cyrilzakka/clinical-trials huggingface dataset:
A Cohort Study of Operationally Tolerant Allograft Recipients

Antirejection medicines, also known as immunosuppressive drugs, are prescribed to organ transplant recipients to prevent their bodies from rejecting the new organ. Some organ transplant recipients can stop taking anti-rejection medicines without rejecting their transplanted organ (this is called 'tolerance'). The purpose of this study will collect samples and data from 'tolerant' liver or kidney transplant recipients in order to find out:

The purpose of this study is to collect samples and data in order to find out:

* How long liver or kidney transplant recipients can remain tolerant;
* What happens in the tolerant recipient's body over time; and
* If there are patterns in the body that are linked to tolerance.

This is a multi-center, prospective, observational study in which operationally tolerant recipients of liver or kidney allografts will be followed longitudinally, with annual collections of clinical data and biological samples. All participants will be followed for the duration of the study, regardless of changes in their tolerance status.

Participants will be recruited by three main pathways:

1. Tolerant participants from current and past Immune Tolerance Network (ITN) trials, including those who have already completed trial participation and those who are anticipated to complete trial participation,
2. Tolerant participants referred by ITN affiliated investigators, academic and community transplant physicians and directly through outreach to transplant affinity groups such as the National Kidney Foundation (NKF), and
3. Tolerant participants from the general transplant community who are reachable through general contact channels such as the ITN website, word-of-mouth referrals from existing participants, and social media.

Eligibility Criteria:
Inclusion Criteria:

* Recipient of single organ liver or kidney allograft from a living or deceased donor;
* At screening, operationally tolerant, as defined by:

  * Absence of any immunosuppressive therapy for ≥52 weeks prior to the screening visit, and
  * No evidence of allograft rejection in the 52 weeks prior to the screening visit, based on the allograft recipient's medical history.
* Normal allograft function, defined as:

  * For liver transplant recipients: Liver function tests (ALT, GGT) both less than or equal to the upper limit of normal (ULN); and,
  * For kidney transplant recipients: Serum creatinine value corresponds to an estimated GFR \> 45 ml/min/1.73 m\^2.
* Receiving regular follow-up for a kidney or liver transplant by a local physician:

  --Participants must be willing to allow the study team to contact and share medical information with this local physician.
* Ability to sign informed consent.

Exclusion Criteria:

* Current malignancy requiring recent surgery, ongoing chemotherapy, or radiation;
* Transplant of another organ;
* Current drug or alcohol dependency;
* Any medical condition that in the opinion of the principal investigator would interfere with safe completion of the trial; and
* Inability to comply with the study visit schedule and required assessments.
Neuroprotection by Magnesium Sulfate Given to Women at Risk of Very Preterm Birth

Magnesium is neuroprotective in neonatal animal models of acquired hypoxic-ischemic and/or inflammatory cerebral lesions. It is associated with a significant reduction of perinatal death and cerebral palsy in some observational studies.

The objective of the study is to assess if prenatal magnesium sulfate given to women at risk of preterm birth before 33 week's gestation is neuroprotective.

This is a randomized controlled trial at 18 french tertiary hospitals with stratification by center and multiple births in women at risk of preterm birth before 33 week's gestation and without vascular disease of pregnancy.

Women received 4 g of a 0.1 g/ml magnesium sulfate solution or isotonic serum chloride solution (0.9%).

The main outcome measures are rates of mortality up to discharge, of severe white matter injury (defined by the presence of cavitations and/or intraparenchymal haemorrhages on cranial ultrasonographic studies) and of combined death and severe white matter injury.

The secondary outcome measures are rates of white matter injury (defined by the presence of cavitations and/or intraparenchymal haemorrhages and persisting hypechogenicities at 15 day intervals on cranial ultrasonographic studies), follow-up at two years of age

Eligibility Criteria:
Inclusion Criteria:

* women pregnant with single, twin or triplet very preterm fetuses younger than 33 week's gestational age if birth was expected or planned within 24 hours

Exclusion Criteria:

* women with vascular disease of pregnancy
* women with severe malformation or chromosomal abnormalities in the fetus
* women with hypotension
* renal insufficiency
* cardiac rhythmic abnormalities
* intake of calcium channel inhibitors
* digitalis or indomethacin less than 24 hours
* persistence of signs of cardiovascular toxicity or tachycardia for more than one hour after cessation of betamimetic intake
* myasthenia
* emergency C section
Influence of Stretching on Muscle Performance

The stretching is performed within sports to improve muscle performance and prevent muscle injury. However, recent studies are contradictory with common practice. Then raised the possibility that stretching before physical activity performed can decrease the muscle performance of healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 30 years.
* History of at least 3 months without performing any physical activity

Exclusion Criteria:

* Recent history of injuries in lower limbs.
* Contraindication to agree with the Par-Q form.
* Make physical activity during the search
* Fails every session of stretching
* BMI above 28
* Pain in the lumbar spine
* I had muscle shortening in Test Thomas (TT) and / or test the popliteal angle (TAP)
Participatory Research to Advance Colon Cancer Prevention

The overall goal of this study is to test strategies to raise rates of colorectal cancer screening among the Latino population in a federally qualified health center that operates multiple clinics. This intervention study will test automated and live prompts to a direct-mail fecal testing program in two phases.

In Phase I (Years 01 - 02), the investigators will tailor and define intervention components using a community-based participatory research approach called boot camp translation (BCT). The ultimate design of the intervention will be defined by patient and provider feedback from BCT. The investigators will then conduct a three-arm patient-randomized comparative effectiveness trial in two pilot clinics to compare 1) automated prompts (i.e., automated phone calls, text messages) to alert and remind patients to complete screening, 2) live prompts (i.e., live phone calls), and 3) a combination approach of automated plus live prompts.

In Phase II (Years 03 - 05), the investigators will spread and test the spread of the adapted intervention to additional clinics within the partnering health center using a two-arm main trial.

Both phases will be guided by an advisory group of clinicians, researchers, policy makers, and patients.

The study will fulfill the following aims:

Aim 1: Develop personalized messages (e.g., phone scripts, text messages, patient portal prompts) and define an intervention using boot camp translation to increase colon cancer screening among Latino populations.

Aim 2: Assess the reach, effectiveness, and differences by subgroup (e.g., preferred language) of a three-arm colorectal cancer screening program among Latino FQHC patients, in 2 clinics, through a patient randomized-controlled trial.

In addition to Usual Care, the arms are:

* Automated Prompts-an automated data-driven program for delivering FIT kit prompts (using automated phone calls, text messages, and/or emails) to patients due for colorectal cancer screening.
* Automated Plus Live Prompts-a higher-intensity program using automated, data-driven strategies for delivering FIT kit prompts plus linguistically and culturally tailored live prompts.

Aim 3: Test the spread of the program across additional clinics using a two-arm randomized approach and develop an implementation guide that includes outreach materials, strategies for incorporating patient input, and resources.

Eligibility Criteria:
Inclusion Criteria:

* Persons aged 50-75 years and not up-to-date with colorectal cancer screening

Exclusion Criteria:

* Persons having colorectal disease (e.g., ulcerative colitis or colectomy), personal history of colorectal cancer or colorectal disease, end-stage or life threatening diseases or, those known to be under hospice care or living in a skilled nursing facility may be excluded.
TOADS Study: TO Assess Death From Septic Shock.

The aim of this study is to assess the causes of death in patients with septic shock in French intensive care units. It is an epidemiologic and descriptive study .

The purpose of this epidemiologic study is to describe with accuracy the reasons and causes of death in patients with septic shock during patients stay in intensive care units. All deceased patients with primary diagnosis of septic shock will be included in this survey and patients baseline characteristics as well as the clinical and data at the time of patient's death will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Died of septic shock in the intensive care unit (ICU)
* At least 6 hours of vasopressors

Exclusion Criteria:

* Legally protected adult patient.
* Less than 6 hours of vasopressors
* Opposition to participation in the study expressed by the patient, family or person of trust
A Study to Look at How Safe Insulin NNC0471-0119 is and How it Works in People With Type 1 Diabetes Mellitus

This study is looking at the safety of the new medicine, insulin NNC0471-0119, its concentrations in the blood and effect on blood sugar for the treatment of type 1 diabetes. Insulin NNC0471-0119 will be compared to faster aspart. The purpose of this study is to test how insulin NNC0471-0119 is tolerated by participants body, how it is transported in participants bloodstream, how long it stays there and how the blood sugar is lowered compared to faster aspart. Participants will get either the new insulin NNC0471-0119 or faster aspart-which treatment participants get is decided by chance. It is the first time insulin NNC0471-0119 is tested in people. Faster aspart is a globally used medication for treatment of diabetes mellitus. Participants will get one single injection in a fasting state which will take place at the study site. The medicine will be injected under the skin in the stomach. The study will last for about 13-53 days, depending on individual visit schedule. Participants will have four clinic visits with the study doctor, one of which will require an in-house visit period of 3 days. During the in-house visit, two intravenous cannulas will be inserted for sampling of blood and infusion of insulin. Participants cannot be in the study if the study doctor thinks that there are risks to their health. Women: Women cannot take part if they are of childbearing potential.


Eligibility Criteria:
Inclusion Criteria:

* Male subject or female subject of non-childbearing potential. Non-childbearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
* Aged 18-55 years (both inclusive) at the time of signing informed consent.
* Diagnosed with Type 1 Diabetes Mellitus (T1DM) greater than or equal to 1 year prior to the day of screening.
* Current total daily bolus insulin treatment less than 0.7(I)U/kg/day.

Exclusion Criteria:

* Known or suspected hypersensitivity to investigational medicinal products (IMPs) or related products.
* Participation in any clinical trial of an approved or non-approved IMP within 90 days before screening.
Brief Intervention for ICU Patients with Alcohol Use Disorders

Patients non-electively admitted to intensive care units (ICUs) will be screened for eligibility. The investigators will include adult patients with risk level alcohol use, defined by AUDIT-C score (\>5 for females, \>6 for males). Informed consent will be obtained from the patient in the end or shortly after the ICU treatment, when they have regained sufficient cognitive function. 600 patients will be randomized to receive either routine treatment or a brief intervention (BI). The BI includes a 20 minute discussion with pre-educated study personnel, option to discussion with a social worker and written material. Primary outcome measure is the amount of alcohol used during the preceding week (g/week), at 6 and 12 months after study entry. The information will be obtained 1)in an interview by a study team member blinded for the intervention arm at 6 months 2) A letter of a telephone interview at 12 months. AUDIT score, EQ-5D and mortality will also be recorded.

An interim analysis by an external reviewer will be performed after the primary outcome has been recorded for 200 patients,


Eligibility Criteria:
Inclusion Criteria:

* AUDIT-C score \>5 (women) and \>6 (men)
* Non-elective admission to the ICU

Exclusion Criteria:

* Terminal illness (expected to survive less than 6 months), palliative care
* Diagnosed severe mental illness (psychos, severe depression, bipolar disorder, personality disorder)
* Cognitive disability
* Diagnosed dementia
* Impaired level of consciousness at discharge from the ICU (expected to remain unchanged \>2 days
* Other substance abuse (excluding cigarette smoking)
* Ongoing treatment for alcohol dependency
* Insufficient language skills (finnish/swedish)
* Expected difficulty in getting contacted by mail or telephone (no permanent address or telephone in use)
Platelet Rich Plasma (PRP) as a Treatment for ACHILLES Tendon Tears

To review the influence of patient derived PRGF on the healing process of Achilles tendon after a surgical correction of a complete tear.

Autologous platelet-rich matrices may aid in post surgical patients by promoting and accelerating tissue healing because of the release of growth factors including transforming growth factor (TGF)-beta1 and platelet-derived growth factor (PDGF) from platelet alpha-granules.

Eligibility Criteria:
Inclusion Criteria:

* A complete tear of Achilles tendon
* Age 18-50 years old

Exclusion Criteria:

* under 18 year of age
* pregnancy
* physical or mental disabilities
Efficacy of Oral AB1010 in Adult Patients With Severe Persistent Corticosteroid Dependent Asthma

The aim of the study is to evaluate, comparatively to a placebo, the activity of oral AB1010, administered at three dose levels during 4 months to patients with severe persistent corticosteroid dependent asthma, assessed on :

* the decrease in corticosteroid therapy
* the asthma control improvement (symptomatic scores, rescue medication intake, respiratory function)
* the pharmacokinetic profile of AB1010
* clinical and biological safety parameters

This is a double-blind, placebo-controlled, randomized, parallel-groups, multicenter study of daily oral AB1010 at doses 3, 4.5 and 6 mg/kg/day.

The study treatment is administered for 16 weeks:

* the first 4 weeks are a run-in period during which corticosteroids remain stable;
* during the following 8 weeks, corticosteroids are decreased every week until weaning or an exacerbation occurs;
* the last 4 weeks are a stabilization period. Patients have to perform a visit every 2 weeks during run-in, then every week for the following 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Known severe persistent corticosteroid dependent asthma (WHO/NHLBI workshop definition).
* Disease duration \> 1 year.
* Stable disease with no exacerbation episode for at least one month before inclusion.
* Daily treated with 10 to 50 mg of equivalent prednisolone, with stable dosage since at least 3 months.
* Known reversibility of bronchial obstruction, defined as an enhancement of FEV1 ≥ 12%, 10 minutes after salbutamol administration, or 14 days after systemic treatment with 1 mg/kg/day of equivalent prednisolone.

Exclusion Criteria:

* Asthmatic patients still exposed to allergens or to triggering factors influencing asthma control.
* History of infection requiring hospitalization or treatment with antibiotics within 2 weeks of screening.
Effective Volemia in Older Adults With Orthostatic Hypotension

Clinical and biological assessments of volemia are challenging in older patients as they are more likely to present non-typical signs. Point of care ultrasonography (POCUS) using heart and lung exploration is a relevant tool to assess volemia in adults with little data in older adults.

The primary objective of the study is to evaluate feasibility of positional POCUS in aging patients.

The secondary objectives are to assess the variability of measurements between decubitus and sitting position.

This is a monocentric study. Twenty patients will be enrolled, aged of 70 years and older. POCUS parameters, duration of procedure and measurements will be recorded for each patients.

Eligibility Criteria:
Inclusion Criteria:

* 70 years and older
* Orthostatic hypotension or venous insufficiency
* Affiliated to a social security or beneficiary

Exclusion Criteria:

* Refusal to participation to the study
* Cognitive disorder
* Unable to keep sitting posture for up to 30 minutes
* Foreign patients under french AME scheme
Efficacy Evaluation of Avance QQ Collagen for Skin Beautification

To assess Avance QQ Collagen product on skin condition improvement


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female adults, age above 18 years old;
* The grade of crow's feet above 2 (Han et al. Sci Rep 13, 18903 (2023));
* Commitment not to use products having activity comparable with that of the product to be tested during the study period;
* Free of any dermatological or systemic disorder that would interfere with results.

Exclusion Criteria:

* Subject with obvious skin surface damage;
* Subject who had oral or topical medication which may affect skin condition within 1 month;
* Subject who is a vegetarian or likely to be acutely allergic to the listed ingredients in the product;
* Female who is pregnant, nursing or planning to become pregnant during the course of the study;
* Received facial laser therapy, chemical peeling in the past 2 months.
The Novel Electrolyzed Water Spray Treatment Mild Periodontitis

The purpose of this study is to test whether spraying the tooth of patients by use of the novel electrolyzed water spray will produce improvement in the condition of mild periodontitis.

In this study, water inculding tap water,pure water and salt water, and an apparatus for producing electrolyzed water (https://www.deposon.com.cn; https://www.deposon.com）were used to generate an electrolyzed water mist spray or spray. This instantly generated electrolyzed water mist spray or spray has oxidation-reduction potential (ORP) ≥1200mv,and contains non-specific total oxidation capacity which equals to 0.28±0.10ppm,0.06±0.04ppm and 3.92±0.39ppm of desolved ozone. This instantly generated electrolyzed water mist spray or spray does not release detectable ≥0.1mg/m3 of gaseous ozone. This instantly generated electrolyzed water mist spray or spray has pH 8.4±0.4 and releases negative air ion.The apparatus for producing electrolyzed water has a positive electrode which is covered by a conductive diamond material (Patent# CN215308550U). This is an open-label, single-arm, and before and after treatment comparison study. This study uses this novel electrolyzed water device and the water spray to treat mild periodontitis.

Eligibility Criteria:
Inclusion Criteria:

* mild periodontitis accompanied by gingival discomfort.
* Patient \> 18 years old.
* Systemically healthy individuals

Exclusion Criteria:

* severe periodontitis.
* 80 years or older.
* Patients who take Anticoagulants or Antiplatelet Agents
* Pregnant or breastfeeding women
Photodynamic Therapy for Benign Dermal Neurofibromas- Phase II

The investigators wish to determine the time to disease progression for benign neurofibromas treated with Levulan Kerastick topical photosensitizer and red light photodynamic therapy (PDT) in patients with neurofibromatosis type 1 (NF1).

The investigators also wish to measure tumor size for control and treatment tumors in order to gain insights into tumor growth rates.

Neurofibromas contain a large quantity of fibrous matter, and it is not anticipated that significant reductions in tumor size can be achieved in large, long established, tumors. Cutaneous neurofibromas, which do not usually become apparent until puberty, continue to increase in size and number throughout adulthood. The psychosocial burden of these disfiguring tumors is significant, and the targeted age group (14-30) is at a life period associated with an acceleration in tumor growth. It is for these reasons that the investigators hope to affect the growth rate of less established tumors, in order to prevent or lessen this burden as the patient progresses further into adulthood.

Therefore, the investigators wish to determine the time to disease progression (defined as 50% growth in size over baseline) for benign neurofibromas treated with PDT in patients with neurofibromatosis type 1 (NF1) in subjects aged 14-30.

The treatment will consist of choosing several neurofibromas of similar size, and applying a topical drug called Levulan, or just the topical application alone (a placebo). Within 24 hours of drug treatment, the neurofibromas will be illuminated with red light (both Levulan and placebo). The Levulan is what is known as a photosensitizer, and will be activated by the red light to potentially kill some of the tumor cells. Approximately every 6 months after, for three years, the tumors will be measured by digital photography and ultrasound to see if they are growing more slowly than the ones with the placebo application alone.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is 14 years or older.
2. Diagnosed NF1, determined by American Academy of Neurology Guidelines (see Diagnosis section).
3. Tumor Location: cutaneous, trunk, or limbs only.
4. Tumor Type: superficial dermal neurofibromas ≤4mm deep.
5. Patient has provided written informed consent.
6. Patient is willing to and can comply with study follow-up requirements.
7. Absence of any other malignancy.

Exclusion Criteria:

1. Life expectancy less than 3 years.
2. Pregnancy.
3. Cutaneous photosensitivity to the wavelengths used to active PDT.
4. A diagnosis of porphyria.
5. Allergy to aminolevulinic acid or any of the topical solution vehicle components.
6. Previous chemotherapy within 6 weeks of proposed PDT.
7. Other concurrent tumor therapy.
Hemodynamic Performance in Stentless Heart Valves

Hypothesis: Stentless bioprostheses will perform superior to stented bioprostheses in different hemodynamic and biomechanical parameters.

The study will investigate turbulence, flow and aortic root movement in a stentless bioprosthesis and compare it to a stented bioprosthesis.


Eligibility Criteria:
Inclusion Criteria:

* Over 65 years old
* Submitted for aortic valve surgery
* No coronary surgery other than LIMA to LAD

Exclusion Criteria:

* Stentless valve implantation not possible
* Contraindications for MRI scan