cyrilzakka/clinical-trials huggingface dataset:
Injections of FloGraft Therapy, Autologous Stem Cells, or Platelet Rich Plasma for the Treatment of Degenerative Joint Pain

This study will assess the outcomes of three currently available regenerative treatments (FloGraft, autologous stem cell therapy, platelet rich plasma therapy) for painful degenerative conditions of the joints. Patients receiving one these treatments will be assessed before the treatment procedure and followed up at four points over the six months after their procedure. Patients' pain, quality of life, and pain medication use at follow up will be compared to baseline levels. The investigators hypothesize that all three treatments will be effective in reducing pain, improving quality of life, and reducing pain medication usage.

This is an open-label, non-randomized study assessing the efficacy of three potentially regenerative treatments for degenerative conditions of the joints of the lower back (facet, sacroiliac), upper extremities (e.g., shoulder), and lower extremities (e.g., hip, knee). These treatments are:

1. A single injection of Applied Biologics' FloGraftTM.
2. A single injection of autologous bone marrow derived stem cells.
3. A single injection of platelet rich plasma.

Subjects will be assessed prior to treatment for their level of pain, quality of life, and pain medication usage. Subjects will be followed up at 4 weeks, 8 weeks, 12 weeks, and 24 weeks after treatment. At each of these follow up visits, pain, quality of life, and pain medication usage will be assessed.

The investigators hypothesize that all three treatment groups will experience reduced pain, improved quality of life, and reduced pain medication usage at follow up.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older,
* Ability to complete follow-up visits,
* Able to understand the study protocol and provide consent,
* Significant pain (average pain in the past month greater than or equal to 5, from 0-10),
* Pain lasting at least 3 months,
* Pain associated with one of the following conditions: lumbar facet degeneration, - OR -degenerative condition causing upper extremity joint pain, - OR - degenerative condition causing lower extremity joint pain.

Exclusion Criteria:

* Current litigation or worker's compensation claim,
* Unstable pain medication dosage,
* Previous surgery at the affected site,
* Injections at the affected site within the past 6 months,
* Uncontrolled psychiatric condition,
* Pregnancy or lactating in women,
* History of adverse reactions to local anesthetic
Population Based Intervention to Prevent Obesity in Kindergartens (TigerKids)

Behavioral intervention at Kindergarten setting aiming at increased fruit and vegetable consumption, decreased intake of high energy foods, snacks, sweets, increased intake of water/low energy drinks, decreased intake of high energy drinks. Physical activity should be more than 1 hour/day and TV/media consumption less than 1 hour/day.

Main questions are:

Do children differ in intervention and control kindergartens according to their nutrition behaviour? Do children in the intervention kindergartens have a higher physical training than such in the control kindergartens? Data were collected with a standardised questionnaire.

Do children differ in intervention and control kindergartens according to their body mass index?

The program is based on actual cognitions and methods of the early education science. In the initial phase study part I (2003-2006) we will study over three years in 75 kindergartens of four administrative districts in Bavaria, Germany: Bamberg, Günzburg, Ingolstadt and Schwandorf.

The objective of the study part II is to evaluate the effects of the TigerKids intervention program on overweight prevalence in childhood. Data concerning BMI, nutrition behavior and physical activity are assessed both at baseline (September/October 2007) and after 10 months intervention in \> 450 control- and intervention-kindergartens in Bavaria.

Eligibility Criteria:
Inclusion Criteria:

* infant of intervention- or control-kindergarten

Exclusion Criteria:

* absence of parenteral consent to participate
Omission of Intact Parathyroid Hormone Testing During Surgery in Treating Patients With Primary Hyperparathyroidism

This clinical trial studies the omission of intact parathyroid hormone testing during surgery in treating patients with primary hyperparathyroidism. Omission of intact parathyroid hormone testing during parathyroid gland removal may help patients with primary hyperparathyroidism to decrease their time under anesthesia, and decrease the overall time and cost of surgery.

PRIMARY OBJECTIVES:

I. Determine the non-inferiority of omission of parathyroid hormone (PTH) in patients who meet the biochemical and radiological criteria compared to current standard of care (i.e. use of intraoperative parathyroid hormone testing).

SECONDARY OBJECTIVES:

I. Cost-analysis to determine savings of omission of intraoperative PTH testing.

OUTLINE:

Patients undergo standard minimally invasive parathyroidectomy without PTH testing during surgery.

After completion of study, patients are followed up at 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Positive 4 dimensional computed tomography (4D CT) for single gland (adenoma) primary hyperparathyroidism
* Preoperative serum calcium levels \>= 10.9 mg/dL
* Preoperative parathyroid hormone (PTH) elevated beyond normal range or inappropriately high for associated calcium level
* Patient has no history of prior neck surgery or external radiation to neck for malignant conditions
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
* Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* Patient has recurrent hyperparathyroidism
* 4D CT positive for multiple gland disease
* Patient has inability to tolerate 4D CT scan (for example; contrast intravenous (IV) allergy, claustrophobia, renal disease)
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or nursing female subjects; may be determined in the preoperative evaluation
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator's opinion deems the subject an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiography \[EKG\], chest x-ray, or pulmonary function tests that preclude a wide excision in the operating room)
Effect of GABA on ADHD and Seizures in Children With Epilepsy.

Effect of GABA on ADHD and seizures in Children with epilepsy.

Effect of Gamma aminobutyric acid on ADHD and seizures in Children with epilepsy.

Eligibility Criteria:
Inclusion Criteria:

* Epilepsy
* ADHD

Exclusion Criteria:

* Epilepsy without ADHD
3D Prediction of Patient-Specific Response

This is a prospective, non-randomized, observational registry study evaluating a patient-specific ex vivo 3D (EV3D) assay for drug response using a patient's own biopsy or resected tumor tissue for assessing tissue response to therapy in patients with advanced cancers, including ovarian cancer, high-grade gliomas, and high-grade rare tumors.

This protocol defines a prospective, open-label, multi-institutional, non-interventional study for the purpose of examining the Assay's clinical use and potential to impact patient outcomes. This Study will establish a registry of clinical parameters, including clinical response, clinical outcomes, Assay performance and potential utilization across multiple types of advanced cancers in consenting patients who have their tumor tissue tested by the Assay. Physicians may have access to Assay results which which predict therapeutic response to cancer drugs most often prescribed to treat the specified indications. For cancers with standard of care (SOC) cancer drug treatments, the Assay panel tests SOC systemic agents per NCCN guidelines, some of which may include both FDA approved and off-label FDA approved therapies. The Assay currently assesses the most common cancer drugs across multiple tumor types. It requires freshly obtained tumor specimen that has not been previously preserved for traditional histologic analysis. The Registry will focus initially on tumor types and agents which have been analytically validated with the Assay and determined to meet strict laboratory qualifications and standards. The Registry will collect data on a limited number of cancer types to include epithelial ovarian cancer (EOC), high-grade gliomas (HGG) limited to anaplastic astrocytoma (AA) and glioblastoma multiforme (GBM), and high-grade rare tumors (RT).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Diagnosis of or suspected diagnosis of EOC, HGG, high-grade RT
* Individual must undergo elective surgery or biopsy to remove tumor tissue
* Consideration as a candidate for systemic therapy with cytotoxic chemotherapy, targeted small molecule inhibitors or immunotherapy
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 3
* Written informed consent in accordance with institutional standards must be obtained from the patient or legal guardian

Exclusion Criteria:

* Inability or refusal of the patient or legal guardian to sign a written informed consent
* Failure to have surgery or a biopsy as part of routine clinical practice
* Refusal to have the Assay performed on their tissue
* Known active cancer metastatic to the brain except for patients with brain metastases that have been treated and are considered stable.
* Inability or unwillingness to receive chemotherapy treatment beyond surgery
* Any coincidental medical condition that, in the Investigator's opinion, would preclude participation in the study or compromise the patient's ability to give informed consent
Assessment of the Phototoxic Potential of LEO 29102 Cream

The purpose of this trial is to evaluate the phototoxic potential of a single application on healthy skin of LEO 29102 cream in different doses.


Eligibility Criteria:
Inclusion Criteria:

* Subjects having understood and signed an informed consent form
* Male adults between the age of 18 and 65 years (both inclusive)
* Healthy subjects without signs of skin irritation on test areas (erythema, dryness, roughness or scaling)
* Subjects willing and able to follow all the study procedures and complete the whole study
* Subjects affiliated to a social security system

Exclusion Criteria:

* Females
* Males who are not willing to use a local contraception for the entire duration of the study, and refrain from fathering a child within 3 months following the study drug
* Systemic treatments which may interfere with the inflammatory reaction (e.g., corticosteroids and other anti-inflammatory drugs) within 2 weeks prior to randomisation
* Systemic or topical treatments suspected of causing photobiological reactions (e.g., tetracycline, thiazides, fluoroquinolones) within 4 weeks prior to randomisation
* Exposure to excessive or chronic UV radiation (i.e., sunbathing, solarium, phototherapy) within 4 weeks prior to inclusion or is planned during the study period
* Dark pigmentation of the skin or skin type that may, in any way, confound interpretation of the study results (skin types V and VI on the Fitzpatrick scale)
* Scars, moles, sunburn or other blemishes in the test area which may interfere with grading
* Any systemic or cutaneous disease on the test area that may confound interpretation of the study results (e.g., atopic dermatitis, eczema, psoriasis)
* Relevant history of or concurrent photo-induced or photo-aggravated disease (abnormal response to sunlight
* Subjects with a history of serious allergy, allergic skin rash or known sensitivity to any component of the investigational products
* Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the last four (4) weeks before randomisation
* Participation in any other current interventional clinical trial based on interview of the subject
* Previously randomised in this trial
* Subjects impossible to contact in case of emergency
* Subjects known or, in the opinion of the investigator, are unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)
* Subjects who are in an exclusion period in the National Biomedical Research Register of the French Ministry of Health
* Subjects under guardianship, hospitalised in a public or private institution for a reason other than research or subject deprived of freedom
Evaluation of Effectiveness of Acupuncture on Quality of Life in Patients With Breast Cancer Receiving Chemotherapy

The aim of this trial is to investigate the effectiveness of acupuncture on quality of life in patients with breast cancer receiving chemotherapy compared to routine care.

At the Mammazentrum Hamburg, Germany, patients with breast cancer receiving chemotherapy have the opportunity to get acupuncture in addition to conventional therapy to maintain quality of life and to reduce the side effects of the chemotherapy such as gastrointestinal disorders. In this randomized trial we aim to investigate the effectiveness of additional acupuncture compared to routine care in patients with breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed breast cancer (invasive, intraductal, hormone-sensitive and not hormone-sensitive, only locoregional metastases)
* current chemotherapy at Mammazentrum Hamburg with regimen FEC/DOC or EC/DOC
* willingness to receive acupuncture within the next 6 month if randomized in acupuncture group
* willingness to refrain from acupuncture within the next 6 month if randomized in control group
* informed consent

Exclusion Criteria:

* distant metastases
* blood coagulation disorder and/or current use of anticoagulants
* serious acute or chronic mental or physical disorders
* clinically relevant cardiac arrhythmia symptoms
* insufficient German language ability
Family Adaptation Study Following the Diagnosis of Hypoplastic Left Heart Syndrome in a Newborn

Survival for one of the most complex forms of congenital heart disease, hypoplastic left heart syndrome (HLHS), has improved dramatically. However, little is known about family stress, coping and outcomes following the diagnosis of HLHS. It is expected that families face emotional, social and financial stressors. Health care professionals have a unique opportunity to positively influence how families interpret and adapt to these stressors. The specific aims of the study are to describe perceived stress, and coping skills utilized, in parents of children with HLHS and their impact on family outcomes measured as well-being, adaptation and caregiver/family quality of life, and to describe changes in stress, coping, and adaptation and differences in perceptions of mothers versus fathers of children with HLHS over the first 14 months of life. The Resiliency Model of Family Adjustment and Adaptation (McCubbin, Thompson, \& McCubbin, 1996) is the theoretical framework that guides this research.

Hypotheses:

1. Family perception of stress, and coping skills utilized, will have an impact on family outcomes measured as well-being, adaptation, and caregiver/family quality of life.
2. Variables influencing perception of stress and variables influencing family coping will be significant predictors of family adaptation outcomes.
3. Perceptions of stress, coping skills utilized, and family adaptation outcomes will improve during the first 14 months of life with an infant with HLHS.
4. Mothers and fathers will report different perceptions of stress, coping skills utilized, and family adaptation outcomes during the first 14 months of life with an infant with HLHS.


Eligibility Criteria:
Inclusion Criteria:

* Parents of all patients diagnosed with complex congenital heart disease requiring hospitalization or intervention during the neonatal period

Exclusion Criteria:

* Parents unable to speak or read English
Cardiac Rehabilitation Program in Improving Cardiorespiratory Fitness in Stage 0-III Breast Cancer Survivors

This clinical trial studies a cardiac rehabilitation program in improving cardiorespiratory fitness in stage 0-III breast cancer survivors. Cardiovascular disease is the leading cause of death of women in both the general population and the breast cancer survivor population. There are many risk factors common to both heart disease and breast cancer development, including physical inactivity. A cardiac rehabilitation program may help improve cardiorespiratory fitness, reduce cardiovascular disease risk factors, and improve quality of life among breast cancer survivors.

PRIMARY OBJECTIVES:

I. Assess the feasibility of conducting a 14-week cardiac rehabilitation (CR) program in women with breast cancer after completion of acute therapy.

II. Preliminarily evaluate the efficacy of CR in improving cardiorespiratory fitness (peak oxygen uptake, maximum volume of oxygen \[VO2 max\]) at baseline and 14 weeks.

III. Explore changes in cardiovascular disease (CVD) risk factors (blood pressure, cholesterol, fasting glucose, and body mass index) between baseline and 14-week follow-up. Blood pressure and body mass index will also be checked at 8 weeks.

IV. Quantify the difference in quality of life (QoL) between baseline, 8 week, and 14 week follow up, adjusting for baseline QoL values.

OUTLINE:

Patients participate in a CR program consisting of 1-hour CR intervention sessions, based on a personalized exercise prescription, 3 times per week for 14 weeks (a total of 36 sessions). Components of the exercise prescription includes intensity, mode, duration, and frequency. Intensity of exercise is guided by the results of a graded exercise stress test, rating of perceived exertion (RPE), heart rate, and symptoms, such as chest pain/angina or shortness of breath. If exercise is well-tolerated during CR sessions, patients are encouraged to supplement their exercise program at home, increasing their exercise frequency to up to 5 times per week. Patients may attend weekly educational sessions offered by the Phase 2 CR program which covers topics such as stress management, smoking cessation, nutrition, and weight loss.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with breast cancer stages 0-III within 6 months after completion of all planned surgery, radiation and or chemotherapy treatments
* Concurrent endocrine therapy permissible
* Ability to understand and the willingness to sign a written informed consent
* Willingness to participate in CR program

Exclusion Criteria:

* Existing CVD
* Existing diabetes
* Contraindications to exercise
* Metastatic breast cancer
* Other concurrent malignancies except skin cancer
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situation that would limit compliance with study requirements
* Pregnant or nursing women
* Unable to give informed consent
* Any contraindication to cardiac stress testing
* Travel distance greater than 50 miles
Is HugeMed Video Laryngoscope Superior to McGrath in Pediatric Patients

Videolaryngoscopes improve laryngeal visualization in children under 3 years. In this study we aimed to compare Hugemed and McGrath videolaryngoscopes regarding their Cormach-Lehane (CL) and percentage of glottic opening (POGO) scores. Furthermore, tracheal intubation success rates, need for cricoid pressure and optimization maneuvers, and hemodynamic changes are compared.


Eligibility Criteria:
Inclusion Criteria:

total of 40 elective surgical patients under the age of 3, classified as ASA 1-3 risk group, who underwent general anesthesia with no anticipated difficult airway.

Exclusion Criteria:

Patients who could not obtain parental consent, those classified as ASA 4 and above, individuals with serious cardiac and respiratory problems, and patients anticipated to have a difficult airway were not included in the study.
Investigation of the Spatio-temporal Gait Parameters in Individuals With Hemiparesis: Effect of Lateralization

The aim of this study was to investigate the effect of lateralization on the spatio-temporal characteristics of gait in individuals with hemiparesis.

A total of 108 individuals within the age range of 20-65 and 36 of whom are right hemiparetic (Group1; 16F, 20M), 36 of whom are left hemiparetic (Group2; 16F, 20M) and 36 of whom are healthy (Group3; 19F, 17M) have been included in the study. BTS G-Walk Gait Analysis System has been used to assess the spatio-temporal gait characteristics.

Eligibility Criteria:
Inclusion Criteria:

for the hemiparetic individuals

* Being between the ages of 20-65,
* Having a stroke for the first time and one-sidedly,
* Having a stable clinical state,
* Having no cognitive disorder (Hodkinson Mental Test ≥ 8),
* Having ≤ 3 from Modified Rankin Score,
* Having no problems with vision and hearing.

for the healthy control group;

* Being between the ages of 20-65
* Having no neurological, musculosceletal, cardiac and cognitive problems that was undergone before and may affect walking.

Exclusion Criteria:

* The existence of vision and hearing problems in both study and control groups,
* The existence of orthopedic, neurological and psychiatric problems that may affect walking.