cyrilzakka/clinical-trials huggingface dataset:
Postcapillary Blood Gas Analysis in Wedge Position (Wedge-BGA)

If pulmonary hypertension is suspected, a right heart catheterization is usually performed to confirm or rule out the diagnosis. As part of this examination, blood samples are taken from various locations as standard and blood gas analyses are performed. One of the most important measurements during the right heart catheterization is the measurement of the pulmonary arterial occlusion pressure by the so-called wedge maneuver. To measure this value, the catheter with inflated balloon must be advanced into the pulmonary vessels until the "wedge" position is reached, i.e. the balloon completely occludes a branch of the pulmonary artery. In this study, the investigators want to characterize patients with pulmonary hypertension of different causes in more detail. To do that, two blood samples (totaling approximately 4 mL of blood, one sample directly after occlusion and the other one two minutes later) will be drawn during the right heart catheterization from the above-mentioned "wedge" position", behind the inflated balloon, and blood gas analyses will be performed on these samples. In addition, various clinical parameters (comorbidities, etc.) will be recorded by means of clinical questionnaires. Follow-up data will be analyzed and correlations with the aforementioned blood gas analyses will be examined. The results of the study will be used to more precisely characterize the still vague concept of secondary pulmonary hypertension. This could help to develop new therapeutic strategies in some subgroups in the future.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have a clearly defined indication for Right heart catheterization.
* Age \> 18 years
* Informed consent for participation in the study will sign

Exclusion Criteria:

* Individuals who are not fully capable of giving consent and understanding the nature, significance, and scope of the study
* Pregnancy and lactation
Clinical Features and Outcome of Wilson's Disease With Generalized Epilepsy in Chinese Patients

Generalized epilepsy is rarely reported in patients with Wilson disease (WD) and lacks experience in clinical practice. We aim to provide better experience for the diagnosis and treatment for WD patients with epilepsy in the future.

A retrospective study was performed in 13 Chinese WD patients with generalized epilepsy. Each patient was diagnosed with WD by clinical evaluation and genetic screening. Patients were given small doses of antiepileptic drugs (AEDs), followed by copper-chelation therapy when the seizures stabilized. Clinical manifestations, brain imaging changes, and treatment and outcome after a long-term follow-up were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Each patient was diagnosed with WD by clinical evaluation and genetic screening and had ever experienced generalized epilepsy

Exclusion Criteria:

* Not WD \& without generalized epilepsy
Long-term Outcomes of Complex Conversion Total Hip Arthroplasty

The purpose of the research study is to examine the long-term outcomes of complex and conversion total hip arthroplasty procedures. By means of both retrospective (chart review) and prospective (in-person clinic visits) radiographs and validated patient-reported outcome scores including the Hip Disability and Osteoarthritis Outcome Score (HOOS) and the Patient-Reported Outcomes Measurement Information System (PROMIS), the research team aims to collect, analyze, and summarize the outcome data. The outcomes of the follow-up appointment will be analyzed in comparison to previous findings over various intervals to assess changes over time, if data is available.


Eligibility Criteria:
Inclusion Criteria:

* Having undergone a conversion total hip arthroplasty (THA) more than five years ago or a complex THA more than ten years ago done by a UNC Health-affiliated physician
* Willingness to receive follow-up care from a UNC Health-affiliated physician or provide outcome data regarding this surgical intervention
* Able to speak and read English
* Able to consent to participation

Exclusion Criteria:

* Less than 18 years of age
* Incarcerated status
Erector Spinae Plane Block Reduces Postoperative Pain Following Laparoscopic Colorectal Operation

The goal of this study is to evaluate the effect of ultrasound guided erector spinae plane block on postoperative pain and quality of recovery after laparoscopic colon surgery.

.The goal of this study is to evaluate the effect of ultrasound guided erector spinae plane block on postoperative pain and quality of recovery after laparoscopic colon surgery.

Eligibility Criteria:
Inclusion Criteria:

* aged between 20 and 70 years, with an American Society of Anesthesiologists physical status of 1 or 2, who were scheduled for laparoscopic colorectal operation

Exclusion Criteria:

* sensitivity to local anesthetic, bleeding disorders , receiving anticoagulant, body mass index (BMI) over 35/kg/m2 spine or chest wall deformity pregnancy tolerance to opioid analgesics inability to use patient-controlled analgesia (PCA)
Comparison Between Amalgam and Hall Technique in Treatment of Carious Primary Teeth

compare between amalgam restoration and hall technique for treatment of decayed primary molars and intervention treatment for decayed primary molars in children, age 3-5 years using split mouth technique in the same child, conventional amalgam restoration and use Stainless steel crown in other side

This study wiII be conducted on 30 chiIdren: The moIars wiII be treated by spIit mouth technique.

(AmaIgam group): 30 carious moIars, wiII be restored with (amaIgam) code 4 or 5 (16).

( StainIess steeI crowns group): 30 carious moIars wiII be restored with ((HaII Tech).

- CIinicaI Assessment:

During follow up periods if:

* Pain
* redness, and
* sweIIing wiII be assessed for presence or absence(18).
* Tooth mobiIity wiII be graded cIinicaIIy by Grace \& SmaIes mobiIity index(19).
* Restoration effecincy.
* Gingival index Gingival index (GI)

Radiographic examination ( Parallel PeriapicaI Radiograph) :

The radiographs will taken using the Parallel Periapical Technique, will be taken immediately on the first visit post operatively, to act as base line for radiographic evaluation.

The following criteria of radiographic assessment will include:

1. ExternaI or internaI root resorption.
2. Inter-radicuIar bone resorption.
3. Widening of the periodontaI Iigament space.
4. PeriapicaI radioIucency.

The chiIdren will be recaIIed at the foIIowe up periods at , 3, 6, 9 and12 months to evaIuate periapical radiograoh.

Eligibility Criteria:
Inclusion Criteria:

1. Apparently healthy children aged from 3-5 years old of both sexes.
2. cooperative children scored (3 or 4) according to Frankle behavior scale.
3. Informed consent were obtained from parents or care givers.
4. Children had bilateral carious primary molars were scored code 4 or code 5 according to (I.C.D.A.S.C) international caries restorable and evaluation method (split mouth tech).

Exclusion Criteria:

1. Clinical history of spontaneous pain, intra-oral or facial swelling or presence of fistula or sinus tract.
2. Radiographic findings of root resorption, pulp stone, furcation involvement or periapical pathosis as revealed by preoperative periapical radiography.
3. Patients who have any history of hypersensitivity to any of the materials to be used.
4. Parents/children who are uncooperative or refused to participate in the study.

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Treatment of Diabetic Retinopathy With Open-Label Anecortave Acetate Sterile Suspension (15 mg)

The purpose of this study is to provide compassionate use of anecortave acetate sterile suspension of 15 mg for a series of five patients as a means to control diabetic retinopathy.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of patients with diabetic retinopathy.
2. Patients must be at least 18 years of age.
3. Visual acuity of 20/30 to 20/320 in study eye on the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart
4. Visual acuity of 20/800 or better in fellow eye on the ETDRS visual acuity chart

Exclusion Criteria:

1. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
2. Patients who have undergone intraocular surgery within the last 2 months.
3. Patient participating in any other investigational drug study.
4. Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication.
5. Inability to obtain photographs to document choroidal neovascularization (CNV) (including difficulty with venous access).
6. Patient with significant liver disease or uremia.
7. Patient with known adverse reaction to fluorescein and indocyanine green or iodine.
8. Patient has a history of any medical condition which would preclude scheduled visits or completion of study
9. Patient has had insertion of scleral buckle in the study eye
10. Patient has received radiation treatment
11. Patient is on anticoagulant therapy with the exception of aspirin
12. Patient is pregnant or nursing.
Study to Assess Efficacy and Safety of PF-06947386 in Japanese Adult Patients With Complicated Intra-abdominal Infection

Study C3591036 is a Phase 3 study to assess the efficacy and safety of PF-06947386 in Japanese adult patients with complicated intra-abdominal infection requiring hospitalization. This is a multicenter, open-label, single-arm study. All eligible participants will receive intravenous infusion of PF-06947386 followed by intravenous infusion of metronidazole.


Eligibility Criteria:
Inclusion Criteria:

* Participant who is capable of giving signed, dated and timed informed consent (or by their legally acceptable representative)
* Participant aged 20 years or older
* Participant who is willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures
* Confirmation of infection by surgical intervention within 24 hours of entry: evidence of systemic inflammatory response; physical findings consistent with intra-abdominal infection; supportive radiologic imaging findings of intra-abdominal infections
* Intraoperative/postoperative enrollment with visual confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis

Exclusion Criteria:

* Participant will undergo surgery for traumatic bowel perforation within 12 hours or perforation of gastroduodenal ulcers within 24 hours. Other intra-abdominal processes that are not infectious.
* Participant has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation
* Participant whose surgery will include staged abdominal repair, or "open abdomen" technique, or marsupialization.
* Participant has evidence of sepsis with shock not responding to IV fluid challenge or anticipated to require the administration of vasopressors for \>24 hours
* Participant has suspected intra-abdominal infections due to fungus, parasites (eg, amebic liver abscess), virus, or tuberculosis
* Participant is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness
* Participant is pregnant or breastfeeding.
* Participant has received systemic antibacterial agents within the 72-hour period prior to study entry except for cases specified in the protocol such that participant is considered to have failed the previous treatment regimen, or participant has received systemic antibiotic agents no more than 24 hours (no more than one daily dose) within the 72-hour period prior to study entry, etc.
* Estimated CrCL ≤50 mL/min calculated by Cockcroft-Gault method.
Analysing Peripheral Skeletal Muscle Function Before and After Endobronchial Valve Treatment

Rationale: Chronic obstructive pulmonary disease (COPD) is characterised by a high prevalence of peripheral muscle dysfunction, which can have significant clinical consequences, including decreased exercise capacity, reduced quality of life, and even a higher mortality rate. Reduction of lung hyperinflation using bronchoscopic lung volume reduction treatment with one-way endobronchial valves (EBV) is a minimally invasive intervention which improves exercise capacity and physical activity in patients with severe emphysema. This positive effect is also related to weight gain and alterations in body composition. The physiologic and structural adaptations of skeletal muscle function after EBV treatment has never been investigated before.

Objective: To investigate the physiological and structural adaptations of peripheral muscle function at a cellular level in response to EBV treatment.

Study design: A single center, prospective clinical trial with a single-arm pretest-posttest design. Patients with severe emphysema who will receive a bronchoscopic lung volume reduction treatment are asked to undergo additional in-magnet exercise testing and muscle biopsies before and after placement of EBVs.

Study population: Patients with severe emphysema who are scheduled to undergo EBV treatment.

Main study parameters/endpoints: The difference in quadriceps phosphocreatine concentration (PCr), quadriceps inorganic phosphorus concentration (Pi), and quadriceps pH at rest, during progressive exercise, and recovery rate will be measured by 31P-MRS to assess the physiological effect of EBV treatment on skeletal muscle function and its bioenergetics. Furthermore, we will perform a detailed histological and biochemical analysis of muscle fiber type composition, mitochondrial density, master regulators of muscle oxidative programming, and mitochondrial respiration before and after EBV treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient is scheduled for a bronchoscopic lung volume treatment using one-way endobronchial valves;
* Patient read, understood and signed the Informed Consent Form.

Exclusion Criteria:

* Inability to perform a cycle ergometry test;
* Contraindications for undergoing a magnetic resonance imaging scan (e.g. claustrophobia, implanted cardiac devices);
* Body length \>190cm;
* Any anticoagulant therapy;
* COPD exacerbation 4 weeks prior to testing.
Non-Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PET)

Non invasive imaging of hypoxia with the aid of PET-scans could help to select the patients having a hypoxic tumour who could be treated with specific anti-hypoxic treatments such as bio-reductive drugs or hypoxic radio-sensitizers. Several 2-nitroimidazoles to which the compound to be tested, HX-4, belongs, labelled with Fluor-18 have already been used in patients. However, bad image quality and unpredictable kinetics limit their use. In extensive pre-clinical models, the combination of HX-4 labelled with Fluor-18 is a promising non-toxic new probe to determine hypoxia.

To determine the toxicity of the hypoxia PET-tracer \[18F\]-HX4 in cancer patients in two dose-steps:

* Step 1 (3-6 patients): a single dose of maximum 6 mCi (222 MBq) dose of \[18F\]HX4 (which contains a maximum of 15 μg HX-4) via a bolus IV injection.
* Step 2 (3-6 patients): a single dose of maximum 12 mCi (444 MBq) dose of \[18F\]HX4 (which contains a maximum of 27 μg HX-4) via a bolus IV injection.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmed solid tumour, primary or secondary stage IV and/ or tumours with no curative treatment options.
* Normal white blood cell count and neutrophils
* Normal platelet count
* No anaemia requiring blood transfusion or erythropoietin
* Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution).
* Calculated Creatinin clearance at least 60 ml/min
* No administration of Fluor-18 in the previous 24 hours
* Capable of complying with study procedures
Dietary Intervention to Improve Cardiometabolic Risk Profile in Individuals with Type 2 Diabetes

This is a randomized controlled trial to examine whether personalized guidance to increase the consumption of fiber rich food items according to the Dutch dietary guidelines, compared to usual care, improves health of individuals with type 2 diabetes.

Previous interventions with fibre supplements show promising results among individuals with type 2 diabetes, but wether these effects are similar when higher fiber intake is achieved through diet and not through supplements remains unclear.

The primary objective of this study is to investigate the effects of personalized dietary guidance to increase the intake of fibre-rich foods, as recommended in the Dutch dietary guidelines, on cardiometabolic risk profile in individuals who have type 2 diabetes, compared to usual care after six months.

The study is a parallel randomized trial over a period of twelve months, including an intervention period of six months and a follow up period of six months. The study population consists of adults with non-insulin-dependent type 2 diabetes, diagnosed by a medical doctor at least 6 months prior to study enrolment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes made by a medical doctor at least 6 months prior to study enrolment
* Adult
* Willing and able to follow dietary intervention
* Willing to participate in both intervention and control group
* Living at a reasonable distance from the research center at Wageningen University \& Research (WUR) (i.e.maximum of ± 1 hour away)

Exclusion Criteria:

* Currently treated with insulin therapy
* Recently (\< 6 months) or currently being under supervision of a dietician
* Pregnant or breast-feeding
* History of bariatric surgery, including gastric banding
* Current participation in a study with an investigational drug or dietary intervention
* Excessive alcohol consumption (more than 14 units for males/7 units for females per week) or drug use
* Clinical disorders that could interfere with the intervention (e.g. gastro-intestinal disorders, auto-immune diseases, psychiatric disorders, uncontrolled heart diseases, serious neurological disorders, renal failure or cancer)
* Not able to speak and understand the Dutch language
* No general practitioner
* Working at the department of Human Nutrition and Health at Wageningen University \& Research
Blood Naloxone Levels Following Intradermal Injection in Humans

The main purpose of this study is to evaluate pharmacokinetics/pharmacodynamics of intradermal administration of naloxone in healthy adult subjects.

Using approved drug formulations, injection devices, and assays, the investigators seek to determine the pharmacokinetics and pharmacodynamics of naloxone in human subjects using an intradermal delivery route. The long-term goal is to develop a product with better pharmacokinetic (PK) and pharmacodynamic (PD) properties than current delivery systems used in opioid overdose rescue. To the best of the investigators knowledge, this is the first study administering naloxone via an intradermal route in humans. Using an FDA-approved intranasal drug formulation, the investigators will administer 8mg/0.1ml of naloxone into the highly vascular dermal layer of the skin using microneedles in 3 healthy volunteer participants and measure plasma concentrations of naloxone for 60 minutes after injection. The investigators primary outcome measure is detectable levels of naloxone in plasma. Secondary outcome measures will be estimates of PK values derived from time versus concentration data.

Eligibility Criteria:
Inclusion Criteria:

* Ability to participate in the informed consent process
* Good peripheral venous access for proposed pharmacokinetic sampling
* Has not taken an investigational drug within prior 30 days (or 5 half-lives, whichever is longer)

Exclusion Criteria:

* Allergy to Naloxone or vehicle constituents (namely parabens)
* Active substance use as defined by a positive screen for drugs of abuse within seven days of study participation
* History of substance use disorder
* Taking opiate/opioid medications for any indication
* Chronic pain disorder
* Pregnant or breastfeeding
* Adults lacking capacity to consent, non-English speaking persons, or prisoners.
* Other medical history or active conditions deemed not safe for participation by the investigator
* Hematocrit \<35%
Miromatrix Biological Mesh for Ventral Hernia Repair

This study is being conducted to gather long-term data of the performance of the Miromatrix Biological Mesh.

Miromatrix Medical Inc. has developed a new biologic mesh, called MIROMESH®. MIROMESH received FDA 510(k) clearance with an indication for reinforcement of soft tissue on March 31, 2014 under K134033. Miromatrix Biologic Mesh is a non cross-linked, acellular surgical mesh that is derived from the highly vascularized porcine liver. This study will serve to provide clinicians with high-quality clinical data in order to provide them with a higher degree of confidence when selecting MIROMESH for ventral hernia repair.

Eligibility Criteria:
Inclusion Criteria:

* between 18 and 80 years old on the day of study enrollment
* ventral or incisional hernia greater than 9 cm2 for which the physician anticipates ability to achieve midline fascia closure following a retro-rectus repair/component separation
* hernia classified as CDC class 1 or 2 preoperatively
* able and willing to sign the consent form and comply with all study visits and procedures
* commit to non-smoking for at least 4 weeks prior to procedure

Exclusion Criteria:

* sensitivity to porcine material
* scheduled for a concomitant procedure of a wound classified as other than clean
* immunocompromised or at risk of immunosuppression (i.e. be HIV positive, be experiencing organ rejection, be a recent or anticipated chemotherapy recipient) as determined by the Investigator
* BMI ≥40
* A1C level ≥10.0
* participating in another clinical study
* cirrhosis, and/or ascites
* diagnosed with a collagen vascular disorder
* American Society of Anesthesiology (ASA) Class 4 or 5
* allergic to tetracycline or kanacmycin
* life expectancy of less than 2 years at the time of enrollment
* any condition in the opinion of the Investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements
Passport to Freedom: Health and Housing

The purpose of the Passport to Freedom (P2F) Health and Housing is to provide formerly homeless women a supportive group to process the impact of trauma on the women's overall health and wellbeing, learn strategies to reduce the symptoms of trauma and stress, and increased ability to cope with everyday stress while maintaining permanent housing.

The proposed project will use a mixed method design to examine the feasibility and effectiveness of the Passport to Freedom (P2F) Program, an intervention for formerly homeless women currently housed through a supportive permanent housing program. P2F involves: three 2-hr sessions to promote physical and emotional wellbeing through mindfulness techniques and health promotion activities; two home visits to provide individualized sessions with a nurse and a community health navigator; and a follow-up session 4 weeks after intervention to discuss the women's perception of the intervention. By the end of the program, women will have improved emotional self-regulation in response to everyday stress, positive perception of managing women's overall health, and increased confidence in maintaining stable housing.

Eligibility Criteria:
Inclusion Criteria:

* Women 18 years to 55 years, may be parents
* Able to read and write English
* Formerly homeless and currently living in permanent supportive housing through the Women's Housing Coalition Program.

Exclusion Criteria:

* Under 18 years of age
* Inability to speak or write English