cyrilzakka/clinical-trials huggingface dataset:
TAP Block Efficacy After Lumbar Spine Surgery Through Anterior Approach: a Randomized, Placebo-controlled Study

Anterior Lumbar Interbody Fusion (ALIF) as well as Direct Lateral Interbody Fusion (DLIF) are established techniques for lumbar interbody fusion. In contrast with posterior approaches, they allow free approach to the anterior disc space without opening of the spinal canal or the neural foramina. However, the additional anterior approach conveys specific concerns, including abdominal pain that may delay recovery after surgery. The transversus abdominis plane (TAP) block is a validated approach for postoperative pain relief following abdominal surgeries. There is currently no evidence of the possible benefits of TAP block as part of multimodal pain management after ALIF/DLIF surgery. The investigator hypothesize that a single-injection TAP block reduces opioid consumption after anterior lumbar fusion surgery. The main goal of this prospective, randomized, double-blind, placebo-controlled study is to demonstrate a \>35% reduction in opioid consumption during the 24h following ALIF/DLIF surgery.

Clinical trial : therapeutic, prospective, randomized,double blind, placebo-controlled, with parallel group, of superiority, in intention to treat, monocentric study.

The main steps of the study are:

* preoperative assessment of eligibility
* exclusion and inclusion criteria, written informed consent, baseline preoperative assessment (see specific section)
* randomization (using a computer generated list) immediately before induction of anesthesia
* TAP block: ropivacaine + clonidine (experimental group, n=20) OR saline (control group; n=20)
* anesthesia (propofol, sufentanil, cisatracurium, ketamine and desflurane) and postoperative analgesia (paracetamol, ketoprofen, nefopam, and patient-controlled analgesia with morphine) similar in both groups
* surgical procedure
* primary outcome parameter (morphine consumption first 24 hours; see specific section)
* secondary endpoints (see specific section, up to 6 months following surgery)

Eligibility Criteria:
Inclusion Criteria:

* Man or woman over the age of 18 yr
* Patients with insurance coverage
* Patients able to provide free and informed consent
* Patients undergoing surgery by the ALIF or DLIF approaches

Exclusion Criteria:

* Patients receiving opioids as chronic treatment
* Patients with contra-indication to regional anesthesia or TAP block
* Patients unable to consent
* Patient refusal
* Patients with contra-indication to any drug included in the anesthesia or analgesia protocol
* Pregnancy or breast-feeding women
A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention

The sponsors of this investigational drug are developing prasugrel (also known as CS-747) as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a balloon angioplasty). Prasugrel was compared with Clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke.


Eligibility Criteria:
Inclusion Criteria:

* A person who has been diagnosed with acute coronary syndrome and is to undergo a percutaneous coronary intervention.
* A person who is of the legal age of 18 and is mentally competent to provide a signed written informed consent.
* If a woman is of childbearing potential (i.e., before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control.

Exclusion Criteria:

* A person who has had an ischemic stroke within the last 3 months or a hemorrhagic stroke at any time in the past.
* A person who has active internal bleeding or has a history of a bleeding disorder.
* Individuals who are at an increased risk of bleeding based on laboratory criteria evaluated by the treatment physician or on medication that can cause bleeding.
* A person who has liver disease; for example, cirrhosis.
* A person who has a condition such as alcoholism, mental illness, or is drug dependent.
* A person who has cardiogenic shock, a refractory ventricular arrhythmia, or congestive heart failure (class IV).
The Relationship Between Body Mass Index and Periodontitis

This study aimed to examine the relationship between body mass index (BMI) and stage/grade of periodontitis per the current classification of periodontal diseases.

142 patients (82 males/60 females) were included in this study. "2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions" was taken as basis to characterize the stage/grade of periodontitis. As well as age, gender, smoking status, and frequency of tooth brushing, medical data of the patients including hypertension, hyperlipidemia, BMI, and diabetes mellitus were obtained from the patient's hospital records. Obesity was assessed by BMI using the "World Health Organization" criteria.

In this retrospective study, dental and medical records of 200 patients diagnosed with periodontitis who applied to Baskent University, Faculty of Dentistry, Department of Periodontology between January 2019 and January 2021 were reviewed. Fifty three patients were excluded due to unclear or missing data, and five subjects were not included as they were under the age of 18. The final study population therefore consisted of 142 patients (82 males/60 females).

As well as age, gender, smoking status, and frequency of tooth brushing, medical data of the patients including hypertension, hyperlipidemia, BMI, and diabetes mellitus were obtained from the patient's hospital records.

Periodontal records of the patients were obtained for six different sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual) per tooth.

Mean ± standard deviation (SD) and median (minimum-maximum) were utilized for quantitative variables, and number of patients (percentage) were utilized for qualitative variables as descriptors. For quantitative variables, Kruskal-Wallis H test was performed to see whether there was a statistically significant difference between categories of the qualitative variable with more than two categories. Chi-square test was used for investigating the relationship between two qualitative variables. For determining the risk factors considered to have an effect on the dependent quantitative variable, univariate and multivariate logistic regression analyses were performed. Statistical significance level was defined to be 0.05.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with periodontitis who applied to Baskent University, Faculty of Dentistry, Department of Periodontology between January 2019 and January 2021

Exclusion Criteria:

* being under the age of 18,
* being pregnant,
* having used antibiotics within the past 3 months,
* having missing data in dental and medical records.
Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C

To evaluate the confocal microscopy changes in keratocyte density at the anterior stromal after Photorefractive keratectomy (PRK) surgery, using intraoperative mitomycin C(Mitolem, LEMERY, S.A. de C.V. Mexico D.F. Reg. 136M92 SSA).

10 eyes of 10 patients underwent PRK,using intraoperative mitomycin C (Mitolem, LEMERY, S.A. de C.V. Mexico D.F. Reg. 136M92 SSA), and 10 eyes for the same patients underwent PRK without intraoperative mitomycin C. A central scan of the total corneal thickness was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy) after surgery, and 1 week, 1 month, 3 months, and 6 months after surgery. Corneal epithelial thickness and the Anterior stroma morphology were analyzed by using the NAVIS software V. 3.5.0 (NIDEK, Multi-Instrument Diagnostic System, Japan).

Eligibility Criteria:
Inclusion Criteria:

* Patients ask for PRK surgery
* Patients with stable refraction in the last year
* Patients without systemic and ocular disease
* Patients with 500 microns in pachymetry normal topography

Exclusion Criteria:

* Patients cannot attend their appointments
* Residual, recurrent or active ocular disease
* Previous ocular surgery except PRK
* Autoimmune or connective tissue disease
* Pregnancy
DSS: Diabetes Surgery Study - Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery

The present study is the first stage of a research program whose ultimate goal is to conduct a randomized clinical trial involving type 2 diabetics with BMI from 30.0 to 39.9 kg/m2. This program will determine the relative effectiveness of RYGB combined with intensive medical management (IMM), versus IMM alone, in reducing CVD event rates and mortality in patients with poorly controlled diabetes. IMM will include rigorous lifestyle modification for weight loss and stepped pharmacologic treatment for diabetes and other CVD risk factors. The proposed study is a randomized trial which will provide an assessment of the efficacy of treatment, in reducing CVD risk factors and also assessing the feasibility, cost, and safety of a larger trial.


Eligibility Criteria:
Inclusion Criteria:

1. Age 30 to 67 years at eligibility visit.
2. Diagnosed with T2DM at least 6 months prior to enrollment, under the active care of a doctor for at least the six months prior to enrollment, and HbA1c ≥ 8.0 %.
3. Body Mass Index (BMI) ≥ 30.0 kg/m2 and ≤ 39.9 kg/m2 at eligibility visit.
4. Willingness to accept random assignment to either treatment group.
5. Expect to live or work within approximately one hour's traveling time from the study clinic for the duration of the two-year trial.
6. Willingness to comply with the follow-up protocol and successful completion of the run-in (described below).
7. Written informed consent.

Exclusion Criteria:

1. Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
2. Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
3. Cardiac stress test indicating that surgery or IMM would not be safe.
4. Pulmonary embolus or thrombophlebitis in the past six months.
5. Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years.
6. Significant anemia (hemoglobin 1.0 g or more below normal range) or history of coagulopathy.
7. Serum creatinine ≥ 1.5 mg/dl.
8. HbA1c \> 14.0%.
40 Week Extension Study Of Asenapine and Olanzapine For Bipolar Disorder (A7501007)(COMPLETED)(P05857)

Bipolar disorder is characterized by mood swings that range from from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. Patients who completed study A7501006 (a 9 week extension study) could continue with the same treatment that they had been receiving: asenapine or olanzapine (a medication that is already approved for the treatment of bipolar mania) in a 40 -week continuation study.


Eligibility Criteria:
Inclusion Criteria:

* Have completed asenapine 3-week and 9 -week studies for the treatment of an acute manic or mixed episode and not had any major protocol violations..

Exclusion Criteria:

* Patients with unstable medical conditions or clinically significant laboratory

abnormalities.
Juvenile Dermatomyositis

This is a retrospective descriptive cross-sectional and observational multicenter clinical and progressive study of juvenile dermatomyositis. The aim is to determine the clinical, paraclinical, and evolutive characteristics and therapeutic modalities from a series of juvenile dermatomyositis identified in Alsace between 2000 to 2015.


Eligibility Criteria:
Inclusion Criteria:

* Age under 16 years
* Have a dermatomyositis according to the diagnostic criteria of Bohan and Peter of 1975

Exclusion Criteria:

* Refusal to participate in the study
Potential Impact of Menthol Ban in Cigarettes and E-cigarettes

Menthol cigarette use remains a major public health problem and the FDA has proposed to ban menthol in cigarettes. However, additional evidence is needed to understand whether menthol flavor in e-cigarettes is important for harm reduction among menthol cigarette smokers in the context of a menthol cigarette ban. The primary aim of this project is to understand how the availability of menthol vs tobacco flavor e-cigarettes influences switching and reduces smoking behavior among adults who currently smoke menthol cigarettes to understand the potential effects in the context of a ban of menthol cigarettes.

Menthol cigarette use remains a major public health problem and the FDA has proposed to ban menthol in cigarettes. However, additional evidence is needed to understand whether menthol flavor in e-cigarettes is important for harm reduction among menthol cigarette smokers in the context of a menthol cigarette ban.

The primary aim of this project is to understand how the availability of menthol vs tobacco flavor e-cigarettes influences switching and reduces smoking behavior among adults who currently smoke menthol cigarettes to understand the potential effects in the context of a ban of menthol cigarettes. The secondary aim of this project is to understand whether smoking behavior outcomes differ by race to understand the impact of these potential menthol ban policies on addressing tobacco-related health disparities.

This single site study will take place over a 4 year study period; approximately 14 weeks for each participant's completion.

150 adults who currently smoke menthol cigarettes will be enrolled and prospectively randomized using a randomization ratio of 1:1:1 to 1 of 3 groups (N=50 per group). Following an initial baseline period where participants have access to their usual menthol cigarettes (Phase I), participants will receive tobacco products to use for 8 weeks based on their assigned group modeling 3 possible regulatory scenarios (Phase II): 1) no menthol ban (menthol cigarettes and e-cigarettes available), 2) menthol ban in cigarettes only (non-menthol cigarettes and menthol e-cigarettes available), 3) menthol ban in both cigarettes and e-cigarettes (non-menthol cigarettes and tobacco e-cigarettes available). A follow-up survey at week 12 will assess tobacco use outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Age 21 or older
* Able to read English
* Currently smoking cigarettes
* Willing to try e-cigarettes
* In good general health

Exclusion Criteria:

* Seeking smoking cessation treatment
* Serious psychiatric or medical condition
* Use of other drugs
* Unable or unwilling to complete study protocol
* Contraindications for study procedures based on medical history
A Study in Healthy Participants Evaluating the Absorption of a BMS-986205 Tablet Into the Bloodstream Compared to a Reference Tablet

This is a Phase 1, open-label, randomized study in healthy participants to evaluate the absorption of a BMS-986205 tablet into the bloodstream compared to a reference tablet. Eligible participants will be randomly assigned to 1 of 2 treatment sequences and will receive a single, oral dose of BMS-986205 twice over 22 days. Participants must remain at the clinical facility for the duration of the study.


Eligibility Criteria:
Inclusion Criteria:

* Signed, written informed consent.
* Healthy male and female participants (not of childbearing potential), determined by medical history, physical examination, electrocardiograms (ECGs) and clinical laboratory tests.
* Normal renal (kidney) function.
* Body Mass Index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive.
* Women must have documented proof they are not of childbearing potential.
* Males who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment and 110 days after the last dose of BMS-986205. In addition, male participants must be willing to refrain from sperm donation during this time.

Exclusion Criteria:

* Women of childbearing potential or breastfeeding.
* Active tuberculosis (TB) requiring treatment or documented latent TB within the previous 3 years. Also excluded are participants with evidence of a past TB infection without documented adequate therapy.
* History of pulmonary, renal, or liver disease; or of cardiac arrhythmias.
* Recent (within 6 months of study drug administration) history of smoking or current smokers. This includes participants using electronic cigarettes or nicotine-containing products such as tobacco for chewing, nicotine patches, nicotine lozenges or nicotine gum.
* Donation of blood to a blood bank or in a clinical study (except screening or follow-up visit) within 4 weeks of study drug administration (within 2 weeks for plasma only).

Other protocol defined inclusion/exclusion criteria could apply.
Adolescents and Health Professionals Faced With the Necessity for Changing to Remote Care During the COVID-19 Outbreak Quarantine (AdoPro-Cov19)

The Maison des Adolescents (MDA) at Cochin Hospital (Paris) is a multidisciplinary service which welcomes adolescents in three different units: consultation, day care and hospitalization. However, the epidemic of coronavirus (COVID-19) in March 2020 which imposed the extreme limitation of contacts and then the confinement of the entire population, required urgent adaptation of care practices. Teleconsultation quickly became essential for most consultations (psychiatrists, psychologists, nurses, but also pediatricians and somatic physicians). In day hospital, daily reception could not be carried out, therapeutic workshops, family interviews, or speaking groups were organized remotely. In hospital unit, the interruption of visits required the organization of remote interviews with families. Far from the comfort of an organized and structured telepsychiatry, the use of videoconferencing was done in an emergency and without preparation. The objective is to explore the experience of adolescents, doctors and psychologists regarding emergency changes in the methods of their follow-up by setting up teleconsultation in the context of the COVID-19 epidemic.

The study will be monocentric, exploratory, and qualitative based on the Interpretative Phenomenological Analysis. 15 adolescents followed in consultation, day hospital or full hospitalization and 15 health professionals working at the Maison des Adolescents will be included. Semi-structured interviews will be carried out by a psychiatrist, based on flexible and evolving interview guides. Qualitative analysis of adolescents and therapists' interviews will allow to explore the experience of teleconsultation by each group of participants and to inform about the advantages and limits of a teleconsultation device in adolescent care.

Eligibility Criteria:
Inclusion Criteria:

* adolescents aged between 11 and 20 years who benefit from follow-up in the structure (at least two face-to-face consultations before setting up teleconsultations) and for whom their follow-up had to be changed urgently in the form of teleconsultation from March 2020 as part of the COVID-19 epidemic. Adolescents will be included in the various consultation, day hospitalization and full hospitalization units. The pathologies will be varied so as to cover different situations and experiences: eating disorders, mood disorders, personality disorders, anxiety disorders, or even chronic somatic illness.
* health professionals working at the Maison des Adolescents at the time of the epidemic, from different specialties (psychiatrists, pediatricians, psychologists, nurses, etc.) and units (consultations, day hospitalization, full hospitalization).
Precision Cancer Therapy in Rare Cancers

Some rare cancers are hard-to-treat and patients have a poor prognosis. It is known that some of these patients have targetable molecular alterations, and some benefit from targeted drugs. However in many cases these drugs are not approved for the rare cancers.

In this study the aim is to do advanced molecular diagnostics to identify possible targets for therapy, and to treat accordingly.

All patients will have the tumour cells diagnosed with a large genepanel, analyzing more than 500 genes on DNA / RNA level. Patients will be treated based on the molecular characteristics of the tumor cells.

Eligibility Criteria:
Inclusion Criteria:

* ECOG 0-2,
* identified biomarker,
* reasonable biochemistry

Exclusion Criteria:

* ECOG 3-5
* serious other diseases
A Study of the Laparoscopically-placed Adjustable Gastric Band for the Management of Obesity in Adolescent Patients

This is a prospective, non-randomized, single center study of a laparoscopically placed, adjustable gastric band medical device for the treatment of adolescent obesity.

Study population We plan to enroll 30 subjects between the ages of 14 and 17 years with the LAP-BAND®. The inclusion criteria are in accordance with recent evidence-based indications for the surgical management of severe obesity in the pediatric population (Pratt, Lenders et al. 2009). The enrollees will be children who have a body-mass index in the 99th percentile, corresponding to a BMI\>= 35 kg/m2, and who exhibit significant comorbidities.

This sample size will provide over 90% power to detect a 15% change in body mass index with a standard deviation of 6, two-tailed alpha of 0.05, and allow for 20% loss to follow-up, using a paired design.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>= 35 kg/m2 and at least one serious comorbidity (type 2 diabetes mellitus, moderate or severe obstructive sleep apnea, pseudotumor cerebri, and severe steatohepatitis)
* BMI =\> 40 kg/m2 and a serious comorbidity (as listed above or at least one other comorbidity (mild obstructive sleep apnea, hypertension, insulin resistance, glucose intolerance, dyslipidemia, impaired quality of life or activities of daily living)
* Must live in Dallas/Fort Worth area so that necessary follow-up can be ensured.

Exclusion Criteria:

* Intention to have another surgical procedure for weight reduction within 12 months of LAP-BAND® placement
* History of pregnancy, or the intention to become pregnant within the next 12 months
* History of substance abuse within one year prior to surgery
* Obesity caused by medically correctable condition
* History of gastric or esophageal surgery, or the presence of an esophageal dysmotility disorder
* Eating disorder that is untreated
* Chronic use of aspirin and/or nonsteroidal anti-inflammatory medications and unwillingness to discontinue the use of these medications
* History of previous bariatric surgery, intestinal obstruction, or peritonitis
* Presence of localized or systemic infection at the time of surgery
* History of congenital or acquired anomalies of the gastrointestinal tract
* History of immunocompromise, or auto-immune, hematologic or dermatologic condition that increases risk of bleeding, breakdown of skin integrity (due to port), or infection.
* Planning to or having high likelihood of moving out of region within 2 years
* Portal Hypertension or Cirrhosis
* Uncorrectable coagulopathy or severe bleeding disorder
* Use of weight loss medications within 6 weeks of procedure