cyrilzakka/clinical-trials huggingface dataset:
Maternal Oxygen Administration for Fetal Distress II

Supplementary oxygen is routinely administered to patients, even those with adequate oxygen saturations, in the belief that it increases oxygen delivery. However, oxygen delivery depends not just on arterial oxygen content but also on perfusion.

Maternal oxygen administration has been used in an attempt to lessen fetal distress by increasing the available oxygen from the mother. However, the effect of supplemental maternal oxygen therapy on fetal acid base status has been debated for more than seven decades.

The investigators found the use of 2 L/min maternal oxygen during the second stage of labor did not adversely affect either the umbilical artery pH value or the fetal heart rate (FHR) pattern distribution.


Eligibility Criteria:
Inclusion Criteria:

at term (\>37 weeks, \<42 weeks), singleton, cephalic presentation, spontaneous or induced labor, normal labor, category I FHR tracings, 2 to 3 cm of cervical dilation in nulliparity, 1 to 2 cm of cervical dilation in multipara, informed consent.

Exclusion Criteria:

respiratory or cardiovascular disease, diabetes mellitus or insulin-treated gestational diabetes mellitus, hypertension or preeclampsia, oligohydramnios, fetal growth restriction, placental abruption, cephalopelvic disproportion, meconium-stained amniotic fluid, tachysystole, having received O2, uterine incision (myomectomy or perforation), anemia, fever, chorioamnionitis, tobacco or alcohol use, disorders in oxygen saturations, hypotension, uncomfortable with facemask.
Radial Shockwave Versus Low Level Laser Therapy in Patients With Chronic Piriformis Muscle Syndrome

The study aims to compare the effects of radiation shockwave and low-level laser therapy on piriformis muscle thickness, lower extremity function, pain intensity, and hip range of motion in patients with piriformis syndrome.

Low back pain affects 75%-84% of the general population in developed countries, with piriformis syndrome being more common in women. piriformis syndrome is a neuromuscular disorder caused by the compression of the sciatic nerve in the infra-piriformis canal, causing sciatic pain, tingling, and numbness. Few studies have examined the effectiveness of shockwave therapy in treating piriformis syndrome, but this study aims to compare results to improve treatment outcomes, save time and money, and add value to physical therapy.

Eligibility Criteria:
Inclusion Criteria:

* Sixty patients' males and females with piriformis syndrome

  * Their age will range from 30-50 years old
  * Body mass index will be 25 to 30 (kg/m²).
* Both males and females.
* Low back pain radiating to posterior thigh, calf and Foot.
* Chronic piriformis syndrome due to micro trauma.
* Gluteal pain with or without radiation through sciatic nerve pathway.
* Faber test and Fair test and Beatty test positive.
* Diagnosed sub-acute and chronic piriformis syndrome.
* One-sided piriformis syndrome.
* Tenderness over lower back, buttocks and hip joint.

Exclusion Criteria:

- Piriformis syndrome due to macro trauma.

* Lumbo-sacral disc lesion and spinal stenosis.
* Lumbar spondylolisthesis.
* Pregnancy
* Recent fracture and surgery of spine, hip, knee and Ankle.
* Baker's cyst.
* Degenerative disease of spine and hip.
* Intermittent vascular claudication.
* Past history of vertebral fracture and spinal surgery
* Spinal tuberculosis.
* Rheumatoid disease.
* Disc pathology and mechanical back pain.
* Presence of malignant disease.
Validation of a Sensor for Non-Invasive Measurements

Subjects will be measured with both a sensor and a reference device

Subjects will participate in a study measuring a single set of paired values. In this case, measurements will take roughly 2-30 minutes to complete, and will involve: 1) attaching the sensor on the subject; 2) attaching one or more reference devices to the subject; 3) making measurements with both the sensor and reference device, either simultaneously or sequentially; and 4) collecting and analyzing the paired value.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 (eighteen) years of age at screening.
2. Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
3. Subject selection will not be based on age, height, or weight.
4. Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition as well as the features of the investigational device tested during the study.

Exclusion Criteria:

1. Subject is participating in another clinical study that may affect the results of either study.
2. Subjects that are pregnant will not be included in the study.
3. Subject is unable or not willing to wear electrode patches as required for a period of up to 168 hours.
4. Subject is considered by the Principal Investigator to be medically unsuitable for study participation.
Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension

The objective of this study is to demonstrate that the MDT-2211 renal denervation system is a safe and effective treatment for uncontrolled hypertension subjects despite treatment with 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic, as best available antihypertensive therapy

The HTN-J study is a multi-center, prospective, unblinded, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the MDT-2211 renal denervation system - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.

Eligibility Criteria:
Inclusion Criteria:

* Individual is ≥ 20 and ≤ 80 years old at time of randomization.
* Individual is receiving a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic (with no changes for a minimum of 6 weeks prior to screening) that is expected to be maintained without changes for at least 6 months.
* Individual has an office systolic blood pressure (SBP) of ≥ 160 mmHg based on an average of 3 blood pressure readings measured at both an initial screening visit and a confirmatory screening visit
* Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.

Exclusion Criteria highlights:

* Individual has an estimated glomerular filtration rate (eGFR) of \< 45 mL/min/1.73 m2
* Individual has an Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP \< 135 mmHg
* Individual has type 1 diabetes mellitus
* Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
* Individual has primary pulmonary hypertension.
* Individual is pregnant, nursing or planning to be pregnant.
Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol

The purpose of this non-inferiority study is to compare the safety and effectiveness of a mineral and bone disease treatment protocol based on calcitriol to one based on paricalcitol in hemodialysis patients using revised Kidney Disease: Improving Global Outcomes (KDIGO) parathyroid hormone targets.

Active vitamin D analogs have been the mainstay of treatment for patients on hemodialysis with mineral and bone disease (MBD) for the past decade. Intravenous calcitriol is an active vitamin D analog which is nearly identical to natural 1, 25 Vitamin D3. Calcitriol results from the hydroxylation of previtamin D3 in the liver and kidney. Paricalcitol, 19-nor-1 , 25-dihydroxyvitamin D2, is a newer agent vitamin D analog. This agent is believed to have an effect more specific to the parathyroid gland, and less specific to absorption of calcium and phosphorus from the gut. Although both formulations appear equally effective in suppressing parathyroid hormone (PTH), studies have suggested a greater calcemic effect with intravenous calcitriol as compared to paricalcitol (1). Due to this, paricalcitol is the predominant active vitamin D analog used in hemodialysis patients in the United States. Two recent changes in the management of hemodialysis patients will likely reduce the amount of active vitamin D analogs used in the near future: the liberalization of PTH goals according to international guidelines, (2) and the implementation of bundled payments for dialysis by Medicare. These changes challenge previous studies that have analyzed the safety and efficacy of these medications. The purpose of this prospective, randomized, cross-over study will be to determine whether calcitriol is as safe and effective as paricalcitol in the treatment of MBD in hemodialysis patients using the revised KDIGO parathyroid hormone targets. Our hypothesis is that calcitriol will be as equally safe and effective as paricalcitol in the treatment of MBD in hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

- All subjects will have been treated for at least three months on hemodialysis with IV paricalcitol. These subjects must have a most recent calcium level within the normal range, most recent phosphorus level \< 8 mg/dL and a most recent PTH between 130-585 pg/mL

Exclusion Criteria:

Patients will be excluded if:

1. age greater than 18
2. active malignancy
3. expected survival greater than 6 months
4. high likelihood of renal transplant during the study period.
5. Low calcium bath
6. prior parathyroidectomy
7. use of calcimimetics
Blood Sample Collection and Health Information Collection From Patients With Invasive Breast Cancer and Their Brothers and Sisters

RATIONALE: Collecting blood samples and health information from patients with invasive breast cancer and from their brothers and sisters over time may help the study of cancer in the future.

PURPOSE: This study is collecting blood samples and health information over time from patients with invasive breast cancer and from their brothers and sisters.

OBJECTIVES:

* Collect blood samples and medical and background information from patients with invasive breast cancer and their affected or unaffected siblings.

OUTLINE: Patients and their siblings undergo blood collection. They also complete medical and background questionnaires.

Patients and their siblings are followed annually for 5 years.

PROJECTED ACCRUAL: A total of 1,000 patients and siblings will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Pathologically confirmed invasive breast cancer (patient)

    * No ductal carcinoma in situ
  * Affected OR unaffected sibling

    * Affected sibling must have had (or currently has) breast cancer only
    * Unaffected sibling must be female
    * No deceased siblings
    * Must be a full-blood related sibling
* Patients receiving treatment on clinical trial ECOG-E1Y97 or ECOG-E3Y92 are not eligible

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Maintenance Therapy for Small-cell Lung Cancer

This study involves patients treated with cisplatin and etoposide (induction therapy), followed by treatment with a drug called S1 (maintenance therapy). The main purpose of this study is to determine if this type of treatment will delay the growth of the tumor and if so, for how long. The primary endpoint is progression free survival and second endpoints are toxicities, overall survival.

Small cell lung cancer (SCLC) accounts for about 20% of lung cancer, has a high degree of malignancy, short doubling time, early and widespread metastasis, is sensitive to chemotherapy and radiotherapy, and has a high initial response rate, but is prone to secondary drug resistance and relapse. The treatment is mainly based on systemic chemotherapy, and if maintenance therapy with S1 after standard EP regimen induction therapy could prolong progression free survival.

Eligibility Criteria:
Inclusion Criteria:

* 1. Histopathologically confirmed patients with extensive small cell lung cancer; 2. Karnofsky performance status ≥60; 3. At least one lesion that can measured by CT; 4. Expected to survive for at least 3 months; 5. Peripheral blood and liver and kidney function within the following allowable range (tested within 7 days before treatment); 6. White blood cell (WBC) ≥3.0×109/L or Neutrophils (ANC) ≥1.5×109/L; Hemoglobin (HGB) ≥80 g/L；Platelet (PLT) ≥100×109/L; 7. Liver transaminases（AST/ALT）\<3.0 times the normal range limit; Total bilirubin（TBIL）\<1.5 times the normal range limit; Creatinine（CREAT）\<1.5 times the normal range limit; 8. Patients of childbearing age (including female and male patients' partner) must take effective contraception methods; Signed informed consent 9. Must be able to swallow tablets

Exclusion Criteria:

* 1. Limited stage disease 2. Metastastic meningitis, spinal compression, Tumor to main vesicular less than 5mm 3. Other pathological types of tumor except for small cell lung cancer; 4. Patients with a history of severe allergies or allergies; 5. Pregnancy or breastfeeding women; 6. Patients who have previously participated in other clinical trials and have not yet terminated the trial; 7. Patients who have acute infection that difficult to control; 8. Subjects with difficulties in swallowing or known drug malabsorption.
Influence of Hematocrit Level on the Visibility of the Venous Network in Magnetic Susceptibility Imaging

Magnetic susceptibility imaging is a magnetic resonance imaging (MRI) technique that uses the magnetic properties of tissues and the BOLD (blood oxygen level-dependent) effect. It allows a better visualization of venous structures and hemorrhagic lesions. These sequences are now used in clinical routine.

The extreme sensitivity of these sequences to the oxy/deoxyhemoglobin ratio makes it possible to describe a new MRI semiology, particularly in the context of cerebral ischemia. The interest of the analysis of the venous network signal, which can reflect cerebral perfusion, has been reported.

However, the influence of the hematocrit level on the signal of the venous network in magnetic susceptibility imaging has not been evaluated at present. It seems important to better define the influence of hematocrit level on the signal of the veins with this sequence to avoid potential diagnostic errors.


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age ≥ 18 years
* Patient referred to GHPSJ for suspected stroke
* Patient who had a brain MRI including the magnetic susceptibility sequence
* Patient for whom a blood count with hematocrit was performed at the same time (within 7 days between the MRI and the blood test)
* French-speaking patient

Exclusion Criteria:

* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
* Elimination of potential biases: recent injection (48 h) of gadolinium, pathology likely to modify the venous signal in magnetic susceptibility imaging (notably arterial occlusion or stenosis), high flow oxygenation, sickle cell disease, thalassemia.
* Patient objecting to the use of his/her data for this research
ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia Intermittent Versus Continuous PEG Asparaginase

The purpose of this study is to investigate if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of Event Free Survival

20% of children with ALL still fails to be cured. The ALL-2008 protocol is a treatment and research protocol that aims to improve the overall outcome of Nordic children and adolescents with ALL in comparison with the ALL-2000 protocol and previous NOPHO protocols.

The specific and primary objectives of the randomised study is:

To test if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of EFS. As secondary endpoints asparaginase antibody production and toxicity including allergic reactions in the treatment-arms will be analysed

Eligibility Criteria:
Inclusion Criteria:

* Childhood ALL
* All mandatory biological data are available6
* Written informed consent has been obtained

Exclusion Criteria:

* Bilineage ALL
* Pre-treatment with glucocorticosteroids or other antileukemic agents for more than 1 week
* ALL predisposition syndromes
* Previous cancer
* Off protocol administration of additional chemotherapy during induction therapy
* Sexually active females not using contraception
* No allergic reactions to PEG Asparaginase
The Global Cardiovascular Risk Consortium

The Global Cardiovascular Risk Consortium (GCVRC) brings together harmonized individual-level data from over 2 million individuals across 133 cohorts, 39 countries, and 6 continents, with recruitment ongoing. The GCVRC examines the impact of classical cardiovascular risk factors-such as body mass index, systolic blood pressure, non-high-density lipoprotein cholesterol, current smoking, and diabetes-on cardiovascular disease (CVD) and death from any cause worldwide.

A small number of modifiable risk factors may account for a significant proportion of cardiovascular disease (CVD) risk. However, the CVD burden attributable to classical risk factors depends on the populations studied and the methodologies used.

The Global Cardiovascular Risk Consortium (GCVRC) is an international collaboration that continuously includes cohort studies from around the world to improve cardiovascular risk prediction. The GCVRC uses extensively harmonized individual-level data from currently more than 2 Mio individuals from 133 cohorts, 39 countries and 6 continents categorized in 8 geographical regions (based on a modification of WHO and United Nations definitions) - North America, Latin America, Sub-Saharan Africa, North Africa and the Middle East, Western Europe, Eastern Europe and Russia, Asia, and Oceania.

The consortium has a special focus on classical, potentially modifiable cardiovascular risk factors: Body-mass index, systolic blood pressure, non-high-density lipoprotein cholesterol, current smoking, and diabetes. Key research questions include examining the impact of these factors on major outcomes by geographical region and sex, as well as estimating associated lifetime risk and the potential lifetime difference when modifying these risk factors.

This work is critical for developing regionally tailored CVD prevention and treatment strategies, identifying residual risk, and improving global cardiovascular health. Based on GCVRC data, a landmark paper on the effect of classical risk factors on new-onset CVD and all-cause mortality was published in the New England Journal of Medicine in 2023 (https://doi.org/10.1056/nejmoa2206916).

Eligibility Criteria:
Inclusion Criteria:

Population-based individual-level data with available information on the classical cardiovascular risk factors including body-mass index, systolic blood pressure, non-high-density lipoprotein cholesterol, current smoking, and diabetes, as well as the outcomes of interest.

Exclusion Criteria:

* Participants with age below 18 years
* No information on the outcome of interest
* No information on the exposure of interest (CVD risk factors)
* History of CVD at baseline
A Study Comparing Obinutuzumab (RO5072759; GA101) 1000 Milligram (mg) Versus 2000 mg in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GAGE)

This open-label, multicenter, randomized study compared the efficacy, safety and pharmacokinetics of obinutuzumab (RO5072759; GA101) 1000 mg versus 2000 mg in participants with previously untreated CLL. Participants were randomized to receive a maximum of 8 cycles (28-day cycle) of obinutuzumab (1000 mg intravenous \[IV\] infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of each subsequent cycle up to 8 cycles or maximum of 8 cycles of obinutuzumab (2000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of each subsequent cycle up to 8 cycles.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CD20-positive B-cell CLL (per International Workshop on Chronic Lymphocytic Leukemia \[IWCLL\] guidelines)
* Rai Stage III/IV or Binet Stage C disease, or Rai Stage I/II or Binet Stage B disease that requires treatment according to IWCLL guidelines
* No previous treatment for CLL chemotherapy, radiotherapy or immunotherapy; no previous rituximab treatment for autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP); prior use of steroids for AIHA or ITP is allowed
* Eastern Cooperative Oncology Group performance status of 0, 1 or 2

Exclusion Criteria:

* Confirmed diagnosis of Transformation of CLL to aggressive B-cell malignancy
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
* Evidence of severe, uncontrolled concomitant disease
* Known active infection or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks before the start of Cycle 1
* Seropositive for human immunodeficiency virus (HIV)
* Positive for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \[HBsAg\] serology)
* Positive for hepatitis C (hepatitis C virus \[HCV\] antibody serology testing)
* Pregnant or lactating women
* Concurrent (or within 7 days prior to first dose of study treatment) systemic corticosteroid use, except for low-dose corticosteroid therapy used to treat chronic medical conditions
Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age

Multicentric, open-label, randomized, pilot comparative study in parallel groups comparing 1 group of subjects receiving 0.057 milligram/kilogram/day (mg/kg/day) or 0.40 mg/kg/week of Saizen® during 1 year to 1 group receiving 0.035 mg/kg/day (0.24 mg/kg/week) of Saizen® during 1 year after an initial 3-year treatment of recombinant human growth hormone (r-hGH) therapy with 0.057 mg/kg/day in both groups.


Eligibility Criteria:
Inclusion Criteria:

To be eligible for inclusion / randomization into this study, the subjects must fulfill all of the following criteria (if there is no inclusion phase, the inclusion criteria will be considered as inclusion criteria for randomization):

* Written consent form signed by the parents / legal guardian, and child if possible
* Subject born SGA and receiving a r-hGH therapy for this pathology
* Recombinant human growth hormone (r-hGH) started at the maximal chronological age of 7 years for girls and 8 years for boys
* Treatment with r-hGH started for at least 30 months and less than 36 months at 0.057 mg/kg/day
* Height gain during the first 2 years of GH treatment \> 1 SD compared with the initial value

Exclusion Criteria:

To be eligible for inclusion in this study the subjects must not meet any of the following criteria:

* Known hypersensitivity to Somatropin or any of the excipients
* Active neoplasia (either newly diagnosed or recurrent)
* Intracranial hypertension
* Known diabetes mellitus
* Proliferative or preproliferative diabetic retinopathy
* Evidence of any progression or recurrence of an underlying intra-cranial space occupying lesion
* Obesity defined as degree 1 on the corpulence curves
* Precocious puberty
* Pubertal status: Tanner breast development stage \> 2 for girls, and testicular volume \> 4 milliliter (mL) or testicular length \> 3 centimeter (cm) and/or testosterone value \>1 nanomole/liter \[nmol/L\] (0.29 gram/mL \[g/mL\]) for boys For girls \> 9 years and Tanner breast development stage 1: uterine size \> 35 millimeter (mm)
* Severe chronic concomitant illness such as chronic renal failure, cystic fibrosis
* Concomitant corticoid treatment or levothyroxine treatment other than substitutive treatment, topical or inhaled treatment
* Participation to any clinical study within the 30 days preceding study entry