cyrilzakka/clinical-trials huggingface dataset:
A Trial Investigating the Effects of Semaglutide on ß-cell Function in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of the trial is to investigate the effects of semaglutide on ß-cell function in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-64 years (both inclusive) at the time of signing the informed consent
* For subjects with type 2 diabetes:
* Male and female subjects diagnosed with type 2 diabetes
* Treated with diet and exercise and/or metformin monotherapy. Metformin dose should be unchanged in a period of 30 days prior to screening
* Body Mass Index (BMI) between 20.0-35.0 kg/m\^2 (both inclusive)
* Glycosylated haemoglobin (HbA1c) between 6.5-9.0 % (both inclusive)
* For healthy control group for graded glucose infusion:
* Healthy male and female subjects
* BMI between 24.0-32.0 kg/m\^2 (both inclusive)
* HbA1c less than 6.5 %

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child bearing potential and not using an adequate contraceptive method. Women of child bearing potential must use an effective method of birth control for the duration of the trial and for subjects with type 2 diabetes for 5 weeks following the last dose of semaglutide. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices), or sexual abstinence or vasectomised partner
* Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiac, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic
* Use of any prescription or non-prescription medication which could interfere with trial pharmacokinetic or pharmacodynamic results, as judged by the investigator or specifically: a) current treatment with systemic (oral or i.v.) corticosteroids, non-selective betablockers, b) thyroid hormones are not allowed unless the use of these have been stable during the past 2 month prior to screening
* History of drug/chemical substance abuse within 1 year prior to screening, or a positive result in the urine drug test
* History of alcohol abuse within 1 year prior to screening, or a positive result in the alcohol breath test
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
A Study of a Single Dose of ASP3291 in Subjects With Ulcerative Colitis

The purpose of this study is to determine the pharmacokinetics (PK) and to assess safety and tolerability of a single dose of ASP3291 in subjects with ulcerative colitis.

After an 11-day screening period, subjects check into a clinic, are dosed on Day 1 and stay in the clinic for 4 days to monitor pharmacokinetic and safety parameters.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a previously documented diagnosis of ulcerative colitis (UC) with endoscopy and histology consistent with diagnosis
* If female, the subject is at least 2 years postmenopausal or is surgically sterile per documentation provided by a third party medical professional or the subject agrees to use 2 highly effective methods of birth control during the study and is not pregnant or lactating
* Subject is willing and able to comply with the study requirements
* Subject has a body mass index (BMI) of \<32 kg/m2
* Subject has ulcerative colitis requiring treatment with 5-aminosalicylic acid (5-ASA)

Exclusion Criteria:

* Subject has undergone previous resective colonic surgery
* Subject has previously diagnosed Crohn's Disease based on medical history
* Subject has an extension of disease limited to ulcerative proctitis
* Subject has active peptic ulcer disease based on medical history
* Subject is currently being treated with any prescription medication except the following: A stable dose of 5-aminosalicylic acid (5-ASA) for at least 2 weeks, oral contraceptives or hormone replacement therapy (HRT)
* Subject has a history of human immunodeficiency virus (HIV)
* Subject has a history of severe allergic or anaphylactic reactions
* Subject has a history of drug or alcohol abuse
Phase I/II Intratumoral DC Immunotherapy With Gemcitabine & XRT in Unresectable Pancreatic Cancer

To determine the safety, feasibility and appropriate dendritic cell dose to vaccinate patients with pancreas cancer


Eligibility Criteria:
Inclusion Criteria:1. Patients must have histologically or cytologically confirmed adenocarcinoma of the pancreas. The site of the primary lesion should be confirmed endoscopically, radiologically, or surgically to be in the pancreas.

2. Patients must be deemed unresectable due to involvement of critical vasculature, adjacent organ invasion, presence of metastasis, or other medical condition making surgical resection unfavorable.

3. Patients must have a primary or metastatic lesion measurable in at least one dimension by RECIST criteria within 4 weeks prior to entry of study 4. More than 4 weeks must have elapsed from the time of major surgery or completion of the last dose of chemotherapy, radiation therapy, investigational therapy and patients must adequately recover from these effects.

5. Life expectancy of \>3 months. 6. Karnofsky performance status \>70%. 7. Patients must have normal organ and marrow functions as defined below: absolute neutrophil count \>1,500/mm3 platelets \>70,000/mm3 total bilirubin \<1.5 mg/dL AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal creatinine within normal institutional limits OR creatinine clearance \>60mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

albumin \> 2.8 mg/dL 8. Patients must have adequate clotting function (platelet \> 70k; INR\<1.4; PTT\<60).

9. Age \>18 years. 10. The effects of DCs on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

11. No history of autoimmune diseases. 12. Ability to understand the study protocol and a willingness to sign a written informed consent document. Exclusion Criteria:1. Patients receiving anticoagulation therapy.

2. Patients who have received prior gemcitabine or radiation therapy to the pancreatic bed 3. Patients receiving any other investigational agents. 4. Patients with known brain metastases will be excluded because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse effects.

5. Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.

6. Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV.
A Study of STAR-0310 in Healthy Adult Participants

This is a randomized, double-blind, placebo-controlled, single ascending dose trial evaluating the safety, tolerability, PK, and immunogenicity of STAR-0310 in healthy adult participants. There are 4 planned cohorts and potentially up to 1 additional cohort which may comprise of healthy adult participants of Japanese descent.


Eligibility Criteria:
Inclusion Criteria:

* Good health as determined by the Investigator based upon a medical evaluation.
* Body mass index (BMI) of 18 to 35 kg/m2 with a weight of at least 60 kg for men and at least 50 kg for women, with a maximum weight of 130 kg for any participant.
* Participants of childbearing potential must have a negative serum pregnancy test at Screening, agree to use highly effective forms of contraception and abstain from egg donation or fertility treatment
* Participants capable of producing sperm must use an effective method of contraception and abstain from sperm donation
* Healthy adults of Japanese descent, where both biological parents and all 4 biological grandparents are of Japanese ethnicity (applicable only for potential cohort of participants of Japanese descent).

Exclusion Criteria:

* Prior or ongoing medical condition that, in the Investigator's opinion, could adversely affect the safety of the participant.
* Known sensitivity to the ingredients of STAR-0310
* Taking any prescription or non-prescription medications within at least 5 half-lives or 7 days, whichever is longer, before the time of admission
* History of exposure to any biologic medication within 90 days or 5 half-lives, whichever is longer, before the time of admission
* Participation in a clinical trial involving receipt of an investigational product within 30 days (small molecule) or 90 days (biologics), or 5 half-lives, whichever is longer, before the time of admission
Evaluation of Triathlon - A New Total Knee Prosthesis System - Triathlon PA vs. Triathlon Pressfit

The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective randomized clinical trial.

The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective randomized clinical trial.

The evaluation is carried out by a prospective randomised RSA-study with Triathlon PA vs. Triathlon Pressfit

Eligibility Criteria:
Inclusion Criteria:

1. Patients suffering exclusively from OA, Stage II-V \[Ahlbäck, 1968 391\] will be operated.
2. Patients requiring knee prosthesis, suitable for the use of Duracon and Triathlon knee system
3. Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographical evaluations and the prescribed rehabilitation.
4. Patients who signed the Ethics Committee approved Informed Consent Form prior to surgery.

Exclusion Criteria:

1. Previous major knee surgery
2. Other significant disabling problems from the muscular-skeletal system than in the knees
3. Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI above 35).
4. Patients with active or suspected infection.
5. Patients with malignancy - active malignancy.
6. Patients with severe osteoporosis, Paget's disease, renal osteodystrophy.
7. Patients immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
8. The patient has a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period.
9. Female patients planning a pregnancy during the course of the study.
10. Patients with systemic or metabolic disorders leading to progressive bone deterioration.
11. Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule.
12. Patients with other severe concurrent joint involvements, which can affect their outcome.
13. Patients with other concurrent illnesses, which are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus or renal disease requiring dialysis.
14. Patients under the protection of law (e.g. guardianship).
Thumb Muscle Thickness and Strength in CMC Osteoarthritis

A total of 34 patients aged between 50-80 years, diagnosed with first carpometacarpal joint osteoarthritis based on hand radiographs taken within the last 3 months, will be included in the study from the Physical Therapy and Rehabilitation outpatient clinic. Sociodemographic data such as age, gender, height, weight, and BMI will be recorded. Based on their current radiographs, patients will be classified into two groups according to the Eaton-Littler classification: Stage 1-2 (early stage) and Stage 3-4 (advanced stage). Pain levels will be assessed using the Visual Analog Scale (VAS). Hand grip strength will be evaluated with a Jamar hand dynamometer, and pinch grip strength will be assessed with a Jamar pinch meter. The thicknesses of the abductor pollicis brevis, first dorsal interosseous, and opponens pollicis muscles will be measured using ultrasound. All assessments will be performed separately for the dominant and non-dominant hands.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 50-80 years.
* Diagnosed with first carpometacarpal joint osteoarthritis.
* Presence of a hand radiograph taken within the last 3 months.
* Volunteered to participate in the study.

Exclusion Criteria:

* Refusal to participate in the study.
* Use of medications that may suppress osteoarthritis flares.
* Presence of rheumatologic diseases causing peripheral joint involvement.
* History of fractures or surgeries involving the first carpometacarpal joint.
* Presence of psychiatric disorders.
* Presence of cognitive impairments that could hinder understanding or performance of study-related tasks.
A Trauma-Informed Approach for Positive Youth Development for Montana Students

Given the prevalence of suicide and mental health issues in rural Montana, this project is intended to help mitigate stressors that may contribute to poor behavioral and mental health in high school-aged children. The immediate goal is to determine viability of a partnership with a rural southwestern Montana school and test the feasibility of a piloted implementation of a trauma-informed yoga intervention to address behavioral health outcomes and positive youth development.


Eligibility Criteria:
Inclusion Criteria:

* Students enrolled in a specific weight training class at predetermined high school in rural Montana

Exclusion Criteria:

* Students not enrolled in a specific weight training class at predetermined high school in rural Montana
Chen-style Tai Chi in Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease

This study will evaluate the effects of Chen-style Tai Chi compared to conventional exercise in pulmonary rehabilitation for COPD patients. Half of participants will receive the Chen-style Tai Chi intervention, while the other half will receive the conventional exercise intervention. Both groups will receive the same eduction and support during pulmonary rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* FEV1 between 30 and 80% of the predicted normal values
* FEV1/FVC ratio \< 70%

Exclusion Criteria:

* Patients with very severe COPD (GOLD IV);
* Patients that had a COPD exacerbations within the preceding 2 weeks of the baseline assessments;
* Significant hypoxemia at rest or during exercise (SpO2 \<85%);
* Already following a rehabilitation program;
* Have physical limitations that compromises participation to a Tai chi and a conventional exercise program
A Study of Physical Activity in Cancer Survivors

The purpose of this study is to determine if increasing physical activity (PA) will increase physical functioning, as measured by cardiovascular endurance, muscular strength, and balance in underserved adult cancer survivors \> 60 years of age and/or those of any age residing at a rural address. Also, to determine if increasing PA will increase quality of life (QOL), as measured by physical functioning and fatigue, in underserved cancer survivors \>60 years of age and/or those of any age residing at a rural address.


Eligibility Criteria:
Inclusion Criteria:

* Adult, cancer survivors (no active disease) at Mayo Clinic Health System (MCHS) in Northwest Wisconsin (NWWI), Southwest Wisconsin (SWWI), Southeast Minnesota (SEMN), or Southwest Minnesota (SWMN)
* Any stage cancer
* Age ≥18 years residing at a rural address (as defined by Rural America, census.gov)
* Completed active treatment of surgery, (neo)adjuvant chemotherapy, and/or (neo) adjuvant radiation. Patients receiving adjuvant endocrine therapy, targeted therapy, or immunotherapy therapies are eligible.
* Ownership of a computer/tablet/smartphone with internet access.
* Willingness to create a google account and maintain the account for use of the Fitbit
* Willingness and ability to attend study visits.
* Must be able to complete semi-tandem (10 seconds), side-by-side tandem \[10 seconds and short physical performance batters(SPPB)\] Score of 6 or greater to qualify for virtual exercise.
* Must be ambulatory without the use of assisted device(s).

Exclusion Criteria:

* Receiving surgery, (neo)adjuvant chemotherapy, (neo) adjuvant radiation, palliative treatment
* Are already performing \>150 minutes/week of moderate activity or 75 min/week of vigorous physical activity
* Cancer-free for greater than 5 years
* Unable to complete weekly interventions/exercise due to traveling or unable to be active for more than 7 consecutive days.
Vitamin D Administration in the Nursing Home

Administration of vitamin D 50,000 units once monthly will:

* Maintain serum 25-OH vitamin D above 20 ng/ml
* Reduce falls
* Increase calcaneal BMD
* Reduce bone turnover
* Be well tolerated: volunteers will not develop hypercalcemia
* Improve performance on a swallowing quality of life questionnaire

1. Research questions: We propose a prospective double-blind, randomized, placebo-controlled trial of once-monthly vitamin D oral capsules (50,000 units) in nursing-home residents.

Subjects from several Wisconsin nursing homes were randomized to receive once-monthly vitamin D oral capsules (50,000 units) or placebo. Blood levels of 25-OH D, parathyroid hormone, serum calcium, and a marker of bone turnover will be measured periodically by standard lab assays. Swallowing quality of life was measured by questionnaire. Appropriate statistical tests (paired T tests, 95% confidence intervals will be calculated with the large sample approximation for binomial variables, other).

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Nursing Home Resident in Wisconsin

Exclusion Criteria:

* Renal Failure
* Hypercalcemia
* Metastatic Cancer
Self-perception of Health Status and Physical Condition of Elderly People Practitioners of Hydrogymnastics

The researcher interest in self-perception of health status and physical condition of the elderly is determinant in an increasingly aging society and where one should seek to improve their quality of life.

Introduction: The researcher interest in self-perception of health status and physical condition of the elderly is determinant in an increasingly aging society and where one should seek to improve their quality of life.

Objective: To study the self-perception of health status and the impact of a physical activity program oriented during 4 months in an elderly population practitioners of hydrogymnastics.

Methods: As instruments were used the questionnaire mos short health survey - 36 items version 2 (SF-36), and the battery of Functional Tests Fitness Test. The questionnaires were filled by the elderly with the presence of the investigator and the physical fitness was evaluated following the protocol of proof. The sample was constituted of 83 elderly individuals over 55 years of age. In statistical terms we used a percentage analysis in the questionnaire and in the evaluation of the physical condition after application of the Kolmogorov-Smirnov test, we used the non-parametric test for two paired variables Wilcoxon.

Eligibility Criteria:
Inclusion Criteria:

* hydrogymnastics practitioners
* participants over 55 years of age

Exclusion Criteria:

-
Validation of Questionnaire in Retinal Degeneration

While inherited retinal diseases are well characterized anatomically and functionally, it is also essential to understand their impact on patients' quality of life, from their ability to perform the tasks of daily living to the psychological impact of the disease on patients. Questionnaires (PRO, Patient-Reported Outcomes) are important tools for assessing this impact. However, PROs validated in French are rare, and often poorly adapted to populations with hereditary retinal degeneration. New PROs particularly adapted to retinal degeneration have recently been validated in English: the Michigan Retinal Degeneration Questionnaire (MRDQ) and the Michigan Vision-Related Anxiety Questionnaire (MVAQ). Validation of a French translation will provide a standardized, reliable tool for French-speaking patients, and enable these questionnaires to be used in gene therapy clinical trials, to assess the efficacy of treatments and their impact on patients' quality of life.

Interventional research of category 2 with minimal risks and constraints. This is a prospective, monocentric, longitudinal, non-randomized study to validate the translation of questionnaires to assess abilities in daily living tasks and the potential psychological repercussions of visual impairment in various hereditary retinal dystrophies.

The research will be conducted in two distinct phases:

Comprehension phase and validation phase

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age: 18 to 80
* Sufficient knowledge of the French language to ensure understanding of the tasks to be performed and the instructions received.
* Signed consent after being informed by the investigator.
* Affiliation with health insurance.
* Affected by one of the following rare pathologies, with different levels of visual field, acuity and contrast sensitivity impairment:
* Non-syndromic rod-cone dystrophy (retinopathy pigmentosa, RP): diagnosis confirmed by a specialist.
* Non-syndromic rod-cone dystrophy: diagnosis confirmed by a specialist.
* Non-syndromic Stargardt's disease: diagnosis confirmed by a specialist.
* Non-syndromic congenital night blindness: diagnosis confirmed by a specialist.
* Non-syndromic achromatopsia: diagnosis confirmed by a specialist.

Exclusion Criteria:

* Pregnancy
* Inability to give informed consent.
* Cataract surgery within 3 months of inclusion.
* Hearing impairment that may interfere with comprehension during the interview.
* Functional amblyopia.
* Inability to comply with instructions to perform study tasks or study visits.
* Drug treatment that may cause motor, visual or cognitive impairment (PSAs, neuroleptics, etc.) or that may interfere with study assessments.
* Other uncontrolled ophthalmic conditions that may interfere with evaluation.
* Participation in another clinical trial that may interfere with the present study.
* Patient under guardianship, curatorship or legal protection
Surgical Approach for Primary Hyperparathyroidism in the Elderly

Following a personal observation and a retrospective analysis of the data, the investigators hypothesise that there is increased frequency of multiple gland disease in primary hyperparathyroidism in the elderly.

This study will include patients over the age of 65, diagnosed with primary hyperaprathyroidism, referred for surgery and suspected to have a single adenoma according to preoperative imaging. Surgery will begin with a focal parathyroid exploration as suspected followed by an exploration of the other gland at the same time. Data will be analysed to determine the frequency of multigland disease in this population.


Eligibility Criteria:
Inclusion Criteria:

* patient with primary hyperparathyroidism.
* patients with an indication for surgery.
* Suspected adenoma on preop images.
* minimum age of 65.

Exclusion Criteria:

* patients younger than 65.
* cases where imaging didn't locate any adenoma.
* patients who did not consent to participate in the study.