cyrilzakka/clinical-trials huggingface dataset:
A Study of the Safety and Effectiveness of an HIV Vaccine for HIV-Positive Patients Receiving Anti-HIV Drugs for at Least 2 Years

The purpose of this study is to see if 2 study vaccines, ALVAC-HIV (vCP1452) and gp160 MN/LAI-2, are safe and effective in boosting the body's attacks on HIV in HIV-positive patients.

HIV-infected patients who have been treated with anti-HIV drugs for a long time may have weakened immune responses. One way to strengthen these responses may be to have a safe and effective vaccine, which will boost immune responses that are specific to HIV.

HIV-infected patients treated with antiretroviral therapy for prolonged periods of time may show decreased levels of HIV-specific immune responses. In these patients, a prime-boost vaccine strategy may induce both humoral and cell-mediated immunity. The hypothesis of this study is that the vaccine strategy selected will be both safe and immunogenic in the patient population being tested.

Patients continue antiretroviral medications throughout the course of this study. All patients receive intramuscular injections of ALVAC-HIV (vCP 1452) and recombinant soluble gp160 MN/LAI-2 on Days 0, 30, 90, and 180. Patients are monitored for safety 30 minutes after each immunization and by telephone contact within 72 hours of each vaccination. In addition, each patient records adverse events in a diary. Patients have regular physical exams, pregnancy tests, and blood drawn for virologic and immunologic assessments. The induction of HIV-specific responses will be measured.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have a viral load (amount of HIV in the blood) of less than 50 copies/ml.
* Have been taking anti-HIV drugs for at least 2 years.
* Are already participating in ongoing clinical trials at the Aaron Diamond AIDS Research Center.
* Are at least 19 years old.
* Practice abstinence or use 2 barrier methods of birth control, both men and women who are able to have children.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have HIV infection that is spreading through the body even though they are taking anti-HIV drugs.
* Are breast-feeding.
* Are pregnant.
* Are allergic to eggs and/or neomycin.
* Show evidence of poor immune responses.
Free Radical Level in SCC of Tongue Patients Tumor, Serum and Saliva

Study comparing level of free radicals in tumor tissue, blood serum and saliva in patients with Squamous Cell Carcinoma of tongue and mouth floor. Patients with benign fibroma of oral cavity and normal gingiva around extracted lower wisdom tooth are used for control


Eligibility Criteria:
Inclusion Criteria:

1. Older than 18 years of age.
2. Mentally healthy
3. SCC of Tongue or Mouth Floor
4. Benign Fibroma of Oral Cavity
5. Lower wisdom tooth extraction -

Exclusion Criteria:

1. Younger than 18 years of age
2. Mentally incapacitated
The Influence of Sperm Morphology and Functional Indices on Blastocyst Development in Assisted Reproduction

Samples from male partners of 120 infertile couples undergoing IVF were analyzed. Sperm morphology was assessed using the SpermBlue staining method, while TZI, MAI, and SDI were calculated. Embryo development was monitored until day 5 or 6. Statistical analyses included regression models and correlation coefficients to evaluate the predictive value of sperm indices on blastocyst development.

For spermatozoa selection we used ZyMot multi in all patients undergoing IVF. After intracytoplasmatic injection of spermatozoa we asses the blastocyst grading in day 5. NEQSI score meaning numerical embryonic quality score index was used for statistical purpose. The spermatozoa morphology indexes were: TZI (teratozoospermia index), MAI (multiple anomalies index), SDI (sperm deformity index) and analyzed with CASA analyzer. All these indexes were assessed in patients and correlated in all groups: patients that had a positive pregnancy test, patients that had a negative pregnancy rate, patients that had no blastocyst in day 5 and patients that had all aneuploid embyos.

Eligibility Criteria:
Inclusion Criteria:

* couples with an infertility diagnosis that underwent an IVF procedure and had obtained at least one blastocyst

Exclusion Criteria:

* donors
* uterine abnormalities
Effectiveness of Lumbopelvic Stabilization Exercises for Pregnancy-related Low Back Pain

The purpose of this study is to examine the effectiveness of lumbopelvic stabilization exercises on women who have undergone Caesarian sections on: 1) disability using the Modified Oswestry Low Back Disability Index (OSW), 2) pain according to the Numeric Pain Rating Scale (NPRS), 3) percent change of muscle thickness of the deep abdominals using ultrasound imaging, and 4) perceived improvement using the Global Rating of Change (GROC).

Pregnancy-related low back pain is a very complex problem. Decreased strength and endurance in the trunk and hip muscles have been shown in those with pregnancy-related low back pain. Lumbopelvic stabilization exercises have been shown to decrease pain and disability in those with low back pain. However, there have been very few studies with post-partum women, specifically those who have undergone Caesarian section births.

The purpose of this study is to examine the effectiveness of lumbopelvic stabilization exercises on women who have undergone Caesarian sections on: 1) disability using the Modified Oswestry Low Back Disability Index (OSW), 2) pain according to the Numeric Pain Rating Scale (NPRS), 3) percent change of muscle thickness of the deep abdominals using ultrasound imaging, and 4) perceived improvement using the Global Rating of Change (GROC).

Eligibility Criteria:
Inclusion Criteria:

* Unilateral low back pain near the sacro-iliac joint (SIJ) (distal and/or lateral to L5-S1 in the buttocks) and/or symphysis pubis
* Pain onset during pregnancy or within 3 weeks of delivery
* Most recent delivery within 6-24 weeks
* At least 2/6 positive SIJ provocation tests (thigh thrust, sacral compression, sacral distraction, sacral thrust, Gaenslen's test)
* Positive active straight leg raise (ASLR) test.

Exclusion Criteria:

* Neurological signs
* Systemic disease
* Currently pregnant
Long-term Academic and Psychosocial Impact of Child's Sleep: Parental Influences

The proposed longitudinal project aims to understand parental influences on children's sleep and will investigate the effect of sleep-related parental factors - (1) parents' value of their children's sleep relative to other activities, (2) parental involvement in setting children's sleep habits and enforcing good sleep hygiene, and (3) parent's own sleep habits - on school-age children's sleep, mental health, socio-emotional resilience, and academic/cognitive performance. It will also investigate the impact of social economic status on these sleep -related parental factors.

Parents can influence their children's sleep in various ways. However, existing studies on parental factors of school-aged children's sleep have seldom moved beyond sleep hygiene and the relationships between parent and child's sleep patterns. A potential factor that has been overlooked is parents' value of their children's sleep - whether they value their children's sleep and prioritise it over other activities, e.g. studying or watching TV. Another variable to consider is the social economic status (SES) of the household, which can influence these parental factors.

The proposed longitudinal project will investigate the impact of SES on several sleep-related parental factors and the effects these parental factors have on children's sleep, mental health, socio-emotional resilience, and academic/cognitive performance. The project will involve school-age children in Singapore (baseline age: 7-12 years) at two time points, time 1 (T1) and time 2 (T2), one year apart.

At each timepoint, children's sleep will be assessed with actigraphy for 1 school week. This will be followed by a lab visit during which sleep-related parental factors, as well as the children's sleep, academic and cognitive performance, socio-emotional resilience, and mental health will be assessed. Lab visits will be scheduled at the end of the school week in the morning and early afternoon so that neurobehavioural functions can be captured during typical school hours.

Investigators hypothesise that parents from low SES households will value their child's sleep less, and therefore, allow their child to trade a larger amount of sleep for other activities. Parents from low SES households will also enforce good sleep hygiene less, and sleep less themselves. Children from low SES households will thus have shorter sleep duration, more sleep disturbance, poorer mental health, poorer socio-emotional resilience, and poorer academic and cognitive performance.

Eligibility Criteria:
Inclusion Criteria:

* Is aged between 7 and 12 years
* Is a Singaporean
* Is English-speaking
* Is not on any long-term medications
* Has no known medical conditions that could affect sleep (e.g. asthma)
* Has no history of psychiatric or neurological disorders
* Has no history of sleep problems / disorders

Exclusion Criteria:

The reverse of the inclusion criteria
Effectiveness of a Structured Intervention to Optimize the Use of Mirabegron

This study was a multicentre, quasi-experimental design, controlled, before-and-after trial to estimate the effectiveness related to the review of mirabegron use and, if appropriate, its discontinuation.

Intervention group: Patients with mirabegron prescription assigned to any of the 17 primary health care centers (PHC) located in the northern area of Barcelona.

Control group: All the other patients assigned to any of the other 34 health care centers in Barcelona belonging to the Catalan Institut of Health (CIH).

The structured intervention included initiatives with general practitioners and urologists/gynaecologists, management support from health care authorities, and monthly feed-back monitoring to general practitioners (GPs).

The follow-up period was 12 months, from January 1st to December 31st, 2017.

A quasi-experimental design with before/after measurement and a control group was used.

The objective was to identify the effectiveness of a training activity on the review of treatments. In addition, it was proposed to establish the duration of medication in real clinical practice, and its prevalence of use before and after the intervention.

Control group: Usual care

Intervention:

* Initiatives for healthcare professionals: information and training with written material, in an diagram format, distributed to all general practitioners.
* Initiatives for specialized hospital care: information regarding the intervention for urologists and gynaecologists.
* Management support with the definition of a structured strategy for all the addresses of the PHC and GPs.
* Monthly monitoring of the intervention (feed-back to all GPs).

The intervention consisted of: a) meetings with all the directors of the PHC; b) informative meetings and sessions in the PHC; c) distribution of the diagram to all the GPs; d) lists of patients with treatment provided periodically from the medication area; and e) review of the treatments by the GPs.

If considered appropriate, and with the consent of the patient, the medication was withdrawn.

A pharmacist and a clinical pharmacologist acted as consultants in case of any doubts regarding specific patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years with mirabegron prescription. The prescription could be performed by a hospital or primary care doctor.

Exclusion Criteria:

* Patients under 18 years
Search for Genetic Basis of Vulvodynia

The purpose of this study is to investigate the possibility of an association between Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).

The short-term goal proposed for the current study was to investigate the possibility of an association between Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).

Eight polymorphic SNPs in the three different genes suspected to be involved in LPV has been examined as follow:

1. HSPE gene: Four polymorphic SNPs: rs4693608, rs11099592, rs6856901 and rs4364254 that were found to be informative in the Ashkenazi Jewish population
2. TRPV1 gene: Two polymorphic SNPs: rs222747 and rs8065080.
3. NGF gene: A novel T to C SNP in the promoter region at position -198 (rs11102930) and rs6330 which was found to be associated with anxiety-related personality traits and has been suggested to may affect intracellular processing and secretion of NGF.

Eligibility Criteria:
Inclusion Criteria:o meeting Friedrich's criteria \[50\] for vulva vestibulitis syndrome

* diagnosed by a gynecological examination with LPV
* diagnosed with a severe degree of the syndrome according to Marinoff \[48\]
* classified with the primary type of the syndrome according to an interview
* with both parents of Ashkenazi origin.
Metadherin mRNA Expression in Bladder Cancer

The study aims to study alterations of MTDH gene expression in the serum of bladder cancer patients compared to control group to evaluate its role as a marker for diagnosis.

,to compare the diagnostic accuracy of MTDH with the previously used marker Bladder Cancer-Specific Antigen-1 (BLCA-1 in the serum of bladder cancer patients .

and to study correlation between expression of the metadherin gene and serum level of BLCA-1, and clinical and histopathological staging in patients with bladder cancer

Urinary bladder cancer (BC) is the ninth most common cancer worldwide. It is the fifth most common malignancy in males and seventeenth most common in females.

In Egypt, bladder cancer represents a massive health burden where it is one of the commonest cancers representing 6.9% in both sexes and 10.7% among men. Its distribution is 8.8% in lower Egypt, 14.2% in middle Egypt and 12.6% in upper Egypt.Almost 50% of patients will experience recurrence of their disease within 4 years of their initial diagnosis.The prognosis of bladder cancer is poor as a result of highly invasive properties of tumour cells.

The optimal treatment selection depends on early diagnosis as well as accurate staging and grading.Currently there is a need for new molecular bio markers that can help clinicians to identify patients requiring early, aggressive treatment.

Metadherin (MTDH) is an oncogene known as Astrocytic elevated gene-1(AEG-1).It was firstly identified in 2002 at fetal astrocytes of persons exposed to HIV-1 and then known as a vital oncogene mediating carcinogenesis,prognosis,invasion and cancer metastasis. AEG-1 expression is raised in bladder cancer tissues relative to normal tissues, and serves as a poor prognostic factor.

Eligibility Criteria:
Inclusion Criteria:

* Males and females.
* 30-80 years old.
* patients with bladder cancer not receiving any treatment

Exclusion Criteria:

1. patients taking chemotherapy or radiotherapy.
2. History of other malignancy.
3. History of autoimmune diseases.
ENSAND 2.0 Evaluation in Nigeria

The Enhancing Access to Safe and Nutritious Diets 2.0 (ENSAND) (2024-2026) project is designed to address the low per capita consumption of vegetables and variety of vegetable consumption in northern Nigeria by working with smallholder farmers to increase production and promoting healthier diets through greater vegetable consumption among farmers and their neighbors. The objective of this evaluation is to assess the effectiveness of GAIN's ENSAND program for increasing the quantity and variety of vegetables consumed by smallholder farmer households participating in the program and neighbor households paired with the farmers. This evaluation will use a quasi-experimental design to assess the impact of GAIN's ENSAND programs on the quantity and diversity of vegetables consumed by smallholder farmers and their neighbors. The evaluation will be guided by the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework. RE-AIM is a framework that is useful for evaluating the program impact of multifaceted and multilevel interventions.


Eligibility Criteria:
Inclusion Criteria:

* Farmer household or neighbor household recruited by ENSAND farmer
* Located within an intervention LGA
* Farmer must be member who is participating in the ENSAND project
* Adult who is ≥ 18 years old
* Able to speak English or Hausa
* Provide informed consent to participate in the study
Increasing Dose Study of Pramipexole in Two-way Cross-over Comparison of ER Tablet Versus IR Tablet in Japanese Healthy Male Volunteers

The objectives of this study were to investigate relative BA at steady state and to investigate dose proportionality of pharmacokinetic parameters

Relative BA at steady state:

* Pramipexole 0.375 mg ER tablet q.d. versus pramipexole 0.125 mg IR tablet t.i.d.
* Pramipexole 1.5 mg ER tablet q.d. versus pramipexole 0.5 mg IR tablet t.i.d.

Dose proportionality of pharmacokinetic parameters:

· Pramipexole ER dosages from 0.375 to 1.5 mg q.d.


Eligibility Criteria:
Inclusion Criteria:

* All subjects participating in the study are healthy male volunteers
* Age between 20 and 40 years
* Body mass index (BMI) between 17.6 and 26.4 kg/m2
* All volunteers must give written informed consent before screening to participate in this study and before first drug administration on Day 1 at Visit 2

Exclusion Criteria:

* Any findings of the medical examination (including blood pressure, pulse rate, ECG, and laboratory test parameters) of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy), psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\>24 hours) within at least one month or less than ten half-lives of the respective drug before the administration of investigational products
* Use of any drugs which might influence the results of the trial within 7 days before the start of drug administration in the study or during the study period
* Participation in another trial with an investigational drug (within 4 months before the start of drug administration)
* Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day and who cannot refrain from smoking at the trial site)
* Alcohol abuse (\>40 g/day)
* Drug abuse
* Blood donation (≥100 mL within 4 weeks before drug administration or during the trial)
* Excessive physical activities from 7 days before the start of drug administration to the end of this study
* Any positive results in hepatitis B surface antigen (HBsAg), anti hepatitis B core (HBc) antibodies, anti hepatitis C virus (HCV) antibodies and human immunodeficiency virus (HIV) test

The following exclusion criteria are of special interest for this study:

* Hypersensitivity to pramipexole or other dopamine agonists
* Supine blood pressure at screening of systolic \<110 mmHg and diastolic \<60 mmHg
Applying Shear Wave Elastography for Adjunct Steroid on Tuberculous Lymphadenitis

1. To prospectively collect the radiologic data from the initial phase till the post-treatment phase of tuberculous lymphadenitis.
2. To prospectively investigate the benefits of corticosteroid on reduction of paradoxical upgrading reaction in patients with tuberculous lymphadenitis based on the results of shear wave elastography.
3. To investigate the potential biomarker of host immunity in response to tuberculosis and predict the development of paradoxical upgrading reaction.

Tuberculosis remained one of the top ten leading cause of death worldwide. There were more than 10 million new diagnoses per year, and up to 1.2 million deaths caused by tuberculosis. Extra-pulmonary tuberculosis is defined as infection outside the lung. Tuberculous lymphadenitis is the most common site of extra-pulmonary tuberculosis, constituting around 30-50% of all cases. A unique manifestation with worsening of symptoms, called paradoxical upgrading reaction (PUR), may develop in 20-50% of patients with tuberculous lymphadenitis during the therapy. Common presentations of the PUR include swollen lymphadenitis with pain or rupture with pus. Patients may fail to complete the treatment and jeopardize the development of drug-resistant pathogen. Limited studies investigated the risk factors associated with the PUR. In our prior study, ultrasound shear wave elastography offers quantified values as the objective parameters to successfully predict the occurrence of PUR. In this study, we aim to investigate the effect of corticosteroid as an adjunct therapy to reduce the PUR from happening in patients with tuberculous lymphadenitis.

Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed of tuberculous lymphadenitis.
* The diagnosis of tuberculous lymphadenitis must qualify any of the following criteria:

  1. microbiological evidence (culture or nucleic acid amplification test)
  2. histology specimen featuring caseating granulomatous inflammation with acid-fast bacilli on smear, or clinical response to anti-tuberculosis therapy.

Exclusion Criteria:

* Participants with age \< 18 years
* Diagnoses based on histologic report turned out to be non-tuberculosis mycobacterial infection
* The tuberculous lymphadenitis involved was surgically removed, without available target to be monitored
* Participant under systemic (oral or parenteral) steroid therapy.
* Participant with active hepatitis B virus infection
* Participant reluctant to be enrolled in the trial
Ultrasound for Detection of Prostate Cancer

Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.

Prospectively recruited patients before prostatectomy and/or definitive radiotherapy will be included in the study. Dual-frequency ultrasound imaging will be compared to standard transrectal ultrasound and MRI. Imaging of primary tumor with dual-frequency ultrasound technology including the use of microbubble contrast-media.

A prostate biopsy and blood sample will be taken from each patient, for histopathology and explorative biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years onwards
* Signed written informed consent to perform rectal and transperineal ultrasound

Exclusion Criteria:

* N/A