cyrilzakka/clinical-trials huggingface dataset:
Diode Laser for Harvesting Gingival Graft

Aims: The aim of present randomized controlled clinical study was to evaluate whether the additional use of diode laser would facilitate the donor surgery, improve the palatal wound healing and reduce post-operative morbidity after the coronally advanced flap (CAF) with connective tissue (CTG) grafts.

Methods: Fifty-two patients with isolated recessions were treated. The CTG resulted from the de-epithelialization of a free gingival graft (FGG) with blade (control group) or diode laser (DL) (test group). The DL was used to de-epithelialize the outer part of the FGG and photo-biostimulate the palatal wound area. Post-operative morbidity was evaluated by using Oral health related Quality of life (QoL), smile related QoL and visual analogue scale-discomfort (VAS). Root coverage outcomes were also evaluated 6 months after operation.

The procedure of connective tissue harvesting from the palate is often characterized by the challenge of obtaining the largest volume of tissue possible on one side while minimizing post-operative pain and reducing the risk of complications on the other.The present clinical study evaluated whether the additional use of diode laser would facilitate the donor surgery, improve the palatal wound healing and reduce post-operative morbidity after the bilaminar periodontal plastic surgery procedure for the treatment of isolated single gingival recession defects with no loss of interdental clinical attachment.

In the test sites, an aluminum, gallium, and arsenide diode laser (wavelength 810 nm and power of 1W) was applied in continuous mode. In the control group,a free (epithelialized) gingival graft was harvested by two horizontal and two vertical incisions defining the area. The post operative course of the patients were evaluated by visual analogical scale and the oral health impact profile

Eligibility Criteria:
Inclusion Criteria:

* Presence of identifiable buccal cemento-enamel junction;
* Presence of a step ≤ 1mm at the cemento-enamel junction level
* No contraindications for periodontal surgery and no periodontal surgery on the involved sites
* Full-mouth plaque score of \<10%; full-mouth bleeding score of \<15%
* No occlusal interferences.

Exclusion Criteria:

* History of periodontitis or abscess formation
* Presence of systemic disease
* Smokers
* Pregnant patients.
Impact of Yoga As Complementary Therapy in Patients Undergoing Radical Prostatectomy

The researchers hope to learn if yoga complementary therapy would improve health-related quality of life, recovery of urinary continence and erectile function in patients who underwent prostate cancer surgery (i.e. radical prostatectomy). We hypothesized that in patients undergoing radical prostatectomy, preoperative and postoperative Yoga complementary therapy would improve health- related quality of life (HRQOL), recovery of urinary continence and erectile function.

This two-arm, randomized controlled pilot study will compare Yoga intervention to usual care group. The aim is to evaluate the efficacy of Yoga complementary therapy on HRQOL in patients who underwent radical prostatectomy (RP). Yoga therapy will be given to the intervention group three times in a week for 6 weeks prior to surgery and then initiated 3 weeks after the surgery for another 6 weeks. The yoga exercise will be tailored to the participant's comfort level. As an exploratory analysis, we will evaluate pro-inflammatory and immunological markers.


Eligibility Criteria:
Inclusion Criteria:

* Men between the age of 30 to 80
* Has been diagnosed with localized prostate cancer (i.e. pathologically and/or radiographically confirmed)
* Is scheduled to undergo radical prostatectomy (i.e. robot-assisted or open-approach)
* Has no other active primary malignancy aside from prostate cancer
* Currently not practicing yoga as a form of exercise and/or meditation
* Does not have uncontrolled pain
* Does not have neurological or musculoskeletal co-morbidity inhibiting exercise
* Has never been diagnosed by health care professionals to have absolute contraindications to exercise testing
* Willing to be randomized to either standard care or intervention group
* Willing to participate in yoga therapy for twelve weeks if randomized to intervention group
* Willing to undergo phlebotomy
* Able and willing to provide informed consent

Exclusion Criteria:

* Men under the age of 30 or over the age of 80
* Has NOT been diagnosed with localized prostate cancer (i.e. pathologically and/or radiographically confirmed)
* Is NOT scheduled to undergo radical prostatectomy (i.e. robot-assisted or open-approach)
* Has other active primary malignancy aside from prostate cancer
* Currently practicing yoga as a form of exercise and/or meditation
* Has uncontrolled pain
* Has neurological or musculoskeletal co-morbidity inhibiting exercise
* Has been diagnosed with psychotic, addictive, and major cognitive disorders
* Has been diagnosed by health care professionals to have absolute contraindications to exercise testing Unwilling to be randomized to either standard care or intervention group
* Unwilling to participate in yoga therapy for twelve weeks if randomized to intervention group
* Unwilling to undergo phlebotomy
* Unable and unwilling to provide informed consent
Perceptions, Representations and Experiences of Malaria Prophylaxis in Patients Born in Endemic Areas and Living in France.

The aim of this study is to analyze the perceptions, representations and expe-riences of malaria prophylaxis in patients born in endemic areas and living in France.

This analysis could lead to better understanding and communication between the medical profession and patients in malaria. It would also provide patient-specific responses to their expectations, as to their families.

Malaria is the most common vector-borne (mosquito-borne) disease in the world. It is caused by a parasite called Plasmodium, and is transmitted to humans by an Anopheles mosquito bite. Malaria rages in most intertropical regions and in 91 countries. Hence, almost half of the world's population is expose. The estimated number of cases was 219 million (CI95 = 203-262) in 2018, including 200 million in Africa (92%). The number of deaths in 2017 reached 435,000, of which 93% in Africa.

In 2018, in metropolitan France, the National Reference Center recorded 2,730 reported cases including one case of indigenous malaria, the other cases were import cases. There were 12.8% of severe forms and 84.9% of the patients were of African origin and had stayed in Africa, without taking anti-malaria chemoprophylaxis.

The fight against malaria is therefore a major public health issue in the world and in France, with in particular the need for better access to pre-trip consultations, in town or in hospital, and improved key messages deliverance on this frequent and potentially serious pathology, and also the means of protection (chemoprophylaxis, repellents and mosquito nets). The role of general practitioners is essential in this fight since they represent the first source of information for 60% of patients.

To this effect, Recommendations for good practice for the management of imported malaria actualized and published in 2018 emphasizes these preventive measures for travelers bound for endemic areas.

The non-compliance rate was estimated at 29% in a 2007 study by Pistone et al. in patients from endemic areas when they are among the most affected patients. These data have not yet been verified for more than 10 years, and it seems important to actualized this knowledge in the light of social changes.

In addition, prevention methods borrowed from herbal medicine are sometimes offered elsewhere, such as Artemisia herbal teas, despite the scientific data that caused a lack of effectiveness.

Overall, few studies have explored the reasons for this obstacle to chemoprophylaxis and classically proposed anti-vector measures and a better understanding could allow a better delivery of information during our consultations.

Eligibility Criteria:
Inclusion Criteria:

* Major patients
* Born in malaria endemic areas and living in France
* Having malaria or not
* Ready for no opposition for participation in the protocol

Exclusion Criteria:

* Patients under guardianship or curatorship
* Patients unable to give free and informed consent
* Patients under judicial protection
Effects of Sub Occipital Muscle Inhibition Technique on Hamstring Flexibility in Post-laminectomy Patients

to find out the effects of sub-occipital muscle inhibition technique in combination with upper cervical spine exercises on hamstring muscle flexibility in post-laminectomy patients.

Laminectomy is a decompression surgery which is performed to decrease pressure on spinal nerves. In this surgical procedure a small bone of vertebrae called lamina is removed. Hamstring muscle stiffness is a major problem in post-laminectomy patients, which results in chronic pain, functional limitation and affect patients activity of daily life.

In post-laminectomy patients hamstring stiffness is more profound than iliotibial Band and piriformis stiffness. Sub-occipital muscle and hamstring are connected via a single neural pathway called superior back line which passes through dura matter. Dura matter is the outer most covering of meninges, Sub Occipital Muscles attached to dura matter by Myodural Bridge through vertebral dural ligament. This connection provides a window for relaxation of dural fascia to decrease tone of connected muscular-skeletal units (in which hamstring is also included). So if any of these muscle units become tight, or tone deterioration occur the other unit is automatically malfunctioned. The study shows that if tone sub-occipital muscle falls, it has been reported that the tone of knee flexors such as hamstring also decreases due to relaxation of myofascia.

However, in post-laminectomy patients, incorporating a neural pathway connection technique involving sub-occipital muscle inhibition for upper neural pathway Dura release may offer more effective and immediate results on hamstring muscle flexibility in the lower neural pathway The sub-occipital muscle inhibition technique is a method of inducing relaxation of the fascia by applying soft pressure to the sub-occipital area.

The rationale of the present study is to find out the effectiveness of Sub Occipital Muscle inhibition technique for stiff hamstring muscle in post-laminectomy patients, pain and disability. To compare the effectiveness of SOM inhibition technique in combination of upper cervical spine muscle stretching,traction etc. with hamstring muscle stretching, lower limb neurodynamic etc.

Eligibility Criteria:
Inclusion Criteria:

* Hamstring muscle tightness, (AKE \< 80) or (more than 20 degree lag in knee extension).
* Back of the thigh pain.
* Prior laminectomy surgical procedure at lumber spine.
* Patients who are willing to participate.

Exclusion Criteria:

* Prior femur and back related fracture,
* Bilateral lower limb pain,
* Any systemic issue.
* Visual hamstring swelling.
* Individual with cervical ligaments instability and migraine.
* Unable to understand the consent form,
* Patients who are not willing to participate in procedure
Study to Evaluate the Effects of MBX-8025 in Patients With HoFH

A 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH).

Open-label, single arm, non-controlled, dose ascending (50 mg/day, 100 mg/day and 200 mg/day) with three consecutive dose escalation periods.

After signing an informed consent subject will enter a screening period and a run-in stabilization period. At the end of run-in period patients will enter treatment phase. MBX-8025 in ascending doses (50 mg, 100 mg, and 200 mg) will be given within three consecutive 4 weeks periods, for a total of 12 weeks. At the end of treatment, subjects will enter a follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements.
2. Male or female with HoFH confirmed by genotype (two mutant alleles at the LDL-Receptor (LDL-R) gene locus or double heterozygotes LDL-R/Apo-B).
3. 18 years of age or older.
4. Existing lipid lowering therapies (statins, cholesterol absorption inhibitors, bile acid sequestrants, nicotinic acid and their combinations, low-density lipoprotein (LDL) LDL-C apheresis) on a stable regimen for at least four weeks before screening visit.
5. Stable lipid lowering diet compatible with a Step I diet of the American Heart Association (AHA).
6. Fasting LDL-C ≥ 4.8 mmol/L (≥ 185.6 mg/dL) during screening.
7. For females or males of reproductive potential, use of at least one barrier contraceptive and a second effective birth control method during the study and for at least two weeks after the last dose.

Exclusion Criteria:

1. Treatment with lomitapide or mipomersen within two months of screening.
2. Heart Failure (HF) with New York Heart Association (NYHA) class III and class IV or a Left ventricular ejection fraction (LVEF) of less than 30%.
3. Uncontrolled cardiac arrhythmia during the past three months of screening.
4. Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft or stroke during the past three months of screening.
5. Planned cardiac surgery, or planned revascularization, in the next four months.
6. Uncontrolled hypertension.
7. Aspartate transaminase (AST) or Alanine transaminase (ALT) ≥ 3 times the Upper Limit of Normal (ULN).
8. Unexplained creatine kinase (CK) ≥ 5 times the upper limit of normal (ULN).
9. For females, pregnancy or breast-feeding.
10. Any other condition(s) that would compromise the safety of the patient or compromise the quality of the clinical study as judged by the Investigator and/or Medical Monitor.
Effectiveness of Duspatalin® in Patients With Post-cholecystectomy Gastrointestinal Spasm

Prospective, multicenter, non-comparative, observational program designed to assess the effectiveness of a 2-6 weeks treatment with Duspatalin® 200mg bis in die = twice a day (BID) and changes in quality of life in patients with post-cholecystectomy gastro-intestinal spasms


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years to 65 years;
* Patients suffering from post-cholecystectomy GI-spasms in the last 3 months with symptom onset at least 6 months prior to inclusion and not requiring surgical treatment;
* Laparoscopic cholecystectomy between 6 months to 5 years before enrollment;
* Patients having been prescribed Duspatalin® (mebeverine) 200 mg BID (bis in die = twice a day) in accordance with approved local label;
* Patient's written authorization to provide data for the program

Exclusion Criteria:

* General and specific contraindications to Duspatalin® treatment according to the local label;
* Planned Endoscopic Retrograde Cholangiopancreatography (ERCP) and/or surgical treatment;
* Being currently treated or having been treated with Duspatalin® within the 6 weeks prior to entering the program;
* Pregnancy or lactation;
* Other conditions that make patient participation impossible (by investigator judgment);
* Previous enrollment in the present program;
* Treatment with other antispasmodics, pain-medication (Nonsteroidal anti-inflammatory drugs (NSAIDs), tramadol, etc.) within 2 weeks prior to inclusion into the observational study.
Survey on Patients After Childbearth Following Bariatric Surgery

Women with a history of bariatric surgery may face various difficulties during pregnancy and puerperal time. Therefore it is assumed the prevalence of mental health disorders might be higher than in average women during and after pregnancy. This could possibly lead to an unsatisfying weight progress and therapeutic non-adherence. These factors shall be observed in the study in order to characterize this special cohort of participants.

Women following bariatric surgery are included at least 6 months after childbirth to evaluate retrospectively pregnancy and puerperal time. For mental health issues questionnaires, a structured clinical interview (SCID) and a psychological interview give an insight to past and present status. In order to evaluate weight progress and nutrient deficiencies routine follow-up care data of bariatric surgery is screened. In order to assess the course of pregnancy and child development data is extracted from pregnancy and child's examinations reports. Furthermore medication adherence, quality of life and sleep are registered by questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* status following bariatric / metabolic surgery due to indication criteria
* childbirth after bariatric / metabolic surgery, at least 6 months ago
* written informed consent

Exclusion Criteria:

-
Medical-biological Research of the Pathogenesis of COVID-19 Disease Caused by SARS-CoV-2

Сonducting in-depth medical and biological studies of the pathogenesis of the disease caused by the SARS-CoV-2 in Moscow, the Moscow region and some other regions of the Russian Federation.

To date, none of the methods used to test for coronavirus infection provide reliable information about the status of an individual's infection. Common tests based on PCR, carried out on the basis of samples taken from the human respiratory tract, give a positive answer in far from all cases. Antibody tests may not record the initial stages of the disease, or may not reveal residual immunity in those who have been ill, while giving cross-reactions to other common coronaviruses.

A comprehensive assessment of the biological parameters of the virus and the parameters of the immune response to infection is required. In this regard, we propose an integrated approach, including the use of PCR testing technology, analysis of the immune response in the form of antibodies of all major classes (IgG, IgA), determination of inflammation markers, C-reactive protein, detailed blood test, ferritin and troponin.

In addition, an analysis of the genetic diversity of strains of the pathogen COVID-19 circulating among various groups of the population of the Russian Federation will be carried out.

To collect and analyze data, it is planned to enter information into a special electronic system and analyze the collected data with a wide range of informative methods that allow "layer by layer" to compare and collect a complete picture of what is happening.

Objectives of the study:

1. Identifying the percentage of infected in the population in Moscow, the Moscow region and some other regions where the epidemic situation in connection with SARS-CoV-2 remains tense;
2. Study of genetic diversity (including metavirome) and dynamics of structural variability of the causative agent of coronavirus infection in the studied regions;
3. Studying the features of the formation and tension of immunity in patients who have undergone coronavirus infection of varying severity;
4. Clarification of the mechanisms of occurrence and development of coronavirus infection.

In the study of biological samples obtained from research participants, methods of proteomics, peptidomics, next generation sequencing (NGS), physicochemical methods of analysis will be used.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 and under 75 years old
* COVID-19 diagnosis confirmed by PCR test
* Written consent to participate in the study

Exclusion Criteria:

* Unwillingness or inability to give written informed consent to participate in the study
* A serious condition with a threat to life or contraindications that prevent the collection of biomaterial
* Oncological diseases outside the stage of remission
Platelet Activation in Chronic Inflammatory Skin Diseases

Platelets are blood cells that are important in coagulation of the blood. These cells have recently been shown to play a role in a number of other biologic processes, for example inflammation. In this study the investigators will determine the extent of platelet activation in people suffering from common chronic skin inflammation-urticaria and allergic dermatitis.


Eligibility Criteria:
Inclusion Criteria: Urticaria or atopic dermatitis -

Exclusion Criteria:Lack of informed consent

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MR Antagonist and LSD1

Lysine specific demethylase-1 (LSD1) is an epigenetic regulator of gene transcription involved in the pathophysiology of elevated blood pressure and likely renal damage in Blacks. This project investigates whether a genetically driven anti-hypertensive approach proves superior in controlling blood pressure and mitigating renal injury in Blacks who carry the risk allele for LSD1 (rs587168). The findings of these investigations may lead to a new approach in treating a subset (\~30%) of the essential hypertension population (Black LSD1 risk allele hypertensives).

This proof-of-principle physiologic study in hypertensive Black LSD1 risk allele carriers testing the hypothesis that reductions in blood pressure will be greater with a genetically-driven anti-hypertensive approach (mineralocorticoid receptor antagonist, eplerenone) compared to a non-specific approach (amlodipine). 56 participants will be enrolled in a 12-week randomized, double-blind, active controlled, outpatient study to assess whether eplerenone (LSD1 specific treatment) proves superior in 24-hr ambulatory systolic blood pressure reduction than amlodipine (non-specific treatment). Participants will be randomized to either eplerenone 50mg or amlodipine 2.5mg with escalations in dose of study drug every 4 weeks if the participant's blood pressure is \> 140/90.

Eligibility Criteria:
Inclusion Criteria:

* untreated as well as currently treated hypertensives
* rs587168 allele carriers
* not on more than two anti-hypertensives
* normal renal, metabolic, electrolyte, and CBC laboratory tests
* self-identified Black race
* age \>17 yrs.

Exclusion Criteria:

* known cardiac disease other than HTN
* renal, circulatory or neurologic diseases
* diabetes
* smoking
* secondary HTN as indicated by history, physical examination or screening blood and urine tests
* smoking
* any drug therapy, except for anti-hypertensives and stable thyroid medication replacement
FMT in Inflammatory Bowel Disease

This is a prospective observational cohort study, over 52 weeks, evaluating the the use of faecal microbiota transplantation amongst patients with Inflammatory Bowel Disease and Microscopic Colitis


Eligibility Criteria:
Inclusion Criteria:

* Patients with inflammatory bowel disease (Crohn's disease or Ulcerative colitis) or Microscopic Colitis proven on the basis of radiology, endoscopy or histology.
* Patients with clinically and endoscopically active, Crohn's Disease, Ulcerative Colitis or Microscopic Colitis
* Patient must have attempted reasonable medical therapies to control their disease without sufficient response.
* All patients have to be capable of attending appointments, as well completing surveys and diagnostic tests for the duration of study follow up
* The patient must be able to identify a likely stool donor

Exclusion Criteria:

* Patients with an enteropathy or colitis which cannot definitively be diagnosed as Ulcerative Colitis, Crohn's disease or Microscopic colitis
* Patients with concurrent Clostridium difficile infection
* Women who are pregnant or intending to become pregnant in the near future (less than 6 months).
* Neutrophils less than 1.0 x 109/L
* Albumin less than 20g/L
* Active gastrointestinal infection as identified by testing
* A patient on steroids (prednisolone, budesonide) at a dose that cannot be safely tapered to zero within 6 weeks of initial FMT, due to the risk of adrenal insufficiency
* Short gut syndrome and/or small intestine less than 1.5m in length as measured intra-operatively
* Perforation or active internal fistulising disease or enterocutaneous fistulae.
* Any patient that the clinicians feel is incapable of participating in the safe use of FMT.
* Current use of antibiotics for any condition