cyrilzakka/clinical-trials huggingface dataset:
Analysis of Ocular Complications of AIDS Patients in Ophthalmic Consultation

Through a cross-sectional descriptive analysis of ophthalmic consultation of AIDS patients in the past 3 years, the basic characteristics of patients were described according to whether there was fundus change, and the clinical characteristics and risk factors of CMVR patients with or without RD were compared.

Patients were divided into normal group, opportunistic infection group, microangiopathopathy group and uveitis group according to the presence of fundus lesions and the types of fundus lesions. The basic information and characteristics of patients in different groups were described. The factors that may be related to ocular fundus disease of AIDS patients were found by statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* AIDS inpatient undergoing ophthalmic consultation

Exclusion Criteria:

* Non-hiv infected patients
Levetiracetam or Pregabalin in Treating Seizures in Patients Undergoing Chemotherapy and/or Radiation Therapy For Primary Brain Tumors

RATIONALE: Levetiracetam and pregabalin are drugs that treat seizures. It is not yet known which drug is more effective in treating seizures caused by primary brain tumors.

PURPOSE: This randomized phase II trial is studying the side effects and how well levetiracetam or pregabalin work in treating seizures in patients undergoing chemotherapy and/or radiation therapy for primary brain tumors.

OBJECTIVES:

* To determine the safety and efficacy of antiepileptic drug monotherapy comprising levetiracetam or pregabalin in treating seizures in patients undergoing chemotherapy and/or radiotherapy for primary brain tumors.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive levetiracetam.
* Arm II: Patients receive pregabalin. Patients are followed at 2 weeks, 2 months, 6 months, and then at 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of primary brain tumor

  * WHO grade II-IV disease
* Undergoing chemotherapy and/or radiotherapy
* No brain tumor without the potential need for chemotherapy (e.g., meningioma without anaplastic features)
* Has had at least one seizure provoked by the brain tumor, justifying introduction of antiepileptic drug (AED) treatment

  * No status epilepticus

PATIENT CHARACTERISTICS:

* Modified Rankin score \< 4 at study enrollment
* Life expectancy ≥ 4 weeks
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known intolerance to the study drugs
* No pre-existing psychosis and/or current suicidality

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent IV AEDs other than benzodiazepines
* Other concurrent AEDs, except phenobarbital, allowed provided they are discontinued within 2 weeks after study enrollment
PET Study to Determine the Relationship Between Plasma Concentrations and Muscarinic Type 1 Receptor (M1AChR) Occupancy of PIPE-307 in Healthy Volunteers

This is a Phase 1, single-center, open-label, adaptive-design PET study to investigate the occupancy of brain muscarinic Type 1 receptors (M1AChR) by PIPE-307 in healthy volunteers.

This is a Phase 1, single-center, open-label, adaptive-design study to investigate the occupancy of brain M1AChR after a single oral dose of PIPE-307 in healthy volunteers by positron emission tomography (PET) using the radioligand \[11C\] PIPE-307.

This study will have an adaptive design to adequately evaluate the relationship between PIPE-307 exposure and brain M1AChR occupancy.

Eligibility Criteria:
Key Criteria:

* Normotensive male or female volunteers between 25-65 years old
* Deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine

Key Exclusion Criteria:

* Clinically relevant abnormal findings at the screening assessments
* Clinically relevant abnormal medical history or concurrent medical condition
* Acute or chronic illness
* Contraindications to MRI, CT, PET, or arterial cannulation procedures
* Significant exposure to research related radiation or other exposure (defined as ICRP category IIb or no more than 10 mSv)
* Positive tests for hepatitis B surface antigen (HBsAg) \& Hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody
* Drug or alcohol abuse
* Smoke more than 10 cigarettes daily
* Loss of more than 400 mL blood
* Vital signs or ECGs outside the acceptable range
A Comparison of Two Different Methods to Reduce Intramusculer Injection Pain

When the literature is reviewed, there are few studies evaluating cold spray or ShotBlocker in reducing pain associated with IM injection. Studies have shown that these applications are mostly used in children during vaccination or intravenous interventions. These methods are less commonly used on adults. Both methods without side effects are important in terms of being cheap, easy to use and reusable. As a result of the researches, these methods can provide a more comfortable injection experience and provide evidence for pain management, especially in adults sensitive to pain.

The aim of the study is to use it to reduce pain associated with IM injection in adults.

To evaluate the effect of cold spray and ShotBlocker applications on pain.

When the literature is reviewed, there are few studies evaluating cold spray or ShotBlocker in reducing pain associated with IM injection. Studies have shown that these applications are mostly used in children during vaccination or intravenous interventions. These methods are less commonly used on adults. Both methods without side effects are important in terms of being cheap, easy to use and reusable. As a result of the researches, these methods can provide a more comfortable injection experience and provide evidence for pain management, especially in adults sensitive to pain.

The aim of the study is to use it to reduce pain associated with IM injection in adults.

To evaluate the effect of cold spray and ShotBlocker applications on pain. In this study, it was used to reduce pain associated with IM injection in adults.

It was aimed to evaluate the effect of ShotBlocker and cold spray application on pain. The research is planned to be completed between February 2020 and December 2020. The universe of the study, which was conducted as a randomized controlled trial model, consisted of all adult patients who received diclofenac sodium treatment in Malatya Turgut Özal Medical Center Emergency Service. 195 patients selected by the simple random sampling method (shotBlocker group = 39, shotBlocker placebo = 39 spray groups = 39, spray group placebo = 39, control group = 39) were included in the study. Participant Introduction Form and Visual Benchmarking Scale (VAS) were used to collect data. According to the characteristics of the data In independent groups, t test, ANOVA test, Mann Whitney U test, correlation were measured.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years or older
* Communication,
* Having no problems with vision and hearing,
* No pain, scar tissue, incision, lipodystrophy and signs of infection in the application area,
* Body mass index between 18.5 and 30,
* There is no history of allergy.

Exclusion Criteria:

-
Amyloid Beta-peptide 1-40 and Alzheimer's Disease

The combined measurement of Ab42 and tau protein (total and phosphorylated) in the spinal fluid has been shown to be promising in the diagnosis of Alzheimer's disease (AD), and has justified its inclusion new diagnostic criteria. However, it can sometimes yield discordant results that are not discriminant (isolated variation in Ab42 or P-181 Tau). To answer this challenge, a new marker has been developed in recent years, namely amyloid beta-peptide 1-40 (Aβ40). This marker reflects the patient's total amyloid deposits and is used to calculate the Aβ42/Aβ40 ratio. This ratio measures the relative variation of Aβ42 as compared to the total amyloid burden. Literature data on this topic are sparse and to date, no report has been published evaluating the utility of this marker in the diagnostic strategy for AD.


Eligibility Criteria:
Inclusion Criteria:

* Patients attending the Memory Clinic of Champagne-Ardennes for memory disorders, and
* Whose diagnostic work-up requires assessment of biomarkers present in the cerebrospinal fluid are considered eligible for inclusion in this study.

Exclusion Criteria:

* Patients who do not have any social security coverage will not be included.
Effect of Clear Aligner Attachment Size on Extrusion of Maxillary Lateral Incisors

Orthodontic treatment has been revolutionized by clear aligner therapy, offering patients a more esthetic and comfortable alternative to traditional braces. In 1999, Align Technology introduced Invisalign. As Invisalign has increased in popularity and demand over the past two decades, clinical trials have shed light on the efficacy of Invisalign treatment. there have been changes in the Invisalign protocol such as introduction of SmartForce features in 2008, such as optimized attachments as well as the implementation of SmartTrack aligner material in 2011. Compared to conventional fixed orthodontic appliances, Invisalign cannot be adjusted on a visit-to visit basis. If ideal tooth movement has not been achieved after completion of the first sequence of aligners, additional trays, known as refinement trays, are required.

There are various expert theories regarding the most effective methods of extrusion and multiple studies performed in vitro to evaluate the efficacy of different attachment types on the extrusion of lateral incisors, however only one in vivo clinical trial exists. There is a need for more randomized clinical trials that evaluate the effectiveness of different attachment designs for achieving optimal extrusion of lateral incisors. By determining the most effective attachment size for maxillary lateral incisor extrusion, this study can help improve treatment outcomes for orthodontic treatment with clear aligners and serve as a guide to assist clinicians in selecting the most effective attachment design.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with either Comprehensive Invisalign or Invisalign Teen treatment
* The maxillary arch has less than 6 mm of crowding or spacing
* Maxillary lateral incisors have a minimum of 0.3 mm of extrusion prescribed in the Tooth Movement Table on the Invisalign ClinCheck for the first set of aligners
* Maxillary lateral incisors within a normal range of bucco-lingual inclination
* Patients 12 years of age or older and either the patient or legal guardian are able to give consent
* Patients confirm good compliance throughout the study period

Exclusion Criteria:

* Patients do not complete all aligners in the first phase as prescribed
* Poor compliance recorded for aligner wear
* Restorations placed or oral surgery completed prior to final scan
* Midcourse intervention to improve tracking such as a bootstrap
* Maxillary lateral incisors not tracking and noted by minimum of 1 mm of aligner material incisally displaced when aligner fully seated
* Treatment plans include surgery or extractions
* Maxillary lateral incisors with pathology and restorations
* Missing teeth other than third molars
* Patients with anterior crossbite
ImpRovEd Care After eSophageCtomy Using an Algorithm for postoperativE Complications - RESCUE Trial

The objective of the RESCUE-trial is to investigate whether implementation of a consensus-based clinical care algorithm to standardize diagnosis and management of postoperative complications reduces 90-day mortality, ICU (re)admission and surgical interventions after esophagectomy for esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

1. Age ≥ 18 years
2. Histologically proven esophageal or gastro-esophageal junction carcinoma (cT1-4aN0-3M0)
3. Scheduled to undergo curatively-intended esophagectomy with gastric tube reconstruction. All techniques (i.e. minimally invasive, robotic, hybrid, open) and approaches (i.e. transthoracic, transcervical, transhiatal) of esophagectomy are suitable for inclusion.
4. Ability to provide written informed consent

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

1. Emergency resection
2. Patients who underwent (additional) total gastrectomy
3. Patients who underwent reconstruction using colonic or jejunal interposition
4. Patients in whom no anastomosis is created during resection
5. Secondary malignancy which determines prognosis
Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer

The main objective of this study is to evaluate the safety and tolerability of xaluritamig monotherapy in adult participants with high-risk biochemical recurrent (BCR) nonmetastatic castration-sensitive prostate cancer (nmCSPC).


Eligibility Criteria:
Inclusion Criteria

* Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features.
* Prostate cancer initially treated by radical prostatectomy (RP) or radiotherapy (XRT) (including brachytherapy) or both (eg, salvage radiotherapy), with curative intent.
* PSA doubling time ≤ 12 months.
* Participants must have biochemically recurrent disease after definitive treatment to prostate by either RP or XRT.
* Screening PSA by the local laboratory ≥ 0.2 ng/mL for participants who had RP (with or without XRT) as primary treatment for prostate cancer or at least 2 ng/mL above the nadir (local assessments) for participants who had XRT or brachytherapy only as primary treatment for prostate cancer.
* Serum testosterone ≥ 150 ng/dL (5.2 nmol/L).
* Participants must have undergone a 68Ga-PSMA-11 or a piflufolastat F18 PET scan during or within 3 months of screening.

Exclusion Criteria

* Present evidence of metastatic disease in conventional CT scan and/or bone scan
* Participants that present prostate-specific membrane antigen (PSMA)-positive lesions in the 68Ga-PSMA-11 or the piflufolastat F18 positron emission tomography (PET) scan may be enrolled if the conventional imaging does not show suspicion of metastatic disease.
* Prior hormonal therapy, exceptions include:

  * Neoadjuvant/adjuvant therapy to treat prostate cancer ≤ 36 months in duration and ≥ 9 months before enrollment, or
  * A single dose or a short course (≤ 6 months) of hormonal therapy given for rising PSA ≥ 9 months before enrollment.
* Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, enzalutamide, apalutamide, or darolutamide for prostate cancer.
* Abiraterone acetate, enzalutamide, apalutamide, or darolutamide are allowed if administered in a neoadjuvant/adjuvant setting ≤ 36 months in duration and ≥ 9 months before enrollment.
* Prior systemic biologic therapy, including immunotherapy, for prostate cancer.
* If, in the investigator's opinion, salvage therapy is the preferred intervention.
* Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.
* Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment.
* Requirement for chronic systemic corticosteroid therapy (prednisone dose \> 10 mg/day or equivalent) or any other immunosuppressive therapies (including anti tumor necrosis factor alpha \[TNFα\] therapies).
Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib

This study is designed to evaluate the discontinuation/re-treatment of pexidartinib therapy in previously treated participants with tenosynovial giant cell tumor (TGCT).

This multicenter study in previously pexidartinib-treated participants with TGCT will provide the Investigators and participants the option at Screening to either continue pexidartinib treatment (Treatment Continuation Cohort) or discontinue treatment with the possibility of re-initiating pexidartinib treatment (Treatment-Free/Re-Treatment Cohort).

Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled and on pexidartinib treatment in one of the following studies: Study PLX108-10 (ENLIVEN), Study PLX108-01, Study PL3397-A-A103 or Study PL3397-A-U126.
* Willing and able to complete the PROMIS Physical Function Scale and EQ-5D-5L throughout the study.
* Willing and able to provide written informed consent prior to any study-related procedures and to comply with all study requirements.
* Females of reproductive potential must have a negative urine pregnancy test at Screening/Baseline (to be confirmed by a serum pregnancy test taken on the last treatment visit of their prior study). They are advised to use an effective, non-hormonal method of contraception during treatment with pexidartinib and for 1 month after the last dose. Males with female partners of reproductive potential should be advised to use an effective method of contraception during treatment with pexidartinib and for 1 month after the last dose. Female partners of male patients should concurrently use effective contraceptive methods (hormonal or non-hormonal).

Note: A female is considered of reproductive potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months) unless permanently sterile (undergone a hysterectomy, bilateral salpingectomy or bilateral oophorectomy) with a confirmed by follicle stimulating hormone (FSH) test level \>40 mIU/mL.

* Male participants must not freeze or donate sperm starting at Screening and throughout the study period, and for at least 5 half-lives or 1 month after the final study drug administration, whichever is longer. Female participants must not donate, or retrieve for their own use, ova from the time of Screening and throughout the study treatment period, and for at least 1 month or 5 half-lives after the final study drug administration, whichever is longer.

Exclusion Criteria:

* Participant has a clinically significant abnormality identified by the Investigator at Screening on physical examination, laboratory tests, or electrocardiogram (ECG) which, in the judgement of the Investigator, would preclude the participant's safe completion of the study.
* Exposure to another investigational drug or current participation in other therapeutic investigational procedures, besides pexidartinib studies, within 1 month prior to start of study treatment. Any known contraindication to treatment with, including hypersensitivity to, the study drug(s) or excipients in pexidartinib.
Preventing Malnutrition and Restoring Nutritional Status in Hospitalized Children

This cluster-randomized trial will evaluate the impact of a multifaceted intervention (including electronic medical alerts) coordinated by a Nutritional Support Team, on adherence to recommended practices for care of starved children, among health personnel of a large university hospital. A key component of the study is to assess whether improved adherence to guidelines leads to a reduction in rates of complications.


Eligibility Criteria:
Inclusion Criteria:

* medical and surgical units in a large teaching hospital providing pediatric acute care.
* any hospital staff with direct patient care who are affiliated with a single unit (includes physicians, nurses, nursing assistants, physiotherapists, dieticians.
* all children recorded as malnourished at their entrance in hospital

Exclusion Criteria:

* neonatal and intensive care units.
* any hospital staff with direct patient care who are not affiliated with a single unit.
* age under one month, liver or kidney abnormalities, severe heart failure, stay less than 2 days.
Does Routine Assessment of Gastric Residuals in Preterm Neonates Influence Time Taken to Reach Full Enteral Feeding?

The study aims to compare routine assessment of gastric residuals versus no assessment of residuals in preterm neonates with respect to time taken for achieving full enteral feeding and the incidence of possible complications, such as feeding intolerance, necrotizing enterocolitis, sepsis etc.

In general, regular assessment of gastric residuals and its´ evaluation prior to every feeding is considered standard practice for preterm neonates in neonatal intensive care units. It is believed useful to confirm correct placement of the orogastric or nasogastric tube and thought of as necessary to aid the decision of enteral feeding advancement by informing about possible remains of contents from previous feeding. Furthermore, evaluation of gastric residuals is routinely performed in order to assess for feeding intolerance and used as a possible indicator of risk for development of necrotizing enterocolitis.

However there is conflicting evidence to support the approach of routine gastric residuals assessment and it seems unclear whether it confers any clinical benefit. Withholding of enteral feeding or cessation of advancement in the amounts given due to misinterpretation of routine gastric aspirates may have a negative impact on the preterm neonate. This can potentially involve prolonged indwelling of venous catheters, higher risk of infection and growth restriction with potentially worse developmental outcome in particular for very low birth weight infants.

This randomized controlled clinical study aims to compare a control group with regular assessment and evaluation of gastric residuals and an intervention group with no routine assessment of residuals prior to feeding advancement, for the time taken to reach full enteral feeding and for occurrence of any observed complications including necrotizing enterocolitis.

Eligibility Criteria:
Inclusion Criteria:

* Preterm neonate, born between 26+0 and 30+0 weeks of gestation
* Birth weight below 1500g
* Parental informed consent obtained

Exclusion Criteria:

* Intrauterine growth retardation (birth weight below 5th centile for given gestational age and gender)
* Life-threatening events requiring full resuscitation at the delivery room (severe hypoxia, bleeding), and persistently raised lactate value of more than 5 mmol/l
* Circulatory instability requiring treatment with inotropes
* Highly suspected early onset sepsis with alteration of general clinical state, in particular with worsened peripheral perfusion and circulatory decompensation prior to study begin (during the first 6 hours after admission to NICU)
* Known malformations of gastrointestinal tract, known diagnosis of congenital diaphragmatic hernia, any other life-limiting serious congenital malformations
Quality of Life of HIV-infected Participants Switched to Raltegravir Versus Other Antiretroviral Regimens (MK-0518-266)

This is a multi-center, longitudinal observational study of adult human immunodeficiency virus (HIV) participants at academic and community-based practices in the United States who are switching from first-line to second-line therapy. The study's primary hypothesis is that HIV participants switching to raltegravir-based regimens will have better Medical Outcomes Study-HIV (MOS-HIV) Health Survey scores than participants switched to non-nucleoside reverse transcriptase inhibitor (NNRTI)-based or protease inhibitor (PI)-based regimens.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of HIV
* Switching antiretroviral regimen(s) for the first time at the start of the study

Exclusion Criteria:

* Currently pregnant
* Presence of active tuberculosis, Hepatitis B, and/or Hepatitis C and receiving treatment for the condition(s) during the study period
* Presence of active pneumonia or other signs of opportunistic infections at the start of the study
* Currently participating in a clinical trial