cyrilzakka/clinical-trials huggingface dataset:
Total Body Perfusion in Patients With Chest Pain

The Purpose of this study is to better understand changes in obstructive coronary artery disease in different organs other than the heart such as the brain and the kidneys using a new generation total body PET scanner.

Patients with chest pain and suspected CAD will be studied using total body PET imaging with O15-water perfusion imaging

Eligibility Criteria:
Inclusion Criteria:

* Documented history of chest pain with CT imaging showing a potential for obstructive coronary artery disease
* Ability to sustain adenosine injection 0.14 mg/kg/min

Exclusion Criteria:

* Second or third degree AV-block without pacemaker
* Sick sinus syndrome
* Consumption of coffee or aminophylline within 12 hours of administration
* Recent use of dipyridmole or dipyridamole-containing medications
* Known hypersensitivity to adenosine
* Unstable acute MI or acute coronary artery syndrome, and prior cardiac transplantation
* Active wheezing and bronchospasm
* Sinus bradycardia with HR\<40 bmp
Sexual Dysfunction and Anorexia Nervosa

The objective of this observational study is to investigate the potential influence of anorexia nervosa on the sexual health of women. The primary focus is to determine the presence of sexual dysfunction in individuals with anorexia nervosa and explore any potential correlation between eating disorders and sexual dysfunction. To facilitate comparison, data from a control group comprising healthy women is incorporated alongside the clinical group data.

numerous studies indicate that women diagnosed with anorexia nervosa experience a discernible impact on their sexual well-being, often accompanied by symptoms of sexual dysfunction (SD). Such dysfunction may manifest as a diminished libido, reduced sexual desire, and challenges in achieving orgasm

Eligibility Criteria:
Inclusion Criteria:

clinic group :

* adult
* women
* diagnosis of anorexia nervosa
* from Slovakia and Czech Republic

control group:

* health women
* adult
* from Slovakia and Czech Republic

Exclusion Criteria:

clinic group:

* health women
* other diagnosis or disorder
* other country

control group:

* presence of some mental illness
* other country
Joint Consultation Between a Neurologist and a Clinical Psychologist

Joint consultations appeared a few years ago in routine medical practice, but they are still not widely used and rarely evaluated.

The primary purpose of the study is to evaluate the impact for the patient of the presence of a clinical psychologist during the joint consultation.

The secondary purpose is to evaluate the impact for the patient and for the neurologist of the presence of a clinical psychologist during the joint consultation


Eligibility Criteria:
Inclusion Criteria:

* patient with a neurodegenerative and/or neurogenetic disease
* adult patient

Exclusion Criteria:

* dementia
* age \<18 years
Isentress Re-examination Study (MK-0518-115)

This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Isentress through collecting the safety and efficacy information in usual practice according to the Re-examination Regulation for New Drugs.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 Infected Adults
* Treated with Isentress 400 mg tablet within local label during the enrollment period

Exclusion Criteria:

* Contraindication to Isentress according to the local label
Comparison of the Effect of Two Different Interventions

The goal of this clinical trial is to compare the effect of two different non-pharmacologic interventions with the control group in reducing pain due to peripheral intravenous catheterization application in children aged 5-12 years.

Hypotheses:

H1: Pain level differs in the group that received PIK with Palm Stimulator compared to the control group.

H2: The level of fear in the group with PIK application with Palm Stimulator differs from the control group.

H3: Satisfaction level is different in the group with PIK application with Palm Stimulator compared to the control group.

H4: The pain level differs in the group that received PIK application by watching cartoons compared to the control group.

H5: The level of fear is different in the group that received PIK application by watching cartoons compared to the control group.

H6: Satisfaction level is different in the group that received PIK application by watching cartoons compared to the control group.

H7: Pain level is different in the Palm Stimulator PIK group compared to the cartoon group.

H8: The level of fear is different in the Palm Stimulator PIK group compared to the cartoon group.

H9: The satisfaction level in the group with PIK application with Palm Stimulator is different from the cartoon group.

H10: PIK application time is different in the palm stimulator group compared to the control group.

H11: PIK application time is different in the cartoon group compared to the co

1. To measure the pain and fear levels of children by placing a palm stimulator on their palms during PIK application
2. Measuring pain and fear levels by watching cartoons to children during PIK application

Eligibility Criteria:
Inclusion Criteria:

1. Voluntary participation in the study,
2. Pediatric patients for whom written and verbal consent has been obtained from the parent,
3. Pediatric patients for whom verbal consent was obtained,

(3) Not under the influence of sedative/anticonvulsant/analgesic drugs, (4) Pediatric patients aged 5-12 years, (5) Pediatric patients who can communicate, understand, and carry out commands and are not dependent on technological devices.

Exclusion Criteria:

1. Not volunteering to participate in the study,
2. More than one PIK attempt,
3. Children with a chronic, acute, or life-threatening illness.
Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment

In this study, the investigators are evaluating the effect of vaginal probiotics on the bothersome side effects of pessary use and the impact on the vaginal microenvironment (lactobacilli, anaerobic bacteria, mobiluncus bacteria, WBCs, cellular debris, epithelial cells, and BVAB-1), and inflammatory environment (cytokines).


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal (no menstruation \>12 months)
* Subjects presenting for 2 week post initial pessary insertion appointment or presenting for routine pessary care follow up appointment
* Planning on continuing to use a pessary for treatment for at least 3 months
* Pessary maintenance performed by provider (as opposed to self-care)
* Able to understand English
* Able/willing to sign informed consent document

Exclusion Criteria:

* Lack of cognitive ability to consent to participate in study and to complete the questionnaires
* Planned prolapse surgery less than 3 months from enrollment
* Presence of vaginal fistulas
* Pessary self-care (patient changes and cleans her own pessary)
* Receiving immunosuppressive therapy or history of immunodeficiency
* Presence of an indwelling vascular access line or structural heart disease
* Within 6 weeks from any abdominal or pelvic surgery or other major surgery
* Allergy to lactobacillus (contents of probiotic)
* Allergy to beta-lactam antibiotics, erythromycin and clindamycin
* Use of any probiotic pills, creams, or suppositories currently
Treatment of Adults With Growth Hormone Deficiency

The objective of this rollover study is to evaluate the long term (1 year) safety of a new weekly administered growth hormone preparation in adults with growth hormone deficiency who were treated with the same experimental preparation in study BPLG-005. In addition, further change in efficacy endpoints of BPLG-005 by prolonged treatment will be evaluated. Additional efficacy and safety data of the experimental preparation will be obtained from the switch-over patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients (male and female) who have completed the Visit 8 of preceding main study (BPLG-005) and are willing to continue their participation in an extension study
* If female, women of child-bearing potential who are using a reliable method of contraception and be willing to use it throughout the study. A negative urine pregnancy test at Visit 0 is required for females of child-bearing potential
* Written informed consent of the patient

Exclusion Criteria:

* Evidence of active malignancy or growth of a previously stable tumor
* Benign intracranial hypertension
* Clinically significant respiratory, cardiac, hepatic, renal, neuromuscular disease
* Non-compliance with medications, un-cooperativeness or drug abuse during the BPLG-005 study
* Patients who are not able to comply with the study protocol for any reason
An Open, Single-arm, Multi Centre Pilot Investigation to Evaluate the Debriding Effect of ChloraSolv® on Chronic Wounds

The primary objective of this clinical investigation is to evaluate the debriding effect of ChloraSolv® on chronic (more than 1 moth) lower leg ulcer.

Approximately 58 subjects from at least two sites in Sweden will be included. Subjects presented with lower leg ulcer, covered with devitalised tissue for 50% or more and being candidate for cleansing, debridement/desloughing will be enrolled. Weekly application of Investigational Product for 6 weeks. Follow-up for wound status evaluation after 12 weeks from baseline. Total time in investigation is 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Full skin ulcer at lower leg covered with devitalised tissue ≥50%
2. Candidate for cleansing, debridement/desloughing
3. Wound area ≥2 cm²
4. Male or female, 18 years of age and above
5. Able to read and understand the Patient Informed Consent and to provide meaningful written informed consent
6. Able and willing to follow the Protocol requirements

Exclusion Criteria:

1. Clinical signs of system progression infection with or without ostemyelitis
2. Wound located where treatment is not possible
3. Subjects not suitable for the investigation according to the investigator's judgment
4. Subjects included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator
5. Known allergy/hypersensitivity to any of the components of the investigational device
6. Pregnant or breast feeding women
7. Other significant medical condition that the investigator determines could interfere with compliance or study assessments
8. Subjects with wounds of duration less than one month
9. Wound area greater than approximately 60 cm²
Treatment of Female Stress Urinary Incontinence: Study Comparing Two Suburethral Slings, Retropubic Approach (TVT) and Trans-Obturator (TVT-O) Approach

The purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: TVT and TVT-O.

Urinary stress incontinence (USI) is a frequent pathology in women. Surgical treatment is required in 30 to 50% of women presenting with USI. Several surgical techniques are currently available.

At the present time, the placement of suburethral slings is one of the most efficient techniques. Furthermore, the placement of a suburethral sling is known to be associated with a low rate of complications.

Currently, two approaches are available for the placement of a suburethral sling: retropubic approach (TVT) and trans-obturator approach (TVT-O). The efficacy of these two approaches seem equivalents. However, the morbidity related to these two techniques is probably different. In retrospective studies, the retropubic approach is associated with a higher rate of bladder perforation. On the other hand, the trans-obturator approach is supposed to be associated with a higher rate of post-operative pain.

Thus, the purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: TVT and TVT-O.

Eligibility Criteria:
Inclusion Criteria:

* Woman over 18 years old
* Clinical diagnosis of stress urinary incontinence requiring surgical management
* Must be able to read and sign the consent

Exclusion Criteria:

* Pregnancy
* Anti-coagulant treatment
* Isolated overactive bladder syndrome
* Genital prolapse requiring surgical treatment
* Concomitant hysterectomy
Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women

To estimate the duration of efficacy with continued treatment of double-blind flibanserin or placebo over twenty-four weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Women over 18 and pre-menopausal
2. FSDS-R above 14
3. Willingness to try to have sexual activity at least monthly
4. Willingness to use an electronic diary daily
5. Stable, monogamous, heterosexual relationship for at least one year
6. Medically acceptable method of contraception

Exclusion Criteria:

1. Clinically relevant conditions which might interfere with the patient's abil ity to participate in the trial
2. Specified medications
3. Sexual function affected by medication
4. Drug dependence or abuse
5. Sexual partner needing treatment
6. Peri-Menopause or Menopause (surgical or otherwise)
7. Pregnancy
8. Pelvic Inflammatory Disease
9. Major depressive Episode
10. Significant ECG abnormalities
11. Significant Neurologic findings
12. Significant GI, Hepatic, Cardiovascular, Renal, Hematologic, Immunologic or Respiratory findings
13. Uncorrected thyroid or endocrine disease
14. Uncontrolled Glaucoma
COLON ERDERLY LOW DOSE

In this retrospective observational study, the case series of patients undergoing first-line treatment for metastatic colorectal adenocarcinoma with doublet fixed-dose and reduced-dose chemotherapy in combination with full-dose monoclonal antibody in patients aged 70 years or older is collected.

Treatment in the elderly first-line patient of metastatic colorectal cancer is often conditioned by the age and general condition of the patient.

Such treatment involves the combination of chemotherapy and biological therapy targeted on the basis of the site and genetic mutations of the colorectal tumour, in particular RAS and BRAF.

With regard to targeted biologic therapy, the choice of monoclonal antibody is determined by tumour site and mutations. In particular, for right-sided and/or RAS/BRAF mutated tumours anti-VEGF therapy with Bevacizumab is the best option, whereas for left-sided and RAS/BRAF WT tumours monoclonal antibodies Panitumunab or Cetuximab are the choice.

In the elderly patient, the intensity of chemotherapy to be combined with targeted biologic therapy varies according to the patient's age, general condition and treatment goals. In particular for patients aged 70 years or older, a valid option is the combination of monochemotherapy with fluorodrugs in combination with bevacizumab. In addition, an Italian randomised trial tested monochemotherapy with 5-Fluorouracil in combination with Panitumumab in RAS WT/BRAF WT tumours and obtained the same efficacy as a doublet of chemotherapy with FOLFOX also in combination with Panitumumab.

Full-dose doublet chemotherapy is hardly feasible in the elderly patient because of the frailty of these patients and the high risk of toxicity.

In this retrospective observational study, we report on the case series of patients undergoing first-line treatment for metastatic colorectal adenocarcinoma with doublet of fixed-dose and reduced-dose chemotherapy in combination with full-dose monoclonal antibody in patients 70 years of age and older.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with metastatic colorectal adenocarcinoma not treated with any therapy in the metastatic phase. Previous (neo)-adjuvant treatment with fluoroderivatives with or without Oxaliplatin is permitted.
2. Age ≥ 70 years
3. G8 score ≥ 12
4. Patients with colorectal adenocarcinoma MSS
5. Patients with BRAF WT colorectal adenocarcinoma
6. Ability to understand and sign the informed consent form.

Exclusion Criteria:

1. Patients with MSI tumours
2. Patients with BRAF V600E mutated tumours
3. Patients not eligible for doublet chemotherapy by clinical decision
Post-Market Study of the 3DKnee™ System

The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery.

Total knee replacement surgery is widely accepted as effective treatment for degenerative joint disease (DJD), osteoarthritis and rheumatoid arthritis. Relief of patient pain and return of mobility are the primary goals that can be accomplished by this surgery. The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery. The study will take place at multiple sites across the United States and be managed by the Encore Medical Clinical Affairs Department. The study will include only patients who meet the indications for use criteria for the 3DKnee™ System and who are candidates for primary knee arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* This must be a primary knee replacement on this knee.
* Patient is over 18 years of age or older
* Have knee joint disease related to one or more of the following

  * degenerative joint disease, including osteoarthritis or traumatic arthritis
  * Avascular necrosis of the femoral condyles
  * Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
  * Moderate valgus, varus, or flexion deformities
  * Rheumatoid arthritis
* Patient is likely to be available for evaluation for the duration of the study
* Able and willing to sign the informed consent and follow study procedures
* Patient is not pregnant

Exclusion Criteria:

* Is younger than 18 years of age
* If there has been a total knee replacement on this knee in the past (no revisions allowed in study)
* Infection, or history of infection, acute or chronic, local or systemic
* Alcoholism or other addictions
* Muscular, neurological or vascular deficiencies which compromise the affected extremity
* Obesity
* Insufficient bone quality
* Loss of ligamentous structures
* High levels of physical activity
* Materials sensitivity
* Prisoner
* Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
* Patient is pregnant
Radiofrequency Ablation for Gastric Metaplasia and Dysplasia

Gastric intestinal metaplasia (IM) and dysplasia, also referred to as intra-epithelial neoplasia, are well recognized precursors of gastric cancer. Apart from endoscopic surveillance, there is no other intervention which predictably eradicates pre-cancerous gastric lesions.

Endoscopic radiofrequency ablative (RFA) therapy has been recently shown to be highly effective in eradicating both IM and dysplasia in patients with Barrett's esophagus. However, the potential role of RFA to remove gastric IM and dysplasia remains unknown. In this study, we determine the feasibility of using endoscopic RFA in treating early gastric neoplasia (metaplasia and dysplasia). Patients with gastric metaplasia and/or dysplasia will be treated with endoscopic RFA. The safety and effects of RFA will be determined.


Eligibility Criteria:
Inclusion Criteria:

1. Histological confirmation of gastric IM or dysplasia.
2. The lesion is no larger than 5 cm in diameter.
3. Age ≥ 18 years.
4. No previous endoscopic mucosal resection or submucosal dissection.
5. No active H. pylori infection.
6. Subject is able to tolerate endoscopy and sedation.
7. Subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form.

Exclusion Criteria:

1. Gastric cancer (intra-mucosal cancer or worse).
2. Prior gastric irradiation or surgery.
3. Anti-platelet or anti-thrombotic medication use that cannot be stopped for 7 days before and after RFA.
4. Gastric ulcers, fistulae and varices.
5. History of alcohol and/or controlled substance dependency.
6. Pregnancy.
MicroPulse TLT - UK Study

This Prospective Interventional Study will assess the efficacy of MPTLT in the UK.

We are establishing a National Study of MPTLT procedures, co-ordinating with all UK treatment centres to capture prospectively, details of all MPTLT surgical procedure and outcomes. This will create a National UK Registry of MPTLT, allowing us to comply with NICE requirements while adding to the quality of evidence available to support this minimally invasive therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with glaucoma or ocular hypertension deemed clinically suitable for MPTLT treatment by their treating ophthalmologist; this includes but is not limited to (a) need for lower IOP, (b) need for fewer medications based on side effects, poor compliance, adverse effect on lifestyle or (c) evidence of disease progression based on function or structure
* Risk of invasive surgical procedure deemed too high by patient or surgeon
* Aged 18 years or older
* The ability to understand and comply with the trial consent process and procedures
* Willingness to be part of a national registry
* Ability to attend for follow-up
* Ability to give informed consent, or consent given by relative or carer

Exclusion Criteria:

* Clinical situations where in the opinion of the investigator, the ocular surface may be compromised by probe contact, including severe ocular surface inflammation
* Inability to give informed consent
* Unwillingness to have clinical data stored in a secure electronic format
* Inability to comply with the study or follow-up procedures
Dexamphetamine Sustained Release Pharmacokinetics and Clinical Validation of Dried Blood Spots

The pharmacokinetics of 10 to 12 individuals receiving 60 mg of sustained release dexamphetamine will be studied. These individuals have received this medication before in a previous trial where the pharmacodynamics were investigated. This trial will last 5 consecutive days during which blood samples will be drawn for pharmacokinetics analyses. Dried blood spots will also be collected for the clinical validation of the bioanalytical method wherein these are used.


Eligibility Criteria:
Inclusion Criteria:

* Have completed at least 80% of the previous study (CATCH)
* Be able and willing to participate in the study and assessments
* Have provided written informed consent.

Exclusion Criteria:

* Any intake of dexamphetamine 7 days or less before the start of the proposed study;
* Contraindications for dexamphetamine
* (desired) pregnancy or continued lactation
* Insufficient command of the Dutch language
* Current participation in another trial