cyrilzakka/clinical-trials huggingface dataset:
Effects of Berries and Berry Fractions on Metabolic Diseases

The study hypothesis is that the bioactive compounds of sea buckthorn berries (Hippophaë rhamnoides), their fractions, and bilberries (Vaccinium myrtillus). have positive effects on lipid and carbohydrate metabolism and will thus reduce the risk of developing metabolic diseases.

The aim of the project was to investigate whether it is possible to reduce the risk of metabolic diseases with supplementing the diet with sea buckthorn berries (Hippophaë rhamnoides), their bioactive fractions, and bilberries (Vaccinium myrtillus). The study design was a randomized cross-over clinical trial. The participants were slightly and moderately overweight female subjects. In total, 110 female volunteers were recruited, and they followed four different berry diets (bilberry, sea buckthorn, sea buckthorn phenolic extract and sea buckthorn oil) in a randomized order for 33-35 days. Each intervention was followed by a wash-out period of 30-39 days. Blood samples were drawn and physical measurements were performed after each period. Eighty volunteers completed the study. Different markers of lipid and carbohydrate metabolism and inflammation were measured form the blood samples.

Eligibility Criteria:
Inclusion Criteria:

* BMI 26-34
* total cholesterol 4.5-8 mmol/l
* LDL chol \>2.5 mmol/l
* triglycerides \<4 mmol/l
* glucose \<6 mmol/l
* insulin \<25 mU/l
* blood pressure \<160/99 mm Hg
* hemoglobin \>120 g/l
* thyroid-stimulating hormone 0.3-4.2 mU/l
* ALAT \<60 U/l
* creatinine \<115 umol/l

Exclusion Criteria:

* pregnancy
* menopause,
* regular smoking
* previously diagnosed diabetes (other than gestational)
* thyroid, renal, hematological, or hepatic dysfunction
* previous myocardial infarction
* cardiovascular medication
* treatment with regular medication other than allergy medication or joint lubricates
* on-going inflammatory disease
Diagnosing Adult Growth Hormone Deficiency

The purpose of this study was to validate the growth hormone releasing hormone (GHRH) plus arginine (GHRH+arg) stimulation test and it´s cut-off limits for diagnosis of adult growth hormone deficiency using the growth hormone (GH) Immulite 2000 Xpi assay calibrated against the IS 98/574 from the World Health Organization. A specific aim was to study the effect of gender and age on the peak GH response in the GHRH+arg test

Adult growth hormone deficiency (AGHD) is a clinical entity including increased abdominal fat mass, decreased muscle mass, low bone density and adverse effects on quality of life and cardiovascular morbidity. These signs are nonspecific, and accurate diagnosis with laboratory tests in needed.

The GHRH+arg test is used to diagnose AGHD, but the cut-off values vary based on controls used. At moment consensus cut-off criteria are BMI specific, but gender and age may also affect the GH response in the GHRH+arg.

Eligibility Criteria:
Inclusion Criteria:

for health patients:

1. age 20-60 years,
2. no symptoms indicative of disease.

for patients:

1. age 16-90 years
2. previous pituitary disease
3. suspicion of growth hormone deficiency

Exclusion Criteria:

for healthy controls:

1. pregnancy,
2. a known or suspected disease,
3. any symptoms indicating disease
4. use of medication
A Study of Safety and Immunogenicity of a Malaria Vaccine Candidate

Shanghai Wanxing Bio-Pharmaceuticals is currently evaluating one malaria vaccine candidate, PfCP2.9 adjuvanted with Montanide ISA 720. This trial is designed to test the safety and immunogenicity of 3 doses and 2 vaccination schedules.

This blood stage candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-endemic areas.

This is a double blind, randomized, controlled Phase I study of PfCp2.9, an experimental malaria vaccine candidate, adjuvanted with Montanide ISA 720.

The primary objective of this study is to assess the safety and reactogenicity of the vaccine in healthy Chinese adult volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female ≥ 18 and ≤ 45 years of age
* Agrees not to donate blood during the course of the trial.
* Signed written informed consent provided.
* Available to participate for the study duration.

Exclusion Criteria:

* History of allergic reactions following any vaccination.
* Involvement in drug or other vaccine trial within four weeks prior to the trial.
* Acute illness within four weeks prior to the trial.
* Presence of fever at the time of vaccination, i.e. body temperature (by axillary) \> 37.5 C.
* Presence of any chronic illness/disease including diabetes mellitus, tuberculosis, leprosy, epilepsy and hypertension determined by medical history or examination.
* Persons on systemic corticosteroids, immunomodulators or anticoagulants within four weeks prior to vaccination.
* Persons with a history of allergic manifestations requiring treatment with injectable antihistamines, adrenaline or steroids.
* Pregnancy. Women should not be pregnant, lactating, or planning pregnancy throughout the study period. A urinary pregnancy test (immuno-chromatography) will be performed for all women of child-bearing potential at entry and prior to each vaccination. Adequate contraception throughout the study should be used if applicable.
* Sexually active woman not using contraceptives.
* Current smoker ( ≥ 20 cigarettes/day).
* History of malaria: persons with a known history of malaria or with positive markers for antibodies to malaria parasite by IFA and/or ELISA.
* History of residing in a malaria endemic region or malaria exposure (travel) within last two years.
* Abnormal hematology and clinical chemistry considered to be clinically significant.
* Abnormal urine routine test considered to be clinically significant
* Persons with positive markers for HBV (HBsAg) and/or HCV (Anti-HCV) infection.
Developing a Checklist of Lymphedema Symptoms in Patients With Head and Neck Cancer

RATIONALE: Developing a symptom checklist for late-effect lymphedema may help doctors learn more about lymphedema in patients with head and neck cancer and plan the best treatment.

PURPOSE: This phase I/II trial is developing a checklist of lymphedema symptoms in patients with head and neck cancer.

OBJECTIVES:

* To develop and validate a symptom checklist for late-effect lymphedema in patients with head and neck cancer. (Phase I)
* To examine late-effect lymphedema symptoms in these patients using the preliminary patient-symptom checklist developed in phase I. (Phase II)
* To examine the psychometric properties of the patient symptom checklist. (Phase II)

OUTLINE:

* Phase I: Experts review an initial symptom checklist for late-effect lymphedema symptoms and provide suggestions concerning its revision. The checklist is further revised using the card sorting method. Patients sort cards labeled with symptoms into groups that they feel are appropriate based upon their own symptom experiences. Sorting is performed according to frequency and severity of symptoms. Patients may write down any symptoms which are not listed on the cards.

Patients undergo collection of demographic and lymphedema-related symptom information. Additional medical information is obtained from patients' medical records.

* Phase II: A final symptom checklist for late-effect lymphedema symptoms is constructed based on the preliminary checklist developed in phase I. The psychometric properties of the preliminary checklist are also assessed.

Patients undergo collection of demographic, lymphedema-related symptoms, and medical information as in phase I.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Patients meeting the following criteria:

    * Diagnosis of local squamous cell carcinoma of head and neck
    * Developed lymphedema after cancer treatment
    * No current evidence of cancer recurrence
    * No metastatic disease
    * Identified from oncology practices at the Vanderbilt-Ingram Cancer Center
  * Volunteer expert meeting the following criteria:

    * Member of the Pain and Symptom Management Team at Vanderbilt-Ingram Cancer Center OR faculty member/clinician associated with the Principal Investigator's prior clinical research at Vanderbilt Medical Center
    * Knowledgeable about the symptoms head and neck cancer patients experience

PATIENT CHARACTERISTICS:

* No history of psychotic illness

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* More than 3 months since prior cancer treatment
* No concurrent chemotherapy or radiotherapy
* No concurrent anti-psychotic medication
The Pathogenesis of Human Senile Cataract

To study the pathological mechanism of cataract by genomics, transcriptomics, and proteomics.

Tissue samples and aqueous humor samples will be collected from each individual patients by cataract surgery. After sample treatment, different techniques will be applied for analysis. And bioinformatics approach is applied for data treatment and analysis.The data of genomics, transcriptomics, and proteomics will be analyzed for study of pathological mechanism of cataract.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the explicit diagnosis of cataract (including senile cataract, congenital cataract, complicated cataract, metabolic cataract, traumatic cataract, etc.) in the operated eye are willing to undergo cataract surgery.

Exclusion Criteria:

* Patients whose cataracts need not be operated
* Patients with any contraindications to cataract surgery
* Patients are unwilling to undergo cataract surgery
Phase 1 Study of Safety and Biological Effects of C326, an Inhibitor of IL-6, in Crohn's Disease

The purpose of this study is to determine whether C326, a new inhibitor of IL-6, is safe in patients with Crohn's disease.

Determination of safety is the most important goal of this first study with C326. Other goals of the study are to examine:

* pharmacokinetics (change in serum concentrations over time),
* biological activity (change in blood markers relecting activity of Crohn's Disease),
* effects on symptoms of Crohn's disease.

Participants may receive either a single or several intravenous infusions of C326 or matching placebo.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 - 65
* Stable, moderately active Crohn's Disease
* Otherwise in generally good health

Exclusion Criteria:

* Variety of concurrent medical conditions
* Various concomitant medications
Comparison Between 2 Techniques for Bilateral Salpingectomy

A comparison between 2 techniques for bilateral salpingectomy during cesarean section.

Primary outcomes are total operative time and bilateral completion of the randomized procedure. Secondary outcomes included surgical complications and post operation complications.

Ovarian cancer is the most lethal gynecologic malignancy. Major contributors to this high mortality are the lack of effective screening strategies, diagnosis at advanced stage of presentation as well as the high risk of recurrence. In the last years the Gynecologic Associations worldwide have recommended that total salpingectomy be considered for potential ovarian cancer risk reduction in benign gynecologic surgeries after completion of childbearing.

However, the data are limit regarding the Preferred surgical technique during cesarean section.

In this randomized controled trial the investigators will compare between various techniques for bilateral salpingectomy during cesarean section.

Primary outcomes are total operative time and bilateral completion of the randomized procedure. Secondary outcomes included surgical complications and post operation complications.

Eligibility Criteria:
Inclusion Criteria:

* Participants undergoing elective Cesarean Section and are interested and have signed informed consent regarding bilateral salpingectomy.

Exclusion Criteria:

* Inability to give informed consent.
* Preterm delivery (\< 37 weeks' gestation).
* Fetal demise.
* Prenatal diagnosis of fetal or placental abnormalities.
* Previous tubal surgery.
* The use of anticoagulants.
* Associated immunosuppressive conditions.
CBT-I for Sleep, Pain, and Inflammation in Crohn's Disease

People with Crohn's disease often suffer from sleep problems. Long term, sleep problems may lead to more flares of Crohn's disease or other complications. In general, people with Crohn's disease also report that sleep problems can worsen symptoms of Crohn's disease the next day. In people with other medical problems, research has also shown that having sleep problems can make other things worse, such as pain and inflammation. In this study, the researchers want to understand the treatment of sleep problems in people with Crohn's disease, and what else might improve if sleep gets better. This study will use Cognitive Behavioral Therapy for Insomnia (CBT-I) to treat insomnia symptoms. CBT-I is the recommended treatment for insomnia and has been shown to improve sleep problems, pain, and inflammation in other groups of people. If this study is successful, it will contribute to understanding how to treat insomnia in people with Crohn's disease and how sleep impacts pain and inflammation. Long term, this information will be helpful in understanding how best to take care of people with Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate Crohn's disease (as assessed by PRO-3 score)
* Insomnia severity index score of 8 or greater
* Sleep onset latency and/or wake after sleep onset of at least 30 minutes
* Access to device and internet/cell phone service sufficient for telehealth

Exclusion Criteria:

* PHQ-9 score of 20 or greater
* GAD-7 score of 20 or greater
* Unstable major psychiatric condition
* Current alcohol or substance abuse
* Current narcotic use for pain control
* Current systemic corticosteroid use
* Current pregnancy or nursing
* Ileostomy or colostomy
* Diagnosis of seizure disorder
* Diagnosis of sleep apnea or positive STOP-Bang screen
* Diagnosis of restless leg syndrome or positive Cambridge-Hopkins RLSq screen
* Night shift, rotating shift work, or frequent travel outside of primary time zone
Effects of Different Inspiratory Muscle Training Protocols in Patients With Chronic Kidney Disease

The goal of this study is to investigate the effects of different IMT protocols on respiratory muscle strength, functional exercise capacity, quadriceps femoris muscle strength (QMS), handgrip muscle strength (HGS), QoL, respiratory function, dyspnoea, fatigue, balance, and PA levels in patients with CKD that were not on dialysis.

Peripheral and respiratory muscle weakness has been reported in patients with chronic kidney disease (CKD). Management of respiratory muscle weakness is crucial, as reduced functional performance is related to respiratory muscle weakness.

Different IMT function protocols with 30-70% of the maximal inspiratory pressure (MIP) have been found to improve these in patients with CKD. The most efficient IMT intensity for patients with CKD is unknown. Therefore, this study aims to investigate the effects of different IMT protocols on respiratory muscle strength, functional exercise capacity, quadriceps femoris muscle strength (QMS), handgrip muscle strength (HGS), QoL, respiratory function, dyspnoea, fatigue, balance, and PA levels in patients with CKD that were not on dialysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CKD stages 1-5 based on the CKD staging proposed by the Kidney Disease Outcomes Quality Initiative who are not on dialysis
* Aged\>18 years
* No change in medications over one month

Exclusion Criteria:

* Uncontrolled hypertension
* Non-stable cardiac disease
* Recent viral infections
* Respiratory, neurological, and orthopedic diseases
* Pregnant and lactating patients
Quadratus Lumborum Block Versus Epidural for Laparoscopic Nephrectomy Kidney Donor

This study aimed to compare Quadratus Lumborum Block to Epidural on Stress Response and Perioperative Cellular Immunological Function of Laparoscopic Nephrectomy Kidney Donor

Sixty-two subjects were given informed consent before enrolling the study and randomized into two groups; quadratus lumborum block and epidural. Non-invasive blood pressure monitor, electrocardiogram (ECG), and pulse-oxymetry were set on the subjects in the operation room. General anesthesia induction was done by fentanyl 2 mcg/kg and propofol 1-2 mg/kg. Endotracheal tube (ETT) intubation was facilitated with Atracurium 0.5mg/kg as muscle relaxant. Maintenance was done by sevoflurane, oxygen, and compressed air. On quadratus lumborum block group, bilateral block using ultrasound will be performed with stimuplex 100mm needle with 20 cc of bupivacaine 0.25% as regimen. On epidural group, epidural catheter was inserted under general anaesthesia on left lateral decubitus position (5 cm depth inside the epidural space) at level Th10-Th11. The catheter insertion was confirmed with vacuum aspiration and negative test-dose. Before first incision, patient will be given continuous epidural Bupivacaine 0.25% 6 mL/hour. Blood sample was drawn for interleukin-6, blood glucose, and c-reactive protein as baseline data. After surgery, patient were extubated until fully conscious and can follow command verbally. Patient will be transported in recovery room post operation.

Eligibility Criteria:
Inclusion Criteria:

* Kidney donor patients undergoing laparoscopic nephrectomy
* Body mass index below 30
* Duration of surgery 4 to 6 hours
* Patients who agreed to participate in this study and sign informed consent.

Exclusion Criteria:

Have contraindication for quadratus lumborum block

* Have contraindication for epidural
* Previous history of local anesthetic drug allergy
* inability to communicate
Addressing Health Disparities in Engagement, Retention, and Utilization of PrEP Among South Florida Women of Color

Women of color (WOC) in South Florida, the region with the highest HIV rates in the U.S., experience significant barriers to accessibility, uptake, and utilization of Pre-exposure prophylaxis (PrEP) for HIV prevention, despite FDA approval since 2012. The purpose of this study is to use a Community-Based Participatory Research (CBPR) approach to finalize, and pilot-test a multi-component evidence-based intervention to reduce health disparities in engagement, utilization, and retention in PrEP care, with the goal of improving HIV prevention outcomes for the target population of WOC in S. Florida, primarily African American, Latina, and Haitian women in 3 designated Ending the HIV Epidemic (EHE) counties: Miami-Dade, Broward, and Palm Beach counties.

The purpose of this study is to use a Community-Based Participatory Research (CBPR) approach to finalize, and pilot-test a multi-component evidence-based intervention to reduce health disparities in engagement, utilization, and retention in PrEP care, with the goal of improving HIV prevention outcomes for the target population of WOC in S. Florida. We will conduct an exploratory pilot of the PrEP intervention, using a quasi-experimental design, among 80 multi-ethnic WOC in Miami-Dade, Broward, and Palm Beach counties to evaluate feasibility, acceptability, and fidelity. PrEP uptake, adherence, and retention in care will be measured over a 4-month period, including biomarkers of adherence. Adult women initiating or returning to PrEP services at our collaborating sites will be recruited, consented, enrolled and complete baseline assessments. They will participate in an adapted Integrating ENGagement and Adherence Upon Entry (iENGAGE) intervention to address social determinants of health barriers to maintaining PrEP care.

Eligibility Criteria:
Inclusion Criteria:

1. \>=18 years of age;
2. female and identifying as female gender;
3. able to provide informed consent;
4. willing to document a negative HIV antibody test before starting PrEP;
5. reporting recent sexual risk (e.g., sex without condoms in last 3 months, sexually transmitted infection (STI) diagnosis in the last 6 months, post-exposure prophylaxis (PEP) use in the last 12 months, transactional sex, partners who are HIV+);
6. report history of alcohol and other drug (AOD) use in last 3 months;
7. willing to screen for medical contraindications to PrEP according to Florida Health Department guidelines;
8. currently not cognitively impaired;
9. reporting no history of bipolar disorder, psychosis, or current need for inpatient psychiatric hospitalization.

Exclusion Criteria:

1. Less than 18 years of age;
2. not female at birth
3. unable to provide informed consent;
4. unwilling to document a negative HIV antibody test before starting PrEP;
5. unwilling to screen for medical contraindications to PrEP according to Florida Health Department guidelines;
6. currently cognitively impaired;
7. reporting recent history of bipolar disorder, psychosis, or inpatient psychiatric hospitalization
SB-480848 in Major Adverse Cardiovascular Events - Integrated Summary of Efficacy and Safety From the STABILITY Trial (LPL100601) and the SOLID-TIMI-52 Trial (SB-480848/033)

The overall objective of this integrated analysis is to evaluate the clinical safety and efficacy of long-term treatment with darapladib enteric coated tablets, 160mg, as compared to placebo when added to standard of care in subjects with clinical manifestations of cardiovascular disease (chronic coronary heart disease (CHD) and post Acute Coronary Syndrome (ACS)). With respect to efficacy, the key purpose of this integrated analysis is to evaluate the effects of darapladib on the following endpoints: urgent coronary revascularization for myoacrdial ischemia, fatal/non-fatal stroke, time to subsequent Major Adverse Cardiovascular Event (MACE), and heart failure requiring hospitalization. The first occurrent of MACE, Major and total coronary events as well as the individual components of MACE will also be evaluated descriptively.

The objective of the integrated safety analysis is to characterize the safety profile of darapladib in subjects with clinical manifestations of cardiovascular disease (chronic coronary heart disease (CHD) and post Acute Coronary Syndrome (ACS)).

The purpose of the integrated efficacy analysis is to test the effects of darapladib on select endpoints which are not part of the testing hierarchies associated with the individual studies, namely: urgent coronary revascularization for myocardial ischemia, stroke, subsequent MACE, and heart failure requiring hospitalization, For all other endpoints, the intent of the integrated analysis is to provide increased precision of the estimated effects of darapladib.

Eligibility Criteria:
Inclusion Criteria:

* This is an integrated analysis therefore inclusion criteria are not applicable.

Exclusion Criteria:

* This is an integrated analysis therefore exclusion criteria are not applicable.
Effects of Gum Chewing on Appetite and Digestion

One obvious property difference between energy-yielding beverages and solid foods is the oral mechanical processing required to prepare the two food forms for swallowing. Considerable human data are consistent with a contribution of mechanical stimulation to appetite suppression. However, no study has isolated this property and assessed its influence on ingestive behavior in humans. This is the aim of the present study. The null hypothesis is that food rheology will have no effect on these indices. The alternate hypothesis is that increased mechanical stimulation will result in stronger satiation/satiety and reduced energy intake. Further, it is hypothesized that the effects of mastication will be less evident in obese compared to lean individuals.


Eligibility Criteria:
Inclusion Criteria:

* body mass index 18 -25 or 30-35 kg/ m2 good health not initiating or terminating the use of medications reported to affect appetite or body weight during the proposed study period stable activity level (no deviation \> 1X/wk @ 30 min/session) no eating disorder (score \<20 of the Eating Attitude Test (EAT-26) no allergies to test foods. not glucose intolerant or diabetic (based on fasting blood glucose between 70-99mg/dl (3.9-5.5mmol/l as recommended by the American Diabetes Association.) no history of GI pathology and self-reported consumer of breakfast and lunch.

Exclusion Criteria:

-