cyrilzakka/clinical-trials huggingface dataset:
Brief HIV Prevention Counseling for STI Patients in South Africa

This is a randomized trial to test a brief single session risk reduction counseling intervention on HIV and STI behavioral outcomes in Cape Town South Africa.

This 5 year study will conduct a randomized clinical trial of a gender and culturally tailored theory-based behavioral risk reduction intervention for men and women who are receiving sexually transmitted infection (STI) diagnostic and treatment services from STI treatment providers in South Africa. As many as one in five South Africans is HIV positive and there are an estimated 1,500 new HIV infections in South Africa each day. The experimental intervention in this study was developed by South African and US investigators and pilot tested in South Africa. The intervention is grounded in the experience of South African health service provider, empirical research on AIDS-related stigmas, and elements of a social cognitive theory of health behavior change. The intervention consists of a single 60-minute risk reduction counseling session delivered within the context of STI services. Participants will be STI clinic patients over age 18 that have been treated for a previous STI. Participants will be baseline assessed and randomized to receive either (a) the 60 min theory-based and culturally tailored risk reduction intervention or (b) a time and contact matched standard of care HIV and health education session. Participants will be followed for 12 months post intervention. Assessments will be conducted using computer assisted interviews (ACASI). The randomized trial will determine the efficacy of the risk reduction intervention for South African men and women receiving STI clinic services. Outcome analyses will include differences between conditions on new STI diagnoses over 12 months. We will also test the mediating effects of attitudes and beliefs on intervention outcomes. Results of this research will therefore test a clinic-based HIV prevention intervention model that is urgently needed in South Africa.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* STI clinic patient diagnosed with an STI at current visit

Exclusion Criteria:

* None
Fluorouracil Plus Radiation Therapy Following Surgery in Treating Patients With Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells left after surgery.

PURPOSE: Phase II trial to study the effectiveness of combining fluorouracil and radiation therapy in treating patients who have undergone surgery for pancreatic cancer.

OBJECTIVES:

* Determine the tolerance of adjuvant fluorouracil with concurrent radiotherapy in patients with resected pancreatic adenocarcinoma.
* Determine survival without local relapse in these patients treated with this regimen.
* Determine overall survival of these patients treated with this regimen.
* Determine the effectiveness of this adjuvant therapy in these patients.

OUTLINE: This is a multicenter study.

Patients receive high-dose radiotherapy 5 days a week for 5 weeks. Patients also receive low-dose radiotherapy 4 times a week during the last 2 weeks of the 5-week course of treatment. Patients concurrently receive fluorouracil IV continuously for 5 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed pancreatic adenocarcinoma
* Complete macroscopic resection of tumor within past 30 days
* No residual visceral or peritoneal metastasis
* Involvement of Vater's ampulla or extrahepatic bile duct allowed
* No vesicular or intrahepatic cholangiocarcinomas

PATIENT CHARACTERISTICS:

Age:

* 18 to 75

Performance status:

* ECOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic:

* Alkaline phosphatase less than 3 times normal
* Bilirubin less than 1.5 times normal

Renal:

* Creatinine less than 1.5 times normal

Cardiovascular:

* No serious cardiac failure

Pulmonary:

* No serious respiratory failure

Other:

* No other untreatable malignant tumors
* No serious psychological, familial, social, or geographical conditions that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy for pancreatic adenocarcinoma

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy for pancreatic adenocarcinoma
* No prior radiotherapy in an anatomically proximal region to treatment area

Surgery:

* See Disease Characteristics
Determination of Accuracy in Measurement of Total Immunoglobulin E Using a Test Device in Atopic Subjects

The purpose of this study is to determine the accuracy of the Novel point of care test (POCT) total IgE assay in atopic patients.

120 patients with atopic conditions and approximately 40 healthy subjects will be enrolled. Fingerstick capillary blood samples will be collected and tested in the POCT device. Venous samples will be collected and sent to a reference laboratory for measurement of serum total IgE using the reference immunoassay method.


Eligibility Criteria:
Inclusion criteria: atopic patients

* Subjects who are diagnosed with atopic condition
* Subjects or legal guardians who are able to give informed consent
* Other protocol-defined inclusion criteria may apply Exclusion criteria: atopic patients
* Subjects who have received anti-IgE antibody treatment
* Subjects who have elevated IgE levels for reasons other than allergic conditions
* Other protocol-defined exclusion criteria may apply Inclusion criteria: healthy subjects
* Subjects who are able to give informed consent for participation in the study according to local requirements / law.

Exclusion criteria: healthy subjects

* Subjects who have received anti-IgE antibody treatment
* Subjects with a suspected or confirmed clinical diagnosis of an atopic condition
* Other protocol-defined exclusion criteria may apply
A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins

This study will investigate the effect of PF-04950615, a new investigational lipid lowering agent, on LDL-C and other lipids.


Eligibility Criteria:
Inclusion Criteria:

* On a stable daily dose of atorvastatin, rosuvastatin or simvastatin.
* Lipids meet the following criteria at screening and prior to dosing: Fasting LDL-C greater than 100 mg/dL and fasting TG less than 400 mg/dL

Exclusion Criteria:

* History of a cardiovascular or cerebrovascular event or procedure during the past year.
* Poorly controlled type 1 or type 2 diabetes mellitus.
* Poorly controlled hypertension.
Volatile Organic Compounds in Staphylococcus Aureus Patients

The zNose® MRSA test is a non-invasive breath test for markers of Staphylococcus aureus, which may predict the probability of bacterial organisms in the anterior nares, throat and respiratory tract, wounds, and anus and therefore be able to replace or supplement current active Methicillin Resistant Staphylococcus Aureus (MRSA) surveillance efforts. It consists of:

* A collection apparatus for collection of volatile compounds from suspected infection sites onto a sorbent trap or Tedlar bag, as well as for the collection of a separate sample of room air.
* Analysis of the volatile organic compounds from suspected infection sites and room air by short acoustic wave gas chromatography.
* Interpretation of the volatile organic compounds with a proprietary algorithm in order to predict the probability of Staphylococcus aureus infection and colonization.

This study will test the hypothesis that we can identify the presence of MRSA by sampling the "head space" above culture media of anterior nare samples provided by patients with MRSA. Additionally, this study will test the hypothesis that we can identify the presence of MRSA by sampling air exhaled through the nostrils (nasal exhalant).


Eligibility Criteria:
Inclusion Criteria:

* Suspicion of staphylococcus aureus infection or colonization
* Able to give samples for zNose® analysis

Exclusion Criteria:

* Inability to provide sample for zNose® analysis
Pharmacokinetics and Pharmacodynamics of RPH-104 in Healthy Subjects

The purpose of this first in human study is to evaluate the safety and tolerability of RPH-104 in humans.

RPH-104 is a macromolecular compound with a molecular weight of 152.715 kilodalton (Data on file) and is capable of binding human interleukin-1 beta (IL-1β). It has also been shown in vitro to be a highly potent inhibitor of IL-1β signalling pathway, with low picomolar inhibitor activity. In this First in Human study, RPH-104 will be evaluated primarily for its safety and tolerability. In a phase I study conducted with health volunteers, a similar monoclonal antibody, canakinumab, was investigated in terms of pharmacokinetics and pharmacodynamics besides efficacy and safety. Similarly, this aimed to investigate effects of RPH-104 on selected pharmacodynamic parameters, including Anti-Drug Antibodies (ADA) along with obtaining first human data on pharmacokinetics of RPH-104 in humans will be investigated in the same study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects.
* Male or female subjects between 18 and 35 years old (inclusive).
* Subject who has normal body weight as determined by a body mass index (BMI) of between 18 kg/m² and 30 kg/m² (inclusive) and within a body weight of ≥50kg and ≤120kg.

Exclusion Criteria:

* Subject who has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, dermatological, neurological, psychiatric, and hematological or immunological disorder(s), and/or any condition that could constitute a potential safety risk factor or could alter the absorption, distribution, metabolism or elimination of the study drugs.
* Subject who has positive immunoglobulin-M (IgM) antibodies against Epstein-Barr virus (EBV)-viral capsid antigen (VCA) (IgM-anti-EBV-VCA) and Cytomegalovirus (CMV).
* Subject who has a positive Quantiferon TB-Gold (TB) test
* Subject who is positive to Human Immunodeficiency Virus-1/2 antibody (HIV-1/2Ab).
* Subject who has serum hepatitis, or is a carrier of the Hepatitis B surface antigen (HBsAg), or is Hepatitis C virus antibody (HCV-Ab) positive.
The Thermogenic and Metabolic Effects of a Whole Food Meal Versus Its Supplemental Equivalent

There is limited research on the amount of calories burned and metabolic differences of a complete supplemental meal in comparison to a whole food meal. The purpose of this study is to analyze the differences in calories burned and metabolic response post-consumption of a meal consisting of whole foods compared to its nutritionally engineered equivalent. Investigators hypothesize that energy expenditure and satiety will be greater following consumption of the whole food meal compared to the supplement meal, whereas, there will be no difference in levels of glucose between the two conditions.

Over 50% of U.S. adults today use some form of dietary supplementation to obtain their nutrient intake. Previous research has shown that certain nutritional supplements may produce varying metabolic and thermogenic (calories burned) responses, when compared to other food sources. The difference in thermogenic response may also suggest that there is a difference between a whole food meal and its supplemental equivalent. If there is a difference in thermogenic response, this may indicate that a meal-replacing supplement, such as a ready-to-drink-shake and/or food bar may not induce the same health benefits as a whole food meal in terms of nutrient digestion, absorption, metabolism and storage. There has not been extensive research on the thermic effect and metabolic differences of a complete supplemental meal in comparison to a whole food meal. The purpose of this study is to analyze the differences in thermogenic and metabolic response post-consumption of a meal consisting of whole foods compared to its supplemental, engineered equivalent. It's hypothesized that energy expenditure and satiety will be greater following the whole food meal compared to the supplement meal, whereas, there will be no difference in levels of glucose between the two conditions.

Eligibility Criteria:
Inclusion Criteria:

* Young healthy females

Exclusion Criteria:

* Participants with specific dietary needs.
* Those with diabetes, impaired fasting glucose, low blood sugar (hypoglycemia) and participants who are classified as high risk.
* Participants with lactose intolerance.
* Participants who regularly use dietary supplements.
Single Photon Emission Computed Tomography of the Normal Human Brain

The objective of the study is to acquire a database of Single Photon Emission Computed Tomographic (SPECT) studies of the brains of normal human subjects in resting and concentrating states. The database will provide a basis for subsequent investigation of meaningful brain differences between clinical and normal subject groups

See brief summary.

Eligibility Criteria:
Inclusion Criteria:

The study seeks to recruit 100 normal human subjects between ages 10 and 90 for SPECT brain imaging. Subjects will initially be screened for psychiatric and other major illnesses with a screening questionnaire; they will also be given a standard DSM-4 computer-administered questionnaire (The DISC for children and teens and the SCID for adults). They will also meet individually with a psychiatrist or psychological assistant for a screening interview.

Exclusion Criteria:

1. Suicidal thinking or behavior
2. Any psychiatric diagnosis assignable under contemporary DSM nosology
3. Unstable medical condition
4. epilepsy, serious head injury, or other significant neurological disorder or use of central nervous system medication.
5. Dementia, mental retardation, or coma
6. Substance abuse or alcoholism
7. Unreliability or inability to adhere to the requirements of the study
8. Inability to personally tolerate the requirements of the study
9. Significant exposure to occupational, diagnostic, or therapeutic radiation within the prior year
10. Pregnancy or breast-feeding
11. A first-degree relative meeting any of criteria 1 through 6.
Impact of 5-fraction Stereotactic Partial Breast Irradiation and Whole Breast Irradiation on Cosmetic Outcome and Patient-reported Outcomes in Early-stage Breast Cancer

This study aim to investigate the effect of 5-fraction stereotactic partial breast irradiation and whole breast irradiation on patient-reported outcomes, cosmetic outcome, and breast tissue fibrosis in early-stage breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed invasive breast carcinoma or ductal carcinoma in situ (DCIS)
* Women who underwent breast-conservating surgery and have a plan to undergoing partial or whole breast irradiation
* Good performance status (ECOG 0-1)

Exclusion Criteria:

* Recurrent breast cancer
* History of ipsilateral breast irradiation
* Positive resection margin status after breast surgery
Gross Examinations Versus Frozen Section for Assessment of Surgical Margins in Oral Cancers

Surgical margin is a significant prognostic factor in oral cavity squamous cell carcinoma (OCSCC)\[1,2,3\]. Intra-operative frozen section (FS) has been routinely used by the surgeons to achieve adequate surgical margins. However published literature has failed to show a conclusive benefit of FS in improving oncological outcomes(4-7). The overall identification rate of the inadequate margins by FS is variable with figures in the literature ranging from25-34%.(8-10)

Revision of margins based on FS is widely practiced in centers where facility for FS is available. However this has not shown to significantly improve local control when compared to cases in which FS was not utilized , in a comparative study done at Tata memorial Hospital(TMH) (5) More-over FS is a costly procedure, and sparsely available in resource- poor countries. In a recently conducted retrospective study of 1237 patients conducted at TMH, the cost benefit ratio of FS for assessment of margin is as low as 12:1(11). In another prospective study performed at the same center , investigators found that gross examination (GE) of margins by the surgeons was as effective as FS, and achievement of gross 7mm margin all around the tumor obviated the need for FS (12). In a recent meta-analysis of 8 studies that looked at the utility of frozen section and had uniformity in frozen section analysis and definition of close margins, they concluded that revision of margins based on FS does not improve oncological outcomes and further prospective studies are needed to explore this contentious issue (13). With this background, a prospective RCT is planned to explore if gross examination by surgeon and subsequent revision of margin (if necessary) is an equally effective alternative to Frozen section based revision in a randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

1. Biopsy proven treatment naïve cases of OCSCC who are planned for curative surgery with en-bloc removal of the tumor with adequate margin
2. In detail assessment of the primary tumor is possible pre-operatively
3. Written informed consent
4. Age more than 18 years

Exclusion Criteria:

1. Multifocal disease
2. Clinically evident field cancerization
3. Previous treatment for oral cavity cancer - Surgery /chemo or radiotherapy -
Study of the Use of Methoxyflurane Vs Placebo in the Management of Pain in Oral and Dental Emergencies in Adults: METODO (METhoxyflurane in ODOntology)

With a chronic shortage of dentists in some regions, and an increase in life expectancy and living conditions, the number of patients admitted to oral health emergencies is on the rise. Pain is the main reason for consultation, and is particularly exacerbated in the orofacial sphere. Dental pain has several etiologies: infectious, inflammatory or traumatic accidents.Beyond the ethical aspects of acute pain management, pain relief is a real objective. Despite prioritization systems, patients can wait a long time in an unsettled environment, with tired and sometimes aggressive patients. Numerous recommendations exist to improve analgesia in emergency departments, but there are still difficulties in effectively and rapidly managing acute dental and orofacial pain. To meet this demand and facilitate the treatment process, an alternative solution using methoxyflurane (Penthrox®) could be considered. This product, mainly intended for emergency services, has been approved in Europe since 2016 for the "emergency relief of moderate to severe pain associated with trauma in conscious adult patients". Thus, it would be interesting to assess the value of methoxyflurane (Penthrox®) in the management of pain in oral emergencies as a wait-and-see solution.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (\> 18 years)
* Conscious patient consulting an oral emergency department with pain assessed as moderate to severe NRS greater than or equal to 4
* Patient has social security affiliation or who beneficiary of such social security
* Patients who have given informed consent

Exclusion Criteria:

* Patients with a history of allergy to methoxyflurane or any of the components of Penthrox (take into account family history of severe allergic reactions)
* Patients with a history of malignant hyperthermia (known or genetic predisposition)
* Patients with hepatic impairment after use of methoxyflurane or halogenated hydrocarbon anesthesia
* Patients with severe renal Failure
* Patients with altered level of consciousness, whatever the cause: head trauma, drug or alcohol abuse
* Patients with cardiovascular instability or respiratory depression
* Pregnant or breast-feeding patients. Therefore, a urine pregnancy test will be performed for all patients of childbearing age eligible to participate in the study
* Patients under legal protection (guardianship and curatorship) or deprived of liberty
* Patients unable to speak or read French fluently, unable to understand the principle of a numerical scale, anxiety and satisfaction questionnaires, and unable to cooperate with tests
Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

Compare the efficacy and tolerability of IRE in combination with either FOLFIRINOX or gemcitabine in patients with locally advanced pancreatic cancer.

Phase II study in which all patients undergoing IRE for the treatment of locally advanced pancreatic carcinoma will receive either FOLFIRINOX or gemcitabine as peri-ablation treatment.

Eligibility Criteria:
Inclusion Criteria:

* greater than or equal to 18 years of age
* diagnosed with stage III pancreatic cancer
* tumor is measurable
* GFR \> mL/min/1.73m2
* willing and able to comply with protocol requirements
* AST/ALT \>3 times upper limit of normal
* stable surgical post-operative course as defined by operative surgeon

Exclusion Criteria:

* participating in another clinical trial for the treatment of cancer at the time of screening
* pregnant or currently breast feeding
* have a cardiac pacemaker or ICD implanted that cannot be deactivated during IRE procedure
* have non-removable implants with metal parts within 1 cm of the target lesion
* had a myocardial infarction within 3 months prior to enrollment
Blood Flow Restriction Resistance Exercise in Lower Cervical Spinal Cord Injury Patients

This study is conducted to investigate the effects of low load Blood Flow Resistance exercise to improve strength and transfer in lower cervical spinal cord injury patientsCervical Spinal Cord injury patients have very less window of opportunity towards functional mode of life. In complete cervical spinal cord injuries only few muscles of upper limb are completely innervated and it is a need to gain maximum output and advantage out of that. Through conventional strength training it is possible to make him do unsupported sitting and transfer But with BFR-RE it may have a possibility to do this procedure in less time than the conventional strength training and patient will save cost of hospital stay as he may timely discharge from hospital early


Eligibility Criteria:
Inclusion Criteria:

* Both male and female, with age between 16-50 years.
* Patients evaluated with C6 to C8 tetraplegic complete injury.
* Patients classified in ASIA A, ASIA B.
* At least Muscle grading of grade 2.
* Patients with sub-acute, chronic stage.

Exclusion Criteria:

* Patients with other neurologic conditions, orthopedic problems, and uncontrolled metabolic diseases.
* Patients with muscles strength grading of less than 2.
* Undergone nerve transfer surgery.
* Patients with acute stage.
* History of DVT.
* Patients who are already performing structured physical activities such as muscle Strengthening exercises.