cyrilzakka/clinical-trials huggingface dataset:
Effect of the Coughing Technique During Subcutaneous Heparin Injection

Objective: to examine the effect of the medium intensity coughing technique during subcutaneous low molecular weight heparin injection on pain severity and individual satisfaction in general surgery patients. Method: a prospective, quasi-experimental study included 100 patients who had prescribed a subcutaneous low molecular weight heparin injection once in 24 hours. Each patient received two injections by the same researcher using standard injection technique with medium intensity coughing technique and only standard injection technique.

Aims and objectives: The aim of this study was to examine the effect on the level of pain severity and satisfaction of patients of the medium intensity coughing technique applied to patients during the administration of subcutaneous low molecular weight heparin (LMWH) injection.

Design: This research was a prospective quasi-experimental study. Methods: It was conducted with 100 patients in the General Surgery Clinic of a university hospital in the Marmara Region of Turkey. Subcutaneous LMWH injections were administered by the same nurse to the outer side of the right and left upper arms by the standard injection technique and the medium intensity coughing technique. Immediately after the subcutaneous LMWH injection was given, a researcher who did not know which injection method had been used asked the patients to evaluate their pain levels by the Visual Analog Scale (VAS) and their satisfaction with the performance of the injection by the Visual Individual Satisfaction Scale (VISS).

Eligibility Criteria:
Inclusion Criteria:

* Participating voluntarily in the study
* Being over the age of 18,
* Having a doctor's prescription for subcutaneous low molecular weight heparin 0.6 mL treatment and not yet having begun treatment.
* Having no coagulation disorder, having no disorder that could affect pain perception, -
* Having no incision, lipodystrophy, or finding of infection at the injection site,
* Having no communication problem

Exclusion Criteria:

* Not wanting to participate in the study, or during the course of the research, wishing to withdraw from the study
* Having any condition which would affect the sensation of pain
* Not being able to agree on a place or time
* Being less than 18 years of age
The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea

The investigation is a prospective, randomized, single blinded, crossover study. The investigation is designed to evaluate the performance, comfort and ease of use of the F\&P Trial Full Face Mask Seal amongst Obstructive Sleep Apnea (OSA) participants. A total number of 40-45 OSA participants will be recruited for the trial by the investigation site

This study will involve three visits to the investigation site. During visit one participants will be randomized to, fitted with and issued with the first trial mask seal for use in- home for 7 ±4 days.

The participants will then come in to return the mask seal and be fitted and issued with the second trial seal for use in home for 7±4 days.

Visit Three will involve the participants returning the second trial seal and providing feedback.

Eligibility Criteria:
Inclusion Criteria:

* Adult (22+ years of age)
* Able to give informed consent
* Apnea hypopnea Index (AHI) ≥ 5 on diagnostic night
* Either prescribed Automatic positive airway pressure (APAP), Continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (PAP) for OSA
* Fluent in spoken and written English
* Existing F\&P full face mask user

Exclusion Criteria:

* Inability to give informed consent
* Participant intolerant to PAP
* Anatomical or physiological conditions making PAP therapy inappropriate
* Current diagnosis of respiratory disease or carbon Dioxide (CO2) retention
* Pregnant or may think they are pregnant.
Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A

The primary objectives of this study are: to evaluate the safety and tolerability of rFVIIIFc administered as a prophylaxis (Arm 1), weekly (Arm 2), on-demand (Arm 3), and surgical treatment regimen; to evaluate the efficacy of the rFVIIIFc tailored prophylaxis regimen (Arm 1); to evaluate the efficacy of rFVIIIFc administered as an on-demand (Arm 3) and surgical treatment regimen. The secondary objectives of this study are: to characterize the PK profile of rFVIIIFc and compare the PK of rFVIIIFc with the currently marketed product, Advate®; to characterize the range of dose and schedules required to adequately prevent bleeding in a prophylaxis regimen, maintain hemostasis in a surgical setting, or to treat bleeding episodes in an on-demand, weekly treatment, or prophylaxis setting.

Participants are assigned to one of three treatment regimens: 1) a tailored prophylaxis regimen, 2) a weekly dosing regimen, or 3) an on-demand regimen. Treatment continued for 28 (±2) to 52 (±2) weeks. PK assessments for all participants are conducted on varying schedules, according to participants' group assignments. Additionally, two subgroups are defined. One subgroup of participants undergo PK profiling with a single dose of the comparator Advate®. A second subgroup consists of participants from any of the treatment arms that required surgery during the study. Depending upon country location, participants might have the option of continuing treatment within study 8HA01EXT (NCT01454739).

Eligibility Criteria:
Inclusion Criteria:

* Male, ≥12 years of age with weight at least 40 kg
* Diagnosed with severe hemophilia A, defined as \<1 IU/dL (\<1%) endogenous Factor VIII)
* History of at least 150 documented prior exposure days to any Factor VIII product
* Platelet count ≥100,000 cells/μL

Exclusion Criteria:

* History of Factor VIII inhibitors
* Kidney and liver dysfunction
* Diagnosed with other coagulation disorder(s) in addition to hemophilia A
* Prior history of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration
Colpopexy and Urinary Reduction Efforts (CARE) Protocol

Pelvic organ prolapse occurs when the muscles holding pelvic organs (e.g., the uterus or bladder) weaken and the organs fall or slide down into the vagina. Pelvic organ prolapse can be corrected with surgery. However, women who have this surgery may develop urinary incontinence. This study will determine how doctors can predict this problem and whether an additional surgical procedure at the time of prolapse surgery can prevent the development of urinary incontinence.

Many women have surgery for pelvic organ prolapse (cystocele, uterine prolapse, rectocele). Women with advanced pelvic organ prolapse may experience stress urinary incontinence following surgery to repair the prolapse. Development of incontinence is unpredictable. This study will determine which, if any, clinical tests are useful for predicting post-operative urinary incontinence. The study will also determine if a Burch urethropexy should be performed routinely or selectively at the time of sacrocolpopexy in continent women.

Women with pelvic organ prolapse who are scheduled for prolapse repair will be randomized to a Burch urethropexy group or to a control group. Women in the Burch group will undergo urethropexy at the time of prolapse repair. Assessments will include a quality of life telephone interview, urodynamic testing, and physical examination. Follow-up evaluations occur at 6 weeks, 3 months, and 1 and 2 years following surgery. Post-operative phone interviews will occur at 3 months, 6 months, and 1 and 2 years.

Eligibility Criteria:
Inclusion Criteria

1. Eligibility for primary procedure (sacrocolpopexy)
2. Eligibility for secondary procedure (Burch colposuspension)
3. Stage II-IV anterior vaginal prolapse, defined as POP-Q Point Aa at -1, 0, +1, +2, or +3 cm.
4. Negative stress incontinence screen
5. Negative stress incontinence screen (MESA questionnaire)

Exclusion Criteria

1. Contraindication for sacrocolpopexy or Burch colposuspension.

   * Anatomic contraindication for Burch colposuspension (i.e., Point Aa fixed at -2 or -3 cm).
   * Surgeon judgment that a contraindication to Burch colposuspension exists.
2. Anticipated geographic relocation within the first three months after surgery (e.g., within approximately 6 months of screening).
3. Inability to provide informed consent or to complete testing or data collection.
4. Currently pregnant.
DermaRep™ Device in the Treatment of Venous Leg Ulcers

This is a First in Human clinical study on the safety and effectiveness of DermaRep™ wound contact dressing. Patients with venous leg ulcers will be treated with standard of care dressings and compression for 4 weeks to establish a baseline wound healing response. All patients will then be treated with DermaRep™ wound contact dressing in addition to standard of care for a further 8 weeks. If the wound has not healed, patients will continue treatment with standard of care only for a further 4 weeks. All patients will be assessed at the 16 week timepoint, the primary endpoint.


Eligibility Criteria:
Inclusion Criteria:

* The patient is at least 18 years of age
* The patient is male and female not pregnant or lactating and using contraception
* The patient has a confirmed venous leg ulcer with:Confirmed actively managed reflux; No exposed tendon or bone; Ulcer surface area between 2cm2 and 80cm; ABPI\>0.8
* The patient agrees to abstain from enrolment in any other clinical trial for the duration of the study
* The patient is able to understand the aims and objectives of the trial and is willing to consent

Exclusion Criteria:

* Study treatment area has exposed bone or tendon
* Poorly controlled diabetes
* Arterial insufficiency (ABPI\<0.8)
* Pregnant/lactating females (tested as per institutional requirements)
* The patient has a severe dermatological disorder (e.g. severe psoriasis, epidermolysis bullosa, pyoderma granulosum)
* The patient is unable to follow the procedures set by the protocol
* The patient has a history of any significant cardiac, pulmonary, renal. hepatic, neurological and/or immune dysfunction that in the opinion of the investigator may compromise patient safety or study objectives
* The patient is taking any known medications that in the opinion of the investigator may compromise patient safety or the study objectives
* The patient has any known allergies to any of the device materials to be used in the trial (egg allergy)
* The patient is a vulnerable or protected adult
* The patient is unable to provide consent
Ultrasound Biomicroscopic Analysis of Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses

To report the Ultrasound Biomicroscopic findings following Cionni Ring bag fixation and in-the-bag IOL Implantation. To assess the relationship of the Bag and Cionni ring positioning in relation to surrounding ocular structures, in pediatric eyes

Cionni ring fixation of the capsular bag in conjunction with placement of an IOL has been found to be safe and effective compared with other current alternatives, even given the exceptionally high difficulty levels and complexity of these cases, in both adult and pediatric eyes. One limitation of techniques requiring trans-scleral suturing is that the suture cannot always be passed under adequate visualization, and, once the knot is secured, the exact position of the Cionni ring cannot always be accurately localized. Analysis of Cionni ring position with respect to the IOL and iris is important, as faulty placement of the ring or IOL can lead to complications which can threaten vision, especially in children with a high predisposition towards postoperative adverse events. Unfortunately, pupillary dilatation and slit-lamp examination may not always be adequate to assess the Cionni ring or the eyelet position, as it occupies the peripheral section of the capsular bag. UBM has been shown to be accurate and reproducible in examining the haptic position in relation to the sulcus and ciliary body, anterior chamber depth (ACD), vitreous incarceration, focal iris abnormalities, angle anatomy, and relationship of the iris to the lens (straight or tilted). This study aims to provide information on UBM findings following Cionni ring implantation in pediatric eyes for non-traumatic subluxation of the crystalline lens.

Eligibility Criteria:
Inclusion Criteria:

* Children less than 18 years of age,
* Non-traumatic Lens Subluxation undergoing Cionni RIng Bag fixation with In-the-Bag IOL implantation

Exclusion Criteria:

* Traumatic Lens Subluxation
* Intraoperative inability to fixate the Cionni Ring
Evaluation of Headache and Childbirth in a Chronic Pain Population

Headache and backache are common symptoms following childbirth. The incidence of these symptoms have been shown to increase during the postpartum period between 5 to 12 months following delivery. By 12 months postpartum up to 45% and 65% of women experience headache and backache, respectively. While studies have reported headache and backache as frequently persistent symptoms beyond the first year postpartum, few studies have specifically interrogated women seeking specialist pain physician input or identified predisposing risk factors. Finally there is little known about typically described pain characteristics of women who suffer with chronic postpartum headache and backache. We aim to compare the prevalence of chronic headache in women that have versus have not experienced childbirth.


Eligibility Criteria:
Inclusion Criteria:

* Women greater than 18 years old
* Agreeing to be contacted for research purposes.
* Able to read and understand English who have had agreed to be contacted with a valid email address

Exclusion Criteria:

* Self identified as non-female
* Age \<18 years old.
* Women without computer or electronic device access or valid email address and women who did not respond
Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria

Paroxysmal nocturnal hemoglobinuria is an acquired chronic hemolytic anemia,this study is designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in patients with classic paroxysmal nocturnal hemoglobinuria.

Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired clonal disorder of the hematopoietic stem cell characterized by intravascular hemolysis, hemoglobinuria, anemia, and thrombosis, Patients may be at high risk of thrombosis and may develop bone marrow failure or aplastic anemia, with low white blood cell and platelet counts,because the manifestation and pathologic processes are complicate,the treatment is very difficult,this study is designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in patients with classic paroxysmal nocturnal hemoglobinuria

Eligibility Criteria:
Inclusion Criteria:

1. Clinical and biochemical signs of classic Paroxysmal Nocturnal Hemoglobinuria
2. Diagnosis confirmed by Ham's test or Flow cytometry Patients have any Flow cytometry data
3. patient should complete levamisole study for at least half a year

Exclusion Criteria:

1. Active infection which requires antibiotic treatment
2. Pregnant or lactating women
3. Epilepsy and mental illness
4. Kidney and liver function abnormal
5. patient who terminate ealy from levamisole study
Study on Sit to Quit Phone Intervention

This study is designed to test the effectiveness of the smoking cessation intervention "Sit to Quit" through a randomized-control trial. This study will compare abstinence outcomes in the Sit to Quit study group to a control group using the North Carolina State Tobacco Quit Line.

This study is designed to test the effectiveness of the smoking cessation intervention "Sit to Quit" through a randomized-control trial. This study will compare abstinence outcomes in the Sit to Quit study group to a control group using the North Carolina State Tobacco Quit Line. This is an investigational study (n=60) designed to test Sit to Quit (STQ) versus Quit Line (QL) through a pilot randomized control trial. The proposed study is designed with double-blind procedures (participants and study staff) for randomization of 60 participants recruited through Duke Smoking Cessation Program into two groups: STQ and QL. STQ participants will receive access to the STQ Instructional Video, the STQ manual, and proactive Quit Coach calls supporting STQ. QL participants will be instructed to contact the NC Quit Line and will receive access to "web Coach" (Alere Well-being site), the Quit Line manual, and proactive Quit Coach calls supporting "Quit for Life." All statistical analysis will be performed under the directions of the statistician designated in key personnel. Outcomes of variables including: demographic variables, evaluation responses, and abstinence rates will be analyzed using general regression models using an ANOVA-based design. The study Principal Investigator Dr. James Davis will ultimately be responsible for data and safety monitoring. Subject data will be collected during visits and captured in the Electronic Medical Record. Data will be collected by phone, and this data will be stored in REDCap. Participants that experience events related to their clinical treatment will be recommended to follow-up with their provider.

Eligibility Criteria:
Inclusion Criteria:

* Patient being treated at Duke Smoking Cessation Program for tobacco use
* Age 18 years or older
* Actively smoking 5 or more cigarettes per day for at least one year
* Fluency in spoken and written English
* Willing to set a quit date within 2 weeks
* Access to a smart phone or internet and telephone
* Willingness to watch 3 videos on computer, receive 5 counseling calls, and attend investigational visits.

Exclusion Criteria:

* CO test under 7 ppm during initial screening
* 8 or above on the Alcohol Use Disorders Identification Test (AUDIT-10)
* 6 or above on Drug Abuse Screening Test (DAST-10)
* 3 or above on Patient Health Questionnaire (PHQ-2) Depression Scale
* Daily use of a second form of tobacco or nicotine (e.g. e-cigarettes, cigars, chewing tobacco, snuff)
* Current use of a smoking cessation medication (e.g. nicotine replacement, Varenicline, Bupropion)
* Intolerable side effects related to, refusal to take, or medical contraindication with nicotine patch
* Symptomatic cognitive or emotive disorder such as untreated schizophrenia, severe untreated depression, or severe untreated anxiety. This is determined by clinical assessment.
Supplementary Food on Prevention of Moderate Malnutrition in Children

The study will evaluate the impact of a supplementary food (cookies) in preventing the risk of developing moderate acute malnutrition (MAM) in preschool mildly malnourished children.

Children will be divided in two groups; one will received the cookie plus 12 educative sessions and the other just the educative program. The study will last 12 months


Eligibility Criteria:
Inclusion Criteria:

* (2-5 years old), who are from low socioeconomic classes (E and D classes)
* reside in rural areas, and with WHZ- between \> -3 and ≤ -2, and
* informed consent given by the subject's mother or caregiver

Exclusion Criteria:

* Severe acute malnutrition (HAZ, WAZ and WHZ-scores ≤-3) based on the 2006 World Health Organization (WHO) reference values (24)
* Vitamin A deficiency (softening, ulceration, cloudiness of the cornea, and dryness of the conjunctivitis), and iodine deficiency (visible goiter)
* (3 or more episodes of loose/liquid stools/per day and lasted more than 24-hours), fever (high temperature that lasted more than 24 hours as reported by the mother/caregiver), and respiratory infections (coughing and/or runny nose that last more than 24 hours).
* Current consumption of other supplementary foods.
* Peanut or other ingredient allergy based on prior report. If some direct family member is allergic to peanuts, child would not be enrolled.
Real World App-based CCAAP Management of Children With Asthma

This study is a multi-center randomized controlled trial of children with asthma. The objective of the study is to compare the App-based efficacy of China Children Asthma Action Plan (CCAAP) and written CCAAP used in management of children with asthma. The main questions are:1. Is the App-based CCAAP effective/feasible in management of children with asthma? 2. Is the App-based CCAAP better than written CCAAP in management of children with asthma?

The study is a multi-center randomized control study.The enrollment period is 3 months. Patients who is in 6-17 years of age will be randomized recruited into two groups: the App-based asthma action plan group and the written CCAAP group. Patients in App group will receive written CCAAP and mobile phone-based asthma self-management APP (Youran Respiratory) which includes an electronic asthma action plan, peak expiratory flow monitor system and Peak Expiratory Flow Meter. Patients in written CCAAP management group will write down the symptoms and PEF in asthma diary. The data of the number of asthma episodes, the improvement of FEV1 , the number of unscheduled medical visits, the score of children's quality of life, the questionnaire of asthma knowledge, ACT / C-ACT score, the absent days of parental work, the absent days of children study, and the cost of health economics will be collected regularly in a year with the interval of 3 months to assess the efficacy of CCAAP in asthma management. The study will recruit 400 cases for each group from ten children's hospitals. The study will be completed in a year.

Eligibility Criteria:
Inclusion Criteria:

* did not receive control treatment or did not reach well-control;
* can perform spirometry pulmonary function tests;
* parents are skilled in using smartphones and APP apps (Android or IOS);

Exclusion Criteria:

* reach the level of asthma well control;
* can not use the smartphone APP software;
* can not cooperate the test of peak expiratory flow;
* did not treatment coexist respiratory disease effectively (such as sinusitis, obstructive sleep apnea-hypopnea syndrome, etc.);
* combined with other systemic diseases outside the respiratory system (such as leukemia, rheumatoid arthritis, etc.).
* receiving allergen-specific immunotherapy.
* undergoing trial for other medications or instruments.
A Study to Evaluate the Effect of the Experimental GLP-1 Drug PF-07081532 on Blood Levels of Common Birth Control Pills, and Drugs Omeprazole and Midazolam, and Effect of GLP-1 Drug Semaglutide on Midazolam Blood Levels in Healthy Adults With Weight in the Obesity Range

Two different groups of healthy volunteers will be chronically treated with GLP-1 drugs PF-07081532 or alternatively Semaglutide. The effect of these GLP-1 drugs on a single dose of the common sedative medication midazolam blood levels will be measured. The effect of chronic PF-07081532 on single doses of the common stomach acid medication omeprazole, and common birth control medication blood levels will also be measured. The hypothesis is that chronic administration of the GLP-1 drugs will minimally affect blood levels from these common medications.


Eligibility Criteria:
Inclusion Criteria:

* Healthy (no clinically relevant abnormalities)
* BMI 30.0-45.4 inclusive

Exclusion Criteria:

* Current or history of significant clinical condition
* Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 or 14 days or 5 half-lives (whichever is longer)
* Pregnant
* Breast feeding