cyrilzakka/clinical-trials huggingface dataset:
Use of Intrapartum Biophysical Profile When Fetal Heart Rate Monitoring is Non-reassuring in Labor

In this research project the investigators want to figure out whether ultrasound (a non-invasive method) can be used to assess how the fetus is doing during labor.

When you are in labor, the heart beat of your fetus is monitored continuously. The normal pattern is reactive and suggests that the fetus is doing well. When the pattern is different from reactive, it is difficult to say if the fetus is doing well or not. Previous investigators have shown that even with the most worrisome fetal heart rate pattern, only 2/1000 cases would require immediate delivery. Currently, we use invasive procedures like taking a drop of blood from fetal head to further assess how the fetus is doing or just proceed with the fastest way of delivery (which could increase the risk associated with surgery). In this research project we want to figure out whether ultrasound (a non-invasive method) can be used to assess how the fetus is doing during labor.

Eligibility Criteria:
Inclusion Criteria:

* Spontaneous or induced labor
* Gestational ages between 35 - 42 weeks
* Singleton pregnancy
* Intrapartum non-reassuring or uninterpretable FHR tracing defined as any tracing that the Labor and Delivery obstetrician is uncomfortable about or feels does not absolutely provide fetal reassurance. Inclusive FHR patterns will be repetitive late decelerations, recurrent moderate to severe variable decelerations, reduced long or short-term variability, prolonged bradycardia (\<120/min) that resolves, persistent fetal tachycardia (\>160/min for \>60 min,) or any other FHR patterns necessitating further fetal well being evaluation (like scalp pH or scalp stimulation).

Exclusion Criteria:

* Multiple gestation
* Gestational age \< 35 weeks
* Patient denial to undergo ultrasound examination during labor
* Abnormal FHR tracing requiring stat delivery
Objective Flap Assessment During Reconstructive Surgery

The main purpose of this study is to test the ergonomics of an investigational imaging system that can take pictures of blood vessels under the skin. In plastic and reconstructive surgery, blood flow to tissue determines whether the tissue can be transplanted from one location to another. This new imaging device uses invisible near-infrared fluorescent light to see blood vessels that otherwise could not be seen by eye. This study will test the system's basic operation and ergonomics in the operating room.

To perform a pilot study of the FLARE™ NIR fluorescence imaging system in conjunction with indocyanine green (ICG) during breast reconstructive surgery utilizing deep inferior epigastric perforator (DIEP) flaps.

Due to patient-to-patient anatomic variation, the vascular perfusion to the cutaneous elements in flaps is unpredictable and of great concern to the surgeon planning the design of the flap. We propose a method of imaging the flap based on the use of invisible near-infrared fluorescent light that has significant advantages for both patient and surgeon.

Specific Aims:

A pilot optimization study of the imaging system in combination with ICG to determine optimal dose, light excitation fluence rate, and camera exposure time.

Eligibility Criteria:
Inclusion Criteria:

* Women or men above the age of 21 who are undergoing unilateral breast reconstruction after mastectomy.
* Women of childbearing age must have a negative pregnancy test as confirmed by anesthesiologist.

Exclusion Criteria:

* Patients with a known or suspected iodide or seafood allergy.
* Patients with known renal, cardiac, hepatic, or pulmonary disease.
* BMI \> 30
The Effect of Heating With Electrical Blanket After Cesarean Section on the Postpartum

It is known that maintaining and maintaining normal body temperature in women after cesarean section facilitates the mother's adaptation to the postpartum period. One of the important problems after cesarean section is hypothermia. Therefore, various methods are used to maintain normal body temperature. One of these methods is the use of electric blankets. This study will investigate the effect of using electric blankets after cesarean section on postpartum comfort, pain, milk quantity and breastfeeding success.

After cesarean section, mothers face more problems than mothers who give birth normally. Post-cesarean pain, breastfeeding problems, anesthesia-related side effects, and postpartum complications are important reasons affecting maternal comfort. After a cesarean section, mothers may experience hypothermia due to the low temperature in the operating room, the incision, and the effects of spinal/general anesthesia. In mothers who develop hypothermia after cesarean section, undesirable results may occur in physiological parameters such as fever, pulse, blood pressure, pain, and intestinal motility. Therefore, body temperature, blood pressure, pulse, saturation, pain, time to first flatus and defecation are the main factors that determine patient comfort after surgery. In the postoperative period, both pharmacological and non-pharmacological treatment methods are used to reduce pain, increase the amount of milk, and increase intestinal motility. It is stated in the literature that non-pharmacological methods such as early mobilization, chewing gum, early oral hydration (consumption of water, warm water, tea, coffee), and hot application are effective in increasing intestinal motility. Using active and passive heating methods to prevent hypothermia after cesarean section are practices that affect postpartum comfort. With this study, it is expected that heating with an electric blanket will prevent hypothermia, increase postpartum comfort, reduce pain, and increase breastfeeding success by affecting the amount of milk.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and over,
* At least primary school graduate
* The one who is married
* Primiparous women who gave birth at term,
* Having the baby with her after birth
* Those who agreed to participate in the study

Exclusion Criteria:

* Those who gave birth at less than 37 weeks of gestation
* Mothers with babies weighing less than 2500 grams
* The newborn has a congenital anomaly,
* Those with a history of high-risk pregnancy
* Those who received any food, including water, other than breast milk until the 10th day of follow-up
* Those with cardiovascular disease problems, those with a history of neurological diseases
* Mothers with nipple problems
* Diabetes Mellitus, those diagnosed with gestational diabetes mellitus,
* Mothers who gave birth with general anesthesia
Comparison of Pediatric Septic Shock Treatment With and Without Central Venous Oxygen Saturation Monitoring

The purpose of this study was to compare ACCM/PALS guidelines performed with and without central venous oxygen saturation monitoring on the morbidity and mortality rate of children with severe sepsis and septic shock.

Background: ACCM/PALS guidelines addresses early correction of pediatric septic shock using physical examination supplemented by indirect measures of cardiac output such as central venous or superior vena cava oxygen saturation (ScvO2\>70%) in a goal directed approach. However, these endpoints are based on unsupported evidence. The purpose of this study was to compare ACCM/PALS guidelines performed with and without ScvO2 on the morbidity and mortality rate of children with severe sepsis and septic shock.

Methods: Children and adolescents with severe sepsis or fluid-refractory septic shock were recruited at two university-affiliated hospitals and randomly assigned to ACCM/PALS without, or with an ScvO2 goal directed (goal ScvO2 \> 70%) resuscitation. Twenty-eight day mortality is the primary end point.

Eligibility Criteria:
Inclusion Criteria:

* patients with severe sepsis or fluid-refractory septic shock that had not responded after 40 mL/kg of any resuscitation fluid or that required cardiovascular agents at any time during resuscitation

Exclusion Criteria:

* refusal to sign the written informed consent
* age less than 1 month or older than 19 years
* uncorrected cyanotic heart disease
* patients receiving exclusive palliative care
* patients that arrived from other hospitals more than 6 hours after the diagnosis of severe sepsis or septic shock.
A Study In Patients With Type 2 Diabetes Mellitus

This study evaluates the effect of medicines for type 2 diabetes and lipids control. This study will require about 6 office visits for lab tests and examinations. All study related medicines and medical examinations will be provided at no cost to the subjects.


Eligibility Criteria:
Inclusion criteria:

* A clinical diagnosis type 2 diabetes mellitus.
* Women must not be pregnant or breastfeeding during the study and 30 days after the study.
* Must sign an informed consent form at the study clinic.

Exclusion criteria:

* Severe chronic diseases that would prevent from participating and completing the study by investigator's judgement.
* Use of an investigational drug within 30 days or 5 half lives before first dose of study medication.
* Insulin use for \> 1 week in past 3 months.
Illinois Workplace Wellness Study

Workplace wellness programs have become a $6 billion industry and are widely touted as a way to improve employee well-being, reduce health care costs by promoting prevention, and increase workplace productivity. Yet, there is little rigorous evidence available to support these claims, partly because the voluntary nature of these programs means that participants may differ from nonparticipants for reasons unrelated to the causal effects of the wellness program. The investigators will implement a randomized control trial to identify the effects of incentives on wellness program participation, produce causal estimates of the effect of wellness programs on health outcomes, determine what kinds of employees benefit from wellness programs the most, and test for the presence of peer effects in wellness participation.


Eligibility Criteria:
Inclusion Criteria:

* Benefits eligible employees at UIUC. Physically located on UIUC campus, not terminated, eligible for benefits.

Exclusion Criteria:

* Members of the research team, employees directly involved with the approval or implementation of the study, family members of the research team.
Driving After Cervical Spine Surgery

This is a single-center, prospective controlled simulation study designed comparing and evaluating the driving performance of subjects who have had cervical spine surgery and the use of a validated driving simulator. To date, there haven't been evidence-based recommendations to determine a patient's "fitness to drive" in the peri-operative or postoperative state. The objective of this study is to delineate the effect cervical spine procedures have on driving performance in the peri-operative time period. The study will take place at New York University Langone Medical Center - Hospital for Joint Diseases which will include the surgeries. The follow up visits will be at the NYU Center for Musculoskeletal Care.


Eligibility Criteria:
Inclusion Criteria:

Study Subjects

* Age between 18 and 80 years
* Indicated for elective cervical spine surgery (including ACDF \[single or multilevel\], posterior cervical laminectomy and fusion, posterior cervical laminoplasty, posterior cervical foraminotomy, cervical disc replacement) after failing at least 6 weeks of non-operative treatment modalities
* Valid driving license
* Regular use of a vehicle
* Signed consent form

Inclusion Criteria

Control Subjects:

* Age between 18 and 80 years
* No pre-existing or recent injuries to neck, torso, back
* No neurologic or systemic debilitating conditions
* Valid driving license
* Regular use of a vehicle
* Signed consent form

Exclusion Criteria:

* Significant visual impairment
* Significant debilitating neurological condition with loss of function of one or more extremities
* Recent extremity surgery
* Recent eye surgery
* Previous history of motion sickness, vertigo in simulated settings
* Recent history of chemical or narcotic dependency involved in active litigation related to their spine problem a the time of screening.
* Involved in workers compensation related to their spine problem at the time of screening
The Effect of Wrist Ankle Acupuncture on Post-Total Hip Arthroplasty Pain

Total hip arthroplasty is one of the most cost-effective orthopedic surgical procedures which can restore hip function and improve the patient's quality of life. However, total hip arthroplasty is significantly associated with postoperative pain. Pain after total hip arthroplasty surgery can adversely affect the patient's early postoperative recovery, postoperative mobility, and hinder rehabilitation.

Wrist ankle acupuncture (WAA) is a simpler acupuncture technique, using fewer points, shallow needle insertion and lighter stimulation. Wrist-ankle acupuncture as multimodal analgesia after orthopedic surgery is useful for reducing pain and reduce the incidence of post-surgical side effects. The primary aim of this study is to investigate whether wrist ankle acupuncture therapy gives better and results for post total hip arthroplasty pain than sham wrist ankle acupuncture

This is a clinical trial study to evaluate and compare the effects of wrist ankle acupuncture and sham wrist ankle acupuncture as a therapy for post total hip arthroplasty pain. The subjects are 32 males/female who just undergone total hip arthroplasty surgery and has returned to inpatient ward. They will be randomly assigned to 2 groups: (1) wrist ankle acupuncture and (2) Sham wrist ankle acupuncture. The subjects will receive two sessions of treatment. The outcome will be assessed before treatment (baseline), after fist acupuncture session, after second acupuncture session and a day after the second session. Patients and the outcome assessors will be blinded to the group allocation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing elective primary total hip arthroplasty surgery at dr. Cipto Mangunkusumo Hospital, Persahabatan Hospital, andFatmawati Hospital
2. Aged over 18 years
3. Willing to sign informed consent

Exclusion Criteria:

1. Have a history of malignancy
2. Revision total hip arthroplasty patient
3. Post-total hip surgery patient treated in ICU.
4. The patient has a mental disorder so he cannot understand the explanation given
Study to Characterize the Pharmacokinetics of Raltegravir in the Gastrointestinal (GI) Tract of Healthy Male Volunteers

The purpose of this study is to characterize the way the first commercially available integrase inhibitor, raltegravir, a new class of antiretrovirals that is used to treat HIV, is distributed into the rectal mucosal tissue. This information will generate important information regarding the drug's penetration into lymphoid tissues that are rapidly depleted in HIV infection. Subsequently strategies to prevent the sexual transmission of HIV and for treating HIV-infected individuals will be designed.

Participants: 14 HIV-uninfected, healthy, male volunteers, ≥18 and ≤49 years of age, will be recruited and enrolled. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG, and clinical laboratory tests. Participants of all races and ethnicities will be considered for enrollment. This study will be conducted at a single site in the United States: the University of North Carolina at Chapel Hill.

Procedures (methods): An outpatient screening visit will be conducted on all potential participants to obtain informed consent and evaluate for eligibility. Once enrolled, all subjects will take 400 mg oral dose of raltegravir twice daily from Day 1 to Day 7. The healthy men enrolled in this study will undergo single-dose and multiple-dose pharmacokinetic sampling. Blood will be collected via peripheral IV at pre-dose, and at 1, 2, 3, 4, 6, 8 and 12 hours post-dose. Subjects will undergo two colonoscopies during sampling visits (Day 1 and Day 7) for the purpose of obtaining gastrointestinal-associated lymphoid tissue (GALT). Each subject will have his biopsy obtained at one of the following time points post-dose: 1, 2, 3, 4, 6, 8, and 12 hours. Seven to ten days after their last inpatient sampling visit, all subjects will complete a follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects between the ages of 18 and 49 years, inclusive, with intact genital tract and gastrointestinal tract. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG, and clinical laboratory tests.
2. Body Mass Index (BMI) of approximately 18 to 30 kg/m\^2; and a total body weight greater than or equal to 50 kg (110 lbs).
3. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
4. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.

Exclusion Criteria

1) any medical condition or finding deemed by the investigators to be ineligible
A Multi-component Intervention on Improving Fruit and Vegetable Consumption in Teenagers and Their Mothers

This study is a longitudinal controlled trial that is designed to investigate the effectiveness of a multi-component intervention on improving fruit and vegetable consumption in teenagers and their mothers.

This study is a longitudinal controlled trial that is designed to investigate the effectiveness of a multi-component intervention on improving fruit and vegetable consumption in teenagers and their mothers. Participants will be allocated in three groups with a) an intervention group in which mothers and children receive the intervention and questionnaires, b) only the children receive the intervention and mothers and children receive the questionnaires, and c) mothers and children are in active control group and only receive the questionnaires. The intervention package contains behavior change techniques targeting outcome expectancy, self-efficacy, action planning, coping planning, and self-monitoring. The active control group receives an information sheet regarding recommendations on fruit and vegetable intake. There will be 3 assessment points in time, with 1 months in between. All the intervention materials and information sheets will be handed to participants after the baseline assessment. The self-monitoring calendar will be collected at time 2 assessment.

The primary outcome of this study is to estimate the dyadic mechanisms between mothers and their children regarding improving fruit and vegetable intake. Secondary outcome is to investigate whether fruit and vegetable consumption did improve in the intervention groups in general and also to find the psychological mechanism behind the changes during the time of the study.

Eligibility Criteria:
Inclusion Criteria:

* They are not involved in the nutritional education
* Ability to understand Persian language Adolescents attending high schools in Qazvin

Exclusion Criteria:

* Does not meet inclusion criteria
Separate and Combined Extrapancreatic Effects of GIP and GLP-1

The two gut-derived hormones, glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) are secreted from intestinal cells in relation to a meal and increase insulin secretion from the pancreas. The hormones also exert effects outside the pancreas, but especially for GIP, these are poorly investigated. Because of this, only GLP-1 based drugs (GLP-1 receptor agonists) are on the market for the treatment of type 2 diabetes and obesity. Nonetheless, a new drug is in clinical development: a combined GIP-GLP-1-receptor agonist (tirzepatide), which has shown better results than GLP-1 alone. The mechanism behind these impressive effects are unknown and in this study, the investigators will look into the exptrapancreatic effects of GIP and GLP-1, separate and combined and thus elucidate the mechanisms of action of this new drug class.


Eligibility Criteria:
Inclusion Criteria:

* Total pancreatectomy
* Caucasians between 30-75 years of age
* Blood haemoglobin \>7.0 mmol/l for males and \>6.5 mmol/l for females

Exclusion Criteria:

* Pancreatectomy within the last 3 months
* Ongoing chemotherapy or chemotherapy within the last 3 months
* Treatment with GLP-1 receptor agonists within the last 3 months
* Renal impairment (estimated by estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73 m2) and/or albuminuria
* Calcium related disease, hypo-/hyperthyroidism
* Known significant liver disease, plasma alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 × normal value or INR (The international normalised ratio based on prothrombin time) outside the normal range
* Severe arteriosclerotic heart disease or heart failure (New York Heart Association (NYHA) group III or IV)
* Pregnancy and/or breastfeeding
* Use of more than 14 units of alcohol per week or abuse of narcotics
* Any condition that the investigator feels would interfere with trial participation
Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Asthma

This is a randomized, double-blind, single-dose, placebo-controlled, 5-period, 5-treatment, crossover, multi-center study to assess the bronchodilatory effect and safety of 2 dose levels of Albuterol Sulfate Pressurized Inhalation Suspension (hereafter referred to as AS MDI), 90 μg and 180 μg, compared with placebo for AS MDI (hereafter referred to as Placebo MDI) and open-label Proventil® hydrofluoroalkane (HFA; hereafter referred to as Proventil) 90 μg and 180 μg in adult and adolescent subjects with mild to moderate asthma. This study design utilizes 10 treatment sequences.

This is a 5-period crossover study. Each Treatment Period is 1 day. Subjects will receive a single dose of randomized study drug at each of the 5 Treatment Visits (Visits 2, 3, 4, 5, and 6), with a 3- to 7-day Washout Period between Treatment Visits.

Eligibility Criteria:
Inclusion Criteria

* Are at least 12 years of age and no older than 65 years
* Have stable (for 6 months) physician-diagnosed asthma with historical documentation of the diagnosis
* Must be receiving 1 of the following required inhaled asthma therapies listed below for at least the last 30 days; Only SABA, which is used as needed for rescue, or Low to medium doses of ICS (alone or in combination with LABA), used regularly as maintenance asthma therapy
* Demonstrate acceptable spirometry performance (ie, meet American Thoracic Society \[ATS\]/European Respiratory Society \[ERS\] acceptability/repeatability criteria
* Pre-bronchodilator FEV1 of ≥40 to \<90% predicted normal value after withholding SABA for ≥6 hours
* Confirmed FEV1 reversibility to Ventolin, defined as a post-Ventolin increase in FEV1 of ≥15%
* only 2 reversibility testing attempts are allowed

Exclusion Criteria:

* Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia)
* Oral corticosteroid use (any dose) within 6 weeks
* Current smokers, former smokers with \>10 pack-years history, or former smokers who stopped smoking \<6 months (including all forms of tobacco, e-cigarettes \[vaping\], and marijuana)
* Life-threatening asthma as defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s)
* Historical or current evidence of a clinically significant disease
* Cancer not in complete remission for at least 5 years
* Hospitalized for psychiatric disorder or attempted suicide within 1 year
* Unable to abstain from protocol-defined prohibited medications during the study