cyrilzakka/clinical-trials huggingface dataset:
Treatment of Olfactory Dysfunction Using Vagus Nerve Stimulation

Hyposmia, a reduced sense of smell, is commonly linked to viral infections like COVID-19. Currently, the sole recommended treatment is olfactory training, a method that is both time-intensive and limited in its effectiveness. Our team has previously evaluated a new type of olfactory training using nasal inserts that show increased adherence to training (compared to standard olfactory training using common household odors) but with similar treatment effect. The investigators recently demonstrated that brief transcutaneous vagus nerve stimulation (VNS) in the cymba conchae region affected participants olfactory abilities but only when a stimulation frequency relevant to olfactory bulb processing frequencies was used. The notion that VNS might modulate olfactory functions stems from findings in rats where VNS of the cervical nerve inhibited neurons within the periglomerular layers of the olfactory bulb. Although there is no known monosynaptic connection between the vagus nerve and the olfactory system in humans, VNS activates areas with mono-synaptic connections to the olfactory bulb, such as amygdala, hippocampus, and the hypothalamus. Given that VNS modulates the olfactory bulb in rats and our treatment protocol modulate olfactory functions in humans, the investigators hypothesize that VNS, when paired with olfactory training, will enhance olfactory functions in patients with hyposmia.

Participants with hyposmia will be recruited and randomly assigned to one of two treatment groups. One group will engage in olfactory training using nasal inserts while the other will use olfactory training with nasal inserts along with VNS. Both interventions will take place at home, Monday through Friday, over a two-month period. To evaluate the outcomes, subjective and objective measures of olfactory function will be collected before, during, and after the treatment, along with assessments of quality of life and overall well-being. Treatment adherence will also be evaluated at the end of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Correct age (18-65)
* Physically and cognitively capable of participating in the study
* Having appropriate olfactory screening test scores (hyposmic)

Exclusion Criteria:

* History of heart conditions
* Individuals with other diagnoses that could affect the study results
Neuromodulation of the Fear Extinction Circuit Using Temporally and Anatomically Specific TMS in Humans

This study aims to explore the mechanisms of how transcranial magnetic stimulation (TMS) impacts fear circuits. The overarching objectives are to understand how varying TMS parameters affect targeted brain regions in order to optimize its impact on enhancing fear extinction memory consolidation in a population with known fear extinction deficiencies: post-traumatic stress disorder (PTSD). 250 subjects will take part in this research study across UTHealth Houston. The study will include preliminary screenings, baseline visits, and experimental visits across four days

The experiments proposed are aimed to understand how timing and location of transcranial magnetic stimulation (TMS) in humans will impact their ability to reduce conditioned fear responses and impact the activation of their brain regions involved in fear regulation. The researchers will use a novel TMS approach to vary timing and location of its delivery so that the researchers can characterize and establish best time and location to obtain optimal impact on fear inhibition, and then test these parameters in PTSD patients and see if such can rescue extinction deficits in PTSD. The anticipated impact is to enhance our understanding of the neural mechanisms of associated with TMS use and explore potential novel approaches for advancing PTSD treatment.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent.
* Inclusion Criteria for PTSD Subjects - Diagnosis of current PTSD
* Inclusion Criteria: Healthy Controls (HC) - no current psychiatric disorders ("Axis I" disorders)

Exclusion Criteria:

* Lifetime history of seizure or significant head trauma or other significant neurologic disease (e.g., tic disorder)
* History of serious/significant psychiatric diagnoses ("Axis I" diagnoses)
* Current significant suicidal ideation, plan or intent or suicidal behavior in past 6 months based on CSSRS and clinical judgment or Self-injurious behavior that involves suicidal intent, requires medical attention, or occurs daily
* Use of neuroleptics within one year prior to study
* Current substance use
* Pregnancy (to be ruled out by urine β-HCG).
* Metallic implants or devices contraindicating magnetic resonance imaging.
* Currently taking medications that lower the seizure threshold. These include antipsychotics, high dose theophylline or stimulants such as methylphenidate. Patients taking bupropion must be on a stable dose (\*last 3 months) and take less than or equal to 300 mg/day.
* Implanted devices in subject's head (shunts, cochlear implants); metal in subject's head (other than dental implants).
* High risk of adverse emotional or behavioral reaction, and/or an inability to understand study procedures or the informed consent process
* Additional exclusion criteria for Healthy controls (HC) group: Current psychiatric diagnosis ("Axis I" diagnosis)
Team Based Psychosocial Care to Promote, Maintain and Restore Wellness of Breast Cancer Patients

Researchers are trying to see if proactive identification and team based individualized care of cancer patients having emotional difficulties can improve quality of life relative to treatment as usual. Also, to see if proactive approaches to maintain wellness can prevent grief among breast cancer patients, experiencing no emotional difficulties relative to treatment as usual.

Consented subjects will be randomized into two separate groups. Groups will be distressed and non-distressed subjects. Each group will be randomized into either intervention education training or standard of care. Both groups will be asked to fill out questionnaires during the duration of the study. Subjects will be remain in the study for up to one year.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of breast cancer within last three years
* Able to communicate in English or with the help of an interpreter.
* Access to a device with internet connection

Exclusion Criteria:

* Breast cancer patients who are considered for hospice or expected survival of less than six months.
* Presence of active suicidal ideations.
* Presence of active psychosis.
* Presence of dementia
Characteristics of COVID-19 Patients in Kazakhstan in Early 2020

The aim of this study is to assess the epidemiological and clinical features of patients diagnosed with COVID-19 in Kazakhstan at the onset of the pandemic.

There is a paucity of data available on the epidemiological and clinical characteristics of coronavirus disease 2019 (COVID-19) in Kazakhstan. While a global effort in search for effective treatments and vaccines against COVID-19 is in effect, it is important that high quality and up-to-date information be available from a broad variety of populations on the dynamics of infection. This is especially important in regions where, due to resource shortage, epidemiologic surveillance may have gaps. To address the current gaps, medical records will be obtained for patients with confirmed COVID-19 during the first months of the pandemic (February-April 2020). The epidemiologic and clinical features including the demographics, clinical manifestation, laboratory parameters, radiologic assessments and clinical outcomes will be analyzed. The results of this study will facilitate the clinical management of COVID-19 patients in Kazakhstan and ultimately inform the ongoing efforts to curb the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the region.

Eligibility Criteria:
Inclusion Criteria:

* Laboratory confirmation of SARS-CoV-2 infection by polymerase chain reaction.
Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by ANP

To evaluate whether ANP as an adjunctive therapy for AMI reduces myocardial infarct size and improves regional wall motion.

The benefits of percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI) are limited by reperfusion injury. In animal models, atrial natriuretic peptide (ANP) reduces infarct size, so the Japan-Working groups of acute myocardial Infarction for the reduction of Necrotic Damage by ANP(J-WINDANP) designed a prospective, randomized, multicenter study, to evaluate whether ANP as an adjunctive therapy for AMI reduces myocardial infarct size and improves regional wall motion.

Twenty hospitals in Japan will participate in the J-WIND-ANP study. Patients with AMI who are candidates for PCI are randomly allocated to receive either intravenous ANP or placebo administration. The primary end-points are (1) estimated infarct size (Σcreatine kinase and troponin T) and (2) left ventricular function (left ventriculograms). Single nucleotide polymorphisms (SNPs) that may be associated with the function of ANP and susceptibility of AMI will be examined. Furthermore, a data mining method will be used to design the optimal combinational therapy for post-MI patients.

J-WIND-ANP will provide important data on the effects of ANP as an adjunct to PCI for AMI and the SNPs information will open the field of tailor-made therapy. The optimal therapeutic drug combination will also be determined for post-MI patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age 20-79 years
2. Chest pain of more than 30 min
3. 0.1 mV ST-segment elevation in 2 contiguous ECG leads
4. Admission to hospital within 12 h of symptom onset
5. First episode of AMI
6. Candidates for PCI

Exclusion Criteria:

1. History of old myocardial infarction
2. Left main coronary artery stenosis
3. Severe liver and/or kidney dysfunction
4. Suspected aortic dissection
5. History of coronary artery bypass graft
6. History of allergic response to drugs
7. Severe hypovolemia
8. Right ventricular infarction
Study of Sitravatinib, Nivolumab and Ipilimumab in Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies

Study 516-008 is an open-label Phase 1 dose escalation/Phase 1b dose expansion study evaluating the safety and tolerability, clinical activity, and PK of sitravatinib in combination with nivolumab and ipilimumab for the treatment of ccRCC and potentially other solid tumor types.

Sitravatinib is a spectrum-selective receptor tyrosine kinase (RTK) inhibitor that inhibits several closely related RTKs including the TAM family (Tyro3/Axl/MERTK), VEGFR2, KIT, and MET.

NIVO/IPI are monoclonal antibodies (mAbs) that inhibit the immune checkpoint proteins programmed death receptor-1 (PD-1) and cytotoxic T- lymphocyte antigen-4 (CTLA-4), respectively.

The current study is designed to evaluate the triple combination of sitravatinib plus NIVO/IPI in patients with solid tumor malignancies that have shown favorable responses to NIVO/IPI combinations in previous clinical trials. Combining sitravatinib and NIVO/IPI is predicted to have complementary effects in triggering a tumor-directed immune response.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Clear-Cell Renal Cell Carcinoma (for initial cohorts under consideration)
* No prior treatment with systemic therapy (for initial cohorts under consideration)
* Adequate bone marrow and organ function

Exclusion Criteria:

* Known or suspected presence of other cancer
* Brain metastases (for initial cohorts under consideration)
* Carcinomatous meningitis
* Immunocompromising conditions
* Impaired heart function
* Active or prior documented autoimmune disease
Once-daily Highly Active Antiretroviral Treatment Regimen Administration in HIV-1 Infected Children in Burkina Faso (ANRS 12103 BURKINAME)

The purpose of this study is to try a known antiretroviral combination in HIV- infected children with only one intake a day, in order to simplify the prescription and improve adherence to treatment. This is what is called a phase II clinical trial, only recruiting and following a small number of children (50) during one year to evaluate the quantity of drug in the blood just before it is taken and one to three hours after it is taken. The other important objective is to study the tolerance of drugs in that mode of prescription of the triple combination.

The data relating to pharmacology tolerance and efficacy of the once-daily combination of 3TC + ddI + EFV have never been studied.

This regimen may lead to a better treatment of the HIV-1 infected children in developing countries, as well as in Europe. Because of its simplicity it would facilitate observance that is one of the essential parameters of efficacy of treatments.

The main objectives are those of a phase II clinical trial:

* Assess the virological and immunological efficacy of a once daily HAART regimen comprising lamivudine (3TC) + didanosine (ddI) + efavirenz (EFV) \[pediatric reference\];
* Analyse the pharmacological characteristics of this combination in children;
* Assess the tolerance;
* Study the appearance of resistance;
* Evaluate the observance to treatment.

  50 HIV-1 infected children aged 30 months to 15 years whose clinical and immunological state (stage B or C) requires antiretroviral treatment, will be included in the study. They should be naive of any ARV treatment (except the treatment received in the framework of PMTCT (Prevention of Mother to Child Transmission).

Data Collection and Development of the Study:

* Monthly clinical examination;
* RNA HIV-1 and CD4 counts;
* Pharmacological dosages;
* Haematology and biochemistry surveillance;
* Genotypic resistance at inclusion; and, in case of unsuccess or failure,
* Assessment of observance according to alternate methods.

Laboratory examinations will be carried out at Centre Muraz except for genotyping and for pharmacological tests sent to Montpellier Teaching Hospital (France).

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected children
* Weight over 12 kgs
* Age over 30 months
* Clinical stage requiring HAART
* Naive to antiretroviral treatment (except PMTCT prophylaxis)
* Mother's or tutor's informed consent signed

Exclusion Criteria:

* HIV-2 or dual HIV infection
* Previous antiretroviral therapy
* Children unable to swallow pills
* Known resistance to non-nucleoside reverse transcriptase inhibitor (NNRTI)
Endogenous Glucoseproduction in Patients With Type 2 Diabetes Mellitus During Oral Glucose and iv. Glucose Infusion

We want to investigate how lack of glucagon suppression during an oral glucose tolerance test in patients with type 2 diabetes contributes to patients postprandial hyperglycemia.

Patients with type 2 diabetes mellitus (T2DM) are not able to suppress their glucagon secretion after a meal or after ingestion of glucose. Previous studies have shown that gastrointestinal hormones might play a role in this phenomenon. However, it has not yet been possible to determine whether this lack of glucagon suppression postprandially results in an increased endogenous glucose secretion, and thus is a factor in the patients postprandial hyperglycemia.

We aim to perform oral glucose tolerance tests and isoglycemic intravenous glucose infusions with and without a continuous glucagon infusion in patients with T2DM and healthy control subjects. The glucagon infusion is aiming at copying the inappropriate "physiological" glucagon response observed in patients with T2DM.

Eligibility Criteria:
Inclusion Criteria:

Patients with T2DM

* Caucasions above 35 years of age with diet and/or tablettreated T2DM of at -least three months (diagnosis acording to WHO)
* Normal haemoglobin
* Informed consent

Healthy Subjects

* Normal fasting plasma glucose (FPG) and normal HbA1C (according to the -World Health Organization (WHO) criteria)
* Normal haemoglobin
* Age above 35 years
* Informed consent

Exclusion Criteria:

* Inflammatory bowel disease
* Nephropathy (serum creatinine \>150 µM and/or albuminuria)
* Severe liver disease (serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) \>3×normal values)
* Pregnancy and/or breastfeeding
* Age above 80 years
* Any condition that the investigator feels would interfere with trial participation

Patients with T2DM

Healthy Subjects

* Diabetes mellitus (DM)
* Prediabetes (impaired glucose tolerance and/or impaired FPG)
* First degree relatives with DM
* Inflammatory bowel disease
* Intestinal resection and/or ostomy
* Nephropathy (serum creatinine \>150 µM and/or albuminuria
* Liver disease (ALAT and/or serum ASAT \>2×normal values)
* Pregnancy and/or breastfeeding
* Age above 80 years
* Any condition that the investigator feels would interfere with trial participation
Comparison of Simultaneous Endotracheal Tube Insertion With GlideScope Use

Patients presenting for elective surgery requiring orotracheal intubation will be randomized to having the ETT inserted into the pharynx simultaneous to GlideScope insertion and then having the ETT advanced under GlideScope guidance into the trachea, or, being intubated in the more common fashion with the GlideScope being inserted first and having the ETT then advanced via the pharynx into the trachea.

Patients presenting for elective surgery requiring orotracheal intubation will be randomized to having the ETT inserted into the pharynx simultaneous to GlideScope insertion and then having the ETT advanced under GlideScope guidance into the trachea, or, being intubated in the more common fashion with the GlideScope being inserted first and having the ETT then advanced via the pharynx into the trachea. The primary outcome is time to intubation. Secondary outcomes include: 1) Ease of intubation as noted by operator (measured on a 10-cm Visual Analogue Scale) 2) Number of intubation attempts 3) Number of failures to intubate 4) Use of external laryngeal pressure 5) Laryngoscopic grade distribution

Eligibility Criteria:
Inclusion Criteria:

1) Adult patient booked for elective surgery requiring orotracheal intubation

Exclusion Criteria:

1. Any patient in whom the use of the GlideScope is contraindicated in the opinion of the attending anesthesiologist.
2. Any patient with cervical spine abnormalities.
3. Any patients with known or probable difficult airways.
4. Any patient requiring rapid sequence induction.
A Multiple Dose Study To Determine Safety, Tolerability, and Pharmacokinetics Of PF-04634817 In Healthy Adult Subjects

The goals of this study are to evaluate the safety and tolerability of multiple ascending doses of PF-04634817 administered orally to healthy adult subjects. In additional, the plasma and urinary pharmacokinetics of multiple ascending doses of PF-04634817 administered orally to healthy adult subjects will be evaluated. Finally, the effect of multiple doses of PF-04634817 on circulating monocytes will be explored.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female (of non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
* Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication;
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day;
* Nursing females;
* Females of childbearing potential.
Monotherapy Versus Placebo Over 10 Days in Integrase Naive HIV-1 Infected Adults

To investigate safety, tolerability and anti-viral activity in Integrase-Naïve HIV-1 infected adults


Eligibility Criteria:
Inclusion criteria:

* Documented HIV-1 infection with screening viral load between 5000 and 300,000 copies/mL.
* Baseline CD4 cell count greater than 100.
* Females must be of non-childbearing potential
* Not have received antiretroviral therapy in the 12 weeks prior to first dose.

Exclusion criteria:

* Must not be infected with hepatitis B or C.
* Patients must not have any acute laboratory abnormality.
* Must not have any active CDC (Centers for Disease Control and Prevention)Category C disease (1993), except cutaneous Kaposi's sarcoma not requiring systemic therapy during the trial.
Silent Ureteral Stone: Impact on Renal Function and Kidney Anatomy

Ureteral stones may be silent in 5.3% of patients. The goal of this study was to prospectively evaluate the impact of a silent ureteral stone on renal function.

The prevalence of nephrolithiasis is increasing worldwide, reaching 5.2% in North America and 10.1% in Italy. The widespread use of computed tomography and ultrasonography have resulted in a greater detection rate of asymptomatic stones and, in part, might explain the trend. Clinically, kidney or ureteral stones range in severity from asymptomatic to presenting with complete renal failure. Therefore, it is not only the alarming incidence of urinary stone disease, but also the associated burden that makes this one of the most concerning conditions in public health.

The situation becomes even more distressing when managing asymptomatic stones. Studies of the natural history of stones have revealed that only 20% of patients yearly actually become symptomatic from a new stone, and one half of those require surgical intervention at some point. The guidelines are well established for the treatment of symptomatic urolithiasis, and many investigators have extensively studied the management of silent kidney stones. Conversely, the same is not true for silent ureterolithiasis. The purpose of the present study is to report the investigators experience managing silent ureteral stones and to prospectively analyze their true influence on renal function.

Eligibility Criteria:
Inclusion Criteria:

* Silent ureteral stone: no subjective/objective symptoms related to the ureteral calculi.
* Patient willing to participate in the study
* Complete pre/post-operative work-up

Exclusion Criteria:

* Treatment outside our institution
* No will to be a part of the study
* Incomplete pre/post-operative work-up
Sulfamethoxazole for the Treatment of Primary PREPL Deficiency

The investigators will evaluate whether sulfamethoxazole, a sulfamide antibiotic, improves the symptoms of primary PREPL deficiency (hypotonia-cystinuria syndrome and isolated PREPL deficiency).


Eligibility Criteria:
Inclusion Criteria:

* patients with molecular confirmation of primary PREPL deficiency
* who are able to follow the study protocol (for the primary endpoint)
* who have given written informed consent

Exclusion Criteria:

* age\<2m
* women of child-bearing age unless using a reliable method for contraception and not pregnant at study entrance
* additional diagnosis with influence on muscle force
* not able to follow the study protocol (for the primary endpoint)
* history of sulfonamide hypersensitivity
* diminished renal function based on serum creatinine
* transaminases higher than 3 times the upper limit of normal
* for the pupillometry: eye pathology with the exception of refractive errors, drugs with influence on the pupillary light reflex