cyrilzakka/clinical-trials huggingface dataset:
Oral Prophylactic Measures on the Occurrence of Pre-eclampsia (OP-PE)

Pre-eclampsia (PE) remains a major source of maternal and perinatal morbidity and mortality especially in low- and middle-income settings. PE, a pregnancy-specific hypertensive disorder, characterized by the development of placental endothelial dysfunction resulting in, among the most common diagnostic features, concomitant hypertension and proteinuria that may evolve into organs with fluctuating clinical specificities. Current studies indicate that periodontal disorders during pregnancy and particularly periodontal pathogens may be related to the risk of PE. Standard oral hygiene methods, based mainly on the joint use of toothbrushes and interdental brushes, reduce periodontal inflammatory risk, modulate of the dysbiotic oral microbiome. The purpose of the present study is to compare the PE outcomes in high-risk pregnant women receiving oral prophylactic measures to a control group. One specific question is addressed as follows according to the PICO principles: In high-risk pregnant women (Population), does oral prophylactic measures (Intervention) have a beneficial effect on PE parameters (Outcome) compared to pregnant women without any specific oral prophylactic measures (Control)?


Eligibility Criteria:
Inclusion Criteria:

* pregnant woman
* women from sub-Saharan Africa
* aged from 18 to 35 years old
* nullipares at the time of the obstetrical consultation
* up to 12 weeks pregnant
* acceptance of the terms and conditions of the study
* signature of the informed consent form,

Exclusion Criteria:

* fetal distress
* congenital uterine and vaginal abnormalities
* infectious or systemic diseases such as HIV, tuberculosis, candidiasis, cancers, hemopathies
* premature termination of pregnancy for medical reasons
* periodontal lesions of stage II, III (i.e., PD ≥ 4 mm, and/or CAL ≥ 4 mm), generalized (\&amp;amp;amp;gt;30% of sites)
* history or treatment of PD
* a course of dental or orthodontic treatment
* absence of the 4 premolar-molar pairs
* less than 20 natural teeth, excluding third molars
* medication affecting the gum and/or oral mucosa
* regularly using interdental brushes and/or dental floss and/or mouthwash
* unable to answer questions or non-cooperative.
Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension

This study is designed to investigate whether sympathoinhibition with moxonidine could provide added metabolic benefit compared to the second line therapy in the current guidelines.

This is a randomised, double-blind, cross-over study. Participants will be randomly assigned to receive either moxonidine 0.4mg daily or amlodipine 5mg and will later receive the alternate treatment.

Comprehensive testing will occur after each 12 week treatment phase and will include assessment of muscle sympathetic nerve activity, gut microbiome analysis and metabolic markers.

Eligibility Criteria:
Inclusion Criteria:

* Age: 25 -70 years
* (Body Mass Index) BMI≥30kg/m2
* Currently weight stable (+/- 3% in previous 6-12 months and not on any specific exercise or dietary program)
* Elevated clinic systolic (Blood Pressure) BP ≥135 or diastolic BP ≥85mmHg,
* on ACE inhibitor for at least 6 weeks prior to baseline assessment

Exclusion Criteria:

* Grade 2-3 hypertension (systolic office BP \>160, diastolic office BP \>100 mmHg)
* Secondary causes of hypertension
* CKD (Chronic kidney disease) stage 4-5 {(estimated glomerular filtration) eGFR\<30ml/min}
* Heart failure NYHA (New York Heart Association) class II-IV
* Recent CV (cardiovascular) event (acute myocardial infarction, acute coronary syndrome, stroke or transient ischaemic attack within the previous six months) unstable psychiatric condition
* medication such as corticosteroids, several antidepressants and antipsychotics
* Female participants of childbearing potential must have a negative pregnancy test prior to treatment
Exploration by UHF MRI of Hypothalamic Networks Associated to Feeding in Obesity and Anorexia

Food intake is a motivated behaviour that consists of seeking, selecting and ingesting nutritional resources from the environment. Its main function is therefore, depending on these conditions, to ensure the supply, in adequate quantities, of the energy and biochemical substrates necessary for the proper functioning and need of the body. Thus, in addition to maintaining the body's fat mass level stable, dietary behaviour is part of the energy homeostasis system and is thus regulated and maintained by the central nervous system.

Although diet regulation involves several brain regions, the way in which these different regions communicate with each other and influence each other to orchestrate appropriate eating behaviour is not yet fully characterized. Among the structures of this network, the hypothalamus, a small structure (less than 1 cm3 in humans) composed of several nuclei such as the lateral hypothalamus, the arched nucleus or the lateral tuberal nucleus plays a crucial role.

The investigators propose to use ultra high field (7T) magnetic resonance imaging equiping the CEMEREM (CHU Timone, APHM, Marseille) to better characterize the role of this crucial small structure in food intake networks in order to better understand the impact of these structural and functional disorders observed in patients with anorexia nervosa and obesity compared to a control population without eating behaviour disorders.


Eligibility Criteria:
Inclusion Criteria:

* No depression (HADS and BECK scores)
* No contraindication to 7T MRI
* Subject with with social insurance
* Subject who has signed the informed consent

For obese patients

* Body mass index \> 30kg/m2
* Body diameter \< 60cm (compatible with 7T MR scanner tube)

For anorexic patients

* mental anorexia according to DMS-V
* Body mass index \< 17kg/m2

For healthy controls

* 18.5kg/m2\<Body mass index \< 25kg/m2
* no feeding behavioral disturbance (SCOFF and EAT 26)

Exclusion Criteria:

* Pregnant or parturiente woman
* subject with other neurological or neuropsychiatric diseases
* subject with addiction
Bone Marrow Grafting for Leukemia and Lymphoma

The purpose of this study is to obtain tissue samples for ongoing studies regarding transplant outcomes and complications.

The purpose of this study is to acquire critical tissue and biological samples that can be evaluated to elucidate underlying mechanisms of disease control, transplant related complications and overall outcomes

Eligibility Criteria:
Inclusion Criteria:- All hematopoietic cell transplant recipients and donors who agree to participate

Exclusion Criteria:- Subject does not agree to participate
Peripheral Artery Tonometry in Children With Type 1 Diabetes and Obese Children

Background: The reactive hyperemia-peripheral artery tonometry (RH-PAT) is a newly developed method for noninvasive endothelial function assessment.

Objective: The goal of this study is to determine whether a significant difference in RH-PAT score is present between adolescents with type 1 diabetes (T1D) in comparison with controls. We will also compare RH-PAT scores in obese adolescents versus controls.


Eligibility Criteria:
Inclusion Criteria:

* 12-19 years of age

Exclusion Criteria:

* type 2 diabetes; obesity in group of type 1 diabetes
Effect of Dexmedetomidine and Bupivacaine for Paravertebral Block

Fracture femur is a common that results in severe pain. Many methods of regional and peripheral analgesia have been described to treat such pain. In this study the investigators consider using paravertebral block to treat post-fracture pain. Additionally, they consider adding dexmedetomidine to the used local anesthetic solution to prolong the duration of this block and hence postoperative analgesia.

Fracture femur is a common injury which is associated with excruciating pain . This pain is one of the most important causes of postoperative morbidity and mortality when it is insufficiently treated pain. Pain induces neuroendocrine stress response causing problems like as reduction in vital capacity, pneumonia, tachycardia, hypertension, myocardial ischemia and even infarction. These problems can be prevented by successful management of postoperative pain.

In patients with proximal femoral fracture, the use of paravertebral blockade produces reliable level of analgesia without need for additional nursing skills or monitoring in the postoperative period. Paravertebral blockade by injection local anesthetic solution alongside the vertebral column produces ipsilateral analgesia.

Currently available local anesthetics as bupivacaine may not provide reliable periods of analgesia resulting in block resolution before the period of worst postoperative pain. The use of a large volume of local anesthetic is one of methods to overcome this problem that may lengthen the duration of analgesia but at increased risk of local anesthetic toxicity. Adding adjuvants is another potential alternative.

Dexmedetomidine, a selective α 2 agonist, has been used to prolong the duration of analgesia of nerve blocks. Dexmedetomidine has also been reported to enhance central and peripheral nerve blockade. Alpha adrenoceptors located at the nerve endings have a possible role in the analgesic mechanisms by preventing norepinephrine release. The spinal mechanism is the principle mechanism for the analgesic action of dexmedetomidine.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical class I or II

Exclusion Criteria:

* Patient refusal.
* Severe or uncompensated cardiovascular disease.
* Severe or uncompensated renal disease.
* Severe or uncompensated hepatic disease.
* Severe or uncompensated endocrinal disease.
* Pregnancy.
* Postpartum ladies.
* Lactating females.
* Allergy to any of the study medications .
* Coagulation disorders.
* Infection at the site of needle insertion
Efficacy of a Novel Multivitamin-Mineral Supplement in Preventing Vitamin Deficiency in Postoperative Bariatric Patients

Approximately 33% of the US adult population can be classified as obese based on body mass index. This epidemic of obesity has resulted in over 200,000 bariatric surgeries performed every year for the treatment of "clinically severe obesity". Roux-en-Y gastric bypass (RYGB) is the most common bariatric procedure performed in the United States and has both restrictive and malabsorptive components. Despite the success of this procedure in creating long lasting weight loss, vitamin and iron deficiencies are common and can lead to significant morbidity if not appropriately addressed. Despite the American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic \& Bariatric Surgery Medical Guidelines that include vitamin and mineral supplementation recommendations, there has been very little prospective research conducted to assess the efficacy and compliance of these micronutrient interventions.

This prospective randomized controlled clinical study will evaluate the efficacy of a novel vitamin/mineral supplement in decreasing micronutrient deficiencies in post operative bariatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 - 65 years of age
* Meet appropriate criteria for Roux-en-Y gastric bypass (RYGB) surgery as determined by the Principal Investigator at The John's Hopkins Center for Bariatric Surgery (JHCBS)

Exclusion Criteria:

* Allergy to a component of the formulations
* Recent (last 3 months) use of a dietary supplement other than a standard non-bariatric specific multivitamin supplement
* Documented levels of fat-soluble vitamins (A,D,E,K) or iron above the normal range
* Pregnant or lactating
* Expected poor compliance with medical regimen as assessed by JHCBS clinic care providers
Effects of Complex Decongestive Therapy on Proprioception, Balance and Tactile Sense

The aim of this study is to investigate the effects of complex decongestive physiotherapy (CDP) on propriseception, balance and sensation in patients with secondary lymphedema that develops in the lower extremities after cancer surgery.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* Having unilateral lymphedema in the lower extremity secondary to cancer surgery

Exclusion Criteria:

* Having bilateral lower extremity lymphedema
* Having an active infection
* Having a mental cognitive disorder
* Being at a level where communication and cooperation cannot be established
* Situations where manual lymphatic drainage is contraindicated (such as severe heart failure and/or uncontrolled rhythm disorder, uncontrolled hypertension, pregnancy, presence of thrombus, active infection)
* Presence of metastasis
A Study To Investigate The Antidepressant Effect Of Lamotrigine In Patients With Bipolar Disorder Using Lithium

This is a study that, in the first 16 weeks, investigates whether lamotrigine versus placebo offers effect on depressive episodes for patients with bipolar disorder (also known as manic depressive disorder) who use lithium. In the following 50 weeks it is investigated whether these patients experience effect on their depressive and/ or (hypo)manic episodes.

A Multicentre, Double-Blind, Randomised, Fixed-Dose Evaluation of the Safety and Efficacy of Lamotrigine (Lamictal®) compared to placebo as add-on therapy to lithium in the Treatment of Bipolar Depression followed by Long-term Prevention of Relapse and Recurrence of Depression and/or Mania in Subjects With Bipolar Disorder

Eligibility Criteria:
Inclusion criteria:

* Patients with bipolar disorder (type I or type II) currently suffering from depression that is at least moderate in severity according to a psychiatrist.
* Currently using lithium.
* Female subjects can't be pregnant or become pregnant during the study.

Exclusion criteria:

* Actively suicidal.
* Rapid cyclers.
* Suffering from significant personality disorders.
* Alcohol or substance dependent or abusive.
* Suffering from significant physical conditions.
The Effect of Kangaroo Care on Father-Baby Attachment

The aim of the research is to evaluate the attachment level of fathers who received kangaroo care training in the antenatal period and applied kangaroo care in the postpartum period to their babies in the first and fourth months.The research will be conducted in a randomized controlled experimental type with educational intervention. The research will be conducted at Islahiye State Hospital with 25 experimental and 25 control group fathers who meet the inclusion criteria. Fathers in the experimental group will be given kangaroo care training during the antenatal period and postpartum kangaroo care will be applied. No intervention will be made to the control group fathers. The Paternal-Infant Attachment Questionnaire (PPAQ) will be applied to fathers in both groups in the first and fourth months and the results will be compared.

The aim of the research is to evaluate the attachment level of fathers who received kangaroo care training in the antenatal period and applied kangaroo care in the postpartum period to their babies in the first and fourth months.The research will be conducted in a randomized controlled experimental type with educational intervention. The research will be conducted at Islahiye State Hospital with 25 experimental and 25 control group fathers who meet the inclusion criteria. Fathers in the experimental group will be given kangaroo care training during the antenatal period and postpartum kangaroo care will be applied. No intervention will be made to the control group fathers. The Paternal-Infant Attachment Questionnaire (PPAQ) will be applied to fathers in both groups in the first and fourth months and the results will be compared.In the study, data will be collected using the father information form, postpartum questionnaire, postpartum kangaroo care competency checklist, kangaroo care application follow-up chart and father-baby attachment scale.

Eligibility Criteria:
Inclusion Criteria:

* 36-38. Coming to the hospital with her partner between weeks of gestation,
* Not having any physical and/or mental health problems,
* Not having a contagious disease transmitted by contact,
* Agreeing to participate in the research,
* Knowing Turkish and/or not having communication problems,
* Using Whatsapp application,
* Expecting a single baby

Exclusion Criteria:

* Being a foreign national, an immigrant or having communication problems,
* Having any physical and/or mental health problems,Having a transient contagious disease through contact,
* Refusing to participate in the research,
* Not using a phone and/or WhatsApp application,
* Expecting more than one baby
Oral Habits Effect on Orofacial Dysfunction and Oral Health Related Quality of Life.

The aim of the present study is to determine the effect of oral habits on orofacial dysfunction and oral health related quality of life among a group of Egyptian children.

Child's OHRQoL is assessed in terms of four main categories: oral symptoms as pain and discomfort, functional limitations as reduced masticatory efficiency due to malocclusion, emotional limitations as reduced self-esteem and social limitations as being teased by other children.

Deleterious Oral Habit is believed to be associated with emotional disturbances and orofacial dysfunction which will certainly affect child's OHRQoL.

Sucking habits, mouth breathing habits and tongue thrusting habits are found to be the most deleterious habits, especially in the selected age group of (5-7) years. It was found that these three deleterious habits are the most practiced habits among Egyptian children aging from 6-9 years (19.6%).

Up to the investigator's knowledge, there are very scanty studies investigating the effect of orofacial dysfunction on OHRQoL in children, only one of them was conducted on children practicing oral habits, but none of them was conducted on Egyptian children.

Eligibility Criteria:
Inclusion Criteria:

* Cooperative Egyptian children aging from (5 - 7) years.
* Medically free children.
* Children whose families accept to participate in this study.

Exclusion Criteria:

* Children with untreated caries.
* Children with previous untreated dental trauma.
* Children with previous orthodontic treatment
* Children with upper respiratory disease
* Children having one or more of the following conditions: MIH, amelogenesis imperfecta, dentinogenesis imperfecta, hypodontia, dental fluorosis.
Identification and Validation of Blood-Based Biomarkers for Early Detection of Asymptomatic Lung Cancer in High-Risk Heavy Smokers

The goal of this observational study is to develop and evaluate a blood test for asymptomatic heavy smokers to screen for those at highest risk of developing lung cancer. The aim of this study is to develop, train, and validate a blood-based screening test designed to detect biomarkers associated with lung cancer. The study will utilize samples collected from 4 distinct cohorts.

1. Participants confirmed to have lung cancer
2. Participants without cancer
3. Participants with moderate risk of lung cancer (indeterminate)
4. Participants confirmed to have other types of cancers linked to smoking

The main question this study aims to answer is whether the blood test can detect existing early-stage lung cancer in heavy smokers without symptoms and to provide insights into device performance and long-term outcomes when scans show no nodules, benign findings, or indeterminate nodules.

Participants will provide blood samples at the start of the study and during follow-up visits at 12 and 24 months. Participants will share information about their smoking history, lung cancer status, and relevant medical history

Researchers will collect blood samples, process them, and analyze the biomarkers at the Everest Detection laboratory. No results will be shared with participants or their doctors. The study will run for about 48 months, including a 24-month enrollment period and 24 months of follow-up to track participants' health and lung cancer outcomes.


Eligibility Criteria:
Inclusion Criteria:

All Participants:

* Understands the study and can provide written informed consent
* Willing and able to provide a blood sample
* Age 30-80
* Current or former smoker

Non-Cancer Cohort:

* Recent CT scan within 3 months AND
* No lung nodules (Lung-RADS 1) or benign/stable nodules

Indeterminate Cohort:

* Recent CT scan within 12 months AND
* Indeterminate lung nodules under active monitoring

Highly Suspicious or Confirmed Lung Cancer Cohort:

* Confirmed untreated lung cancer OR
* Highly suspicious lung nodules undergoing diagnostic work-up

Other Cancer Cohort:

- Confirmed, untreated cancer associated with smoking

Exclusion Criteria:

* Cancer diagnosis within the last 5 years
* Systemic therapy, radiation, or surgery for cancer within 1 year prior to enrollment
* Any history of hematologic malignancies or myelodysplasia
* Known infection with HIV, HCV, or HBV
* Active pregnancy
Atherectomy Followed With a Drug Coated Balloon in the Treatment of Long Femoropopliteal Lesions

The study is a prospective, multicenter, randomized pilot study to evaluate the clinical outcome of the plaque atherectomy system followed by the UltrafreeTM drug coated balloon catheter versus the drug coated balloon in patients with chronic long femoropopliteal lesions.

This is a multicenter, prospective, randomized, controlled comparison study. A total of 100 subjects will be enrolled into this study and will be randomized on a 1:1 basis to either drug coated balloon angioplasty combined with atherectomy or drug coated balloon angioplasty for subjects with long de-nove or restenosis femoropopliteal lesions( Stenotic lesion\>15cm or Chronic total occlusion between 6-15cm). Angiographic patterns of the target lesion, including lesion length, calcification grade, and minimal lumen diameter (MLD) prior to and after the intervention, ultrasound images of the target lesion at 12-month follow-up will be independently adjudicated by an independent angiographic and ultrasound core lab. The primary endpoint is primary patency at 12 months based on Kaplan-Meier survival analysis. Follow-up visits are scheduled at 1,3,6,12,24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be between 18 and 85 years old;
2. Chronic, symptomatic lower limb ischemia defined as Rutherford categories 3-5;
3. Stenotic, restenosis, or occlusive lesions in the native femoropopliteal artery which meets all of the following criteria: Stenotic lesion(\>70% diameter stenosis) \>15cm or Chronic total occlusion between 6-15cm; Target vessel is 3.0 to 7.0 mm in diameter (visual estimate); Guidewire must be across the target lesion within the true lumen before study randomization;
4. Patent distal popliteal artery and at least one patent distal runoff;
5. Willing to comply with the follow-up evaluation;
6. Written informed consent prior to any study procedures.

Exclusion Criteria:

1. Women during pregnancy and lactation, or patients with baby planning;
2. Life expectancy\<2 years;
3. Target lesion/vessel with in-stent restenosis
4. Target restenosis/vessel lesion previously treated with drug coated balloon or atherectomy \<12 months
5. Subjects s who are currently participating in other interventional drug or device trials;
6. Angiographic evidence of thrombus within the target vessel
7. Subjects have a history of stroke within 3 months;
8. Subjects have a history of myocardial infarction, thrombolytic therapy, or angina pectoris within 2 weeks;
9. Concomitant Renal failure with a serum creatinine\>2.0mg/dl; Subjects with known allergy to heparin, low molecular weight heparin, and contrast agents.