cyrilzakka/clinical-trials huggingface dataset:
Development of a Psychosocial Assessment Database for Reconstructive Hand Transplantation

A prospective multicenter study utilizing standardized instruments for the psychological assessment of hand transplant candidates pre and post-transplant as well as those candidates excluded for transplantation.

The semi-structured psychological interview describes the assessment of significant psychosocial characteristics and it is based on the psychosocial domains of the "Transplant Evaluation Rating Scale (TERS)" by Twillman and colleagues for evaluating organ transplant candidates. The interview guide was developed as a tool to guide clinicians through the interview process for hand transplant candidates. The protocol highlights issues that are specific for reconstructive hand transplantation and give clinicians an immediate understanding of what type of information is necessary to conduct a comprehensive psychosocial assessment.

Additionally, the psychological assessment provides standardized psychological screening procedures and continuous follow-up ratings by psychometrical testing. The test battery will be performed at the time of initial psychosocial assessment, immediately after transplant, at six and twelve months for the transplant candidates and at initial evaluation, six and twelve months for candidates excluded for transplant.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* Undergoing evaluation for hand transplantation

Exclusion Criteria:

* unable to complete surveys
Somatostatin Receptor PET Imaging to Guide Radiotherapy Dose Escalation in High Risk Meningiomas.

High-risk meningiomas always require postsurgical radiation treatment. Recent evidence has shown that increased radiation therapy dose may be associated with increased intracranial control of disease. In order to better define the volume of radiation treatment, the addition of PET imaging with somatostatin receptor tracers adds additional information compared to encephalon MRI with MoC alone.The present study aims to investigate whether radiation treatment with higher doses than the standard and defined using PET imaging can be safe and at the same time effective in order to increase progression-free survival in high-risk meningiomas.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 16 years;
* Ability to express appropriate informed consent to treatment;
* Diagnosis of grade III meningioma (regardless of presence of residual) or diagnosis of recurrence of grade II meningioma (regardless of presence of residual) or first diagnosis of grade II meningioma with presence of residual;
* In case of recurrence, confirmation can be either histological or radiological;
* Not previous brain-level radiotherapy;
* Performance status: ECOG=0-2.

Exclusion Criteria:

* Refusal to radiation treatment (i.e., absence of signed informed consent);
* Other concomitant oncologic therapies
* Current pregnancy;
* Grade I meningiomas or Grade II meningiomas if operated on at first diagnosis with radical resection;
* Inability to perform MRI with MoC or PET.
POCUS for Small Bowel Obstruction in the ED: a Retrospective Study

This study protocol aims to evaluate the impact of point-of-care ultrasound (POCUS) on the diagnosis and management of small bowel obstruction (SBO) in the emergency department (ED). SBO is a potentially life-threatening condition that requires prompt diagnosis and management. Currently, the diagnosis of SBO is based on clinical evaluation and imaging tests, including plain abdominal radiography and computed tomography (CT) scan. POCUS is a bedside imaging technique that is rapid, non-invasive, repeatable, cost-effective and radiation-free, and can provide valuable information for the diagnosis and management of SBO. The primary objective of this study is to compare the time to diagnosis of SBO between patients who undergo POCUS intestinal loops examination and those who do not undergo POCUS in the ED. The secondary objectives include comparing the hospital length of stay, the rate of surgical intervention, the rate of complications, and the mortality rate between the two groups. This is a monocentric retrospective cohort study that will include all adult patients (\> 18 years old) who presented to the ED with suspected SBO. The study population will be divided into two groups: the POCUS group and the non-POCUS group. The sample size calculation will be based on the assumption of a 30% reduction in the time to diagnosis of SBO in the POCUS group compared to the non-POCUS group, with a power of 80%. The results of this study may provide more robust evidence on the diagnostic accuracy and impact of POCUS for SBO in the ED.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Clinical suspicion of SBO based on history and physical examination
* Plain abdominal radiography (AXR) or CT scan performed in the ED

Exclusion Criteria:

* Pregnancy
* Known bowel obstruction
* Previous abdominal surgery within 30 days
* Refusal or inability to consent
Interaction of Apelin and Angiotensin in the Systemic Circulation

The apelin-APJ system is a relatively new discovery. It has generated interest in part due to it's apparent ability to counteract the renin-angiotensin system, which is frequently overactive in many cardiovascular disease.

Apelin improves that pumping ability of the heart and we wish to know if this action persists in the presence of increased levels of angiotensin II.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* Healthy volunteers

Exclusion Criteria:

* Lack of informed consent
* Age \< 18 years,
* Current involvement in other research studies,
* Systolic blood pressure \>190 mmHg or \<100 mmHg
* Malignant arrhythmias
* Renal or hepatic failure
* Haemodynamically significant aortic stenosis
* Severe or significant co morbidity
* Women of childbearing potential.

Any regular medication

* Previous history of any cardiovascular disease
Metabolism Study to Investigate the Impact of a Sequential Oral Contraceptive

The purpose of this study is to confirm the safety of SH T00658ID with regard to plasma lipids, hemostatic variables, and carbohydrate metabolism. In addition, the pharmacokinetic parameter following the long term administration of SH T00658ID will be assessed.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Healthy female volunteers between 18 and 50 years requiring contraception

Exclusion Criteria:

* Pregnancy or lactation
* Any conditions that might interfere with the outcome as well as all contraindications for OC use
Implanted Phrenic Nerve Stimulator Database.

Phrenic nerve stimulation is a neurostimulation technique that allows patients who are dependent on external mechanical ventilatory support to regain their breathing autonomy. This study aim at long term following of patients who may be candidates for permanent implanted phrenic nerve stimulator.

During 10 years, the study will be conduct to obtain the quality of life evolution and medical complications in patients candidates but not implanted, and in patients candidates then implanted with the phrenic nerve stimulator.

Eligibility Criteria:
Inclusion Criteria:

* Patients with central respiratory paralysis (medullary lesions or supramedullary lesions, whatever their causes) or patients with congenital central hypoventilation (including Ondine syndrome by Phox2B mutation) or acquired (whatever the cause), with permanent hypoventilation or related to sleep.

Exclusion Criteria:

* Patient not affiliated to the social security system
* Patient unable to oppose his participation in research
* Patient not understanding French
Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide

This double-blind, randomized, two-cohort, placebo-controlled, parallel group study characterized the pharmacokinetics, safety, and tolerability of MNTX following single doses and at steady-state during multiple dosing and assessed the effects of aging on the pharmacokinetics, safety and tolerability of MNTX.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy Males and females who were between the ages of 18 and 45 years and healthy males and females who were 65 years of age and older.
2. Subjects who were non-smokers
3. Subjects with body weights within range of 70-100 kg (154-220 lbs).

Exclusion Criteria:

1. Subjects who had previously been exposed to MNTX
2. Subjects with a history of vasovagal episodes or fainting within the past five years
3. Subjects with a history of psychiatric or neurologic disorder
4. Subjects with a history of narrow-angle glaucoma or intraocular hypertension
5. Subjects who had tested positive for hepatitis B surface antigen, IgM hepatitis B core antibody, hepatitis C antibody, or HIV
6. Subjects who have had a diagnosis of alcohol or substance dependence.
Improving Tumor Oxygenation in Cervical Cancer

The Phenomenon of Tumor Hypoxia Many solid tumors are relatively resistant to treatment with ionizing radiation and certain chemotherapeutic agents such as anthracyclines that are affected adversely by acidic pH. These effects have primarily been attributed to the presence of hypoxic cells within the tumor. The relevance of hypoxia with respect to failure of radiotherapy to cure certain malignancies has had a chequered history. However, in recent years the evidence that hypoxia plays a central role in relative radioresistance has become more compelling.

Since approximately two-thirds of all women suffering from cervical carcinoma receive radiation as a component of their therapy, an enhanced understanding of the interactions between hypoxia and radiation as a component of their therapy, an enhanced understanding of the interactions between hypoxia and radiation resistance is critical to improving outcome among those with cervical cancer.


Eligibility Criteria:
Inclusion Criteria:

* The subject will have a malignant tumor of the cervix which is not curable by surgery in which it has been determined the subject is to receive the standard care of treatment of radiation therapy and chemotherapy.
* The subject must have adequate bone marrow function, renal function, hepatic function and neurologic function.
* The subject should be free of active infection requiring antibiotics.
* The subject must have signed the approved informed consent
* If the subject is of childbearing age, they must have a negative urine pregnancy test with effective contraception
* The subject must have met pre-entry requirements

  1. Physical examination to include pelvic examination, blood counts, assessment of liver and kidney status through blood studies
  2. A serum pregnancy test
  3. Detectable tumor will be measured.

Exclusion Criteria:

* The subject has not been clinically staged for their cancer
* The subject has evidence of or is being treated for an active infection
* The subject cannot perform the appropriate follow-up or complete the study for whatever reason.
* The subject has not consented to an additional tumor biopsy and MRI after my seven days of treatment with methazolamide
* The subject has evidence of chronic obstructive pulmonary disease
* The subject is currently breastfeeding
* The subject is pregnant
* The subject takes aspirin chronically
* The subject has a history of Stevens-Johnson syndrome
* The subject has not signed the approved informed consent
Adjuvant Therapy for Intermediate Risk HER2 Positive, Lymph Node Negative Early Breast Cancer With Chemotherapy Combined Target Therapy

Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and easy recurrence and metastasis. The emergence of HER2 targeted drugs has greatly improved the prognosis and survival of such patients. At present, for HER2 positive breast cancer patients with negative lymph nodes, chemotherapy drugs combined with trastuzumab is the current standard treatment scheme, and in most cases, chemotherapy uses a combination of two drugs, while the main beneficiaries of the trastuzumab and pertuzumab are concentrated in the group of patients with positive lymph nodes. Can targeted therapy be used to reduce the progression of chemotherapy and further achieve efficient and low toxicity strategies. It is planned to explore the efficacy and safety of T1-T2, HER2 positive early breast cancer patients with negative lymph nodes to achieve chemotherapy reduction based on risk stratification.


Eligibility Criteria:
Inclusion Criteria:

* 1) Treatment in Peking University People's Hospital for radical resection of breast cancer and had hospitalization records;
* 2) Postoperative pathology confirmed invasive breast cancer, and the pathological stage was T1c, N0, HER2 positive, with other high-risk factors (G3, or hormone receptor negative); Or the pathological stage is T2, N0, and there are no high-risk factors (G3, or hormone receptor negative);
* 3)Signed an agreement to participate in the PKUPH Breast Disease Cohort study at Peking University People's Hospital.

Exclusion Criteria:

* 1) Lack of clinical pathological data (such as imaging data, pathological data);
* 2) Preoperative neoadjuvant therapy;
* 3) Patients with metastatic breast cancer or bilateral breast cancer;
* 4) Failed to undergo curative surgery.
The Vascular and Metabolic Effects of Sunitinib in Patients With Metastatic Renal Cell Carcinoma

Rationale: The introduction of angiogenesis inhibitors, like sunitinib and bevacizumab, has improved the outcome of patients with several types of cancer remarkably. However, their application is hampered by side effects, such as development of hypertension with consequences for renal and cardiac function. Moreover patients treated with angiogenesis inhibitors may suffer from weight loss, and insulin sensitivity during treatment appears to change. The treatment with angiogenesis inhibitors, will improve life expectancy of patients with various cancer diagnoses and therefore the clinical relevance of both short term and long lasting adverse events will translate into reduced quality of life. In addition, premature withdrawal of angiogenesis inhibitors due to side effects may result in lower response, shorter duration of response and possibly a shorter survival. Therefore, adequate treatment of above mentioned side effects in patients treated with angiogenesis inhibitors is of relevance for the response rate, the duration of progression free survival and overall survival and for quality of life.

Mechanistic insight in the pathogenesis of these side effects will help optimizing treatment.

Objective: The primary objective of the study is to investigate the effect of sunitinib on endothelial function, insulin sensitivity, renal function and renal blood flow.

Study design: Single-centre non randomized observational study Study population: 30 Patients (\>18 years old) starting with sunitinib as treatment for metastatic renal cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Subject is able and willing to sign the Informed Consent Form
* Age 18 years or older
* WHO performance status 0-2
* Life expectancy ≥ 12 weeks
* mRCC patients in which the treatment of choice is sunitinib

Exclusion Criteria:

* Use of corticosteroids
* Any evidence of severe or uncontrolled diseases other than renal cell carcinoma eg, unstable or uncompensated respiratory, cardiac, hepatic or renal disease.
* Known risk of the patient transmitting HIV, hepatitis B or C via infected blood
* Patients being treated with oral anticoagulants if to be included in group A.
LYNX: A Novel Mobile App to Support Linkage to HIV/STI Testing PrEP for Young Men Who Have Sex With Men

This study is testing the acceptability and feasibility of a highly interactive mobile application (app) to promote HIV/sexually transmitted infection (STI) testing and uptake of pre-exposure prophylaxis (PrEP) among young men who have sex with men (YMSM).

Using the Information-Motivation-Behavior Skills (IMB) model, we have developed LYNX, a highly interactive mobile app to promote accurate risk perception and increase HIV/STI testing and linkage to PrEP among young men who have sex with men (YMSM). Key components of the app include Sex Pro (a personalized HIV risk score), a sex diary to facilitate accurate data collection; HIV/STI testing information and reminders; access to home HIV/STI testing options; a geospatial-based locator of HIV/STI testing sites and PrEP clinics; PrEP information and videos; and online PrEP navigation.

This study is part of the iTech NIH U19, which has an overall goal to develop innovative technology-focused interventions addressing the HIV prevention and care continuum for youth.

Eligibility Criteria:
Inclusion Criteria:

* No HIV test in the past 3 months (self-reported).
* Not known to be HIV-infected (self-reported).
* Not currently taking PrEP (self-reported).
* Owns an Apple operating system (iOS) or Android mobile phone and willing and able to download the LYNX app onto their phone.
* Willing and able to attend an in-person baseline visit in the Tampa or Chicago area.
* Able to understand, read, and speak English.
* Participants ages 15-18: self-report at least one episode of anal intercourse with a male or transfemale partner during the last 6 months
* Participants ages 19-24: self-report evidence of high risk for acquiring HIV infection including at least one of the following:

  1. at least one episode of condomless anal sex with an HIV-positive or unknown HIV status male or transfemale partner during the last 6 months; or
  2. Anal sex with 2 or more male and/or transfemale partners during the last 6 months; or
  3. Exchange of money, gifts, shelter, or drugs for anal sex with a male or transfemale partner during the last 6 months; or
  4. Sex with a male or transfemale partner and has had an STI during the last 6 months.

Exclusion Criteria:

* Currently enrolled in another HIV intervention study
* Prior enrollment in an HIV vaccine trial with receipt of experimental vaccine product
* Enrollment in an earlier phase of LYNX study
* Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Adhesive Performance of Glass Ionomer and Resin Based Adhesive Systems: A 3 Years Prospective Clinical Evaluation

This study aimed to clinically evaluate the 3-years clinical performance of glass ionomer and resin based adhesive systems in Class V restorations.

The formulated null hypothesis was that there is no significant difference in the clinical performances between glass ionomer and resin based adhesive systems in Class V restorations for 3-years.

The research question was as follows: Do glass ionomer adhesives in class V restorations present better clinical performances than resin based adhesive systems according to the modified United States Public Health Service (modified-USPHS) criteria?

Eligibility Criteria:
Inclusion Criteria:

1. Patients with primary caries involving cervical surface only with ICDAS 2 and 3.
2. Patients with normal and full occlusion.
3. Patients with tooth gives positive response to testing with an electric pulp tester.
4. Patients must have a good oral hygiene.
5. Patients with opposing teeth should be natural with no restorations.

Exclusion Criteria:

1. High caries risk patients with extremely poor oral hygiene.
2. Patients involved in orthodontic treatment or periodontal surgery.
3. Patients with periodontally involved teeth (chronic periodontitis).
4. Patients with heavy bruxism habits and clenching.
5. Patients with abutments should be excluded.
Safety and Feasibility of Imaging at 10.5 Tesla

This unique NMR instrument is the first of its kind, and the most advanced system that is capable of brain, torso and extremity imaging in humans at such a high magnetic field. It will be transformative in performance relative to 7Tesla, and significantly expand the capabilities of multinuclear MRI, fMRI, morphological imaging, MRS etc. in the human brain and body.

In addition, to the known and potential benefits of performing anatomic and functional imaging studies at 10.5T, there are also known short-term side effects associated with subjecting humans to such high magnetic fields. This protocol will study the magnitude and variability of the short term and long term physiological, cognitive and vestibular effects while also assessing the feasibility of acquiring the types of data needed for translating research protocols onto this higher field strength scanner.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and 70
2. Able to self-consent
3. Weight less than 190 pounds
4. Participated in high field MRI studies (7T or higher)

Exclusion Criteria:

Subjects with metallic, magnetic, and/or electrically conductive implants or external devices.

1. Ferromagnetic implants
2. Any foreign metal objects in the body
3. History of shrapnel or shot gun injury
4. Cardiac pacemakers
5. Defibrillator
6. Neuronal stimulator
7. Magnetic aneurysm clip
8. Large tattoos on the abdomen or the brain and neck
9. Hip replacement
10. Too large to fit in the magnet (body mass index \>= 40, approx.)
11. Severe claustrophobia
12. Women who are pregnant
Study of the Safety and Immunogenicity of Long-term GNR-069 Therapy in ITP Patients

It is a phase III extension study to assess safety and immunogenicity of long-term therapy with GNR-069 in patients with idiopathic thrombocytopenic purpura

It is an extension study in patients with ITP who completed participation in RMP-ITP-III clinical trial.

The study will be conducted in three stages:

* Transition visit - 1 day (transition of clinical trial participants from the RMP-ITP-III study to the RMP-ITP-III-X study);
* Treatment period - minimum 26 weeks;
* Follow-up period - 1 week. Patients will then be provided with the study therapy till the product market access with only safety data collection.

Eligibility Criteria:
Inclusion Criteria:

* Completion of participation in the study RMP-ITP-III while maintaining the clinical effectiveness of romiplostim therapy

Exclusion Criteria:

* Hypersensitivity to the components of the study drug or E. Coli proteins;
* Pregnancy or breastfeeding;
* Any diseases and conditions that, in the opinion of the Investigator, may hinder the patient's participation in the study
Ayurvedic Herbs in Diarrhea Predominant Irritable Bowel Syndrome

In the present study the investigators are trying to evaluate the effect of Murraya koenigii leaves, Punica granatum and Curcuma which is administered to the patients in a combined form as tea. This study will help to evaluate the effect of these preparations scientifically in improving the IBS symptoms.

see above

Eligibility Criteria:
Inclusion Criteria:

* Irritable Bowel Syndrome according to Rom-III
* Subtype Diarrhea or Alternating
* discomfort or pain \> 1 times a week
* discomfort or pain \> 4 on a Visual Analog Scale

Exclusion Criteria:

* Inflammatory bowel diseases (test results necessary)
* Lactose, Fructose Malabsorption (test results necessary)
* Celiac Disease
* Pregnancy or Breastfeeding
* Colectomy or Hemicolectomy \>50cm
* Severe metabolic disorders, hormonal disorders, cardiac or respiratory failure, liver or renal diseases
* severe depression, psychotic or psychiatric disorders, substance abuse
* cancer within the last 5 years
* allergy to caraway
* acute inflammatory diseases