cyrilzakka/clinical-trials huggingface dataset:
Pre- and Post-restriction Chocolate Candy Consumption

Craving differs from hunger because it occurs even when a person is in a satiated state and in the absence of an energy deficit. Craving is usually triggered by specific foods and may be attributable to certain sensory properties of foods. Foods that are craved are often regarded as less healthy choices, and are higher in energy content. Chocolate is one of the most commonly reported foods craved by people in this country. Together, craving for chocolate has been suggested to be a possible cause of weight gain and access to chocolate therefore needs to be restricted.

However, it remains unknown if restriction may induce maladaptive eating behaviors of chocolate cravers. The anticipation of going on a diet has been shown to cause restrained and disinhibited eaters to react by consuming more chocolate. In this study, we will examine if this response is also found in chocolate cravers when they are asked to undergo three weeks of chocolate restriction. This study will also examine chocolate cravers' response after the chocolate restriction is lifted. We hypothesize that chocolate consumption of cravers will increase both before and after chocolate restriction is imposed. We also hypothesize that chocolate craving is specific to the food rather than its sweet taste, and that chocolate cravers are less willing to substitute chocolate for salty snacks, natural snacks, and sweet non-chocolate snacks during the restriction.


Eligibility Criteria:
Inclusion Criteria:

Sixty adult participants (age 18-60 years) who are regular chocolate candy eaters (\> 4 times/week, at least 1 serving each time) are needed to complete this study. Additional eligible criteria include:

* Subjects high and low in restraint/disinhibition based on TFEQ
* BMI between 18-35
* American born, or have lived in United States for majority of life, as different cultures have been shown to have lower chocolate preferences and consumption.
* Snack on a regular basis
* No allergies to test foods
* Not taking medications that affect appetite or metabolism
* Willing to comply to study protocol and to eat test meals
* Consume chocolate, or chocolate candies more than 4 times per week

Exclusion Criteria:

* If a participant does not fit the above requirements, they will be excluded from participating in the study.
Caregivers' and Physicians' Treatment Preference in Parkinson Patients Treated With Neupro® Requiring Caregiver Support

The study objective is to evaluate advantages and disadvantages of Neupro® versus oral anti-Parkinson medication by caregivers and physicians in idiopathic Parkinson's Disease patients requiring caregiver support in nursing home or outpatient care settings.


Eligibility Criteria:
Inclusion Criteria:

* Only patients having signed the consent form regarding study information, data transfer and data use
* The patients suffer from idiopathic Parkinson's Disease (iPD) treated with a combination of L-dopa or another oral iPD drug and Neupro® for at least one month
* The patients require caregiver support documented as per medical records (e.g. based on German level of care intensity 1 or greater)
* The decision to prescribe Neupro® must have been made by the physician independent of his/her decision to include the patient in the study

Exclusion Criteria:

* Patients not fulfilling the inclusion criteria
* And according to Summary of Product Characteristics (SmPC): Hypersensitivity to the active substance or to any of the excipients, magnetic resonance tomography (MRT) or cardioversion
Prospective Registry of Anterior Cruciate Ligament Reconstructions

The purpose of the study is to investigate factors that are associated with outcomes of injury to the anterior cruciate ligament (ACL) in the knee among patients who are undergoing surgical reconstruction. This study is a registry of all patients having knee surgery at our institution performed by 4 fellowship-trained orthopaedic surgeons. The surgeon documents patient information on standard data forms including risk factors and surgical findings.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing ACL surgery

Exclusion Criteria:

* Previous surgery on the affected knee
* Posterior cruciate ligament injuries
* Grade 2 lateral collateral ligament or medial collateral ligament injuries
Connected Ovulation Test Efficacy Study

Clearblue Connected Ovulation Test System (COTS) has been designed for home use by women who are either planning or trying for a pregnancy. This study will determine the difference in pregnancy rate of female volunteers seeking to get pregnant who use COTS in comparison to those not using an ovulation product to assist with conception.


Eligibility Criteria:
Inclusion Criteria:

* Actively trying to conceive
* At least 2 regular consecutive cycles since last pregnancy/ miscarriage/ or since stopping breastfeeding
* Willing to use their own smartphone for the duration of this study and to download and install the study app
* Willing to disclose their pregnancy status and provide urine samples to test markers related to pregnancy and fertility
* Have internet access on their phone for the duration of the study
* Willing to give informed consent and comply with the investigational procedures

Exclusion Criteria:

* Currently or previously employed by SPD, Alere, Abbott, Unipath or P\&G, or affiliates
* Has an immediate relative\* currently or previously employed by SPD, Alere, Abbott, Unipath or P\&G or affiliates
* There is a reason why the volunteer should not get pregnant e.g. they are taking a medication or have a medical condition which means they should not get pregnant
* Trying to conceive for more than 6 months (if less than 35 years old) and more than 3 months (if 35 years old or over)
* Has been diagnosed with Polycystic Ovarian Syndrome (PCOS)
* Has PCOS symptoms: very irregular cycles, hirsutism
* Using or has previously used infertility medications or hormone replacement therapy containing hCG or LH (e.g Pregnyl)
* Are taking clomiphene citrate or other ovulation induction drugs
* Using any treatment which may affect the menstrual cycle (e.g. the contraceptive pill)
* Currently pregnant or breastfeeding
* Peri- or post-menopausal, e.g. experiencing symptoms: Irregular menstrual periods, hot flushes, night sweats, sleep disturbances, and mood swings
* Have abnormal liver or kidney function
* Taking medication containing tetracycline
* Using or undergoing any other medical treatment for fertility such as ovulation drugs, artificial insemination and assisted fertility such as IVF or ICSI
* Has a phone that is known to be incompatible with COTS
Hydro-mechanical Defragmentation of Pulmonary Embolism

Evaluating the safety and outcomes of hydro-mechanical defragmentation of high risk pulmonary embolism with contraindication for thrombolytic therapy

In high risk pulmonary embolism , the main aim of therapy is to rapidly recanalize the affected pulmonary arteries with thrombolysis or embolectomy; to decrease right ventricular afterload and reverse right ventricular failure and shock, prevent chronic thromboembolic pulmonary hypertension , and decrease the recurrence risk.

The first-line treatment in patients with acute high risk pulmonary embolism presenting with persistent hypotension and/or cardiogenic shock is intravenous thrombolytic therapy. However a significant proportion of patients may not be a candidate for Intravenous thrombolysis because of major contraindications. An alternative option in patients with absolute contraindications or has failed intravenous thrombolysis is surgical embolectomy , but the number of experienced tertiary care centers that can do emergency surgical embolectomy are limited.

Percutaneous catheter mechanical fragmentation of proximal pulmonary arterial clots followed by injection of 200 ml saline at high pressure using power injector can be used as an alternative to intravenous thrombolytic therapy and surgical embolectomy because of their ability to rapidly recanalize occluded pulmonary blood flow.

Eligibility Criteria:
Inclusion Criteria:

* Patients with angiographically confirmed acute high risk pulmonary embolism with shock index \>1.
* Pulmonary arterial occlusion with \>50% involvement of the central (main and/or lobar) pulmonary , and pulmonary hypertension (mean pulmonary artery pressure \>25 mmHg)
* Patients with high risk pulmonary embolism who cannot receive fibrinolysis
* Patients with acute intermediate-high risk pulmonary embolism with adverse prognosis (new hemodynamic instability, worsening respiratory failure, severe RV (right ventricle) dysfunction, or major myocardial necrosis)

Exclusion Criteria:

* Patients with echocardiographically confirmed right sided thrombi.
* Patients with low-risk pulmonary embolism or intermediate-low risk acute pulmonary embolism with minor RV dysfunction, minor myocardial necrosis, and no clinical worsening
* Anaphylactic reaction to contrast media.
* Acute renal failure or severe chronic non-dialysis dependent kidney disease.
* Uncooperative patient
Prophylaxis of Ileostomy Closure Site Hernia by Placing Mesh

Design Prospective , randomized, parallel phase IV.

Objectives Main objective

* Evaluate the effectiveness of the placement of a resorbable mesh in the prevention of incisional hernia of the abdominal wall at the site of a loop ileostomy when it is "closed " to rebuild the intestinal transit. The effectiveness evaluation is done by tracking with scheduled patient visits for 12 months, assessing the physical examination the presence or absence of an incisional hernia and an abdominal tomography at the end of the 12 months .

Secondary objectives Comparison of complications(morbidity and mortality) to assess safety and tolerability of the placement of the mesh described .

Experimental: Reinforcement with Absorbable Mesh Closure of the ileostomy closure incision is reinforced with insertion of a rectangular segment (1 cm wide and the length corresponding to the incision) of a prosthetic commercially available GORE® BIO-A® Tissue Reinforcement prosthesis (W. L. Gore \& Associates, Flagstaff, Arizona, USA) mesh. The BIO-A® prosthesis is inserted using a "sandwich" method between the edges of the incision and maintained in situ with a continuous polydioxanone (PDS) suture following a suture length to wound length (SL:WL) ratio of 4:1.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a loop ileostomy closure

Exclusion Criteria:

* Patients under 18
* Pregnancy and Lactation
* Patients allergic to polyglycolic / trimethylene carbonate
* Carrier of prosthetic mesh in the ostomy
* Patients presenting midline hernia.
* Patients affected by inflammatory bowel disease
Pro-resolving Effect of MAG-DHA in Cystic Fibrosis (PREMDIC)

Monoglyceride of DHA (DHA-MAG) is a lipid compound for which intestinal absorption would increase the ratio DHA / arachidonic acid (AA) and promote the synthesis of specific metabolites involved in the resolution of inflammation.

The PREMDIC project, initiated at the Centre Hospitalier Universitaire de Sherbrooke, is a randomized double-blind study for people with cystic fibrosis (CF) and aims to evaluate whether daily supplementation monoglyceride of DHA (a fatty acid omega-3 family) will reduce lung inflammation and improve pulmonary function.

The goal of the study is:

To investigate the efficacity of oral administration of MAG-DHA to increase DHA bioavailability and reduce lung inflammation of patients with cystic fibrosis

The specific objectives of the project are :

* Determine the effect of MAG-DHA on lipid membranes of the blood mononuclear cells.
* Evaluate the effect of MAG-DHA on lung inflammation (determination of Human leukocyte elastase and alpha1 antitrypsin complexes : pHLE).

For this study, 20 cystic fibrosis patients are recruited. Patients are divided into 2 groups of 10 and received a daily dose equivalent to 3 g of placebo (sunflower oil) or MAG-DHA.

The project takes place over a period of 3 months and patients must travel to the research center for a total of five visits including recruitment.

For the 2 groups, DHA ratio / AA is measured in membranes of mononuclear cells. Forced expiratory volume in 1 second (FEV1) is determined and pHLE complexes are detected in plasma as a marker of inflammation.

Eligibility Criteria:
Inclusion Criteria:

1. forced expiratory volume in 1 second (FEV1) between 30 - 90%.
2. no respiratory exacerbations during the last 2 weeks before the start of the study
3. not have clotting problems or a history of bleeding diathesis
4. patients with liver function abnormalities are included in the study

Exclusion Criteria:

1. pregnant women or those not using contraception.
2. known allergy to fish and / or seafood.
Prediction of Dysplasia Within Sessile Serrated Polyps Using Endoscopic Imaging; a Prospective Observational Study

Study of endoscopic imaging in the detection of dysplasia within serrated colonic lesions \>= 8mm in size

Observational study Structured endoscopic imaging protocol devised Applied prospectively to sequential SSP \>= 8mm detected in a tertiary endoscopic resection cohort Review of specimens by blinded specialist pathologists Review of incongruent cases by endoscopists and pathologists

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to a tertiary endoscopic resection practice with any sessile serrated polyp (SSP) \>= 8mm

Exclusion Criteria:

* Patients referred to a tertiary endoscopic resection practice without sessile serrated polyps (SSP)
The Effect of Pelvic Floor Physiotherapy on Vaginal Elasticity

Women suffering from stress urinary incontinence are offered pelvic floor physiotherapy as an optional treatment. Strengthening of the pelvic floor is measured to date by manual examination and lacks precise evaluation. The vaginal tactile imager assists in evaluation of the changes in the pelvic floor after physiotherapy.

Women with stress urinary incontinence will undergo 6-10 pelvic floor strengthening physiotherapy sessions. The participants will undergo a short examination of vaginal elasticity using a vaginal tactile imager prior to beginning physiotherapy and additional examinations after 6 treatments, 10 treatments and 3 and 6 months post-treatment cessation.

Eligibility Criteria:
Inclusion Criteria:

* women suffering from stress urinary incontinence.

Exclusion Criteria:

* women suffering from urge urinary incontinence.
* women suffering of mixed urinary incontinence.
Three-Dimensional Ultrasound (3D US) in Parturients

The purpose of this study is to compare accuracy of a new three-dimensional ultrasound (3D US) technique with the traditional palpation method for identification of the needle insertion site on patients' skin before epidural needle placement in pregnant women. The investigators hypothesize that the needle puncture site identified by 3D US is located within a 5 mm radius from the puncture site identified by palpation.

Traditionally, the manual palpation of lower back is used to identify the skin insertion point for the epidural needle placement in obstetric patients. Recently, two-dimensional ultrasound (2D US) scanning before the epidural needle insertion proved to improve an accurate determination of inter-vertebral levels and spine midline. 2D US is also useful in determining the depth to the epidural space and needle insertion angle. A three-dimensional ultrasound (3D US) technique is a new advancement in the ultrasound technology. 3D US allows for a real-time, visual guidance of the epidural needle insertion. This study will assess weather 3D US, compared to palpation, can accurately identify the skin needle insertion site for the epidural needle placement.

Eligibility Criteria:
Inclusion Criteria:

* ASA I or II
* Greater than or equal to 19 years old
* Term pregnancy (greater than or equal to 38 weeks gestation age)
* Ability to read English in order to understand the consent form

Exclusion Criteria:

* BMI greater than or equal to 40
* Scoliosis
* Previous difficult regional anesthesia/analgesia
* Previous lower back surgery
* Active labour
* Allergy to epidural tape, surgical paper tape, or felt pen
TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for Advanced HCC

The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies in patients with advanced-stage hepatocellular carcinoma (HCC).

Transarterial chemoembolization (TACE) can induce immunogenic cell death and tumor-specific immune response which results in the release of tumor antigens and transform "cold" tumors with lacking immune effector cells into "hot" tumors with immune effector cells infiltration. This provides a theoretical basis for TACE combined with immune checkpoint inhibitors (ICIs) in hepatocellular carcinoma (HCC) patients. The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies(including, VEGF-TKI/ bevacizumab) in patients with advanced-stage HCC. This real-world study also would like to explore the optimal combined treatment and subgroup of HCC patients for providing further information for clinical practice and trials.

Eligibility Criteria:
Inclusion Criteria:

1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of extrahepatic spread and/or macrovascular invasion;
3. Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
4. Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
5. TACE was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment;
6. Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment；
7. Has repeated measurable intrahepatic lesions;

Exclusion Criteria:

1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
2. Unable to meet criteria of combination timeframe described above;
BoneFit: Multimodal Prehabilitation for People Preparing for Orthopaedic Surgery

To conduct a pilot feasibility study to determine the effect of a student-led prehabilitation service in people awaiting total hip or knee replacement surgery.

The aim of BoneFit is to provide local people living in the Hull region with a needs-based prehabilitation care package to improve their physical and mental health, quality of life \& reduce their length of hospital stay, complications and readmission rates to hospital following orthopaedic surgery (total hip replacement, or total knee replacement.

Currently, Hull University Teaching Hospitals do not offer a prehabilitation service for local patients. The University of Hull will partner with them to provide a student-led multimodal prehabilitation service for referred patients awaiting orthopaedic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Waiting for unilateral total hip or knee replacement surgery for a minimum of 6 months;
* Able to provide informed consent;

Exclusion Criteria:

* Previous hip or knee surgery;
* Any medical conditions for which moderate to vigorous exercise is contraindicated;
* Patellar or hip joint instability;
* Any other disease/condition which severely effects functional performance e.g. stroke or Parkinson's disease;
* Chronic depression or significant psychiatric disorder;
* Enrolled in a clinical trial (or recently completed one);
* Cognitive impairment which would affect compliance to BoneFIt service;
* Patients unable or unwilling to commit to required study follow-ups
* Pregnancy;
A Prospective, Non-interventional Study of the Use of Dolutegravir as Part of Combination Antiretroviral Therapy in Routine Daily Practice in Germany

DOL-ART is a multi-center, prospective, non-interventional study of the use of doluetegravir as part of an antiretroviral combination therapy in routine daily practice in Germany. The primary study objective is a descriptive characterization of the frequency of therapeutic monitoring measures in HIV-infected patients under dolutegravir-containing ART in routine daily practice in Germany.

The study is designed to enroll approximately 400 patients. There are no protocol-mandated visits or procedures associated with the study. Each patient is expected to participate for a maximum of 3 years or until premature discontinuation (i.e., discontinuation of dolutegravir, due to death, withdrawal of consent, lost to follow-up).


Eligibility Criteria:
Inclusion Criteria:

* Documented HIV infection
* Age ≥ 18 years
* Decision for the first initiation of dolutegravir as part of an ART by the attending physician irrespective of inclusion in this observational study
* Prior to the start of this study, the patient must have been receiving a dolutegravir-containing ART for at least 4 weeks

Exclusion Criteria:

* Discontinuation of dolutegravir as part of an ART prior to the start of the study documentation
* Participation in a clinical trial during this study
* Participation in a clinical trial or compassionate use program with dolutegravir being or having been part of the investigational medication