cyrilzakka/clinical-trials huggingface dataset:
Short-term Perfusion Angiography Pilot Study (SPA)

The Short term Perfusion Angiography (SPA) study is designed to collect 2D Perfusion data from Critical Limb Ischemia (CLI) endovascular (interventional) procedures for information on device performance in a real-world setting.

This clinical study is designed to collect pre and post procedural imaging data using 2D Perfusion (2DP) software in patients receiving an endovascular intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥ 18 years of age.
2. Subject or their legally authorized representative understands the research nature of the study and is willing and capable of providing informed consent
3. Subject has appropriate femoral arterial access
4. Subject presents with a Rutherford classification of 4 to 6.
5. Planned DSA with endovascular intervention below the knee on one or both limbs. This may include patients who undergo:

   1. Above the knee (ATK) and below the knee (BTK) intervention during the same procedure.
   2. Only BTK intervention.
   3. ATK intervention with staged future BTK intervention within 6 weeks of the initial procedure.

Exclusion Criteria:

1. Subjects whose ATK intervention is limited to only the common femoral or iliac arteries
2. Subject is unwilling or unable to comply with the protocol including all follow-up visits
3. Subject with active atrial fibrillation at time of procedure
4. Critical limb ischemia due to acute arterial occlusion.
5. Subject with documented ejection fraction \< 40% and/or prolonged bradycardia (\< 60 beats per minute)
6. Inability to collect toe pressure on index limb from subject
7. Subjects with history of or known reaction or sensitivity to contrast agent that cannot be pre-medicated or any other condition that precludes an endovascular intervention and DSA
8. Female subject of childbearing potential who is pregnant (she must have negative pregnancy test within the 48 hours prior to enrollment), or plans a pregnancy during study period,
9. Subject life expectancy \< 3 months,
10. Subject is participating in a potentially confounding device or drug clinical trial that interferes with this study
11. Investigator considers subject to be a poor candidate for the study or believes that the patient may compromise the study, e.g., concomitant conditions (reasons will be documented) )
Treatment of Cerebral Toxoplasmosis in HIV/AIDS

Neurological manifestations of Cerebral toxoplasmosis or Toxoplasmic encephalitis (TE) in most advance stage HIV infected patients composed of fever, headache, alteration of consciousness with focal neurological signs/symptoms such as include hemiparesis, cranial nerve palsies, and ataxia. Generalised convulsions, in ¾ of patients. Moreover meningeal irritation sign or herniation sign may be presented as life threatening condition

Background: Toxoplasmic encephalitis (TE), caused by Toxoplasma gondii, is common in AIDS patients. TE can result in tissue destruction via massive inflammation and brain abscess formation. METHODS: Randomized controlled trials were performed in AIDS patients to assess which drug regimen was optimally effective for the treatment of TE. AIDS patients with TE were randomly divided into 3 groups that received a 6-week course of either pyrimethamine (50 mg/ day or 100 mg/day) plus sulfadiazine (4 g/day) and folinic acid (25 mg/day) or trimethoprim (10 mg/kg/day) plus sulfamethoxazole (50 mg/kg/day) (TMP-SMX), and results were evaluated with respect to clinical response, mortality, morbidity, and serious adverse events. The primary outcome was defined as death in the first 6-week period. The secondary outcome was successful treatment within 6 weeks without severe adverse events, bone marrow suppression, drug-induced rash, or any other event that caused a change in the treatment regimen. RESULTS: The results from this study showed that in AIDS patients, TE was most successfully treated with the combination of pyrimethamine (50 mg/day) plus sulfadiazidine (4 g/day) and folinic acid (25 mg/day); failure rates were not significantly different among the 3 treatment groups. Conclusions: Available data suggest that of the currently available options, treatment of TE with pyrimethamine at 50 mg/day plus sulfadiazidine at 4 g/day provides the best primary outcome for AIDS patients with TE; however, because this study was terminated prematurely, we suggest that treatment with intravenous TMP-SMX be further evaluated to determine its efficacy.

Eligibility Criteria:
Inclusion Criteria:

* AIDS
* Age \> 16 years
* Clinical Diagnosis of Cerebral toxoplasmosis, Toxoplasmic encephalitis
* Positive serum titer for Toxoplasma gondii or Positive CSF titer for Toxoplasma gondii after treatment within 2 weeks
* CT scan suspected toxoplasmosis, ring enhancing lesion
* CD4\<200

Exclusion Criteria:

* Sulfa drugs allergy
* positive lymphoma cell cytology in CSF
* no informed consent by patients or first degreee relatives
* CD4 \>200
Continuous Positive Airway Pressure Device or Deep Inspiration Breath Hold in Reducing Tumor Motion in Patients Undergoing Stereotactic Body Radiation Therapy for Lung Cancer

This pilot phase I/II trial studies how well a continuous positive airway pressure device or deep inspiration breath hold works in reducing tumor movement in patients undergoing stereotactic body radiation therapy (SBRT) for lung cancer. The continuous positive airway pressure device works by blowing air into the lungs while patients wear a face mask or nozzle to help expand their airways and lungs. Deep inspiration breath hold is a standard technique that uses active breath-holding to restrict movement of the body. Using a continuous positive airway pressure device may work better than deep inspiration breath hold in lowering the amount of tumor movement during stereotactic radiation body therapy.

PRIMARY OBJECTIVES:

I. To compare the two methods of tumor motion management, continuous positive airway pressure (CPAP) and deep inspiration breath hold (DIBH) and to estimate the decrease in tumor motion from free breathing for CPAP and DIBH.

SECONDARY OBJECTIVES:

I. To determine if CPAP is a more time-efficient option for tumor motion management than is DIBH.

Ia. Determine if CPAP is better tolerated by patients than is DIBH. Ib. Determine the reproducibility of lung expansion and tumor motion reduction by CPAP.

Ic. Determine if the dosimetric coverage of the tumor and the sparing of the normal tissues with CPAP is comparable to that with DIBH.

Id. Measure treatment time differences between CPAP and breath hold (DIBH) treatments.

OUTLINE:

Patients undergo free-breathing, DIBH, and CPAP CT simulation scans. If patient has difficulty exhaling on CPAP, then patient undergo biphasic positive airway pressure (BiPAP) CT simulation. The attending physician then compares all 3 simulation treatment plans (free-breathing, DIBH, and CPAP/BiPAP) and determines which method to use during SBRT. If CPAP/BiPAP is chosen as preferred method, patients wear CPAP/BiPAP over 1 hour prior to SBRT, then again during SBRT over 30-60 minutes. All other patients complete free-breathing or DIBH during SBRT over 30-60 minutes.

Eligibility Criteria:
Inclusion Criteria:

* The patient will receive stereotactic body radiotherapy in the Thoracic Radiation Oncolcogy Service at MD Anderson.

Exclusion Criteria:

* The patient has a contra-indication for using a CPAP device.
* The patient has not signed a study-specific informed consent for this study.
* The patient is uncooperative.
* The patient has reduced consciousness.
* The patient has sustained trauma or burns to the face.
* The patient has undergone any facial, esophageal, gastric or sinus surgery within the last 3 months.
* The patient has idiopathic pulmonary fibrosis (IPF) as documented in their medical history.
* Adults who are unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from this study.
Children´s Foot and Footwear Temperatures

This research aims to find thermal differences in foot in a group of children, detecting the most suitable footwear to acquire optimal foot temperature and taking into account that children in school age usually wear sports shoes instead of school shoes in most dimensions of daily life. It is assumed by general population that sports shoes increase sweating and provide less perspiration apart from biomechanical criteria, so for this reason the investigators are going to examine which thermal pattern offers each variety of footwear.

Infrared thermal image allows detecting object´s temperature visually in a non-contact way. That makes the technique useful for different applications like in construction/ building, ecology, industry and medicine. Evolution of thermographic equipments makes it more accessible. It is a non- contact, non- invasive technique that helps researchers monitoring body temperature. So that, it is used to investigate ocular, liver, kidney and brain diseases, dental diagnosis, breast cancer detection or even sports injuries.

It is increasing the use of thermographic imaging in podiatry, so the main trials concerned to diabetes mellitus, vascular disorder or dermatological applications.

Nevertheless, there is little known about children´s foot temperature. Main studies are related to core temperature or variations in temperature among different parts of the body of enfants.

In consequence, the investigators found a lack of information related to such a significant topic, not only for podiatrists, but also for population in general.

Eligibility Criteria:
Inclusion Criteria:

* Healthy 9- 10 years old children

Exclusion Criteria:

* Vascular disease or another pathology that could interfere with thermal pattern of foot
* Wore sports shoes daily
* Used any kind of plantar orthoses, heels...
* Didn´t have correctly singed informed consent
* Wore sandals
* Had a bandaged feet
Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)

The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with hepatic insufficiency and with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

* Adult healthy subjects or adult cirrhosis patients
* Body mass index: \>=18.5 and \<30.0

Exclusion Criteria:

* Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study (except for cirrhosis patients with hepatic diseases)
Patients With Hidradenitis vs Patients With Psoriasis: Psychological Impact

The aim of this study is to evaluate the psychological impact of psoriasis or hidradenitis suppurativa on patients, in order to compare both pathologies.


Eligibility Criteria:
Inclusion Criteria:

* Men and women at least 18 years old at the time of selection.
* Subjects diagnosed with psoriasis or hidradenitis suppurativa
* Subjects who had completed the questionnaires for psychological impact.
* Patients should be able to understand and communicate with the investigator.

Exclusion Criteria:

* Subjects suffering from a serious concomitant illness.
* Subjects with a mental illness.
* Subjects who are performing psychiatric treatment.
* Patients who have alcohol dependence or drug abuse.
* Subjects that present legal incapacity or limited legal capacity.
* Subjects presenting illiteracy or language barriers.
Effects of GABAA Receptor Modulation by AP-325 on Insulin Secretion in Patients with Type 2 Diabetes

The aim of this single-center, prospective, randomized, double-blind, placebo-controlled, 2-arm parallel-group interventional study is to investigate the effect of 4-week treatment with AP-325 on C-peptide release as measure of insulin secretion compared to placebo in type 2 diabetes (T2D) patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T2D
* Age between 25 and 75 years
* HbA1c ≥6.5 and ≤9.5 %
* BMI ≤ 45 kg/m2
* Treatment-naive or stable antihyperglycemic therapy with metformin, α-glucosidase-inhibitor and/or SGLT2 inhibitor
* Ability to give consent

Exclusion Criteria:

* Acute infections (hsCRP \> 5mg/dl, body temperature \>37.5°C)
* Insulin therapy or treatment with sulfonylureas, glinides, GLP-1 receptor agonists, thiazolidinediones; current treatment with DPP-4 inhibitors or during the 4 weeks prior to baseline examination
* Uncontrolled hyperglycemia, e.g. fasting blood glucose \>240 mg/dl
* Heart rate \<50 or \>100 beats per minute; systolic blood pressure \<100 or \>160 mmHg; diastolic blood pressure \<50 or \>100 mmHg; uncontrolled hypertension
* Creatinine clearance \<60 ml/min (eGFR by MDRD formula)
* Severe chronic illnesses, such as congestive heart failure (NYHA III/IV), liver insufficiency (Child-Pugh Class B/C), history of acute coronary syndrome, stroke
* Anemia (Hb \<12 g/l for men, Hb \<11 g/l for women)
* Participation in another intervention study within 2 months before the examination
* Hypersensitivity against AP-325, placebo or other ingredients of IMP
* Immunocompromising diseases
* Immunomodulatory drugs (e.g. oral cortisone preparations, biologicals)
* Thyroid diseases with an unstable metabolic state (change in L-thyroxine dose within the past 6 weeks, TSH and fT4 outside the normal range)
* Planned pregnancy, pregnant or lactating women, positive pregnancy test, and woman of childbearing potential not using two adequate methods of contraception, including a barrier method and a highly efficacious non-barrier method
* Past (≤ 5 years) or current history of psychiatric disorders, including psychiatric depression
* HIV, hepatitis B or C disease
* Previous / current alcohol and / or drug abuse
* Malignant cancer
* BIA and MR-incompatible metal or magnetic implants, devices or objects inside of or on the body, claustrophobia
* Treatment with the following drug groups or agents:

Anticoagulant drugs (exception: acetylsalicylic acid 100 mg/day), dihydropyridines (e.g. nifedipine, amlodipine), azilsartan, losartan and irbesartan, celecoxib; if applicable, other drugs that are predominantly metabolized by CYP2C9

* Inhibitors or inducers of CYP2C9, CYP3A4, such as amiodarone, verapamil, rifampicin
* Poor CYP2C9 metabolizer
A Cognitive Behavioral And Structural HIV Prevention Intervention for Young Ugandan Sex Workers

This study develops and tests a behavioural and structural intervention to prevent unprotected sex among young female sex workers. Half the participants will receive the intervention and half will receive the standard of care.


Eligibility Criteria:
Inclusion Criteria:

* HIV-uninfected women, aged 15-24 years, being sexually active and having engaged in any form of transactional sex at least once in the last 3 months, agreeing to participate in all intervention sessions and to all study procedures and interviews planned over 18 months of follow-up.

Exclusion Criteria:

* presence of any physical or mental condition likely to cause inability to provide consent or hinder study participation; HIV infection
Neuromodulation and Language Acquisition (Stage Ib)

The purpose of this study is to determine whether rivastigmine or pramipexol are effective in boosting semantic language acquisition in healthy subjects.

Our prior work shows that d-amphetamine and the dopamine precursor levodopa markedly improve word learning success in healthy subjects. In this randomized, placebo-controlled, double-blind clinical trial, we probe whether a selective d2/d3 dopamine agonist (pramipexole) or cholinergic neuromodulation (rivastigmine), after a titration period of five days, will yield a learning enhancement comparable to using levodopa in healthy subjects. The expected scientific results will strengthen the basis for transferring neuromodulatory interventions from the laboratory to stroke patients with language dysfunctions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* 20-35 years old
* Right handedness
* Left language dominance (as assessed by functional transcranial Doppler ultrasonography \[fTCD\])

Exclusion Criteria:

* Neurological/psychiatric/metabolic/cardiac disorders
* Asthma
* Known allergic reactions to one of the experimental drugs
* Other drugs affecting the central nervous system
* Leisure drug ingestion during the past 4 weeks (urine test)
* Smoking cessation during the past 2 weeks
* \> 6 cups of coffee or energy drinks per day
* \> 10 cigarettes per day
* \> 50 grams of alcohol per day
A Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in Healthy Participants

The primary purpose of this study is to evaluate the pharmacokinetics (PK) of SPR720, azithromycin, and ethambutol, administered separately and co-administered, in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between ≥18.0 and ≤32.0 kilograms per meter square (kg/m\^2) and weight between 50.0 and 100.0 kilograms (kg) (inclusive) at the Screening visit.
* Medically healthy without clinically significant medical history, abnormalities in physical examination, laboratory tests, vital signs, or electrocardiogram (ECG) at the Screening visit.
* Has suitable venous access for repeated blood sampling.
* Has ability and willingness to abstain from alcohol, caffeine, xanthine-containing beverages or food (coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) or products containing any of these from 48 hours prior to study drug administration until discharge from the clinical research unit (CRU).

Exclusion Criteria:

* Has a history of clinically significant acute illness or surgery within the previous 3 months prior to Screening Visit or Day -1.
* Has a known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication.
* Has any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract \[including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas\]). History of uncomplicated appendectomy ≥1 year prior to Screening Visit would not be considered exclusionary at the discretion of the Investigator.
* Is unable to swallow the dosage forms.
* Has received any other investigational medicinal product or participation in another investigational clinical study that included drug treatment within 30 days prior to Day 1 dose (based on the timing of the last Follow-up Visit for the previous study to Day 1 of the current study).

\[Note: Other inclusion and exclusion criteria as per protocol may apply.\]
Cardiac Autonomic Reactivity and Behavioral Response to Pain in Full-Term Neonates

Background: Heel lancing is a routine procedure for the diagnosis of phenylketonuria in infants. Despite the short- and long-term adverse effects of pain, there are no guidelines for the reduction of such pain. Previous studies evaluated different treatment modalities; however, in most of them, pain response was assessed by subjective measures.

Aims of study: 1. To characterize the pain response of infants by using a computerized analysis of the ECG. 2. To compare six different methods of pain reduction during heel lancing in newborns.

Methods: The time, geometric and frequency domains of the infants' ECG will be computed during heel lancing. 150 healthy full-term infants will be evaluated in six treatment groups: breastfeeding, bottle feeding, skin-to-skin contact, lying on a table without anything, lying with a pacifier and lying while getting a glucose solution. The differences in pain response to these six treatment modalities will be assessed and compared to the infants' length of cry, and scoring of the infants' behavioral response.


Eligibility Criteria:
Inclusion Criteria:

* normal full-term newborns (\>38 weeks)
* Apgar score \>=8 at five minutes after delivery.

Exclusion Criteria:

* congenital anomalies
* medical complications
* need for oxygen administration
Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice

In a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. Based on the results of that study, this formulation is currently in a phase III study for that population.

The current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed active head lice infestation
* Parent or guardian must be able to apply treatment

Exclusion Criteria:

* Allergy to pediculicides or hair care products
* Scalp conditions other than head lice
* Previous head lice treatment within the past 4 weeks
* Current antibiotic treatment
Study of COR388 HCl in Healthy Subjects

The study is a randomized, double-blind, placebo-controlled, dose escalation, first-in-human trial of the safety and tolerability of COR388 HCl in healthy male and female subjects.


Eligibility Criteria:
Major Inclusion Criteria:

1. Males of reproductive potential must agree to use double-barrier contraceptive measures or avoid intercourse from Day -1 through 28 days after the dose of study drug;
2. Females of child-bearing potential must be non-lactating, have negative serum pregnancy test results at screening visit and Day 1; agree to use double-barrier contraceptive measures or avoid intercourse from Day -10 through 28 days after the dose of study drug;
3. Body mass index (BMI) ≥19 to ≤32 kg/m2;
4. Good health as determined by the absence of clinically significant deviation from normal, by medical history, physical examination, laboratory reports, and 12-lead electrocardiogram (ECG) prior to enrollment;
5. Non-smoker and non-tobacco user for a minimum of 3 months prior to screening and for the duration of the study;
6. Able to understand and willing to comply with all study requirements, and follow the study medication regimen.

Major Exclusion Criteria:

1. History or current evidence of cardiac, hepatic, renal, pulmonary, endocrine, neurologic, gastrointestinal, hematologic, oncologic, infectious, or psychiatric disease as determined by screening history, physical examination, laboratory reports, or 12-lead ECG;
2. Need for any concomitant medication (with the exception of hormonal contraceptives as allowed for females of child-bearing potential);
3. Use of any prescription drug within 14 days prior to the first dose of the study (with the exception of hormonal contraceptives for females of childbearing potential);
4. Use of any non-prescription drug and/or herbal supplements within 7 days prior to the first dose of the study;
5. History of significant allergic reaction to any drug;
6. Participation in another investigational new drug research study within the 30 days prior to the first dose of the study;
7. History of alcohol or drug abuse or dependence within 12 months of screening as determined by the Investigator;
8. Positive urine screen for prohibited drugs or positive alcohol screen on Day -1.