cyrilzakka/clinical-trials huggingface dataset:
A Pharmacokinetics, Pharmacodynamics and Safety Study of Warfarin in Combination With Tamiflu (Oseltamivir)

This is an open-label, randomized, 2-period crossover study, to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of warfarin in combination with Tamiflu (oseltamivir) in participants stabilized on warfarin. Participants will be randomized to receive either their warfarin followed oseltamivir and warfarin, or by oseltamivir and warfarin followed by warfarin. The treatment periods will be separated by a washout period of at least 4 days. Participants will continue receiving warfarin once daily at a prescribed usual dose throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have been receiving warfarin once daily for at least 4 weeks prior to Screening
* Participants must have regular International Normalized ratio (INR) monitoring during warfarin therapy prior to study entry, and be willing to be trained in the use of CoaguCheck devices
* INR must fall within a target range of 2.0-3.5
* Body mass index (BMI) between 18-32 kg/m\^2 inclusive

Exclusion Criteria:

* An INR value between screening and Day -1 lower than 2.0 or greater than 3.5
* A change in prescribed daily warfarin dose between Screening and Day -1
* History of any coagulopathy
* Consumption of health products or supplements containing vitamin K
* Pregnant or lactating women
* Confirmed positive urine and/or blood test for drugs of abuse at Screening or Day -1
Effect Low Pressure Pneumoperitoneum and Pulmonary Recruitment on Postoperative Pain

The investigators want to test the hypothesis that the addition of a recruitment manoeuvre to a low pressure pneumoperitoneum will lead to an additional reduction in postoperative pain. Therefore the investigators will conduct a prospective randomized controlled, single blind trial.

Two groups:

1. A cholecystectomy at a low pressure pneumoperitoneum (8-10 mmHg)
2. A cholecystectomy at a lowpressure pneumoperitoneum (8-10mmhg) and at the end a pulmonary recruitment manoeuvre (5 sec at max 40 cmH2O).

Eligibility Criteria:
Inclusion Criteria:

* ASA I and II

Exclusion Criteria:

* refusal to give consent
* cholecystitis
* BMI above 35
* intolerance to one of the pain medication
* pregnancy
Reproductive Function and Mood in Women With Bipolar Disorder

This study will determine the effect of medication for bipolar disorder on the reproductive function and whether mood changes occur during the menstrual cycle in women with bipolar disorder.

Bipolar disorder is a serious condition that can have devastating effects on social and psychological functioning. Evidence suggests that medications for bipolar disorder may influence reproduction function among women. This study will determine reproductive function and mood changes in women who are currently on medication for bipolar disorder.

This study will comprise women with bipolar disorder and age- and body mass index (BMI)-matched healthy controls. Participants will have their reproductive function and mood changes assessed for 3 consecutive menstrual cycles. Daily, participants will report about their mood, sleep patterns, life events, and any psychiatric medications; this information will be entered into a computerized system named ChronoRecord. In addition, participants will measure their basal body temperature and collect their urine every morning to assess for ovulation. Blood collection will occur at study entry and between Days 3 and 6 of every menstrual cycle to determine levels of reproductive hormones. Participants will be asked to fast for 12 hours prior to every blood collection. During the first month of the study, an extra study visit will occur. Participants will undergo a physical exam for determination of excessive hair growth (hirsutism) and BMI. Additionally, insulin resistance will be measured, and participants will be asked to complete a questionnaire that will be used to determine their past and current menstrual function, as well as the reproductive and psychiatric history of their families.

Eligibility Criteria:
Inclusion Criteria for All Participants:

* Have been menstruating for at least 4 years prior to study entry
* Participants must be willing to travel to Stanford University at own expense for study visits

Inclusion Criteria for Bipolar Disorder Participants:

* Participants should have a diagnosis of Bipolar I, Bipolar II, or Bipolar not otherwise specified (NOS), and be under the treatment of a physician who can be contacted in case of an emergency
* Current treatment with any mood-stabilizing agent for a period of at least 3 months (e.g., divalproex sodium, lithium, other mood stabilizer, or atypical antipsychotic)

Inclusion Criteria for Healthy Controls:

* No past or present diagnosis of mental illness

Exclusion Criteria for All Participants:

* Current alcohol or substance abuse or dependence within 6 months prior to study entry
* Meets criteria for another DSM-IV Axis I disorder
* Contraceptive steroid use within 3 months prior to study entry
* Current use of medication that may affect steroid metabolism
* Menopausal
* Endocrine disease such as diabetes or hypothyroidism
* Uncontrolled medical illness
* History of long-term corticosteroid use
* Organic mood disorder
* Pregnancy or breastfeeding within 3 months prior to study entry
Blood Bioavailability of Two Different Doses of a β-alanine Supplement (BIo-β)

The purpose of this study is to To study the blood bioavailability of a sustained-release β-alanine granulated supplement of two different doses (10 g and 20 g).

Subjects will consume 10 g of β-alanine one day by 4 ingestions of 2.5 g separated by 1 hour and 15 min. While on another day 20 g of β-alanine by 4 ingestions of 5 g separated by 1 hour and 15 minutes, with a washout period of 15 days between the two doses. Subsequently, the amino acid levels in blood will be analyzed after the product intake and during a period of 8 hours.

Each day of visit the paresthesias (moment of appearance, intensity and sensations) will be studied at different times.

Eligibility Criteria:
Inclusion Criteria:

* Men between 18 and 60 years old.
* Cyclists with more than two years of cycling experience.
* Bicycle training at least twice a week.

Exclusion Criteria:

* Suffer a lasting injury that prevents you from training in the month prior to surgery.
* Subjects with a chronic illness.
* Having consumed in the three months prior to the start of the study any β-alanine supplement.
* Making changes in diet or exercise during the study.
* Inability to understand the informed consent form.
* Consumption of other supplements that could alter the results of the study.
Pain Modality Treatment After Hemorrhoidectomy

Hemorrhoidectomy is one of the operations that causes the greatest intensity of pain. Treatment of postoperative pain is essential for the well-being of the patient. Long-term use of opioids and different drugs can have unintended consequences.

The objective is to corroborate which pain treatment modality is better in patients after hemorrhoidectomy.

Patients who have undergone a hemorrhoidectomy are included in the study, the pain treatment modality is conceived by the treating surgeon or anesthesiologist. The first modality is to administer pain killers on-demand depending on visual analog scales of pain and the second modality to give pain killers on determined hours.

Eligibility Criteria:
Inclusion Criteria:

Elective surgery for hemorrhoids

Exclusion Criteria:

Mental retardation Incapacitated patient Under 18 years old
Prognostic Markers of Inflammation in Infants Undergoing Cardiopulmonary Bypass

This study evaluates the effect of heart-lung bypass on babies undergoing cardiac surgery. The investigators want to learn more about the inflammation that exposure to bypass creates in the body by studying markers of inflammation and cell injury in the bloodstream. Additionally, the investigators want to examine if these markers can predict which babies develop post-surgical complications. The hypothesis is that babies who undergo bypass will have higher levels of these markers than babies not exposed to bypass and that these markers will correlate with how the baby does clinically after surgery.

This study will evaluate markers via blood sampling in babies with congenital heart disease who do not undergo cardiac surgery, those that undergo surgery without bypass, and those that undergo surgery with bypass. The overall goal is that this study will lead to useful biomarkers and lay the groundwork for future novel therapies aimed at improving outcomes for babies who require heart-lung bypass.

This is a minimal risk observational study looking at markers of inflammation and cell injury in the bloodstream of babies with congenital heart disease, with a particular emphasis on whether these markers can predict low cardiac output syndrome in infants who undergo heart-lung bypass. Low cardiac output syndrome is a common postoperative complication marked by poor blood flow to the body affecting nearly 1/3 of infants post-bypass and is associated with significant morbidity and mortality.

Babies not requiring surgery will serve as the control group. Infants in group 1 will have 0.5 ml of blood drawn prior to discharge. This will be scavenged from the laboratory when possible. Infants in groups 2 and 3 will require serial blood draws over peri-operative time points each in the volume of 0.5 ml.

Group 2:

T0 = Before surgery (in the OR) T1 = After chest closure or end of case (in the OR) T2 = On admission to the pediatric intensive care unit T3 = Timed 4-6 hours after the time of admission T4 = Timed 12 hours (+/- 1 hour) after the time of admission T5 = Timed 24 hours (+/-1 hour) after the time of admission

Group 3:

T0 =Pre-cardiopulmonary bypass to be obtained in the operating room just prior to surgery T1 = After going on bypass (but prior to modified ultrafiltration) T2 = After modified ultrafiltration T3 = On admission to the pediatric intensive care unit T4 = Timed 4-6 hours after the time of admission T5 = Timed 12 hours (+/- 1 hour) after the time of admission T6 = Timed 24 hours (+/-1 hour) after the time of admission

Eligibility Criteria:
Inclusion Criteria:

* Infants \< 6 months of age
* Born at ≥ 36 weeks gestational age
* Birth weight ≥ 2.5 kilograms
* Postnatally confirmed congenital heart disease by echocardiogram

Exclusion Criteria:

* Requiring ≥ 2 vasopressors prior to surgery
* Preoperative proven sepsis within one week of surgery
* Prior surgery within one week of cardiac repair (except PA banding which is not excluded)
* Cardiac catheterization within one week of surgery
* Significant extra-cardiac anomalies that may impair organ function
Subcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients

To compare the effects of low-dose versus high-dose subcutaneous ( SC ) aldesleukin ( interleukin-2; IL-2 ) on immunologic and virologic markers in HIV-infected patients. To compare the effects of monthly versus bimonthly administration of SC IL-2 on these markers.

Interleukin-2 is a protein that is naturally produced by lymphocytes. In an initial study, patients in an earlier stage of HIV-1 infection tended to tolerate SC IL-2 better than those with more advanced infections, and those with higher baseline CD4+ counts tended to derive the greatest benefit.

Interleukin-2 is a protein that is naturally produced by lymphocytes. In an initial study, patients in an earlier stage of HIV-1 infection tended to tolerate SC IL-2 better than those with more advanced infections, and those with higher baseline CD4+ counts tended to derive the greatest benefit.

Patients are randomized to one of four treatment arms; patients receive either low-dose or high-dose SC IL-2 for 5 days either on a monthly or bimonthly schedule for approximately 6 months.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV positivity.
* CD4 count \>= 500 cells/mm3.
* No history of AIDS-defining opportunistic infection, or malignancy other than mucocutaneous Kaposi's sarcoma.

Concurrent Medication: Required:

* Concurrent FDA-approved antiretroviral therapy (AZT, ddI, ddC, d4T).

Prior Medication: Required:

* FDA-approved antiretroviral therapy for at least 6 weeks prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Significant cardiac, pulmonary, thyroid, renal, or CNS disease.

Prior Medication:

Excluded:

* Prior IL-2.
* Systemic corticosteroids, chemotherapy, or experimental therapy within 4 weeks prior to study entry.
Retrospective Evaluation of Total Hip Replacement After Acetabular Fractures

In 1965, Emile Letournel and Robert Judet reported their experiences on acetabular fractures at the 5th day of the Raymond Poincaré Hospital in Garches. Classification Letournel is still relevant and in use today.

Many studies have sought to determine if the treatment had to be surgical or orthopedic. Although the standard treatment of displaced fractures of the acetabulum is the reduction and osteosynthesis, some advocate the THA in elderly patients with comminuted fracture of the acetabulum, impaction of the femoral head or acetabular impaction affecting more than 40% of the articular surface and including bearing zone. All these treatments and those supported have been studied in the literature.

However the study of the laying of total hip remote trauma after acetabular fracture osteosynthesis or treated conservatively, is not rich in literature. Only a few articles have been published in recent years.

Indeed, a recent review of the literature are nearly 11 series focusing on the results remotely hip prostheses for treatment of acetabular fracture. These two prospective series with between 21 and 63 patients. All authors report rates well above those reported complications for primary arthroplasty, with a revision of rates ranging between 0 and 26.5%.

Fractures of the acetabulum are covered in our service by one operator using the same release technique based on the stiffening. The objective of this study is to determine whether the systematic surgical treatment of these patients by an experienced operator reduces the high complication rate.

II. objectives:

1. Evaluation of the rate and type of complications intraoperative and postoperative, and revision rates.
2. Evaluation of clinical results based on surgical strategies.

III. Methodology

This is a single-center retrospective study single-operator regarding the evaluation of surgical practice cited in goal.

Patients were aware of the potential use of their data for medical research through oral information provided by the doctor at the signing by the patient's consent related to the surgery.

IV. Nature of the data collected

The data is anonymous and unidentifiable.

Data collected include:

* The characteristics of the patient, as well as its history,
* The particular technical operating data,
* The nature of possible post-operative complications
* The clinical and radiological assessment at follow: AP pelvic radiograph, Harris score and score Postel Merle D'aubigné.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have had a fracture of the acetabulum ostéosynthèsée treated conservatively or who had a total hip replacement by secondary intention.
* Operated at St. Joseph's Hospital between 2005 and 2013
* Decline minimum of one year.

Exclusion Criteria:

• Total first-line hip arthroplasty following fracture of the acetabulum made within two months following the date of the initial trauma.
Observation Versus Immediate Surgery of Low Risk Bladder Cancer

This trial is a randomized, multi-center, non-inferiority study comparing observation versus immediate surgery for low grade, noninvasive bladder cancer.


Eligibility Criteria:
Inclusion Criteria:

* History of low grade, noninvasive urothelial carcinoma of the bladder with a new recurrence that meets the following criteria:
* total tumor burden ≤3cm in size (multiple lesions permitted)
* low grade appearance (grade 1 or grade 2)
* noninvasive appearance (Ta)
* no history of carcinoma in situ (CIS) or lesions concerning for CIS
* negative urine cytology (atypical or suspicious for low grade neoplasm are acceptable)

Exclusion Criteria:

* High grade and/or invasive and/or carcinoma in situ disease
* Concomitant upper tract urothelial carcinoma
* Any patient who is pregnant or who may have plans to become pregnant.
* Positive cytology
Novel Stretching Device Versus Night Splints

A set of 100 patients previously diagnosed with plantar fasciitis will be given initial questionnaires about their symptoms and randomly assigned either night splints or the novel calf stretching device. The participants will use each device for 6 weeks. At the end of those 6 weeks, they will return for a follow up questionnaire. The answers in the questionnaire will be analyzed to compare the effectiveness of night splints to calf stretching.

The attached recruitment brochure will be distributed to physician's offices, and possibly placed as an ad in the newspaper. Potential participants will call the enclosed number and an appointment will be arranged to be evaluated at our research facility in Carterville, IL. During their initial evaluation which will take 30 minutes to 1 hour, each participant will complete medical history pertinent to plantar fasciitis and questionnaires regarding symptoms and physical activity. The research participants will then stand on the tssfad1 device for 5 to 10 minutes during which time their triceps surae flexibility will be assessed by measuring the distance from their heel to the platform at the 30-degree setting. Measurements for each foot will be taken with a distance sensor every 5 seconds for a 5 minute period.

The investigators will then use a random number generator program from www.random.org to generate a number between 1 and 100. Participants with an odd number will be assigned home use of standard night splints. Those with an even number will be provided with a TESS unit to be used at home a minimum of 5 minutes twice per day.

The participants will use their device for 6 weeks. They will receive a check in phone call at the 3 week mark of their participation.

Contact numbers will be given to each participant should they have any questions or concerns during the six-week interval. Each participant will be asked to maintain a daily log of their pain level on a visual analog scale and of their estimated time using each device.

Participant's random number will be used to link data in the study to the participant. The investigators will not be using patient identifiable information such as name, date of birth, medical record number, or other personal information for the record.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years and older
* diagnosis of plantar fasciitis
* ability to understand the purpose of the study
* ability to safely use the device they are assigned after education and return demonstration.

Exclusion Criteria:

* patients with ankle fusion or significant balance impairment which would prohibit safe use of the TESS device
Improvement of ARDS Ventilation-perfusion Matching by Prone Positioning Assessed by EIT

Acute Respiratory Distress Syndrome (ARDS) is a highly lethal disease with limited treatment options. In recent years, prone position ventilation has been shown to improve the mortality rate and lung injury of ARDS patients by promoting lung recruitment, improving ventilation/perfusion (V/Q) ratio, enhancing respiratory system compliance, promoting sputum drainage, and effectively avoiding overinflation of the dorsal lung. Electrical Impedance Tomography (EIT) technology has been used to evaluate the effect of prone position ventilation on lung V/Q matching, and some studies have confirmed that prone position ventilation can improve lung V/Q matching and oxygenation index. However, previous studies were mostly case reports or small-sample physiological studies that lacked dynamic changes in lung V/Q matching during repeated prone position ventilation. Therefore, this study hypothesizes that prone position ventilation can increase lung V/Q matching in ARDS patients, and its improvement is correlated with changes in oxygenation index, invasive ventilation time, and patient prognosis. Repeated prone position ventilation can maintain lung V/Q matching at a higher level, no longer affected by changes in body position, which can accelerate pulmonary function recovery and improve the prognosis of ARDS patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old;
2. meet the diagnostic criteria of Berlin's definition for ARDS;
3. invasive ventilation time \< 48h;
4. PaO2/FiO2 \< 150mmHg.

Exclusion Criteria:

1. Contraindication to the prone position;
2. Contraindication to the EIT;
3. Hemodynamically unstable;
4. Patients with hypernatremia;
5. Patients have received extracorporeal membrane oxygenation treatment.
Contingency Management in the Delivery of HAART to Drug Users in Chennai, India

Drug use (DU) is a major risk factor for HIV infection in many regions of the world. However, as highly active antiretroviral therapy (HAART) has been rolled out in South and South East Asia, less than 2% of individuals initiated on HAART were drug users (DUs) or former DUs, despite the fact that approximately 20% of HIV infections in the region are ascribed to DU. India is home to about 2.4 million HIV-infected individuals. Though, injection drug users contribute to only about 3% of all HIV infections in India; it is estimated that there are between 168,000 and 1.1 million DUs in India with HIV prevalence about 30%. Novel approaches are needed to engage disenfranchised populations in HIV care in lower and middle income countries, where the burden of HIV disease is growing. Incentive-based strategies (or contingency management) have been shown to be effective in reducing illicit drug use, smoking cessation, and weight loss. Short-term pilot studies have also shown that incentive-based strategies can improve electronically-monitored rates of adherence to HAART in the US, and a recent study in Africa showed that a small incentive approximately doubled the rate that individuals returned to learn the results of their HIV test. However, to date there is no experience with the use of incentive-based interventions to improve engagement into care and risk-reduction among out-of-care HIV-infected DUs in developing world settings. The investigators propose to conduct pilot randomized trial comparing a voucher incentive strategy to a control condition to improve engagement in HIV care and HIV treatment outcomes among out-of-care, treatment-eligible, HIV-infected DUs in Chennai, India. Subjects in the incentive arm will be eligible to earn incentive vouchers for 1) initiating HAART at a government-sanctioned HIV treatment clinic, 2) adherence to scheduled follow-up visits at the HIV clinic, and 3) achieving suppression of HIV RNA. Subjects will be enrolled from a mature research venue in Chennai, YR Gaitonde Centre for Substance Abuse-related Research (YRGCSAR), which focuses the epidemiology and natural history of HIV in DUs. Preliminary data from this pilot study will be used to inform the design of a phase-III study.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Provide written informed consent
* Provide a history of injection or non-injection drug use in prior 30 days
* Documented evidence of HIV infection
* Be ART naïve (by self-report)
* Satisfy Indian National Guidelines for initiation of HAART (any of the following)

  * Absolute CD4+ count \< 200 cells/ µl
  * AIDS-defining illness with any CD4+ count
  * Absolute CD4+ count between 200 - 350 cell/ µl with HIV-related symptoms

Exclusion Criteria:

* Indicates an intention to migrate in the next 12 months
* Any medical or psychiatric condition that the study physician believes to be a contraindication to study participation.
* Enrolled in another HIV treatment program