cyrilzakka/clinical-trials huggingface dataset:
Clinical, Cognitive and Neural Effects of Potentiation of ECT by rTMS in Treatment-Resistant Depression

Electroconvulsive therapy (ECT) is one of the most effective treatments for treatment-resistant depression (TRD). However, due to response delay and cognitive impairment, ECT remains an imperfect treatment. In this multicenter, randomized, double-blind, sham-controlled study, our objective is to assess the priming effect of rTMS sessions before ECT on clinical, cognitive and neural response in patients with TRD.

80 patients with TRD will be assigned to active or sham rTMS before ECT treatment. Five sessions of active/sham rTMS will be administered over the left dorsolateral prefrontal cortex (20 Hz, 90% resting motor threshold, 20 2 s trains with 60-s intervals, 800 pulses/session) before ECT (which was active for all patients) started. Then, from the sixth ECT session, an rTMS session will occur the day before each ECT session. Clinical assessment, cognitive assessment and brain imaging (structural MRI, resting state functional MRI, MR spectroscopy) will take place before and after 10 ECT sessions. Clinical, cognitive and neural changes will be compared between both groups after 10 ECT sessions.

The primary outcome will be the response rate after 10 ECT, i.e. the percentage of patients who achieved a reduction of 50% or more from their initial Hamilton Depression Scale score (HAMD-21 items).

Eligibility Criteria:
Inclusion Criteria:

* Patients with Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria
* HAMD score ≥15
* In case of unipolar disorder: no remission after at least two different antidepressants prescribed at a dose and duration sufficient for the current episode
* In the case of bipolar disorder: no remission despite lithium at an adequate plasma level combined with lamotrigine or quetiapine monotherapy at full dose
* No change of antidepressant or mood stabilizer treatment for at least 15 days
* To be rTMS-naive
* Without benzodiazepine or antiepileptic treatment for at least 15 days
* To understand spoken and written French
* Having given their informed, written consent

Exclusion Criteria:

* Contraindication to Electroconvulsive therapy (ECT), repeated Transcranial Magnetic Stimulation (rTMS), Magnetic Resonance Imaging (MRI), anesthesia
* Patients who have received ECT in the last 6 months
* Patients suffering from poorly stabilized epilepsy, serious neurological or systemic disorders
* Patients with a serious substance use disorder (other than nicotine or caffeine) according to DSM-5 criteria
* Patients suffering from severe hearing problems
* Subjects already treated with an electrical or magnetic stimulation technique
* Women who do not have adequate contraception, pregnant or breastfeeding women
* Being deprived of liberty by an administrative or judicial decision
* Patients participating or having participated in an interventional clinical trial within 30 days before the inclusion visit
Muscle Activity During Load Carriage in ROTC Cadets

Army ROTC Cadets who are currently enrolled in Military Science courses will be asked to participate in this experimental research design. A total of 30 healthy cadets consisting of approximately 24 males and six females will be recruited, as this will provide an accurate representation of the overall Army demographics with 17% being female.

Paperwork: After providing consent, participants age and gender will be documented, and height and weight will be measured and documented. Participants will complete a modified version of the Modified Oswestry Low Back Pain Disability Questionnaire, which has been adjusted to be more specific to the military population. The questionnaire will be filled out indicating the cadet's current level of pain. They will then complete the same questionnaire indicating their pain within the last year.

Protocol: First, the skin will be prepared and surface electromyography (EMG) electrodes will be placed. Dynamic, surface EMG data will be obtained of the gluteus medius, gluteus maximus, erector spinae, rectus femoris, and biceps femoris muscles in accordance with SENIAM (Surface Electromyography for the Non-Invasive Assessment of Muscles) guidelines. Skin preparatation will consist of trimming hair if the skin surface at which the electrodes have to be placed is covered with hair. Next, the skin will be cleaned with alcohol. The skin will be allowed to dry prior to electrode placement. Lastly, skin will be abraded to reduce impedance. Following electrode application, participants will complete five minutes of light activity on a bike or treadmill for warm-up. Next, in order to normalize the data, manual muscle tests will be performed for each of the six muscles being test. Then, participants will walk at a speed of four miles per hour for 10 seconds as a dynamic measurement for normalizing the data.

After completion of the two normalization protocols, participants will complete a five kilometer (3.1 mile) walk on a treadmill at a speed of three miles per hour, with and without a 35 lb. load carried in a traditional rucksack. The load conditions will be randomized and counterbalanced in order to mitigate effects of fatigue, and the conditions will be performed in two separate sessions (separated by 24-48 hours).


Eligibility Criteria:
Inclusion Criteria:

* current enrollment in military science courses and member of Army ROTC

Exclusion Criteria:

* current musculoskeletal injuries
Using of Acellular Dermal Matrix in Cleft Palatal Fistula and Compare With Use of Conchal Cartolage

The fact that still exist is which method for repairing of secondary cleft palatal fistula is the best. This study will have shown whether using of Acellular dermal Matrix decreased the fistula formation versus using Conchal Cartilage during secondary fistula. Among studies that published, they have not consensus for using acellular dermal matrix. Most of the questions are about cost effectiveness, time that surgery and rehabilitation need and patient risk ( risk of transmission disease from other human tissue )

Observational study composed of a prospective cohort group receiving ADM compared to a retrospective historical cohort group with Conchal Cartilage.

Primary objectives:

The primary objective of this study is to determine whether ADM would lower the incidence of palatal fistula in patients undergoing secondary cleft palate fistula repair.

Secondary objectives:

1. hypo nasality speech after surgery
2. Improvement Speech Score

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as having cleft palate fistula, with ADM will be included in this study.

Exclusion Criteria:

* Selection will be based on the patient's willingness to allow to participate in the study.
* Patients with diagnosed craniofacial syndromes will be excluded from the study.
* Children with known wound healing defects, will be excluded from the study.
Study on Evaluating the Effectiveness of Statins in the Treatment of Moyamoya Disease

The purpose of this study is to investigate the effectiveness of statins in the treatment of moyamoya disease based on multimodal magnetic resonance imaging.


Eligibility Criteria:
Inclusion Criteria:

1. The imaging examination meets the diagnostic criteria for moyamoya disease;
2. Sign the informed consent form;
3. Age ≥18 years old;
4. Baseline mRS score ≤2 points;
5. The patient receives revascularization/conservative treatment;
6. There is at least 1 imaging follow-up result.

Exclusion Criteria:

1. Patients with atherosclerosis, autoimmune diseases, meningitis, Down syndrome, cranial trauma, or those who have undergone radioactive head irradiation, as these conditions may lead to secondary cerebrovascular disease and contribute to the development of Moyamoya syndrome;
2. Individuals under the age of 18;
3. Participants who refuse to take part in this study;
4. Pregnant patients;
5. Those with concurrent intracranial aneurysms, cerebrovascular malformations, brain tumors, or hydrocephalus;
6. A history of stroke occurring more than three months prior to the diagnosis of Moyamoya disease;
7. Individuals with a history of coronary heart disease or previous cardiovascular and cerebrovascular surgical interventions, including cerebral revascularization, intracranial artery stent implantation, carotid artery stenting, endarterectomy, coronary artery bypass grafting, or coronary stent implantation;
8. Allergies to contrast media;
9. Patients with missing imaging data or whose image quality cannot be analyzed;
10. Individuals who refuse or are unable to undergo imaging follow-up;
11. Patients receiving other types of lipid-lowering drug treatments.
Drug-coated Balloons and Drug-eluting Stents in Diabetic Patients

Drug-eluting stents (DES) have long been recommended as the default device for patients undergoing percutaneous coronary intervention (PCI). Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel-coated on the balloon.

DCB angioplasty has the following advantages compared to DES implantation: Firstly, the drug in DCB is uniformly distributed and released, whereas the drug release of DES via the stent platform is uneven -85% of the vascular wall is not covered by the stent strut. Secondly, there is no alloy in the vessel after DCB angioplasty, while the coronary stent platform and polymer might cause temporal or persistent inflammatory response leading to intimal hyperplasia. Finally, there is no metal cage restraining vessel motion after DCB, and the physiological function of coronary arteries would be maintained.

Currently, DCB constitutes an important treatment option in ISR, which is endorsed by the 2018 European Society of Cardiology Guidelines on myocardial revascularization. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice.

Diabetes is associated with worse outcomes after coronary revascularization and has been identified as an independent predictor of adverse events in patients with cardiovascular disease. Although some small sample size RCTs and observational studies have suggested that the clinical prognosis of DCB is non-inferior to the drug-eluting stent (DES), there is still a lack of evidence comparing the DCB versus DES for de novo or ISR coronary lesions in diabetic patients. The current study aims to compare the long-term efficacy of DCB to DES in de novo or ISR coronary lesions in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with diabetes mellitus
2. Received PCI by a drug-coated balloons only strategy or drug-eluting stents only strategy

Exclusion Criteria:

1. Under the age of 18
2. Unable to give informed consent
3. Currently participating in another trial or participants unable to comply to follow-up
Clinical Trial With Riluzole in Spinocerebellar Ataxia Type 2 (ATRIL)

ATRIL is a multi-centric, double-blind randomized, two-arm controlled study. 42 SpinoCerebellar Ataxia type 2 (SCA2) patients, both gender, at least 18 years of age will be included.

Riluzole 50 mg will be administered (per os) twice a day, versus one group with placebo for 12 months.

Riluzole (Rilutek®) is a benzothiazole drug, market approved, for Amyotrophic Lateral Sclerosis (ALS). It delays the onset of ventilator-dependence or tracheostomy in selected patients and may increase survival.

Scale for the Assessment and Rating of Ataxia (SARA) will be used at M0, M6 and M12. To assess primary criterion, the percentage of patients with a decrease of at least 1 point of the SARA score between the inclusion visit, and Visit 3 (Months 12) will be calculated.

Inherited cerebellar ataxias are genetically heterogeneous neurological disorders. They are characterized by ataxic gait and cerebellar dysarthria that progresses over time with loss of ambulation and speech. The mutations by expansions of CAG triplets in the genes ATXN1 (SCA1), ATXN 2 (SCA2), 3 (SCA3), CACNA1A (SCA6), ATXN 7 (SCA7), and TBP (SCA17) are responsible for 50% of hereditary forms There is no curative or preventive treatment. This phase III study is a multi-centric, double-blind randomized, two-arm controlled study (one group with 50 mg Riluzole twice a day versus one group with placebo), to measure the efficacy of treatment with riluzole in SCA2 patients during 12 months. Amelioration is defined by a 1 point decrease of the SARA score.

Eligibility Criteria:
Inclusion Criteria:

* Genetically diagnosed SCA2 (CAG triplet in ATXN2 ≥ 33)
* At least 18 years of age
* Signature of informed consent
* Covered by social security
* SARA score ≥ 5 and ≤ 26
* Age at onset ≤ 50 years old

Exclusion Criteria:

* Treated with riluzole prior to the study
* Hepatotoxic medication
* Hypersensitivity to the active substance or to any of the excipients
* Serious systemic illnesses or conditions known for enhancing the side effects of riluzole
* Contraindications for MRI examination
* Participation in another therapeutic trial (3 months exclusion period)
* Pregnancy or breastfeeding
* Non abstinence or absence of effective contraception for women
* Inability to understand information about the protocol
* Persons deprived of their liberty by judicial or administrative decision
* Adult subject under legal protection or unable to consent
* Other ataxic syndromes than SCA2
The Effect of Intravenous L-kynurenine (LKYN) on Cerebral Hemodynamics in Healthy Volunteers

To measure the cerebral hemodynamic effect of L-kynurenine.

Aim: To investigate the physiological effect of L-Kynurenine after intravenous administration to healthy volunteers.

Hypothesis: L-kynurenine induces vasodilation in the cerebral vessels and trigger headache in healthy individuals.

Methods: 6 healthy volunteers will receive intravenous infusion of L-kynurenine using the following doses 50 microgram/kg, 100 microgram/kg, 150 microgram/kg, 300 microgram/kg, 500 microgram/kg, 1 mg/kg and 5 mg/kg over 20 min on 7 different days with at least 1 day in between. Before and after infusion (at 20, 40, 60, 80 and 100 min) we will record vital signs, circumferences of middle cerebral artery, superficial temporalis artery and headache intensity and characteristics.

The subjects will then have a questionnaire about headache for the following 24 hours.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteers of both sexes.
2. 18-60 years.
3. 50-90 kg.
4. Women of childbearing potential must use adequate contraception.

Exclusion Criteria:

1. All primary headaches
2. First-degree relative with migraine
3. Headache less than 48 hours before the tests start
4. Daily consumption of drugs of any kind other than oral contraceptives.
5. Pregnant or nursing women. Cardiovascular disease of any kind, including cerebrovascular diseases.
Interest of Placental Alpha-microglobulin-1 Detection Test to Assess Risk of Premature Delivery in Reunion Island

Prematurity is the leading cause of mortality and perinatal morbidity. Despite the many preventive measures and use of tocolytic therapy, the incidence of premature births has not decreased in recent decades. In 2010 the preterm birth rate (single child, born alive) was still 5.5% in France and 11% in the population of Reunion. In 50% of cases, premature birth is related to spontaneous premature labor layout without rupture of amniotic membranes, called threat of premature birth.The threat of premature birth, defined by the combination of cervical modifications and regular and painful uterine contractions from 22 weeks of amenorrhea and 36 weeks of amenorrhea + 6days, is the major cause of hospitalization in pathological pregnancies services. But all threat of premature delivery situations do not cause premature delivery. In our service, only 30% of patients hospitalized for threat of premature delivery give birth prematurely in accordance with published international data. The diagnosis of threat of premature delivery is difficult and it is still not possible to differentiate a "false labour" of a "real labour".

Currently the diagnosis of threat of premature delivery in routine is based on the combination of vaginal examination, the ultrasound, cervical length, but this strategy lacks specificity.

In absence of prognostic tool for predicting more reliably the risk of premature delivery in situation of threat of premature delivery, the medical cares are maximalist.: hospitalization, conducting paraclinical investigations, prescription of tocolytics treatments and conducting antenatal corticotherapy. it seems particularly necessary to identify more efficient prognostic criteria that the clinic and ultrasound for judging the severity of threat of premature delivery in other words to predict the risk of premature delivery to adapt and adjust the care of patients after diagnosis of threat of premature delivery.


Eligibility Criteria:
Inclusion Criteria:

* All patients received in programmed or emergency consultation;
* Pregnant, between 24 weeks of amenorrhea and 33 weeks of amenorrhea + 6 days;
* With painful regular uterine contractions confirmed by monitoring;
* Patient affiliated to a social security scheme;
* Informed consent signed by patient if adult or by legal representant for minor subjects

Exclusion Criteria:

* cervical cerclage placement;
* proved vaginal infection and/or vaginal ongoing treatment;
Effect of Lidocaine Phonophoresis Versus Pulsed Ultrasound on Myofascial Pain Syndrome in Athletic Children

A topical anesthetic gel lidocaine has been widely used as a local anesthetic to reduce the pain and discomfort. It provides local analgesia by blocking the initiation and transmission of impulses. Lidocaine topical anesthetic gel allows the use of high concentrations of the anesthetic bases without concern about local irritation, uneven absorption or systemic toxicity (Argoff, 2000 ). So, the aim of this study is to compare between the effect of lidocaine phonophoresis and pulsed ultrasound in myofascial pain syndrome in swimmers children.

Fourty five children (athletic swimmers) participated in this study, and were classified into three groups ; First control group A : this group consisted of fifteen children were receiving traditional physical therapy program. Second study group B: this group consisted of fifteen children were receiving pulsed ultrasound in addition to traditional physical therapy program as the same as in group A. Third study group C: this group consisted of fifteen children were receiving lidocaine phonophoresis in addition to traditional physical therapy program as the same as in group A. Treatment program in the three groups applied three times a week for three successive months. The study was done in the outpatient clinic of Ismailiy Sporting Club, Ismailia, Egypt.

Eligibility Criteria:
Inclusion Criteria:

* • Age range from 10 to 14 years.

  * All children have regional neck pain complaint.
  * Tenderness in cervical trigger points in the midpoint of the upper border of trapezius muscle, from grade II to grade IV according to tenderness grading scheme (Hubbard and Berkoff, 1993) (Appendix I ) ● The diagnosis of an active MTrP in the upper trapezius according to (Ardiçet al . , 2002 and Bruno, 2005)

Exclusion Criteria:

* • Neurological disorders.

  * Dermatological disorders.
  * Acute trauma prior to the study.
  * Fibromyalgia, systemic disease and drug allergy history were excluded from the study.
  * Having myofascial trigger points injection.
  * Chronic pain in both sides of the body.
Trends of Mastectomy and Breast-Conserving Surgery in Female Breast Cancer Patients

Breast cancer is the most common cancer in women across the world, accounting for 25.2% of cancer cases among females and 14.7% of cancer-related deaths among females worldwide. The survival rates are markedly lower in the developing countries compared to developed countries, as well as the age at diagnosis. Core management of breast cancer includes surgical removal of the tumor either by breast-conserving surgery (BCS) or mastectomy (removal of the whole breast). Choosing between these two procedures may be influenced by factors that have yet to be studied in Saudi Arabia. The investigators aimed to determine the prevalence of BCS and mastectomy and the factors that may influence the choice of procedure. This retrospective study was carried out by reviewing the records of female breast cancer patients who underwent BCS or mastectomy at King Abdulaziz University Hospital between 2009 to June 2017, excluding those with metastasis (distant spread of the cancer) or recurrence. Using frequencies for the rate, and multivariate tests, the investigators analyzed different demographic, clinicopathological, and radiological factors to detect correlations with procedure choice.


Eligibility Criteria:
Inclusion Criteria:

* Female, diagnosed with breast cancer, underwent surgery on the breast tumor in King Abdulaziz University Hospital

Exclusion Criteria:

* Patients with metastatic breast cancer or recurrence of the cancer before the surgery
Plasma Pharmacokinetics of Alkylresorcinol Metabolites; New Candidate Biomarkers for Whole Grain Rye and Wheat Intake

The purpose of this study is to investigate the kinetics of two known alkylresorcinol metabolites in human subjects after intake of high-fiber rye bread. Whole grain rye is the most abundant source of alkylresorcinols.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, volunteer

Exclusion Criteria:

* Hemoglobin below 125 mmol/L in females and below 135 mmol/L in males use of antibiotics within 3 months before entering the study
Stereotactic Body Radiotherapy Versus Conventional Radiotherapy in Medically-Inoperable Non-Small Lung Cancer Patients

A multi-centre randomized controlled open-label trial in medically inoperable patients with biopsy-proven early stage non-small cell lung cancer (NSCLC). Eligible and consenting patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) or conventional radiotherapy (CRT) in a 2:1 ratio. Radiotherapy will be administered as soon as possible following randomization and subjects will be followed for 5 years post-randomization for cancer recurrence, toxicity and survival. The primary outcome is local control (LC). The trial will be conducted at 16-20 clinical centres throughout Canada.


Eligibility Criteria:
Inclusion Criteria:

1. T1/T2a N0 M0 NSCLC, either by: (a) histological confirmation (squamous cell, adenocarcinoma, large cell carcinoma, or not specified) and CT thorax and/or PET-CT evidence, or (b) a suspicious growing nodule on serial CT imaging, with malignant PET Fluorodeoxyglucose (FDG) avidity, for which a biopsy would be extremely risky.
2. Deemed medically inoperable (as reviewed by a thoracic surgeon and defined as surgically resectable but, because of underlying physiological medical problems \[e.g. chronic obstructive pulmonary disease (COPD), heart disease\], surgery is contraindicated) or Radiotherapy is preferred by the patient due to high operable risk.

Exclusion Criteria:

1. Less than 18 years of age.
2. Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher.
3. Prior invasive malignancy within the past 3 years (excluding non-melanomatous skin cancer).
4. History of ataxia telangiectasia.
5. Previous radiotherapy (RT) in the vicinity of the tumour, such that significant overlap could occur.
6. Previous pneumonectomy with Stage I lung cancer in the remaining lung.
7. Diagnosis of idiopathic pulmonary fibrosis and/or interstitial lung disease.
8. Planned for other anticancer therapy (chemotherapy, biological targeted therapy).
9. Female, who is currently pregnant or lactating.
10. Geographic inaccessibility for follow-up.
11. Unable to provide informed consent.