cyrilzakka/clinical-trials huggingface dataset:
Perioperative Warming Measures in Cesarean Delivery

The purpose of this study is to evaluate the best method for keeping patients warm during cesarean deliveries and the effect of temperature change on the patient and baby


Eligibility Criteria:
Inclusion Criteria:

* scheduled for elective cesarean section under neuraxial anesthesia
* singleton pregnancy

Exclusion Criteria:

* gestational age of less than 37 week
* emergency cesarean
Women's Health Project for Women Wanting to Lose Weight

The prevalence of obesity has steadily increased in the United States. This can lead to the worsening of type 2 diabetes mellitus, hypertension, sleep apnea, coronary artery disease and osteoarthritis. The medical management of obesity involves dietary counseling and education, behavioral counseling with goal setting, and exercise. Patients with short sleep periods in the range of 5 to 7 hours per night are often heavier than normal sleepers even after controlling for other factors. We hypothesize that the addition of focused counseling on healthy sleeping to counseling on healthy eating (dieting) and healthy exercise can help women lose weight.

None needed

Eligibility Criteria:
Inclusion Criteria:

* Any woman between the ages of 18 and 70 who is interested in counseling for weight loss
* The body mass index (BMI) must be over 25 (overweight category) and below 40 (morbidly obese)

Exclusion Criteria:

* Women who cannot reasonably expect to commit the time needed for 6 visits, two lab draws, and completion of three one week sleep logs
* Women who have had recent hospitalization or major surgery and cannot participate in a self directed exercise program
* Women with significant cardiac or respiratory disease and cannot participate in a self directed exercise program
Relationship Between Oral Health Status and Unexplained Female Infertility in Turkish Population

Periodontal diseases and dental caries are initiated by a pathogenic biofilm, in a susceptible host, affecting the tooth periodontium and hard tissues. Its possible association with many biologic systems has been studied. In this study, researchers investigated association between oral health and female infertility, and what is the biological rationale for such relationship.

Power analysis was performed with the G-Power software package to determine sample size.

To cover possible data loss, 10% of a group were added to each group. Medical and dental examination will be performed both of control and experimental groups. In dental examination decayed, missing, or filled teeth (DMFT) index will be used according to World Health Organization (WHO 1997) criteria. All teeth were visually using the International Caries Detection and Assessment System (ICDAS-II).

To analyze the correlation between oral health status and female infertility linear regression test and for comparison of both the groups (case and control), two sample t test and chi square test were used.

Eligibility Criteria:
Inclusion Criteria:

* Women who had regular menses and can't conceive despite a long-term regular sexual intercourse for more than 12 months
* Women with normal hormone values and uterine cavity with at least one healthy fallopian tube.
* All male partners have a semen specimen with minimum 5 million motile sperm in the ejaculate.
* The control group members have minimum two normal pregnancies

Exclusion Criteria:

* Patients who have history of f; hydrosalpinx, polycystic ovarian syndrome, endometriosis grade 3-4, thyroid disease, tubal surgery, hyperprolactinemia, autoimmune diseases, diabetes mellitus, uterine/cervical anomalies, active liver disease, cardiovascular disease, premature ovarian failure, smoking and alcohol consumption, poor socioeconomic level, HIV-infected, obesity (body mass index ≥ 30 kg/m2), chronic upper respiratory tract diseases and dental fluorosis.
* Patients using fluoride supplements and orthodontic appliances
Registry for Patients With Wilms' Tumor Suppressor Gene 1 (WT1) Mutation Associated Diseases

The Wilms' tumor suppressor gene 1 (WT1) encodes for a transcription factor which plays an important role during urogenital development. Patients carrying a WT1 germline mutation show symptoms like proteinuria, Wilms tumors, genital malformations and kidney failure. Milder variants are possible and classification is not always possible. In this registry we are collecting detailed clinical data of affected individuals to establish genotype-phenotype correlations with the greater goal to optimize patient care.

The Wilms' tumor suppressor gene 1 (WT1) encodes for a transcription factor which plays an important role during urogenital development. Patients carrying a WT1 germline mutation show symptoms like proteinuria, Wilms tumors, genital malformations and kidney failure, which usually occur in early childhood. Milder variants are possible and classification as one of the three rare syndromes associated with WT1 mutations (Denys-Drash syndrome, Frasier syndrome or WAGR syndrome) is not always possible. In this registry we are collecting detailed clinical data of affected individuals to establish genotype-phenotype correlations with the greater goal to optimize patient care.

Eligibility Criteria:
Inclusion Criteria:

* Germline mutation in WT1 gene

Exclusion Criteria:

* none
A Modified Minimally Invasive Approach Towards Le Fort I Osteotomy: a Prospective Study

Nowadays, maxillary Le Fort I osteotomy is a safe and routinely performed procedure. The conventional approach is characterized by a vestibular incision extending from molar-to-molar, associated with a pterygomaxillary disjunction performed with a curved chisel. Adequate mobilization of the maxilla during Le Fort I osteotomy requires an effective separation of the maxillary tuberosity from the pterygoid plates of the sphenoid bone. However, as initially described by Precious (1991) and later by Hernandez-Alfaro (2013), a true pterygomaxillary osteotomy is not necessary to achieve successful disjunction. Furthermore, Hernandez-Alfaro combined his technique of pterygomaxillary disjunction, the so-called "Twist technique", to a minimally invasive protocol, performing the complete Le Fort I osteotomy through a 20 to 30 mm long horizontal vestibular incision. Although promising, the technique remains highly sensitive from a technical standpoint, and its true accuracy has not been comprehensively evaluated.

The purpose of this study is to present and validate a minimally invasive approach towards Le Fort I osteotomy, using a modified pterygomaxillary (PTM) disjunction technique. The primary outcome is to evaluate the accuracy of the technique using rigid voxel-based registration of the 3D virtual treatment planning and the 4 weeks postoperative CBCT images. Secondary outcomes include the surgical time necessary to complete the procedure and the presence of intraoperative and early postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients of all ages
* Patients of all genders
* A Le Fort I osteotomy is planned, as part of a bimaxillary orthognathic procedure
* The surgery is planned with 3D Virtual Treatment Planning (Maxilim v. 2.3.0.3.0.)
* The planning is transferred with 3D CAD/CAM tooth-borne splint and vertical internal bony reference landmarks
* The maxilla is repositioned first during the surgery (maxilla first sequence)

Exclusion Criteria:

* Patients not eligible according to abovementioned criteria
* Simultaneous extraction of impacted teeth 18 and/or 28
* Previous maxillary orthognathic surgery
* Previous Surgical Assisted Rapid Palatal Expansion (SARPE)
* Syndromic condition, including cleft lip and palate
* Segmental Le Fort I osteotomy
* Adjuvant Zygomatic osteotomy
* Maxillary impaction higher than 3 mm
* Maxillary advancement greater than 5 mm
Improving Quality of Care for the Dying Patient in Hospice: A Quasi Experimental Trial in Liguria Region

This is a before-after phase II study, according to the Medical Research Council framework, investigating the feasibility of introducing the Liverpool Care Pathway for the dying patient (LCP) in 5 Ligurian hospices.


Eligibility Criteria:
Inclusion Criteria:

* All patients deceased in the hospice during the evaluation period
* Approval of ethics committee

Exclusion Criteria:

* Prior use of LCP in the hospice
* Deceased was a relative of a hospice member of staff
WP01 - Normothermic Liver Preservation

A multicenter randomized controlled trial to compare the efficacy of ex-vivo normothermic machine profusion with static cold storage in human liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age or greater
* Subject is registered as an active recipient on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation
* Subject, or legally authorized representative, is able and willing to give informed consent and HIPAA authorization
* Subject is able and willing to comply with all study requirements

Exclusion Criteria:

* Subject requiring all of the following at the time of transplantation: oxygen therapy, inotropic support, renal replacement therapy
* Subject has acute/fulminant liver failure
* Subject undergoing simultaneous transplantation of more than one organ
* Subject is pregnant or nursing
* Concurrent enrollment in another clinical trial. Subjects enrolled in clinical trials or registries where only measurements and/or samples are taken (NO TEST DEVICE or TEST DRUG USED) are allowed to participate.
Task Oriented Mirror Therapy for Upper Limb Motor Function in Stroke Patient

Stroke remains a major public health disease worldwide ,it usually associating with damage to the motor function and other functional disabilities. Persistent upper extremity dysfunction affects many post strokepatients and is strongly associated with decreased activities of daily living . Mirror therapy one of the rehabilitation that is beneficial for neuroplasticity .This therapy is used to improve motor function after stroke .

OBJECTIVES:

The objectives of this study are :

1. To imorove upper limb motor function and
2. To improve activities of daily lving .
3. To enhance motor skills.

HYPOTHESIS:

Alternate Hypothesis:

There will be statisticallly significant difference in high intensity task oriented mirror therapy and low intensity task oriented mirror therapy on upper limb motor function ,activities of daily living and enhancing motor skills in stroke patients (p\<0.05)

Null Hypothesis:

There will be no statisticallly significant difference in high intensity task oriented mirror therapy and low intensity task oriented mirror therapy on upper limb motor function

,activities of daily living and enhancing motor skills in stroke patients (p\>0.05)

RESEARCH DESIGN : Experimental study .Randomized control trail.

Eligibility Criteria:
Inclusion Criteria:

* Both genders.
* Age of patient 45 years and above
* Both ischemic and hemorrhagic stroke ( subacute and chronic stroke). Cognitive function relatively intact score \> 24 MoCA
* The patient can sit with / without support for more than 30 min

Exclusion Criteria:

* Subjects with visual impairments or unilateral neglect.
* having global aphasia.
* unstable medical conditions or comorbidities.
* score 3 and above on modified ashworth scale.
* patient with orthopedic condition or any fractures.
NK Activity Modulation Induced by Intravenous Lidocaine During Colorectal Laparoscopic Surgery

Surgical resection is the best treatment option for colorectal cancer. Despite this radical approach, recurrences within five years are still common. Several authors have proposed that the immunosuppressive state surrounding the perioperative period was a key element of cancer cells spread.

A particular subtype of T lymphocytes, the Natural Killer cells (NKs), is the main actor of the innate immune system. Several factors of the perioperative period can reduce activity of NKs such as stress, pain, opioids and general anaesthetics.

Lidocaine is a local anaesthetic that has been widely used intravenously for abdominal surgeries. Intravenous lidocaine has been shown to reduce pain scores, morphine consumption, ileus time and length of stay in major colorectal surgeries. It reduced markers of systemic inflammation as well.

The authors hypothesize that the use of intravenous lidocaine during laparoscopic surgeries for colorectal cancer resection will preserve NKs activity.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted for resection of colorectal cancer under laparoscopic surgery
* American Society of Anesthesiologists class I-III.
* The subject is able to understand the study objectives, the experimental protocol and procedures, and is capable of providing an informed consent.

Exclusion Criteria:

* Subjects allergic to any of the study drugs.
* BMI \> 35 kg/m2.
* Severe renal or hepatic failure.
* Pregnancy.
* Emergent procedure.
* Heart failure NYHA \> III.
* Systolic blood pressure \< 90 mmHg.
* Advanced heart block (unless patient has a pacemaker).
* Unstable angina and/or myocardial infarction within past 6 weeks.
* FEV1 ≤ 0.8 L.
* Oxygen-dependent patient.
* Electrocardiographic abnormalities
* Treatment with immunosupressive drugs, corticosteroids, NSAIDS, antiarythmic
* Morphine intolerance or allergy
Comparative Analysis of Transperineal Versus Transrectal Approaches for MRI-Targeted Biopsy of the Prostate for the Detection and Characterization of Prostate Cancer

The purpose of this study is to investigate a transperineal biopsy approach (outside of the rectum) using MRI targeting to facilitate better access to the whole prostate gland and provide limited risk of infectious complications after biopsy.

Prostate cancer is the most common malignancy and the second most common cause of cancer death in men in the Western hemisphere. Definitive diagnosis of prostate cancer relies on biopsy of the prostate gland, which is historically performed by taking 12 random biopsies of the prostate by placing a needle through the rectum under ultrasound guidance. Recently, advances in MRI techniques have allowed identification of suspicious lesions within the prostate prior to biopsy, which has given rise to targeting biopsy cores to high-suspicion areas using fused ultrasound-MRI images. However, the most commonly used transrectal approach to biopsy is associated with a growing rate of infectious complications as well as poor sampling of the anterior region of the prostate, which is furthest from the rectum.

Eligibility Criteria:
Inclusion Criteria:

* No contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations) Area of suspicion or known cancer focus on previously obtained mpMRI of the prostate (at least one lesion with MRI suspicion score \>3/5)

Exclusion Criteria:

* Prior pelvic radiotherapy
* Evidence of urinary tract infection or significant urinary retention
* Prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpMRI
* No evidence of suspicious lesions on mpMRI
* Irreversible coagulopathy
* Contraindication to sedation
Study to Assess the Kinetic of the Analgesic Effect and Tolerability of Eschscholtzia Californica Versus Ibuprofen and Placebo in the Treatment of Pain After Surgery of the Third Molar

Study to determine the kinetic of the analgesic effect of 500 mg and 1000 mg of Eschscholtzia Californica per os and placebo in patients undergoing dental surgery over an observation period of 6 hours. In a secondary analysis, kinetic of analgesic effect comparison between Eschscholtzia californica 500 mg, 1000 mg and Ibuprofen 200 mg


Eligibility Criteria:
Inclusion Criteria:

* Male or female above 18 or below 61 years old
* Patient having to undergo a third molar removal from the lower jaw under local troncular anesthesia (articaine + adrenaline)
* Type of inclusion of the molar:

  * Molar in the sub-mucosa: Type II
  * Molar partially impacted in the bone: Type III
* Patient suffering from at least moderate to severe pain after surgical removal of an impacted third molar, defined by a 4 point verbal rating scale
* Patient's informed consent in accordance with the French legislation
* Patient affiliated to the Social Security System

Exclusion Criteria:

* Pregnant or nursing female or female of childbearing potential not using a medically approved method of contraception like oral contraception or intrauterine contraceptive device
* Patient with any pathology inducing a chronic pain
* Patient having taken any drug with analgesic properties in the 24 hours previous to the administration of the study drug
* Patient with concomitant administration of other Non-Steroid Anti-Inflammatory Drug(s) (NSAIDs) or analgesic agents
* Patients treated by an antibiotic different from those required for the dental surgery which administration is started 48 hours prior to the tooth removal
* Patient with significant peri-operative complication judged by the investigator
* Patient with anti-coagulants concomitant treatment (including heparin)
* Patient with severe hepatic or renal insufficiency which judged to be regarded as clinically relevant by the investigator or any known clinically significant disease which may induce a risk for the patient in participating to the trial
* Patient with mental disturbance
* Patient with non controlled diabetes
* Patient with acute infections
* Patient with respiratory insufficiency, asthma
* Patient unable to comply with the protocol
* Patient having taken part in a clinical trial in the past month or already participating in another trial
* Patient deprived of their freedom by a judicial or administrative decision
* Adults under guardianship
* Persons hospitalized in medical or social establishments
* Patients in emergency situation
* Patient with a known or suspected hypersensitivity to the trial medication, to Ibuprofen, Paracetamol, anesthetic used (articaine, adrenaline), to the preventive antibiotic treatment (penicillin, macrolides)

Post study exclusion period: the patient will not be able to participate in any other trial for a period of two weeks after the end of this trial
Visual Performance With Spatial Light Modulator

Eye's aberrations have been known to degrade human visual performance and the visual performance is significantly improved when correcting the aberrations in the central visual field. However, how the aberration correction affects the peripheral visual performance is not well understood. Moreover, how central and peripheral vision interacts remains unclear.

To conduct the study, we will use an adaptive optics vision simulator equipped with a Shack-Hartmann wavefront sensor and a spatial light modulator (see details in procedures section of the protocol). This system is capable of noninvasively controlling the eye's optical quality and evaluating visual performance simultaneously over a wide area of visual space. This study provides insights into the visual performance in the periphery visual field, and interaction between central and peripheral visual fields.

The goal of this study is to evaluate the visual performance at central and peripheral visual fields after correcting the ocular aberrations. An optical system equipped with a liquid crystal spatial light modulator will be used to achieve this goal non-invasively.


Eligibility Criteria:
Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

* Is between the ages of 18 and 60.
* Has normal corneas i.e. no corneal infections, no systemic pink eye, no clinically significant dry eye, and no corneal dystrophies.
* Has refractive errors less than +/- 10.0 Diopters in both eyes.

Exclusion Criteria:

A person will be excluded from the study if he/she:

* Adults between the ages of 18-60 who are unable to give informed consent
* Individuals below 18 years old
* Individuals above the age of 60
* Pregnant women (self-reporting, hormonal changes may alter the refractive status of the eye)
* Prisoners
* Students for whom you have direct access to/influence on grades
* People who do not understand or speak English
* Has clinically significant dry eye.
* Has clinically significant cataract.
* Has spherical refractive error that exceeds the limits outlined above.
* Is unable to hold his or her head steady for the duration of study measurements.
Power V360 - Promoting Optimal Wellness Among Elders Through Vitalize 360

The primary purpose of this project was to implement Vitalize 360, a comprehensive assessment system and wellness coaching program for vulnerable, low income, community dwelling older adults, and to determine if this program is effective in promoting and sustaining self-management skills to increase well-being and functional health among this group. Designed specifically for community-dwelling older adults, Vitalize 360 provides a unique opportunity to guide elders in selecting personal goals that align with their assessment results and develop an action plan for goal achievement. This strategy holds potential as an effective mechanism to empower elders to implement behaviors that promote healthy aging.

The purpose of this project was to determine if Vitalize 360, a comprehensive assessment system and wellness coaching program was effective in promoting and sustaining increased physical activity and improved mood, health status and quality of life. A repeated measures, secondary analysis design was the selected approach Data from 161 participants were used to test the hypotheses. After one year, the sample had improvement with increased socialization while physical activity level fluctuated over time suggestive of a seasonality effect. Paired t-tests and repeated measures analysis revealed no statistically significant improvement in physical activity level, mood, health status or quality of life. Vitalize 360 provides a unique opportunity to guide elders in selecting personal goals that align with their assessment results and develop an action plan for goal achievement. When used among vulnerable and frail elders, some modifications are needed to provide sustained, favorable outcomes.

Eligibility Criteria:
Inclusion Criteria:

Age 60 years and over, residing in subsidized housing sites operated by Hebrew SeniorLife and participating in Vitalize 360 program

Exclusion Criteria:

younger than 60 years, not participating in Vitalize 360 program and not a permanent resident of housing sites.