cyrilzakka/clinical-trials huggingface dataset:
Primipara Pregnant Women and Motivational Interview

The first birth is the most important moment a woman experiences in her life as she embarks on her motherhood journey. Waiting for the birth of a new life can be very exciting for mothers. Positive birth is an approach that asks the woman to approach her birth story from a positive perspective and to have a stronger, more impressive and positive birth experience. Primipara pregnant women especially benefit from and need this positive birth approach. Motivational interviews are interviews conducted to support positive births and to help women develop a positive attitude towards their birth experiences.

This planned study was planned as a randomized controlled trial with pre-test and post-test measurements, with the aim of determining the level of traumatic birth perception in primipara women who were given or not given training and examining the effects of positive birth motivational education by taking into account the need for education with numerical data.


Eligibility Criteria:
Inclusion Criteria:Must be between the ages of 20-35, have a primipara pregnancy (30-34 weeks of gestation), be a Turkish citizen, have no history of risky pregnancy, have no psychological disorders, and wish to participate in the study voluntarily.

-

Exclusion Criteria:Having an unplanned or involuntary pregnancy, having a threat of premature birth, wanting to leave the job at any time.

-
PFO Occlusion and Atrial Fibrillation

Interventional closure of patent foramen ovale (PFO) associates with reduced risk of stroke recurrence in patients with cryptogenic ischemic stroke as reported in the recent CLOSE and REDUCE trials. The long-term follow-up results of the RESPECT and DEFENSE-PFO trial confirmed these findings. PFO closure is therefore recommended in patient with cryptogenic ischemic stroke and PFO according to the current German interdisciplinary guidelines. It is likely that the number of PFO closure procedures will increase significantly in the near future. However, new onset atrial fibrillation (AF) appears to increase in patients following this procedure. In the REDUCE study, new onset atrial fibrillation was detected in 6.6% patients in the PFO closure group compared with 0.4% in the control group (medical treatment); 59% of these patients were diagnosed within the first two weeks following the procedure and 83% within 45 days, respectively. These results were consistent with the CLOSE study: AF was detected in 4.6% patients in the intervention group vs. 0.9% in the control group. Up until today, markers to identify and quantify the individual risk of AF onset are lacking. Furthermore, under-reporting and under-detection of AF occurrence after PFO closure is likely. This study is designed to to assess the prevalence and and identification of electrophysiological and echocardiographic parameters of new-onset AF.


Eligibility Criteria:
Inclusion Criteria:

* Previous embolic stroke with undetermined source with...
* palpitations with clinical indication for an electrophysiological study (control group)
* PFO and clinical indication for interventional PFO closure according to current guidelines (intervention group)
* Sinus rhythm at time of inclusion with no history of AF
* Planned EP study due to reported palpitations or documented burden of non-sustained atrial arrythymias (\>100 atrial ectopic beats /24 hours, atrial tachycardia)
* Written informed consent

Exclusion Criteria:

* previously documented AF
* indication for therapeutic anticoagulation
* uncontrolled diabetes mellitus
* acute coronary syndrom or acute cardiac decompensation within the last 6 months before enrollment
* enrolled in another study
* BMI \> 40 kg/m²
* patients who are pregnant of breastfeeding life expectancy \< 6 months
* relevant peripheral artery disease
* substance abuse
Cobiprostone for the Prevention of Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concurrent Radiation and Chemotherapy

Treatment for head and neck cancer often involves a combination of chemotherapy and radiation.

One of the unfortunate consequences of standard care for head and neck cancer is the development of painful mouth sores, known as oral mucositis.

This study will evaluate the use of cobiprostone spray to prevent oral mucositis, when given for the duration of radiation and chemotherapy (RT/CT) standard care.


Eligibility Criteria:
Inclusion Criteria:

* Recently-diagnosed (within the last 6 months), histologically-documented, non-metastatic squamous cell carcinoma of the oral cavity and/or oropharynx amenable to radiotherapy with concurrent chemotherapy as the definitive treatment modality.
* Clinical treatment plan calls for a minimum of 50 Gy cumulative radiation dose administered via continuous course of external beam irradiation to the oral cavity and/or oropharynx via intensity-modulated radiation therapy (IMRT) and/or image-guided radiation therapy (IGRT), combined with conventional or weekly/tri-weekly cisplatin or carboplatin chemotherapy regimen.

Exclusion Criteria:

* Subject has received prior radiation to the head and neck region (+/- chemotherapy).
* Subject has had any other prior invasive malignancy, unless disease-free for a minimum of 3 years.
* Subject has metastatic disease (M1) Stage IV-C.
* Subject has a presence of mucosal ulceration or oral mucositis at screening or develops this prior to randomization, and/or has unhealed wounds remaining from surgical resection and/or excisional biopsy procedure.
* Subject is using a pre-existing feeding tube for nutritional support at study entry.
Optimization of Assessment and Grading for Lid Wiper Epitheliopathy

The purpose of this study is to assess eyelid margin staining, termed "lid wiper epitheliopathy" (LWE), in three populations. The hypothesis is LWE will be more prevalent in symptomatic contact lens wearers than non-symptomatic contact lens wearers and least prevalent in asymptomatic non-contact lens wearers.


Eligibility Criteria:
Inclusion Criteria:

* Has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Has had an ocular examination in the last two years;
* Has clear corneas and no active ocular disease;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Has any ocular disease;
* Has a systemic condition that may affect a study outcome variable;
* Is using any systemic or topical medications that may affect ocular health;
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
* Has undergone corneal refractive surgery;
* Currently wears contact lenses on an extended wear basis (overnight);
* Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
* Other protocol-defined exclusion criteria may apply.
Impact of Secukinumab on Clinical and Patient Reported Outcomes in Patients With Psoriasis

The study was conducted to describe the demographics, disease characteristics, disease severity, comorbidities and patient reported outcomes at baseline and follow-up periods among adult patients diagnosed with PsO in CorEvitas' PsO Registry under routine medical care initiating secukinumab (SEC).

This is a retrospective analysis of a prospective observational cohort using CorEvitas' PsO registry of adult PsO patients. This study describes clinical and patient reported outcomes among adult patients initiating Secukinumab (SEC). Biologic experienced and naïve patients are examined separately. This study also describes changes in clinical and patient reported outcomes over time.

CorEvitas' Psoriasis Registry is a prospective, observational cohort of adult PsO patients starting systemic therapy, launched in April 2015 with sites in the US and Canada. Data collection occurs every \~6 months at routine dermatology visits. This study included US PsO patients who initiated secukinumab at or after enrollment and had a subsequent 6- and/or 12-month follow-up visit (Apr 2015 to Dec 2020).The index date is defined as the date of the first SEC initiation at or after enrollment.

Eligibility Criteria:
Inclusion Criteria:

The patient must:

* Have been diagnosed with PsO by a dermatologist.
* Be at least 18 years of age.
* Be willing and able to provide written informed consent for participation in the registry.
* Have started on or switched to an eligible systemic PsO treatment at enrollment1 or within the previous 12 months of the date of enrollment.

Exclusion Criteria:

* Patient is participating in or planning to participate in an interventional clinical trial with a nonmarketed or marketed investigational drug (i.e. phase I-IV drug trial).
T-116_Procera-Bridge Zirconia - A Clinical Study

The objective of the study is to evaluate the clinical performance of Procera® Bridge Zirconia veneered with NobelRondo Zirconia.

The study was designed to be an open, 5-year, prospective, multi-center clinical post-market study. The objectives of this clinical study were that industrial centrally produced 3- or 4-unit bridges of yttrium-oxide partially-stabilized (Y-TZP) zirconia (Procera Zirconia) in combination with the veneering ceramic material NobelRondo will show sufficient CDA ratings (90% R+S) and a sufficient survival rate after 1 and 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible
* Indication: same indication as for metal supported bridges
* Obtained informed consent from the patient

Exclusion criteria

* Currently known alcohol, drug or medication abuse, judged by the investigator, which might influence the follow-up program
* Patients where a bridge part connection area of 3 mm of diameter is not possible to obtain (short clinical crowns)
* Mobility of the abutment teeth exceeding grade I
* Patients with pathologic pocket formation at abutment teeth
* Patients with complete dentures in the opposing jaw
* Patients with a removable partial denture in the same jaw
Efficacy and Safety Study of Individualized and Standardized Acupuncture Treatment for Knee Osteoarthritis

The purpose of this study is to verify the efficacy and safety of acupuncture treatments (Individualized, Standardized acupuncture) for patients with knee osteoarthritis (OA).

The investigators targeted the patients with knee OA. After treatment in 4 groups - individualized acupuncture treatment, standardized acupuncture treatment, sham-needle treatment, and waiting groups - the investigators will compare the effects of pain relieving and daily performing improvement. So the investigators will confirm the efficacy of acupuncture, and further the best treatment method. In addition, the investigators are going to evaluate the safety of abnormal reaction during the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. At least 20 years of age, but below 80 years of age
2. Knee pain from OA in one or both knees in the last 3 months or more
3. Presence of knee OA diagnosed by an orthopedist based on American College of Rheumatology classification criteria
4. Knee pain from OA in one or both knees rated \> 4 cm on a 10 cm Visual Analog Scale (VAS)
5. An understanding of the objectives and methods of the clinical trial, and willingness in completing the consent form.
6. Those who are reliable and willing to cooperate in this test, and obey the restrictions for the next 3 months

Exclusion Criteria:

1. Trauma to or surgery on the knee(s) within 6 months prior to enrollment, causing pain or functional problems
2. A history of prolotherapy, injection of hyaluronic acid or cortisone within the last 3 months
3. A physical or laboratory finding indicating infection, presence of an autoimmune disease, or inflammatory arthritis
4. Serious organic disease, and severe dysfunction due to the medical illness (e.g. Arrhythmia, Angina pectoris, Stroke, Asthma, etc.)
5. More severe pain in regions other than the knee joint.
6. Pregnant
7. When researchers evaluate that it is not appropriate to participate in this clinical test
Feasibility of the Latella Implant System for Medial Osteoarthritis (OA)

The objective of this study is to evaluate the safety and technical feasibility of implanting the Latella Implant System in the treatment of patients with medial osteoarthritis of the knee.


Eligibility Criteria:
Inclusion Criteria:

* History of pain as due to medial osteoarthritis

Exclusion Criteria:

* Rheumatoid arthritis
* Joint or ligament instability
* Metal ion allergy
PMCF 8 Year Results TRJ®

The intention of this Post Market Clinical Follow-Up study is to obtain mid-term results of the TRJ® endoprosthesis. Aim is to include those patients that have received a TRJ® Total Hip Arthroplasty in 2012 and already did participated in a clinical study taking place in 2014 to obtain 2 years results


Eligibility Criteria:
Inclusion Criteria:

* patients have received a TRJ® prosthesis in 2012
* Patient did participate in the 2 years results evaluation 2014
* Patient gave his written consent for study participation

Exclusion Criteria:

* patient is pregnant
* patient \< 18 years
Evolution and Risk Factors Associated With Geographic Atrophy Progression

Age-related macular degeneration is one of the leading causes of blindness worldwide. The factors that induce the progression of geographic atrophy, the advanced form of dry age-related macular degeneration, remain poorly understood. The aims of this study are to describe the natural history of geographic atrophy and identify potential risk factors associated with a faster spread of atrophy that may be used to develop rational therapies.

Age-related macular degeneration is the leading cause of blindness in developed countries. Geographic atrophy is the advanced form of dry age-related macular degeneration, and currently has no effective therapy. Little is known about the risk factors that drive the progression of geographic atrophy, and yet they are crucial to understand the mechanisms of the disease. Therefore, the identification of risk factors associated with a faster spread of atrophy may help contribute to identify the causes of the disease and, ultimately, to develop new therapeutic strategies to manage the disorder.

The current prospective, observational, natural history study has the following objectives:

* Describe the natural history of geographic atrophy in anatomic and visual terms
* Identify risk factors associated with a faster enlargement of atrophy

The main hypothesis is that lipofuscin accumulation at the borders of atrophy as seen with fundus autofluorescence imaging is associated with a faster progression of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Both sexes
* 50 years of age or older
* Uni or bilateral areas of geographic atrophy in the macula (as defined as areas devoid of retinal pigment epithelium measuring at least 0.5 disk areas on a 35º fundus photograph centered on field 2) secondary to age-related macular degeneration
* Willing to provide Informed consent

Exclusion Criteria:

* Other causes of geographic atrophy aside from age-related macular degeneration (ie, drug induced, central serous chorioretinopathy)
* Prior history of wet age-related macular degeneration
* Other significant concomitant macular diseases (ie, significant epiretinal membrane, stage II-IV macular hole)
* Previous treatment with macular laser photocoagulation, photodynamic therapy, antiangiogenic drugs or other treatments for wet age-related macular degeneration
* Intraocular surgery aside from phacoemulsification
* Inability to measure the full extent of the area of atrophy on a 35º fundus autofluorescence image centered on field 2
* Areas of geographic atrophy in direct contact with peripapillary areas of atrophy
Impact of CKD on Children and Their Families

Based on the available literatures, previous studies have investigated the impact of CKD and dialysis on patient's health among adult and elderly population. As far as we know, this is the first empirical study that investigates the impact of CKD on children functional capacity and their families QOL.

The current study will be done to investigate the long term effect of the CKD itself on different dimensions of the child health to understand the unique characteristics of pediatric CKD. Also, it will be beneficial for designing a comprehensive physical therapy protocol for prevention of different complications and to improve their wellbeing healthcare. Additionally, it will be beneficial to determine the family and parental stresses and to build the rehabilitation plan for the child considering the possible family issues regarding the child condition.

Eligibility Criteria:
Inclusion Criteria:

* Age from eight to twelve years.
* Both genders.
* Diagnosed with ESRD (stage 5) based on the glomerular filtration rate (GFR \< 15 mL/minute/1.73 m2).
* Able to understand and follow instructions during assessment procedures.
* Willing to participate in the study and attend the assessment procedures.

Exclusion Criteria:

Children of the following criteria will be excluded from the study:

* Cardiopulmonary disorders
* Uncontrolled hypertension
* Unstable angina
* Severe uncontrolled diabetes
* Neurological or cognitive disorders with functional deficits
* Significant cerebral or peripheral vascular disease.
Effect of Aerobic Exercises Versus Incentive Spirometer Device on Post-covid Pulmonary Fibrosis Patients

the aim of this study will be to investigate the effect of aerobic exercises vs incentive spirometer device on post-covid patients with residual lung diseases.

To our knowledge, there have been no enough studies that investigated the effect of aerobic exercise and incentive spirometer in pulmonary rehabilitation on post-covid syndrome patients.

Therefore, this study may open up ways to other researchers to investigate and build up on this effect if present and address such an important issue.

The finding of this proposed work may help patients with post-covid syndrome and complain of lung diseases by addressing their complains of symptoms like chest pain, dyspnea, and cough and provide a possible solution to enhance their quality of life and increase their participation in daily life activities.

Patients of post-covid syndrome with residual lung problems will be recruited after approval of ethical committee of the faculty of physical therapy, Cairo university. All participants will sign a written informed consent form.

The subjects will be randomly assigned into one of three groups:

* Group I (experimental) will receive aerobic exercises program and traditional chest physiotherapy.
* Group II (experimental) will receive incentive spirometer device treatment and traditional chest physiotherapy.
* Group III (control) will receive traditional chest physiotherapy only. The measures will be taken before and after treatment program.

Eligibility Criteria:
Inclusion Criteria:

* Hemodynamic stable (MAP not less than 60mmHg, systolic pressure \>80mmHg and diastolic pressure not \<60mmHg)
* Age from 40 to 85 years.
* Both sexes.
* All patients were positive covid-19 infected patients and passed at least 4 weeks after confirmation.
* All patients suffer from respiratory complications.
* All patients included are actively breathing.
* All patients included are fully aware and conscious.

Exclusion Criteria:

* Hemodynamic Instability.
* Severe Head Injury.
* Increased intracranial pressure.
* Anemic Hb\<8.
* Active Smoking.
* Severe Bronchospasm.
* Low BP (systole \<80, diastole \<60).
* Subcutaneous Emphysema.
* Rip Fractures.
* Untreated Pneumothorax.
Effect of the EpiSchool App on Teachers' Epilepsy Knowledge, Attitudes, and Self-Management

The aim of this study was to determine the effects of the training given to the teachers of children with intellectual disabilities with the "Epilepsy Management at School Mobile Health Application" and the "Digital Epilepsy Education Guide" on teachers' epilepsy knowledge, attitudes, and self management levels. This study was planned in a pretest, posttest design, follow-up, randomized controlled study. The sample of the study will consist of 90 teachers. Intervention-1 (Epilepsy Management at School Mobile Health Application, n=30), intervention-2 (Digital Epilepsy Education Guide, n=30) and control group (group without any intervention, n=30) will be included in the study. The data collection tools to be used in the research will be applied to all three groups at the same time intervals (T0: Just before the application phase of the research, T1: 15 days after the application, T2: one month after the application). The data will be collected using the Personal Information Form, the Knowledge and Attitudes Toward Epilepsy Among School Teachers Scale, and the Epilepsy Self-Management Scale for Teachers. Statistical Package for the Social Sciences (SPSS) 25.0 package program will be used in the analysis of the data.


Eligibility Criteria:
Inclusion Criteria:

* Working at special education schools affiliated with the Ministry of National Education in Antalya Province,
* Teachers of children with moderate to severe intellectual disabilities,
* Having a smartphone with internet access and either an Android or iOS operating system.

Exclusion Criteria:

* Teachers of children with hearing and visual impairments, without intellectual disabilities
* Teachers of children with mild intellectual disabilities
Endoscopic Stomach and Pouch Reduction in Patients With Weight Regain Following Roux-En-Y Bypass Surgery

The Roux-En-Y gastric bypass procedure is the most commonly performed bariatric procedure in the United States. Despite initial weight loss, some patients experience weight regain that may be related to an increase in the size of the gastric pouch and/or stoma. A second surgical procedure to reduce the size of the pouch and/or stoma is typically associated with a higher risk of death or complications than the original gastric bypass procedure. This study will evaluate a less invasive, endolumenal alternative to pouch and stoma revision as a means of producing weight loss in patients who have regained weight following gastric bypass.


Eligibility Criteria:
Inclusion Criteria:

* 18 yrs of age or older and \< 65 yrs of age
* At least 2 yrs post-Roux-En-Y gastric bypass surgery
* Initially achieved at least 50% weight loss
* At enrollment, has regain at least 15% of weight loss
* BMI 40 or greater or 35 or greater with one or more co-morbidities
* Stoma diameter at least 20 mm
* Completes successful nutritional screening
* Is a candidate for a surgical revision procedure
* Is a reasonable risk to undergo general anesthesia
* Completes successful cardiopulmonary evaluation
* ASA Classification of less than or equal to III
* Able to provide written consent
* Able to return for protocol-specified evaluations

Exclusion Criteria:

* Esophageal stricture or other anatomy/condition that precludes passage of endolumenal instruments
* Previous bariatric revision procedure
* Has another causal factor for weight regain other than stoma or pouch dilatation
* Non-mobile or has significant impairment of mobility that will limit compliance with post-op exercise program