cyrilzakka/clinical-trials huggingface dataset:
The Effect of Eucaloric High-Protein Fiber Diet in Healthy Adults: A Repeated Single-Arm Clinical Trial

The aims of this study is to investigate the effect of eucaloric high protein and fiber diet on healthy subjects.

Several studies have shown that high protein diet can reduce body fat, increase muscle mass, and improve some metabolic parameters of subjects. Also, several studies have shown that high intake of fiber could reduce body weight and improve cardiometabolic parameters. Therefore, combining high-protein diet and high-fiber diet should have a positive synergistic effect on several of anthropometric and metabolic parameters. The aims of this study is to investigate the effect of eucaloric high protein and fiber diet on healthy subjects. Thirteen healthy subjects, age 29,85 ± 4,06 years old, with body mass index (BMI) 29,55 ± 4,12 kg/m2 were prescribed eucaloric high protein diet for two weeks, followed by washing period for two week. Then, they were prescribed with eucaloric high protein and high fiber diet for two more weeks. Twenty grams of dietary fiber were in the form of isomaltooligosaccharides (IMO) based creamer formulae. Their body composition, waist circumference, fasting blood glucose, blood uric acid and total cholesterol concentration were measured after every dietary intervention.

Eligibility Criteria:
Inclusion Criteria:

* (BMI) of \>= 25.0
* Healthy subjects

Exclusion Criteria:

* pregnant,
* under any medication
* having any kind of diseases and acute infection
A Study to Evaluate the Effects of D-1553 on PK of Midazolam, Caffeine, Rosuvastatin, Furosemide, Digoxin, and Itraconazole or Omeprazole on PK of D-1553

This is a phase I study to evaluate drug-drug interactions (DDIs) of D-1553 as a perpetrator combined with midazolam (CYP3A4 substrate), caffeine (CYP1A2 substrate), rosuvastatin (OATP1B1/OATP1B3 substrate), furosemide (OAT1/OATP1B3 substrate), and digoxin (P-gp substrate) and to evaluate DDIs of D-1553 as a victim combined with itraconazole (inhibitor of CYP3A4 and P-gp) and omeprazole (proton-pump inhibitor) in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who volunteer to participate in this clinical trial, understand the study procedures and sign the Informed Consent Form (ICF) in writing.
* Male, aged 18-45 years (both inclusive) at the time of signing the ICF.
* Non-smokers or subjects who smoked no more than 5 cigarettes or 1 pipe per day within 3 months prior to screening.

Exclusion Criteria:

* Subjects with any clinically significant acute diseases as judged by the investigators within one month prior to screening.
* Subjects who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody.
* Subjects with a history of blood or needle phobia.
* Subjects with a history of hypersensitivity to the investigational drug and/or any preparation ingredients.
To Evaluate the Efficacy and Safety of PEG-rhG-CSF（Jinyouli®） in Reducing Neutropenia in Patients With Cervical Cancer

A Prospective, open, randomized, controlled clinical study to evaluate the efficacy and safety of PEG-rhG-CSF(PEGylated recombinant human granulocyte stimulating factor injection) in reducing neutropenia during TP(docetaxel+cisplatin) regiment simultaneous radiochemotherapy and adjuvant chemotherapy in patients with cervical cancer


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18, ≤70 years old;
2. Cervical cancer patients diagnosed by histopathology;
3. Need to receive multi-cycle radical concurrent radiochemotherapy;
4. FN risk \> 20% if rhG-CSF was not accepted; High risk factors associated with FN and planed to use the same protocol in subsequent cycles(docetaxel+cisplatin regimen)；
5. Performance status score(KPS)≥70;
6. No obvious blood system disease,absolute neutrophil count（ANC）≥ 1.5×10\^9/L, platelet count≥80×10\^9 /L, hemoglobin（Hb）≥75 g/L, and no bleeding tendency;
7. The patient signs the informed consent.

Exclusion Criteria:

1. With infection difficult to control, or received system antibiotic treatment within 72 h before chemotherapy;
2. Any bone marrow abnormalities and other hematopoietic ;
3. Had received bone marrow or hematopoietic stem cell transplantation within 3 months;
4. with other malignancies not cure, or with brain metastases;
5. Liver function tests:total bilirubin(TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were all ≥2.5 times normal upper limit.
6. Renal function tests: serum creatinine (Cr)\> 1.5 times normal upper limit;
7. Allergic to the drugs or other genetic engineering biological products from Escherichia coli;
8. Suffering from mental or neurological disorders;
9. Investigator think it is not suitable for recruiting.
Symprove (Probiotic) as an add-on to COVID-19 Management

The major impact of COVID-19 has been that the severity of respiratory symptoms require intensive hospital treatment. There is significant mortality and many of the survivors have a delayed recovery requiring intensive prolonged rehabilitation.

COVID-19 is a multi-systemic disease in which different mechanisms within the body are affected; including the 'Gut microbiome'. 'Gut microbiome' refers to the bacteria living in intestines. While some bacteria is harmful, many are extremely beneficial and necessary for a healthy body. Many patients have gastrointestinal symptoms and there is a major change in the gut micro flora (microbiome), which may have an adverse effect on the respiratory symptoms. The probiotic, Sivomix, was given to hospitalized COVID-19 patients was associated with a more rapid recovery in gastrointestinal symptoms on day 3 and 7, and an eight fold reduction in the requirement for mechanical ventilation in an open trial.

This is a randomized clinical trial, with a recruitment target of 60 patients admitted with COVID-19 symptoms to the general medical wards. Patients will be randomized to receive the probiotic, Symprove, or placebo in addition to their standard of care treatment. Patients will need take either probiotic/placebo daily for 3 months. All follow-up will be whilst they are an inpatient or as a telephone follow-up; they will not need to attend at the hospital to participate.

There is a biological sub-study incorporated into the protocol, but participation is optional. If patients consent to this, they will also need to provide blood, faecal and saliva samples at baseline, Day 7 and final visit (3 months after randomisation). Patients who consent to providing biological samples will need to visit the hospital at Day 7 and final visit.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic patients who are hospitalised with respiratory COVID-19
* Ability to give informed consent
* Aged 20-85

Exclusion Criteria:

* Patients not meeting the inclusion criteria that have COVID-19
* Inability to consent
* Pregnancy
* Severe pre-existing mental health disorders or addictions
'Fibrosis in the Lost Hepatitis C Population - Track, Trace and Treat'

Objective:

To coordinate active tracing of chronic hepatitis C patients lost to follow-up to inform them about there disease severity and treatment options.

Study design: This is a prospective cohort study, which will start as a pilot study in the Radboudumc Population: lost to follow-up chronic hepatitis C patients in the region Nijmegen. This so-called lost population consists of all patients, that in the past have been identified at the Radboudumc but who are currently lost to or have been withdrawn from follow-up. The time-span of interest will be 2000-2015. We estimate that this project will retrace 100 lost patients through this search.


Eligibility Criteria:
Inclusion Criteria:

* ever diagnosed with hepatitis C, lost to follow-up

Exclusion Criteria:

* none
Placement of the Double-Lumen Tube Without Fiberoptic Bronchoscope Assistance

laryngoscope combined with chest CT in double lumen endotracheal tube accurate positioning

Comparing the traditional method of double lumen endotracheal tube intubation and laryngoscope combined with chest CT guide the precise localization of double lumen endotracheal tube

Eligibility Criteria:
Inclusion Criteria:

* BMI less than 35 kg/m2
* ASA classifications of I-III, modified Mallampati classification 1 or 2 general anesthesia were included-

Exclusion Criteria:

* Exclusion criteria included age younger than 18 yr
* ASA class IV or V
* Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions-
Clomiphene Citrate (CC)/Gonadotropin/Gonadotropin Releasing Hormone (GnRH) Antagonist Versus Gonadotropin/GnRH Agonist

Objective: To compare the efficacy of using mild ovarian stimulation protocol and conventional stimulation protocol in IVF outcome.

Design: Prospective randomized trial

Setting: University IVF setting. Patient(s): The study compromised a total 200 subinfertile couple that women had regulary menstruation.

Intervention(s): Patients were randomized to treatment clomiphene citrate, gonadotropin and GnRH antagonist (100 patients) or GnRH agonist and gonadotropin ( 100 patients).

Main outcome measure: Clinical pregnancy rate.

Key Words: clomiphene citrate, GnRH agonist, GnRH antagonist, in vitro fertilization, pregnancy rate.


Eligibility Criteria:
Inclusion Criteria:

* female patient age 18-35 years, presence of a regular and proven ovulatory menstruation cycle with a length of 26-35 days
* basal FSH \<10 IU/L and body mass index (BMI) of 18-30 (kg/m²)
* Indication for IVF were unexplained infertility, mild male factor, tubal factor, early stage endometriosis and cervical factor

Exclusion Criteria:

* patient requiring ICSI
Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections

This study will assess the safety and efficacy of cefepime/VNRX-5133 compared with meropenem in both eradication of bacteria and in symptomatic response in patients with cUTIs.


Eligibility Criteria:
Inclusion Criteria:

* Adult male and female
* Documented diagnosis of pyuria
* Documented diagnosis of cUTI or Acute Pyelonephritis (AP)

Exclusion Criteria:

* Receipt of effective antibacterial drug therapy for cUTI for more than 24 hours during the previous 72 hours prior to randomization
* A urine culture result is resistant to meropenem or a gram negative pathogen is not identified or more than 2 microorganisms are isolated or a confirmed fungal UTI is identified
* Required use of nonstudy systemic bacterial therapy
* Suspected or confirmed prostatitis or urinary tract symptoms attributable to sexually transmitted disease
* Patients with perinephric or renal abscess
* Patients with renal transplantation or receiving hemodialysis or peritoneal dialysis
* Abnormal labs
Measuring Cowpea Consumption in Young Children and Pregnant Women in Ghana

Current dietary assessment methods rely on self-report food intake such as food frequency questionnaires, 24-hr dietary recall, or diet diaries, and the prevalence of misreporting with these tools is estimated at 30-88%.A reliable and convenient way to measure the quantity of cowpea consumed by an individual. The hope is to identify a novel set of dietary biomarkers that will measure cowpea consumption, be free from participant recall bias, and serve to quantify legume intake. A total of 40 subjects, 20 children (9-21 months) and 20 pregnant women (\>18 yr) will consume 3 distinct daily intake dosages of cooked cowpeas with the daily intake increased every 5 days. Urine samples will be collected 3 times during each 5-day period and blood spots will be collected during a washout period and at the end of the final 5-day period. Urine samples will undergo metabolite detection via ultra-performance liquid chromatography tandem mass spectrometry in positive and negative ion mode. Peaks are quantified using area-under-the-curve (AUC) and each metabolite is quantified in terms of its median-scaled relative abundance for the metabolite across the entire data set. A repeated measures 2-way ANOVA will be used to compare cowpea metabolite abundances over time and with respect to variation in an individual baseline levels.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children between the ages of 9-21 months and pregnant women \> 18 years of age and between 20-25 weeks of gestation.

Exclusion Criteria:

* Children with acute malnutrition, congenital abnormalities, chronic debilitation disease such as heart disease, cerebral palsy, or HIV infection. For the pregnant women they should also be free from acute malnutrition, without known complications such as gestational diabetes, pre-eclampsia, gestational diabetes, or hypertension
To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)

This trial will be conducted to evaluate the immunogenicity, reactogenicity and safety of the liquid formulation of GSK Biologicals' HRV vaccine compared to the lyophilized formulation of GSK Biologicals' HRV vaccine


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks.
* Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

* se of any investigational or non-registered product (drug or vaccine) other than the HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/ administration of a vaccines not foreseen by the study protocol except for DTPw, HBV/Hib and OPV vaccines within 14 days before each dose of HRV vaccine and ending 14 days after.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Household contact with an immunosuppressed individual or pregnant women.
* Previous confirmed occurrence of RV GE.
Microbiome and Rectal Cancer

The purpose of our study is to determine if an association exists between the microbiome of those with rectal adenocarcinoma who are complete pathologic responders and those who have a partial or no response to neoadjuvant therapy.

This study will help to further elucidate the association of bacteria with rectal cancer, while also characterizing the genes associated with that risk. Furthermore it will attempt to better understand which patients may have an optimal response to neoadjuvant chemoradiation allowing for possible predictive metagenomics evaluation, investigators may be able to augment treatments as well as provide recommendations for the success and cost effectiveness of cancer care.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Locally Advanced Rectal Adenocarcinoma (T3)
* Standard 5FU based chemoradiation
* Total Neoadjuvant Therapy per OPRA protocol guidelines

Exclusion Criteria:

* Age \< 18 years
* Stage I or Stage IV rectal adenocarcinoma
* Rectal cancer other than adenocarcinoma
* Genetically associated cancer (HNPCC, FAP etc.) or highly suspicious for genetically associated cancer
* Prior history of rectal adenocarcinoma (i.e. recurrent colorectal adenocarcinoma)
Noninvasive Monitoring in Lower Body Negative and Positive Pressure Tests

The goal of these studies is to assess the use of phonocardiograhy to monitor blood volume. We will evaluate phonocardiographic parameters in normal subjects in increasing levels of lower body negative pressure (LBNP) and lower body positive pressure (LBPP).


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Good health
* Free of systemic diseases
* No contraindications to LBNP/LBPP exposure
* Normal resting systolic blood pressure (SBP, 100-140 mm Hg) and diastolic blood pressure (DBP, 60-90 mm Hg)

Exclusion Criteria:

* Pregnancy
* Prior history of cardiovascular disease
Impact of Highest Drain Fluid Amylase Levels on Surgical Outcomes and Postoperative Interventions in Patients Undergoing Pancreaticoduodenectomy

This study investigated the impact of highest drain fluid amylase (DFA) level on postoperative pancreatic fistula (POPF) severity and outcomes of patients undergoing pancreaticoduodenectomy (PD) with POPF. Patient demographics of biochemical POPF and clinically relevant POPF (CR-POPF) were compared. Predictive factors were assessed using binary logistic regression. Receiver operating characteristic curve analysis was performed to determine the optimal cutoff value of highest DFA (beyond 3 days post-PD). The investigators compared length of hospital stay, surgical mortality rates, and need for postoperative interventions by highest DFA level.


Eligibility Criteria:
Inclusion Criteria:

* underwent PD from October 2010 to September 2018 in our institution

Exclusion Criteria:

* younger than 20 years of age
* clinical information was unavailable due to private or legal issues
* receiving PD without pancreaticojejunostomy
Perineal Self-Acupressure

The primary aim of this study is to test a non-medicinal technique for chronic constipation. The core of the technique is to have subjects repeatedly press on and massage their perineum before defecation to fragment and soften the stool before it passes the lower rectum and anus. The technique will be evaluated as a complementary treatment to standard treatment of constipation (patient educational materials about treatments such as stool softeners, laxatives fiber supplements, and increased exercise). Although this technique has been studied for other conditions (for example in pregnant women to prevent birthing-related injuries), and it is recommended anecdotally by some physicians, this would be the first time it will be studied for chronic constipation in a randomized, controlled clinical trial.

$50 dollars in compensation is provided for about an hour of participant's time.


Eligibility Criteria:
Inclusion Criteria:

* Must have experienced the following symptoms for at least three months:

  * Straining during at least 25 percent of defecations
  * Lumpy or hard stools in at least 25 percent of defecations
  * Sensation of incomplete evacuation for at least 25 percent of defecations
  * Sensation of anorectal obstruction/blockage for at least 25 percent of defecations
  * Manual maneuvers to facilitate at least 25 percent of defecations (eg, digital evacuation, support of the pelvic floor)
  * Fewer than three defecations per week
* Must have experienced one or more of those symptoms at least six months ago.

Exclusion Criteria:

* Younger than 18 years old.
* Pregnant women.
* Significant weight loss (more than 10% of usual body weight in the preceding 6 months).
* History of blood mixed in stool.
Show Me How You Move and I Will Tell You Who You Are

The aim of this experiment is to gain a better understanding of the body movement patterns of patients with balance disorders (following damage to the vestibular system), as well as their cognitive performance profile. To achieve this, we will need to assess the performance of both patients and healthy subjects with no balance disorders. We will be using a newly-developed artificial intelligence tool to analyze body movement patterns on the basis of participants' videos, and we will also be evaluating participants' performance in a few simple tests of reaction times to image presentations on computer and/or tablet/smartphone.

If you agree to take part in this experiment, you will be asked to perform a simple walking exercise in a corridor (filmed and supervised by a physiotherapist) as well as a few objective cognitive measurement tests (reaction time to attentional and vigilance tasks on computer and/or tablet/smartphone) and subjective tests (self-reported questionnaires) requiring around 40 minutes of investigation in total.

In the long term, the results of this research will make it easier to assess balance disorders in patients with vestibular pathology, and better quantify any cognitive difficulties they may have.


Eligibility Criteria:
For patients :

Inclusion Criteria:

* Age between 18 and 90 years old.
* Vestibular loss diagnosed by senior ENT doctors with the gold standard ENT measures (caloric testing, head impulse test and/or vestibular evoked myogenic potential, ocular and cervical).

Exclusion Criteria:

* Previous neurological disorders (stroke, dementia, ...)
* Current medication interfering with the testing (reducing reaction time).
* Visual difficulties interfering with the testing (Visual field reduction,...)
* Age below 18 years old.

For healthy controls :

Inclusion criteria :

- Age between 18 and 90 years old.

Exclusion criteria:

* Previous neurological disorders (stroke, dementia, ...)
* Current medication interfering with the testing (reducing reaction time)
* Visual difficulties interfering with the testing (Visual field reduction,...)
* Vertigo or balance complains or an history of previous vestibular disorder.
* Age below 18 years old.
* Not being able to understand the consigns of the task.
Battlefield Acupuncture for Pain in Hidradenitis Suppurativa

The investigators will investigate battlefield acupuncture as a treatment for the pain of hidradenitis suppurativa.

Participants will report their pain level daily for 4 weeks. At week 2 and 3, they will get acupuncture in the ears.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* dermatologist-confirmed diagnosis of hidradenitis suppurativa
* significant pain from hidradenitis at least twice weekly
* stable treatment regimen for hidradenitis during study period

Exclusion Criteria:

* disease or disfigurement of the ear that prevents battlefield acupuncture of the ears
* other chronic pain that will interfere with the ability to rate hidradenitis pain
The Effects of Dietary Erythritol on Platelet Reactivity and Vascular Inflammation

The purpose is to conduct a dietary intervention study in which human participants will consume beverages sweetened with erythritol or aspartame, each for 2 weeks, in a randomized crossover design

There is a strong correlation between plasma erythritol concentrations and adverse cardiovascular events in high risk individuals. It has also been demonstrated that consumption of dietary erythritol leads to high levels of plasma erythritol. There is in vitro evidence that erythritol at comparable concentrations promotes platelet activation. However, there is no direct evidence that links human consumption of erythritol with the onset of platelet activation and adhesion leading to inflammation. The investigators seek to fill this evidence gap by conducting a randomized crossover dietary intervention study in which human participants will consume beverages sweetened with erythritol or aspartame, each for two weeks.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 27 kg/m2

Exclusion Criteria:

* • History of blood clot, transient ischemic attack (TIA), stroke, angina, heart attack, or peripheral vascular disease, or current cancer diagnosis.

  * Pregnant or lactating women
  * Current, prior (within 12 months), or anticipated use of medications for treatment of hyperlipidemia, high blood pressure or diabetes, or any medication that in the opinion of the investigators will confound results.
  * Unwilling to forego the use of anti-inflammatory medication during study.
  * Unwilling to forego the use of marijuana during the study.
  * Use of tobacco.
  * Strenuous exerciser (\>4 hours/week at a level more vigorous than walking).
  * Surgery or medication for weight loss.
  * Diet exclusions: Food allergies or dietary restrictions that may undermine compliance to dietary protocol, routine ingestion of more than 2 sugar-sweetened beverages or 2 alcoholic beverage/day. Unwillingness to consume artificial or noncaloric sweeteners. Habitual consumption (\>10 gram/day) of beverage or foods that contain erythritol. Recent or current weight loss diet.