cyrilzakka/clinical-trials huggingface dataset:
The Volumetric Analysis of Fat Grafting

Title: The Volumetric Analysis of Fat Grafting for Aesthetic Body Contouring.

Subjects who wish to undergo fat grafting for aesthetic body contouring will be offered enrollment to the study. The study will consist of a Screening/Baseline visit, Surgery day and 3 follow up visits. Each follow up visit will utilize Vectra 3D photography (Canfeild, NJ) to collect volumetric data. At the conclusion of the study, Volume data from Baseline and 3 follow up visits will be analyzed to determine fat retention rates.


Eligibility Criteria:
Inclusion Criteria:

1. Females or Males in good general health age 18 - 65 years of age
2. Must be willing to give and sign a HIPAA form and informed consent form
3. Must be willing and able to comply with all study protocols and schedules
4. Negative urine pregnancy test prior to surgery treatment (if applicable)
5. The patient must have had a stable weight (no fluctuation of \>15 pounds in a year), diet, and physical activity for the previous 6 months

Exclusion Criteria:

1. Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial
2. History of breast cancer if fat grafting to breasts
3. Patients who smoke or use nicotine products
4. Any UNCONTROLLED systemic disease -a potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
5. Diabetes Mellitus
6. Subject has a clinically significant coagulation disorder or disease, defined as a platelet count \< 100,000 per microliter or International Normalized Ratio \> 1.5 within 4 weeks of surgery
7. Patients under the age of 18
8. Patients undergoing fat grafting but refuse enrollment
9. Patients with an active infection
10. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
High Concentration of Sugar Solution Irrigation Promotes the Healing of Infected Wound

Surgeons easily get wound infections. Most wound infections will be cured by applying medicines and changing dressing in very short period of time. But some wounds are severely contaminated combined with fat liquefaction, crateriform ulcer and large undermined lacuna, so changing dressing takes a very long time. In order to better change the dressing, it needs to expose the wound thoroughly, which requires to completely open the healed skin, so the healing will be slowed down. Some scholars lay stress on prevention. Wound infection control concerns prevention--not therapy--of an infrequent but expensive kind of surgical morbidity.(1.2)Some scholars think that the main armamentarium of the attack is the use of topical anti-infectives, which invade the bacteria where they reside, and, consequently, reduce their numbers and promote wound healing.(3)For example, silver is reemerging as a viable treatment option for infections encountered in burns, open wounds, and chronic ulcers. But it is expensive and is difficult to acquire silver-containing dressings. And Recent findings, however, indicate that the compound delays the wound-healing process and that silver may have serious cytotoxic activity on various host cells. (4) As High concentration of sugar solution, honey appears to heal partial thickness burns more quickly than conventional treatment (which included polyurethane film, paraffin gauze, soframycin-impregnated gauze, sterile linen and leaving the burns exposed) and infected post-operative wounds more quickly than antiseptics and gauze.(5)This study involve the use of another high-concentration of sugar solution (HCSS) to lavage infected wounds when changing dressings.


Eligibility Criteria:
Inclusion Criteria:

1. Patients conducted surgical operation in the hospital within 2 weeks. The wound had swelling and lots of secretions;
2. Except for the incision, primary surgical site has been recovered smoothly. Patients didn't accept secondary operation in the same site;

Exclusion Criteria:

1. Except for the wound that can't use healthy skin closure in Phase I
The Northwestern University Two-Generation Study of Parent and Child Human Capital Advancement

The Northwestern University Two-Generation Child and Family Outcomes Study (NU2Gen) of the Community Action Project of Tulsa County's (CAP Tulsa's) CareerAdvance® program examines the effects of CareerAdvance® on parent and child human capital outcomes (e.g., child academic achievement, parent educational advancement and certification, and psychological and family functioning), and (2) explore mechanisms that might give rise to program effects (e.g., home language environment; coping, balance, and stress; and parent and academic and career identity).

The Northwestern University Two-Generation Study (NU2Gen) of Parent and Child Human Capital Advancement is funded through Community Action Project of Tulsa County's (CAP Tulsa) Health Profession Opportunity Grant (HPOG II) from the Administration for Children and Families and through the HPOG II University Partnership grant. The federal awards support the implementation of CareerAdvance®, a workforce training and career employment program for parents living in Tulsa, Oklahoma and the surrounding communities, as well as our Northwestern-based research project.

CareerAdvance® provides education and training, career coaching, and other supportive services for parents while their children attend CAP Tulsa-run Head Start programs, other Tulsa-area public preschool programs, and Tulsa-area K-12 public schools. The explicit goal of the program is to promote the economic self-sufficiency and well-being of low-income families across generations.

The evaluation is composed of two parts: the Two-Generation Human Capital Outcomes Study and the Two-Generation Explanatory Mechanisms Study. Through parent surveys and parent and child administrative data we will examine the effects of CareerAdvance® on parent and child human capital outcomes (e.g., child academic achievement, parent educational advancement and certification, and psychological and family functioning). Using innovative measurement tools (e.g. Language Environment Analysis (LENA)) along with parent and child focus groups and interviews, we will also explore mechanisms that might give rise to program effects (e.g., home language environment; coping, balance, and stress; and academic and career identities). Participants will actively take part in the study for three years and we will collect child administrative data for study parents' children until they turn 18 years old or graduate high school, whichever occurs last. Current funding for NU2Gen is through September 2020.

Eligibility Criteria:
Inclusion Criteria:

* Applicants to CAP Tulsa's CareerAdvance® program under the HPOG II evaluation study, including participants who are randomly assigned not to participate in CareerAdvance® by the HPOG II evaluation study.

Exclusion Criteria:

* Not proficient in English
Health Effects of a Nordic Diet Rich in Plant-based Foods and Fish

The purpose of this study is to investigate the effects of a Nordic diet rich in plant-based foods and fish on indicators of cardiovascular disease risk at two different levels of salt intake.

The study is a 20-wk randomized controlled crossover trial. The subjects follow a salt-restricted diet during the study. The study begins with a 4-wk run-in phase for all subjects. After that the subjects are randomly allocated to one of two groups. Group 1 consumes a healthy Nordic low-salt diet enriched with plant-based foods and fish for 16 weeks. Group 2 consumes a low-salt diet for 16 weeks. During the 16 weeks, both groups receive salt and placebo capsules in a double-blind, crossover fashion (8+8 weeks).


Eligibility Criteria:
Inclusion Criteria:

* prehypertension or hypertension (systolic blood pressure 130-159 mmHg or diastolic blood pressure 85-99 mmHg)

Exclusion Criteria:

* smoking
* regular use of medications
* intestinal disorders
* symptomatic cardiovascular disease
* obesity (BMI\>35 kg/m2)
* vegetarianism
* high intake of alcohol
* allergy to fish
* pregnancy
A Study in Healthy Men to Test How Well Different Doses of BI 1819479 Are Tolerated

This is a study to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1819479 in healthy male Japanese subjects receiving single rising doses (SRD) in order to provide the basis for a clinical development of BI 1819479 in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests at screening visit
* Japanese ethnicity, according to the following criteria: born in Japan, have lived outside of Japan \<10 years, and have parents and grandparents who are Japanese
* Age of 18 to 45 years (inclusive) at screening visit
* Body mass index (BMI) of 18.5 to 24.9 kg/m2 (inclusive) at screening visit
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
* Subjects who agree to minimise the risk of making their partner pregnant by fulfilling any of the following criteria starting from the admission to trial site until 90 days after administration of trial medication

  * Use of adequate contraception, any of the following methods plus condom: intrauterine device, combined oral contraceptives that started at least 2 months prior to the first drug administration.
  * Vasectomized (vasectomy at least 1 year prior to enrolment)
  * Surgical sterilization (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner.
  * Female partner is postmenopausal, defined as no menses for 1 year without an alternative medical cause.

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator at screening visit
* Repeated measurement of systolic BP outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic BP outside the range of 40 to 90 mmHg, or PR outside the range of 40 to 99 beats per minute (bpm) at screening visit
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance at screening visit
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
Dupilumab Compassionate Use Study

This is a single patient expanded access, compassionate and non-emergency use study that provides patients with severe asthma, who do not qualify for ongoing clinical trials with dupilumab, access to this investigational treatment.

This study is being undertaken to determine whether dupilumab has efficacy in extremely severe asthma, and to allow a very severe asthma patient, who has been tried on nearly every immunosuppressive drug, early access to a potentially effective therapy.

The patient will continue in the study indefinitely. Safety will be evaluated and serious adverse events will be reported.

Eligibility Criteria:
Inclusion Criteria:

* Sever systemic corticosteroid dependent asthma for more than 5 years

Exclusion Criteria:

* Disease other than asthma
* Circulation eosinophils more than 1500/ul
* Current smoker or more than 10 pack years

This is a single-patient study. The University of Pittsburgh site is not enrolling new patients.
Knee Related Subchondral Bone Lesions Treated With IOBP

The study will be a prospective, multicenter clinical study evaluating clinical and patient reported outcome measures of subjects receiving IOBP® surgical technique using Angel cPRP and BMA processing system to treat subchondral bone pathology (SBP).

The study will be a prospective, multicenter, clinical study, enrolling both male and female patients. Subjects will be identified among the investigators' patient population scheduled for the IOBP® procedure and as being diagnosed with symptomatic SBP that have failed conservative management. IRB approval will be obtained by each participating institution.

The primary outcome measure is adverse event evaluation to determine whether IOBP® can prevent further surgical intervention (i.e., knee replacement surgery, HTO, or calcium phosphate stabilization of SBP) when used to treat symptomatic SBP of the knee.

Eligibility Criteria:
Inclusion Criteria:

1. Able to read, understand, sign and complete informed consent
2. Male or female subject between the ages of 18-60 years
3. Subject has had pain for greater than three months
4. Subjects with single SBP in tibia or femur confirmed by minimum 1.5T MRI (including coronal, axial, sagittal, lateral femur, and lateral tibia views) and are candidates for an IOBP® procedure
5. Subject has stable ligaments
6. Subject has neutral alignment (max 5° varus or valgus)
7. Subject has a VAS score greater than or equal to five
8. Subject is scheduled to undergo surgical intervention using IOBP®

Exclusion Criteria:

1. Subject has diabetes Type I, Type II uncontrolled, or Type II insulin dependent
2. Subject has had lower extremity surgery within six months
3. Subject has had more than two prior surgical procedures in the operative leg
4. Subject has a neuromuscular condition
5. Subject has a current infection
6. Subject has a BMI \>35
7. Subject has subchondral bone collapse or Kellgren Lawrence grade IV osteoarthritis
8. Subject has joint surface collapse in late stage avascular necrosis
9. Subject has majority of pain associated with alternate conditions
10. Subject has had subchondral bone pathology caused by acute trauma
11. Subject is not neurologically intact.
12. Subject has history of invasive malignancy (except non-melanoma skin cancer)
13. Subject that has a planned or scheduled additional surgery within the course of the study (lower extremity)
14. Subject has an active substance abuse problem
15. Subject is currently taking narcotic pain medication
16. Subject is pregnant or planning to become pregnant
17. Subject is on worker's compensation
18. Subject has a concomitant procedure not including meniscectomy, synovectomy, chondroplasty, or removal of loose body
19. Inability to complete study requirements and follow-up visits
20. Subject that has a bone marrow aspiration that does not meet 60cc
Study of Phosphorylated Metabolism Profile as Predictive Biomarker of Cognitive Decline in Memory Complaint.

Alzheimer disease is a frequent disease in the late ages that results in global alteration of cognitive functions. In which memory complaint can be isolated in the early stages.

Physiopathology of neuronal degenerescence in Alzheimer disease is complex, two main histological lesions are known, amyloid plaques and neurofibrillar tangles. Beyond the histological knowledge, alterations of neuronal metabolism are described such as oxydative phosphorylation and glycolytic pathway. These metabolism alterations are involved in neuronal death.

Multi-nucleus magnetic resonance spectroscopy is a non-invasive non-irradiant imagery technique already used in routine. This technic allows the phosphoenergetic pool assessment, that inform about cellular metabolism.

The aim of the study is to explore the phosphorylated metabolism patterns as predictive biomarkers of cognitive decline in patients with a memory complaint diagnosed.


Eligibility Criteria:
Inclusion Criteria:

1. Memory complaint, leading to a medical visit at the Centre Mémoire de Ressources et de Recherche (CMRR) of Poitiers, and for which an MRI is needed in routine exploration.
2. Age inferior at 90 years old
3. Mini Mental State Examination (MMSE) score between 20 and 30
4. Patient without guardianship measure, without restricted liberty.
5. Patient who benefits from social security

Exclusion Criteria:

1. Vascular, tumor, inflammatory pathology diagnosed by MRI
2. Other diagnosed neurodegenerative disease than Alzheimer disease
3. Other non neurodegenerative neurological disease
4. Vital risk at short term
5. Severe and uncontrolled psychiatric disease
Hyperlipidemia and Statin Therapy in Amyotrophic Lateral Sclerosis

The role of hyperlipidemia and lipid lowering therapy (LLT) in Amyotrophic Lateral Sclerosis (ALS) pathophysiology and its impact on disease progression and survival is unclear. The investigators analyzed the correlation between lipid levels with disease progression and survival in ALS patients and the association of LLT with these outcomes.


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of laboratory-supported probable, probable, or definite familial, sporadic ALS, according to a modified El Escorial criteria (ref), by the study investigators
* Time from disease onset is less than three years

  * 18 years of age
* Subjects with diagnosis of hyperlipidemia and/or taking lipid lowering medications will not be excluded from study.

Exclusion Criteria:

* Requirement for tracheotomy ventilation or non-invasive ventilation for \> 23 hours per day
* Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc)
* A clinically significant history of significant medical illness (advanced cancer, chronic inflammatory/infectious conditions, etc) within six months of baseline
* Use of progestins, anabolic steroids, and corticosteroids within 45 days of baseline visit. Therapy is allowed as medically indicated after baseline visit.
Core Body Temperature Measurement During Hot and Cold Environmental Exposure

Accurate measurement of core body temperature at the scene of an accident is critical for both diagnosis and treatment/triage decisions for hypothermic patients. Measurement in the lower third of the oesophagus is considered the gold standard of CT reading, but invasive and hardly applicable with a conscious patient. Tympanic membrane sensors for CT reading have been widely tested by may be unreliable in extreme environmental temperatures. Similarly, the Double Sensor device is a non-invasive device and is promising for prehospital use but has not been sufficiently verified under very cold and hot environmental conditions. Furthermore, comparisons of different non-invasive methods with oesophageal measurement in extreme conditions are lacking. The objective of these studies is to compare different techniques of core body temperature measurement with exposure to cold and hot environments.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* ASA class 1

Exclusion Criteria:

* \<18 years old
* American society of anesthesiologists class \>1
* history of ear, nose, throat surgery
* congenital malformation of head/throat/ear/nose
* absence of informed consent
Prospective Evaluation of Adjusted Body Weight Dosing of Acyclovir in Obesity

Patients receiving acyclovir as standard of care will be enrolled into this study. The currently recommended dosing strategy at our institution for obese patients is to receive intravenous acyclovir dosed per an adjusted body weight \[IBW + 0.4(TBW-IBW)\]. They will have blood drawn once prior to the first dose of acyclovir and 10 times thereafter, over a total time period of 12 hours. These patients will already be hospitalized for other reasons, and will not be required to make additional trips to the hospital. A total of approximately 4-5 tablespoons of blood will be drawn for this study. Ten obese patients and 10 matched control (non-obese) patients will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years of age
* Receiving intravenous acyclovir 5 mg/kg (TBW for normal weight patients and ABW40 for obese patients) as part of their routine care
* Weight \> 190% of ideal body weight (IBW) for "obese" patients or weight 80-120% of IBW for matched control patients.

Exclusion Criteria:

* Receipt of acyclovir or a pro-drug of acyclovir (valacyclovir, ganciclovir, valganciclovir, famciclovir) in the prior 24 hours
* Serum creatinine \>1.5 mg/dL
* Hypersensitivity to acyclovir
* Patients requiring ventilator support or vasopressors in the prior 24 hours
* Receipt of probenecid, mycophenolate, tenofovir, or zidovudine in the prior 7 days
* Significant anatomical deformities that influence body habitus (i.e. amputation)
* Prior inclusion in this study
Frequency of Formula Change Prior to the Accurate Diagnosis of Pyloric Stenosis

The purpose of this study is to determine if there is an increase in the frequency of formula change in patients with pyloric sctenosis prior to being correctly diagnosed.

The study can be described as a prospective and retrospective study in which information will be gathered from questionnaires, analysis of medical records, and the information obtained from diagnostic procedures (i.e. Laboratory results, ultrasonography). The time of enrollment will be at the time of hospital admission for the study group and the control group. The length of time for which the patient will be involved with the study will coincide with the length of stay in the hospital. This will be a single center trial involving Maimonides Medical center. Approximately 50-100 subjects will be enrolled overall to give the study more credibility.

Methods and Procedures:

1. Study Participants: All patients admitted to Maimonides Medical Center with a diagnosis of pyloric stenosis two to nine weeks of age. Patients will be excluded from the study if there is a diagnosed milk allergy, history of prior abdominal surgery, or history of prematurity or metabolic disease. Controls will be made up of the same age range, with similar exclusion criteria, and will consist of patients admitted for other reasons than listed above, such as bronchiolitis and rule out sepsis.

2: Data: Data will be received through the completion of questionnaire.

3. Data collection and processing: Questionnaire responses will be analyzed and the responses will be statistically analyzed for correlation.

Benefits: Through participation in this study, patients may help future patients diagnosed with pyloric stenosis be brought to the attention of a medical professional.

Risks: With maintenance of confidentiality, risks to participants in this study are negligible.

Eligibility Criteria:
Inclusion Criteria:

* infants ages 2-9 weeks

Exclusion Criteria:

* infant not ages 2-9 weeks or patients with history of medical problems