cyrilzakka/clinical-trials huggingface dataset:
Post-market Multi-Center RETRO-Prospective Study to Assess Long-term Clinical Outcomes NMSC Patients Treated With eBx

The purpose of this retrospective-prospective study is to evaluate lesions after treatment for BCC or SCC NMSC in order to gain a better understanding of the durability of the treatment, and risk of late toxicities for this patient population.

This is a retrospective-prospective study design. The study is post-market, on-label observational study for the treatment of NMSC. Patients who completed treatment at least five years from the last treatment will be identified and existing data as required by this protocol in the patient's record will be collected in addition to conducting office visits or telehealth visits (video) for long-term follow-up.

The study will include:

Identifying patients, retrospectively, who completed treatment a minimum of five years from the last treatment. The history and demographic data will be collected from up to 300 subjects previously treated with eBx for the treatment of NMSC. Patients will have an office visit or telehealth visit in order for the investigators to assess the lesion site, document absence of recurrence, treatment for recurrence (if applicable), and long-term toxicities at the time of the prospective visit.

Eligibility Criteria:
Inclusion Criteria:

1. Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System according to standard of care;16
2. Provides informed consent;
3. Greater than 40 years of age;
4. Pathological diagnosis confirmed to be squamous cell carcinoma, or squamous cell carcinoma-in-situ, or basal cell carcinoma prior to treatment;
5. Cancer Staging included in this study:

Stage 0: Tis, N0, M0 Stage 1: T1a, b, c, N0, M0 Stage 2: T2a, N0, M0

Exclusion Criteria:

1. Target area is adjacent to a burn scar;
2. Any prior definitive surgical resection of the cancer, prior to Radiation Treatment;
3. Known perineural invasion;
4. Actinic Keratosis;
5. Known spread to regional lymph nodes;
6. Known metastatic disease;
7. Lesion treated with Mohs surgery.
Extended Platelet Rich Fibrin in Mandibular Alveolar Ridge Splitting

Thirty two healthy implants will be selected from the outpatient clinic of the oral and maxillofacial department of Mansoura university to be included in this study for replacement of lost posterior teeth with limited bone width.


Eligibility Criteria:
Inclusion Criteria:

* Patient age 18 years old and older.
* Patient's cooperation, motivation and good oral hygiene.
* Atrophic posterior mandible of horizontal alveolar dimension range between 3 - 6 mm at the crest, with minimum 10 mm vertical height from the alveolar crest to the superior border of the inferior alveolar canal.
* Absence of undercuts in buccal aspect of the ridge.
* Favorable occlusion and no parafunctional habits.
* Patients able to comply with the required recall visits.
* No gender preface in selection of the patients.
* Acceptable inter-arch space for the future prosthesis.

Exclusion Criteria:

* Any pathological condition at the site of surgery.
* Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.
* Patient taking drugs that could affect bone healing process as immunosuppressive drugs and bisphosphonates.
* Heavy smoking and alcoholism.
* Parafunctional habits such as bruxism and clenching.
* Signs of acute infection or pus discharge.
* Untreated periodontal disease or bad oral hygiene.
Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity

This prospective randomized controlled study is conducted to analyze the effect of Goserelin on ovarian function in women with breast cancer in China.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women 18 to 49 years of age are eligible for enrollment
* Patients have operable stage I to IIIA breast cancer for which treatment with adjuvant or neoadjuvant cyclophosphamide-containing chemotherapy was planned.
* Eligible participants had taken no estrogens, antiestrogens, selective estrogen-receptor modulators, aromatase inhibitors, or hormonal contraceptives within the month before enrollment.
* Human chorionic gonadotropin negative by urine test before entering the group.
* Informed consent, understanding and compliance with the requirements of the study.
* No significant chronic disease and any organ dysfunction.

Exclusion Criteria:

* Exceptions were made for the use of hormonal contraception in women younger than 35 years of age that was discontinued before randomization.
* Use of hormonal treatment for up to 2 months for the purposes of in vitro fertilization and cryopreservation of embryos or oocytes before randomization.
* Patients with metastatic lesions or history of bilateral ovariectomy,ovarian radiation were excluded.
* Patients received previous adjuvant endocrine therapy for breast cancer are not suitable to this trial.
* Patients with uterine and/or adnexal diseases needing medical or surgical treatment are not suitable.
* Allergic to active or inactive excipients of GnRHa is an exclusion criterion.
Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism

This study will look at the changes taking place in the blood levels of key markers of oxidative stress. Oxidative stress is the biological equivalent of rust on a car. It changes vital cell chemistry. It is known to occur at high pressure oxygen, but little is known about changes at pressures slightly greater than normal atmospheric pressure.

Hyperbaric therapy is used in a variety of medical conditions. It is being tested in this study only for safety. It is not being assessed for the ability of hyperbaric oxygen to improve the clinical condition of children with autism.

This study was felt to be important since autism appears to be associated with oxidative stress and hyperbarics was being used "off-label" for this condition without safety studies.

Blood will be drawn immediately prior to a one hour session of hyperbarics (HBT. A catheter will be inserted in to a vein and converted to a heparin lock indwelling port for the next blood draw. The child (ages 5-12 years) will then undergo 1 hour of compression at 1.3 atmospheric pressure (4 psi above room air pressure). Supplemental oxygen will be provided to the child.

A second blood draw from the catheter site will be accomplished immediately after the child comes out of the HBT chamber.

These will be sent to the laboratories for evaluation of changes in reduced glutathione and lipid peroxides.

Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed with autism ages 5-12 and undergoing hyperbarics

Exclusion Criteria:

* Seizures, acute URI, or inability to ventilate ears
Long-term Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis

This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 for long-term dosing in chronic kidney disease and hyperphosphatemia patients on hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease patients on hemodialysis
* Hyperphosphatemia
* Written informed consent

Exclusion Criteria:

* Patients with gastrointestinal surgery or enterectomy
* Severe cardiac disease patients
* Patients with severe constipation or diarrhea
* Patients with a complication of malignant tumors
* Patients with uncontrolled hypertension
* Patients treated with parathyroid intervention
Microcirculatory Mapping of the Aging Hand and Foot

Currently, dorsal hand rejuvenation is an upcoming issue as patients seek plastic surgeons to address this highly visible area, although no specific statistics concerning the number of patients undergoing dorsal hand rejuvenation have been published yet. The solitary use of fillers, fat, sclerotherapy, skin excision, resurfacing and combinations of the above mentioned therapies have been reported in the literature, but still there is a lack of scientific literature about functional microcirculation of the dorsum of the hand.

Furthermore, there is a lack of scientific data about functional microcirculation of the plantar foot in healthy subjects compared to patients suffering from Diabetes mellitus or peripheral arterial occlusive disease. Consequently, the aim of this study is the evaluation of the functional microcirculation of hands and feet in healthy subjects as well as patients suffering from the above mentioned diseases.


Eligibility Criteria:
Inclusion Criteria:

* Both healthy subjects and patients suffering from diabetes mellitus or manifested peripheral arterial occlusive disease aged between 18 and 75 years

Exclusion Criteria:

* soft tissue inflammation or osteomyelitis, liver disease, cardiac dysfunction, arterial hypotension
The Effect of Tranexamic Acid on Uterine Blood Flow After Vaginal Delivery

Postpartum hemorrhage is the most common cause of maternal death across the world, responsible for more than 25% of maternal deaths annually. Although effective tools for prevention and treatment of are available, most are not feasible or practical for use in the developing world where many births still occur at home with untrained birth attendants . primary postpartum hemorrhage is excessive bleeding from or in the genital tract within 24 hours of delivery of the fetus which affects the general condition.

Postpartum hemorrhage is responsible for around 25% of maternal mortality worldwide , reaching as high as 60% in some countries. Postpartum hemorrhage can also be a cause of long-term severe morbidity, and approximately 12% of women who survive postpartum hemorrhagewill have severe anemia.

Tranexamic acid is an antifibrinolytic compound which is a potent competitive inhibitor of the activation of plasminogen to plasmin. At much higher concentrations it is a non-competitive inhibitor of plasmin. The inhibitory effect of tranexamic acid in plasminogen activation by urokinase has been reported to be 6-100 times and by streptokinase 6-40 times greater than that of aminocaproic acid.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women (37-42 weeks),
* with spontaneous labor
* Women who were expected to normal vaginal birth.
* women with a live fetus.

Exclusion Criteria:

* multiple gestations
* polyhydramnios
* macrocosmic baby
* grand multipara
* women with hypertensive disorders
* previous history of postpartum hemorrhage
* abnormal placentation (placenta previa or placental abruption)
* history of any uterine scarring (including cesarean section)
* history of blood/liver/renal/heart diseases.
Effect of Manual Therapy on Non Specific Neck Pain

The aim of this study is to investigate the effects of Mulligan concept Reverse Natural Apophysial Glide Technique (RNAGS)technique applied to the thoracic region on pain, limitation of movement, and functionality in individuals with mechanical neck pain.

When we look at the studies investigating the effectiveness of different treatment modalities in non-specific neck pain (NSNP), there is no method accepted as the gold standard for the treatment of NSNP. One of the preferred treatment options for NSNP is physiotherapy and rehabilitation. Physiotherapy and rehabilitation includes electrotherapy modalities, therapeutic exercises, joint mobilisation and manipulations, myofascial release. Among these treatments, manual therapy, which targets the harmony of structure and function, is one of the most preferred treatment methods by physiotherapists. Manual therapy provides improvement by orienting the body's biomechanics, circulation and body structure by directly affecting the joints, muscles and soft tissues. In the literature, there are studies on both cervical mobilisation and thoracic mobilisation for neck pain. Cervical mobilisation and manipulation in neck pain are controversial because they carry certain risks. It has been reported that mobilisation of the thoracic spine decreases pain in the cervical region and increases mobilisation in this region. When the literature was examined, there was no study examining the effect of the Mulligan concept natural apophyseal reversal technique applied to the thoracic region on NSNP. This study was planned to investigate the effect of natural apophyseal reversal on pain and mobility limitation in individuals diagnosed with NSNP.

Eligibility Criteria:
Inclusion Criteria:

* Those between the ages of 18-65
* Those with neck pain lasting at least 3 months
* Individuals diagnosed with mechanical neck pain by a specialist physician

Exclusion Criteria:

* Those with a history of spinal surgery
* Those with a history of whiplash injury
* Those with a history of trauma in the cervical and thoracic region
* Pregnancy
Development of a Questionnaire to Evaluate Patient Expectations for Breast Reconstruction in Women With Breast Cancer or Other Conditions

RATIONALE: A questionnaire that evaluates a patient's expectations about breast reconstruction surgery may help doctors improve patient education before surgery and increase patient satisfaction after surgery.

PURPOSE: This clinical trial is developing a questionnaire to evaluate patient expectations for breast reconstruction in women with breast cancer or other conditions.

OBJECTIVES:

* Develop and validate a questionnaire to evaluate preoperative expectations about breast reconstruction in women with breast cancer or other conditions.
* Determine variations in expectations related to patient characteristics.
* Develop educational modules to help patients understand realistic outcomes.
* Identify patient groups at risk for dissatisfaction.

OUTLINE: This is a 3-part study.

* Part 1 (first 80 patients): Both preoperative and postoperative patients (50 patients total) undergo an interview by a research study assistant about their expectations for breast reconstructive surgery. Some of these patients will also complete a pilot version of a questionnaire about their expectations for breast reconstructive surgery (30 patients total).
* Part 2 (next 200 patients): Preoperative patients complete questionnaires (the preliminary questionnaire developed after part 1 and the MSKCC BREAST-Q \[Reconstruction Module\]) about their expectations for breast reconstructive surgery after patient education about breast reconstructive surgery. Some of these patients (100 patients) also complete the Brief Cope addressing emotional expression and emotional processing styles of coping, Impact of Events Scale, and Life Orientation Test-Revised (LOT-R) questionnaires.
* Part 3 (final 200 patients): Preoperative patients complete a questionnaire (final questionnaire developed after part 2) about their expectations for breast reconstructive surgery after patient education about breast reconstruction and once after surgery. Patients also complete the Breast Reconstruction Outcomes Questionnaire (MSKCC BREAST-Q) once before surgery (after patient education) and once after surgery measuring patient satisfaction and quality of life. A small group of patients complete the Body Image Scale (BIS) and the LOT-R addressing body image, sexuality, personal well-being, and lifestyle.

Eligibility Criteria:
Inclusion Criteria:

* Female.
* Age \> or = to 18 to 75 years.
* Patients who are presenting for consultation about breast reconstruction

Exclusion Criteria:

* Inability to speak or understanding English
* Inability to provide meaningful informed consent due to physical, cognitive, or psychiatric disability.
* Prior breast reconstruction surgery.
Motor Disability of Children With Cerebral Palsy Using Motor Transcranial Magnetic Stimulation

Transcranial magnetic stimulation (TMS) has opened new potential avenues for the treatment of neuropsychiatric diseases via the effects of modulation on neuroplasticity. Repetitive TMS (rTMS) is a non-invasive method of stimulation neural pathways in the brain of conscious subjects through the intact scalp. The investigators hypothesize that excitatory rTMS applied over the motor cortex would increase motor cortex activity and result in an increase in the inhibitory input through the corticospinal tract to the spinal cord, thus reducing alpha neuron hyperactivity and consequently clinical spasticity. In this study, the investigators will apply the stimulation on the legs motor cortex area, which can cover supplemental motor area (SMA). Therefore, not only the spasticity, but also the motor control of legs both can be modulated by stimulation. Theta burst stimulation is a condition of rTMS which was designed by the co-investigator. It has controllable, consistent, long-lasting, and powerful effects on motor cortex physiology and behavior. The investigators therefore design this protocol using theta burst stimulation on the motor cortex of the patients of cerebral palsy. The investigators expect that there would be an effect on the reduction of spasticity after rTMS on the brain of children with CP, thus improving the motor control of legs.

In this study, the investigators design 3 steps to find out the optimal condition of rTMS for the treatment and managing of motor disability of CP. The first is to find out the optimal intensity of rTMS. The second is to find out the optimal duration of rTMS and long term effects. The third is to compare the effectiveness of botulinum toxin injection, rTMS, and combined therapy (botulinum toxin injection and rTMS) for children with CP.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of mild to moderate CP with spastic diplegia or hemiplegia according to clinical criteria
* age 7-20 years
* no use of botulinum toxin in the past 4 months
* no significant perceptual or communication disturbances
* no other peripheral or central nervous system dysfunction
* no active inflammatory or pathologic changes in lower limb joints during the previous 6 months
* no active medical problems, such as pneumonia, upper gastrointestinal bleeding, or urinary tract infection
* no active problems of epilepsy and EEG without epileptiform discharge
* ability to walk 20m without walking aids, such as a cane, quadricane or walker

Exclusion Criteria:

* Metabolic disorders, such as inborn error of metabolism, electrolyte, and endocrine disorders.
* Active infectious disease, such as meningitis and encephalitis.
* Patients with active medical problems, such as pneumonia, upper gastrointestinal bleeding, or urinary tract infection.
* Poor compliance or intolerance for the TMS therapy
* Subjects with metallic implants or pregnancy.
* EEG show epileptiform discharge
Effects of Body Structures and Function on Actıvıty and Partıcıpatıon in Patıents wıth Carpal Tunnel Syndrome

The aim of our study is to determine pain, sensation and electrodiagnostic findings in CTS; to examine its effects on activity and participation.

50 patients aged 20-55 years diagnosed with mild and moderate carpal tunnel syndrome according to AANEM will be included. VAS, LANSS, Boston Carpal Tunnel Questionnaire (Symptom Severity Scale - Functional Status Scale), Q-DASH, hand grip sensitivity measurement, hand pressure sensitivity measurement will be applied to the participants. In order to examine the relationship between body structure and functions (Pain, Sensation, EMG findings) and activity and participation with the AMOS program, the maximum likelihood method will be selected and a structural equation model (SEM) will be established.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with mild-moderate CTS
* Being between the ages of 20-55
* Volunteering to participate in the study

Exclusion Criteria:

* Being diagnosed with severe CTS
* Have systemic inflammatory disease
* Having a disease that can cause polyneuropathy, such as diabetes mellitus
* Being receiving psychotherapy
* Illiteracy
* Have a hearing problem
* Have cognitive impairment
* Having a pacemaker
Clinical Trial Comparing TaurolockTMHep100 (Taurolidine 1.35%) and 0.9% Saline As Prevention of Recurrent Catheter-related Bloodstream Infections

The purpose of the trial is to compare two catheter lock solutions (active: 1.35% taurolidine and placebo: 0.9% saline), on the occurence of catheter related blood stream infection, in patients with intestinal failure and a central venous catheter for home parenteral support.

Patients with long-term intestinal failure rely on Home Parenteral support (HPS) delivered through a central venous catheter(CVC). Catheter Related Blood Stream Infections(CRBSI) are a frequent complication leading to increased morbidity, hospital admissions, cost, and risk of repeated replacement of the CVC. The infections often originate from contamination of the catheter hub, and growth of microorganisms on the inner lumen of the catheter imbedded in a biofilm. To prevent infections good hygiene guidelines and the use of a catheter lock solution is applied.

The primary objective is to compare two catheter lock solutions, 1,35% taurolidine and 0.9% saline, on the occurence of recurrent CRBSIs. The secondary objectives are to compare the two devices according to other catheter-related complications, adverse events and costs.

Patients with at least one prior CRBSI is included. Patients instill the solution in their CVC after each infusion of HPS, with a minimum of three times per week, depending on their individual HPS programme.

Before the blinded randomization the patients will be paired according to age and stratified according to prior CRBSI incidence.

Duration of the instillation will be 24 months.

Eligibility Criteria:
Inclusion Criteria:

Patients receiving HPS at the department of Medical gastroenterology, Rigshospitalet, who have at least one prior CRBSI and thereby demonstrated susceptibility towards developing CRBSI while on HPS and the following:

1. Signed informed consent form
2. Has a single-lumen subcutaneously tunneled CVC
3. Has been at least 3 weeks since termination of the antibiotic treatment for their last CRBSI

Exclusion Criteria:

Patients who:

1. have a known hypersensitivity/allergy to TauroLockTMHep 100 or heparin and/or their excipients
2. are pregnant, lactating or nursing
Patient Understanding of LiverMultiScan

This is a qualitative study to determine which factors affect the patient experience of having a liver MRI, what information patients would like to receive after their MRI, and how patients would like this information communicated to them.

This is a qualitative study to determine which factors affect the patient experience of having a liver MRI, what information patients would like to receive after their MRI, and how patients would like this information communicated to them. Each individual will receive at least an MRI scan (LiverMultiScan), with many also receiving a FibroScan (Transient Elastography). Patients will then undergo a focused qualitative interview, as well as filling out a questionnaire. The interviews will be thematically analysed and trends identified by significance.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with experience of liver disease.
* Individuals over the age of 16.
* Individuals willing to give informed consent for participation in the study.

Exclusion Criteria:

* Individuals with any contraindication to magnetic resonance imaging.