cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Dara-CyBorD in Previously Untreated and Relapsed Subjects With Multiple Myeloma

The purpose of this study is to evaluate complete response plus (+) very good partial response (CR+VGPR) rate following 4 cycles of induction therapy of daratumumab in combination with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD), in previously untreated subjects, and in relapsed subjects with multiple myeloma, as defined by the International Myeloma Working Group (IMWG) criteria.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with documented multiple myeloma (MM) as defined by the International Myeloma Working Group (IMWG) 2015 criteria: Clonal bone marrow plasma cells greater than or equal to (\>=) 10 percent (%) or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following CRAB (calcium level, renal dysfunction, anemia, and destructive bone lesions) features and myeloma defining events as in the protocol
* Subjects with previously untreated myeloma or relapsed myeloma with one prior line of therapy including an induction regimen which may be followed by autologous stem cell transplantation and single agent maintenance therapy. For previously untreated subjects an emergency course of steroids (defined as no greater than 40 milligram (mg) of dexamethasone, or equivalent per day for a maximum of 4 days) is permitted. In addition, radiation therapy is permitted prior to study entry, during screening, and during Cycles 1-2 of study treatment as needed for lytic bone disease
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
* A woman of childbearing potential must have 2 negative serum (beta (β) human chorionic gonadotropin) or urine pregnancy tests during screening, the first one within 28 days prior to the first dose of study drug and the second within 24 hours prior to the first dose of study drug
* A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control example, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug

Exclusion Criteria:

* Refractory to any proteasome inhibitor (PI) or the combination of PI and immunomodulatory drug (IMiD) agents (such as lenalidomide), defined as failure to respond or progression within 60 days of the end of PI therapy
* Exhibiting clinical signs of or has a known history of meningeal or central nervous system involvement by multiple myeloma
* Has known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) less than (\<) 50 percent (%) of predicted normal
* Has known moderate or severe persistent asthma within the past 2 years, or currently has uncontrolled asthma of any classification
* Is known to be seropositive for human immunodeficiency virus, known to have hepatitis B surface antigen positivity, or known to have a history of hepatitis C
Safety and Tolerability After Four Weeks of Treatment With AZD1656 in Patients With Type 2 Diabetes

The purpose of this study is to assess the 1 month safety and tolerability after multiple oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Insulin


Eligibility Criteria:
Inclusion Criteria:

* type II diabetes patients, female with non child-bearing potential
* Subjects with T2DM diagnosis for at least one year, treated with insulin alone or insulin in combination with other anti-diabetic drugs. Subjects must have been treated with insulin the last 3 months prior to enrolment (screening)
* HbA1c \<11% at enrolment (screening) (HbA1c value according to international Diabetes Control and Complications Trial \[DCCT\] standard).
* FPG in the range of 7.0 to 13.0 mmol/L (126 to 234 mg/dL)

Exclusion Criteria:

* History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
* Use of glitazones, warfarin, amiodarone within 3 months prior to enrolment (screening) and use of potent CYP450 inhibitors, eg, ketoconazole and macrolide antibiotics within 14 days before randomisation.
* Any clinically significant abnormality identified on physical examination, laboratory tests or ECG, which in the judgment of the investigator would compromise the patients' safety or successful participation in the clinical study.
Anti-Inflammatory Efficacy of Ginger Containing Dentifrice in the Control of Biofilm Induced Gingivitis

The goal of this clinical trial is to test efficiency of using toothpaste containing (Ginger) over a period of three month to control on gingival inflammation and plaque accumulation through measuring the clinical periodontal parameters (Gingival Index (GI), Bleeding on probing (BOP) and modified Quigley-Hein Plaque Index (mQHPI ) in comparison with Colgate total toothpastes in patients with biofilm induced gingivitis.

Objectives:

1. Measuring the clinical periodontal parameter (gingival index) and salivary cytokine IL-1β and superoxide dismutase SOD over a period 3 months before and after using Capitano (ginger containing) and Colgate total toothpastes for patients with gingivitis.
2. Measuring the clinical periodontal parameter ((Gingival Index (GI), Bleeding on probing (BOP) and modified Quigley-HeinPlaque Index (mQHPI )) over a period 3 months before and after using Capitano (ginger containing) and Colgate total toothpastes for patients with gingivitis by ELISA.
3. correlation between ( Interleukin 1 beta and SOD) and clinical periodontal parameters

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 20-35 who will volunteer to participate.
2. Apparently good general health.
3. Patients with gingivitis (having ≥30% bleeding sites with no PPD \>3 mm, intact periodontium and no loss of periodontal attachment).
4. Those with a minimum of 20 natural teeth.

Exclusion Criteria:

* 1. Those with chronic disease, immunocompromised patients, pregnant, on contraceptive and lactating women.

  2. Those currently using any mouthwash. 3. Those on antibiotic therapy and anti-inflammatory medications during the study and at the last 2 months before the study.

  4. Those having a history of hypersensitivity to any product used in the present study.

  5. Those with a recent tooth extraction. 6. Those having periodontitis. 7. Those who smoker or alcoholism. 8. Those with extensive untreated dental caries, diseases of hard and soft palate and subjects wearing orthodontic appliances, removable dentures, implant, crown and bridge or presenting with abnormal salivary flow.
Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia

The goal of this research study is to evaluate the effectiveness, tolerability and safety of rivastigmine capsules in males and females between the ages of 50 and 85 years old with probable vascular dementia.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 50 and 85 years old
* Have contact with a responsible caregiver 3 or more days per week
* Be male or a female who is surgically sterilized or one year post menopausal

Exclusion Criteria:

* Current diagnosis of severe or unstable cardiovascular or other diseases
* Current diagnosis of active, uncontrolled seizure disorder, Parkinson's disease or Alzheimer's disease
Prophylactic Oxytocin Before Versus After Placental Delivery to Reduce Blood Loss in Vaginal Delivery

Randomized controlled study to assess the efficacy and safety of the timing of administration of prophylactic oxytocin via intramuscular route (before compared to after placental delivery) on blood loss in vaginal delivery.

400 patients will be recruited for the study,Informed consent will be obtained from all patients following the research criteria once they are admitted in active labor, but they will be enrolled and randomized only when they reach the second stage of labor (fully dilated cervix) as it will be difficult in this stage to counsel patients.

The recruited patients will be subjected to the following:

* History taking: with particular emphasis on past medical history (especially for bleeding tendency), past obstetric history.
* Checking vital signs, General and abdominal examination.
* laboratory investigations: complete blood count (CBC)
* Findings of the initial obstetric evaluation follow up, labor duration and the need for oxytocin augmentation will be recorded through a partogram.
* All deliveries will be attended by a senior resident in the hospital.
* Included patients will receive the medication according to randomization tables.
* After allocation, patients will be excluded only if they required cesarean section, instrumental delivery or had multiple or deep vaginal tears that compromise estimation of uterine blood loss.
* All patients will undergo gentle traction to the umbilical cord while providing counter traction against the uterine fundus after signs of placental separation; appearance of bleeding, elongation of the cord.
* All patients will undergo cord clamping and cutting within 30 seconds of delivery.
* All patients will undergo uterine massage for 30 seconds after placental delivery.
* Vital signs (blood pressure and pulse) will be checked 15 minutes, 1 hour and 6 hours after placental delivery.
* CBC will be collected 6 hours after delivery.

Eligibility Criteria:
Inclusion Criteria:

1. Multiparous women (had previous one, up to four deliveries)
2. Term pregnancy (37 completed weeks at least).
3. Singleton viable cephalic pregnancy.
4. Vaginal delivery.

Exclusion Criteria:

1. Primigravida.(first pregnancy)
2. Grand multiparous. (had previous 5 or more deliveries)
3. Maternal illness (involving pregnancy induced condition; PIH,GDM or chronic medical condition; hypertension, cardiac , renal problems)
4. Previous cesarean section, uterine surgery.
5. Patients with bleeding tendency.
6. Previous history of Ante-partum hemorrhage.
7. Previous history of postpartum hemorrhage.
8. Abnormal site of the placenta (detected by ultrasound)
9. Macrosomic baby (EFW more than 4000 gm estimated clinically or by ultrasound)
10. polyhydramnios.(detected by ultrasound)
11. Multiple gestation.
12. Chorioamnionitis.
13. Suspected fetal problem(anomaly, distress)
14. Instrumental delivery.
15. Multiple or deep vaginal tears that compromise the estimation of uterine blood loss.
16. Cesarean delivery
Blood Flow Technique Effect on the Muscle Mechanics

This study will be a study in which we take measurements with the myotonPRO device to determine whether the resistant exercises performed without the blood flow restrictive technique and with the blood flow restrictive technique affect the biceps muscle of the participants, who were divided into groups by randomization method after determining the 1 max repetition you can lift.


Eligibility Criteria:
Inclusion Criteria:

* Being a healthy male or female volunteer between 18 and 35 (who has not participated in any resistance training program for at least 6 months).
* Being right-hand dominant according to the results of the Edinburgh Handedness Inventory.

Exclusion Criteria:

* Having a history of biceps musculoskeletal injury.
* Having any condition that prevents participation in resistance exercise.
* Having cardiovascular disease.
* Using medication for blood pressure control.
The Role of Optic Nerve Sheath Fenestration in Leukemic Patients Having Increased Intracranial Pressure

Optic nerve sheath fenestration (ONSF) first described by De Wecker in 1872 for the treatment of neuroretinitis. Since then, optic nerve sheath fenestration has become well established procedure for treatment of papilledema in medically uncontrolled patients of idiopathic intracranial hypertension.

Optic nerve sheath fenestration (ONSF) first described by De Wecker in 1872 for the treatment of neuroretinitis. Since then optic nerve sheath fenestration has become well established procedure for treatment of papilledema in medically uncontrolled patients of idiopathic intracranial hypertension. Indications for ONSF in cancer patients are not well established, but a few case reports have shown success of ONSF in patients with perineural metastasis of breast cancer, increased intracranial pressure with papilledema due to a brain tumor, leukemia and optic nerve sheath meningioma. This study is conducted to establish the role of optic nerve sheath Fenestration in leukemic patients mainly those suffering from acute lymphoblastic leukemia.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of progressive visual loss and papilledema did not improve despite the maximal medical therapy prescribed.
* Informed written consent was obtained from the parents/care providers of the study participants.

Exclusion Criteria:

* Can not get the informed consent
Parametric Mapping in Paediatric Magnetic Resonance Imaging

Magnetic resonance imaging (MRI) is increasingly an important tool for diagnosis and management of cardiac diseases in children.

One of the uses of MRI is tissue characterisation, in which the signal characteristics of the cardiac muscle (myocardium) can be determined with special techniques, known as parametric mapping.

There is increasing evidence that parametric mapping may be able to identify regions of scarring in the myocardium, or detection of oedema/inflammation in the setting. This in turn can help predict disease course and add value to the management of patients.

There is also evidence that other structures that are visualised in parametric mapping aside from the heart (e.g. liver and spleen) can also help improve diagnostic accuracy and guide management.

Currently the majority of studies describing the use of parametric mapping is focused on adults, with limited data on its use in children.

The parametric mapping values can also differ amongst different machines, so calibration with normal subjects are also required.

Magnetic resonance Imaging (MRI) can provide tissue characterisation without radiation and need for invasive biopsy.

Parametric mapping techniques (T1 mapping, extracellular volume fraction, T2 mapping, T2\* mapping) are methods of quantitative analysis of tissue properties, and are currently commercially available.

T1 mapping, extracellular volume fraction (ECV) and T2\* mapping provides knowledge about the tissue properties of the myocardium, interstitium and adjacent structures,and can provide information for diagnosis of fibrosis, inflammatory and infiltrative diseases.

T2 mapping is useful for assessing oedema, which may be useful in monitoring disease activity such as myocarditis.

Parametric mapping has proven clinical utility in iron deposition, amyloid disease, Anderson-Fabry disease and myocarditis.

In addition to assessment of cardiac muscle, tissue characterisation can also be performed in adjacent organs that are included in the field of view of parametric mapping (e.g. liver and spleen).

Parametric mapping may provide important diagnostic information for decision making, patient monitoring and management planning.

The investigators aim to

1. recruit healthy volunteers as controls to establish normal local reference ranges for parametric mapping values
2. recruit patients undergoing clinically indicated cardiac MRI to perform parametric mapping, and compare the parametric mapping values between normal controls and patients.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Paediatric patients \<=18 years of age with suspected or confirmed cardiac disease undergoing clinically indicated MRI

Exclusion Criteria:

* Unstable or uncooperative patients that cannot tolerate MRI
* Patients with contraindications for MRI (e.g. patients with implanted devices that are not MRI compatible)
Epidemiology of Acute Self-poisoning in Emergency Services in France

Acute self poisoning is a leading cause of suicide attempts and leads to frequent emergency department visits. However, the exact epidemiology of acute self poisoning is not known. The description of the clinical pathway and the characteristics of patients with acute self poisoning could lead to an improvement in emergency care.

The Investigators will conduct a 48h observational study in emergency services in France. Investigators primary objective is to gathered epidemiological clinical and treatment data during emergency dispatch, prehospital care and inhospital emergency care.

Acute self poisoned patients will be prospectively and anonymously recruited by emergency physicians in charge during two days. Acute self poisoning is define as follow: intentional medicine intake in the 24h hours before emergency department admission.

Epidemiological, clinical, toxicological and treatment data will be gathered. Outcome of patient will be prospectively assessed at 30days.

All data will be transmitted to the principal investigators. Then, 20% of the data will be monitored by an independent committee.

Exhaustivity will be retrospectively assessed by the number of inclusions in 10 emergency centers divided by the total number of possible inclusions in these centers.

Finally, an independent statistician will be in charge of the analysis.

Eligibility Criteria:
Inclusion Criteria:

* acute self poisoning defined as the intentional intake (oral, nasal, injection etc.) of medicines during the 24h before first medical contact

Exclusion Criteria:

* cardiac arrest at first medical contact (dispatch or physician)
* acute self poisoning without any medication intake
* non intentional poisoning
Effects of Bile Acids and Bile Acid Sequestrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass

The purpose of this study is to examine the effects of bile acid and bile acids sequestrants on GLP-1 Secretion, during a meal, in patients after Roux-en-Y gastric bypass.


Eligibility Criteria:
Inclusion Criteria:

* Uncomplicated RYGB performed minimum 3 months prior to the study.
* Fasting plasma glucose \< 7,0 mM, HbA1c \< 48 mmol/mol 3 months after RYGB

Exclusion Criteria:

* Fasting plasma glucose \> 7,0 mM, HbA1c \> 48 mmol/mol 3 months after RYGB.
* Dysregulated thyroid diseases, use of antithyroid treatment.
* Late diabetic complications as retinopathy, renal insufficiency, neuropathy or previous pancreatitis.
* Complications to RYGB. Documented reactive hypoglycaemia, severe dumping (vomiting, diarrhea, severe abdominal pain after food intake).
* Cholecystectomy
Efficacy of PLEM100(Inbody®) in Children

Evaluation of efficacy of PLEM100(Inbody®) in measuring the sedation level in pediatric patients

The investigators plan to gather the basic data relevant to measurement of the level of consciousness/sedation in pediatric patients with developing brain by using PLEM100(Inbody®)

PLEM100 (Inbody®) is a medical equipment to measure, based on phase lag entropy algorithm, the level of patient consciousness, which is expressed by PLE score ranging from 0 (burst suppression or deep sedated) to 100 (awake).

In this study, pediatric patients aged from 3 to 6 years old who undergo total intravenous general anesthesia are chosen as target subjects. The investigators measure how PLE score changes during 1) anesthesia induction, 2) anesthesia maintenance, 3) emergence from anesthesia. Then, the PLE score would be validated by analyzing the correlation with the consciousness level expressed in University of Michigan Sedation Scale (UMSS).

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients to be operated under general anesthesia, aged from 3 to 6 years
* Written Consent is available from a parent who has been explained about the study
* Elective surgery

Exclusion Criteria:

* Patients who cannot be attached by PLEM100 (Inbody®) sensors to the forehead or the side of the head
* Patients Having Cerebral Vascular Diseases in the past or present
* Patients with Developmental delay
* Patients to be admitted to intensive care unit or sedated after receiving operation
* Patients who researchers decide are not eligible to be enrolled in the study because of various factors including clinical test results.
Efficacy of an Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis

The primary purpose of this study is to determine whether a single ultrasound-guided intra-articular injection of botulinum toxin A associated to splinting is effective in reducing pain at 3 months in base-of-thumb osteoarthritis.

Base-of-thumb osteoarthritis is a common condition affecting middle-age persons. Base-of-thumb osteoarthritis induces pain and hand-specific limitations in activities. For short and midterm effects, therapeutic options usually include splinting, exercise therapy and intra-articular injections of glucocorticoids or hyaluronic acid. However, evidence of efficacy of intra-articular therapies in base-of-thumb osteoarthritis and international guidelines are inconsistent. Recently, the use of intra-articular botulinum toxin A as a pain killer has raised intense interest. The exact mechanisms of pain modulation by botulinum toxin A in osteoarthritis are unclear. It has been suggested that botulinum toxin A could directly reduce peripheral sensitization and indirectly reduce central sensitization. Indeed, recent studies suggest an inhibitory role of botulinum toxin A on the release of mediators involved in nociception, such as P substance, calcitonin gene-related peptide and glutamate. Open and randomized controlled trials of botulinum toxin A in knee osteoarthritis support short to mid-term positive clinical effects on pain. However, no study has reported results for base-of-thumb osteoarthritis

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Pain intensity on a self-administered 11-point pain numeric rating scale ≥ 30
* Pain involving the base-of-thumb
* X-ray evidence of base-of-thumb osteoarthritis with at least 2 of the 4 following items involving the trapeziometacarpal joint : osteophytes, joint space narrowing, subchondral bone sclerosis or subchondral cysts
* 1990 American College of Rheumatology classification criteria for hand osteoarthritis adapted to base-of-thumb osteoarthritis
* Medical examination
* Written consent
* Health insurance
* For women of childbearing age, a negative urinary pregnancy test

Exclusion Criteria:

* History of thumb surgery
* History of inflammatory or crystal-associated rheumatic disease
* Neurological disorders involving the hands other than carpien canal syndrom
* Collagen disorders involving the hands : Dupuytren, Marfan or Ehlers-Danlos diseases
* Osteoarthritis predominating at the scaphotrapezial joint on X-Ray
* Hand or wrist trauma ≤ 2 months
* Hand or wrist intra-articular injections ≤ 2 months
* Contra-indication to botulinum toxin A injection or to splinting
* Cognitive or behavioral disorders making the assessment impossible
* Participant unable to speak, read and write french
* Bilateral BTOA without predominant symptomatic side
* Pregnancy and breast feeding
* Persons referred to in Articles L 1121-5; 6; 8; 9 of the Public Health Code (protected minors or adults, guardianship or trusteeship, etc.)
* Patient with epilepsy