cyrilzakka/clinical-trials huggingface dataset:
Upregulation of PSMA Receptors After Androgen Deprivation Therapy on PSMA PET/CT Imaging in Prostate Cancer

Prostate specific membrane antigen (PSMA) is a unique membrane bound glycoprotein, which is overexpressed on prostate cancer cells and is well-characterized as an imaging biomarker of prostate cancer. Studies have shown that PSMA PET/CT can detect prostate cancer lesions with excellent contrast and a high detection rate even when the level of prostate specific antigen is low. PSMA imaging is considered the gold standard in imaging of biochemical recurrence, with detection rate of recurrence in 79.5% of patients, in the largest series of 1007 patients. Despite these excellent results, there remains approximately 20% of patients in whom the site of biochemical recurrence cannot be identified and further research is needed into improving detection rates.

Androgen deprivation therapy (ADT), represents the standard of care treatment for most men with a rising serum PSA and no evidence of disseminated disease on imaging modalities. There has been some preliminary data that imaging patients early after initiation of ADT therapy may increase detection rates of recurrence sites.

The objective of this study is to evaluate if prostate cancer patients with biochemical recurrence and negative PSMA PET/CT can demonstrate in-vivo upregulation of PSMA receptors in an attempt to improve detection rates of recurrent prostate cancer. Patients who are started on ADT when clinically indicated, will have repeat PSMA PET/CT at 4 weeks following initiation of ADT therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male sex
* Age 18 years or older
* Previous diagnosis of prostate cancer following radical prostatectomy or primary radiation therapy, with biochemical recurrence.
* Prior negative PSMA PET/CT within 2 months prior to study entry
* ECOG performance status 0 - 3, inclusive
* Able to understand and provide written informed consent
* Initiation of androgen deprivation therapy within 5 weeks prior to study PSMA PET/CT
* Able to tolerate the physical/logistical requirements of a PET/CT scan

Exclusion Criteria

* Medically unstable patients
* Patients who exceed the safe weight limit of the PET/CT bed (200 kg) or who cannot fit through the PET/CT bore (70 cm diameter)
* Patients with unmanageable claustrophobia
Efficacy and Safety Study of Xyotax to Treat Prostate Cancer

The purpose of this study is to determine whether Xyotax, a conjugate of the taxane drug paclitaxel, is effective in the treatment of prostate cancer that is no longer responsive to hormone therapy.

Prostate cancer is the second leading cause of cancer death in American men. Hormonal ablation, in the form of medical or surgical castration, is the cornerstone of management for metastatic prostate cancer; however, treatment options for a patient in whom androgen ablation fails are limited. Docetaxel and paclitaxel, taxanes that are cell cycle specific, play a major role in advanced hormone-refractory prostate cancer treatment. In preclinical studies, Xyotax, a conjugate of paclitaxel with enhanced permeability and retention in tumor tissue, has an improved therapeutic profile, with both decreased systemic drug-related toxicities and enhanced efficacy. Xyotax as a single agent has been studied in a broad variety of syngeneic and xenogeneic tumor models. Recognizing that taxanes are active in prostate cancer and preclinical data reports activity with Xyotax in docetaxel and paclitaxel resistant cell lines, there is significant rationale to develop this agent in prostate cancer. Thus, a phase II study is needed to evaluate the antitumor activity in two subsets of hormone refractory prostate cancer patients: those with no prior systemic and those with one prior systemic therapy.

Eligibility Criteria:
Inclusion Criteria:

* Progressing adenocarcinoma of the prostate having failed prior hormone therapy
* Free of serious co-morbidity
* Have a life expectancy of ≥ 24 weeks
* Maintaining castrate status (either surgically or hormonally)

Exclusion Criteria:

* Patients with central nervous system metastases, except those patients who have had excision or radiotherapy and remain asymptomatic, off steroids and with no evidence of disease as shown by MRI for at least 6 months
* Patients known to be HIV positive
* Patients with active autoimmune disease
* Patients involving concurrent anticancer drug therapy
* Patients with unstable medical condition, such as uncontrolled diabetes mellitus or hypertension; active infections requiring systemic antibiotics, antivirals, or antifungals; clinical evidence of cardiac or pulmonary dysfunction including, but not limited to: unstable CHF, uncontrolled arrhythmias, unstable coagulation disorders, or recent myocardial infarction (within 6 months)
Evaluation of a New Surgical Technique for Macular Hole Which Was Not Closed After a Previous Surgery

Macular hole is an infrequent retinal pathology (2 to 4/1000) which most often affects people aged over 60, and twice common in women than men.

The vast majority of cases are idiopathic. Without treatment, the macular hole evolves through a series of stages until the extension of the diameter (up to 500 microns and higher values). With a fully developed macular hole, patients complain of metamorphopsia and decreased visual acuity.

This pathology has clearly benefited from advances in microsurgery and better understanding of its pathophysiology. Macular hole treatment has evolved to include small-gauge pars plana vitrectomy with or without internal limiting membrane (ILM) peeling and placement of intraocular gas tamponade.

The postoperative closure rate is close to 80%, but strongly depends on the initial characteristics of the hole, its diameter remaining the main prognostic factor. Thus for macular holes \<400 microns, the closure rate is close to 92% dropping to 56% for macular holes above 400 microns. In case of surgical failure, one or more reoperations can be proposed, but with a lower closure rate.

The quest for a surgical technique presenting a greater success rate is a common goal to all retinologists.

Here the investigators propose a new surgical technique, derived from the FLAP method, and consisting of an inner limiting membrane transposition.

The objective of this study is to evaluate the feasibility of a new surgical technique for the treatment of macular holes already operated but without macular hole closure, allowing these patients a new therapeutic alternative. The success of this technique will be confirmed by detecting postoperatively the presence of the transposed internal limiting membrane into the foveal region.


Eligibility Criteria:
Inclusion Criteria:

1. Patient aged over 18,
2. Patient who already received at least a macular hole surgery,
3. Period of at least 4 months since last macular hole surgery,
4. Patient who underwent peeling of the internal limiting membrane,
5. Presents in OCT an open criteria macular hole,
6. The presence of a cataract in the preoperative clinical examination is not against indication. Its removal can be integrated to the surgery,
7. Patient who signed the consent form

Exclusion Criteria:

1. Patient with against-indication or surgical anesthetic,
2. Macular Hole "flat open" or closed,
3. No progressive macular pathology other than the presence of a macular hole (retinal detachment, Macular degeneration related to age) Idiopathic and secondary macular holes are eligible if they have already been operated with the prior internal limiting membrane coat.
4. Patient unaffiliated or not the beneficiary of a social security system, or equivalent health insurance,
5. Pregnant or breastfeeding women,
6. Absence of patient consent,
7. Patient in exclusion period involved in another study,
8. Patient on administrative or judicial supervision
Efficacy and Safety of Ginkgo Biloba in Middle-aged Cognitively Intact Adults

The primary objective of this study was to assess the efficacy and safety of Gingko biloba film-coated tablets in improving cognitive function and neuropsychological functioning of middle-aged cognitively intact adults.


Eligibility Criteria:
Inclusion Criteria:

* Male and female healthy subjects with no known clinically significant pathology as assessed by the investigator
* Mini-Mental State Examination (MMSE) score ≥ 28
* Age range: 40 to 60, inclusive
* Females must test negative for pregnancy
* Clinical laboratory tests must be within normal limits or, if out of normal range, clinically acceptable to the Investigator
* Urine drug screen for illicit drugs must be negative at screening
* Subjects must have given written informed consent in accordance with ICH-GCP (International Conference on Harmonization - Good Clinical Practice) and local laws and regulations

Exclusion Criteria:

* Any serious disorder that may interfere with his/her participation in the trial and the evaluation of the safety of the test drug
* Pre-treatment and/or concomitant treatment with any drug that may influence the trial symptomatology and may interfere with the evaluation of cognitive function
* Alcohol and drug abuse according to DSM-IV (Diagnostic and Statistics Manual, Version IV)
* Individuals drinking more than 6 cups of coffee or tea/day
* Individuals smoking more than 10 cigarettes/day
* Subjects who in the opinion of the investigator are heavy users of other tobacco or nicotine products
* Subjects currently taking a cognition enhancing substance, including any Ginkgo or ginseng product
* Any subject regularly taking a medication who might stop doing so at some time during the active dosing phase, if the medication is deemed by the investigator to influence the outcome of the trial
* Female subjects of child-bearing age who are not using adequate means of birth control
* Pregnancy and/or lactation
* Any subject who, according to the Investigator, is unable to perform the CDR cognitive tests or the neuropsychological tests in a satisfactory and consistent manner
* Relevant allergy or known hypersensitivity to the investigational product or its excipients
* Individuals under anticoagulant treatment
* Individuals with a current disorder likely to modify computerised cognitive testing
* Individuals having a history of cancer (any type, excluding surgically removed and treated basal cell carcinoma)
* Clinically significant and not treated thyroid disease
* Participation in another clinical trial within the last 3 months prior to the start of the study and concurrent participation in another clinical trial
Insulin Balanced Infusion System

The purpose of this study is to study the use of a counterbalancing system of glucose and insulin infusion with frequent blood glucose monitoring and combined adaptive algorithm can produce tight glycemic control without hypoglycemia; study to develop a closed loop for use in intensive care units and surgery

The study is using an experimental design outpatient with individuals having treatment using an automated closed loop glucose control unit; glucoses are measured every 5 minutes using a intravenous glucose sensor and infusion of glucose and insulin are altered without manual intervention as directed by algorithm

Eligibility Criteria:
Inclusion Criteria:

* type 1 or type 2 diabetic individuals on insulin ages 21-85 with A1c 7-9.9%
* glucose at time of study \> 150 mg/dl

Exclusion Criteria:

* pregnancy
* renal or hepatic disease
* corticosteroids
* poor intravenous access
* anemia
* electrolyte abnormality
Foot Reflexology in Diabetic Patients with Neuropathic Pain

This study was carried out to determine the effect of foot reflexology applied to diabetic patients with neuropathic pain on their quality of life, hope and pain levels.

This research, which was designed as a randomized controlled and experimental study, was conducted between January 2022 and December 2022. It was determined that foot reflexology application increased the quality of life and hope level of diabetic patients with neuropathic pain and decreased the level of pain.

Aim: This study was carried out to determine the effect of foot reflexology applied to diabetic patients with neuropathic pain on their quality of life, hope and pain levels.

Material and Method: This research, which was designed as a randomized controlled and experimental study, was conducted between January 2022 and December 2022. The data of the study consisted of 102 diabetic patients with neuropathic pain, 51 of whom were experimental and 51 were controls. As data collection tools; Patient Information Form, Herth Hope Scale (HHI), Four-Question Neuropathic Pain Questionnaire (DN4Q), Neuropathic Pain Impact on Quality of Life Questionnaire (NePIQoL), and Visual Analog Scale (VAS) were used. A total of 12 sessions of foot reflexology were applied to the patients in the experimental group, twice a week for 6 weeks. No intervention was performed on the patients in the control group.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and over
* Do not have any physical or mental illness that will prevent communication,
* Diabetic neuropathic pain \[with a total score of at least 4 and above according to the Four-Question Neuropathic Pain Questionnaire (DN4Q)\]
* Patients who can read, write and speak Turkish

Exclusion Criteria:

* Complications developing during reflexology practice,
* Not attending at least one of the practice sessions,
* It was planned to exclude patients who wanted to leave at any stage of the study.
Acute Inflammation After Wisdom Tooth Removal

Third molar (wisdom teeth) extraction is one of the most frequent intervention in dentistry. Nevertheless, little is known about the level of general body inflammation of subjects with impacted or semi-impacted third molars. Moreover, The possible effects of surgical removal of wisdom teeth on the overall health are not known.

Thus, a study in which 40 subjects has been designed. Twenty subjects were affected by bilateral wisdom tooth pathology necessitating for extraction of both teeth. Control group comprised 20 subjects with absence of wisdom teeth or completely erupted wisdom teeth without pathology associated to or history of previous extraction of both wisdom teeth.

In both groups a medical and dental examination will be performed at the baseline and 3 months after baseline for the control group or after the second third molar extraction in the control group. Blood will be also withdrawn to assess systemic inflammation and other systemic parameters.

Parameter were evaluated via high sensitive c reactive protein (CRP), lipids, fibrinogen, oxidative stress and endothelial function analysis.

Third molar extraction is one of the most frequent intervention in dentistry. Nevertheless, little is known about the systemic aspect of subjects with impacted or semi-impacted third molars and the possible effects of surgical removal on their systemic parameters. A case-control study of 40 subjects has been designed to evaluate i) the overall systemic inflammation and metabolism of subjects with bilateral third molars compared to subjects with no third molars and ii) the effect of bilateral removal in the immediate and medium postsurgical period. Systemic parameters are evaluated via high sensitive c reactive protein (CRP), lipids, fibrinogen, oxidative stress and endothelial function analysis.

Eligibility Criteria:
Inclusion Criteria:

* cases: bilateral wisdom tooth pathology.
* control: agenesia/previous extraction/no symptoms of the lower third molars.

Exclusion Criteria:

* younger than 18 years and older than 65 years;
* pregnant or lactating females;
* females using contraceptive methods;
* suffering from any systemic illness;
* undergoing any pharmacological treatment within 30 days prior to the inclusion
* patients affected by periodontal disease (radiographic diagnosis of vertical bone defects or bone resorption equal to 20% of the root length);
* patients with periapical and periradicular radiolucent areas X-ray detectable;
* patients unable to participate to study.
Effects of Therapeutic Exercise With Elastic Bands on Strength and Pain in Women With Non-specific Neck Pain.

The study consists of an intervention of 16 therapeutic exercise sessions during 8 weeks with a frequency of two sessions per week. All sessions had a practical focus (strength and stretching exercises) with the help of elastic bands. In addition, they had an initial session and another at the end of the intervention in which measurements of the different variables (cervical pain, cervical flexor strength, cervical extensor strength and strength of the scapular stabilising musculature) were taken on two occasions, at the beginning of the study and at the end of the intervention, an average of 2 months.

Nonspecific neck pain has a higher incidence in women than in men. Female sex is a risk factor for this pathology. Clinical practice guidelines highlight the importance of preventing neck pain through exercise. There are previous studies on the effects of strength programmes on patients with non-specific neck pain, but none have used elastic bands as an implement, despite the fact that it is one of the most commonly used implements in physiotherapy clinics. Therefore, the aim of this study is to investigate the effects of an elastic band therapeutic exercise intervention in women with non-specific neck pain. It was previously hypothesised that this intervention would have positive effects on pain and strength in the cervical and scapular region.


Eligibility Criteria:
Inclusion Criteria:

* Women.
* 18-65 years of age.
* With non-specific neck pain for at least three months, with pain intensity (30-70 on a VAS).

Exclusion Criteria:

* Any previous neck or shoulder surgery, fibromyalgia, cervical radiculopathy/myelopathy, history of the whiplash injury, cognitive disorder.
* Missing more than sessions.
* Not being able to attend the measurement sessions.
Comparison of a Chemically Activated Composite Resin Alkasite With Resin Composite in Atypical Caries Lesions of Deciduous Teeth

Atypical cavities, which involve more than two surfaces, one being buccal or lingual/palatal, are a challenge for restorative dentistry, since the risk of restorative failure is related to the number of surfaces involved. Thus, the purpose of this umbrella project is to conduct a randomized controlled trial (RCT) to evaluate the efficacy and patient-centered outcomes of a chemically activated composite alkasite resin in atypical deciduous molar lesions. Primary molars of children aged 4 to 7 years with at least one atypical cavitary lesion in primary molars will be selected for the RCT. The selected teeth will be randomly divided into: Alkasite chemically activated composite resin and Bulk fill composite resin. Clinical and radiographic follow-up of the lesions will be performed for 6 and 12 months. The effectiveness of the treatments will be evaluated by the longevity of the restorative procedures and paralysis of the lesions. Patient-centered outcomes will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Children will be included who have at least one posterior tooth with atypical caries lesion.

Exclusion Criteria:

* Patients with special needs will be excluded, with general health conditions that may affect the oral cavity, non-cooperating in relation to the examination, which use orthodontic apparatus and the parents/guardians or children not to consent to their participation in the study. In addition, teeth with pulp exposure, spontaneous pain, mobility, presence of swelling or fistula close to the tooth, furcation or cervical injury, teeth with restorations, sealants or enamel formation defects will be excluded.
The Efficacy of MK-8291 in Participants With Post-herpetic Neuralgia (PHN) With Allodynia (MK-8291-012)

This study aims to determine whether MK-8291 is effective in reducing pain in participants with post-herpetic neuralgia (PHN) with allodynia.

The primary hypothesis is that when compared to placebo, treatment with MK-8291 reduces the change from Baseline in participant-reported pain intensity by 1 on an 11-point numeric rating scale.


Eligibility Criteria:
Inclusion Criteria:

* non-pregnant female (and/or partner) agrees to use two acceptable methods of birth control throughout the trial until 2 weeks after the last dose of treatment
* female is postmenopausal or surgically sterile
* has a clinical diagnosis of PHN with allodynia for at least 3 months duration after healing of rash
* has a body mass index (BMI) =\< 35 kg/m\^2, inclusive
* is in good health, with exception of PHN
* is on a stable dose for at least 30 days prior to screening if taking any of the following: opioids, non-opioids, paracetomol, non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, antidepressants
* is a nonsmoker or has not used nicotine or nicotine containing products for at least prior 3 months

Exclusion Criteria:

* has a non-PHN chronic pain state
* has a history of clinically significant and inadequately treated endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* has a history of malignant cancer
* has a history or presence of esophagitis
* has a history of significant multiple and/or severe allergies (e.g. food, drug, latex), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
* is positive for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus (HIV)
* had major surgery, donated or lost approximately 500 mL of blood within 4 weeks prior to screening
* has participated in another investigational trial within 4 weeks prior to screening
* has a history of risk factors for Torsades de Pointes, has hypokalemia or hypomagnesemia
* has a history or presence of clinically significant cardiac arrhythmia, taking substances with the target of reducing heart rate and or exercising endurance sports
* has had an injection of local anesthetics or steroids in the region affected by PHN, within 35 days prior to randomization
* anticipates using prescription and non-prescription drugs or herbal remedies during trial
* consumes excessive amounts of alcoholic or caffeinated beverages
* uses cannabis, any illicit drugs, or has a history of drug (including alcohol) abuse within 12 months of screening visit