cyrilzakka/clinical-trials huggingface dataset:
Application of Haptonomy and Pregnancy Adjustment, Paternal Attachment

The pregnancy process is experienced not only by the mother, but also by the fathers, so it is thought that the application of haptonomy, which is the science of love, communication and feeling together, will confirm the emotional existence of the baby in the prenatal period, and support the attachment of the father and the adaptation of the mothers to pregnancy.

Therefore, this study; It was aimed to evaluate the effect of haptonomy application on prenatal attachment of fathers and compliance with pregnancy and to contribute to the midwifery literature of the results.

In accordance with the literature review, no similar study was found in our country. The reason for the application of haptonomy in pregnancy is the sense of touch, which develops in the first 2 months of pregnancy and is an emotional sense. The pregnancy process is experienced not only by the mother, but also by the fathers, so it is thought that the application of haptonomy, which is the science of love, communication and feeling together, will confirm the emotional existence of the baby in the prenatal period, and support the attachment of the father and the adaptation of the mothers to pregnancy. Therefore, this study; The aim of this study was to evaluate the effect of haptonomy application on prenatal attachment of fathers and adaptation of pregnant women to pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* At least primary school graduate,
* Being at the 24th and 32nd week of pregnancy
* Living with your partner

Exclusion Criteria:

* Having problems with his wife
* Living apart with his wife
* Pregnant women who have completed the 32nd gestational week
Does the Format of the Adult ADHD Self-Report Scale Impact the Results

The World Health Organization Adult ADHD Self-Report Scale v1.1 (ASRS) is frequently used in family medicine clinics to screen for ADHD. Numerous studies have found the ASRS has a low positive predictive value. Compounding this concern is the format of the ASRS. Specifically, the answers on the ASRS that lead to screen positive results are shaded in gray and grouped together, which may make it easy for patients to discern which responses should be selected for a positive screen.

The ASRS is used widely to screen for ADHD in adults. It has 18 questions, with response options "never," "rarely," "sometimes," "often," and "very often." The 6 questions considered most predictive of ADHD are grouped together in Part A and questions that are meant to provide additional cues are grouped together in Part B. The options that are considered a positive response vary between questions; for some questions the option is at least "sometimes," while for others it is at least "often." The positive response options are shaded on the ASRS. A person is considered to have a positive screen if 4 of the 6 questions in Part A are positive.

The objective of this trial is to determine if the shading and grouping on the ASRS impacts screening results. This trial has a 2x2 factorial design set in a family medicine clinic(s). When a patients check in for an appointment, clinic staff will offer them a survey that includes 1) demographic questions and 2) 1 of the 4 versions of the ASRS, the version they receive is randomized (with programming). Most patients will take approximately 5 minutes to complete the survey prior to them seeing the family physician.

Eligibility Criteria:
Inclusion Criteria:

* 19 - 65 years old
* Patients who are registering for their appointment at the family medicine clinic
* Patients who are expected to be in the reception area for ≥5 minutes before going to a clinic room

Exclusion Criteria:

* Any patients who do not have the capacity to complete the form (e.g., cognitive impairment, unable to read English, unable to use a computer)
Awareness Enhancing Interventions

The purpose of this study is to determine if increasing awareness and, thus, enhancing positive attitudes about research, prior to recruitment attempts, will increase participation in cancer clinical research among African American (AA) cancer survivors so that recruitment efforts can focus on the most optimal and cost- effective approaches

In this project, 2000 AA potential AMPLIFI project participants will be randomized to the awareness-enhancing intervention (AWEI) or to the comparison condition in which they do not receive AWEI intervention but only the Adapting Multiple Behavior Interventions that Effectively Improve Cancer Survivor Health (AMPLIFI) basic recruitment strategy (No AWEI). Randomization for the AWEI Randomized Controlled Trial (RCT) will occur soon after the AMPLIFI recruitment letter is sent, and AWEI interventions will be delivered over a two-week period between the AMPLIFI recruitment invitation letter and the AMPLIFI recruitment call. Survivors randomized to AWEI intervention will be exposed to 8 different combinations of the AWEI components according to different types of strategies and type of information reflecting the survivor voice or not. Subsequent to the AMPLIFI recruitment call, a 20% random sample of cancer survivors will be surveyed over the phone to assess intervention fidelity.

Eligibility Criteria:
Inclusion Criteria:

* African American/Black
* adults (age ≥50 years old)
* diagnosed with obesity/physical activity associated cancers that have a 70% or greater 5-year relative cancer-free survival rate multiple myeloma, localized kidney cancer and loco- regional cancers of the colorectum, female breast, prostate, endometrium, and ovary).
* 1-5 years post diagnosis
* reside in an area with wireless coverage
* In the AMPLIFI recruitment pool
Prospective Collection of Whole Blood Specimens from RhD Negative Pregnant Women

The purpose of this research is to collect blood samples and data from pregnant women who are Rh negative. The blood will be used for the future research and the development of non-invasive prenatal tests to identify Rh blood type status of the baby during pregnancy.

This is a prospective multi-center blood collection study. Women 18 years of age or older with a viable singleton pregnancy between12 weeks and 28 weeks gestation will be enrolled.

Whole blood samples will be collected from each enrolled patient. Maternal specimens will be processed to plasma and stored for future testing with non-invasive prenatal tests to identify fetal Rh status.

Baby RhD blood type status will be recorded after delivery. All obstetric clinical management will take place per standard clinic practices and procedures and will not be altered by participation in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide written informed consent
2. 18 years of age or older at enrollment
3. Women with a viable pregnancy (with documented fetal heartbeat) between 12 weeks, 0 days and 28 weeks, 0 days gestational age
4. Women with RhD negative antigen status by serology
5. Willing to provide neonatal ABO and RhD genotyping status

Exclusion Criteria:

1. Women with multiple gestation pregnancy
Sugammadex and Heart Failure

Although anticholinesterase reversal agents have been used in combination with anticholinergic drugs for over half a century, it has been suggested that they should be used with caution in patients with underlying cardiovascular disease. As sugammadex has no endogenous targets, it is unlikely to cause any adverse cardiovascular effects. This selective relaxant binding agent is specifically designed to encapsulate rocuronium, which can, therefore, promptly restore neuromuscular function regardless of any levels of NMB as the dose is increased.

Some reports, however, suggest that sugammadex may have increased time to effect in some patient populations like the elderly, patients in intensive care and renal failure patients. A less dynamic circulation and increased transfer time to the effector site in these subjects are likely explanations for this effect. The present trial was designed to assess the safety and efficacy of sugammadex 2.0 mg kg-1 for the reversal of rocuronium-induced NMB in patients with heart failure.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 yr or older
* categorized as American Society of Anesthesiologists class 3-4 and New York Heart Association class 2-4
* with an ejection fraction \<25%
* scheduled to undergo elective surgery for cardiac resynchronization therapy, an automated implantable cardioverter-defibrillator (ICD), or battery replacement of an ICD or biventricular pacemaker, during general anaesthesia.

Exclusion Criteria:

* expected to have a difficult intubation for anatomic reasons
* they had a neuromuscular disorder
* a personal or family history of malignant hyperthermia
* or known allergy to medication used during general anaesthesia
* not able or willing to give written informed consent.
Effectiveness of PEA Compared to Placebo on Acute Menstrual Pain

This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed Palmitoylethanolamide (PEA) compared to placebo on menstrual pain in otherwise healthy participants 18 years and over.


Eligibility Criteria:
Inclusion Criteria:

* Women who experience mild to moderate menstruating pain
* Aged 18 years or over
* History of over the counter (OTC) analgesic use for the treatment of menstrual pain
* Self-reported history of menstrual cramp pain occurring during four of the past six menstrual cycles.
* Typically requires at least one dose of an OTC analgesic medication such as naproxen, aspirin, ibuprofen or acetaminophen taken on at least 1 day of menstrual cycle for the treatment of mild to moderate menstrual cramp, and normally experiences pain relief from these medications.
* Otherwise healthy
* Able to provide informed consent
* Regular menstrual cycle (28 days ± 7 days) and period
* Agree not to participate in any other clinical trial while enrolled in this trial

Exclusion Criteria:

* Secondary cause for dysmenorrhea (i.e. endometriosis, adenomyosis, uterine fibroids or infection)
* Any bleeding disorders, recent surgery or concurrent blood thinning treatment
* Unstable or serious illness (e.g., kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, lung conditions, chronic asthma, diagnosed psychological or mood disorder) (1)
* Current malignancy (excluding BCC) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
* Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy
* Pregnant or lactating women
* Active smokers, nicotine use or drug (prescription or illegal substances) abuse
* Chronic past and/or current alcohol use (\>14 alcoholic drinks week)
* Allergic or hypersensitive to any of the ingredients in active or placebo formula
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
* Participated in any other clinical trial during the past 1 month

  1. An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
Reconstruction of Atrophic Maxillary Ridges Using Mandibular Blocks With and Without Coverage Using Collagen Membrane

Is the use of collagen membrane on top of particulate bone mixture covered by onlay bone block in Maxilla better than the use of mixture of particulate bone covered by onlay bone block without the use of collagen membrane, in terms of bone quality and bone quantity?

Soft tissue dehiscence could result due to flap irritation as a result of, closure under tension, intraoperative or postoperative recipient site infection, postoperative edema, which in turns compromises stability of onlay bone blocks thus osseintegration of bone block. Any attempt of bone recontouring and resuturing fails since there is no vascular bed. Ideal requirements of barrier membranes are, they should be biological compatible, they must act as a barrier membrane, unwanted fibroblasts should be hindered from entrance while allowing diffusion of nutrients, tissue integration (biological adhesion), tissues should be able to grow into the membrane but not through it. Space maintainer, it should be sufficiently stiff, so as not to collapse into the underlying particulate bone under the pressure of soft tissue and it should be ease in its manipulation, adaptation and handling, as for example, collagen membrane. Some types of collagen membrane, contain some degrees of stretchability.

Eligibility Criteria:
Inclusion Criteria:

* Patients with maxillary residual alveolar bone height not less than 8 mm.
* Alveolar bone width from less than or equal 5 mm.
* Both sexes.
* At least missing single tooth.
* Previous Failed Implants.
* Previous Failed Grafting.

Exclusion Criteria:

* Heavy smokers more than 10 cigarettes per day.
* Patients with alcohol abuse
* Patients with narcotic abuse.
* Patients with bone disease that may affect normal healing, example; hyperparathyroidism.
* Patients had radiotherapy and chemotherapy in head and neck.
* Patients had neoplasms in sites to be grafted. 18
* Patients with Metabolic diseases uncontrolled diabetic patients, Glycated hemoglobin (Hb A1c) more than 7 mg\\dl.
* Pregnant females.
* Patients with Para functional habits, apprehensive and non-cooperative.
* Bone pathology related to the site to be grafted.
* Psychological problems, stress situation (socially or professionally), emotional instability, and unrealistic patients' expectations.
* Intraoral soft and hard tissue pathology.
* Systemic condition that contraindicate implant placement.
* Under the age of 18 years.
Fragility Assessment in Adults With ADHD and Mental Retardation

Frailty is a age dependent physiological state of vulnerability. Frailty is screened by the phenotypic model (5 clinical criteria) or the cumulative model (various clinical and biological criteria). Currently, aging with autism spectrum disorder and mental retardation (ADS-MR) is poor described. Nevertheless many data indicate that people with ADS-MR may present an early aging.

Principal aim of this study is to determine if frailty in people with ADS-MR aged over 20 years depend on age. Secondary aims are to evaluate frailty prevalence, to describe with details health according to age, and to verify the frailty index validity for predicting falls, hospitalisation and death, in this population of ADS-MR patients aged over 20 years.

This monocentric and prospective study will include 60 ADS-MR patients aged over 20 years and living in Languedoc-Roussillon's medico-social care homes. Patients are evaluated at the time of inclusion. Frailty index is calculated from 104 clinical and biological criteria. Furthermore the investigator staff collect data about ADS severity (CARS), adaptative and intellectual functionning (Vineland), and psychiatric and somatic comorbidities (Reiss scale, DSQIID and CIRS). Falls, hospitalisations or death occurrence is then collected every year during 5 years.

The connection between frailty index and age will be studied using linear regression. The frailty index validity will be analysed using ROC curves. Modelisation of the falls, hospitalisations or death risk in the 5 years after the initial evaluation will help in identification of the more frailty predictive criteria.

Calendar :

This study will take place during 60 months. 4 first months will be devoted at the ethic and administrative issues. Inclusion will take place during 26 months. Follow-up will take 5 years. Last months will be used for data analysis and articles submission.

Perspectives :

This study will be the first describing frailty evolution during aging in patients suffering from ADS-MR. It will be useful for creating a new, simple and pragmatical frailty screening tool specific for ADS-MR patients in order to detect earlier which patient are the most frail.

Eligibility Criteria:
Inclusion Criteria:

* ADS diagnosis using DSM-5 or CIM-10 criteria, associated to mental retardation
* Age over 20 years
* Patient living in Languedoc-Roussillon's medico-social care home
* Patient benefiting from social security
* Patient or legal representative consent collected

Exclusion criteria:

* Patient or legal representative disagreement to participate at the sudy
* Pregnant woman or nursong mother
* Patient with Down syndrom
Real-world Insights of People With Human Immunodeficiency Virus (HIV) Infection

This study is designed to identify the burden associated with HIV and its treatment, and assess their health-related quality of life (HRQoL) by measuring key HRQoL domains, including satisfaction with treatment and care, and internalised stigma (ISAT). The study will also explore data for various important subpopulations such as subjects who are virally suppressed; who we anticipate will be the majority of study subjects. The study design is an observational, cross sectional study employing subjects' own mobile phone devices for data entry.


Eligibility Criteria:
Inclusion Criteria:

* \>= 21 years old
* Language:Read and Understand English / Spanish
* Positive diagnosis of HIV infection by a healthcare provider (self-reported)
* Possesses a smartphone that has internet access

Exclusion Criteria:

* Not Applicable
Effects of Probiotic Ayran on Gingivitis

Objectives: This study investigates the effects of daily consumption of probiotic ayran drink on gingival inflammation and the development of experimental gingivitis.

Methods: A total of 54volunteer students were included in the present randomized, double-blind, placebo-controlled trial.The participants were divided randomly into two groups; The Control group consisted of 27 participants who consumed placebo ayran, while the 27 participants of the Test group consumed probiotic ayran (containing Lactobacillus acidophilus and Bifidobacterium bifidum) for 42 days twice a day.After 42 days, mechanical plaque control was interrupted for 5 days. The clinical parameters of gingivitis; Plaque index (PI), gingival index (GI), probing bleeding (BOP), probing depth (PPD) were recorded at baseline, day 42 (beginning of experimental gingivitis) and day 47 (the end of experimental gingivitis). At the same time points, gingival crevicular fluid had been collected for analysis of matrix metalloproteinase - 8 (MMP-8).

The most used and studied probiotics in the periodontal literature are lactobacillus and bifidobacterium. The current study aims to observe the effects of daily ayran consumption containing a probiotic combination of Lactobacillus acidophilus and Bifidobacterium bifidum on plaque development and gingival inflammation in an experimental gingivitis model of healthy individuals. The null hypothesis of this study using of probiotics has no additional benefit for periodontal health.

This study evaluates the effects of daily consumption of ayran containing a probiotic combination of Lactobacillus Acidophilus and Bifidobacterium Bifidum on plaque development and gingival status in healthy individuals with experimental gingivitis.

Eligibility Criteria:
Inclusion Criteria:

* Systemic healthy
* Subjects with gingivitis defined as a BOP sites ≥ 10% and PD ≤ 3 mm
* No radiographic bone loss
* Non-smoking participants

Exclusion Criteria:

* History of using antibiotics or anti-inflammatory drugs or probiotic preparations or food supplements in the last 6 months,
* Undergoing orthodontic treatment,
* Active carious lesions
* Mouth breathing
* History of allergy for milk or fermented milk products.
* Taking medications affecting the gingiva and/or oral mucosa
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery

The purpose of this study is to examine the superiority of YM150 to the placebo and to evaluate the dose-dependent response of YM150 in patients undergoing elective total knee replacement surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects is scheduled for elective primary total knee replacement surgery
* Written informed consent obtained before screening

Exclusion Criteria:

* Subject has history of deep vein thrombosis and/or pulmonary embolism
* Subject has a hemorrhagic disorder and/or coagulation disorder
* Subject has had clinically important bleeding occurred within 90 days prior to the screening visit
* Subject has an acute bacterial endocarditis, retinopathy, hypertension, or thrombocytopenia
* Subject is receiving anticoagulants/antiplatelets
Reducing Edema Following Refractive Surgery

Determine if edema plays a role in refractive surgery

Prospective, comparative study

Eligibility Criteria:
Inclusion Criteria:

1. Patients who underwent bilateral Refractive surgery for myopic correction.
2. Age 18-60.
3. Evidence of an epithelial defect.
4. Uncorrected visual acuity at study visit better than 20/40
5. Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements, including the required study follow-up visits.

Exclusion Criteria:

1. Any other anterior segment abnormality other than that associated with Refractive surgery.
2. Any abnormalities associated with the eye lids.
3. Prior laser treatment of the retina.
4. Any ophthalmic surgery performed within three (3) months prior to study excluding Refractive surgery.
5. Diagnosis of glaucoma.
6. Active diabetic retinopathy.
7. Clinically significant inflammation or infection within six (6) months prior to study.
8. Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator.
9. Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational device.
10. Intolerance or hypersensitivity to topical anesthetics
11. A medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
12. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.
Prediction of Getting Peripheral Neuropathy in Patients Treated With Bortezomib?

Investigation of which patients treated with bortezomib that have increased risk of developing peripheral neuropathy.

The study aims to include 20 patients with multiple myeloma that are initiating bortezomib treatment. The patients must follow their normal treatment cycles while getting blood drawn during their treatment period however maximal 9 cycles.

Blood is dawn before treatment initiation and approximately once per cycle in order to measure neurofilament light chain (NFL) before and during treatment. The primary outcome is to relate the level of NFL during treatment with the level at baseline and as a secondary outcome to relate the level of NFL to the cumulative dose of bortezomib.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years of age
* Must speak and understand Danish
* Must be able to and willing to give informed consent
* Diagnosed with myeloma and in need for treatment
* Must not be a candidate for transplantation and must be a candidate for bortezomib treatment.
* Must not previously have been treated with proteasome inhibitors
* Eastern Cooperative Oncology Group (ECOG) Performance status (PS) ≤ 3

Exclusion Criteria:

* Other underlying cancer disease - with exception of a) basal cell carcinoma, b) healed carcinoma in situ cervicis uteri, c) other cancer disease with minimal risk of recurrence or d) prostate cancer with low glean score
* Previous treatment with neurotoxic chemotherapy
* Known polyneuropathy or at diagnosis have polyneuropathy degree 1 with pain or degree 2 without pain.
* Simultaneous amyloidosis/POEMS syndrome
* Patients who have received chemotherapy previously and patients with diabetes, HIV and neurodegenerative diseases.