cyrilzakka/clinical-trials huggingface dataset:
SKAMo-1: Characterization of the Upper Layers of Skin

Diabetes is a frequent disease characterized by chronic hyperglycemia, and its prevalence is increasing worldwide. Historically, patients with diabetes were required to monitor capillary blood glucose concentration up to several times a day through fingertip sampling.

Recently marketed devices now allow measurements of interstitial fluid blood glucose continuously, thus limiting pain associated with sampling. However, they are still invasive and have to be changed every 14 days.

Therefore, to optimize continuous glycemia monitoring while avoiding pain, discomfort, and the risk of infection, non-invasive methods are needed. Among the different strategies being developed, optical wearable sensors with specific signal processing are a promising option. The sensors detecting this optical signal will be included in a device. Yet, wearing a device may slightly modify several properties of the skin, such as its humidity and thermal regulation, and subsequently have an impact on the measured optical signal. Therefore, it is important to better understand how a device affects these characteristics to include these parameters in the future device algorithms.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥ 18 years and ≤ 60 years
* Signed informed consent
* Person who is affiliated to a social security scheme or who is beneficiary of such a scheme

Exclusion Criteria:

* Body mass index (BMI) \> 30 kg/m2
* Any acute or chronic disease with vascular impact
* Any cutaneous disease on sites implicated in the study (dorsum of the forearm)
* Allergy to one of the material used in the sham device and during the procedure of the study
* The persons mentioned in articles L1121-5 to L1121-8 of the public health code may not be included in this research
* Subject who would receive more than 4500 euros in compensation due to his or her participation in other research involving the human person in the 12 months preceding this study
Buddhist Awareness Training Program and Qigong Psychosocial Interventions for People With Insomnia

This study aims to compare the efficacy of the Mahayana Buddhist Awareness Training Program (ATP) with a Qigong group in treating people with insomnia in Hong Kong. It also aims to investigate the underlying mechanisms, including changes in brain activity and heart rate variability during wakefulness, through which these two Eastern mind body interventions improve sleep quality. It is expected that ATP will be as efficacious as Qigong in enhancing sleep quality. Compared to the Qigong intervention, the more mind-based ATP will lead to more improvement in mental health and greater reductions in hyperarousal brain activity. Compared to ATP, the more body-based Qigong will lead to greater improvement in physical health and heart rate variability.


Eligibility Criteria:
Inclusion Criteria:

* (1) being a resident of Hong Kong;
* (2) age between 50 and 75 years old;
* (3) possessing the ability to read and write in Chinese;
* (4) obtaining a Pittsburgh Sleep Quality Index (PSQI) score \> 5 at baseline
* (5) demonstrating willingness to provide informed consent and adherence to study protocol.

Exclusion Criteria:

* (1) Beck Depression Inventory-II suicidal ideation score \>= 2;
* (2) current use of hypnotic medications or any prescription medications that may influence sleep;
* (3) necessity to take such medications during the trial period;
* (4) ongoing therapies or clinical trials for insomnia;
* (5) intention to undergo such clinical interventions during the trial period;
* (6) working in shifts;
* (7) engagement in considerable mindfulness practices exceeding 15 minutes per day;
* (8) regular participation in different forms of Qigong, aerobics, yoga, Tai Chi, or martial arts practice at least once a week in the past six months;
* (9) limited mobility or health conditions that hinder the performance of specific Qigong movements;
* (10) currently receiving psychological, psychiatric or counselling services at least once a month;
* (11) having been diagnosed with schizophrenia or psychosis by a clinician;
* (12) having an active metal implant, pacemaker, or defibrillator in the body that affects objective assessment;
* (13) impaired skin integrity or allergies to electrode gel or adhesive at the wearable EEG device placement site;
* (14) pregnancy
A Study of PF-07260437 in Advanced or Metastatic Solid Tumors

A study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of PF-07260437, a B7-H4 x CD3 bispecific mAb, in participants aged ≥18 years of age with advanced or metastatic breast cancer, ovarian cancer or endometrial cancer. Adult participants with other advanced or metastatic high B7-H4 expressing tumors may be considered after discussion with and approval from sponsor.


Eligibility Criteria:
Inclusion Criteria:

* Part 1: Histological/cytological diagnosis of selected locally advanced or metastatic breast cancer, endometrial cancer and ovarian cancer
* Part 2A:In second line or more, participants with histological/cytological diagnosis of locally advanced or metastatic HR+ HER2- breast cancer showing high B7-H4 expression
* Part 2B: In second line or more participants with histological or cytological diagnosis of locally advance or metastatic HR+ Her2- breast cancer or triple negative breast cancer (TNBC) with no biomarker pre-selection
* Part 2C: In second line or more participants with histological diagnosis of locally advance or metastatic triple negative breast cancer with high B7-H4 expression
* Thyroid function within normal laboratory range; in participants with abnormal thyroid function if Free T4 is normal and participant is clinically euthyroid, participants is eligible

Exclusion Criteria:

* Participants with any active malignancy within 3 years prior to enrollment
* Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including participants with massive uncontrolled effusions \[pleural, pericardial, peritoneal\], pulmonary lymphangitis, and over 50% liver involvement).
* History of Grade ≥3 immune mediated adverse events (including liver function tests that where considered drug related and cytokine release syndrome) that was considered related to prior immune modulatory therapy (eg, immune checkpoint inhibitors, co stimulatory agents, etc.) and required immunosuppressive therapy within 1 year of treatment.
Two Electroacupuncture Waveforms for Different Severity Groups of Bell Palsy

Bell palsy (BP) is the most common cause of acute facial palsy, which leads to functional and esthetic disturbances for patients and results in a lowered quality of life. Electroacupuncture (EA) received attention as an alternative and complementary treatment method. The low-frequency continuous wave EA and the intermittent wave EA have been used in the management of BP. The aim of this study is to compare the efficacy and safety of these two electroacupuncture waveforms for different severity groups of BP.

The investigators will recruit 60 patients with BP whose ENoG test indicate a mild to moderate facial nerve damage, as indicated by the ratio of amplitude of the compound muscle action potential (CMAP) of the affected side comparing to normal side is 20% or higher. And the investigators will recruit 60 patients with BP whose ENoG test indicate a severe damage, as indicated by the ratio of amplitude of the CMAP of the affected side comparing to normal side is less than 20%. Both the two types of patients will be randomly divided into either the low-frequency continuous wave group, or the intermittent wave group, and receive 4 weeks treatment. The primary outcomes is change from baseline score of the Facial Nerve Grading System 2.0. The secondary outcomes are change from baseline score of the Sunnybrook grading scale, and change from baseline value of the amplitude of the CMAP of the affected side in the ENoG test.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as BP by specialist.
2. The score of FNGS 2.0 ≥ 15 at the day 21 since the onset of BP.
3. 18 years ≤ age ≤ 65 years.
4. Received prednisolone within 72 hours since initial symptoms of BP, the prednisolone dose used was 60 mg per day for 5 days and then reduced by 10 mg per day.
5. Signed informed consent and volunteered to participate in this study.

Exclusion Criteria:

1. Facial palsy caused by other diseases or injury.
2. Ramsey-Hunt syndrome.
3. Bilateral facial palsy.
4. History of previous facial palsy.
5. Manifesting facial spasm, facial synkinesis or contracture at day 21 since the onset of BP.
6. History of surgery on face.
7. Combined with uncontrolled diabetes mellitus, uncontrolled hypertension, serious heart, liver, kidney damage or cognitive impairment, aphasia, mental disorders.
8. Installing pacemakers.
9. Pregnant and lactating patients.
Cast vs. Splints for Minimally Displaced Distal Radius Fractures in the Elderly

The purpose of this prospective randomized study is to add to the body of knowledge on the treatment of minimally displaced distal radius fractures in patients over 60 years of age. The investigators believe that treating minimally displaced distal radius fractures in people over 60 with a removable splint and early range of motion will provide greater patient satisfaction, fewer complications, and earlier functional returns to pre-injury for these patients compared to those treated with a short arm cast which immobilizes the limb for at least four weeks, and has been shown to lead to longer recovery and possible residual stiffness. The investigators hope to provide sufficient evidence in directing treatment that will give the most efficacious and the most satisfactory return of prior function to patients. Since distal radius fractures in the elderly are common because of poorer bone quality, the elderly proportion of the population is increasing, and controlling health costs is of current concern, answering the question of which treatment produces the best results for all these concerns is of increasing importance now.


Eligibility Criteria:
Inclusion Criteria:

1. Colles' Fracture - Distal radius fracture with dorsal angulation, apex volar (satisfies non-operative radiographic criteria before or after reduction
2. Isolated upper limb injury
3. No previous wrist fracture
4. Available for follow-up
5. Between 60 and 100 years of age

Exclusion Criteria:

1. Less than 60 years of age
2. Fractures that do not meet non-operative criteria or are deemed unstable by surgeon, subsequently requiring surgery after first clinic visit.
The Effect of Subcutaneous Infusions of 3 Doses of DG3173 on Growth Hormone Levels in Untreated Acromegalics

This study is designed to assess the effect of the different continuous s.c. infusion treatments on the human growth hormone (hGH) levels in untreated acromegalic patients in comparison to a standard dose of octreotide. In addition, the pharmacokinetic profile and the safety and tolerability of DG3173 after continuous s.c. infusion will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Men, women of non child-bearing potential, or women of child-bearing potential who either abstain from sexual intercourse, have a sterile partner or practice two medically approved, non-hormonal methods of contraception
* Diagnosis of acromegaly of pituitary origin
* Have an age-adjusted insulin-like growth factor type 1 (IGF-1) concentration ≥1.2 times the upper limit of normal range on at least one measurement in the 12 months prior to screening (Visit 1) AND a second raised value screening
* Have at least one random hGH level of ≥5 μg/L in the 12 months prior to screening AND a second raised value at screening
* Have given written informed consent
* Ability to comply with the requirements of the protocol for the study

Exclusion Criteria:

* Previous specific treatment for acromegaly in the 12 months prior to screening, including somatostatin analogues (SSAs); surgery; radiotherapy and pegvisomant
* Treatment with dopamine agonists in the 3 months prior to screening
* Uncontrolled hypertension
* Type I diabetes mellitus, poorly-controlled type II diabetes mellitus (glycosylated haemoglobin \[HbA1c\] ≥7.5%) and patients requiring insulin treatment
* Gallstones or gravel that could cause biliary obstruction
* Hyperprolactinaemia
* Participation in a clinical study within 60 days prior to screening
* Receipt of blood, blood products or plasma derivatives 60 days prior to screening
* Body mass index (BMI) below 22 or above 37 kg/m2
* Pregnancy, lactation or use of any hormonal based contraceptives
* Concomitant intake of corticosteroids or levodopa
* A history of active alcohol abuse or drug addiction
* Positive viral serology screening result for hepatitis B surface antigen, antibodies to hepatitis C virus, or human immunodeficiency virus type 1 and 2
* Evidence or suspicion of tumour expansion
* Clinically significant abnormality in screening ECG in the opinion of the Investigator
* Any clinically significant abnormal in screening laboratory safety test (biochemistry, haematology and dipstick urinalysis) in the opinion of the Investigator
* Any disease which in the Investigator's opinion would exclude the patient from the study
Safety and Efficacy of Autologous Umbilical Cord Blood Mononuclear Cells Transfusion in Neonates

To study the safety and efficacy of Autologous Umbilical Cord Blood Mononuclear Cells transfusion on clinical outcome in preterm infants

This is a Phase 1 clinical trial that constitutes two time points cohorts with 100 participants per cohort who will receive intravenous doses of Autologous Umbilical Cord Blood Mononuclear Cells --25 million cells/kg, 48 hours after birth. And the placebo will be 0.9% sodium chloride.The investigator will proceed the groups during the same period.

1. Demographic Data and Baseline Characteristics of the Studied Groups were collected:

   * Gestational age (weeks)
   * Birth weight (g)
   * gender
   * Cesarean section delivery
   * Antenatal steroids
   * Prolonged rupture of membrane
   * Multiple pregnancies
   * APGAR score at 5 minutes
   * Thrombocytopenia before intervention
   * CRP before intervention (mg/L)
   * TNF-α(tumor necrosis factor α ) before intervention (pg/mL)
2. Assessment of clinical condition in the course by measurement of arterial blood pressure, heart and respiratory rates and skin temperature was recorded continuously
3. Autologous cord blood mononuclear cells doses is 25 million cells/kg ，the infusion speed is 4ml/kg/h， 8-12h，and with same volume of 0.9% sodium chloride as placebo.
4. The following are monitored at 3、7、14、21 days after birth:

   * mortality, incidence of sepsis, neonatal respiratory distress syndrome (NRDS), bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), necrotising enterocolitis (NEC), intraventricular haemorrhage (IVH), Hypoxic Ischemic Encephalopathy (HIE), anaemia, thrombocytopenia, neutrophil,TBNK cells subgroup, before hospital discharge.
5. Long-term follow up: in 1m, 3m, 6m,1y: neurodevelopment \[Bayley Scales of Infant\], asthma, anemia and physique growth.

Eligibility Criteria:
Inclusion Criteria:

* Twenty-eight weeks to thirty-seven weeks

Exclusion Criteria:

* Preterm infants with major congenital malformations, chromosomal anomalies, inborn errors of metabolism and clinical or laboratory evidence of a congenital infection
Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding

Problematic uterine bleeding after the insertion of the LNG IUS is a well documented side effect. The levonorgestrel intrauterine system (LNG IUS) was approved for treatment of heavy menstrual bleeding (HMB) by the FDA in October 2009. To reduce the incidence and severity of post-insertional uterine bleeding, pretreatment with norethindrone acetate may effectively slough the endometrium prior to insertion of the LNG IUS.

This study will examine whether or not pretreatment with oral norethindrone acetate prior to the insertion of a hormonal intrauterine device will affect post-insertional uterine bleeding. The subjects enrolling in the study will have documented heavy menstrual bleeding (HMB) and desire the levonorgestrel intrauterine system (LNG IUS) (Mirena®, Bayer, Inc. Pittsburgh, PA) for symptomatic relief. HMB for this study is defined as heavy bleeding at regular intervals at least 20-40 days apart. Subjects will be randomized to one of two groups. One group will receive norethindrone acetate for two consecutive months prior to LNG IUS insertion while the other group will proceed with direct insertion of the LNG IUS with no hormonal pre-treatment. Subjects will be followed for a period of 180 days post LNG IUS insertion. Bleeding patterns will be recorded daily.

Eligibility Criteria:
Inclusion Criteria:

* You must be between 18-45 years old
* You have Heavy Periods

Exclusion Criteria:

* You are pregnant
* You are currently using hormonal contraception or hormonal therapy
* You have a history of pelvic inflammatory disease (and have not had a normal pregnancy since)
* You had an infected abortion within the last three months
* You have abnormal or cancerous cells of the cervix or uterus
* You have an actine infection in your genital organs
* Known or suspected breast cancer
* Active liver disease or tumors
* Allergy to levonorgestrel or norethindrone
* You currently have deep vein thrombosis, pulmonary embolism, or history of these conditions
* you currently have active or recent (within the past year) arterial thromboembolic disease (such as a stroke or myocardial infarction) these conditions
Primary Prevention ICD French Registry

The indication of implantable cardioverter defibrillator (ICD) therapy for primary prevention of sudden cardiac death has been introduced later in France than in other parts of the World. Overall, we aimed to assess the risk-benefit ratio of this strategy over a 10 year period.


Eligibility Criteria:
Inclusion Criteria:

* Coronary artery disease or dilated cardiomyopathy with low ejection fraction implanted with an ICD in the setting of primary prevention (criteria at the discretion of the physician)

Exclusion Criteria:

* Setting of secondary prevention
* Other cardiopathies such as congenital, channelopathies, valvulopathies
4D-CT-based Ventilation Imaging for Adaptive Functional Guidance in Radiotherapy

To develop and investigate a novel radiotherapy technique for preserving lung function based on a map of lung function.


Eligibility Criteria:
Inclusion Criteria:

* Eligible disease(s)/stage(s) AJCC Stage I, II, III or IV lung cancer of any histology to be treated using radiotherapy will be eligible for this study. Note that we will carefully consider the inclusion of cases with turbulent flow or greater flow velocities (Cabahug et al., 1996; Crawford et al., 1990) and COPD cases (Magnant et al., 2006) due to the impaction of aerosol particles in central airways.
* Allowable type and amount of prior therapy. Any types and amounts of prior therapy will be allowed for this study.
* Age restriction and/or gender/ethnic restrictions
* Patients must be greater than or equal to 18 years of age.
* There are no gender or ethnic restrictions.
* Life expectancy restrictions - None.
* ECOG or Karnofsky Performance Status
* Not employed. Note that patients will need to be sufficiently healthy to undergo audiovisual (AV) biofeedback to generate high quality 4D-CT images.
* Requirements for organ and marrow function None.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Children (less than 18 years of age), pregnant women, Stanford employees or students, or prisoners will be excluded from this study.
Lupus and Observance

A poor therapeutic observance is described between 3 and 76% cases in systemic lupus. It is associated with an increased risk of relapses, hospitalizations, morbidity and poor renal prognosis.

New treatment protocols exist and are indicated in second intention in case of good compliance. An assessment of therapeutic adherence is therefore essential.

Patients with systemic lupus diagnosed for at least 6 months, or skin lupus, who have been prescribed with Plaquenil (hydroxychloroquine), will be included in the study.

The study primary objective is to determine risk factors for non-observance

The secondary objectives are to:

* Measure the observance rate of patients with systemic lupus in Martinique.
* Describe the parameters that influence observance: evaluation of the disease and associated comorbidities, psychosocial assessment, assessment of the doctor-patient relationship, evaluation of the disease representations.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Systemic lupus defined according to the diagnostic criteria of the American College of Rheumatology " 1997, diagnosed for at least 6 months; Or Skin Lupus
3. Consultation or hospitalization at the University Hospital of Martinique, in either services of Internal Medicine, Rheumatology or Dermatology.
4. Prescription of hydroxychloroquine (Plaquenil®) for at least 6 months
5. Affiliate or beneficiary of a social security scheme.
6. Patient not opposed to participate in the study

Exclusion Criteria:

1. Age \<18 years or patient under guardianship
2. Patient not speaking and / or not understanding French
3. No prescription and/or contraindication to hydroxychloroquine
4. Systemic lupus outbreak with neurological impairment defined by SLEDAI score by a psychosis (disruption of normal activity in relation to a severe alteration of the perception of reality. Includes: hallucinations, incoherence, impoverishment of the content of thought, illogical reasoning, bizarre behavior, disorganized or catatonic) or brain damage (with impairment of mental functions with impaired orientation, memory or other brutal appearance and fluctuating evolution).
5. History of psychiatric disorders: personality disorders, psychoses, severe depression
6. Hospitalization with a life-threatening clinical condition that does not allow to answer questions
7. Non affiliated patient or beneficiary of a social security scheme.
8. Patient refusing to participate in the study
Daily Vinegar Ingestion and Metabolic Health

The purpose of this study is to determine if vinegar ingestion promotes beneficial changes to metabolic health parameters in healthy, overweight adults.

Recent research, in animal and human subjects, suggests that vinegar intake is inversely associated with insulin resistance, mood states and depression, inflammation, and other disease parameters. The study will be conducted as a randomized controlled trial in overweight adults to further examine these relationships and possible mechanisms. Although the mechanisms are not known, research suggests that changes in the gut microbiome, a response to the ingestion of the postbiotic acetic acid, may factor into the beneficial effects of vinegar ingestion. Through analyses of blood, changes in key blood metabolites associated with mood states (e.g., gamma-aminobutyric acid) as well as markers of gut health (e.g., LPS binding protein) and inflammation (e.g., CRP) will be assessed. Additionally mood state will be assessed using validated measures and determine risk for metabolic syndrome, a cluster of risk factors associated with many chronic conditions. It is hypothesized that vinegar ingestion will promote beneficial changes to these health parameters.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* non-smoker
* free of chronic disease by self-report
* able to speak, read, and understand English
* able to consent.
* BMI ≥ 25 and ≤ 35

Exclusion Criteria:

* adherence to specific diets for weight loss
* vegetarian
* report GERD or regular heartburn
* unwilling to consume vinegar daily for 4 weeks
* pregnant or lactating women
* recreational drug use, alcohol intake above recommendations (1 drink/day for women, 2 drinks/day for men - or none)
* competitive level physical training (e.g., physical activity above recommendations as set by the Physical Activity Guidelines for Americans)
* scoring 1 or higher on question 9 of the PHQ-9 questionnaire.