cyrilzakka/clinical-trials huggingface dataset:
Effects of Oral Pre-loads on Subsequent Energy Intake

The aim of this project is to investigate the effect of erythritol (given as pre-load), compared to sucrose, sucralose, and water on energy intake during a subsequent ad libitum test meal in healthy participants.

Furthermore, the release of GI hormones, glycemic control, appetite-related sensations, GI tolerance, sweetness and liking in response to the pre-loads will be investigated.

The subjects will participate in four study days. The screening will last 60 minutes, the study days about 4.5 hours each. After a simple-carbohydrate standard dinner, the subjects have to do an overnight fast until the next morning. Subjects will receive fixed equisweet doses of sucrose (33.5g), erythritol (50g), sucralose (0.0558g), or water as oral pre-loads in a blinded, randomized (counterbalanced) fashion (t = -15 min). Fifteen minutes after the administration (t = 0 min), a standard solid test meal will be presented and ad libitum calorie intake will be measured. The end of the test meal will be after 20 minutes or as soon as the subject stops eating for more than 5 minutes. Blood samples (to measure: glycemic control and GI hormones) will be collected at t = -16, t = -1, t = 15, t = 30, t = 60, t = 90, t = 120, t = 150, t = 180 min and appetite-related sensation rating will be collected at t = -16, t = -1, t = 15, t = 30, t = 60, t = 90, t = 120, t = 150, t = 180 min. GI symptoms and nausea are assessed at t = -16, -1, 30, 60, 120 and 180 min. At t = -10 min subjects are asked to rate the perceived sweetness and liking of the pre-load and at t = 180 min the perceived liking of the test meal.

Eligibility Criteria:
Inclusion Criteria:

* Healthy normal weight subjects with a body-mass index of 19.0-24.9
* Normal eating habits (eating breakfast; no diets; no dietary changes; no vegetarians/vegans, no intolerances/allergies)
* Age 18-55 years
* Stable body weight (+/- 5%) for at least three months
* Informed Consent as documented by signature (Appendix Informed Consent Form)

Exclusion Criteria:

* Shift worker
* Fructose intolerance
* Pre-existing consumption of erythritol and/or sucralose more than once a week
* Substance abuse
* Regular intake of medications, except anticontraceptive
* Chronic or clinically relevant acute infections
* Pregnancy: although no contraindication, pregnancy might influence metabolic state. Women who are pregnant or have the intention to become pregnant during the course of the study are excluded. Female participants of childbearing age have to use safe contraception (oral, injectable, or implantable contraceptives, intrauterine contraceptive devices, or tubectomy). In female participants a urine pregnancy test is carried out upon screening.
* Participation in another study with investigational drug within the 30 days preceding and during the present study.
Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612

Subjects were previously vaccinated at 11 to 17 years of age. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled.

Subjects were previously vaccinated at 11 to 17 months of age with GSK Biologicals' meningococcal vaccine 134612 or with Mencevax™. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new studies will be enrolled. The subjects will have 4 blood samples taken: at 24, 36, 48 and 60 months after vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they and/or their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female having been vaccinated with a meningococcal vaccine in the primary study 109069.
* Written informed consent obtained from parent(s)/guardian(s) of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the subject's first visit.
* History of meningococcal disease; such cases will be documented.
* Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since previous vaccination in study 109069.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
* Administration of immunoglobulins and/or any blood products within the three months preceding the subject's first visit.
* Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy
* Subjects who withdrew consent to be contacted for follow-up studies.
Randomized Study of Positron Emission Tomography - Computed Tomography (PET/CT) in Pre-Operative Staging of Lung Cancer

Patients with possible operable non-small cell lung cancer are randomised to conventional staging, or conventional staging and PET/CT. According to, patients with operable tumor will be referred to surgery, and the number of thoracotomies and futile thoracotomies wil be compared with the two groups in order to asses the possible benefit of PET/CT.

Patients with possible operable NSCLC after staging with CT are randomised to PET-CT with FDG or not, prior to mediastinoscopy. All patients are referred to mediastinoscopy unless a positive FDG uptake results in a positive biopsy suggesting stage IV disease.

Biopsies are performed according to the following criteria:

1. Lymph nodes are numbered according the Mountain classification, and abnormal lesions must be confirmed histologically, by mediastinoscopy or thoracotomy.
2. PET-positive lesions in the liver must be biopsied unless ultrasound or MRI unequivocally indicate the lesions are benign cysts or haemangioma.
3. PET-negative adrenal lesions are accepted without biopsy if CT scan indicate the lesion is a benign adenoma.
4. PET-positive bone lesions must be evaluated by plain x-ray, CT, MRI, or bone scintigraphy. In case of equivocal findings a biopsy must be performed.
5. PET-positive brain lesions must be confirmed by CT or MRI.

Number of patients:

Patients with clinically operable NSCLC after CT-staging are included. All patients must have mediastinoscopy performed.

All patients referred to mediastinoscopy can be randomised after informed consent. A total of 430 consecutive, non-selected patients are planned. It is anticipated that approximately 60% of the referred patients with clinical stage I-IIIa NSCLC will undergo thoracotomy, and a risk of type I and II error of 5% and 10%, respectively, is accepted. Thus a total of 215 patients are randomised in each arm in order to observe an absolute difference of 15% in the number of thoracotomies. This number seems to be sufficient to evaluate differences in the secondary endpoints.

After inclusion of a total of 220 patients, corresponding to 110 PET-scans, an interim analyses are performed. In case of a highly significant difference in the number of thoracotomies (p \< 0,001) the study will be closed.

Eligibility Criteria:
Inclusion Criteria:

1. Clinically operable NSCLC after CT
2. Fit for thoracotomy and lobectomy or pneumectomy after lung function tests
3. CT-scan of thorax, including liver and adrenals with no signs of distant metastases.
4. No medical condition contraindication surgery.
5. Age 18-80
6. No claustrophobia.
7. Negative pregnancy test.
8. No diabetes mellitus.
9. Signed informed consent.

Exclusion Criteria:

1. Radiologically M1 disease.
2. Pregnancy
3. Known claustrophobia.
4. Estimated FEV1 \< 30% of expected after surgery.
5. Diabetes mellitus.
Feasibility and Acceptability of an Online Program to Promote Physical Activity Among Black Women

This study will identify strategies for modifying a physical activity intervention, previously delivered in a face-to-face format, for online implementation.

Research demonstrates the health-related benefits of participation in daily physical activity (PA), including prevention and treatment of chronic diseases. Despite this knowledge, the majority of US adults, particularly black women, do not achieve recommended levels of PA and, consequently, have higher rates of related chronic disease. An efficacy study led by the proposed Principal Investigator developed and tested an in person, 10-month group-based faith-integrated (FI) or secular (SEC) PA intervention, compared with a self-guided control (SG) for black women. Both FI and SEC were superior to SG for increasing daily steps after 10 months, and FI was superior to SG for increasing daily steps 12 months post intervention. Barriers to program participation noted by participants included childcare and work responsibilities and proximity to the group meeting location. The 2018 PA Guidelines Advisory Committee Scientific Report highlighted the need for effective strategies to promote PA, including internet-delivered interventions which have demonstrated strong evidence for effectiveness at increasing PA levels. Limited data exist regarding the efficacy of internet-delivered interventions in racial/ethnic minority groups. Online delivery of our evidence-based program may increase reach and address known barriers to PA program participation in black women. This project will explore strategies for adapting the program for web-based delivery of the existing curriculum. R21 phase aims are: Aim 1: Solicit input from individuals representative of the population of focus to inform the translation of the FI curriculum for online use; Aim 2: Use the knowledge gathered in Aim 1 to adapt existing FI and SG curricula for online use; Aim 3: Assess acceptability of the online curricula in an advisory group similar to the target population. Investigators will conduct focus groups with black women to understand factors that would influence online delivery of the curriculum. A 12-member advisory group will be convened to assist with developing materials/strategies to adapt the curriculum for online delivery. In an iterative approach where material is tested, refined, and retested until complete, investigators will engage the advisory group in feasibility testing of the online curriculum

Eligibility Criteria:
1. self-identified female
2. black/African American
3. \> 18 years of age
4. self-reported low active (i.e., achieving \< 150 minutes per week of moderate-to-vigorous physical activity)
5. no physical limitations or medical conditions that would be impacted by physical activity
6. own a smartphone or computer with reliable high speed internet access
7. able to speak and read English fluently; 8) potentially interested in participating in an online health intervention.
Efficacy of Acapella on Spirometry Measures in Patients With Bronchiectasis

1. Acapella group. Will use Acapella device for 3 times per day for 15 minutes for 7 days beside medications and routine chest physical therapy program .
2. Only routine physical therapy program group ( control group). Will only take medications and routine chest physical therapy program.

1. Acapella group.Will use Acapella device for 3 times per day for 15 minutes for 7 days beside medications and routine chest physical therapy program.
2. Only routine physical therapy program group( control group). Will only take medications and routine chest physical therapy program Spirometer measures such as forced vital capacity (FVC) and forced expiratory volume in the first second (FEV1) will be measured for every patient before and after the end of 7 days.

Eligibility Criteria:
Inclusion Criteria:

1. bronchiectasis patients.
2. Age range between 40 to 55 years old of both gender.
3. Cooperative patients.

Exclusion Criteria:

1. Patients with severe cardiac disorders.
2. Un controlled hypertensive patients.
3. Un controlled diabetic patients.
Imaging of Neuroendocrine Tumors With PET and Fluoro-18-DOPA (F-DOPA)

Imaging of neuroendocrine (NETs), such as carcinoids and pheochromocytomas (PHEOs), is suboptimal, limiting curative treatment. The investigators wanted to explore the use of PET and F-DOPA i.v. for the localization of these types of neoplasms. The investigators used a similar protocol as they had used for PET (Positron emission tomography) or FDG (Fludeoxyglucose) imaging in oncologic patients. F-DOPA, prepared according to United States Pharmacopeia (USP) guidelines, was approved by the North Shore University Hospital Radiation Safety Committee in 1989 and 1994 for the study of neurological diseases and used uneventfully.

Background: Pre surgical conventional imaging of neuroendocrine tumors (NETs) with CT, MRI, In-111 octreotide or 1-123-MIBG (metaiodobenzylguanidine) scintigraphy has limitations. This pilot study tried to improve the localization of these tumors with F-18-F-DOPA PET scanning.

Methods: The investigators studied 22 patients, the majority referred with clinical diagnosis of carcinoid (9) or NETs (9) and a few with pheochromocytoma/paraganglioma (3). Carbidopa was administered prior to the F-DOPA injection in 12 patients. Comparison was made with prior conventional imaging. The F-DOPA findings, read blindly to the findings of other modalities, were compared with results of subsequent surgery (2), endoscopy (1), or a long-term follow up of mean duration of 49 months (for 20 patients). Two subjects were lost to follow-up.

Eligibility Criteria:
* Inclusion Criteria:

  * 23 years of age and older
  * Appropriate diagnosis by referring physician
* Exclusion Criteria:

  * Less than 23 years of age
  * Greater than 81 years of age
  * Pregnancy
  * Lactation
  * Prior history of radiation treatment
  * Chemotherapy or anti-tuberculosis medications.
Aerobic Interval Training in Patients With Atrial Fibrillation

The purpose of this study is to determine the effect of aerobic interval training in patients with paroxysmal or persistent atrial fibrillation, especially to see if the burden of atrial fibrillation and symptoms are reduced.

Long term endurance sport practice is associated with a higher incidence of atrial fibrillation. Moderate/light physical activity seems to be associated with a lower incidence. The underlying mechanisms are uncertain. In order to examine the effect of training in this population, the investigators will perform a randomised controlled study with aerobic interval training in patients with paroxysmal/persistent atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with paroxysmal or persistent atrial fibrillation, that are able to perform aerobic interval training.

Exclusion Criteria:

* Performing high intensity training (pulse \>90% of max) for more than 2 times a week.
* Moderate intensity training more than 30 min, more than 3 times a week
* Previous open heart surgery
* EF \<40%
* Significant aorta stenosis
* Mitral insufficiency, \>gr. 2
* Pacemaker
* Earlier coronary intervention and not complete revascularization
Cerebral Blood Perfusion Changes After General Anesthesia for Craniotomy

Few studies look into cerebral blood flow (CBF) changes during emergence from general anesthesia for craniotomy. The purpose of this study is to demonstrate CBF changes during emergence from general anesthesia for craniotomy, through monitoring blood oxygen saturation of jugular vein bulb and transcranial Doppler.

30 patients undergoing selective craniotomy (craniotomy group) for supratentorial brain tumor removal and 30 patients undergoing selective abdominal surgery (abdominal surgery group) are planned to be enrolled in the study. Mean blood flow velocity in middle cerebral artery (Vmca), mean arterial pressure (MAP), blood oxygen saturation of jugular vein bulb (SjvO2) (only measured in craniotomy group)and arterial CO2 partial pressure (PaCO2) will be measured before general anesthesia, at tracheal extubation, and 30,60, 90, 120 min after extubation in both groups.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesia (ASA) physical status I or II
* Scheduled for selective supratentorial tumor removal surgery or major abdominal surgery.

Exclusion Criteria:

* Patients with evidence of systemic hypertension, intracranial hypertension, cerebrovascular diseases, other coexisting medical conditions likely to affect cerebral autoregulation.
* Preoperatively planned delayed tracheal extubation.
* Pregnant or nursing women
Efficacy and Safety of Two Treatment Regimens of Topical MOB015 in Adults With Distal Subungual Onychomycosis

Onychomycosis is a fungal infection that affects fingernails and/or toenails.

The purpose of this trial is to investigate if MOB015 is effective and safe for treatment of patients with fungal infection of the toenails.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. 18 - 70 years
3. DSO of at least one of the great toe(s) affecting 25 % to 75 % of the target nail (verified by blinded assessor before randomization)
4. Positive culture for dermatophytes (i.e. Trichophyton species; T. rubrum or T. mentagrophytes)
5. Signed written informed consent

Exclusion Criteria:

1. Proximal subungual onychomycosis
2. DSO of both great toenails where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 2 mm)
3. "Spike" of onychomycosis extending to eponychium of the target nail
4. Presence of dermatophytoma (defined as demarcated and localised thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail
5. Other conditions than DSO known to cause abnormal nail appearance
6. Topical antifungal treatment of the nails within 1 month before screening
7. Systemic use of antifungal treatment within 3 months before screening
8. Signs of severe peripheral circulatory insufficiency
9. Immunosuppression
10. Participation in another clinical trial with an investigational drug or device during the previous 4 weeks before screening
11. Known allergy to any of the tested treatment products
12. A pregnancy test indicating pregnancy in a woman of childbearing potential at screening (visit 1)
13. Pre-menopausal (last menstruation ≤ 1 year prior to screening) sexually active women who :

    * are pregnant or nursing
    * are not surgically sterile
    * are of child bearing potential and not practising an acceptable method of birth control, or does not plan to continue practising an acceptable method of birth control throughout the trial (acceptable methods include intrauterine
A Trial of Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy

This is a single-institution, prospective, one-to-one randomized controlled research study. Subjects medically determined to need a cholecystectomy will be consented for surgery and study participation prior to enrolment in this study. Patients will then be randomized to receive either a single port laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* Pre-operative diagnosis of one of the following:

  * Pancreatic cholecystitis
  * Biliary cholic
  * Biliary dyskinesia
  * Choledocholithiasis status post endoscopic retrograde cholangiopancreatography/sphincterotomy
  * Gallbladder polyps
  * Other diagnosis at the discretion of the surgeon

Exclusion Criteria:

* Acute cholecystitis
* Gallstones \> 2.5cm in length on ultrasound
* Suspected presence of common duct stones
* History of jaundice
* History of gallstone pancreatic
Assessment Of Sildenafil On Erectile Function And Intercourse Satisfaction And To Validate A New Subject Questionnaire

To evaluate the effectiveness of sildenafil on erectile function and intercourse satisfaction in men with ED as well as to validate the new Sexual Experience Questionnaire which incorporates functional and emotional elements of a man's sexual experience into one comprehensive questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Documented clinical diagnosis of erectile dysfunction, defined by a score of less than or equal to 25 on the Erectile Dysfunction domain of the International Index of Erectile Function

Exclusion Criteria:

* Subjects who have been treated with more than 6 doses of sildenafil or any other phosphodiesterase type 5 inhibitor
Soft Part Management for Surgical Fractures of the Lower Limb

The assessment consists in comparing corticoids injection versus placebo in surgery of lower limb fractures The aim of study is to assess (state cutaneous, efficacy, safety) corticoids injection on a prospective, randomized analysis

One of the major problems of below-knee fractures is edema (delaying surgery time and post-operative complications for healing).

The effect corticosteroids (anti-edema and anti-inflammatory) is used in neurosurgery and maxillofacial surgery.

So, it seemed judicious to evaluate the effectiveness of corticosteroids in bolus preoperatively in order to limit the importance of the edema before intervention to prevent adverse effect of the edema on the cicatrization.

This study will aim to confirm this indication or not on the contrary to change current practices.

Eligibility Criteria:
Inclusion Criteria:

* Patient over the age of 18, hospitalized in the Orthopedics Department for a leg fracture (ankle, tibia: proximal, diaphysis, distal) requiring surgery within 72 hours of the trauma
* Patient covered by the social security system
* Patient giving informed consent

Exclusion Criteria:

* Open fracture with infectious risks cauchoix 2 and 3
* Multiple trauma,
* Pathological fracture on primary or secondary lesions,
* Pre-existing bone disease (excluding osteoporosis) of the operated limb,
* Diabetes,
* Pre-existing trophic disorders on one of the 2 lower limbs,
* Long-term corticotherapy,
* Pathology of the pituitary-adrenal axis,
* Any other contraindication to glucocorticoids: any infectious condition, some developing viral diseases (including hepatitis, herpes, chicken pox, shingles), hypersensitivity to one of the constituents
* Hypernatremia and hypochloremia
* Pre-existing severe cardiac injury
* Contraindication to TegadermTM
* Patient placed under guardianship, tutorship or safeguard of justice,
* Pregnant or lactating women,
SEP Changes During Deep Anesthesia

The relation between burst and suppression periods in transcranial and direct cortical recorded EEG with cortical amplitudes median nerve somatosensory evoked potentials is studied.

60 patients are included in this study: 15 patients undergoing brain tumor surgery, 15 spine surgery (University Hospital Düsseldorf) and 30 patients during general surgical procedures (Helios Klinikum Wuppertal).


Eligibility Criteria:
Inclusion Criteria:

* Location Helios Klinikum Wuppertal: neurological healthy patients, which undergo an elective surgery under general anaesthesia
* Location Department of Neurosurgery, University Hospital Düsseldorf: all patients with intracranial interventions and the possibility to place a stripe electrode without complications on cortex (it is decided by the surgeon while surgery because of the situs and tumorlocation)

Exclusion Criteria:

* periodical consumption of drugs and pharmaceuticals which influence cortical excitability
* intraoperative contraindication for required depth of anaesthesia
* neurological pre-existing illness
* advanced hepatic insufficiency