cyrilzakka/clinical-trials huggingface dataset:
Global Registry and Natural History Study for Mitochondrial Disorders

The main goal of the project is provision of a global registry for mitochondrial disorders to harmonize previous national registries, enable world-wide participation and facilitate natural history studies, definition of outcome measures and conduction of clinical trials.

The global mitochondrial registry and natural history study is part of the EU-financed GENOMIT project, co-ordinated by Dr. Holger Prokisch, Technische Universität München (TUM).It aims at advancing the understanding of the natural history of mitochondrial disease to inform the design and facilitate the conduction of clinical trials. It also serves as a catalyst for translating basic research results into clinical practice.

The global mitochondrial registry and natural history study provides for all contingencies of national ethics and data protection rules including data access management.

Currently participating networks are:

* German network for mitochondrial diseases - mitoNET, Germany/Austria
* Italian Registry of Mitochondrial Patients - Mitocon, Italy

The inclusion of other networks and countries is possible and explicitly welcome. A major advantage of the global registry is that countries can join in, saving a lot of time, effort and funding.

Eligibility Criteria:
Inclusion Criteria:

* suspected or confirmed mitochondrial disease
* willingness to participate

Exclusion Criteria:

* unwillingness to participate
Observational Study at the Influence of Malnutrition on Infections

The purpose of this trial is to determine whether nutritional status has an impact on nosocomial infections. Study population are patients undergoing early neurological rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Patients in early neurological rehabilitation
* informed consent given

Exclusion Criteria:

* none
Pre-Hospital Cerebral Oxygenation and End-Tidal CO2 During Cardiopulmonary Resuscitation (CPR)

Cerebral saturation will be measured pre-hospital during an out-of hospital cardiac arrest with O3TM regional oximetry for Root® (Masimo®). The O3TM regional oximetry for Root® (Masimo®) is a device that can measure not only cerebral saturation but also end-tidal CO2 (capnography). Currently, end-tidal CO2 is already measured during Advanced Life Support following most recent European Resuscitation Guidelines but with another monitor. Until now it is the only parameter which may predict return of spontaneous circulation. Because of this, researchers want to measure both with the same device, which gives the investigators the opportunity and advantage to compare end-tidal CO2 and cerebral saturation very precisely. In this manner researchers want to investigate the predictive value of cerebral saturation and compare it end-tidal CO2.


Eligibility Criteria:
Inclusion Criteria:

* all consecutive OHCA patients

Exclusion Criteria:

* DNR code
* no possibility to attach cerebral oxygenation sensor
Patient Specific Talus Spacer Post Approval Study

Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.

This is a Humanitarian Device Exemption (HDE) approved device called the Patient Specific Talus Spacer. This is a post approval study to determine the safety and probable benefit of the Patient Specific Talus Spacer in commercial use. The Patient Specific Talus Spacer is a solid polished replica of the patient's bone to allow the patient to regain motion and reduce pain.

Eligibility Criteria:
Inclusion Criteria:

1. Subject plans to undergo implantation of the Patient Specific Talus Spacer for avascular necrosis of the ankle joint independent of this research protocol;
2. Avascular necrosis of the ankle joint;
3. Age 21 years old or older;
4. Subject has good general health; and
5. Subject signs a written informed consent form (ICF) prior to the surgical procedure.

Exclusion Criteria:

1. Presence of any contraindication identified in the device Instructions for Use;
2. Surgeon determines that the patient is not appropriate for the Talus Spacer procedure based on the device IFU (including the enumerated Warnings and Precautions);
3. Based on the medical opinion of the surgeon, the patient is not appropriate for the Talus Spacer procedure;
4. For female subjects, pregnancy;
5. Active systemic disease, such as AIDS, HIV, or active infection;
6. Active infection or the skin is compromised at the surgical site; and
7. Systemic disease that would affect the subject's welfare;
8. Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results;
9. Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the time course of follow-up.
10. If the Sponsor has notified the site that 30 subjects have been enrolled in the study with a Cobalt Chromium Patient Specific Talus Spacer, and the surgeon believes that a Cobalt Chromium Patient Specific Talus Spacer is the best option for the patient.
11. If the Sponsor has notified the site that 30 subjects have been enrolled in the study with a Titanium (Ti6Al4V) with Titanium Nitride (TiN) coating Patient Specific Talus Spacer, and the surgeon believes that a Titanium (Ti6Al4V) with Titanium Nitride (TiN) coating Patient Specific Talus Spacer is the best option for the patient.
Study of KN026 in Combination With Palbociclib and Fulvestrant in Patients With Advanced Breast Cancer

This is an open-label, multicenter, dose-escalation and parallel-group expansion Phase II clinical trial to evaluate the efficacy, safety and tolerability of KN026 in combination with palbociclib and fulvestrant in women or male with HER2-positive metastatic breast cancer .The subjects will receive 20 mg/kg IV Q2W+ palbociclib 100/125 mg/day orally+/-Fulvestrant 500 mg IM until progressive disease, unacceptable toxicity or death.

KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject \>= 18 years;
* Histologically or cytologically confirmed, metastatic or locally advanced unresectable HER2-positive;
* Adequate organ function assessed within 7 days prior to first trial treatment
* ECOG score 0 or 1;
* Left ventricular ejection fraction (LVEF) ≥ 50% at baseline;
* Life expectancy \>3 months

Exclusion Criteria:

* Untreated active CNS metastasis or leptomeningeal metastasis;
* Uncontrolled tumor-related pain;
* Has received other anti-tumor treatment or an investigational drug within 28 days or within 5 times of half-life (whichever is shorter, and no less than 2 weeks) prior to the first trial treatment;
* Major surgery for any reason within 28 days;
* Curative radiation within 3 months of the first dose of trial treatment;
* History of uncontrolled intercurrent illness;
* Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance
Pharmacogenomics of Contraception: Genetic Variants and Etonogestrel Pharmacokinetics

The proposed study will investigate the relationship between genetic variants and serum contraceptive hormone levels, specifically the progestin etonogestrel. This study will provide the foundation for future pharmacogenomic investigations of more commonly used contraceptive methods with higher failure rates.

Approximately 700 reproductive age women (18-45) with an Etonogestrel (ENG) contraceptive implant in place for more than 1 year will be enrolled. Participants will undergo a blood draw for measurement of ENG concentration (serum) and genotyping (whole blood) and complete a questionnaire regarding their demographics and contraceptive, gynecological, and obstetrical history. The research investigators will also consent participants for use of their genetic samples and clinical data in future unspecified research.

The serum samples will be de-identified for ENG analysis, which will be done using a liquid chromatography-mass spectrometry method. Additional whole blood samples collected at the enrollment visit will undergo DNA extraction. A candidate gene study was conducted using the first 350 participants. The research investigators selected 120 genetic variants for 14 target genes involved in progestin metabolism, regulation, and function for this candidate gene study. A Genome Wide Association Study will be performed using all 700 participants. Genotyping will be performed using a custom MultiEthnic Global Array chip through the Colorado Center for Personalized Medicine.

Eligibility Criteria:
Inclusion Criteria:

* women of reproductive age (18-45 years)
* have had an ENG contraceptive implant in place for 12-36 months

Exclusion Criteria:

* Use of medications or supplements in the past four weeks which could impact serum ENG levels through inhibition or induction of CYP enzymes (specifically CYP-3A4)
* Medical conditions that could impact baseline liver function (e.g. hepatitis, cirrhosis)
* Body mass index (BMI) less than 18.5
Study Assessing Utility of a Clinical Questionnaire to Identify Subjects With Features of Both Asthma and Chronic Obstructive Pulmonary Disease (COPD)

The primary objective of the study is to identify demographic and non-spirometric clinical features predictive of the asthma-COPD overlap population. The study aims to explore and identify characteristics of the Asthma-COPD Overlap Syndrome (ACOS) patient's clinical profile that enable clinical differentiation from subjects with a primary diagnosis of either asthma alone (without persistent obstruction) or COPD alone (without reversibility). The study is designed as a targeted medical history survey which consists of a 41-item questionnaire, which will be administered by a qualified health care practitioner at the time a subject's medical history is taken. The questionnaire has been developed to elicit specific details of the respiratory history, including the following: bronchodilator use, disease progression, variation in symptoms, atopic history, symptom triggers, vagal bias, burden of disease, symptom presentation, co morbidities and age of onset. In addition, demographic information, standard medical history, co morbidity and spirometric results will also be obtained and analyzed in conjunction with the questionnaire results. Approximately 1000 subjects are required for the study.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be 18 years of age or older.
* Subject has been diagnosed as having asthma and/or COPD.
* Informed consent is required for independent sites initiating this protocol
Temporary Anchorage Devices for Ridge Preservation

Alveolar bone is a bony portion surrounding the root of a tooth. The alveolar bone disappears gradually when the tooth is extracted. This bone loss often becomes a problem if a patient wants to close the missing tooth space with orthodontic treatments (braces), or to get a dental implant (a metal post replacing a tooth). Therefore, we would like to place small screws at the extraction sites to preserve the alveolar bone when the teeth need to be extracted and a patient cannot start treatments some time.

Mini-screws (small metal screws) are routinely used for regular orthodontic treatment. We will recruit patients who require extractions of two upper small molars (maxillary premolars) on both right and left sides. We will place one mini-screw on one side while the other side will be untouched after teeth extractions. Both sides will be followed at 8 months for examinations.

The purpose of this study is to investigate the effects of transcortical mini-screws on ridge preservation following tooth extraction with a split mouth design. The study will evaluate clinical and radiographic outcomes following transcortical screw placements at extraction sites compared to non-treated extraction sites.

Specific Aim 1: To evaluate the clinical outcomes between the treated sites with a transcortical screw (the experimental group) and the non-treated sites (the control group) Null Hypothesis: There will be no differences in clinical parameters between the two groups.

Approach: The investigators will conduct a prospective split-mouth design clinical study. The investigators will compare the clinical changes in vertical bone height and horizontal bone width at 8 months from baseline (tooth extraction).

Specific Aim 2: To evaluate the radiographic outcome between the experimental group and the control group Null Hypothesis: There will be no difference in alveolar ridge height and width between the two groups.

Approach: The study will measure ridge height and width using cone beam computed tomography (CBCT) at baseline and 8 months.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* two maxillary premolars (left and right) required to be extracted based on recommended dental treatment plans

Exclusion Criteria:

* uncontrolled hypertension
* diabetes mellitus
* subjects with a history of a long-term use of corticosteroid (\> 6 months)
* subjects with a history of taking oral/IV bisphosphonates within the past 2 years
* smokers
Human Mesenchymal Stem Cells in the Synovial Fluid of the Hip

Previous studies have shown an increase in the concentration of mesenchymal stem cells (MSC's) in the setting of osteoarthritis of the knee and its correlation to severity. Researchers have shown that as there is an increase in the severity of the disease, the concentration of stem cells also increases. The purpose of this study is to determine if there is the same increase in stem cell concentration in patients with osteonecrosis (ON) of the femoral head.

Since the treatment of osteonecrosis is related to the severity of disease, namely articular cartilage collapse, the purpose of this study is to determine if the MSC concentration in synovial fluid can be correlated to disease stage. In order to do this the investigators will:

Milestone #1:

Determine the concentration of MSC's in the synovial fluid in patients with osteonecrosis. This work will be carried out utilizing FACS-based technique to synovial fluid stem cell sub-population.

Milestone #2:

Compare concentrations of MSC's in patients with pre collapse, post collapse osteonecrosis and "normal" hips. Patient-derived MSC will be quantified at the different stages of disease and assays will be performed in order to assess their viability. A control group will be selected in patients undergoing hip arthroscopy for femoral/acetabular impingement (FAI). Since FAI does not affect the intraarticular environment of the hip, theoretically these patients would have a "normal" concentration of synovial stem cells.

Eligibility Criteria:
Inclusion Criteria:

* Patients consented to undergo a THA (post-collapse osteonecrosis), hip arthroscopy or minimally invasive core decompression
* Preoperative radiographic diagnosis of ON or FAI (femoral/acetabular impingement)

Exclusion Criteria:

* Pregnant females
* Active infection, HIV, Hepatitis C or B, syphilis Immunodeficiency
* Patients receiving hematopoetic growth factors or anti-angiogenesis products
A Study to Measure Energy Expenditure and Food Intake in Participants With Obesity Using Tirzepatide

This is a study of tirzepatide in participants with obesity. The main purpose is to learn more about how tirzepatide affects the number of calories participants burn and the amount of food they eat. The study lasted for 28 weeks and will include about 21 visits to the study center.


Eligibility Criteria:
Inclusion Criteria:

* Have body mass index of 30 to 45 kilograms per square meter (kg/m²), inclusive
* Have a stable body weight in the past 1 month prior to screening
* Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff

Exclusion Criteria:

* Have undergone gastric bypass or bariatric surgery
* Have a diagnosis of type 2 diabetes
* Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data
* Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening
* Have any lifetime history of a suicide attempt
* Patient Health Questionnaire-9 (PHQ-9) score of 15 or more at screening
* Positive responses to selected items on the Columbia Suicide Severity Rating Scale (C-SSRS)
Functional and Quality of Life Outcomes Following Viscosupplementation for Knee Osteoarthritis

This study will compare changes in outcomes following viscosupplementation for knee osteoarthritis.

The specific aims of this study are to compare the changes in knee pain symptoms, physical function, gait parameters and quality of life in persons with knee OA following a standard viscosupplementation injection series of hyaluronic acid (HA) over a one year period.

Eligibility Criteria:
Inclusion Criteria:

* 21 years of age or older
* osteoarthritis degeneration, degenerative joint disease or degeneration
* fully cognizant of study procedures
* willing to carefully participate in all study processes and assessments

Exclusion Criteria:

* less that 21 years of age
* allergic reactivity to hyaluronic acid
* current knee infection, infection around injection site or any skin disease
* pregnancy or lactation
* non-ambulatory
Prosthetic Limb Movement Feedback for Upper and Lower Extremity Amputees

To assess the functional characteristics and utility of upper and lower limb prosthetic devices (advanced bionic and current clinical standard-of-care) that incorporate physiologically relevant touch and/or movement feedback.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria are adults (18 years or over) with major limb amputation (at or above wrist or ankle).

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Exclusion Criteria:

Exclusion criteria are any skin or pain conditions that would preclude ability to withstand pressures on their limb or to wear a prosthetic socket, or cognitive barriers precluding providing informed consent.

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Liberal Use of Sodium in Ambulatory Heart Failure

This study investigates the effects of an increased sodium intake in heart failure patients with reduced ejection fraction and age-matched volunteers without heart failure.

At the start of the study, baseline investigations are performed including assessment of vital signs (blood pressure, heart rate, pulse oxygen saturation), weight, Everest congestion score (consisting of grading of dyspnea, orthopnea, jugular venous distention, rales, edema and fatigue), echocardiography, 24h urine collection, bio-impedance measurements and blood sample analysis with plasma renin and aldosterone Subsequently, a run-in phase of 2 weeks, without intervention, will start. After this run-in period, participants will be reassessed with the same baseline investigations. In addition, a skin biopsy will be performed as well as a blood volume measurement.

In the next phase of the study, salt intake will be increased with 3 grams daily. The salt will be packed in capsules containing 1 g of sodium chloride (NaCl). Patients will be asked to take one capsule with their breakfast, lunch and dinner. Every 2 weeks a follow-up visit is planned.

After 4 weeks of increased salt intake, a new skin biopsy will be taken and a blood volume measurement will be performed.

Eligibility Criteria:
Inclusion Criteria:

1. Heart failure patients:

   * Left ventricular ejection fraction ≤40% on echocardiogram obtained at inclusion
   * Stable dose of guideline-recommended disease modifying drugs for at least 3 months.
   * Maximum daily loop diuretic dose of 40 mg furosemide equivalents with a stable dose for the last month
2. Healthy volunteers:

   * Age \> 60 y
   * Normal ejection fraction (\>50%) without heart failure
   * No neurohormonal blockers for hypertension
   * Normal NT-proBNP

Exclusion Criteria:

* Heart failure hospitalization for congestion or myocardial infarction in past 3 months
* Permanent atrial fibrillation
* New York Heart Association (NYHA) class III-IV
* Estimated glomerular filtration rate (eGFR) \< 30 mL/min
* Signs of congestion
* Severe right ventricular dysfunction
* Severe valvular disease
* Cardiothoracic anatomy not allowing satisfactory and reproducible recordings of echocardiogram
* Inability to fully comprehend and/or perform study procedures in the investigator's opinion.
Dormia Basket Versus Extraction Ballon in Proximally Migrated Biliary Stents

Dormia basket versus extraction ballon in proximally migrated biliary stents:A randomized controlled clinical trial

Dormia basket versus extraction ballon in proximally migrated biliary stents:A randomized controlled clinical trial The study aims to evaluate the efficacy of dormia basket versus extraction biliary balloon in management of proximal stent migration

Eligibility Criteria:
Inclusion Criteria:

1. Adults
2. both gender
3. Patients with biliary stenting following ERCP and who had signs of biliary obstruction.

Exclusion Criteria:

ERCP without stent insertion.
Informant Questionaire on Cognitive Decline in the Elderly (IQCODE) and Delirium in Geriatric Patients

To investigate the usefulness of the Informant Questionaire on Cognitive Decline in the Elderly (IQCODE) to predict delirium in elderly patients admitted to Emergency Department (ED) with geriatric assessment and transferred to Geriatric ward.

Design: The project will be conducted as a prospective study.

Methods:

Exposure: The short IQCODE is a 16-item questionnaire that ask relatives about changes in the elderly patients cognitive performance over the previous 10 years. The score range from one to five, with a high score reflecting bad evolution through the years.

Settings: Patients (aged ≥75 years) admitted to ED (medical and surgery) and transferred to a geriatric ward at Aarhus University Hospital, who meet the inclusion criteria will be asked if the staff is allowed to contact their relatives. By oral consent, the relatives are interviewed by telephone or at the hospital. The IQCODE are filled in during the interview.

In the geriatric ward the assessment of delirium by a positive Confusion Assesment Method (CAM) is done twice a day and is part of the regular procedure in the Geriatric Department at Aarhus University Hospital.

Sample size: The power calculation is based on a pilot study of IQCODE. The study that included 32 75-year-olds from geriatric ward at Aarhus University hospital, showed an no incidence of delirium of when the IQCODE-score was ≤3,125. On the contrary the incidence of delirium was 15% when the IQCODE-score was \>3,125. With a power of 90% and a significance level of 5%, 76 patients should be included in each group to predict delirium.

Time frame: Of the 80 admitted to the geriatric wards, only 20% in the pilot study had an IQCODE-score ≤3,125. With an expected response rate of 70%, the data collection period is expected to last five months.

Eligibility Criteria:
Inclusion Criteria:

Patients admitted to the emergency medical and surgery ward and transferred to a geriatric ward at Aarhus University Hospital in the period from the 20th of March to September 2017.

Exclusion Criteria:

* Patients transferred to the geriatric ward in the evening and night as well as weekends and holidays, when there is no Geriatric staff present.
* Patients who upon admission are dying assessed by a geriatrician
* Patients with stroke where aphasia is present
* Patients with severe dementia without language
* Patients who are inability to understand or speak Danish