cyrilzakka/clinical-trials huggingface dataset:
WB-DW-MRI vs CHOLINE-PET/CT for Selecting Treatments in Recurrent Prostate Cancer

The purpose of this study is to determine the effectiveness of whole-body diffusion-weighted magnetic resonance imaging (WB-DW- MRI) in detecting metastases by comparing the results with those from choline-positron emission tomography-computed tomography (choline-PET/CT) in patients with metastatic/oligometastatic prostate cancer. Patients with this disease profile who could benefit from treatment with stereotactic body radiation therapy (SBRT) were selected and their responses to these techniques were rated.

This was a prospective, controlled, unicentric study, involving 46 consecutive patients from our centre who presented biochemical relapse after adjuvant, salvage or radical treatment with external beam radiotherapy, or brachytherapy. After initial tests ( bone scintigraphy, CT, pelvic MRI) 35 patients with oligometastases or without them were selected. 11 patients with multiple metastases were excluded from the study. WB-DW- MRI and choline-PET/CT was then performed on each patient within one week. The results were interpreted by specialists in nuclear medicine and MRI. If they were candidates for treatment with ablative SBRT (SABR) they were then evaluated every three months with both tests.

Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer histologic diagnostic after one treatment
* 5 o less lessions
* Asimptomatic lessions
* Informed Consent Form signed

Exclusion Criteria:

* Not capability to perform NMR os CT/PET scans
Mostafa Maged Four-stitch Technique in Closure the Episiotomy During Vaginal Delivery

Most primigravida is confronted with episiotomy during childbirth to prevent the perineal and vaginal lacerations which could be performed at birth. There are many types of episiotomy which are median, mediolateral, and J-shaped episiotomy.

Prevention of the formation of the dead space during the repair of episiotomy so avoiding hematoma formation in the episiotomy area after child-birth.

The Mostafa Maged four-stitch technique uses absorbable vicryl threads with round needles 75 mm.

Methodology: This technique will be applied to all women with episiotomy at the time of delivery or having tears in the perineum or the vagina. The technique uses absorbable vicryl threads with round needles 75 mm long. The technique includes the vaginal epithelium and the deep muscle layer together continuously at the same sutures. Assessment of the perineal area in the next twenty-four hours till discharge looking for (edema - hematoma - septic wound - continence - ecchymosis - dyspareunia).

Eligibility Criteria:
Inclusion Criteria:

1. Primigravida patients having episiotomies or tears in the vagina
2. Age between 18 to 40 years old

Exclusion Criteria:

1. Smokers
2. Diabetics
3. Morbidly obese patients
4. Chronic diseases such as renal diseases
Repeating Patterns of Sleep Restriction and Recovery

Goal of this study is to test the hypothesis that repeated exposure to cycles of insufficient sleep increases susceptibility to a variety of disease states by progressively compromising the integrity of stress response systems.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.5 and 30 kg/m2
* For female participants: regular menstrual cycles
* Daily sleep duration in the normal range
* Blood chemistry in the normal range

Exclusion Criteria:

* Active infection/disease
* History of psychiatric, neurological, pain-related, immune, or cardiovascular disease; significant allergy
* Pregnant/nursing
* Respiratory disturbance index of \>5 events/hour on polysomnographic sleep study, leg movements with arousal \>10/hour; sleep efficiency \<80%
* Regular medication use other than oral contraceptives
* Donation of blood or platelets 3 month prior to or in-between study arms
Frequency of Occurrence and Risk Factors of Postoperative Nausea and Vomiting During Elective C-section Under Spinal Anesthesia With Preventive Medication

The aim of this study is to learn about the incidence and risk factors of nausea and vomiting during planned caesarean section under spinal anesthesia.

The main question it aims to answer is : What are the incidence and risks factors of postoperative nausea and vomiting (NV) during planned caesarean section under spinal anesthesia with administration of intrathecal morphine and multimodal antiemetic prophylaxis ?

Patients who will be managed according to the standard protocol in use in the department will have to answer specific questions about NV in the post-interventional recovery room and on 2 further visits in the first 24 hours post-caesarean section.


Eligibility Criteria:
Inclusion Criteria:

Any patient requiring elective caesarean section under spinal anesthesia, at a gestational age \>37 weeks of amenorrhea in the context of a single-fetal pregnancy.

Exclusion Criteria:

Failure to understand the French language; Contraindication to locoregional anesthesia; Nausea and/or vomiting in the 24 hours preceding the procedure; Type 1 or type 2 insulin-requiring non-gestational diabetes; Allergy or contraindication to one of the products used in the usual management protocol; Severe preeclampsia; Height \<150 cm
Hydroxychloroquine in Untreated B-CLL Patients

Eligible CLL patients who sign an informed consent will be started on hydroxychloroquine 400mg po daily for up to one year. They will be monitored for disease status as well as adverse reactions after two weeks and then every 4 weeks. Ophthalmologic exams is required at baseline and every 6 months or sooner if the patient develops any visual disturbances.

This is a single-center, open-label, single arm Phase 2 study evaluating the feasibility, and efficacy of treating CLL subjects with hydroxychloroquine. The study schema and schedule of events are as follows:

Prior to beginning hydroxychloroquine:

* Blood samples to be taken.
* Baseline tests confirming diagnosis of CLL as defined above (if not already obtained in records)
* Physical exam performed
* Either six months prior or 4 weeks within starting HCQ ophthalmologic exam documented
* Days 1-365 subject takes hydroxychloroquine 400mg/day
* At 2 weeks: CBC and chemistry
* Every 4 weeks: CBC, chemistry, history (including the inquiry about the presence or absence of visual symptoms) and physical exam.
* Starting at 4 weeks: blood samples taken for laboratory companion studies taken at office visit every 8 weeks.
* At 6 months (+ or - 30 days): subject will have follow up ophthalmologic exam). This will also be done in the presence of any visual/ocular symptoms.

All subjects must meet the selection criteria for registration in this study. All subjects must have a peripheral blood sample submitted. It is estimated that approximately 70 subjects will be screened. The anticipated accrual period is 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Flow cytometry confirmed B-CLL
* No prior chemotherapy or immunotherapy
* Performance status 0-2
* Age \> 18 years old
* If childbearing age, woman you must be willing to use birth control for length of hydroxychloroquine use
* Must have capacity to consent for study and sign consent form
* Asymptomatic CLL not requiring treatment at time of study entry

Exclusion Criteria:

* Pregnancy
* Significant optic nerve pathology as documented by an opthalmologic exam
* Hypersensitivity to 4-aminoquinoline compound
* Patients taking cardiac glycosides and cyclosporine
Treatment Of Bronchiolitis With Heated Humidified High Flow Nasal Cannula - Prospective And Retrospective Research

Bronchiolitis is an acute lower airway infection caused by a viral infection. It is a major cause of winter admissions to pediatric wards. Accepted therapies include oxygen support and IV fluids, whereas other supportive therapies such as inhalations are of questionable benefit. Moderate to severe cases are a source of distress to patient, parents and medical staff often necessitating Pediatric Intensive Care Unit admission. Heated Humidified High Flow Nasal Cannula (HHHFNC) therapy has been shown lately to improve the work of breathing, oxygen saturation, and CO2 pressure (PCO2) values as well as decrease PICU admissions and intubation rates. We planned a prospective and retrospective study in order to check the feasibility of using HHHFNC in a primary pediatric ward and its effect on clinical well being, respiratory status and PICU admission.

Supportive Care, Single Group Assignment, Open Label, Non-Randomized, Efficacy Study

The research is devised as follows:

Prospective section: We will enroll children 0-2 years old, diagnosed with Bronchiolitis in our ward (Pediatrics C) during the months of November-March 2014-2016. Children will be evaluated according to a Bronchiolitis Severity Score devised by Wang and Co which was successfully used in previous research. Children answering criteria for moderate or severe Bronchiolitis according to Wang and Co. will be enrolled pending written consent by both parents.

Our prediction is to enroll a total of 200 children during the 2 winter seasons during 2014-2016.

Retrospective section: We will examine up to 200 cases of children aged 0-2 years hospitalized due to Bronchiolitis in Pediatrics C during 2014-2016 which were not enrolled in our research (due to lack of consent/unavailable HHHFNC etc.). We will compare clinical data and vital parameters between the groups treated with HHHFNC and those who were not.

Eligibility Criteria:
Inclusion Criteria:

in age interval, diagnosed with Bronchiolitis

Exclusion Criteria:

Chronic heart/lung disease, immunocompromised state
A Phase 1 Study of ABT-869 in Subjects With Solid Tumors

The objective of this study is to evaluate the pharmacokinetics, safety and tolerability of ABT-869 in Japanese patients with solid tumors up to the Recommended Phase Two Dose that was determined in a previous the M04-710 study.


Eligibility Criteria:
Inclusion Criteria

* Subjects aged from 20 to 75 years and ECOG PS of 0-2 at screening.
* Subject must have a solid tumor that is refractory to standard therapies or for which a standard effective therapy does not exist.
* The subject must have adequate bone marrow, renal and hepatic function.
* Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and up to six months following completion of therapy.
* The subject must voluntarily sign and date an informed consent.

Exclusion Criteria

* The subject currently exhibits symptomatic or intervention indicated CNS metastasis.
* The subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic or any investigational therapy within 4 weeks of enrollment or has not fully recovered from toxicity resulting from past treatment(s) that affects the assessments in this study at the enrollment.
* The subject with the following conditions during screening assessment.

  1. proteinuria CTC grade \> 1 as measured by urinalysis and 24 hour urine collection
  2. diastolic blood pressure (BP) \> 95 mmHg; or systolic blood pressure (BP) \> 150 mmHg
  3. a history of or currently exhibits clinically significant cancer related events of bleeding
  4. LV Ejection Fraction \< 50%
  5. received a cumulative dose of Anthracycline \> 360 mg/m2 for treatment of cancer
  6. receiving therapeutic anticoagulation therapy
  7. having fractures except for chronic bone lesion due to bone metastases
* The subject exhibits evidence of other clinically significant uncontrolled condition(s).
The Role of Methycobalamin in Early Dementia Patients With Vitamin B12 Deficiency and Hyperhomocysteinaemia.

Patients who fit the inclusion criteria are admitted into the study. They are given 3 IV injection of MBL in the first week and one tablet three times a day for 16 weeks.


Eligibility Criteria:
Inclusion:

* Patients with Dementia
* Serum B12 \< 200 pmol/l
* Serum Homocysteine level \> 11.0 micro mol/L

Exclusion:

Significant communication problems

* deafness, dysarthria, dysphasia etc.
* unstable DM or hypertension
* alcohol abuse
* co-existing diseases which may affect cognition e.g. cognitive cardiac failure, respiratory failure
* folate \< 10 g/dl
* haemoglobin concentration \< 10g/d
* abnormal thyroid function test or VDRL
Effectiveness of a Manual Therapy Protocol in Patients With Masticatory Muscle Disorders

Comparing the efficiency between manual therapy protocol and effleurage in patients with temporomandibular disorders.

The investigators want to get better insights into the outcome of a manual therapy protocol compare with effleurage. The treatment is meant for people who has masticatory muscle disorders. Besides, if the trial can reduce the pain's intensity and the trial can improve range of motion in the dysfunction of temporomandibular joint. The results will be register on the short and long term.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are between 18 and 60 years old.
* Patients who have myofascial pain or myofascial pain and restricted oral opening taking into account Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
* Patients who have pain in their masticatory muscles while they are doing functional activities with their temporomandibular joint for, at least, the last six months.

Exclusion Criteria:

* Patients who cannot receive manual therapy.
* Patients who took or have been taking pills in the last two months before they start in the trial like: antidepressants, antiepileptics, muscle relaxants or medications for metabolic diseases; because they affect the musculoskeletal system.
* Surgery intervention in the temporomandibular joint.
* Patients who have received physiotherapy sessions in the last six months.
* Red flags: malignant or inflammatory tumors, infectious diseases that contraindicate manual therapy, cervical surgery, previous history of whiplash, fibromyalgia, trigeminal neuralgia, osteoarthritis or rheumatoid arthritis.
* Patients who lost their teeth (excluding the third molar) or people using a total or partial dentures.
Pharmacogenetics of Torasemide and Spironolactone in Hypertension Treatment

Phase III interventional study to evaluate the different efficacy of Torasemide and Spironolactone in reducing systolic blood pressure in carriers and non-carriers of the different genotypic combinations for Lanosterol and Uromodulin

The investigators will enroll 144 naïve hypertensive subjects who will undertake 2-4 weeks of run-in and 4 weeks of treatment (7 day window at each visit). During this period partecipants will follow a low sodium diet (about 5g/day) and will be monitored with blood chemistry tests

Eligibility Criteria:
Inclusion Criteria:

* male (25-65 years) and female (45-65 years in menopause defined as "12 consecutive months of amenorrhea for which no other physiological or pathological cause has been identified in woman over 45 years of age")
* newly diagnosed hypertensive patients never treated before or on single antihypertensive drug therapy
* hypertension grade I or II (according to 2013 ESH guidelines, in the patient untreated or despite therapy), defined as the following:

  * at visits T-4 and T-2 (week -4 and week -2 ± 7 days, run-in period) the mean of the last 3 consecutive SBP measurements must be \>=140 mmHg and/or diastolic BP\>= 90mmHg
  * at the T0 visit (week 0 ± 7 days, enrollment), the mean of the last 3 consecutive systolic BP measurements must be \>=140 mmHg and \<180 mmHg and diastolic BP must be \>=90 mmHg and \<110 mmHg
* signing of the informed consent for participation in the study and for genotyping.

Exclusion Criteria:

* known causes of secondary hypertension
* stage II hypertension (SBP\>= 180 and SBP\>=110 mmHg
* history of renal artery stenosis
* significant kidney disease (eGFR-CK-EPI less than 60 mL/min)
* refractory hypokalemia or hyponatremia (Napl \< 126 mEq/L)
* hyperkalemia (K \> 5.5 mEq/l)
* hypercalcemia
* symptomatic hyperuricemia
* liver disease (transaminases greater than 3 times the maximum laboratory value)
* cardiac pathologies (previous myocardial infarction, atrial fibrillation in progress, etc.)
* diabetes (fasting blood sugar \>126mg/dL)

  -. current statin treatment
* obesity (BMI \>30 kg/m2)
* ongoing pregnancy
* breastfeeding in progress
* anuria
* hypovolemia and dehydration
* known hypersensitivity to the study drugs (Spironolactone or Torasemide) or to any of the excipients
* ongoing therapy with aminoglycosides or cephalosporins
* participation in a clinical study in which an investigational drug was administered within 30 days or 5 half-lives prior to the study drug
* patients unable to express valid consent
National Observatory of Mycoplasma Infections in Children Under 18 Ages in France

This study was set up because of an unusual increase in the number of cases of mycoplasma infections in France between June and November 2023.

Clinical data from children with mycoplasma infections will be collected to characterise this infection and facilitate hospital management.

In this study, the number of cases will be collected. In addition, we will determine the clinical, biological and microbiological characteristics of these cases.

These following data will be collected: signs or symptoms associated with this infection, clinical complications, biological and microbiological tests done during hospitalisation, treatment used during hospitalization, results of thoracic x-ray and lung ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Age \<18 years (only hospitalized children)
* Documented mycoplasma infection (positive multiplex PCR and/or positive serology)

Exclusion Criteria:

* Refusal by one of the parents or by Child in understanding age
Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma

The purpose of this study is to assess safety and efficacy of brentuximab vedotin in combination with bendamustine in patients with relapsed or refractory Hodgkin lymphoma. It is an open-label, 2-stage study designed to determine the recommended dose level of bendamustine in combination with brentuximab vedotin. The study will assess the safety profile of the combination treatment and determine what proportion of patients achieve a complete remission.


Eligibility Criteria:
Inclusion Criteria:

* Histopathological diagnosis of classical Hodgkin lymphoma
* Failed standard front-line therapy
* Measurable disease of at least 1.5 cm as documented by radiographic technique
* Eastern Cooperative Oncology Group performance status less than or equal to 2

Exclusion Criteria:

* Received prior salvage therapy, including radiotherapy
* Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
* Concurrent use of other investigational agents
Ultrasound-guided Percutaneous Neuromodulation in Anterior Cruciate Reconstruction

The objective of the study is to demonstrate the efficacy of the ultrasound-guided percutaneous neuromodulation technique in the femoral nerve in patients who underwent surgery for the anterior cruciate ligament.

After being informed about the study and the potential risks, all subjects who accept the study and give their informed consent in writing, the subjects will participate in a randomized, longitudinal and prospective clinical trial divided into two groups (control group and experimental group) with the main objective of demonstrating that the ultrasound-guided percutaneous neuromodulation technique is effective for the treatment of pain in subjects undergoing surgery for the anterior cruciate ligament.

Subjects belonging to the control group will perform a physiotherapy protocol and those belonging to the experimental group will undergo two interventions of the ultrasound-guided percutaneous neuromodulation technique combined with the physiotherapy protocol. The same number of measurements will be performed on all subjects.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged between 18 and 55 years who have undergone surgery for an anterior cruciate ligament (ACL) in a period of time between 2 and 6 weeks of evolution with or without meniscal injury (meniscal regularization / meniscal suture / meniscectomy, etc.).
* have pain or loss of sensitivity in the operated knee and that they have signed the informed consent.

Exclusion Criteria:

* Subjects with chronic joint disease; prosthesis or osteosynthesis in the intervention area, as well as heart disease, neoplasia and coagulopathy.
* Subjects consuming analgesics.
* Subjects with belonephobia or insurmountable fear of needles
* History of lumbar pathology (lumbar hernia/protrusion) due to possible involvement of the lumbar plexus.
* Subjects with a history of neurological or orthopedic disorders
* Subjects with bilateral symptoms.
* Subjects with epilepsy, pacemaker or pregnant.
A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions

The purpose of this study is to study in couples and to evaluate the safety of personal lubricant products.

Study to evaluate the safety of Class II personal lubricant devices.

Eligibility Criteria:
Inclusion Criteria:

* Normal, healthy males and females \>18 years of age
* In committed heterosexual relationship for \>6months
* On acceptable method of birth control

Exclusion Criteria:

* Pregnant or breastfeeding
* Allergy to product ingredients
* Irritation or infection in genital area
* Unstable or uncontrolled medical condition
A Randomized, Multicenter Study of the Safety and Performance of Fabian PRICO for Saturation Targeting With Non-invasive Respiratory Support

This study is planned as a part of the post market clinical follow-up (PMCF) on a CE marked product. The purpose of this study is to assess, in a routine clinical environment at two centers the use of fabian-PRICO with noninvasive ventilation and its safety and performance at targeting and maintaining accurate SpO2 levels.

This is a randomized cross-over study. Subjects will be assigned to two, nominally 12-hour interventions, one with standard manual titration of FiO2 and the other with automated adjustment (PRICO). The order of these two interventions will be random.

In addition to the ventilators data, basic demographics (i.e., gestational age, birth weight, age, weight at study) of the participating infants will be recorded in the eCRF.

This study has no additional follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Infants in the neonatal unit that require non-invasive respiratory support and supplemental oxygen provided by fabian Therapy evolution ventilator
* \<37 + 0 weeks gestation
* \<10 kg at study entry
* FiO2 \> 0.25
* Informed consent form obtained as per EC requirements

Exclusion Criteria:

* Not expected to complete 24 hours of non-invasive respiratory support
* Congenital anomalies
* Uncontrolled hemodynamics
* Severe airflow obstruction
* Intracranial hypertension
* Start of caffeine therapy within 12 hours
* Attending physician does not believe participation in the study is in the patient's best interest