cyrilzakka/clinical-trials huggingface dataset:
Two Time a Week vs. Five Time a Week Blood Flow Restriction Training Program for the Lower Extremity.

This study will randomize healthy adults who regularly perform resistance training exercises for the lower extremities (2x a week) to one of three groups: a blood flow restriction (BFR) exercise group that trains 2x a week, a BFR exercise group that trains 5x a week, and a control group that does not perform any additional BFR exercise. Those randomized to the BFR groups will perform the unilateral 90-0 knee extension exercise followed by the bilateral squat. Subjects will have the BFR applied to their dominant lower extremity and will perform 4 sets (30/15/15/15 reps) per exercise. Training will initial start at 30% of 1RM with training intensity increased by 5% every 2 weeks. The training program will last 8 weeks.

Pre- and posttests include ultrasound imaging of the dominant leg rectus femoris and strength testing via hand held dynamometry.


Eligibility Criteria:
Inclusion Criteria: healthy adults 18 years of age who currently perform weight-lifting (i.e., resistance training) exercise 2x a week.

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Exclusion Criteria: current musculoskeletal injury; surgery to the low back or lower extremities during the prior year; one or more contraindications to blood flow restriction training.

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Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma

The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Follicular Lymphoma (FL).


Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory follicular lymphoma grade I-II
* Tumor verified to be CD20 positive
* CT scan showing demarcated lesions

Exclusion Criteria:

* Previous treatment with rituximab resulting in less than partial response
* Previous radioimmunotherapy
* Previous stem cell transplantation
* Received the following treatments within 4 weeks prior to entering this study:

  1. Anti-cancer therapy
  2. Glucocorticosteroids unless less than 10 mg prednisolone/day
  3. Radiotherapy
* Received Mitomycin C or Nitrosoureas within 6 weeks prior to entering this trial
* HIV positivity
* Hepatitis B or hepatitis C
* Uncontrolled or chronic bacterial, fungal or viral infection
* Other cancer diseases, except certain skin cancers, cervix cancer and breast cancer
* Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases
* WHO performance status of 3 or 4
* If you are participating in another trial with a different new drug 4 weeks before you enter this trial
* Current participation in any other clinical study
* Pregnant or breast-feeding women
* Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial
Citalopram as a Posterior Cortical Protective Therapy in Parkinson Disease

This Parkinson disease (PD) trial will test whether 26 months of citalopram, compared to placebo, can alter the build-up of toxic amyloid-beta plaques in the visuospatial cortex of the brain linked to visuospatial cognitive impairment in PD.

This study is a proof-of-concept Parkinson disease trial aimed at delaying visuospatial cognitive decline, an important component of Parkinson dementia. In Parkinson disease, low-range cortical Abeta plaque levels associate with serotonin terminal losses. Multicenter Parkinson disease observational findings show that selective serotonin reuptake inhibitors (SSRIs) associate with lower dementia conversion risk and different cerebrospinal fluid Abeta-42 levels. This study aims to test the hypothesis that citalopram use in Parkinson disease will reduce visuospatial cortex Abeta plaque accrual, leading to an amelioration of longitudinal visuospatial cognitive decline linked to Parkinsonian dementia. The study will test this hypothesis in a randomized placebo-controlled trial of citalopram 20mg daily over 26 months in Parkinson disease subjects (age ≥65) without depression (n=58).

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a Parkinson Disease (PD) diagnosis based on the United Kingdom Parkinson's Disease Society Brain Bank Research Center clinical diagnostic criteria
* Modified Hoehn and Yahr (HY) scores spanning 2.0 to 3.0
* Age 65 years or greater

Exclusion Criteria:

* Diagnosis of an atypical parkinsonian condition
* Participants on neuroleptics and participants with a history of use of anti-depressants (including selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), bupropion, St. John's Wort or other serotoninergic agents in the year preceding study enrollment
* Evidence of a large artery stroke or mass lesion on brain imaging
* Participants with a life threatening comorbid illness
* Severe claustrophobia precluding PET imaging
* Inability to participate in research procedures involving ionizing radiation
* Pregnancy or breastfeeding
* Participants with active depression as defined by a Geriatric Depression Scale score of \>10 or on the basis of clinical diagnosis by the PI
* Participants who report active suicidal ideation as defined by an affirmative answer to questions 1 and 2 on the C-SSRS
* Participants with baseline HY scores \<2.0 or ≥3.0
* Participants with a QTc interval on baseline EKG \>0.45 for men or \>0.47 for women
* Subjects taking certain contraindicated medications at baseline
* Subjects unable to swallow pills
* Subjects with a previous history of mania, ongoing hepatic impairment or epilepsy
* Subjects with a known allergy to citalopram or escitalopram
* Subjects with substantial cognitive impairment or dementia that would prevent them from providing informed consent
* Subjects in another ongoing clinical trial
* Subjects with treatment-naieve Parkinson disease
Diagnostic Performance of a Combination of Leukocyte Cell Surface Markers in Predicting the Risk of Severe Bacterial Infection in Febrile Children Under Three Months of Age in the Emergency Department: a Pilot Study.

Fever is a frequent reason for emergency department (ED) visits in infants under 3 months of age. Although viral infections are the most common etiologies, the prevalence of severe bacterial infections (SBI) is high (10%). While in infants with SBI, establishing the diagnosis and initiating rapid intravenous antibiotic therapy is necessary, every effort should be made to avoid it in those at low risk of SBI.

Clinical examination and biomarkers are still sub-optimal for assessing the risk of SBI. As a result, the vast majority of these children receive inpatient intravenous antibiotic therapy.

Flow cytometry is a technique for measuring the expression of biomarkers on the cell surface of leukocytes in response to infection. A French team has identified a combination of some fifteen leukocyte cell surface markers that perform excellently in discriminating between bacterial and viral infections in a population of adults presenting to the emergency department with a suspected infection. However, there are no similar studies in children.

The objective of the study is to assess the diagnostic performance of a combination of biomarkers on the cell surface of leukocytes in discriminating between bacterial and viral infection. Infants less than 3 months of age, visiting the ED for fever will have an extra blood sample in order to measure those biomarkers. The performance of those biomarkers to identify SBI will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Children aged between 7 and 90 days
* Visiting the emergency department with fever (Temperature greater than or equal to 38° measured rectally in the emergency department or reported by parents) OR whose fever is detected during the emergency department visit (Temperature greater than or equal to 38° measured rectally in the emergency department)
* Consent signed by one of the two parents/guardians

Exclusion Criteria:

* Weight less than 2,500 grams
* Chronic illness (heart failure...)
* Known immune deficiency
* Congenital anomaly significantly modifying the probability of bacterial infection (pulmonary malformation, esophageal atresia...)
* Antibiotic therapy in the previous 48 hours
* Clinically evident source of fever: skin infection, joint infection, etc.
* Parents or guardians unable to understand French
* Non-affiliation with a social security scheme (including AME)
Breastfeeding Planning Card Trial in Scotland

This study evaluates the efficacy of a "breastfeeding toolkit" card delivered as part of antenatal care in promoting breastfeeding maintenance.

The project is an evaluation of an intervention that will start on January 1 2024.

From January 1 2024 through to March 31st 2024 midwives will present to patients attending their 24 week antenatal appointment a breastfeeding toolkit card.

The trial compares breastfeeding rates across patients who receive the card and those whose 24-week antenatal appointment occurred in the three months October 1 2023 - December 31 2023.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in NHS Grampian

Exclusion Criteria:

None
A Double Blind, Double Dummy, Randomized, Comparative Study Of The Efficacy And Safety Of Valdecoxib 40 Mg Twice Daily, As Needed In The First Menstrual Cycle Day And Then Once A Day, And Piroxicam 40 Mg Once A Day In The Treatment Of Patients With Primary Dysmenorrhea

To compare the analgesic efficacy, safety, and tolerability of valdecoxib versus piroxicam in subjects with moderate to severe menstrual cramping pain associated with primary dysmenorrhea.


Eligibility Criteria:
Inclusion Criteria:

* History of primary dysmenorrhea with moderate to severe menstrual cramping pain for which the patient took analgesic medication for at least three of six previous menstrual cycles before enrollment
* Subjects were to have been in good health and were to have had a complete physical exam (including a pap smear and an endovaginal or pelvic ultrasound, unless the subject had had these examinations performed within 6 months prior to the Screening Visit and the results were normal) prior to inclusion

Exclusion Criteria:

* Subjects who were pregnant, lactating, breastfeeding or not using adequate methods of birth control
Levemir-Body Composition and Energy Metabolism

The objectives is to compare the changes in body composition (primary objective), diabetes parameters, energy expenditure and energy intake between Insulin detemir (Levemir® - Novolin® 4 pen) and insulin glargine (Lantus® - Solostar®) both in combination with Metformin and insulin secretagogues (SU) between baseline and after 6 months of insulin therapy in 80 type 2 diabetic patients failing on oral diabetic agents .


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients who require basal (long-acting) insulin for the control of hyperglycemia according to the opinion of the investigator.
* Inadequate Glucose control: Hemoglobin A1c (HbA1c) percentage in the range of ≥ 7.5 - 12.0%
* Stable body weight for previous 3 months (± 5 kg).
* Structured exercise lower than 4 hours per week.
* Metformin ≥1.5 g/day

Exclusion Criteria:

* Any medical, social or geographic condition, which, in the opinion of the investigator would not allow safe or reliable completion of the protocol.
* Type 1 Diabetes Mellitus
* Previous treatment with insulin (\< 6 months prior inclusion). Insulin therapy for less than 6 days at the time of an acute event is acceptable.
* Secondary diabetes mellitus (i.e. steroid induced, Cushing syndrome, chronic pancreatitis, cystic fibrosis, etc.) and maturity-onset diabetes of the young
* Proliferative retinopathy/maculopathy requiring treatment
* Hypoglycemia unawareness or recurrent major hypoglycaemia
* Pregnancy and breast-feeding
* Unstable coronary artery disease
* Heart Failure as defined by class IV according to NYHA classification
* Recent (\< 6 months) history of myocardial infarction, stroke or T.I.A, ventricular arrhythmias, or unstable supra-ventricular arrhythmias.
* Renal Insufficiency. Creatinine clearance \< 40 ml/min (MDRD formula).
* Acute (\< 2 months) or Chronic infectious diseases requiring either hospitalization or antibiotic treatment for more than 2 weeks
* Recent (\< 1 year) diagnosis of systemic malignancies except thyroid and skin cancer
* Major psychiatric diseases
* History of drug addiction
* Previous bariatric surgery
* Medication that affects weight such as

  * Systemic corticosteroids (prednisone)
  * Anti-obesity medication (Xenical® or Meridia®)
  * Megace ®
  * Antidepressant medication associated with significant weight impact such as Zyprexa®, Remeron® based on investigator judgment.
  * Growth hormone therapy or testosterone supplementation should be initiated for at least 6 months and at stable dose for 3 months prior to enrolment
  * Medication that affects glycemic control and hypoglycemic unawareness based on investigator judgment.
An Open Study for Steroid Resistant, Non-Thymectomized MG Patients

The purpose of the study is to investigate the efficacy and safety for steroid resistant, non-thymectomized MG patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed as myasthenia gravis
* Those whose MG symptoms are not controlled by the treatment with prednisone

Exclusion Criteria:

* Those who had undergone thymectomy
AI-Assisted TelerehabiLitAtion System (ATLAS) for Post-discharge Continuation of Rehabilitative Care

The study team proposes ATLAS (AI-Assisted TelerehabiLitAtion System) a two-part solution. The first-Rebee AI-assisted telerehabilitation device-assists in inpatient rehabilitation, and allows patients to continue with their physical rehabilitation when discharged and waiting for Day Rehabilitation Centre (DRC). The second-a structured programme to train and familiarise patients and caregivers to Rebee over patients' Community Hospital (CH) inpatient rehabilitation stay-adopts an evidence-based approach to increase uptake and adherence to Rebee.


Eligibility Criteria:
Inclusion Criteria:

1. Rehabilitation Diagnostic Group (RDG): Total Knee Replacement / Deconditioning
2. Age 60 and above
3. Speak English/Mandarin
4. Able to follow instructions, no cognitive impairment
5. No MDRO (MultiDrug Resistant Organism)
6. Suitable and able to wear motion sensor on upper and lower limbs
7. Suitable and able to engage in Rebee exercises

Exclusion Criteria:

1. Not under RDG: Total Knee Replacement / Deconditioning
2. Below 60 years old
3. Unable to speak English/Mandarin
4. Cognitive impaired, unable to follow instructions
5. Has MDRO
6. Not suitable to wear motion sensor on upper and lower limbs
7. Refusal to participate / give informed consent
Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure: Application to the COVID-19 Pandemic

Automated quantification of the pulmonary volume impaired during acute respiratory failure could be helpful to assess patient severity during COVID-19 infection or perioperative medicine, for example.

This study aims at assessing the correlation between the amount of radiologic pulmonary alteration and the clinical severity in two clinical situation :

1. SARS-CoV-2 infections
2. Postoperative hypoxemic acute respiratory failure.


Eligibility Criteria:
Inclusion Criteria:

* Subject admitted to a care unit of the University Hospitals of Strasbourg or the University Hospital of Nancy and presenting a suspicion of SARS-CoV-2 infection or postoperative hypoxemic respiratory failure
* Able to understand the objectives and risks of the research and to give dated and signed informed consent.

Subjects may also be included in emergency or immediate life-threatening situations.

* Subject with insurance covering

Exclusion Criteria:

* Pregnant woman (pregnancy confirmed by a urine or blood test)
* Subject usually on home oxygen therapy
* Subject under court protection
* Subject under guardianship or curatorship
Blastocyst Culture Using Time-lapse in Good Prognosis IVF Patients and Elective Single Embryo Transfer

Choosing the best embryo for transfer has become the major challenge in in vitro fertilization (IVF). Morphology alone is obviously not enough and time-lapse incubation has added embryo development kinetics as another selection criterion.

This study was designed to select for the top blastocyst to be replaced, while increasing the pregnancy chance, with the local legislation regulating the number of embryos to be transferred and to establish a morphokinetic standard to be used in our clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* patients in their first or second ART treatment cycle
* no recurrent spontaneous abortions
* age\<35 years
* BMI\<28 kg/m2
* ≥8 oocytes retrieved

Exclusion Criteria:

* severe endometriosis
* polycystic ovary syndrome
* hydrosalpynx
* uterine pathology
* severe male factor (presenting less than 5 million motile sperm cells in total in the ejaculate)
* very severe morphological sperm defects (mainly globozoospermic or macrocephalic samples)
Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer

The main objective of this investigator initiated study is to study if preoperative intravenous iron is effective in reducing need for allogenic blood transfusion in patients with gastric cancer who will undergo a standardized gastrectomy including both total and subtotal gastrectomies. The hypothesis is that intravenous iron reduces the need for perioperative blood transfusions.


Eligibility Criteria:
Inclusion Criteria:

- Patients with gastric cancer who will undergo a gastrectomy

Exclusion Criteria:

* Patients under 18 years old
* Patients not in full understanding
* Hemoglobin levels \> 155 g/l for women and \>167 g/l for men (upper reference limits for the laboratory of Helsinki University Hospital district) preoperatively.
* Transferrin saturation level \>50%
* Emergency gastrectomy
* Palliative gastrectomy
* Acute bacterial infection
* Known hypersensitivity to the active substance, to ferric carboxymaltose or any of its excipients, or to other parental iron products
* Clinical evidence of iron overload or disturbances in the utilisation of iron
* Patients \<35 kg
* Dialysis therapy for chronic renal failure
* Hemochromatosis
* Polycythemia vera
* Pregnancy
* Patients in need of direct blood transfusion ( Criteria for this are hemoglobin \< 80 g/l or \< 90 g/l if the patient is symptomatic or has a history of heart disease)
Study to Evaluate Recovery From Postoperative Pain After Sleep Apnea Surgery

The purpose of this study is to assess whether tonsillectomy and UPPP performed using the study device to treat Obstructive Sleep Apnea (OSA) symptoms in adults is associated with less postoperative pain during the 21-day postoperative recovery period compared to electrocautery dissection.

This prospective clinical study is designed to assess whether tonsillectomy and UPPP performed using the study device to treat OSA symptoms in an adult population is associated with less postoperative pain during the 21-day postoperative recovery period compared to electrocautery dissection. The amount of post-operative pain will be assessed daily over the 21-day post-operative recovery period using two general measures: 1) self-reported pain intensity and 2) self-reported pain medication administration, including frequency of use and dose. Further, timing of self-medication will be analyzed separately.

Eligibility Criteria:
Inclusion Criteria:

* Subject is \> or = 18 years of age
* Subject has positive diagnosis of Obstructive Sleep Apnea confirmed by polysomnographic study
* Subject is a surgical candidate for UPPP and tonsillectomy with or without tongue base somnoplasty
* Subject signs IRB-approved informed consent form
* Subject is willing and able to complete required follow-up.

Exclusion Criteria:

* Subject has had a previous tonsillectomy
* Subject's RDI \>40
* Subject has a history of chronic use of narcotic pain medications
* Subject is unable to take liquid opioid analgesics
* Subject requires additional surgical procedures (such as nasal septoplasty or FESS) within 28 days of enrollment
Tiotropium+Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)

The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components ( tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD).


Eligibility Criteria:
Inclusion criteria:

1. Diagnosis of chronic obstructive pulmonary disease.
2. Relatively stable airway obstruction with post FEV1\< 80% predicted normal and post FEV1/FVC \<70%.
3. Male or female patients, 40 years of age or older.
4. Smoking history of more than 10 pack years.

Exclusion criteria:

1. Significant disease other than COPD
2. Clinically relevant abnormal lab values.
3. History of asthma.
4. Diagnosis of thyrotoxicosis
5. Diagnosis of paroxysmal tachycardia
6. History of myocardial infarction within 1 year of screening visit
7. Unstable or life-threatening cardiac arrhythmia.
8. Hospitalization for heart failure within the past year.
9. Known active tuberculosis.
10. Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
11. History of life-threatening pulmonary obstruction.
12. History of cystic fibrosis.
13. Clinically evident bronchiectasis.
14. History of significant alcohol or drug abuse.
15. Thoracotomy with pulmonary resection
16. Oral ß-adrenergics.
17. Oral corticosteroid medication at unstable doses
18. Regular use of daytime oxygen therapy for more than one hour per day
19. Pulmonary rehabilitation program in the six weeks prior to the screening visit
20. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
21. Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA
22. Pregnant or nursing women.
23. Women of childbearing potential not using a highly effective method of birth control
24. Patients who are unable to comply with pulmonary medication restrictions
Respiratory Muscle Strength and Aerobic Capacity in Scleroderma

Primary aim of this study was to compare respiratory muscle strength, aerobic capacity, dyspnea, pulmonary function tests and fatigue values with healthy controls. The secondary aim was to evaluate the relationship between respiratory muscle strength and other parameters in these patients and to examine the factors that may affect respiratory muscle strength. Respiratory muscle strength, aerobic capacity, respiratory function tests and fatigue will be evaluated

Scleroderma is a systemic connective tissue disease characterized by progressive thickening of the skin, the etiology of which has not been fully elucidated, in which microvascular damage, immune activation and fibrosis play a role. Primary aim of this study was to compare respiratory muscle strength, aerobic capacity, dyspnea, pulmonary function tests and fatigue values with healthy controls. The secondary aim was to evaluate the relationship between respiratory muscle strength and other parameters in these patients and to examine the factors that may affect respiratory muscle strength. The study will include 15 patients and 15 healthy individuals of the same age and gender. Respiratory muscle strength, aerobic capacity, respiratory function tests and fatigue will be evaluated

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with Ssk according to ACR/EULAR criteria
* Stable medical treatment for 3 months

Exclusion Criteria:

* Having a regular exercise habit (doing regular exercise at least once a week for the last 3 months)
* Comorbidity with another chronic disease that may affect aerobic capacity or respiratory muscle strength
* Having concomitant acute respiratory diseases
* Having a smoking habit
* History of orthopedic or neurologic disease in the lower extremities that may prevent cycling