cyrilzakka/clinical-trials huggingface dataset:
Ultrasound-Guided Technique in Distal Radial Artery Catheterization Study

The research project is focused on examining the clinical effectiveness of an enhanced ultrasound dynamic needle tip positioning method for guiding distal radial artery puncture and catheterization. Anticipated results suggest that the improved ultrasound dynamic needle tip positioning method will surpass tactile guidance in terms of the success rate of the first puncture attempt, as well as overall puncture and catheterization success rates.

The distal radial artery access route has several advantages; however, it comes with drawbacks like tortuous anatomy and a smaller lumen diameter. Compared to the wrist radial artery approach, it is more prone to spasm and has a lower success rate for puncture and catheterization. This clinical study aims to explore the effectiveness of an enhanced ultrasound dynamic needle tip positioning method for guiding distal radial artery puncture and catheterization.

In this prospective, randomized, single-center study, we will enroll 112 patients scheduled for percutaneous coronary angiography. They will be randomly assigned to either the control group (56 cases) or the study group (56 cases) using digital odd-even randomization. The control group will undergo conventional tactile guidance, while the study group will be guided by the improved ultrasound dynamic needle tip positioning method.

Parameters to be compared between the two groups include the success rate of the first puncture attempt, overall puncture success rate, number of puncture attempts, success rate of catheterization, time to successful catheterization, proportion of sheath sizes used, incidence of hematoma, and incidence of radial artery occlusion 24 hours post-procedure. The anticipated outcome is that the improved ultrasound dynamic needle tip positioning method will enhance the success rate of the first puncture attempt, overall puncture success rate, and catheterization success rate, while reducing the number of puncture attempts and operation time.

Eligibility Criteria:
Inclusion Criteria:

Patients between the ages of 18 and 85 who agree to undergo coronaroangiography

Exclusion Criteria:

1. Absence of radial artery pulsatility.
2. Abnormal Allen test.
3. Hemodynamic instability.
4. Preoperative ultrasound showing a distal radial artery diameter less than 1.8mm.
Management of Third-stage of Labor After Second Trimester Medical Pregnancy Termination

Prospective randomized trail which compare 2 regimens for third-stage management after second trimester medical pregnancy termination : 10UI intra venous oxytocin or no additional medication after fetal expulsion. Primary outcome was the incidence of placental retention.

Complication of third stage of labor in second trimester medical pregnancy termination is not well studied. Accord to publications, the placental retention rate is 30 to 40% in these situations. Placental retention may be associated with increased blood loss, increased requirement for blood transfusion anesthetic and operative complications, and infectious morbidity. The high incidence of retained placenta is an area of clinical concern. Publications reveal a wide variation in practices but there are only few studies about third stage of labor in second trimester medical pregnancy termination. The study is a prospective randomized trial. Two third stage management strategies are compared: 10 units of intra venous oxytocin (group 1) and no additional medication (group 2) after fetal expulsion. It concerns pregnancies between 14 and 28 weeks gestation.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and older
* medical pregnancy termination between 14 and 28 weeks gestation
* informed consent obtained

Exclusion Criteria:

* less than 18 years old
* refusal to consent
* in utero fetal death
Study on the Association of GSTP1 and Other Gene Polymorphisms With Platinum-induced Myelosuppression

This study intends to design a retrospective and prospective, cohort study to explore the association between genetic polymorphism of GSTP1 A313G rs1695 or others and adverse effects of platinum drugs, aiming to explore the risk factors of myelosuppression caused by platinum drugs, and provide data support for optimizing anti-tumor chemotherapy regimen, improve medication safety and improve the compliance of chemotherapy in patients.

Patients with pulmonary malignant tumors receiving platinum-containing chemotherapy regimen were included in the retrospective and prospective bidirectional cohort study to collect the basic information of the subjects, including gender, age, smoking history, primary site, basic liver and kidney function, chemotherapy regimen, etc. The polymorphisms of glutathione S transferase (GSTP1 A313G) were detected by Sanger dideoxy termination sequencing. To study the risk factors related to myelosuppression during chemotherapy, and to preliminarily explore the characteristics of myelosuppression caused by combination chemotherapy with platinum.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with non-small cell lung cancer with clear imaging or pathological evidence
2. Using a chemotherapy regimen containing platinum
3. Conducted blood routine and biochemical tests
4. Signed informed consent

Exclusion Criteria:

1. Blood routine and other relevant tests were not performed
2. Suffering from primary bone marrow system disease
3. Other reasons for not meeting the experimental requirements
OPT-IN: Online Parent Training Intervention for Young Children Diagnosed With Autism Spectrum Disorder

The goal of this observer-blinded randomized controlled clinical trial is to determine the effectiveness of a fully-online, parent-mediated, video-based, self-directed intervention for young children with autism (12-60 months) who have been diagnosed with autism in the last six months. The main question\[s\] it aims to answer are:

1. Does an online intervention for autistic children result in improved adaptive behaviour, compared to a psychoeducational control group?
2. Does an online intervention for autistic children result in reduced autism symptoms in children, and decreased stress and increased self-efficacy in parents, compared to a psychoeducational control group?
3. What are the predictors of response to intervention (i.e., child sex and age; initial autism symptoms and adaptive behavior; and parent self-efficacy, stress, and education).

Parents will be given six compulsory and eight optional online modules that will teach them skills to use while interacting with their autistic children to improve social and communication behaviours and minimize behaviours that interfere with learning.

The comparison group will receive six compulsory and eight optional online modules that will teach them about autism more broadly including diagnostic criteria, symptom profiles across development, etc.


Eligibility Criteria:
Inclusion Criteria:

* Child diagnosed with Autism or Autism Spectrum Disorder within the last six months at baseline

Exclusion Criteria:

* Parent does not speak English well enough to complete questionnaires
* Parent or child has complete vision or hearing loss.
* Parent or child is medically unstable.
Effects of 5 mg vs. 20 mg Desloratadine on Skin Lesions in Patients With Chronic Urticaria (CU)

The purpose of this study is to compare urticaria lesions (size, kinetics) by thermography, volumetry and digital time lapse photography in CU patients treated with desloratadine 5 mg or desloratadine 20 mg. Hypothesis: Updosing of desloratadine (20mg) is more efficient in the treatment of urticarial lesions as compared to standard dosing (5 mg desloratadine).


Eligibility Criteria:
Inclusion Criteria:

1. Outpatients with moderate to severe CU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch.
2. Patients must exhibit spontaneous urticaria lesions in the randomization visit.
3. History of beneficial effects of antihistaminic treatment.
4. Age between 18 and 60 years.
5. Female patients must be using adequate contraceptive precautions (highly effective method), or they must be postmenopausal, surgically sterilised, or hysterectomised (for details please see protocol).
6. Female patients must be using adequate contraceptive precautions (contraceptive pill, depot, double barrier methods), or they must be postmenopausal, surgically sterilised, or hysterectomised.
7. Voluntarily signed written informed consent.

Exclusion Criteria:

1. The presence of permanent severe diseases, especially those affecting the immune system, except CU.
2. The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhea diseases, congenital malformations or surgical mutilations of the gastrointestinal tract).
3. History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia.
4. History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy.
5. Evidence of severe renal dysfunction
6. Evidence of significant hepatic disease (liver enzymes twice the upper reference value).
7. The presence of galactose intolerance, lapp lactase deficiency or glucose galactose malabsorption.
8. History of adverse reactions including hypersensitivity to DL and Loratadine.
9. Intake of medicaments that could cause QT changes (drugs listed on www.qtdrugs.org).
10. Presence of active cancer which requires chemotherapy or radiation therapy.
11. Presence of acute urticaria / angioedema including laryngeal edema
12. History or presence of alcohol abuse or drug addiction.
13. Participation in any clinical trial within 4 weeks prior to enrolment.
14. Intake of oral corticosteroids or other immunosuppressive therapy within 14 days prior to the beginning of the study.
15. Use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study.
16. Pregnancy or breast-feeding.
17. Existing or planned placement in an institution after ruling according to § 40 passage 1 number 4 AMG (Arzneimittelgesetz).
Sildenafil IV Bolus Study

The objective of this study is to assess the safety, tolerability and pharmacokinetics of intravenous sildenafil (10 mg) administered as a bolus injection to patients with Pulmonary Arterial Hypertension already receiving and stable on oral Revatio 20 mg TID.


Eligibility Criteria:
Inclusion Criteria:

* Subjects (≥18 years old) receiving oral Revatio 20 mg TID for PAH within the approved indication (EU Summary of Product Characteristics) for a minimum of 1-month and who, in the investigator's opinion, have demonstrated good tolerability. Subjects with PAH who are nil by mouth for any reason (eg, elective surgery or medical procedure, TPN feeding, gastrointestinal disturbance etc) may also be included in the study provided they are haemodynamically stable (see Inclusion Criterion 4) and the 6 hour period of blood pressure and pulse monitoring in the study does not interfere with any planned medical or surgical intervention.
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
* Subjects who are willing and able to comply with scheduled visits, treatment plan and study tests and procedures.

Exclusion Criteria:

* Any subject receiving Revatio outside ('off-label') of the current Summary of Product Characteristics (SmPC).
* Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
* Introduction of potent CYP 3A4 inhibitors (eg, ketoconazole, itraconazole and ritonavir) within the previous 1 month of screening.
Relative Bioavailability of Two Lutikizumab Formulations and Pharmacokinetics, Safety, and Tolerability of Lutikizumab in Chinese Participants

The purpose of this study is to compare the bioavailability of two different formulations of lutikizumab, and to assess adverse events (AEs) and how lutikizumab moves through the body in healthy Chinese participants.


Eligibility Criteria:
Inclusion Criteria:

* Male and female healthy volunteers aged between 18 and 60 years.

  -- Part 2 only: Participant must be first-generation Han Chinese of full Chinese parentage residing outside of China. Participant must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
* BMI \<= 18.0 to \<= 29.9 kg/m\^2 after rounding to the tenths decimal, at screening and upon initial confinement.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

* Use any medications, vitamins, and/or herbal supplements within the 2 week period or 5 half-lives (whichever is longer) prior to study drug administration.
* History of: epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic ,gastrointestinal, hematologic, demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease, glaucoma, psychiatric disease or disorder, or any uncontrolled medical illness.
* Prior exposure to lutikizumab.
Assessing Function and Pain After Total Knee Arthroplasty With Combined Femoral and Popliteal Nerve Block

The goal of this interventional study is to examine whether a pain management technique of combined femoral and popliteal nerve block is effective in total knee arthroplasty patients. The main questions it aims to answer are:

Are there differences in postoperative outcomes? Does the nerve block, age, preoperative quadriceps muscle strength and Oxford Knee Score of the patient predict early functional ability? Participants underwent total knee arthroplasty and assessments. Researchers compared pain management techniques to assess effects on postoperative outcomes and identified the importance of preoperative variables a predictors of early functional ability. Further research is required to refine postoperative pain management strategies.


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18
* Electively assigned for primary knee replacement surgery.
* The American Society of Anesthesiologists physical status score 1-3.

Exclusion Criteria:

* Revision surgery.
* Patients suffering from chronic pain syndrome or chronic opioid use.
* Patients with previous neurological deficits in the lower extremities.
* A cognitive state that does not allow signing of consent or understanding simple instructions.
Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth

To evaluate the effect of estradiol with or without a prior gonadotropin releasing hormone analogue on insulin sensitivity and vascular function in transgender females compared to cisgender controls.


Eligibility Criteria:
Inclusion Criteria (transgender females):

* Identify as a transgender female
* Age 13-16 years at the time of enrollment
* If on a gonadotropin releasing hormone analogue, \> 6 months exposure
* Plan to start estradiol clinically in \< 4 months

Inclusion Criteria (cisgender males and females):

* Males and females ages 13-16 years

Exclusion Criteria:

* Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures
* Antipsychotic medication use
* Type 1 or 2 diabetes (by medical history)
* Polycystic ovarian syndrome (PCOS for cisgender females)
* Hypertension (resting BP ≥ 140/90 mm/Hg)
* Weight\> 400 lbs
* On oral progesterone medications (including oral progesterone or progestin, combined oral contraceptives or etonogestrel implant)
* Pregnancy (for cisgender females)
Combined PENG and LFCN Block for Total Hip Arthroplasty

A clinical trial investigating the effect of a combined locoregional anesthesia technique on the postoperative analgesia outcomes after a total hip arthroplasty. A PENG block will be used in combination with a LFCN block. The results will be compared to a control group that is solely treated with intravenous analgesia. This technique aims to provide improved pain scores after surgery without interference of revalidation.


Eligibility Criteria:
Inclusion Criteria:

* adult patients who underwent a primary total hip replacement under general anesthesia

Exclusion Criteria:

* insulin dependent diabetes mellitus
* chronic pain
* severe dementia or mental retardation
* allergy to local anesthetics
Metabolism of NNK in Japanese Americans

The risk of lung cancer varies by individual and by ethnic/racial group. In this study the investigators will explore how individual differences in the metabolism of a tobacco-specific lung carcinogen may contribute to the variable risk of lung cancer between ethnic/racial groups.

In this 10 day clinical trial, Japanese Americans will smoke a cigarette containing deuterium-labeled 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), a tobacco-specific lung carcinogen. The study cigarette will be smoked for 7 days.

This will allow for NNK metabolic profiling and determining the effect of CYP2A6 genotype on the level of NNK α-hydroxylation in Japanese Americans smokers using \[pyridine- D4\]-NNK containing cigarettes.

Eligible subjects will provide a baseline 24 hour urine sample. Study cigarettes spiked with labeled NNK will be provided to the subjects to smoke over a 7 day period. During this time, 24 hour urine samples will be collected over days 5, 6 and 7 on study cigarettes. Blood will be drawn on days 6 and 7 on study cigarettes. Samples will be analyzed for NNK metabolism.

Eligibility Criteria:
Inclusion Criteria:

1. Japanese American - one, but preferably 2 biological parents of Japanese descent
2. 21 years or older
3. Daily smoker
4. Eligible urinary ratios of total 3-hydroxycotinine to cotinine (3HC/COT):

   * "Little or no-CYP2A6 activity" defined as a 3-hydroxycotinine:cotinine ratio of \<0.6 or
   * "Relatively high" CYP2A6 activity defined as a 3-hydroxycotinine:cotinine ratio of \>3.0.
5. Stable and good physical and mental health
6. Provided written informed consent to participate in the study

Exclusion Criteria:

1. Unwilling to avoid other nicotine containing products during the study and no use of any nicotine-containing products except cigarettes for 1 week prior to their study visits
2. Currently taking any medications that affect relevant metabolic enzymes
3. Experiencing medical conditions that might affect biomarkers of exposure and effect
4. Pregnant or nursing or planning on becoming pregnant during the study
5. Unable to read and understand English
Safety and Efficacy of Coaxial Smart Drain (Redax TM) in Uniportal-VATS

The aim of the study is to evaluate efficacy and safety of "Smart Coaxial drain" (Redax TM, Poggio Rusco, Mantova, Italia) in terms of total amount of effusion drained, incidence of residual effusion at Chest X-Ray and patient's comfort in Uniportal- and Biportal-VATS upper lobectomies.

In particular, to evaluate in Uniportal-VATS upper lobectomies the efficacy and safety of smart coaxial drains compared with standard silicone chest tubes.

At the end of lung surgery, usually surgeons placed one or more chest tubes. There are several types of chest tubes and the type used by surgeons depends on centre avaiability/ local practice or surgeon choice etc...Coaxial smart drains are used in clinical practice since several years in Thoracic Surgery. In thoracoscopic (VATS) surgery usually only one chest tube is placed. In this study, we evaluate the efficacy of placement of 28Fr "coaxial smart drain" chest tube versus 28 Fr standard chest tube after Uniportal- or Biportal-VATS upper lobectomies in terms of total amount of effusion drained, incidence of residual effusion at Chest X-Ray and patient's confort.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergone upper right or left lobectomy in Uniportal- or Biportal-VATS

Exclusion Criteria:

* Patients undergone open surgery
* Patients undergone middle or lower lobectomies
* Patients undergone chest wall/or wedge resections
Cartilage Versus Temporalis Fascia Graft in Tympanoplasty for Recurrent Tympanic Membrane Perforation '' Comparative Study ''

Use of Cartilage Versus Temporalis Fascia as a Graft in Tympanoplasty for Recurrent Tympanic Membrane Perforation

The main aim of successful tympanoplasty is to create a well aerated closed cavity after total removal of the disease. Numerous types of grafting materials have been used for closure of the tympanic membrane including fascia, periosteum, perichondrium, cartilage, vein, skin, and fat tissue . Autografts are thought to be the most compatible grafting materials with the best surgical results in tympanoplasty Temporal muscle fascia is composed of irregularly arranged elastic fibers and fibrous connective tissue. For this reason postoperative dimensions of temporal muscle fascia are unpredictable.

Cartilage has a constant shape, firmer than fascia and also lack fibrous tissue, so that postoperative dimensions remains the same and beside this, it is also nourished by diffusion and show great adaptation with TM . These advantages make the cartilage graft more preferable by otologists recently.

the use of cartilage graft in many different ways such as perichondrium cartilage island technique, palisade technique or cartilage reinforcement technique

Eligibility Criteria:
Inclusion Criteria:

* patients with safe chronic suppurative otitis media patient with recurrent perforation patirnt with coductive hearing loss

Exclusion Criteria:

* sensorineural hearing loss active infection compromised immune system
The PPHgb Study: Non-Invasive Hemoglobin Measurement

This project is a prospective observational study aimed to assess the use of non-invasive hemoglobin measurement in anticipating postpartum hemorrhage and predicting estimated blood loss. The non-invasive hemoglobin device is the Radical-7 Pulse CO-Oximeter which is a spectrophotometer manufactured by Masimo, Inc. Participants in the study will be undergoing a cesarean delivery at the George Washington University Hospital and during delivery the patient will wear the device on their fingertip so that hemoglobin measurements can be continuously recorded. No changes from routine medical management will occur during the study.

This project is a prospective, observational study aimed to predict bleeding using hemoglobin trends measured non-invasively in patients undergoing elective cesarean delivery at the George Washington University Hospital.

The primary outcome is trend in hemoglobin measurement, at which additional interventions are required to control hemorrhage. The overall goal is to be able to determine a threshold point in which a drop in the hemoglobin level indicates severe bleeding in anticipation of postpartum hemorrhage. Through the observation of the continuous monitoring of hemoglobin across all participants and correlating those with severe hemorrhage to the magnitude of drop or time of drop, this could potentially optimize the hemorrhage protocol and might limit the need for blood transfusion and decrease maternal mortality and morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women age 18 - 50 years old
* Patients scheduled for cesarean delivery at \>34 weeks gestation
* Patients who failed trial of labor and require cesarean delivery

Exclusion Criteria:

* Patients with spontaneous or operative vaginal delivery
* Patients with hemoglobinopathies (qualitative defects, sickle-cell anemia) and hemoglobin synthesis disorders (quantitative defects such as thalassemia)
* Patients with peripheral vascular diseases and skin conditions that affect blood vessels in the digit
* Patients with hyperbilirubinemia