms
* pregnancy
* worker's compensation or liability cases
* peripheral neuropathy
* signs of lumbar radiculopathy
* inability to complete the required outcomes forms or comply with the recommended treatment regimen
Copper Concentration & Histopathologic Changes in Liver Biopsy in Participants With Wilson Disease Treated With ALXN1840

The main objective of the study is to evaluate the change in liver copper (Cu) concentration following 48 weeks of treatment with ALXN1840 in adult participants with Wilson Disease (WD) who have been previously treated for at least 1 year with standard of care (that is, trientine, penicillamine, or zinc). In the Treatment Period, efficacy and safety of ALXN1840 will be assessed at Week 48.

Participants who complete the 48-week Treatment Period will be offered the opportunity to continue their treatment in a 48-week Extension Period that will offer additional time for evaluation of long-term efficacy and safety of ALXN1840. There will be no liver biopsies during the Extension Period.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of WD by Leipzig Criteria ≥ 4 or by historical test results.
2. Continuous treatment for WD with penicillamine, trientine or zinc for at least 1 year prior to screening.
3. Body mass index \< 30 kilograms/meter squared.
4. Able to cooperate with a percutaneous liver biopsy.
5. Willing and able to follow protocol-specified contraception requirements.
6. Capable of giving signed informed consent.

Exclusion Criteria:

1. Decompensated cirrhosis or Model for End Stage Liver Disease score \> 13.
2. Modified Nazer score \> 7.
3. Clinically significant gastrointestinal bleed within past 3 months.
4. Alanine aminotransferase \> 2 × upper limit of normal.
5. History of bleeding abnormality or known coagulopathy, including platelet count \< 100,000, and international normalized ratio for prothrombin time ≥ 1.5.
6. Participant unwilling to accept blood products, if required.
7. Marked neurological disease requiring either nasogastric feeding tube or intensive inpatient medical care.
8. Hemoglobin less than lower limit of the reference range for age and sex.
9. Participants in renal failure, defined as in end-stage renal disease on dialysis (chronic kidney disease 5) or creatinine clearance \< 30 milliliters/minute.
10. Lymphoma, leukemia, or any malignancy within the past 5 years.
11. Current or chronic history of liver disease not associated with WD.
Paclitaxel and Capecitabine in Treating Women With Metastatic Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel and capecitabine in treating women who have metastatic breast cancer.

OBJECTIVES: I. Determine the safety, response rate, and efficacy of combination therapy with paclitaxel and capecitabine as first or second line therapy in women with metastatic breast cancer.

OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours on day 1 and capecitabine orally twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed for survival status every 3 months upon completion of treatment.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic breast cancer Bidimensionally measurable disease Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 to 75 Sex: Female Menopausal status: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: ANC at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) Renal: Creatinine less than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Eligible patients may have received prior chemotherapy in metastatic or adjuvant setting with the following exceptions: At least 12 months since prior fluoropyrimidine therapy At least 12 months since prior taxane therapy Only 1 previous chemotherapeutic regimen in the metastatic setting Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified
Reasons for Nonattendance Inpatient Colonoscopy

The absence of colonoscopy is a clinical problem that can't be ignored. According to previous studies, the absence rate for outpatient colonoscopy is between 4% and 29%. The aim of this study is to determine the reasons for colonoscopy appointment cancellations among inpatients and to identify the factors associated with colonoscopy nonattendance.


Eligibility Criteria:
Inclusion Criteria:

* inpatients older than 18 years.
* inpatients undergoing colonoscopy

Exclusion Criteria:

* Emergency colonoscopy.
* Pregnant or breastfeeding.
* Lack of complete data.
Exploratory Study of Ultrasound Signs of Native Septic Arthritis of the Knee

Primary objective: Description of ultrasound abnormalities seen in native septic arthritis of the knee during each visit.

Primary endpoint: Describe the ultrasound abnormalities observed on Day 0, Day 10, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee.

Secondary Objectives:

1. Search for poor prognostic factors in native septic arthritis of the knee.
2. To look for an association between initial sonographic factors and the use of joint lavage.
3. Look for associations between sonographic signs and clinico-radio-biologic factors at each visit (D10, 6 weeks, 3 months and 6 months)

Eligibility Criteria:
Inclusion Criteria:

* Male or female of legal age
* Bacteriologically proven native septic arthritis
* Meets the definition of septic arthritis: Bacteriological documentation of joint puncture fluid-Native articulation
* Free subject, without guardianship or trusteeship, or subordination
* Non-opposition of the patient after clear and fair information about the study

Exclusion Criteria:

* Presence of material in the affected joint
* Arthritis with Mycobacterium Tuberculosis.
* Patients benefiting from a reinforced protection, namely: minors, pregnant and/or breast-feeding women, persons deprived of liberty by a judicial or administrative decision, adults under legal protection
The Regression Pattern of Primary Lesions in Lung Cancer After Definitive Radiotherapy

Definitive radiotherapy is one of the important methods for inoperable locally advanced lung cancer. The recommended dose for definitive radiotherapy is 60-70Gy, and the optimal dose is still uncertain. Residual lesion after radiotherapy is a risk factor for recurrence. High doses to targeted tumor areas can effectively improve the local control rate, while minimizing toxic side effects. The regression pattern of primary lesions in lung caner after radiotherapy has not been clarified. This study intends to retrospectively collect clinical data of lung cancer patients with definitive radiotherapy, and explore the pattern of tumor regression after radiotherapy. It will help optimize the radiotherapy plan for lung cancer, so as to improve the efficacy and prognosis.

This study intends to retrospectively screen and include participants according to inclusion and exclusion criteria, and collect the clinical data of participants by previous medical records. Imaging tools will be used to quantify changes in the spatial location, diameter and volume of target lesions to evaluate tumor regression rate and radiotherapy efficacy, and to explore tumor regression pattern and establish model. In addition, the relationship between tumor regression rate, incidence of adverse radiation events, prognosis and related factors will be analysed.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old;
2. Stage II-III lung cancer with a clear pathological diagnosis report or medical record, not undergoing surgery before radiotherapy;
3. The primary lung lesion received definitive radiotherapy (defined as conventional fractionation radiotherapy with dose ≥50Gy, stereotactic radiotherapy with biologically effective dose ≥100Gy);
4. The target lesion of the lung receiving radiotherapy can be measured;
5. Imaging data can be obtained before and after radiotherapy;
6. Complete radiotherapy as planned, or the actual received dose has reached the defined definitive dose.

Exclusion Criteria：

1. Before radiotherapy, the primary lesion of the lung had received local treatment such as surgery or ablative treatment;
2. The radiotherapy plan was not completed, and the actual dose received did not reach the definitive dose (defined as conventional fractionation radiotherapy with dose \<50Gy, stereotactic radiotherapy with biologically effective dose \<100Gy)；
3. Required imaging data cannot be obtained;
4. Other conditions considered by the investigator to be inappropriate for enrollment.
Japan Dose Regimen Study of AZD1656 in Japanese Type 2 Diabetes Mellitus Patients

The purpose of this study is to compare the effect on glucose control of 3 different AZD1656 dosing regimens with placebo in Japanese type 2 diabetes mellitus (T2DM) patients, as evaluated by the change in HbA1c from baseline to the end of treatment at 4 months.


Eligibility Criteria:
Inclusion Criteria:

* women of non-childbearing potential.
* Provision of informed consent prior to any study specific procedures
* Naïve T2DM patients with HbA1c ≥ 7.5% but ≤ 10% or T2DM Patients treated with one or two oral anti-hyperglycaemic agent(s) with HbA1c ≥ 7.5% but ≤ 9.5% at enrolment visit (Visit1)

Exclusion Criteria:

* Clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, hepatic disease and haematological disease.
* The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history.
* Participation in another clinical trial and/or intake of another investigational drug within the last 30 days prior to enrolment visit
Postoperative Changes in Head and Neck Cancer Patients Undergoing Surgery

The aim of this study is to evaluate the postoperative changes after a major surgery in head and neck cancer patients. Each participant will be evaluated three times: (1) One day before surgery; (2) one month postoperative and (3) three months postoperative. Assessments included blood pressure, anthropometric measurements, physical measurements and questionnaires on quality of life, nutritional status and cancer symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of head and neck cancer patients planned for an elective major surgery
* More than 18 years of age
* Able to read, write and understand French

Exclusion Criteria:

- Neurological or orthopedic impairments not suitable for testing
Observational Registry for Iltamiocel Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence

The main purpose of this registry is to collect observational, long-term safety and effectiveness data in subjects who have received at least one dose of iltamiocel as part of the CLBT clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Has completed participation within 15 months in the CLBT clinical study for females with persistent or recurrent SUI following surgical treatment (i.e., either subject has completed all follow-up visits or has been officially exited from the study).
* Has received at least one dose of iltamiocel as part of the CLBT study.
* Must be willing and able to comply with the study procedures, is able to understand all study requirements and must agree to read and sign the informed consent form prior to any study-related procedures.
* Has access to a phone or electronic device to allow completion of electronic documents

Exclusion Criteria:

* Has only received placebo as part of the CLBT study.
* Unable or unwilling to provide informed consent.
Dietary Supplement for Joint: the OLE Study

This clinical study evaluates if the oral administration of Bonolive can contribute to the improvement of functionnality in healthy elderly people with knee discomfort.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 55 years of age
* BMI between 18.5 and 29.9 kg/m2 (normo and overweight)
* Moderate knee pain (the most painful knee is considered)
* Able to follow the instructions of the study
* Able to perform physical tests
* Having signed an informed consent

Exclusion Criteria:

Related to knee

* Recent trauma (\< 1 month) of the knee responsible of the symptomatic knee
* Subject with knee/joint surgery/replacement and ACL (Cross Ligament) injury in the target knee
* Concurrent articular disease interfering with the evaluation of pain such as articular dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis, chondromatosis, villonodular synovitis of the knee, seronegative spondyloarthropathy, rheumatoid arthritis, gouty arthritis , infectious arthritis, radiculalgia in the lower limbs, arteritis
* Prosthesis in the target knee
* Diagnosed arthrosis eligible to knee/joint surgery/replacement

Related to treatments

* Analgesics to manage knee pain 24h before inclusion visit
* Corticosteroids injection in the target knee in the month preceding inclusion
* Hyaluronan injection in the target knee in the last 6 months
* Oral corticotherapy ≥ 5mg/day in the last 3 months
* Symptomatic slow-acting drugs (SYSADs) treatment (Chondroitin, diacerein, glucosamine, soy and avocado unsaponifiables) in the last 3 months
* Other dietary supplements used for articular disorders in the last 3 months
* An anticipated need for the duration of the trial of corticosteroids or hyaluronan injection, oral corticotherapy, arthroscopy, analgesics other than listed as rescue treatments, which are forbidden during the trial
* Arthroscopy in the last 6 months
* Allergy or contra-indication to Oleuropein, to maltodextrin or any ingredient present in the product, or intolerance to rescue treatment (Paracetamol and NSAIDs)
* Treatments based on strontium ranelate, bisphosphonates, selective estrogen-receptor modulator (SERM) and parathormone (PTH) during the year before inclusion

Related to associated diseases

* Severe and uncontrolled diseases (liver or renal failure, lung/heart severe disease, Parkinson, progressive malignant neoplasia or in remission for less than 5 years, HIV, etc.)
* Lower or upper extremity surgery or fracture in the last 3 months
* Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee
* Swallowing disorder

Related to patients

* Close collaborators to the investigational team, the study coordinator (Artialis) or to the Sponsor (Nestlé)
* Currently participating or having participated in another therapeutic clinical trial in the three previous months
* Having made a blood donation in the past month
* Under guardianship or judicial protection
* Pregnancy, breastfeeding, planned conception
* Premenopausal women or women without tubal ligation or contraception.
Stress-induced Sleep Deficits and a Complementary Therapy

The COVID-19 pandemic and social isolation order induced stress/anxiety as well as cellphone dependence. As a result, sleep disruption and mental distress became major health concerns. Gamma-aminobutyric acid type-A receptor (GABAAR) is one of the key players in modulating sleep. Dihydromyricetin (DHM), an herbal compound, plays a role in GABAAR modulation and mitigating anxiety. The investigators' partner in China obtained 288 participants who completed the online survey to gain insight into how stress/anxiety and time spent on cellphones affected sleep and mood. The participants were then enrolled in a randomized placebo-controlled double-blind study to assess the effects of DHM on sleep and improvement on stress/anxiety and cellphone using time.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects were recruited in Chengdu and Beijing (city) in China,
* Able and willing to sign informed consent,
* Between 18 -60 years old at time of consent,
* No alcohol, drug, and smoking,
* Not using sleep medication(s) or other psychiatric medications.

Exclusion Criteria:

* Pregnant or Breastfeeding women,
* Currently taking any medications for sleep,
* Reported naps \> 3 times per week
* History of sleep apnea,
* Current alcohol, drug, and smoking
Ventricular Remodeling and Heart Failure After Myocardial Infarction: a Community Study

To comprehensively characterize Left Ventricular (LV) remodeling after Myocardial Infarction (MI) in the community, study the association between patterns of remodeling and biological pathways and examine the association between the predictors of remodeling and heart failure after Myocardial Infarction.


Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized patients with a clinical diagnosis of Myocardial Infarction.
2. Residents of Olmsted, Dodge, Goodhue, Wabasha, Winona, Fillmore and Mower Counties.
3. Able to provide informed consent.

Exclusion Criteria:

1. Previous clinical diagnosis of Myocardial Infarction
2. Previous diagnosis of Heart Failure and/or Cardiomyopathy
3. Diagnosis of Apical Ballooning Syndrome
4. Planned Coronary Artery Bypass Graft (CABG) during index hospitalization
5. Unable to provide informed consent
Study of ASN51 in Adults With Early Alzheimer's Disease

The main purpose of this study is to evaluate the safety, tolerability, and effect on biomarkers of disease pathophysiology and pathology, pharmacokinetics (PK), and preliminary effects on measures of clinical efficacy of multiple doses of ASN51 in adult participants with early Alzheimer's disease (AD).


Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female age 50 to 80 years.
2. A clinical diagnosis of Alzheimer's disease (AD) at either the mild cognitive impairment or mild AD dementia stage per National Institute on Aging and the Alzheimer's Association, consistent with Stage 3 and Stage 4 in the Food and Drug Administration (FDA) draft guidance for early AD.
3. Mini-Mental State Examination score of 20 to 28 (inclusive).
4. A plasma pTau217 result consistent with the presence of amyloid pathology.
5. Must have a care partner who, in the investigator's judgment, has frequent and sufficient contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities. The care partner must be literate and provide informed consent.

Key Exclusion Criteria:

1. Any medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause to the participant's cognitive impairment (e.g., current history of substance abuse, uncontrolled vitamin B12 deficiency or abnormal thyroid function, stroke or other cerebrovascular condition, normal pressure hydrocephalus, Parkinson's Disease, Lewy body dementia, cerebral amyloid angiopathy, frontotemporal dementia) or could lead to discontinuation, lack of compliance, interference with study assessments, or safety concerns.
2. Non-amnestic presentation of AD as judged by the investigator.
3. Woman of childbearing potential.
4. Any prior or ongoing exposure to active or passive anti-amyloid immunotherapy, anti-tau immunotherapy, an anti-tau antisense oligonucleotide or gene therapy, or O-linked-β-N-acetylglucosaminidase (O-GlcNAcase) inhibitor.

Other protocol defined inclusion and exclusion criteria could apply.
Sympathetic and Vascular Function in Takotsubo Syndrome

The primary objective of this prospective, observational study is to compare muscle sympathetic nerve activity at rest and during stress between female patients with Takotsubo syndrome and healthy, matched volunteers.

* Do Takotsubo patients have an increased sympathetic nerve activity compared to controls?
* Do Takotsubo patients have an exaggerated sympathetic nerve activity response to stress?
* Does the sympathetic nerve activity response to stress in Takotsubo change after receiving the beta blocking agent metoprolol?

Participants will be examined with muscle sympathetic nerve activity recording in the peroneal nerve at rest and during cold pressor test. After intravenous injection with beta blocking agent (metoprolol) or placebo (saline) in a 1:1 randomized fashion, muscle sympathetic nerve recording at rest and during stress will be repeated.

Female Takotsubo patients included in the SAFT (sympathetic and vascular function in Takotsubo syndrome) study will be invited to undergo microneurography recording of muscle sympathetic nerve activity (MSNA) at rest and during stress one week to two month after study inclusion. Responses to stress with and without the commonly used betablocking agent metoprolol will be compares.

Microneurography will be performed in the morning after a light caffeine-free breakfast with the subject supine and awake. Any medication with a beta blocking agent will be discontinued 24 hours prior to examination. MSNA will be recorded by inserting a tungsten electrode into the sympathetic nerve fibres of the peroneal nerve, with simultaneous blood pressure and heart rate monitoring.

MSNA recording will then continue during stress induced by placing one of the subjects hand in ice-cold water for 90 seconds (cold pressor test).

After intravenous injection with beta blocking agent (metoprolol) or placebo (saline) in a 1:1 randomized fashion, MSNA recording at rest and during stress will be repeated.

Age- and gender-matched healthy volunteers will be recruited as controls and examined similarly with microneurography at rest and during stress.

MSNA recordings will be amplified, computerized and saved for further analyses. MSNA will be quantified as burst incidence (burst per 100 heartbeats), burst frequence (bursts per minute) and relative median burst amplitude (%). MSNA activity will be compared between Takotsubo patients and controls and before and after betablockade in Takotsubo patients.

Eligibility Criteria:
Inclusion Criteria:

For patients:

* Diagnosis of Takotsubo cardiomyopathy

For Controls:

* Matching age with Takotsubo patients
* Signed informed consent

Exclusion Criteria:

* Coronary anathomy precluding intracoronary investigations
* Severe obstructive pulmonary disease
* Kidney failure with estimated glomerular filtration rate \< 30 ml/min/m2
* Active malignancy
* Pericarditis