cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Diabetes Control and Effect on Transmission and Development of Tuberculosis

Clinical test (essay) randomized to evaluate the toxicity adherence and efficiency of the chemoprophylaxis of tuberculosis (TB) in subjects with Diabetes Mellitus (DM) and latent TB. (600 subjects followed(continued) by 15 months). 3rd stage. Patients with DM and TB will be included to determine if the strict control of the dm achieved in clinics of the first level of attention improves clinical manifestations of tb, the result of treatment, the frequency of relapses, the mortality and the transmission to contacts.

Elispot will be used to measure TB development and the time for the bacteriological negativization and biochemical parameters as well as tuberculin skin test (TST), quantiferon, in contacts. (160 patients 600 contacts followed(continued) for 12 months). additional there will be evaluated the socioeconomic impact of both diseases and his(her) control. 1er year: transverse study and recruitment years 2 and 3 participants' follow-ups in clinical tests(essays).


Eligibility Criteria:
Inclusion Criteria:

* Positive HIV TST tuberculin

Exclusion Criteria:

* Previous TB treatment Hepatic failure AIDS
Cue Exposure Training for Overweight Children

The primary objective of the study is to investigate the effectiveness of two intensive two-session trainings, the conventional psycho-education and food cue exposure, on eating in the absence of hunger, binge eating and Body Mass Index (BMI) change in overweight/ obese children.


Eligibility Criteria:
Inclusion Criteria:

* Being a patient in the Maastricht University Medical Center COACH unit for obese children and adolescents.
* Overweight, according to the sex and age specific cut-off point for overweight in children, as defined by Cole and colleagues (2000).
* Age: 12 - 18 years

Exclusion Criteria:

* Not being overweight (anymore, due to weight loss)
* Not able to speak and/or write Dutch
Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy

The purpose of this study is to compare the effect of pregabalin in reducing the neuropathic pain in postoperative patients who have undergone single level Microdiscectomy for prolapsed intervetebral lumbar disc.

All patients were informed in detailed regarding the risk and complications and given written and informed consent, coming to our clinics were assessed by one of the senior team members of the spine, patient fulfilling the eligibility criteria were selected and included in the study. One week before the surgery the patients who met the eligibility criteria were randomized in a double-blind manner (participant and investigator) in a ratio of 1:1 into Group-A (Pregabalin 7mg, twice daily) or Group-B (Placebo, twice daily). The pain scores were recorded by VAS and Roland Morris score system on preoperative day compared to the scores on the 1st week postoperative follow-up.

Eligibility Criteria:
Inclusion Criteria:

* All patients with severe CLBP and/or leg pain
* Patients with static or dynamic leg pain
* Patients with leg pain resulting from localized lumbar or lumbosacral segmental instability
* Spinal stenosis at levels L2-S1 or caused by isthmic spondylolisthesis (grade I and II)

Exclusion Criteria:

* Patients with previous lumbar surgery
* Patients allergic to gabapentinoids
* Patients with renal impairments
* Patients who are already on opioids, benzodiazepines, barbiturates, ethanol (alcohol)
* Patient presented with diabetes and other drugs that depress the central nervous system
* Patients who are already on ACE inhibitors as they may enhance the adverse/toxic effect of Pregabalin.
Effect of Extended-release Oxymorphone Taken With or Without Food on Cognitive Functioning

The purpose of the study is to determine whether extended-release oxymorphone hydrochloride taken orally with a high-fat meal, generating an approximately 50% higher Cmax, impacts cognitive functioning, using Cambridge Neuropsychological Test Automated Battery (CANTAB) tests, to a greater extent than when taking under conditions of fasting.

Oxymorphone 40 mg ER affects cognitive performance similarly within 3 hours post dose, whether given on an empty stomach or after a high-fat meal, suggesting that the altered pharmacokinetics, fed versus fasting and as described above, is not relevant for the medication's impact on cognition. Hence, the direction for oxymorphone ER to be dosed at least 1 hour before or 2 hours after eating, at least from a cognitive perspective, may be without merit.

Eligibility Criteria:
Inclusion Criteria:

1. Man or woman, 18-65 years of age, inclusive
2. Able to provide informed consent and comply with all study procedures
3. Women of childbearing potential with a negative urine pregnancy test at screening and on adequate contraception
4. Chronic, non-malignant, painful condition, treated with long-acting opioid (methadone, OxyContin®, MS (Morphine Sulfate) Contin®, Kadian®, Avinza®, Fentanyl®, Opana® ER)
5. Opioid treatment for at least 3 months prior to screening at a minimum dose of 90 mg of morphine equivalents per day or 50 mcg of the fentanyl transdermal patch
6. Dose of opioid treatment stable for at least 1 week prior to screening and expected to be stable from screening through end of second testing
7. Weight at screening 100-300 pounds, inclusive

Exclusion Criteria:

1. Pregnant or breastfeeding
2. Gastrointestinal disorder or S/P gastrointestinal surgery impacting absorption of study medication (delayed gastric emptying, partial or complete gastrectomy)
3. Alcohol or substance abuse within 2 years of screening
4. Consumption of alcohol within 24 hours of a screening or testing visit
5. Consumption of xanthine-containing beverages (coffee, tea, coke) on the morning of a screening or testing visit
6. Impaired kidney or liver function (transaminase levels more than 3 times elevated; estimated creatinine clearance less than 50 mL/min)
7. Epworth sleepiness scale (ESS) score 16 or higher at screening
8. Medically concerning hypertension (≥ 160/100) or unstable cardiovascular illness
9. Any clinically significant illness that would interfere with study participation or put the subject at risk
10. Exposure to investigational medication within 30 days of screening
Long-Term Use Of Pegaptanib In Patients For Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.

All the patients whom an investigator prescribes the first Macugen® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility Criteria:
Inclusion Criteria:

* Patients need to be administered Macugen® in order to be enrolled in the surveillance.

Exclusion Criteria:

* Patients not administered Macugen®.
Haplo T-Cell Depleted Transplantation in High-Risk Sickle Cell Disease

This study is being done to determine the safety and outcome (long-term control) of a high-dose chemotherapy regimen followed by an infusion of CD34 selected (immune cells) stem cells from a partially matched adult family member donor, called haploidentical stem cell transplantation, in high-risk sickle cell disease patients.

Funding Source - FDA OOPD

The purpose of this study is to investigate host myeloimmunosuppressive conditioning followed by familial haploidentical T cell depleted allogeneic stem cell transplantation in patients with high risk Sickle Cell Disease (SCD). It is hypothesized that it will be safe and well tolerated, and result in sustained donor chimerism, acceptable engraftment and immune reconstitution. Also, that it will limit SCD related organ damage resulting in improved and/or stable neurological, neurocognitive, pulmonary and pulmonary vascular function and health related quality of life (QOL).

Patients 2-20.99 years of age with a diagnosis of high-risk SCD and with an unaffected HLA partially matched family donor and meeting eligibility criteria (inclusion and exclusion criteria) are eligible.

Eligibility Criteria:
Inclusion Criteria:

* Homozygous Hemoglobin S Disease, or Hemoglobin S Beta0/+ thalassemia
* Patients must demonstrate one or more of the following Sickle Cell Disease Complications

  1. Clinically significant neurologic event (stroke) or any neurologic deficit lasting \>24 hours that is accompanied by an infarct on cerebral MRI
  2. Minimum of two episodes of acute chest syndrome.
  3. Recurrent painful events (at least 3 in the 2 years prior to enrollment).
  4. Abnormal TCD study requiring starting on chronic transfusion therapy.
  5. At least one silent infarct lesion on a MRI scan of the head.
* A familial haploidentical donor without homozygous sickle cell disease
* Adequate organ function (renal, liver, cardiac and pulmonary function)
* Karnofsky or Lansky (age appropriate) Performance Score ≥50%
* Liver biopsy is optional to assess for iron overload in chronically transfused patients.

Exclusion Criteria:

* Females who are pregnant or breast-feeding
* SCD Patients with documented uncontrolled infection
* SCD patients who have an unaffected HLA matched family donor willing to proceed to donation
* Karnofsky/Lansky (age appropriate) Performance Score \<50% (hemiplegia alone secondary to a previous stroke is not an exclusion)
* Demonstrated lack of compliance with medical care.
* Clinically significant fibrosis or cirrhosis of the liver
* Previously received a HSCT
RAMSETE: RAD001 in Advanced and Metastatic Silent Neuro-endocrine Tumors in Europe

To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line treatment of patients with metastatic papillary carcinoma of the kidney.


Eligibility Criteria:
Inclusion criteria:

1. ≥ 18 years old
2. Patients with advanced (unresectable or metastatic) biopsy proven non-syndromic neuro-endocrine carcinoma, low or intermediate grade
3. Radiological documentation of disease progression within 12 months prior to study entry. If patients received anti-tumor therapy during the past 12 months, they must have radiological documentation of progressive disease (PD) while on or after receiving the therapy
4. Patients may have received previous treatments (chemotherapy, biotherapy, peptide-receptor radionuclide therapy); an overall maximum of 3 systemic treatment is allowed
5. Patients with at least one measurable lesion
6. Patients with an ECOG (Eastern Cooperative Oncology Group) Performance Status 0-2
7. Adequate bone marrow function
8. Adequate liver function
9. Adequate renal function
10. Adequate lipid profile

Exclusion criteria:

1. Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma
2. Patients with carcinoid with hormone related symptoms (diarrhea ≥ 4 stools per day and/or flushes)
3. Patients with Islet cell carcinomas or pancreatic NET
4. Patients who received prior therapy with Vascular Endothelial Growth Factor (VEGF) pathway inhibitor within 4 weeks prior to study entry
5. Patients who entered peptide receptor radionuclide therapy (PRRT) within 3 months prior to study entry
6. Patients who received CT, biotherapy or radiotherapy within 4 weeks prior to study entry
7. Patients who have previously received systemic (mammalian target of rapamycin) mTOR inhibitors
8. Patients with a known hypersensitivity to everolimus or other rapamycins or to its excipients
9. Patients with uncontrolled central nervous system (CNS) metastases
10. Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent
11. Patients with a known history of HIV seropositivity
12. Patients with autoimmune hepatitis
13. Patients with an active, bleeding diathesis
14. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
15. Patients who have a history of another primary malignancy and off treatment ≤ 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix
16. Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods
17. Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start
18. Patients unwilling to or unable to comply with the protocol
Intra-Abdominal Hypertension in Neonatal Intensive Care Patients

The observational study is designed to determine the feasibility of performing Intra-Abdominal Pressure (IAP) via bladder pressure measurements and of tracking IAP in neonates who require bladder catheterization. Correlation of IAP measurements with clinical status of the neonatal abdomen will help determine threshold values for Intra-Abdominal Hypertension (IAH) in the neonate.

An increasingly common cause of Multiple Organ Dysfunction Syndrome (MODS) is mechanical injury/ischemia caused by elevated pressures within the abdominal cavity. This phenomenon has been termed intra-abdominal hypertension (IAH) with the final pathway of multiple organ dysfunction and failure termed abdominal compartment syndrome (ACS). In the neonate, IAH is known to accompany omphalocele, gastroschisis and diaphragmatic hernia repair. IAH has also been found to cause a need for neonatal extra corporeal membrane oxygenation (ECMO) and/or a subsequent failure of ECMO treatment.

While abdominal compartment syndrome is the final physiologic and clinically apparent expression of severe elevations of intra-abdominal pressure, earlier in the course of this process, significant organ dysfunction occurs at a sub-clinical level. If mild to moderately elevated abdominal pressure can be detected early, it may allow clinicians to intervene early and reverse the process, preventing progression to ACS and possibly reducing morbidity and mortality.

To date no study has investigated the correlation between bladder pressure (a surrogate measure of IAP) in neonates who may or may not have ACS. Thus, the ranges of normal and elevated IAP are not determined. There is suggestion from pediatric ICU patients that the threshold for IAH in children is less than that in adults. Likewise, the threshold for IAH in neonates may be expected to be even lower, but this remains to be determined.

In this study, IAP (via bladder pressure measurements) will be measured with a commercially available and FDA approved system which utilizes an electronic pressure transducer, tubing, and any bedside patient monitor with pressure measurement inputs. These types of monitors are standard in the NICU. The pressure transducer is attached to the bladder catheter via a two-way valve, allowing urine drainage in-between taking bladder pressure measurements. A small amount of sterile saline is infused into the bladder in order to make the IAP measurement. While there is an indwelling urinary catheter, bladder pressure measurements will be taken every 2-4 hours.

Eligibility Criteria:
Inclusion Criteria:

* Any NICU patient is eligible for enrollment in this study if his/her medical condition has required the placement of a bladder catheter for urine drainage and who does not meet any of the following Exclusion Criteria.

Exclusion Criteria:

* Bladder trauma
* History of recent bladder surgery
* Neurogenic bladder
Multicenter Retrospective Study on Streptobacillus Moniliformis Infections in France

French data on Streptobacillus moniliformis infections (zoonosis transmitted by rat bites) are rare and there are no case series in the literature to date. This is a pathology presenting atypical clinical manifestations for a bacterial infection and which therefore remains underdiagnosed. Streptobacillus moniliformis infections can be fatal without appropriate antibiotic treatment. This study could improve diagnosis, develop early treatment strategies and contribute to the overall understanding of zoonotic diseases


Eligibility Criteria:
Inclusion Criteria:

* Minor patient aged 1 to 17 years
* Adult patient ≥18 years
* Proven Streptobacillus moniliformis infection between 01/01/2007 and 31/12/2023
* Subject not objecting, after being informed, to the reuse of their data for the purposes of this research
* Holders of parental authority not objecting, after being informed, to the reuse of their data for the purposes of this research their child for the purposes of this research

Exclusion Criteria:

* Subject and/or holder of parental authority having expressed opposition to participating in the study
The Influence of Deep TMS on Cerebellar Signs in Patients With Machado Joseph Disease

To test the effects of low frequency deep rTMS using the novel HCERMJD-coil on cerebellar deficits in patients with SCA3 and to establish its safety in this population.

Investigator is anticipate that stimulation of the cerebellum with the novel HCERMJD-coil may induce significantly therapeutic effects in patients with SCA3 and will pave the way for establishing a novel and effective treatment for this disorder.


Eligibility Criteria:
Inclusion Criteria:

* SCA3 patients aged 20 - 80 years, with detectable clinical signs and confirmed genetic diagnosis.

Exclusion Criteria:

1. Patients who have concomitant epilepsy.
2. History of seizure or heat convulsion.
3. Patients on neuroleptics.
4. Patients with dementia (MMSE\<25) or any unstable medical disorder.
5. History or current unstable hypertension.
6. History of head injury or neurosurgical interventions.
7. History of any metal in the head (outside the mouth).
8. Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
9. History of frequent or severe headaches.
10. History of migraine.
11. History of hearing loss.
12. History of cochlear implants
13. History of drug abuse or alcoholism.
14. Pregnancy or not using a reliable method of birth control.
15. Participation in current clinical study or clinical study within 30 days prior to this study.
Implementing Screening and Brief Interventions for Excessive Drinkers in Primary Health Care

The objective of this study is to investigate the efficacy of an implementation program specifically designed to increase alcohol screening and brief intervention rates in primary health care.

Alcohol is an important risk factor for several diseases, even when consumed moderately. Screening and advising at-risk drinkers to cut-down is a highly effective and cost-effective intervention when conducted in primary healthcare settings. However, these interventions are seldom implemented at the primary care level.

Twelve out of the 26 primary health care units of the Dão Lafões Grouping of Primary Health Care Centres will be randomized to two groups: the intervention arm will receive the new implementation program; the control group will be on a waiting list for receiving the implementation program and will receive the intervention after the testing phase of the trial is completed. The study will last for one year, starting in January 2017. The implementation program was designed in order to overcome known barriers for implementing alcohol screening and brief advice in primary health care. The Behaviour Change Wheel and the Theoretical Domains Framework were used to pinpoint the constructs and behaviour change techniques most suited to address the barriers in order to achieve practice changes.

Eligibility Criteria:
Inclusion Criteria:

* Primary health care units of the Dão Lafões Grouping of Primary Health Care Centres (family physicians/general practitioners, family medicine residents, practice nurses and receptionists)

Exclusion Criteria:

* Primary health care units with four or less general practitioners
* Primary health care units that have a specific alcohol program already implemented
Triplenex (triple Fixed Combination) Use Evaluation in Patients with Glaucoma

This project purpose is to evaluate the effectiveness, ocular surface quality, medication adherence and quality of life in 46 glaucoma patients in use of three separate drugs (Bimatoprost 0.3%, Timolol Maleate 0.5% and Brimonidine Tartrate 0.2%) comparing with triple combination, Triplenex. In this clinical trial approved by the Unifesp Etical and Research Comitte, volunteer glaucoma patients will be recruited from Unifesp Glaucoma Sector and VerMais Glaucoma Sector. They will be randomly divided em two groups,Group I is going to be treated with Triplenex (1 drop twice a day) and Grupo II with Brimonidine Tartarate (1 drop twice a day), Timolol Maleate (1 drop twice a day) and Bimatoprost (1 drop at night). At baseline visit a complete ophthalmolgical exam will be performed along with three questionnaires ("Ocular Surface Disease Index", "Glaucoma Treatment Compliance Assessment Tool" and "National Eye Institute Visual Function Questionnaire"),retinography, visual field, optic nerve OCT in all patients. This procedure will be repeated at baseline and within 4, 8, 12 weeks.

This clinical study aims to compare the use of the hypotensive eye drop Triplenex, a fixed triple combination (currently available only in Brazil, Mexico, and Chile), with the globally recognized combination of the same drugs administered separately. The combination of the eye drops Bimatoprost 0.3%, Timolol Maleate 0.5%, and Brimonidine Tartrate 0.2% in separate vials is traditionally used in patients with difficult intraocular pressure control or advanced glaucoma that requires a low target pressure for proper disease management. The fixed triple combination intends to improve patient adherence while maintaining the efficacy of intraocular pressure control and progression of glaucoma. This study arises in the context of a lack of literature comparing Triplenex to the three original drugs and the absence of data on its influence on adherence, ocular surface, and the quality of life in the daily lives of glaucoma patients.

Eligibility Criteria:
Inclusion Criteria:

* patients with diagnosed glaucoma
* above 18 years old
* in use of at least 3 different glaucoma eyedrops classes
* informed consent form granted

Exclusion Criteria:

* secundary glaucoma
* previous ocular surface disease
* previous intraocular surgeries (except cataract)
* previous ocular trauma
* current use of contact lenses use
* current use of steroids or systemic medications that may change ocular surface
* any study's drug intolerance