cyrilzakka/clinical-trials huggingface dataset:
Communication Strategies to Increase HPV Vaccination Intention

This research aims to identify communication strategies to improve the uptake of vaccines using an experimental design, focusing on the Human Papillomavirus (HPV) vaccine, which is highly effective in preventing HPV-related cancers. However, low HPV vaccination rates among adults remain a significant public health challenge. Although randomized controlled trials (RCTs) have demonstrated that interventions can increase vaccine uptake in children, few RCTs have been conducted on adults. To address this gap, a multidisciplinary investigative team with expertise in communication, medicine, nursing, and behavior-change intervention research, and a history of extensive collaboration, will conduct a survey experiment on a national sample of over 3,689 adults to identify the most promising theory-based messages to strengthen HPV vaccine intentions.


Eligibility Criteria:
Inclusion Criteria:

* 18-45 years old

Exclusion Criteria:

* Under 18 and over 45 years old
* Received HPV vaccine or unsure about receipt
Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081)

The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.


Eligibility Criteria:
Inclusion Criteria:

* Greater than one year history of migraine
* Attacks typically mild when they begin and progress to moderate or severe
* Experience 1-4 migraine attacks per month

Exclusion Criteria:

* More than 15 headache days per month
* Heart disease
* Uncontrolled high blood pressure
Association of Plasma Transfusions and Invasive Fungal Infection

Although lacking strong evidences, plasma transfusions are commonly used in critically ill neonates. To date, the relationships between plasma transfusions and nosocomial infection remain controversial and no study has reported the relationships between plasma transfusion and invasive fungal infection (IFI)

Our aim is to explore the association between plasma transfusions and IFI in critically ill neonates

Eligibility Criteria:
Inclusion Criteria:

* all critically ill neonates admitted in hospital

Exclusion Criteria:

* severe congenital abnormality;
* died within 24 hours or left neonatal intensive care unit within 24 hours according to their parents' decisions;
* parents' decision not to participate.
Safety Study of Dantrolene in Subarachnoid Hemorrhage

Subarachnoid hemorrhage (SAH) is a devastating acute brain injury due to bleeding onto the brain surface from a ruptured aneurysm. Cerebral vasospasm (cVSP; critical narrowing of brain arteries) is a known complication after SAH and significantly increases disability and death after SAH. Vasospasm is difficult to treat and can lead to stroke. Animal studies have shown that the muscles in the artery wall play a role in cVSP.

Dantrolene has been FDA approved and extensively used in clinical practice as a muscle relaxant for more than 30 years. It has been shown to provide some benefit in animal studies of cVSP, as well as in a small number of humans. However, the first human studies have only been observational and over a short period of time.

This study will evaluate the safety and tolerability of intravenous dantrolene given every 6 hours over seven days to patients with or at risk for cVSP after SAH. The goal is to determine if future efficacy studies should be done to determine if treatment with Dantrolene may improve the outcome of patients with cVSP after SAH.

Once eligibility criteria are met, patients will be randomized to either dantrolene-IV or placebo (equiosmolar, volume-equivalent sterile water with 5% mannitol as dantrolene-IV also contains 5% mannitol). Study subjects will be visited daily by a study nurse to determine side effects, tolerability, record hemodynamic measures and laboratory values. Patients will have daily serum Na, osmolality, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALK) measured. In addition, daily bedside transcranial doppler will be performed by a blinded examiner. Patients will undergo cerebral angiograms per clinical routine. Angiographic measurements of arterial narrowing will be performed by a blinded radiologist. Specific stop criteria are pre-defined.

Eligibility Criteria:
Inclusion Criteria:

* Documented aneurysmal SAH by computed tomography angiography (CTA), magnetic resonance angiography (MRA) or angiography
* Secured aneurysm (coiled or clipped)
* Enrollment achievable within 14 days after SAH

Exclusion Criteria:

* Pregnancy
* Prior history of cirrhosis or hepatitis B/C, or any two of the following three liver enzymes elevated to greater than: ALT \>120 Units/L, AST \>120 Units/L, alkaline phosphatase \>345 Units/L (three times upper limit of normal)
* Patients on verapamil
* Patients with brain edema and/or elevated intracranial pressure (\>25mm Hg)
* Patients treated with hypertonic saline or mannitol prior to enrollment
* Patients with too severe SAH with low likelihood of survival (Hunt \& Hess 5)
The Effect of Cryotherapy in Pain Control, Function and Quality of Life in Individuals With Knee Osteoarthritis

The purpose of this study is to verify the effect of cryotherapy in pain control, function and quality of life in individuals with knee osteoarthritis.

The purpose of this study is to verify the effect of cryotherapy in pain control, function and quality of life in individuals with knee osteoarthritis. This is a randomized controlled clinical trial, double-blinded. Will participate in the study 60 patients with knee osteoarthritis, diagnosed with clinical and radiographic criteria of the American College of Rheumatology, of both sexes, aged between 40 and 75 years. The total number of subjects will be divided randomly into two groups of 30 subjects each. During four consecutive days, for a period of 20 min, each group will receive one type of intervention around the knee with osteoarthritis: the cryotherapy group will receive an application of ice bags with compression and the placebo group will receive an application of sand bags with compression, the weight and volume of the sand bags will be similar to that used in cryotherapy. Every individual will have the following variables evaluated one day pre- and one day post-intervention: pressure pain threshold (Algometry), pain index (VAS), physical function questionnaires (WOMAC, KOOS) and physical activity (IPAQ). Two physical function tests will also be carried out: the 30s sitting and standing chair and the Timed Up and Go (TUG). Thermographic images will also be obtained for further temperature analysis of the knee with osteoarthritis. Moreover, after a period of 3 months, participants will perform a follow-up in which will be measured the VAS, WOMAC and KOOS questionnaires. Also, some Yes/No questions about the continued use of the therapy will be asked,

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with knee osteoarthritis based on clinical and radiographic criteria of American College of Rheumatology
* Osteoarthritis signals in at least one of the compartments of the knee joint (tibiofemoral and / or the patellofemoral joint)
* Do not perform regular physical activity - less than three times a week regularly
* Grade 2 or 3 according to the criteria of Kellgren \& Lawrence knee osteoarthritis radiographic examination scale.
* Minimum score of 4 cm in Visual Analogue Scale (total 10 cm)
* Body Mass Index less or equal to 45 kg/cm2

Exclusion Criteria:

* Physical therapy within 3 months prior to the research project
* Corticosteroid injection in the knee (in the previous 6 months)
* Medical condition (cardiorespiratory, neurological and / or musculoskeletal)
* Previous ankle, knee or hip surgery
Examination of The Relationshıp Between Body Mass Index And The Skin-Epidural Space Distance

Aim: The aim of the study; to investigate whether there is a relationship between body mass index (BMI), waist circumference, and abdominal subcutaneous adipose tissue and the skin-epidural space distance measured by USG.

The research was carried out in the block room in the preoperating room of Dokuz Eylül University Practice and Research Hospital and with 42 volunteer operating room workers aged between 18-59 years. Height, weight and waist circumference measurements were made with standard measuring instruments, and other measurements were completed by ultrasonography (USG) separately by an anesthesiologist and a radiologist. For ultrasonographic evaluation, left lateral decubitus, right lateral decubitus and in sitting position, skin-dural junction, skin-vertebra corpus, anterior complex distances, upper and lower SIAS levels were examined with convex probe as transverse median. In addition, abdominal subcutaneous fat thickness measurements were made with a linear probe in the supine position. The statistical correlations of all measurements were examined.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 59 years old.
2. ASA I-II classification.
3. Body Mass Index (BMI): 18.5-29.9 kg/m2.

Exclusion Criteria:

1. Individuals under 18 or over 59 years old.
2. Those with a history of vertebral surgery.
3. Patients diagnosed with spinal deformities (excluding scoliosis ≤10 degrees, kyphosis \<30 or \>80 degrees).
4. Individuals with rheumatologic diseases affecting skeletal structure such as ankylosing spondylitis, rheumatoid arthritis.
5. Presence of wounds or infections in the lumbar region.
6. Volunteers who underwent epidural or spinal interventions in the lumbar region within the last month.
7. Individuals with bone implants affecting posture, such as hip or knee prostheses.
8. Pregnant women.
9. Individuals with conditions like Cushing's syndrome, hypothyroidism, acromegaly causing lumbar edema.
10. Volunteers using corticosteroids.
11. Obese individuals (BMI: \>29.9).
A Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension

To evaluate the safety and effectiveness of the ROX Coupler used to create an arteriovenous anastomosis in the iliac region (between the iliac artery and vein) in subjects with hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Mean 24-hour ambulatory blood pressure monitoring (ABPM) SBP ≥ 140 mmHg at screening.

Exclusion Criteria:

* Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.
Ethiopia Group Antenatal Care Study at the Health Post Level

The purpose of this study is to determine the acceptability, feasibility, and effectiveness of a group antenatal care (G-ANC) model introduced at the health post level compared to usual antenatal care (ANC) among women who report intention to receive ANC at the health post level.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 15 years at the time of enrollment; pregnant 15-17 year-olds will be treated as emancipated/mature as per local regulations
* Gestational age less than or equal to 20 weeks at the time of enrollment determined by last menstrual period (LMP), pelvic exam, fundal height, quickening, ultrasound, and/or timing of fetal heart tones and pregnancy test
* Pregnant women able and willing to provide adequate locator information
* Planning to reside at their current location for at least 10 months
* Agree to participate in the study and continue ANC at health post
* Willing to participate and consent to follow up for up to 6 weeks post-delivery
* Are willing to receive group antenatal care at the health post level (during the intervention period)

Exclusion Criteria:

* Women who plan to travel away from the study site for more than four consecutive weeks during ANC or after 6 weeks post-delivery
* Women who are unable provide consent
* Women who have any condition that in the opinion of the investigator or designee, would complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Pupillary Changes as a Potential Biomarker for Escitalopram in Relation to CYP2C19 Polymorphism

To study the impact of CYP2C19 polymorphism on escitalopram pharmacokinetics and pharmacodynamics measured as changes in pupil diameter

Escitalopram, the therapeutic active S-enantiomer of citalopram, is a selective serotonine reuptake inhibitor (SSRI) used for treatment of depression and anxiety disorders. The antidepressant effect is probably due to a stimulation of the serotonergic neurotransmission caused by the inhibition of the presynaptic serotonin reuptake. This inhibition may also be responsible for the increased pupil diameter seen in volunteers treated with racemic citalopram. Based on escitaloprams pharmacodynamic properties it is expected to have the same affect on pupil diameter. A dose/response relationship has not yet been established but theoretically the pupillary changes might serve as a biomarker for the serotonergic effect of escitalopram.

Escitalopram is demethylated in part by the polymorphic cytochrome P450 enzyme 2C19 (CYP2C19); but the impact of CYP2C19 polymorphism on the total metabolism of escitalopram is still to be investigated.

Objective: The aim of this study is to investigate the pharmacokinetics and pharmacodynamics in CYP2C19 extensive metabolizers (EMs) and poor metabolizers (PMs) and to investigate whether change in pupil size reaction to a light stimulus can act as a biomarker for the serotonergic effect of escitalopram.

The study will be conducted as a randomized, double blinded; placebo controlled two phases cross-over trial with single and repeated doses of 20 mg escitalopram and equivalent placebo. Sixteen healthy volunteers (8 EMs and 8 PMs) will participate in the trial. Prior to the trial, approximately 400 volunteers will be phenotyped by omeprazole metabolic ratio in order to identify the CYP2C19 EMs and PMs.

During the two phases blood samples will be drawn and pupil sizes will be measured at fixed time points after drug administration.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer
* Age: 18-45 years
* Phenotyped for CYP2C19 activity

Exclusion Criteria:

* Drug or alcohol abuse
* Allergy towards escitalopram
Integrated Mindfulness-based Cognitive Behaviour Therapy Versus Cognitive Behaviour Therapy for Provoked Vestibulodynia

This randomized trial, nicknamed the COMFORT (Cognitive therapy or Mindfulness FOR Treatment of pvd) study, will compare the effects of an 8-session group Mindfulness-based Cognitive Therapy (MBCT) to an 8-session group Cognitive Behavioural Therapy (CBT) for women with provoked vestibulodynia (PVD). Women with PVD will be randomly assigned to attend either eight sessions of group MBCT or CBT. Each session is 2.25 hours long and spaced 1 week apart. The purpose of this study is to determine whether the 8-session MBCT intervention for PVD is no worse than an 8-session CBT intervention for decreasing women's pain intensity, sexual distress, catastrophizing and hypervigilance towards pain.

PURPOSE:

The purpose of this study is to determine whether an 8-session MBCT intervention for PVD is no worse than an 8-session CBT intervention for improving women's pain intensity and reducing their sexual distress, catastrophizing and hypervigilance towards pain. The investigators will also examine whether pain improvements at follow-up are mediated by changes in self-compassion and mindfulness (in the MBCT arm only) and moderated by pre-treatment credibility, personality, and anxiety sensitivity.

HYPOTHESES:

1. At follow-up (4 weeks, 6 months and 12 months post-treatment), women in the MBCT arm will experience a greater decline (vs. pre-treatment) in vestibular pain intensity compared to women in the CBT arm.
2. At follow-up (4 weeks, 6 months and 12 months post-treatment), women in the MBCT arm will experience a greater decline (vs. pre-treatment) in sex-related distress, pain catastrophizing, hypervigilance, and self-reported pain during intercourse/other penetrative sex compared to women in the CBT arm.
3. The investigators hypothesize that improvements in pain intensity during vestibular touch will be mediated by changes in self-compassion and mindfulness in the MBCT arm only at 6 and 12 months follow-up.
4. The investigators hypothesize that pre-treatment credibility, personality, and anxiety sensitivity will significantly moderate improvements in pain intensity during vestibular touch at 6 and 12 months follow-up.
5. The investigators hypothesize improvements in both arms on the "Patient Global Impression of Change Scale" and significantly greater improvements in the MBCT arm relative to the CBT arm at follow-up (4 weeks, 6 months and 12 months post-treatment).

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of provoked vestibulodynia (PVD)
* 19 years of age or older
* premenopausal
* fluent in English
* during the study, women must agree not to change any medications they are taking for PVD.

Exclusion Criteria:

* unprovoked vulvar pain, other pathology causing pain with penetration, or chronic pelvic pain
* being uncomfortable and unwilling to participate in a group setting.
Effectiveness of N-acetyl Cysteine, Acetyl L- Carnitine and Medicated Paraffin Oil in Aluminium Phosphide Poisoning

Aluminium Phosphide is a pesticide used in developing countries to prevent rodents and pests from spoiling the harvested grains. it is presented as tablets which can be administered accidently to humans or for committing suicide. this pesticide is fatal even in small concentration as mortality rate can reach 75- 100% of cases. in this study researchers tried to add some supplements to the routine treatment to improve and decrease the fatality rate.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients with history of acute intoxication with AlP presented to the Poison Control Center of Ain-Shams University hospitals during the period of the study

Exclusion Criteria:

1. Patients less than 18
2. Patients presented with delay time exceeding 12 hours after acute intoxication.
3. Patients with history of cardiac, renal or hepatic diseases.
4. Patients who show hypersensitivity to NAC, ALCAR or paraffin oil.
Korean Multicenter Randomized Controlled Trial (RCT) of Pidogul for Patients With Coronary Stenting

The aim of the current study is to compare the antiplatelet efficacy and safety of clopidogrel napadisilate and clopidogrel bisulfate in Coronary Artery Disease (CAD) patients after coronary stent implantation.


Eligibility Criteria:
Inclusion Criteria:

* Korean men and women between the age of 20 and 85
* Patients who were diagnosed as having CAD
* Patients who were planned to undergo PCI

Exclusion Criteria:

* Patients who were not treated with PCI or intended to treat with PCI but failed
* Patients who were were taking or had taken other antiplatelet or anticoagulant for more than 2 weeks within the prior 30 days
* Patients who were had a history of alcohol abuse or intoxication; (4) had hypersensitivity to clopidogrel or aspirin
* Patients who were had hypersensitivity to clopidogrel or aspirin
* Patients who were had abnormal laboratory results indicative of liver disease
* Patients who were had blood coagulation disorders, uncontrolled severe hypertension, active bleeding, or history of severe bleeding, such as intracranial hemorrhage or ulcer bleeding
* Patients who were were pregnant, breastfeeding, or not using effective methods of contraception
* Patients who were had other contraindication to study drug
* Patients who were had participated in another clinical study within 4 weeks prior to the start of this study
Cumulative Live Birth Rate With eSET After Preimplantation Genetic Screening Versus Conventional In-vitro Fertilization

The purpose of this randomized clinical trial is to compare the efficacy and safety with transfer of embryos selected by next generation sequencing (NGS) versus conventional morphological criteria. Subjects with 3 or more blastocysts on day 5 of embryo culture will be randomized to the PGS or IVF group. A Freeze-all strategy and a single frozen blastocyst transfer will be performed in both PGS and IVF groups. The primary outcome is the cumulative live birth after transfers of up to 3 single blastocycsts in both groups.

This is a multicenter, randomized clinical trial comparing the efficacy and safety with transfer of embryos selected by next generation sequence (NGS) and morphologic criteria versus by morphological criteria alone. Subjects who obtain 3 or more good-quality blastocysts will be randomized to PGS or IVF group. All embryos will be frozen and a single thawed blastocyst will be transferred in both PGS and IVF group. Subjects in the PGS group will have 3 blastocysts sequenced and euploid embryos will be subsequently transferred. Subjects in the IVF group will have blastocysts selected by morphology assessment. The cumulative live birth rate will be counted after transfers of all euploid embryo in the PGS group and 3 blastocysts in the IVF group within 1 year after randomization.

Eligibility Criteria:
Inclusion Criteria:

1. Women who are participating in their first cycle of IVF or ICSI
2. Women ages 20 to 37 years.
3. Women who obtain 3 or more good-quality blastocysts defined as morphological score of inner cell mass B or A, trophectoderm C or better, and grade 4 or better on day 5 of embryo culture will be randomized.

Exclusion Criteria:

1. Women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus uni-cornate, bicornate, or duplex); untreated uterine septum, adenomyosis, submucous myoma, or endo-metrial polyp(s); or with history of intrauterine adhesions.
2. Women with untreated hydrosalpinx;
3. Women who are indicated and planned to undergo PGD, for example, parental abnormal karyo-type or diagnosed with monogenic disease;
4. Women who use donated oocytes or sperm to achieve pregnancy;
5. Women with contraindication for assisted reproductive technology or for pregnancy, such as poorly controlled Type I or Type II diabetes; undiagnosed liver disease or dysfunction (based on se-rum liver enzyme testing); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; uncontrolled hyper-tension, known symptomatic heart disease; history of or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma; undiagnosed vaginal bleeding.
An Iron-containing Food Product for the Prevention of Diminished Iron Status in Soldiers

Military personnel face intense physical and cognitive demands. Diminished iron status affects physiologic responses to these challenges. Both cross-sectional and longitudinal studies indicate a significant decrement in iron status in enlisted female military personnel immediately following basic combat training (BCT). Decrements in iron status are associated with diminished cognitive and physical performance, and may affect body composition. The primary objective of this randomized, placebo controlled study is to assess the utility of an iron-containing food product for maintaining iron status during BCT. This study will provide insight into the utility and efficacy of an iron-containing food product for the maintenance of iron status during military training. Furthermore, it will provide novel scientific data regarding the relationship between iron status and physical and cognitive performance in female Soldiers.


Eligibility Criteria:
Inclusion Criteria:

* Female US Army Recruit
* Participating in Basic Combat Training

Exclusion Criteria:

* Male
* Pregnancy
* Diagnosed hemochromatosis
* Diagnosed thalassemia
* History of ulcerative colitis
* Allergy to chocolate
The Development of De-novo Stress Urinary Incontinence After Stage II-III Pelvic Organ Prolapse Surgery

Surgery for Stage II-III Pelvic organ prolapse


Eligibility Criteria:
Inclusion Criteria:

* Pelvic organ prolapse stage II-III
* has no incontinence before surgery

Exclusion Criteria:

* had surgery before
* Pelvic organ prolapse stage I or IV