cyrilzakka/clinical-trials huggingface dataset:
APIDRA Registration Study

To collect effectiveness and safety data during the treatment with Apidra glulisine (HMR1964) by means of subcutaneous injections to patients with Diabetes Mellitus 1st type during 12 weeks-active phase.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes Mellitus 1st type, with НbA1c level in the range of ≥ 6,5 - \<=11%, receiving the regimen of multiple injections of insulin during one year.

Exclusion Criteria:

* Active proliferative diabetic retinopathy connected with focal or panretinal photocoagulation or vitrectomy carried out within 6 months before visit 1, or any unstable (quickly progressive) form of retinopathy, which may need in surgical intervention (including laser photocoagulation) during study
* Diabetes Mellitus of the 2nd type
* Patients transmitted pancreatectomy
* Patients transmitted transplantation of pancreas or islet cells
* Probable therapy by means of products not approved by study minutes during the study
* Anamnestic indications of convulsive disorders
* Allergic reaction on insulin or any filler of preparation Apidra (glulisine)
* Clinical serious diseases of cardiovascular system, liver, nervous system, endocrine system, oncologic diseases or other serious system diseases, which complicate keeping of minutes or interpretation of study results, and, at the investigator's opinion, impede the safe participation of patients in study
* Drug addiction or alcoholism
* Disturbance of liver functions confirmed with the increase of ALT or AST activity up to the level twice as high as the upper standard limit (these indications may not be single)
* Disturbance of functions of kidneys confirmed with the level of creatinine in serum that is more than 177 mµmol/l at visit 1 (this indication may not be single)
* Pregnancy or breast-feeding

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Owlet Band Observational Study: Observe the Use of a New Pregnancy Tracker for Expecting Mothers

This is an observational research study of a new pregnancy tracker used to gather information about a pregnant woman's general wellness.

The Owlet Band is a wellness product (similar to a fitbit), it is not designed to be a "medical device". The study involves women age 18 and older who are currently pregnant, at least 24 weeks' gestation or later, and who live in the USA. Up to 8,000 pregnant women are expected to participate in the study. This study will involve review of Owlet Band data and participant responses to questionnaires throughout the study. The purpose of this research is to observe if using the new Owlet Band and the associated iPhone app can help pregnant women in managing their habits, anxiety, stress, enhancing bonding and attachment to their infant, while still maintaining their standard medical care.

Eligibility Criteria:
Inclusion Criteria:

* Must be at least 24 weeks pregnant with a singleton pregnancy
* Must be at least 18 years of age
* Must currently live in the United States
* Must have a compatible smartphone (Apple iOS Version 13 or above)
* Able to read and understand English in order to provide Informed Consent and follow study instructions

Exclusion Criteria:

* NA
Study to Assess the Safety of Dupilumab (REGN668/SAR231893) Administered Concomitantly With Topical Corticosteroids (TCS) in Patients With Moderate-to-severe Atopic Dermatitis (AD)

The purpose of this study was to assess the safety of Dupilumab administered concomitantly with topical corticosteroids (TCS) in patients with moderate-to-severe atopic dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged 18 years or older
2. Chronic AD that had been present for at least 2 years

Exclusion Criteria:

1. Prior treatment with Dupilumab
2. Hypersensitivity to corticosteroids or to any other ingredients contained by the TCS product used in the study
3. AD lesions located on face, flexural, and genital areas
4. Certain treatments and medical procedures, undertaken within a particular time frame prior to the baseline visit, preclude eligibility for participation in the study
5. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
6. Treatment with an investigational drug within 8 weeks
7. Known history of human immunodeficiency virus (HIV) infection
8. Presence of certain laboratory abnormalities at the screening visit
9. History of certain opportunistic infections or certain clinical parasite infections
10. History of malignancy within 5 years before the baseline visit, with certain exceptions
11. Pregnant or breast-feeding women
12. Travel within 12 months of study start to areas endemic for parasitic infections, such as developing countries in Africa and the tropical and subtropical regions of Asia
13. History of alcohol or drug abuse within 2 years of the screening visit
14. Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results
ESCAPE : Evaluation of Spinal Conservation by Endoscopic Procedures to Avoid Fusion

The recent development and expansion of endoscopic surgery has made it possible to offer an alternative to this therapeutic escalation. This method allows decompression procedures to be performed using optimized and minimally destructive surgical approaches, which contributes to preserving the physiological function of the lumbar spine and in particular its stability.

The main hypothesis of the research is that the use of endoscopic techniques for decompression of the lumbar spine allows a reduction in the indication for lumbar arthrodesis.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old
* Patient consulting for a medical reason involving a spinal pathology in the investigating center :

Syndrome adjacent to an old lumbar arthrodesis defined on preoperative radiographs by an antero-posterior translation \> 3 mm, segmental kyphosis \> 10° or a disc height reduced by more than 50%, or on preoperative MRI by central stenosis of grade C or D of the Schizas classification or a herniated disc Grade 1 or 2 degenerative spondylolisthesis, i.e. with slippage less than 50% of the depth of the underlying vertebral body.

Lumbar stenosis complicating lumbar scoliosis defined by a deformation with rotation of the vertebral bodies on a frontal radiograph (absence of centering of the spinous process between the two pedicles of the vertebra concerned) and a Cobb angle greater than 20° or a rotational dislocation .

- Indication for spinal surgery by endoscopy

Exclusion Criteria:

* Patient under guardianship or curatorship,
* Persons deprived of liberty by judicial or administrative decision,
* Persons undergoing psychiatric treatment under duress requiring the consent of the legal representative
* Persons unable to express their consent,
* Persons under legal protection,
* Patient not affiliated to a social protection scheme.
Efficacy Study of Vaginal Mesh for Anterior Prolapse

The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery for anterior prolapse compared to traditional vaginal reconstructive surgery without mesh.

Multiple vaginal, abdominal and laparoscopic procedures have been described for surgical correction of pelvic support problems. However, conventional pelvic reconstructive surgeries have been associated with a 20-30% prolapse recurrence rate. The anterior vaginal wall is the site most often recognized as the area of vaginal prolapse recurrence. Minimally invasive surgical procedures using mesh have rapidly developed in the field of pelvic floor reconstruction in an attempt to improve surgical cure rates. Unfortunately, safety and efficacy data have lagged behind the technical advancements.

This trial will randomize women with advanced anterior wall prolapse to two treatment arms: vaginal reconstructive surgery with mesh and vaginal reconstructive surgery without mesh. The primary outcome is cure of anterior wall prolapse at one year. Secondary outcomes are cure of apical and posterior wall prolapse, quality-of-life measures and complication rates. Patients will be approached for recruitment only after they have made the decision to undergo vaginal surgery for anterior prolapse. The patient and examiner will be blinded to the surgical treatment assignment. Interim measurement of primary and secondary outcomes will be conducted three months post-operatively. Additional follow-up will be conducted at one-year intervals subsequent to the expected one-year endpoint.

Eligibility Criteria:
Inclusion Criteria:

1. women age \> 21
2. diagnosed with stage II-IV vaginal prolapse who desire reconstructive surgery
3. available for 12 months of follow-up
4. able to complete study questionnaires and assessments.
5. available for 12 months follow-up

Exclusion Criteria:

1. Uterus in place.
2. No anterior vaginal prolapse.
3. Medical contraindications, e.g. current urinary tract, vaginal or pelvic infection, history of pelvic irradiation, history of lower urinary tract malignancy, chronic steroid use or a compromised immune system.
4. Current intermittent self catheterization.
5. Pregnancy or desire for future fertility.
6. Presence of an adnexal or ovarian mass.
7. Shortened vagina.
8. Other laparoscopic or abdominal/pelvic surgery in the past 3 months.\*
9. Known neurologic or medical condition affecting bladder function, e.g. multiple sclerosis, spinal cord injury.
10. Need for surgery requiring an abdominal incision.
11. \<12 months post-partum. (Enrollment can be deferred until time requirement has been met).
Dynamo: a Tailored Lifestyle Promotion Intervention Among Pediatric Patients With Cardiometabolic Risk Factors

The Dyn@mo lifestyle intervention (CHU Sainte-Justine, Quebec, Canada) targets children and adolescents aged 6 to 17 years old with cardiometabolic risk factors, such as obesity, hypertension, disorders in glucose regulation or dyslipidemia. Its primary goal is to promote physical activity and reduce sedentary time to improve childrens' cardiometabolic profile. To do so, the intervention relies on gathering data on mobility and physical activity using wearable sensors. These data provide a detailed picture of real-life conditions and physical activity levels, improving the health care professional's ability to tailor counseling. The investigators are presently in the implementation phase of this intervention.


Eligibility Criteria:
Inclusion Criteria:

* children ages 6 to 18 years of age with a BMI \> 95th percentile for age and sex

Exclusion Criteria:

* children with a physical or psychological condition that would impair their ability to participate in physical activity
XELOX/mFOLFOX Plus Vitamin D3 vs. XELOX/mFOLFOX as Firstline Chemotherapy in mCRC

The study is a randomized,multicenter, double-blinded,phase III study. To explore the affection of vitamin D3 in combination with oxaliplatin plus fluoropyrimidine versus oxaliplatin plus fluoropyrimidine as first-line chemotherapy in previously untreated advanced or metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent.
* males and females, ≥18 years of age
* All subjects must have inoperable, advanced or metastatic colorectal cancer and have confirmed histologically adenocarcinoma.
* Subject must be previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease.
* Prior adjuvant or neoadjuvant chemotherapy and/or radiotherapy are permitted as long as the last administration of the last regimen occurred at least 12 months prior to randomization.
* ECOG performance status score of 0 or 1.
* Subjects must have at least one measurable lesion or evaluable disease by CT of MRI per RECIST1.1 criteria.
* Screening laboratory values must meet the following criteria in 7days before the first day of cycle 1:

  1. Hemoglobin ≥9.0g/dL;
  2. Neutrophils ≥1500/mm3;
  3. Platelet ≥100,000/mm3;
  4. Total Bilirubin ≤1.5\*ULN
  5. AST ≤2.5\*ULN (or ≤5.0\*ULN if liver metastases are present), and ALT ≤2.5\*ULN (or ≤5.0\*ULN if liver metastases are present)
  6. Serum creatinine ≤1.5\*ULN or calculated creatinine clearance \>50mL/min
* Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days before randomization. All subjects of childbearing potential must agree to follow instructions for method of contraception for the duration of study treatment and 6 months after the last dose of study treatment.
* Life expectancy ≥3 months.

Exclusion Criteria:

* Concurrent diseases:

  1. Prior malignancy active cancer except for locally curable cancer that have been cured over 5years,or carcinoma in situ.
  2. Known brain metastasis
  3. Any serious or uncontrolled medical disorder or active infection.
  4. Known history of positive test for HIV or AIDS;
  5. Hepatitis B virus or hepatitis C virus is active;
* Within 4 weeks before randomization had operation, enlarged area radiotherapy(local radiotherapy within 2weeks) and other study drugs.
* Subjects with ≥ Grade 2 peripheral neuropathy.
* Pregnancy or breastfeeding.
Deuterium Metabolic MRI and [18F]FDG PET for Assessment of Treatment Response Following Radioembolization

Radioembolization, also known as Selective Internal Radiation Therapy (SIRT), is a liver-directed therapy for patients suffering from hepatic metastases. As SIRT is a liver-directed treatment, only patients with liver-only or liver-dominant disease are eligible for treatment. FDG-PET/CT is known to outperform conventional anatomical imaging modalities (CT or MRI) for treatment response assessment, also being of prognostic value. Subsequently following SIRT, patients are restaged with FDG-PET/CT. However, optimal timing of restaging following treatment is unknown (most commonly after 1 or 3 months, according to local institutional guidelines). More importantly, intrinsic resolution of FDG-PET/CT limits its utility in patients with small metastases, as image quality is worsened by high background noise, due to physiologic FDG uptake / metabolism in normal liver parenchyma. Additionally, FDG as radiopharmaceutical increases additional radiation burden to patients. This study will investigate the potential of metabolic MRI (7T MRI), non-invasively imaging metabolites using X-nuclei (e.g. 31P MRSI) and more importantly, the application of Deuterium Metabolic Imaging (DMI) with non-radioactive deuterated glucose, as a potential alternative over FDG-PET/CT.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years)
* Referred for SIRT and deemed eligible by the multidisciplinary tumor board
* Size of at least one liver metastasis ≥ 1 cm on contrast enhanced CT / MRI (measurable according to RECIST 1.1) and 18FDG-avid metastatic liver disease (uptake \> healthy liver uptake; measurable according to PERCIST)
* Written informed consent

Exclusion Criteria:

* Patients having FDG-negative disease (according to PERCIST)
* Patients with diabetes mellitus
* Patients having a general contra-indication for SIRT
* Patients with contra-indications for 7T MR scanning
* Patient unable to complete study scan (laying still for a long time)
* Patient unable or incapable to follow study proceedings
Assessment of Psychological Symptoms Among Fibromyalgia Patients

Fibromyalgia is a syndrome characterized by chronic widespread pain at multiple tender points, joint stiffness, and systemic symptoms (e.g., mood disorders, fatigue, cognitive dysfunction, and insomnia) \[14\] without a well-defined underlying organic disease. Nevertheless, it can be associated with specific diseases such as rheumatic pathologies, psychiatric or neurological disorders, infections, and diabetes.

The prevalence of fibromyalgia has been estimated to be around 1%-2% (3.4% for women and 0.5% for men) \[5, 6\].

The etiology and pathogenesis of fibromyalgia are still not fully understood. Several factors such as dysfunction of the central and autonomic nervous systems, neurotransmitters, hormones, immune system, external stressors, psychiatric aspects, and others seem to be involved.

diagnosis is principally based on the two major diagnostic criteria defined by the ACR in 1990 \[7\]: (1) a history of widespread musculoskeletal pain present for at least three months, and (2) tenderness in at least 11 of 18 defined tender points

Psychiatric problems seem to contribute considerably to the development of fibromyalgia. The prevalence of psychiatric conditions among patients affected by fibromyalgia is higher than among subjects complaining of other rheumatic diseases . The most common disorders associated are anxiety, somatization, dysthymia, panic disorders, posttraumatic stress, and overall depression \[8\]. Depression is more frequently associated with fibromyalgia than with other musculoskeletal diseases \[9\] Depression worsens fibromyalgic symptoms and vice versa, and antidepressants represent a cornerstone of fibromyalgia therapy \[1011\].

Over the last decade, it has been repeatedly shown that noninvasive repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex (M1) induces analgesic effects both in experimental pain \[1216\] , probably by activating pain modulation systems.

Another way studied to relieve fibromyalgia pain is sphenopalatine ganglion block

In our study we will evaluate the effect of repetitive transcranial magnetic stimulation and sphenopalatine ganglion block on fibromyalgia pain and psychiatric symptoms.

rtms will be applied on primary motor area (M1) for 20 sessions (5 daily per week for 4 weeks)with 20 HZ and 3000pul with evaluation of pain and psychological symptoms befor intervention and after 10 sesions and after 1 month of last session compared to sphenopalatine ganglion block effect .

Eligibility Criteria:
Inclusion Criteria:

- Women aged from 18 to 60 years old Diagnosed as fibromyalgia with resistence to pharmacological treatment

Exclusion Criteria:

* Previous psychiatric disorders Sever cognitive dysfunction Other medical or neurological disorders Pregnant females
Tongji Maternal and Child Health Cohort

This is a population-based study to obtain data for the evaluation of current used recommendations for weight gain during pregnancy released by IOM (2007) and investigate the association between maternal diet and the health outcomes of mother and offspring.

This is an ongoing population-based prospective cohort study to obtain data for the evaluation of current used recommendations for weight gain during pregnancy released by IOM (2007) and investigate the association between maternal diet and the health outcomes of mother and offspring. 8649 pregnant have been recuited from the first trimester of pregnancy. All datas including the general information, sociodemographic facts, physical exam (body weight, height, blood pressure, etc), laboratory test (hemoglobin, glucose concentration, etc.) and dietary survey (FFQ, 24h food recall) have been collected during the cohort study. Blood sample leftover from the clinical use are remained and stored at -80℃for further measurements. Obstetric characteristics, maternal and perinatal outcomes have been observed and recorded. Growth and development paremeters such as weight, length and head circumference as well as disease information of infants have been collected , feeding pattern and feeding history will be surveyed. All data collected will be used for group analysis only and all private and individual records will be kept secret.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women attending the first visit (\<16 weeks ) at at a maternity clinic in one of these following hospitals in Wuhan, China: HMCHH, CHW,WMCHH,JMCHH.

Intention to visit the maternity clinic regularly in HMCHH or CHW or WMCHH or JMCHH.

* Intention to eventually deliver in HMCHH or CHW or WMCHH.
* The pregnant woman and her husband are Chinese.

Exclusion Criteria:

* Pregnant women on chemotherapy.
* Exclude women on certain medications - e.g. psychotropic drugs.
* Exclude women with significant medical conditions e.g. psychosis etc.
Variability of Movement on an Altered Inertial Dynamics Task

The overall goal of this research is to compare the effects of two different exercise programs on gait function in older adults. The investigators want to determine if participation in lateral stepping exercise program for six weeks will improve gait functions compared to forward walking exercise program.

The overall goal of this research is to compare the effects of two different exercise programs on gait function in older adults. It is expected that improved control of foot placement in the lateral stepping task will transfer to improved control during typical forward walking. Moreover, it is expected that lateral stepping gait training will have a greater effect on recurrent fallers older adults than on the non-fallers older adults and young adults. It is also expected that the above beneficial results will be retained in a follow-up test six weeks after completion of the intervention and will result in improvements in common clinical balance tests that are used to assess fall risk. Therefore, in the current proposal, older adults aged 65 years of age and over are being asked to participate.

Eligibility Criteria:
Inclusion Criteria:

Subjects must

* be aged between 19 and 35 for the young adult group
* be over 65 years of age for the older adult groups
* be independently residing in the community
* be able to provide informed consent
* be able to walk independently without an assistive device or 30 minutes in three-minute sections interspersed with rest periods.

The older participants must either have sustained two or more falls in the past year (i.e. Fallers) or not have sustained any falls in the past year (i.e. Non-Fallers).

Exclusion Criteria:

* Neurological disorder or progressive neurologic condition - epilepsy, Alzheimer disease and other dementias, stroke, multiple sclerosis, Parkinson's disease, brain infections, brain tumors.
* Movement disorder - ataxia, dystonia, Huntington's disease, myoclonus, Parkinson disease, progressive supranuclear palsy, Wilson disease.
* History of Cardiovascular events this includes any history of heart problems (such as heart attack, chest pain, or conditions which affect the heart's muscles, valves, or rhythm)
* Current injury or moderate to severe pain affecting the lower limbs, pelvis, back, trunk.
* Surgery within the past 6 months.
* Current participation in any other study that involves walking, balance, or training.

Medications will not prevent inclusion in the study however they will be recorded to enable consideration in subsequent post-hoc analyses.
L-arginine Versus Sildenafil in Children With Beta Thalassemia Associated With Pulmonary Hypertension

This study compares L-arginine Versus Sildenafil as treatment for pulmonary hypertension in Children with Beta Thalassemia

This study focuses on different lines of treatment for pulmonary hypertension in children with thalassemia as this study discusses the Effect of L-arginine Versus Sildenafil in Children with Beta Thalassemia Associated with Pulmonary Hypertension

Eligibility Criteria:
Inclusion Criteria:

* Children with thalassemia and pulmonary hypertension.

Exclusion Criteria:

* Rheumatic heart diseases.
* Other comorbid disease