cyrilzakka/clinical-trials huggingface dataset:
Semi-supervised Exercise Program Before Bariatric Surgery

Background: Patients awaiting bariatric surgery, apart from suffering higher BMI, show a large number of comorbidities and a low physical fitness. These factors are associated with a longer surgery time, a longer hospital stay and a greater number of operative complications. To reduce these disadvantages, a nutritional intervention is performed to reduce total weight and the comorbidities associated with obesity prior to surgery. However, the prescription of an exercise program, which can be an effective tool to improve these factors, is not usually part of the usual care of these patients.

Objective: To know the effects of a semi-supervised exercise program on body composition, cardiovascular risk factors and operative complications in bariatric patients.

Methods: Approximately 3 months before surgery, 60 patients awaiting bariatric surgery will be recruited. Patients will be randomized into two groups: a) an experimental group (n = 30); b) a control group (n = 30). The experimental group will perform a semi-supervised exercise program, while the control group will only perform the corresponding evaluations. Both groups will be assessed for body composition, cardiovascular risk factors, physical condition, quality of life and physical activity levels at the beginning and at the end of the intervention. In addition, surgery time, hospital length of stay and operative complications will be evaluated in both groups.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20-55 years.
* All patients awaiting bariatric surgery.

Exclusion Criteria:

* Patients with chronic respiratory diseases
* Patients with cardiovascular diseases
* Inability to perform exercise
Real World Data Study Assessing The Persistency Of Xalacom And The Other Fixed Dose Combination Products, Duotrav And Ganfort, In The United Kingdom

The hypothesis is that there is no difference in persistency between Xalacom and the alternative fixed dose combination products (Duotrav and Ganfort) over a 12 month period.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had received a prescription for either Xalacom, Ganfort and DuoTrav
* Greater than 18 years old
* Diagnosed with glaucoma or ocular hypertension
* Registered at the primary care practice for \> 12 months

Exclusion Criteria:

* None
Cryoablation of Low Risk Small Breast Cancer- ICE3 Trial

To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and distant recurrence of early stage breast cancer .


Eligibility Criteria:
Inclusion Criteria:

1. Competent to sign informed consent
2. Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the following criteria:

   1. Unifocal primary disease NOTE: Patients with multifocal and/or multicentric in breast cancer, or evidence of EIC are NOT eligible. Patients with contralateral disease will remain eligible.
   2. Tumor size ≤1.5 cm in greatest diameter in the axis parallel to the treatment probe AND ≤1.5 cm in the axis anti-parallel to the treatment probe AND ≤1.5 cm in Anterior/ Posterior dimension. Tumor size ≤1.5 cm in greatest diameter as measured by breast ultrasound, mammogram and/or MRI. The largest dimension measured will be used to determine eligibility.
   3. Nottingham grade 1-2. Specifically, nuclear and mitotic scores must be less than or equal to 2.
   4. Estrogen receptor-positive, progesterone receptor-positive, HER2 negative
3. Age\>= 50
4. Breast size adequate for safe cryoablation
5. Lesion must be sonographically visible at the time of treatment.
6. History of previously treated ipsilateral or contralateral breast carcinoma is not an exclusion criteria if the investigator is certain newly diagnosed carcinoma is new unifocal primary tumor.

Exclusion Criteria:

1. Presence of lobular carcinoma
2. Presence of luminal B pathology
3. Nottingham score of 3 (specially nuclear and mitotic score\>2)
4. Presence of microinvasion, or invasive breast carcinoma with extensive intraductal component (EIC)
5. Presence of multifocal and/or multicentric in breast cancer
6. Presence of multifocal calcifications
7. Presence of prior or concurrent neoadjuvant chemotherapy for breast cancer
8. Presence of prior en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer
9. Patient that is not suitable to cryoablation procedure according to the physician opinion
10. ER AND PR negative, or Her2 positive noted on pre-cryo biopsy
A Comparative Study for Efficacy and Safety Between 4% Hydroquinone Cream With or Without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma

A Comparative study for Efficacy and Safety Between 4% hydroquinone cream with or without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma

Primary Objective:

* To compare clinical efficacy by Modified MASI score between Fractional Picosecond 1,064 nm laser and daily application of 4% hydroquinone with 4% hydroquinone alone Secondary objectives
* To compare the clinical endpoints of Mexameter Melanin Index, brownish spot and Ultraviolet spots by VISIATM complexion analysis, The Antera 3D® imaging technology for pigmentation, quality of life by Dermatology Life Quality Index and patient's satisfaction between Fractional Picosecond 1,064 nm laser and 4% hydroquinone with 4% hydroquinone alone

Eligibility Criteria:
Inclusion Criteria:

* Female with melasma lesion on bilateral sides
* Age between 18-65 years
* Dermal or mixed type melasma, confirming by Wood's lamp test
* Willing to participant in this study and signed in informed consent form

Exclusion Criteria:

* Pregnancy / lactation
* Having an activity or working outside the building or unable to avoid heavy UV light
* Allergic to UV sunscreen, topical anesthetics , topical corticosteroid or hydroquinone Treatment with laser or chemical peeling within 3 months
* Treatment with Skin Lighting medication / food supplements within 4 weeks
* Currently use of topical retinoid, hydroquinone or corticosteroid within 4 weeks
* Use of whitening cream such as alpha arbutin, azelaic acid, kojic acid ascorbic acid or any cosmetics within 2 weeks
* Uncontrolled medical illness include non-skin cancers, coagulopathy
* Intra-cardiac device - pacemaker
* Photosentive conditions such as diabetes, thyroid disease, liver and kidney disease and photosensitive dermatosis
* Currently taking anticoagulant such as warfarin
* Active skin infection or acute dermatitis at testes skin sites
* Unable to follow and comply to the study protocol
PI3Kβ Selective Inhibitor With Paclitaxel, Advanced Gastric Adenocarcinoma

This is a Phase Ib/IIa, open-label, non-randomized, dose-escalation, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of oral GSK2636771 in combination with intravenous (IV) paclitaxel in two independent subject populations: subjects with PTEN-deficient, advanced gastric adenocarcinoma.

This is a Phase Ib/IIa, open-label, non-randomized, dose-escalation, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of oral GSK2636771 in combination with intravenous (IV) paclitaxel in two independent subject populations: subjects with PTEN-deficient, advanced gastric adenocarcinoma. This study will be conducted in two phases: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase (Phase Ib) is designed to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D) of GSK2636771 administered in combination with paclitaxel. The Dose Expansion Phase (Phase IIa) will further evaluate the safety and clinical activity of the RP2D as determined in the Dose Escalation Phase.

Eligibility Criteria:
Inclusion criteria:

1. histologically or cytologically confirmed diagnosis of advanced gastric adenocarcinoma
2. Has a PTEN-deficient tumor as documented from archival or fresh (from biopsy) tumor tissue or has shown genomic alterations in PI3K pathway genes (PIK3CB, PI3KR1, PTEN, etc.) as assessed in a local laboratory.
3. Has had no prior taxane exposure (preferred) or at least 6 months since last taxane exposure.
4. Eastern Cooperative Oncology Group performance status of 0 or 1
5. measurable or evaluable disease as determined by RECIST 1.1.
6. Is able to swallow and retain orally administered medication
7. adequate baseline organ function

Exclusion criteria

1. prior treatment with any AKT, mammalian target of rapamycin (mTOR) inhibitors or PI3K pathway inhibitors
2. Has any unresolved Grade 2 (per CTCAE v4.0) toxicity from previous anti-cancer therapy at the time of enrollment such as neuropathy, except alopecia or Grade 2 anemia (if hemoglobin is ≥9.0 g/dL)
3. Has CNS metastases
4. Has a QTc interval \>450 msec or QTc \>480 msec for subjects with bundle branch block (BBB)
5. Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GSK2636771 or hypersensitivity to drug formulated in polyoxyl 35 castor oil, NF such as paclitaxel.
Non Invasive dP/dt to Detect an Acute Ischemic Myocardial Dysfunction in Emergency Department

Most patients presenting to the emergency department with chest discomfort have a nonischemic ECG and biomarkers of myocardial necrosis within normal limits. These patients are routinely admitted to hospital because of diagnostic uncertainty for occult MI or ischaemia.

Acute myocardial ischemia is associated with acute mycardial dysfunction We tested a non-invasive plethysmographic arterial pressure change index of myocardial performance (dP/dt) that could be added to the diagnostic triage of ischaemia in the ER avoiding unnecessary admissions.

For patients with chest pain , the ECG remains the most important initial risk assessment tool. Myocardial ischemia or infarction is highly likely in patients with significant ST segment changes on the ECG or elevation in myocardial markers of necrosis. Identification of high-risk patients is more difficult in those with non ischemic ECG and negative markers on presentation.

One of the most sensitive indices of contractility is the rate of increase of intraventricular pressure during isovolumetric contraction, (left ventricular dP/dt and arterial dP/dt). Dp/dt (dP/dt ejc ) represents the rate of change of pressure during ejection. It has been shown that cardiac contractility and dP/dt decreases during acute myocardial ischemia.

We theorized that a higher value of dP/dt would be found for non ischemic chest pain than during ischemic chest pain because ischemia reduces myocardial contractility, whereas chest pain of non cardiac origin increases dP/dt by the stress of the pain itself.

The current study describes a noninvasive plethysmographic dP/dt changes in patients presenting at the emergency department with acute chest pain, which could be added to the diagnostic triage of ischemia in the ED, thus decreasing the number of unnecessary admissions.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 year old
* Chest pain that lasted less than 12 hours

Exclusion Criteria:

* traumatic chest pain
* arrythmias
* STEMI
Reliability and Validity of 10 Meters Walk Test Among Children

Timed Motor Function Tests (TMFTs) determined the walking abilities of an individual. During Covid-19 pandemic direct observation may not be feasible to record Timed motor function in children. Hence, the reliability and validity of video based observation and online based observation (VBO and OBO) methods to be explored. Middle school going children age group between 8 and 12 years was recruited for the study on the basis of convenience sampling. Sample size selected for each age group was according to sample size criteria of Interclass coefficient analysis. After anthropometrics, 10 meters walk test was recorded using three methods; VBO, OBO and direct observation for three times to estimate intrarater reliability and three days within a week to estimate test-retest reliability. The mean of three readings was used to find the estimated value. Direct observation method was used as a criterion measure method to report concurrent validity. After concurrent validity, Test-retest Reliability and Intrarater Reliability of VBO and OBO was reported. Reliability and validity of VBO and OBO with direct observation was reported by recording 10 meters walk test in children.


Eligibility Criteria:
Inclusion Criteria:

1. Asymptomatic middle school going children
2. Boys and girls in the age group between 8 and 12 years
3. Independent walking has achieved at age of 14 months
4. Able to understand and follow commands of examiner.

Exclusion Criteria:

1. Any Neurological disease
2. Any musculoskeletal disease in Lower Limb
3. Deformity in Lower Limb
4. Past history of surgery in Lower Limb in past 1 year
5. Any cardio-respiratory difficulties. -
Effectiveness of MBSR Among Teachers at Upper Secondary Schools and Schools of Health and Social Care

The aim is to evaluate the effectiveness of online Mindfulness-based Stress Reduction among school teachers in Danish upper secondary schools and schools of health and social care on mental well-being in the teachers and their students. The study is a cluster-randomised trial including 43 schools; 76 teachers; 1.000 students.


Eligibility Criteria:
Inclusion Criteria:

* School teacher at a Danish upper secondary school or school of health and social care that commit to participate in a trial aiming to implement and evaluate the effectiveness of a school-based mindfulness programme.

Exclusion Criteria:

* acute treatment-demanding clinical depression or a diagnosis of psychosis or schizophrenia
* abuse of alcohol, drugs, medicine
Both Column Fixation Corridor in Pelvic Surgery

The concepts of the Both Column Fixation Corridor (BCFC) and Both Column Screws (BCS) have emerged as innovative approaches in orthopedic surgery yet have not been extensively explored in the literature. This study aims to evaluate the feasibility and potential advantages of this novel screw fixation technique, thereby filling the existing gap in knowledge and establishing standards for its application.

Pelvic CT data will be collected from 400 healthy adults, including 200 males and 200 females. The Synapse software will be utilized to simulate the placement of both anterior and posterior Both Column Screws (BCS) in the Both Column Fixation Corridor (BCFC). Screws will be virtually implanted into the BCFC using the "Ozturk Procedure," a technique developed based on clinical practice. Measurements will include the thickness and length of each BCS for both anterior (aBCS) and posterior (pBCS) placements, as well as the distances from the screw centers to the spina iliaca anterior superior (SIAS). Additionally, the necessary caudo-cranial (CCT) and centro-lateral tilts (CLT) for achieving axial fluoroscopic visualization of the BCFC will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 to 65 years.
* Both male and female participants.
* Participants with healthy pelvic anatomy as determined by CT imaging, without any previous fractures, deformities, or surgical interventions that could alter the pelvic structure.

Exclusion Criteria:

* History of pelvic or acetabular fractures.
* Previous pelvic surgeries that could alter the anatomical structure.
* Conditions significantly affecting bone quality, such as osteoporosis or metabolic bone diseases.
Adipose Tissue Derived Stromal Vascular Fraction (SVF) Application in Treatment of Long Bones Nonunion

Nonunion is a major complication of fractures.Per cutaneous bone marrow concentrate (BMC) application around fracture ends is being utilized with great success . Mesenchymal Stem Cells (MSCs)are one of the major cell types found in BMC responsible for results Adipose tissue is an alternative source for MSCs. Besides abundant and readily accessible it also overcomes issue of morbidity with bone marrow aspiration.

this retrospective analysis to report the outcome in patients treated with fluoroscopic guided percutaneous injection of SVF at the site of fracture as an outpatient procedure between November 2012 to August 2018.

Nonunion is of major complication of fractures .The overall rate of non-union is still not clear but estimates from the published literature suggests a range between 5-10% of the total fractures.The gap in non-healing management has instigated the search for novel osteo-inductive substances. bone marrow concentrate is being utilized for many year with excellent results .Mesenchymal Stem Cells (MSCs)are one of the major cell types of the Bone Marrow Aspirate Concentrate (BMAC)that self-renovates and differentiates into multiple cell types of mesodermal origin such as osteoblasts, chondrocytes, and adipocytes.

Adipose tissue is an alternative source for MSCs .besides abundant and readily accessible it also overcomes issue of morbidity with bone marrow aspiration.

This retrospective analysis was conducted to report the outcome in patients treated with fluoroscopic guided percutaneous injection of SVF at the site of fracture as an outpatient procedure between November 2012 to August 2018.

The purpose of this study is to report the feasibility of minimally invasive percutaneous injection with autologous SVF and study the osteo-inductive efficacy of Adipose derived stromal cells in SVF in the management of non-union.

Eligibility Criteria:
Inclusion Criteria:

* Non-union or delayed union diagnosed after x-ray examination More than 4 cm distance from the joint

Exclusion Criteria:

* Multiple major fracture or untreated major fracture
* Infected fracture
* HIV, hepatitis B or hepatitis C infection at the time of screening
* Diagnosis of cancer
* Active treatment with immunosuppressive drugs or anticoagulant agents
* Known allergic reaction to components of study treatment and/or study injection
Ovarian Tissue Cryopreservation for Fertility Preservation in Girls and Women

This study will compare efficacy of ovarian tissue freezing using slow-freeze versus vitrification methods.

The primary objective of this study is to determine the efficacy of ovarian tissue cryopreservation using slow-freeze and vitrification methods in enabling long-term preservation of ovarian function and fertility, in females undergoing treatment that may cause infertility. This study will provide study participants with their own tissue to cryopreserve and reserve for future use and:

* Determine the efficacy of ovarian cryopreservation techniques.
* Provide long-term follow up for patients who have undergone ovarian tissue cryopreservation for participants' own use.

In addition to providing study participants with the future opportunity to use their tissue with the intent to reinstate ovarian function, this study will provide research tissue to the embryology research lab at the Family Fertility Center at Texas Children's Hospital that will be used to:

* Optimize techniques for ovarian tissue cryopreservation of ovarian tissue for use in future retransplantation).
* Investigate factors affecting successful maturation and quality of immature oocytes obtained from ovarian tissue including growth factors, hormones and other culture conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Female Patients only
2. 0-42 years of age.
3. Will undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy that places the patient at risk for impaired ovarian function and infertility OR, have a medical condition or malignancy that requires removal of all or part of one or both ovaries.
4. May have newly diagnosed or recurrent disease. Those not enrolled at the time of initial diagnosis are eligible if they have not received therapy that is viewed as likely to result in complete and permanent loss of ovarian function.
5. Signed an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient's legally authorized guardian(s) must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services.

Exclusion Criteria:

1. Girls and women with psychological, psychiatric, or other conditions which prevent giving informed consent.
2. Girls and women whose underlying medical condition significantly increases their risk of complications from anesthesia and surgery.
3. Girls and women who are permanently menopausal, as documented by history and FSH levels.
4. Girls and women who are pregnant.
The Effects of an Empowerment Program for Parents of Children With Autism

This study aims to evaluate the effectiveness of an empowerment program that includes both parent training and motivational interviewing for parents of children with autism, supporting their competence in the care of their children.

This study was conducted to evaluate the effectiveness of an empowerment program for parents of children with autism to support their competence in caring for their children. This randomized controlled study was conducted in Manisa city center/Turkey, in 2022. A total of 69 parents (intervention: 34, control: 35) were included in this unblinded, two-group randomized controlled interventional study. A parent empowerment program, including four parental training sessions and two motivational interview sessions, were applied to the parents in the intervention group. The Parental Self-Efficacy Scale, Zarit Care Burden Scale, Perceived Stress Scale, and Family Empowerment Scale were used to evaluate the effectiveness of the empowerment program.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were having a child diagnosed with ASD between the ages of 6 and 14, being literate, and volunteering to participate in the study.

Exclusion Criteria:

* Having a child with a concomitant disability or disease (e.g., epilepsy, attention deficit, and hyperactivity disorder, other physical or mental disabilities), previous participation in an education program with similar content, or parents who did not participate in at least two-thirds of the empowerment training program or did not attend all motivational interview sessions were excluded from the study, and their data were not included in the analysis.
Effects of Thermotherapy on Chronic Neck Pain

Chronic neck pain is a common worldwide problem. In the majority of cases, patients are treated by medication, referral to a physiotherapist or thermotherapy. Thermotherapy - the therapeutic application of topical heat - provides an easy to apply self-help strategy in patients with chronic neck pain. However, despite the frequent use in clinical practice, there is no research regarding this topic yet.

The aim of this study was to evaluate whether thermotherapy self-treatment for chronic neck pain induces changes in perceived pain intensity and in sensory processing.


Eligibility Criteria:
Inclusion Criteria:

* non-specific neck pain the last 3 months
* mean pain intensity of at least 4 on a 10-level numerical rating scale with "0" meaning "no pain" and "10" meaning "worst pain imaginable"

Exclusion Criteria:

* radicular symptoms
* congenital spine deformity
* skin diseases in the painful area to be treated
* pregnancy
* insulin-dependent diabetes mellitus
* rheumatic diseases
* oncologic diseases
* steroid medication
* anticoagulation medication
* recent invasive or surgical treatment of the spine