cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of the Use of Ginger Extract in the Management of Motion Sickness

This is an open-label, case control study of 180 patients presenting motion sickness, who will perform a motion sickness assessment questionnaire before and after treatment with dry ginger (Z. officinale) extract.

This open-label, self-paired, case-control study will evaluate 180 patients presenting motion sickness. The primary study objective is to evaluate the use of dry Z. officinale extract 160mg (containing 8mg gingerol) in the treatment of patients presenting motion sickness. The secondary objectives are to evaluate the effect of the treatment on the scores and subscores of the Motion Sickness Assessment Questionnaire (MSAQ) before and after treatment, as well as to assess treatment tolerability in this population. The total study duration will be seven days. A total of four specific motion sickness assessments will be performed, one pre-treatment and three during the treatment period, which consists of an oral dose of 160mg ginger extract 30 minutes prior to the trip under evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes between the ages of 18 and 65
* Clinical presentation of motion sickness
* Female participant of reproductive age agrees to use birth control during study period
* Patient has read, understood, signed and dated informed consent document

Exclusion Criteria:

* Hypersensitivity to any component of the study drug
* History of biliary calculus
* History of gastric irritation
* Hypertension \> 145 / 100mmHg
* Concomitant use of other medicinal products for the treatment of motion sickness
The Effect of IPS-MA- a Modified Early Supported Employment Intervention for Individuals with Mood or Anxiety Disorders

The aim of the present study, is to evaluate the effect of a supported employment intervention, IPS-modified for people with mood and anxiety (IPS-MA) on employment or education, when offered to people with onset mood or anxiety disorders who are not likely to be able to return to work within three month.

The hypothesis is that the IPS-MA method is associated with a shorter recovery period and more people returning to work or education, compared to treatment as usual.

Background: The IPS-MA method is a modified Individual Placement and Support (IPS) intervention, aiming at supporting people with mood or anxiety disorders regain their workability and return to work or education. Previous studies have showed, that IPS has an effect on employment when offered to people with severe mental illness. Further studies are crucial to demonstrate whether the modified IPS, the IPS-MA method, has an effect when offered to people with mood or anxiety disorders who are not yet chronified.

Methods/design:The trial design is a randomized, assessor-blinded, clinical trial of the IPS-MA method in addition to treatment as usual compared to treatment as usual alone for 326 participants diagnosed with a mood or anxiety disorder, living in the Capital Region of Denmark. The primary outcome is competitive employment or education. Secondary outcomes are days of competitive employment or education, disease symptoms, level of functioning, and quality of life at follow-up 12 and 24 months after baseline.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed following the International Classification of Diseases (ICD-10) criteria of affective disorder (F30-39) or anxiety disorder (F40-41)
* Not able to work within 3 months
* Associated with the Mental Health Center Copenhagen, Frederiksberg, Hillerød, Hvidovre or Ballerup
* Only having had contact to the Mental Health services during the past 3 years
* Having had competitive employment or attending a study within the past two years.
* Has returning to work or education as an important goal
* Under the age of 60
* Able to speak, read and understand danish
* Has given informed consent verbally and in writing

Exclusion Criteria:

* A somatic disease that effects the workability
* Substance og alcohol abuse
* have a guardian or a forensic psychiatric arrangement
* not given informed consent
UC Cohort - The Influence of Diet on Gut Microbiotas

The purpose of this research is to determine if different diets have different effects on the inflammation in the colon.


Eligibility Criteria:
Inclusion Criteria:

1. Adults ≥ 18 years old
2. Ability to give informed consent
3. Diagnosis of ulcerative colitis
4. Moderate UC disease activity defined by a Mayo Score of \>6 with endoscopic score of 2
5. On a baseline diet characterized by:

   * Fiber intake of \< 15g/day
   * \> 18% of daily calories from protein

Exclusion Criteria:

1. Prior history of gastrointestinal surgeries (except appendectomy and cholecystectomy)
2. Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
3. Use of NSAIDs or aspirin and unable or unwilling to stop taking two weeks prior to permeability test and for the duration of the study
4. Use of osmotic laxatives and unable or unwilling to stop taking one week prior to permeability test and for the duration of the study
5. Use of oral corticosteroids and unable or unwilling to stop use of oral corticosteroids within the previous 2 weeks and for the duration of the study
6. Multiple dietary restrictions or unable/unwilling to alter dietary protein or dietary fiber.
7. Unwilling to stop ingestion of alcohol and artificial sweeteners such as Splenda™ (sucralose), Nutrasweet™ (aspartame), sorbitol, xylitol, lactulose, or mannitol 2 days before and during the permeability testing days, e.g. foods to be avoided are sugarless gums or mints and diet beverages
8. Unwilling to stop stenuous exercise (running \>5 miles or equivalent) one week prior to the permeability tests
9. Bowel preparation for colonoscopy less than one week prior to completion of the first stool kit and permeability test and flexible sigmoidoscopy and upper endoscopy
10. Pregnancy or plan to become pregnant during the study time frame
11. Vulnerable adult
12. Known bleeding disorders or takes medications that increase risk of bleeding from mucosal biopsies
13. Use of oral antibiotic(s) within the past 4 weeks (can be enrolled after 4-week washout period)
14. Use of commercial probiotic formulations and unwilling to stop for the duration of the study
15. Diagnosis of diabetes
16. Any other disease(s), condition(s) or habits(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes
THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE)

Endovenous interventions are keyhole operations for varicose veins that are carried out from within the vein itself. Varicose veins are enlarged veins close to the surface of the skin. They are connected to the bigger deeper veins in the leg (known as deep veins). Because of this, operations to close the varicose veins can increase the chance of a blood clot forming in the deep veins. Blood clots in the deep veins happen in around 1 in 50 people after endovenous operations. A clot in the leg can cause swelling, pain, and other long-term problems. If a clot in the leg breaks off and travels to the lungs, it can cause problems with the lung' ability to move oxygen from the air into the blood and may, in rare cases, be life threatening.

Varicose vein procedures may carry a slightly higher risk of blood clot formation, and we are currently unsure if current clot reducing medicines are beneficial in preventing blood clots in people having varicose vein procedures.

This study will investigate if it is worthwhile prescribing medicines to reduce blood clots after varicose vein procedures.


Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years)
* Scheduled to undergo endovenous intervention of truncal varicose veins under local anaesthesia
* Treatment technologies including radiofrequency, laser, mechanochemical, foam sclerotherapy and cyanoacrylate glue

Exclusion Criteria:

* Clinical indication for therapeutic anticoagulation e.g., atrial fibrillation
* Previous personal or first-degree relative history of VTE
* Thrombophilia
* Female patients of childbearing potential who have a positive pregnancy test
* A history of allergy to heparins or direct oral anticoagulants
* A history of heparin-induced thrombocytopenia
* Inherited and acquired bleeding disorders
* Evidence of active bleeding
* Concomitant major health problems such as active cancer and chronic renal and/or liver impairment
* Known thrombocytopenia (platelets known to be less than 50 x 109

  /l)
* Surgery or major trauma in the previous 90 days
* Recent ischemic stroke in the previous 90 days
* Inability to provide consent
To Demonstrate the Relative Bioavailability of Metformin HCL 500 mg Extended Release (XR) Tablets Under Fasting Conditions

To demonstrate the relative bioavailability of Metformin HCl 500 mg XR tablets under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Quadrupled Semitendinosus Graft in Anterior Cruciate Ligament Reconstruction

Randomized controlled trial comparing reconstruction of anterior cruciate ligament (ACL) with autologous quadrupled semitendinosus graft or with both semitendinosus and gracilis. It is intended to specially evaluate if by using only the semitendinosus (ST) tendon, the strength of the limb for hamstrings is affected different compared to using both gracilis and ST.

Data checks programmed by a third party after inclusion of participant number 10, 20, 30 and 42. This includes source data verification.

Simple size calculations estimating a difference of 50% in strength improvement between both groups at the six months follow-up visit. 80% power and 5% alpha error.

Strength measured with dynamometer, laxity with ACL laxity tester and function with 3 scores: IKDC, Tegner-Lysholm and KOOS.

Missing data will be minimized by double checking when registering data. It might be necessary to increase sample size to 50 patients of intermediate analysis show it is necessary to find an statistically significant difference.

Trial could be stopped early if one intervention shows to be better in the intermediate analysis. These analysis will be conducted after the first 16 and 32 participants have been included.

Eligibility Criteria:
Inclusion Criteria:

* Patients with anterior cruciate ligament injury that are candidates for surgical reconstruction with hamstrings. They should be at least 16 years old.

Exclusion Criteria:

* Multiligament injuries. Re-ruptures of the ACL.
Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease

The purpose of this study is to determine whether LJP 394 (abetimus sodium) is safe and effective in delaying and reducing renal flares in patients with lupus nephritis.

LJP 394 (abetimus sodium) is a unique drug that is specifically designed to lower production of antibodies to double-stranded DNA. These antibodies are believed to contribute to kidney damage in patients with Systemic Lupus Erythematosus (SLE). Rising levels of these antibodies seem to be associated with exacerbations of kidney disease that are known as "renal flares." Currently, anti-inflammatory and cytotoxic drugs are used to treat renal flares. Unfortunately, these drugs are often associated with certain unpleasant side effects. The purpose of this trial is to determine whether LJP 394 can delay or reduce the number of renal flares. It is possible that if renal flares can be delayed or reduced, patients may be able to take smaller amounts of anti-inflammatory or cytotoxic drugs and therefore suffer fewer of the side effects associated with these treatments.

Eligibility Criteria:
Inclusion Criteria

* Diagnosed with SLE
* Historical evidence of SLE renal disease
* Elevated levels of dsDNA antibodies
* Weight of 40 kg or greater

Exclusion Criteria

* Active SLE renal disease
* Use of certain anti-inflammatory or cytotoxic therapies or therapeutic interventions during the months immediately before dosing
* Clinical laboratory test values outside of certain limits
* Malignant disease or immunodeficiency syndrome
* Acute or chronic infections
* History of serious heart disease
A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis

To explore the safety of FE 999322 (microbiota suspension) and FE 999324 (microbiota capsule) versus placebo in subjects with active mild to moderate ulcerative colitis (UC).


Eligibility Criteria:
Inclusion Criteria:

* Subject aged ≥18 at screening
* Established diagnosis of ulcerative colitis by standard clinical, endoscopic and histological criteria, for more than 3 months at screening

Exclusion Criteria:

* Active disease or history of Crohn's disease
* Active disease or history of irritable bowel syndrome (IBS) or any other chronic intestinal disease apart from UC
* Active gastrointestinal infection.
Hypnosis for Eye Surgery

Perioperative stress for cataract surgery in the elderly is considerable even in the absence of pain. For these patients with a high comorbidity level, the perioperative situation comprising factors such as uncomfortable positioning, dull ambience, face cover, poor sedation, and anxiety might not only reduce intraoperative compliance but induce cardiac ischemia and hypertensive crises. Hypnosis is supposed to increase patient comfort, to shield the patient from organic stress and to improve intraoperative compliance without side effects even in old and very ill patients. In a controlled study, we, the investigators at the University of Heidelberg, compared phakoemulsification under topical anesthesia as usual (and placebo hypnosis) with either additional hypnosis or hypnoanalgesia without topical anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Cataract

Exclusion Criteria:

* Uncorrected hearing disability
* Pharmacological beta-blockade
Effects of Rehydration During Physical Exercise on Acute Kidney Injury Biomarkers

Rehydration during and after physical exercise is essential to avoid acute kidney injury.

Soft drinks are commonly used during exercise. High intake of carbohydrates is leading to obesity and metabolic disorders. Fructose intake is leading to uric acid abnormalities and kidney injury.

30 healthy soccer players will be studied. During four training sessions subjects will intake 500 ml 7% soft drinks containing glucose, fructose, saccharose or xylitol.

Changes in acute kidney injury markers, markers of kidney tubular function as well as changes in CRP, glucose, cholesterol and uric acid levels will be studied..


Eligibility Criteria:
Inclusion Criteria:

* age above 18 years
* well-trained soccer players
* informed consent

Exclusion Criteria:

* chronic diseases, especially kidney problems
* sigificant changes in urinalysis
* creatinine level above normal values
Determining Oral Phosphate Tolerance Across the Spectrum of Glomerular Filtration Rate

Over 20 million people in North America (including 2 million Canadians) have chronic kidney disease. These individuals die from diseases of the heart and blood vessels more often than they need dialysis. This is due to hardening of the arteries caused by calcium deposits inside the blood vessel walls. These deposits damage the vessels, causing them to lose flexibility. This makes them unable to respond to the changing demands of the body, and eventually leads to blockages such as stroke and ultimately death.

High levels of phosphate in the blood have been consistently linked to the development of calcium deposits inside blood vessel walls. The kidney is the only organ in the body that can eliminate phosphate that is not required by the body. As kidney function becomes worse, body levels of phosphate increase. However, investigators do not know the time point in the course of kidney disease that problems begin in the way phosphate is eliminated into the urine by the kidneys. Investigators will test the response of the kidneys to a phosphate challenge taken by mouth in subjects who are having accurate measures of kidney function performed by a method called 'inulin clearance'.

The investigators believe that the results of this study will provide important information identifying when investigators should be concerned about body levels of phosphate increasing. This information may lead to changes in the way investigators treat patients by reducing the levels of phosphate in the diet at a much earlier time point then is presently recommended.

Fractional excretion of phosphate will be measured pre- and 60 minutes and 120 minutes following an oral challenge of 500 mg of oral phosphate in a group of patients with gold standard measures of glomerular filtration rate.

Eligibility Criteria:
Inclusion Criteria:

* stable chronic kidney disease

Exclusion Criteria:

* unable/unwilling to give informed consent;
* pregnant or breast-feeding;
* known allergy to shellfish, iodine or inulin;
* have evidence of impaired bladder emptying defined as a post-void residual of greater than 20 ml.
Circulating Tumor Material in Colorectal Cancer and Melanoma

Observational study to allow the collection of blood and medical information to evaluate the role of circulating tumor material in patients with colorectal cancer and melanoma


Eligibility Criteria:
Inclusion Criteria:

* The subject must be a patient at the Hospital of the University of Pennsylvania

  1. Patients with presumed stage II, III, or IV colorectal cancer with planned surgical resection of either the primary tumor or metastatic lesion(s) being evaluated at the Hospital of the University of Pennsylvania
  2. Patients with histologically confirmed melanoma stage IIb, IIc, IIIa, IIIb, or IIIc/IV scheduled for surgical resection being evaluated at the Hospital of the University of Pennsylvania.
* The subject must be able to provide informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf.
* The subject must be 18 years of age or older.

Exclusion Criteria:

* The subject is not able to provide informed consent.
Home Based Environmental Adherence Trial

To conduct a randomized trial in asthmatic children to compare the effectiveness of a home-based allergen control program with a customary educational program delivered in offices

DESIGN NARRATIVE:

Two-hundred-forty children, 6 to 17 years of age, were recruited to participate in the study. Following the collection of baseline data, all families in the study received standard environmental control education prior to randomization to the control or experimental group. This education provided parents and children with information about such topics as the child's sensitivity profile, the relationship between exposure to allergens and asthma, and the risks of passive smoking. All families were given information on how to receive environmental control aids and services available by mail at no or reduced costs.

Once families were randomized, those in the control group received no additional intervention. Those in the experimental group received a home-based allergen control intervention delivered by trained environmental counselors. Primary outcomes were changes in asthma-related quality of life and changes in targeted allergen levels in the home. Secondary outcome measures included self-efficacy for environmental allergy control, FEV1, and parent-reported health care utilization.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Mechanism of Drug-drug Interaction Between Salvianolate Injection and Aspirin

The combination of anti-platelet medicine treatment and Chinese traditional medicine (TCM) promoting blood circulation to removing blood stasis is widely used in treatment for cardiovascular disease. However, the material foundation, effective mechanism and drug-drug interaction is still not clear. In order to solve the puzzle of rational use of Joint application by TCM and Western Medicine(WM),investigators conduct a research on mechanism of drug-drug interaction between salvianolate injection and aspirin based on metabolic enzyme and PK-PD model. This clinical trial contain three groups, aspirin group, salvianolate injection group and combination (salvianolate injection+aspirin) group. Investigators collect blood samples at special time points during post-administration.Investigators have already find out the Salvianolate's pharmacokinetic characteristics in vivo and establish the biological sample-testing analysis method in previous research. Depending on these results, this clinical trial aim to explore the pharmacodynamics-pharmacokinetics(PK-PD) characteristics of combination with Salvianolate and aspirin through biomarkers, blood concentration. Finally clarify the TCM and WM material basis and mutual mechanism of drug interaction and guide reasonable clinical prescription.


Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria of coronary heart disease.
2. Meet the diagnostic criteria of stable angina pectoris.
3. Meet the diagnostic criteria of syndrome of blood stasis.
4. Angina in grade I-II according to Canadian cardiovascular society (CCS).
5. It could be enrolled if the subject taking aspirin or salvianolate injection with one month regularly。
6. The subjects were informed and voluntarily signed informed consent.

Exclusion Criteria:

1. Severe heart disease (acute myocardial infarction of acute myocardial infarction in 6 months), severe cardiopulmonary dysfunction (eg: cardiac function II)
2. Poorly controlled hypertension(systolic pressure \>160mmHg or diastolic pressure \>100mmHg).
3. Diabetics.
4. Severe primary diseases such as liver and renal hematopoietic system damage. Such as:liver function（ALT≥2×ULN、AST≥2×ULN）,kidney function（Cr\>1.0×ULN) or nervous and mental disorder.
5. Pregnant, breast-feeding and menstrual women, or women planning pregnancy within 3 months.
6. Subjects who participated in clinical trials in recent 3 months.
7. Subjects who took surgery treatment or had hemorrhagic tendency in recent 4 weeks.
8. Subjects who had drug allergy history or with allergic constitution.
9. Subjects who has mental or physical disorders.
10. Subjects who had bad compliance or is not suitable for this clinical trial by investigator's judgement