cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a PREHABilitation Protocol Using Adapted Physical Activity (APA) for Multiple Myeloma Patients Eligible for Intensive Autologous Stem Cell Transplantation Treatment

Adapted physical activity for patients with haematological malignancies generally has positive effects on quality of life, fatigue and physical condition. However, some studies show little or no effect.

This may be explained by inefficient protocols, but also by low rates of patient acceptability regarding the proposed exercises.

The multiplicity of APA protocols and the fluctuation of their results mean that validity, methodology and effects on patients need to be verified before they can be considered for implementation in healthcare services. A program must prove its feasibility, but patients must also adhere to it.

Acceptability can be measured by adherence, which represents the number of validated sessions in relation to the number of planned sessions, and by attrition, which corresponds to the number of stops or drop-outs for any reason. The various APA programs offered in the context of intensive auto or allograft treatment are limited, notably by adherence, which can fall by as much as 24%, and attrition, which can be as high as 67%. Optimization of the proposed exercises and follow-up methods is therefore necessary in order to propose an APA program that will be feasible, effective and acceptable to a maximum number of patients.

To meet these objectives for patients with multiple myeloma eligible for autologous stem cell transplantation, the protocol for this study took into consideration the various recommendations of previous publications and the guidelines from HAS (French National Authority for Health).

The ultimate goal of this study is to validate, in terms of effectiveness and acceptability, the methodology and in particular the use of new specific tools for optimizing an APA program. It will subsequently be offered to all patients with multiple myeloma eligible for autologous stem cell transplantation, independently of their age or physical condition, while respecting their rhythm and physical condition.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old.
* CML patient in chronic phase, eligible for oral therapy.
* Diagnosis of multiple myeloma.
* Patient eligible for autologous stem cell transplantation.
* Patient capable to read, understand and complete a questionnaire in french.
* WHO less than or equal to 2.
* Patient affiliated with french social security.
* Patient with a medical prescription for APA.

Exclusion Criteria:

* Patient with previous cancer within the previous 3 years (except basal cell and squamous cell skin cancers, carcinomas in situ of any type that have been previously resected, and stable prostate or breast cancers more than 3 years old and undergoing adjuvant hormone therapy).
* Medical contraindications to APA (heart failure, angina, unbalanced hypertension, bone metastases, severe osteoporosis, etc.)
* Sensory or motor neuropathy.
* Patient deprived of liberty, under guardianship or curatorship.
* Patient considered socially or psychologically unfit to be enrolled in a study.
D-Cycloserine Augmentation of Behavior Therapy for Individuals With Body Dysmorphic Disorder

The purpose of the study is to conduct a double-blind, placebo-controlled study of D-cycloserine (DCS) augmentation of behavior therapy in individuals with Body Dysmorphic Disorder (BDD). Specifically, we intend to randomize 50 individuals with BDD to receive either DCS (n = 25) or placebo (n = 25) one hour prior to 8 of 10 behavior therapy sessions.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Primary diagnosis of Body Dysmorphic Disorder as determined by DSM-IV criteria
* BDD Yale-Brown Obsessive Compulsive Scale score greater than or equal to 24
* Females of childbearing potential must have a negative urinary beta-HCG test
* Subjects currently taking psychotropic medication must be on a stable does for at least two months prior to initiating study procedures

Exclusion Criteria:

* Pregnant or breastfeeding women will be excluded
* People taking medications that may interfere with DCS
* History of seizure disorder or other serious medical illnesses such as cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
* Comorbid psychiatric diagnoses (alcohol dependence, bipolar disorder, psychosis, borderline personality disorder, organic mental disorder, or development disorder). If subjects have any other comorbid disorder, the BDD symptoms have to be the primary concern.
* Persons taking medications that may lower seizure threshold, including clozapine, pethidine, and the following antibiotics in high dosage: penicillins, cephalosporins, amphotericin, and imipenem
* Those deemed to pose a serious suicidal or homicidal threat will be excluded
* Current psychotherapy or failure to benefit from ten or more sessions of previous ERP treatment is a rule-out
Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream

An open-label study to evaluate the safety and the ability of Imiquimod 5% cream, applied topically, to clear superficial basal cell carcinoma and to keep it clear for 5 years of follow-up.

Evaluate the long-term sustained clearance rate, defined as the proportion of those subjects clinically clear of basal cell carcinoma (BCC) at the treated superficial BCC (sBCC) target tumor site at the 12-week posttreatment visit who remain clear during a 5 year follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Have at least 1 previously untreated superficial basal cell carcinoma tumor
* Minimum tumor size 0.5 cm2 and maximum diameter of 2.0 cm

Exclusion Criteria:

* Evidence of clinically significant, unstable medical conditions
* Cannot have recent use of topical steroids or retinoids in the treatment area.
Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis

End-stage renal disease (ESRD) is a condition in which the filtration function of the kidneys has deteriorated, necessitating dialysis or transplantation. With an aging population, the number of patients undergoing dialysis for CKD is constantly increasing.

There are different types of dialysis treatment: hemodialysis and peritoneal dialysis.

Hemodialysis involves exchanges between blood and a dialysate (a liquid used to purify blood) via a dialyzer (artificial filter), coordinated by a generator. This method requires a vascular approach, of which there are 3 types: the arteriovenous fistula (AVF), the arteriovenous graft and the central venous catheter.

The AVF remains the vascular access of choice for hemodialysis sessions, and its preservation is an essential objective for patients with CKD.

One of the major challenges for AVFs is to achieve a successful puncture, an act performed around 310 times a year per patient, for dialysis performed three times a week with double needles. This repeated procedure can cause damage to the AVF, leading to complications such as stenosis, thrombosis, aneurysm, superficial infection, hematoma, bleeding, parietal rupture or dissection.

However, there is no official recommendation on the most conservative puncture technique for AVF. In view of the number of patients concerned and the recurrence of puncture, it would seem essential to evaluate the impact of bevel orientation on the occurrence of complications during dialysis by means of a randomized prospective study.


Eligibility Criteria:
Inclusion Criteria:

* male or female with Chronic Kidney Disease
* patient requiring 4-hour hemodialysis sessions, 3 times per week, in a dialysis center
* Native arteriovenous fistula (AVF) (without prosthesis), mature, with no prior puncture, located in the upper limb
* First fistula for a hemodialysis patient
* Expected duration of dialysis ≥ 1 year
* Double-needle dialysis
* Hemodialysis possible on AVF
* Average AVF flow rate between 500 and 2,000 mL/min
* Affiliated with a social security scheme
* Free and informed consent

Exclusion Criteria:

* Auto-dialysis at home
* Puncture using the buttonhole technique
* Patient requiring AVF puncture with a catheter
* Planned transplant within the next 12 months
* Previous AVF creation, except for the fistula of interest
* Patient with a history of cancer within the past 5 years or active cancer
* Patient under court protection or guardianship
* Pregnant and breast-feeding women
* Patient with psychiatric pathologies or cognitive disorders
* Patient follow-up difficult or impossible for geographical or other reasons, at the investigator's discretion
Real World Effectiveness of Eptinezumab in Participants With Migraine

The purpose of this study is to examine how eptinezumab compares to other advanced preventive medications in a real-world community setting in adult participants with episodic migraine (EM) or chronic migraine (CM). These objectives include exploring the comparative effectiveness on patient reported outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of migraine per International Headache Society (IHS) International Classification of Headache Disorder (ICHD)-3 guidelines at least 12 months prior to screening.
* Have a history of ≥ 8 migraine days/month in 2 of the previous 3 months as confirmed by the treating physician through medical records.
* Be able to understand the clinical description of treatment options and have the capability to participate fully in making their treatment preferences known.
* Be willing to accept randomization to any of the possible study medications if allocated to that treatment arm.
* Be willing and capable of completing daily reports and other participant reported outcome measures using a smartphone-based application.

Exclusion Criteria:

* The participant has a history of severe drug allergy or hypersensitivity, or known hypersensitivity or intolerance to either eptinezumab, erenumab, fremanezumab, galcanezumab or their excipients.
* The participant has previous history of use of any of the study drugs (for example, eptinezumab, Botox, erenumab, fremanezumab or galcanezumab). Note that only previous Botox use for treatment of migraine is exclusionary. Prior use of Botox for cosmetic purposes is allowed.
* The participant has a diagnosis of CM and has hypersensitivity to botulinum toxin preparation or to any of the components in the formulation.
* The participant has used opioids or butalbital-containing products greater than 4 days per month in the last month.

Other inclusion and exclusion criteria may apply.
Ranibizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion in Patients With Fair Vision

The purpose of this study is to determine the effect of ranibizumab for the treatment of macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in patients with initial fair visual acuity.

Lucentis was approved for ME due to BRVO based on the results from BRAVO study. The inclusion criteria in BRAVO was "best corrected visual acuity (BCVA) 20/40 to 20/320". Therefore, the patients with VA better than 20/40 who are out of inclusion criteria of BRAVO study had no treatment and just wait to reach spontaneous improvement. But, there is unmet needs of these patients and, in actual clinical practice, many retina specialists treat these patients with Ranibizumab. These patients have been experiencing VA improvement after the injection. Based on these clinical backgrounds, the investigator wants to suggest the treatment guidelines in these patients group, which is, early treatment of ranibizumab would be effective and increase patients' QOL. In other words, there are many experiences in these cases among ophthalmologists, but there have been no clinical trials that can endorse the treatments. To confirm the efficacy of ranibizumab in patients with initial fair vision, the investigators started the prospective randomized clinical trial on the efficacy and safety of ranibizumab for the patients.

Eligibility Criteria:
Inclusion Criteria:

1. Foveal center-involving macular edema secondary to BRVO diagnosed within 12 months before study enrollment
2. ETDRS chart BCVA: 63 to 77 letters (20/32 to 20/50 Snellen equivalent)
3. CFT \>= 300 um (mean of measurements obtained at screening and Day 0)
4. Signed consent informed
5. male or female, age ≥18 years old

Exclusion Criteria:

1. Prior episode of RVO: Past history of RVO in the study eye diagnosed before 1 year of study enrollment.
2. BCVA improvement \>10 letters between screening and Day 0
3. History of other ocular diseases (e.g. diabetic retinopathy, age-related macular degeneration)
4. Laser treatment within 3 months before baseline
5. Intraocular corticosteroid use within 3 months before baseline
6. Anti-vascular endothelial growth factor (VEGF) treatment in the study or fellow eye within 3 months before baseline
7. Intraocular surgery other than cataract surgery, Cataract surgery within 6 months before baseline
8. Stroke or myocardial infarction ≤3 months before baseline
9. Pregnancy or plan to have baby in female
Calcitriol Supplementation in COVID-19 Patients

This is a randomized, open label study to evaluate the efficacy and safety of calcitriol supplementation in COVID-19 patients with vitamin D deficiency.

This is a randomized, open label study to evaluate the efficacy （clinical and laboratory change）and safety （serum calcium） of calcitriol supplementation in COVID-19 patients with vitamin D deficiency.

Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized symptomatic COVID-19 patients;
2. COVID-19 nucleic acid Ct value \< 28 (both orf1ab gene Ct value and N gene Ct value \< 28);
3. Vitamin D deficiency: 25OHD ≤ 20ng/ml;
4. Age: 18-70 years old;

Exclusion Criteria:

1. Asymptomatic COVID-19 patients ；
2. Hypercalcemia;
3. History of primary hyperparathyroidism;
4. History of triple hyperparathyroidism;
5. Patients who are allergic to calcitriol;
6. Pregnant or lactating women;
7. Patients with severe heart or lung diseases or tumor history;
8. Patients already taking vitamin D or its similar preparations;
9. Participants in other interventional clinical studies (including taking paxlovid);
10. Patients with renal insufficiency (eGFR\<60ml/min/1.73m2);
11. Patients considered unsuitable for this study by the investigator；
An Investigation Into Bone Micro-architecture in Women With Type 2 Diabetes

The number of people with type 2 diabetes is growing. This puts a lot of pressure on the health care systems. Type 2 diabetes is often associated with health problems, like poor eyesight, muscle coordination, muscle strength, and blood flow. Poor bone health may also be a concern for people with type 2 diabetes.

A large proportion of people with type 2 diabetes will break a bone in their lifetime. The risk of this happening in older people with type 2 diabetes is greater than the risk in older people without diabetes. Fracturing a bone can be very painful, and lead to serious consequences, especially if the individual experiences a hip fracture. The elevated fracture risk, seen in those with type 2 diabetes, is puzzling because people with type 2 diabetes often appear to have normal, healthy bones compared to people of the same age without diabetes.

Bone micro-structure, which is not assessed by traditional bone densitometry systems (ie: DXA) contributes to overall bone strength.

The hypothesis of this study is that bone micro-structure is of poorer quality (reduced trabecular thickness, increased trabecular spacing) in postmenopausal women with type 2 diabetes, compared to age-matched control participants.


Eligibility Criteria:
Inclusion Criteria:

* female
* \>= 65 years old
* postmenopausal for \> 5 years (WHO definition of menopause)

Exclusion Criteria:

* currently taking osteoporosis related medication (HRT, SERM, bisphosphonate, PTH, calcitonin, fluoride)
* had cancer in past 10 years, likely to metastasize to bone (ie: breast, lung)
* have intrinsic bone disease (ie: Paget's Disease, Cushings syndrome)
* have untreated malabsorption syndrome (ie: Celiac Disease)
* renal insufficiency (CrCl \<30ml/min)
* hyperparathyroidism, hypoparathyroidism
* chronic systemic glucocorticosteroid use \> 3mos, dose\>2.5mg daily
Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis

This study aims to compare high-efficiency post-dilution on-line hemodiafiltration and high-flux hemodialysis regarding mortality, hospitalization rate, several clinical and laboratory parameters, and required medications.

The investigators hypothesize that high-efficiency post-dilution on-line hemodiafiltration may provide better outcome, less morbidity, higher quality of life, and lesser requirement of medications.

The proposed controlled, randomized study aims to compare high-efficiency post-dilution on-line hemodiafiltration and high-flux hemodialysis regarding mortality, hospitalization rate, several clinical and laboratory parameters, and required medications.

Seven hundred and eighty HD patients will be taken into the study. The study will last for two years with an intermediate analysis at the first year. The patients will be randomly placed in two groups:

1. Post-dilution on-line hemodiafiltration,
2. High-flux hemodialysis.

In both groups, FX series high-flux helixone membranes will be used, duration of each session 240 minutes, and blood flow rates 250-400 ml/min. ONLINEplus integrated Fresenius 4008S machines will be used for on-line post-dilution HDF. Substitution volume will be above 15 liters in hemodiafiltration sessions.

Echocardiography for determination of left ventricular geometry, pulse wave velocity analysis to assess arterial stiffness, evaluation of nutritional and inflammatory state, assessment of life quality, depression and cost analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years
* on maintenance bicarbonate HD scheduled thrice weekly 12 hours/week,achieved mean single pool Kt/V above 1.2
* willingness to participate in the study with a written informed consent

Exclusion Criteria:

* To be scheduled for living donor renal transplantation
* To have serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease
* Pregnancy or lactating
* Current requirement for HD more than three times per week due to medical comorbidity
* GFR greater than 10 ml/min/1.73 m2 as measured by the average of urea and creatinine clearances obtained from a urine collection of at least 24 hours
* Use of temporary catheter
* Insufficient vascular access (blood flow rate lower than 250 ml/min)
* Mental incompetence
Study to Evaluate the Effects of a Formula on the Gut Health of Healthy Chinese Infants and Young Children

The infant gut microbiota, a major driver of the maturation of the immune system, is formed through the successive establishment and development during infancy and early childhood. It can inhibit the growth of pathogenic bacteria, prevent the occurrence of diseases and improve the child's quality of life. It is therefore important to regulate the microbiota balance in infants and young children.

This objective of this post-launch study is to evaluate the effects of a formula with prebiotics and milk fat on the gut microbiota and stool characteristics of healthy Chinese infants and young children. The duration of the study for each participant is 32 days and includes 3 study visits.


Eligibility Criteria:
Inclusion Criteria:

* The gestational age was 37-42 weeks at birth;
* Birth weight ≥2,500 g and ≤ 4,500 g;
* Chinese nationality;
* Weight and height are within normal range (i.e. WHO Child Growth Standards

  * 2SD);
* No relocation across provinces/ cities in the past 1 year and no plans to relocate during the study period.
* Breastfeeding reference: breastfeeding at the time of enrollment, and the mother intends to continue breastfeeding throughout the study period;
* Intervention arm: formula feeding / habitual milk drinking (formula milk, milk and other dairy products) at the time of enrollment, and willing to change from the original milk powder / dairy product to the study formula, and consume it as instructed during the study period;
* The child's parent(s) / guardian has access to a mobile phone on which the secure digital WeChat platform can be installed and used, connect to the network, take photographs and record defecation, and complete questionnaires during the study;
* The child's parent(s) / guardian is of legal age of consent, has sufficient command of Chinese (Mandarin) language to complete the informed consent and other study documents, is willing and able to fulfill the requirements of the study.
* The child's parent(s) / guardians can be contacted directly by telephone or WeChat;

Exclusion Criteria:

* Neonatal asphyxia at birth;
* Chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or may impact study outcomes;
* Cognitive and developmental disorders;
* Antibiotic usage up to 2 weeks before enrollment;
* Ongoing antibiotic treatment;
* Taking probiotic supplements or formula with probiotics up to 1 month before enrollment;
* Participation in other clinical trials;
* Parent(s)' / guardian's refusal to participate in the study;
* Known or suspected allergy to cow milk, soy or fish
Impact of Hydrocortisone Administration on White Blood Cell Gene Expression in Patients With Severe Sepsis

The purpose of this pilot study is to (1) examine the changes in gene expression in patients who suffer from severe sepsis and whose shock (inadequate oxygen delivery to vital organs) state does not respond to fluid and vasopressor administration, (2) to show that our sampling method of isolating RNA provides reliable and consistent data, (3) provide a basis for future gene expression studies in critically ill patients

Severe sepsis is characterized by inadequate perfusion of vital organs due to infection. More than 750,000 cases of severe sepsis occur each year in the United States. Mortality among patients with severe sepsis ranges from 7% to 50%. Initiation of antibiotic therapy within the first hour of diagnosis as well as fluid resuscitation and hemodynamic stabilization are primary goals of therapy.

Steroid administration has been shown to improve outcome in the subset of severe sepsis patients suffering from relative adrenal insufficiency. Although initial studies using high dose short course steroid therapy did not demonstrate efficacy, more recent studies of low dose longer duration hydrocortisone administration demonstrated a significant reduction in mortality at 28 days. The mechanism by which steroid administration affords protection is unclear. We hypothesize that steroid administration changes white blood cell gene and protein expression in severe sepsis patients from an immuno-inflammatory profile to a pattern consistent with healing.

Our first specific aim is to obtain plasma and total cellular RNA from leukocytes in the blood of ten patients admitted to Stanford Medical Center with the diagnosis of severe sepsis and adrenal insufficiency. Significant and distinct variations in whole blood leukocyte gene expression patterns occur depending upon the method of RNA isolation. We will attempt to demonstrate that our sampling method provides reliable and consistent data.

Our second specific aim is to begin an analysis of gene expression patterns in white blood cells before and after steroid administration in patients suffering from severe sepsis with relative adrenal insufficiency. We will use a protocol for assessment of gene expression that was developed by members of our research team.

Eligibility Criteria:
Inclusion Criteria:

* Admission Diagnosis of Sepsis
* Evidence of Relative Adrenal Insufficiency
* Hypotension (Mean Arterial Pressure less than 60 mm Hg) Refractory to a. Fluid Resuscitation b. Dopamine infusion (greater than 5 micrograms/kg/min) c. Phenylephrine infusion (greater than 1 microgram/kg/min)

Exclusion Criteria:

* Use of Immunosuppressant Medications
* Immune Compromised Due to Disease (e.g., HIV infection)
* Transfusion of Blood Products within the past 7 Days
* Use of Cytokine Therapy (i.e., G-CSF)
* History of Bone Marrow Transplantation