cyrilzakka/clinical-trials huggingface dataset:
Alveolar Bone Graft Cortical Nasal Floor

Alveolar bone graft is one of the main step of the surgical care of the patients who are suffering from cleft lip and palate. They are usually performed before the lateral incisor eruption, at about 5 years old and using cancellous bone taken from the iliac crest.

The aim of the study is to show if adding a cortical graft to the cancellous cause more complications, which may be source of partial or total graft loss in the 6 month following the observation

This is an observational, retrospective and monocentric study. To be included, patients had to suffer from a clef lip and palate or alveolar cleft and had to have an alveolar bone graft with gingivo-periosteoplasty in the pediatric plastic surgery unit of the Montpellier hospital from June 1999 to Mai 2016. They were divided into two groups : the first with patients who had a cortical and cancellous bone graft and the second with patients who had a cancellous graft only.

Both groups were followed 6 mounts after the operation to look for the occurence of complications which lead to a graft loss. Bilateral cleft are seen as 2 graft events

Eligibility Criteria:
Inclusion criteria:

* Patients with a clef lip and palate or alveolar cleft
* Grafted in the Montpellier pediatric surgery unit from june 1999 to mai 2016
* Followed during 6 months of post operative follow up

Exclusion criteria:

* No post operative follow up
* other alveolar bone graft in the past medical history
MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids

Magnetic resonance (MR)-guided high-intensity focused ultrasound (HIFU) ablation for fibroids is an outpatient approach for controlling symptom with an excellent safety record. It is important to exclude in advance patients who would not benefit from this treatment. For that purpose this study assesses the influence of fibroid elasticity and diffusion on ablation efficiency during treatment by MR-HIFU

Pre-procedural predictors of treatment efficacy will be useful for excluding in advance patients who would not get benefit of this treatment. It seems that elastography, cellular density and perfusion could be considered as predictors. Fibroid elastography will be quantified by MRE Resoundant® system and pelvic ultrasound. Perfusion and cellular density will be quantified by MR diffusion.

Eligibility Criteria:
Inclusion Criteria:

* Woman
* Aged more than 18 years
* Not postmenopausal
* Having one or two symptomatic fibroid with size \< 15cm.
* Leiomyoma type Funaki 1 or 2 on pre-therapeutic MRI
* Normal cervicovaginal smear performed within 2 years prior to inclusion
* Myoma technically accessible to MR-HIFU treatment verified on pre-therapeutic MRI
* SSS score on UFS-Qol ≥ 10
* Signed informed consent prior to any study related procedure
* With a medical insurance

Exclusion Criteria:

* Contraindicated to MR examination, gadolinium contrast injection (pregnancy etc..).
* Presence or suspicious of pelvic malignant tumor
* Myomas causing haemorrhage (meno-metrorrhagia) associated with anemia (Hb \<10g/dl)
* Pregnant or lactating woman
* Small submucous myoma accessible for hysteroscopic treatment.
* Active pelvic infection
* Presence of calcification, surgical staples, or rigid implant in the passage of the ultrasound beamo People placed under legal protection, or participating in another research protocol including an exclusion period still in progress at pre-inclusion.
Prognostic Risk of Patients With Essential Hypertension for Cardiovascular Events (PROSPECT)

The registry study aims to determine serial biomarkers to prognosis of Essential Hypertension

The study aims to investigate the role of candidate biomarkers in the prognosis of Essential Hypertension. In the prognosis part of the study, patients with confirmed hypertension are enrolled. The outcome is unstable angina, coronary revascularization, acute myocardial infarction, heart failure, atrial fibrillation, ischemic cerebral infarction, hemorrhagic cerebral infarction, transient ischemic attack, doubling of serum creatinine or end-stage renal disease (defi ned as eGFR less than 15 mL/min/1·73 m² or need for chronic dialysis) and all-cause mortality.

Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria for the study program were as follows:

Men or women of any racial background, 18 years of age and older, with systolic BP greater than or equal to160 mm Hg, and presence of three or more cardiovascular risk factors or disease.

The qualifying risk factors were male sex, age older than 50 years, verified diabetes mellitus, current smoking, high total cholesterol, left ventricular hypertrophy by electrocardiogram, proteinuria on dipstick and raised serum creatinine between 150 and 265 umol/L. The qualifying diseases were verified coronary disease, cerebrovascular disease or peripheral arterial occlusive disease, or left ventricular hypertrophy with strain pattern.

Exclusion Criteria:

The exclusion Criteria for the study program were as follows:

Secondary hypertension, pregnancy, history of heart failure or left ventricular ejection fraction less than 40%, myocardial infarction within one month, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting, cerebrovascular disease, severe liver disease, severe chronic renal failure (eGFR less than 30 mL/min/1.73 m2) in the past three months.
Phase I/II Study of High-Dose Acyclovir for Central Nervous System or Disseminated Neonatal Herpes Simplex Virus Infection

OBJECTIVES: I. Evaluate whether high-dose acyclovir decreases acute and long-term morbidity and mortality in neonates with central nervous system or disseminated herpes simplex virus (HSV) infection.

II. Evaluate whether high-dose acyclovir is safe and tolerated in the newborn. III. Assess resistance to antiviral medication. IV. Amplify disease classification for the purpose of predicting prognosis. V. Assess any changes in viral excretion patterns. VI. Evaluate whether antigens and antibodies specific for HSV glycoproteins within the cerebrospinal fluid (CSF) predict long-term neurologic outcome.

VII. Evaluate whether specific antigens and antibodies in the CSF appear late after treatment and are indicative of insidious reactivation of virus in the brain.

PROTOCOL OUTLINE:

Neonates are treated with intravenous acyclovir for 21 days. Patients are followed at day 28, and at 6, 12, 24, 36, and 48 months.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Herpes simplex virus infection that is disseminated or localized to the central nervous system Virologically confirmed by 1 of the following methods:

* Tissue culture
* Monoclonal antibody staining
* Electron microscopy

--Prior/Concurrent Therapy--

No concurrent antiviral therapy

--Patient Characteristics--

Life expectancy: No imminent demise

Birth weight at least 1200 g Gestational age over 32 weeks
Resolution Endoclips Vs Epinephrine Injection and Heater Probe

To compare the efficacy of a novel endoscopic clipping device(Resolution Clip™) and conventional epinephrine injection and heater probe thermocoagulation in control of peptic ulcer bleeding and prevention of recurrent bleeding

The mortality of peptic ulcer bleeding remains high despite advances in endoscopy and medical therapy. Endoscopic therapy effectively controls peptic ulcer bleeding and substantially reduces recurrent bleeding. However, the best endoscopic therapy is still unclear. The current standard of therapy is injection with diluted epinephrine and heater probe (3.2mm) thermo-coagulation. However, it may be associated with complications such as precipitation of myocardial ischemia or heater probe perforation.

Endoscopic clipping is an emerging modality of endoscopic treatment, it mimics the use of surgical ligature on bleeding artery. Endo-clipping has the theoretical advantage over injection and heater probe in that the tissue reaction or damage will be much milder.

Resolution Clip™ is a newly developed endo-clipping device. It is superior to older generations of endo-clips in that it allows repeated closures and re-opening of clip so as to facilitate accurate deployment onto bleeding artery to ensure its optimal placement for hemostasis.

Consecutive patients with endoscopically confirmed bleeding peptic ulcer will be invited to participate in this double-blind, randomised trial, which compares the efficacy of Resolution clip and conventional dual endoscopic therapy. Patients will be compared for 30-day treatment failure rate.

Eligibility Criteria:
Inclusion Criteria:

* Age \>16 , can obtain written consent
* Ulcers that require endoscopic therapy with SRH: Forrest I a, Ib, II a and II b

Exclusion Criteria:

* Moribund patients with terminal malignancy
* Pregnancy
* Intercurrent ulcer complication that prevents treatment and surgery becomes mandatory such as bulbar stenosis and ulcer perforation
Pain and Stress Management for Fibromyalgia

This interventional, randomized controlled study seeks to test the effects of an innovative emotional exposure and processing treatment that targets stress resolution, by comparing it with cognitive-behavioral therapy and a Fibromyalgia education comparison condition. The investigators also will test proposed mediators of the intervention, including improved autonomic regulation, and explore which subgroups of patients benefit the most from each approach.


Eligibility Criteria:
Inclusion Criteria:

* Meet Fibromyalgia (FM) criteria of the American College of Rheumatology (ACR)either:

  * 1990 ACR criteria including tender points
  * 2010 ACR modified clinical criteria that does not include tender points

Exclusion Criteria:

* Co-morbid autoimmune disorders, including rheumatoid arthritis and systemic lupus
* Other serious medical conditions that can impair health status independent of FM
* Current psychotic disorders (schizophrenia, bipolar disorder, etc.),dissociative identity (multiple personality) disorder, active suicide risk
* Alcohol/drug dependence in past 2 years
* Cognitive impairment or dementia
* Currently have pending (or recently received - within 2 years) FM pain related disability or workman's compensation
* Unable to fluently read or converse in English
* Planning to move from the area in the next 14 months
* Judgment of principle investigator as not appropriate for this trial or all intervention arms
Emergency Peripartum Hysterectomy: A Prospective Study in Iran

The purpose of this study is to determine the effects of peripartum hysterectomy for maternal hemorrhage.

Emergency peripartum hysterectomy is a life-saving surgical procedure which performed to control massive hemorrhage. This study was conducted to determine the factors leading to and maternal mortality and morbidity rates among the women whose underwent peripartum hysterectomy with the focus on referral or non-referral patient status.

Eligibility Criteria:
Inclusion Criteria:

* Women who have nonresponse hemorrhage after delivery

Exclusion Criteria:

* Women who delivered before 24 weeks
Effectiveness of Rotation-advancement and Straight-line Surgical Approaches in Repairing Unilateral Cleft Lip Defect

compare different effects of Rotation-advancement based on the Millard technique and Straight-line based on Fisher modification as surgical approaches in repairing lip defect of unilateral cleft lip patients.

Twelve participants with unilateral cleft lip equally divided into two groups. Both groups were photographed preoperative and postoperative. The Control group treated using (Rotation-advancement) based on the Millard technique; and the test group treated using (Straight-line) technique based on Fisher modification.

Eligibility Criteria:
Inclusion Criteria:

* Have complete unilateral cleft lip
* from birth to 4 years old

Exclusion Criteria:

* syndromic cleft patient
Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen

The purpose of the study is to test the effect of a bowel preparation and boosts regimen on PillCam® procedure, colon cleanliness and capsule excretion time.

Interim analysis will be done after 20 subjects are enrolled in order to assess the 1st arm. Following the analysis of the first phase results, and per need, 30 more subjects may be enrolled under a different regimen (2nd arm). Second Interim analysis will be done in order to assess the 2nd phase results. Following the analysis of the 2nd phase results, and per need, up to 30 additional subjects may be enrolled under a third regimen (3rd arm).

Eligibility Criteria:
Inclusion Criteria:

1. Subject is between 50 - 75 years of age.
2. Subject received an explanation about the nature of the study and agrees to provide written informed consent.

Exclusion Criteria:

1. Subject has dysphagia or any swallowing disorder
2. Subject has congestive heart failure
3. Subject has Diabetes type I.
4. Subject has had prior abdominal surgery other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator
5. Subject has a cardiac pacemaker or other implanted electro medical device.
6. Subject has any allergy or other known contraindication to the medications used in the study
7. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
8. Subject with any condition believed to have an increased risk for capsule retention such as Crohn's disease, intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or NSAID enteropathy.
9. Subject with gastrointestinal motility disorders
10. Subject has known delayed gastric emptying
11. Subject has any condition, which precludes compliance with study and/or device instructions.
12. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
13. Subject suffers from life threatening conditions
14. Subject currently participating in another clinical study
Development of the Partial Pressure of Carbon Dioxide During Exercise and at Night in Patients With Chronic Obstructive Pulmonary Disease (COPD) IV

The aim of this study is to investigate the development of partial pressure of carbon dioxide during the 6-min walking test and during night in Chronic Obstructive Pulmonary Disease (COPD)-patients (GOLD stage IV). Therefore the partial pressure of carbon dioxide, oxygen saturation and the heart rate are registered by a device called "Sentec" during the mentioned periods. In addition a measurement of activity is realised by an activity monitor ("Sensewear").


Eligibility Criteria:
Inclusion Criteria:

* COPD IV with and without a respiratory insufficiency
* maximal paCO² of 55mmHg at admission (taken at rest by blood gas analysis without LTOT)

Exclusion Criteria:

* paCO² \> 55mmHg
* non-invasive ventilation
* acute exacerbation
Treatment of Plantar Warts

This study is to compare the efficacy and safety of topical 30% potassium hydroxide solution and topical 45% hydrogen peroxide solution in treatment of plantar warts.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis by clinical and dermoscopic examination of plantar warts

Exclusion Criteria:

* history of hypersensitivity to any component used in this study
* pregnancy and breastfeeding
* patients who receive immune suppressive therapy
* patients who received any wart treatments during the last 2 months before enrollent in the study
* patients who refused participation in the study
Hypertension in Minorities Database-Workshop and Publication

To develop a comprehensive database publication (databook) utilizing available published and unpublished data on the prevalence of hypertension and its treatment and control in selected minority populations in the United States -- Hispanic, Asian and American Indian.

BACKGROUND:

Data on hypertension among minority populations were lacking prior to the workshop and databook publication. Several reasons why the data were lacking include the biological and cultural diversity of America's minorities, their wide dispersal across the country, and the fact that key data such as death certificate information have sometimes not been recorded.

DESIGN NARRATIVE:

The objective was accomplished in a two-phase approach as follows: Phase l. In June, 1994 a workshop was held in Washington, D.C. on the epidemiology of hypertension in minorities. The workshop, entitled "The Epidemiology of Hypertension in Hispanic Americans, Native Americans, and Asian/Pacific Islander Americans" included as participants the investigators who had relevant datasets and were willing to participate in the effort. The investigators were requested to use common definitions of hypertension in their workshop presentations when feasible. In addition, in preparation for a databook publication, each study was asked to provide summary data, using common definitions and a common format, on the prevalence of hypertension in the study population. Data presentations and interpretations at the workshop enabled the investigators and consultants to identify further research needs, further feasible data analyses utilizing available data, and special target groups for demonstration research efforts to enhance the potential success of intervention efforts.

Phase 2. A database publication (databook) was designed to include a summary of the workshop proceedings with the appropriate data and interpretations along with summary data from the studies presented in a standard, unified format. The databook, entitled "Hypertension in Hispanic Americans, American Indians and Alaska Natives, and Asian and Pacific Islander Americans" was published in 1996 and presented the prevalence of hypertension and its treatment and control by age, sex, and minority status, along with other information the planning committee considered relevant.

Eligibility Criteria:
No eligibility criteria
Calcipotriol as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA)

The purpose of this pilot study is to determine if calcipotriol shows potential to be an effective treatment for Central Centrifugal Cicatricial Alopecia (CCCA). This study aims to evaluate calcipotriol due to the possible anti-inflammatory effects that may affect the hair growth cycle.

Calcipotriol, a vitamin D analog, has been topically used to treat alopecia areata, a form of non-scarring autoimmune alopecia in several studies. It is possible that Vitamin D plays a role in sustaining the hair follicle's immune privilege through anti-inflammatory effects such as controlling Interferon gamma (IFN-γ) production. A recent study showed a significant decrease of vitamin D in Black patients with Central Centrifugal Cicatricial Alopecia (CCCA)"

Eligibility Criteria:
Inclusion Criteria:

* Women who are eighteen years of age or older
* biopsy-proven and/or clinical diagnosis of CCCA Stage II-IV
* must be on stable treatment without changes for at least 3 months
* Subjects will be recruited from outpatient dermatology clinics at the Wake Forest Baptist Health Department of Dermatology.

Exclusion Criteria:

* Males
Comparative Efficacy Study to Demonstrate the Non-inferiority of I-DROP® MGD Versus 2 Competitor Eye Drops in Managing Evaporative Dry Eye

A Pilot Comparative study between I-DROP MGD vs two commercially available lubricant eye drops for the management of evaporative dry eye

Pilot, randomized, double-blind, prospective, non-inferiority study to demonstrate the safety and efficacy of I-DROP MGD vs two commercially available preservative-free lubricant eye drops for the management of evaporative dry eye

Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years of age and has full legal capacity to volunteer.
* Has read and signed an information consent form.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Has dry eye disease as per the TFOS DEWS II definition with a clear moderate to severe evaporative Dry Eye:

  * OSDI ≥ 13
  * And TBUT \< 10 seconds
  * And \>5 spots of corneal fluorescein staining OR \> 9 conjunctival spots
  * Meibomian Gland score of 1 or higher using NEI grading criteria.

Exclusion Criteria:

* Is participating in any concurrent clinical or research study.
* Is wears contact lenses.
* Is using any systemic medications that could impact the aqueous tear layer, including antihistamines, vitamin A analogues, phenothiazines, anti-anxiety drugs, antidepressants, and other medications with anticholinergic activity.
* Has undergone eye surgery involving the cornea or conjunctiva.
* Aqueous deficient DED patients.
* Is currently or has used any of the study drops in the last 3 months.
* Has any known allergy or intolerance to any of the study drops.
* Has any known active ocular disease such as allergies and/or infection or any ocular disease that in the opinion of the investigator may affect a study outcome variable
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable (e.g. uncontrolled autoimmune disease or uncontrolled immunodeficiency disease).
* Has known sensitivity to sodium fluorescein.
* Is pregnant, lactating or planning a pregnancy at the time of enrolment?
* Unwilling to stop using their habitual artificial tears for the study.
* Has been fitted with punctal plugs within 30 days before the study screening visit.
* Contact lens users can still qualify for the study, however, participants should restrain their contact lens use to a very minimum during the study duration.
Evaluation of Contrast-enhanced Ultrasound Imaging for the Early Estimate of Bevacizumab Effect on Colorectal Cancer Liver Metastases

Bevacizumab, an anti-angiogenic agent, plus fluorouracil based chemotherapy is considered a new standard for the treatment of metastatic colorectal cancer. Contrast-enhanced ultrasound with gas-encapsulated microbubbles can be used to assess tumour vascularity, particularly hepatic metastases, and may become a useful tool for monitoring anti-angiogenic therapies. The aim of this prospective, multicenter, non-randomized study is to evaluate the usefulness of hepatic contrast-enhanced ultrasound to predict response to bevacizumab based chemotherapy in patient with metastatic colorectal cancer. The primary objective of this study is to compare the functional vascular changes related to bevacizumab based chemotherapy and evaluated by hepatic contrast-enhanced ultrasound with classic RECIST criteria. The secondary objectives are to do a characterization of the pharmacokinetic of bevacizumab, to explore the pharmacodynamic effects of bevacizumab on functional vascular changes of hepatic metastases evaluated by hepatic contrast-enhanced ultrasound and to analyze the possible relationships between treatment efficacy or toxicity and constitutional gene polymorphisms linked to the bevacizumab.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed colorectal tumor
* first line treatment by a bevacizumab based chemotherapy
* Target hepatic metastases of size lower than 5 cm and higher than 5 mm detected by conventional ultrasonography and CT or MRI
* Life expectancy \> 2 months
* OMS status =\< 2
* Major surgery, open biopsy, or significant traumatic injury within 28 days prior to Day 0
* informed consent signed

Exclusion Criteria:

* no target hepatic lesion detected by conventional ultrasonography
* Prior bevacizumab treatment
* Prior chemotherapy treatment for advanced disease
* Clinically significant cardiac disease (e.g. myocardial infarction or stroke within 12 months, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure not well controlled with medication, endocarditis and prosthetic valve) and any contraindications in sulphur hexafluoride administration
* Blood pressure \>= 180/110 mmHg
* Daily and chronic treatment by aspirin or AINS
* Anticipation of need for major surgical procedure within 7 days prior day 0
* Urine protein \> 1g/24 Hours
* Any contraindication in enhancing bevacizumab treatment
* Serious, uncontrolled, concurrent infection(s) or illness(es)
* pregnant and lactating woman