cyrilzakka/clinical-trials huggingface dataset:
OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates

The goal of this crossover randomized clinical trial is to assess the effects of osteopathic manipulative treatment (OMT) compared to standard of care repositioning in children diagnosed with positional/deformational plagiocephaly. The main hypothesis is that children who received OMT will show significantly improved anthropometric measures of cranial symmetry over those receiving the current pediatric standard of care of repositioning.

This is a two-arm, randomized cross-over clinical trial. With parental consent, pediatric patients (infants \<4 months of age) will be organized into one of two groups:

1. Those who receive OMT with emphasis on osteopathic cranial manipulative medicine (OCMM) to restore cranial symmetry.
2. Those who receive standard care only with repositioning attention from the parents After 8-weeks of being in the first group, each participant will cross-over into the second group (OMT or repositioning) N = 122 subjects diagnosed with deformational plagiocephaly (DP) are to be recruited (to allow for natural attrition and loss to follow up) with the recruitment to continue until 61 patients have been placed in each of the two groups and will cross-over to the respective treatment group (OMT and standard of care repositioning therapy).

Timeline: It is projected that to recruit and carry out the assessments and interventions (8-weeks of each group with 12-months of follow-up longitudinally), it will require two years (24-months) from the beginning of the study to completion.


Eligibility Criteria:
Inclusions:

* Diagnosed with positional plagiocephaly
* Under 4-months of age (between birth - 4 months) at the time of enrollment

Exclusions:

* Preterm birth (\<37 weeks)
* Genetic syndromes
* Craniofacial defects/deformities (e.g. cleft lip/palate)
* Brachycephaly/scaphocephaly
* Hypotonia
* Hypertonia
* Craniosynostosis
* Head trauma or other neurological illnesses
* Lost to follow up
* Patient whose parents (or legal guardians) disagree to attend 8-treatments of OMT and 2 additional measurement sessions
* Prior helmet therapy, physical therapy, or OMT before the date of enrollment
Cyclophosphamide in Myalgic Encephalopathy/ Chronic Fatigue Syndrome (ME/CFS)

Significant clinical improvements of ME/CFS symptoms were observed in two patients with long-standing ME/CFS who received adjuvant chemotherapy including cyclophosphamide for breast cancer, also in one ME/CFS patient who received chemotherapy including iphosphamide for Hodgkin lymphoma.

Three pilot ME/CFS patients were thereafter treated with six intravenous infusions four weeks apart, in two of these with a significant clinical response.

The hypothesis is that a subset of ME/CFS patients have an activated immune system, and that ME/CFS symptoms may be alleviated by treatment with cyclophosphamide as intravenous pulse infusions four weeks apart, six infusions in total.

The purpose of the present study is to treat ME/CFS patients with cyclophosphamide as intravenous pulse infusions four weeks apart, six infusions in total. The effects on ME/CFS symptoms and tolerability/side effects during 12 months follow-up will be registered, and additional tests will be performed to objectively register changes in physical ability during follow-up. Studies to investigate possible large vessel endothelial dysfunction and skin microvascular dysfunction will be performed before start of intervention and during follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ME/CFS according to "Canadian" criteria (2003)
* Duration of ME/CFS at least 2 years
* Mild/Moderate, Moderate, Moderate/Severe and Severe ME/CFS may be included
* Age 18-65 years
* Signed informed consent

Exclusion Criteria:

* Patients with fatigue who do not comply by the diagnostic "Canadian" criteria (2003) for ME/CFS
* Duration of ME/CFS less than 2 years
* Mild ME/CFS
* Very severe ME/CFS (bedridden requiring help for all tasks)
* Patients where the workup uncovers other pathology as possible cause of symptoms
* Pregnancy or breast feeding
* Previous malignant disease (except basal cell carcinoma of skin and cervical carcinoma in situ/dysplasia)
* Previous long-term systemic treatment with immunosuppressive agents (e.g. azathioprine, ciclosporin, mycophenolate mofetil). Except steroid treatment for e.g. obstructive lung disease or autoimmune diseases such as e.g. ulcerative colitis
* Serious endogenous depression
* Lack of ability to complete the study including follow-up
* Reduced renal function (creatinine \> 1.5 x UNL)
* Reduced liver function (bilirubin or transaminases \> 1.5 x UNL)
* Known hypersensitivity to cyclophosphamide or metabolites
* Reduced bone marrow function
* Ongoing cystitis or urinary tract obstruction
* Known HIV positivity, previous hepatitis B or hepatitis C, or reason to suspect other ongoing and clinically relevant infection
Single Versus Multi-port Robotic Assisted Sacrocolpopexy for Repair of Vaginal Apex Prolapse

A prospective randomized controlled study intended to compare the efficacy of 2 methods of robotic assisted sacrocolpopexy for the repair of vaginal apex prolapse:

1. Via single-port.
2. Via multi-port.

One hundred female patients diagnosed with vaginal apex prolapse will be recruited to a prospective randomized controlled study intended to compare the efficacy of 2 methods of robotic assisted sacrocolpopexy:

1. Via single-port.
2. Via multi-port. The patients will be evaluated and randomized 2 weeks before the expected date of surgery during which eligibility will be examined.

Patients' electronic files will be reviewed post operatively to acquire information regarding medical history, prolapse scores, surgical information, anesthesia information and surgical complications.

Patients will have 3 week and 3 month post operative follow-up sessions to determine surgical success, late complications and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Female patients with vaginal apex prolapse that are eligible for repair by sacrocolpopexy.

Exclusion Criteria:

* Patients after previous hysterectomy.
* Patients after previous surgical procedures for prolapse repair.
Development of Protocols and Methods for Image Processing and Enhancement of Magnetic Resonance Imaging (MRI) Data.

The purpose of the study is to develop new methods for image processing and enhancement of MRI data. Different setting of acquisition parameters used in conventional clinical MRI protocols will be defined, to create "New Protocols".

The specific aim of this study is to assess and to improve the performance of our image processing methods, by comparing diagnostic qualities of images obtained by conventional MRI protocols with those obtained by corresponding New Protocols' and processed by our image enhancement method.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers for clinical MRI examination
* Patients undergoing clinical MRI examination
* Capable to provide an informed written consent form

Exclusion Criteria:

* Any contraindication to MRI scanning, such as pacemakers or heart rhythm disturbances, permanent cosmetics or certain metallic implants in the body (excluding dental implants).
* Age \<18 years old
* Pregnancy
* Claustrophobia
* Decisional incapacity, mentally disabled,
* MRI exam under sedation or monitoring equipment.
Suprazygomatic Maxillary Nerve Block Effect on Systemic Inflammatory Response in Cleft Palate Surgeries

the aim is to determine the value of adding bilateral supra zygomatic maxillary nerve block to general anesthesia in attenuating the systemic inflammatory response in paediatrics.

Cleft lip and palate are some of the most common craniofacial malformations, with an incidence ranging between 0.1 and 1.1 per 1000 births. Early surgical intervention for cleft palate (CP) repair is essential for proper feeding and phonation as well as reduction of complications such as frequent sinusitis and other respiratory tract infections.

Surgical injury stimulates the systemic inflammatory response. The neuroendocrine response leads to stimulation of the sympathetic nervous system resulting in tachycardia, hypertension and activation of the hypothalamic-pituitary adrenal axis. This induces the release of hormones such as adrenocorticotropic hormone (ACTH), catechol-amines (norepinephrine and epinephrine) and cortisol and increase in white cell count which is proposed to have a detrimental effect on the postoperative immunity. Furthermore, the production of pro-inflammatory cytokines including interleukins (IL) e.g.IL-1, IL-6, IL-8 and tumour necrosis factor alpha (TNF-α) by innate immune cells such as neutrophils and macrophages, interacting with damaged cells and platelets, leads to the production of acute phase proteins from the liver such as C-reactive protein (CRP), fibrinogen and complement proteins.

Regional blocks provide good pre-emptive analgesia when given in combination with general anaesthesia (GA). It is associated with hemodynamic stability, rapid recovery, reduction of supplemental analgesia consumption in addition to favourable effect on systematic inflammatory response. Using bilateral suprazygomatic approach of maxillary nerve block during CP repair is hypothesized to provide such mentioned settlement of a regional block.

Eligibility Criteria:
Inclusion Criteria:

* Primary and secondary cleft palate Surgeries.
* American Society of Anesthesiologists physical status (ASA) I to II patients.
* Age group: 1-5 years old.

Exclusion Criteria:

* Presence of coagulation disorders.
* Peripheral neuropathy.
* Local infection or lesion in puncture site.
* Allergy to local Anesthetics.
* Physical status: ASA III or above.
A Study in Subjects With Retinitis Pigmentosa

An open-label Phase II clinical trial, 8 (eight) subjects with retinitis pigmentosa due to rhodopsin mutations (including P23H) will be identified and treated with serial intravitreal injections of ADX-2191 in the worse seeing eye. Ocular structure and function will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Up to 8 adult patients age 18 or older
2. Diagnosis of retinitis pigmentosa due to rhodopsin gene mutation, including P23H
3. Impairment on Visual Field as determined by perimetry

Exclusion Criteria:

1. Age \< 18 years
2. Pregnant
3. Previous inflammatory/infectious events involving the eyes
Efficacy of an Occupational Time Use Intervention for People With Serious Mental Illness

The purpose of this study is to test the efficacy of a new Occupational Time Use Intervention designed to increase activity participation and improve meaning in the lives of people with serious mental illness living in the community.

5 Assertive Community Treatment (ACT) Teams from Kingston (n=2), Belleville (n=1), and Ottawa (n=2) will be involved in a 12 week randomized controlled trial of our Time Use Intervention. 20 subjects (4 subjects from each team) will participate in this pilot study and will be treated individually by their ACT team Occupational Therapist (1 OT per ACT Team). This pilot test will help to determine the clinical utility and efficacy of our treatment protocol.

Comparison: Standard ACT treatment with the Occupational Time Use Intervention vs. Standard ACT treatment

Eligibility Criteria:
Inclusion Criteria:

* Adults (18-65 years of age);
* Primary diagnosis of a severe psychiatric disorder with a psychotic feature;
* Team and self-perceived occupational disengagement (low activity levels);
* Fluent in English;
* Living in a community setting and receiving ACT treatment;
* Own legal guardian (thus competent to give consent to participate), and are willing to give written informed consent to participate in the study.

Exclusion Criteria:

* Unstable mental health;
* Lack of interest in a time use intervention;
* Satisfied with current time use and occupations;
* ACT Team Occupational Therapist is subject's main Case Manager.
The Acute Effects of Low Temperature for Long Time Heat Treatment of Pork Semitendinosus on Satiety

Cooking meat at low temperatures for prolonged times is widely used among chefs and in food service due to the possibility to obtain a consistent and appealing eating quality. The method is generally termed low-temperature long-time (LTLT) cooking. In LTLT cooking, meat is vacuum-packed and heated at temperatures between 50°C and 65°C in a water bath for several hours. LTLT has several benefits - improved tenderness and juiciness, less cooking loss, better vitamin retention and uncompromised food safety.

A recent PhD thesis concluded that one of the mechanisms behind the changes in eating quality during LTLT cooking was due to the proteolytic degradation in the muscle tissue. The activity of proteolytic enzymes has shown to be dependent on heating temperature and time where the cathepsins were found to remain active during heat treatment. At 58°C the cathepsin B+L activity is increased compared to 48°C and 53°C and at 55°C compared to 25°C, 40°C and 70°C. A prolonged heating time of 17 hours at 58°C has also shown to increase cathepsin B+L activity. The proteolytic degradation results in the occurrence of peptides and amino acids such as tryptophan, tyrosine, leucine and histidine which could lead to a faster degree of satiety when consumed.

According to the aminostatic hypothesis by Mellinkoff, a rise in plasma amino acids elicited by protein ingestion could assist in the suppression of food intake and the onset of satiety.

The investigators therefore hypothesize that the ingestion of LTLT cooked pork would induce a faster satiety response due to the higher availability of peptides and amino acids prior to digestion. An acute meal study will elucidate this. LTLT cooking will be performed by the "cook-chill" method to mimic real life where meat is rapidly chilled after heat treatment, stored at 0-2°C and reheated and browned prior to serving.


Eligibility Criteria:
Inclusion Criteria:

* Participants who have provided written informed consent
* Healthy men
* Ages between 18 and 60 years
* BMI between 18.5 and 30 kg/m2
* Pork eaters

Exclusion Criteria:

* Any food allergy, dislike or special diet of relevance to the study (e.g. vegetarian)
* Daily use of prescription medicine or over-the-counter drugs affecting appetite, energy expenditure or protein metabolism
* Use of dietary supplements (including protein supplement, powders, shakes) up to 1 month before the first meal test
* Irregular eating schedule (e.g. skipping breakfast)
* Self-reporting currently dieting or having lost/gained significant amount of weight (±3 kg) in the previous 3 months
* Any known chronic diseases (e.g. cancer, heart disease, diabetes, neurological disorders)
* Vigorous physical activity more than 10 hours/week
* Smoking, smoking cessation within the past 3 months or nicotine use (electronic cigarettes) (\>10 cigarettes per day)
* Participants who work in appetite or feeding related areas
* Participation in other intervention studies
* Participants not able to comply with the study protocol as judged by study personnel
Determinants of Post-Exercise Eating Patterns

This study examines potential physiological and psychological determinants of food intake in response to exercise. Specifically, beyond measuring actual food consumption and physiological markers typically assessed during exercise and appetite work (i.e. appetite hormones, blood glucose), the investigators wish to investigate the influence of individual behavioural differences (attitudes towards eating, licensing/compensatory health beliefs, self-regulation, and exercise-associated motivation) on the relationship between exercise and eating behaviour.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Inactive (\< 90 min of moderate-intensity exercise a week)
* BMI: 23 and above
* Age between 21 to 40 years
* Normal fasting blood glucose levels equal to or less than 5.9 mmol/L
* Non-smoker
* No know allergies or intolerance to food
* Not on any prescribed medication
* No physical disabilities and/or restrictions; not averse to exercising on a stationary bike or treadmill running
* No aversion to blood sampling procedures (e.g. finger prick, cannulation)

Exclusion Criteria:

* Female,
* Smoker,
* Fasting blood glucose \> 5.9 mmol/L,
* Resting blood pressure \> 140/90 mmHg,
* Any major medical/health conditions including

  * Diabetes,
  * Metabolic disease
  * Hypertension,
  * Cardiovascular disease,
  * Thyroid disorders,
  * G6PD deficiency.
* Allergic or intolerant to foods presented in the study.
* Physical disabilities and/or restrictions.
* Individuals that are adverse to exercising on a stationary exercise bike or treadmill.
* Adverse to blood sampling procedures (i.e. cannulation, finger pricks, venepuncture).
Autologous CAR T-Cells Targeting the GD2 Antigen for Lung Cancer

This is a phase 1, single-center, open-label study that enrolls adult subjects with extensive stage lung cancer or stage IV non-small cell lung cancer that is platinum-refractory and received PD-1 and/or PD-L1 therapy. The purpose of this study is to test the safety of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the GD2 antigen (iC9-GD2.CAR.IL-15 T cells) in subjects with lung cancer. How much (dose) of the iC9-GD2.CAR.IL-15 T cells are safe to use without causing too many side effects and what is the maximum dose that could be tolerated will be studied.

Modified immune cells as an experimental treatment that combines antibodies and T cells will be used. Antibodies are proteins that protect the body from foreign invaders like bacteria. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill viruses and other cells, including tumor cells. Although antibodies and T cells have been used to treat cancer and they both have shown promise, neither alone has been able to cure most patients. This study will combine T cells and antibodies to create a more effective treatment.

The treatment that is being researched in this study is called autologous T lymphocyte chimeric antigen receptor cells targeted against the disialoganglioside (GD2) antigen that expresses Interleukin (IL)-15, and the inducible caspase 9 safety switch (iC9). The short name for this treatment is iC9.GD2.CAR.IL-15 T cells therapy is an experimental therapy and has not been approved by the Food and Drug Administration. There are two steps. In the first step, blood will be collected from the subjects to prepare the iC9-GD2.CAR.IL-15 T cells. T cells will be isolated from the blood and modified to make iC9-GD2.CAR.IL-15. In the second step, the iC9-GD2.CAR.IL-15 T cells produced from the subject's own blood will be administered to the subject.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent to undergo cell procurement explained to, understood by, and signed by the subject.
2. Subject has a life expectancy of ≥ 12 weeks.
3. Subject must be platinum-refractory and either currently receiving or has previously received a PD1/PDL1 inhibitor
4. Use of systemic corticosteroids at doses ≥10 mg prednisone daily or it's equivalent; those receiving \<10 mg daily may be enrolled at the discretion of the investigator.
5. Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to cell procurement.
6. Subject has demonstrated adequate organ function.

Exclusion Criteria:

1 . Subject has less than 12 weeks of life expectancy.

2. Subject did not receive platinum-based chemotherapy

3. Subject does not have adequate organ function.
Pilot Study on Safety and Efficacy of MD05 in Comparison With Beta-TCP in Patients Undergoing Sinus Floor Augmentation

The primary objective is the area of newly formed bone (%) as assessed by histomorphometry with either MD05 or beta-TCP.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring two-stage unilateral maxillary sinus floor augmentation (sinus lift) in case of insufficient bone height in the area of the posterior maxilla, prior to insertion of dental implants
* Residual bone height at the site of planned implantation \> 1 mm and \< 5 mm
* Male and female outpatients, 18 to 75 years old
* Female patients must be infertile (either sterilized or postmenopausal). If a patient's menopausal status at screening is uncertain, levels of follicle stimulating hormone (FSH) should be determined. Patients with an FSH level \> 25 IU/l and absence of menstrual bleeding \> 6 months will satisfy the definition of postmenopausal status.
* Patient has given informed consent.

Exclusion Criteria:

* Women of childbearing potential, lactating women
* Participation in another clinical study within 30 days prior to study start
* Previous participation in this study
* Last dental extraction (maxilla, posterior to canine) within the last 3 months
* Failed sinus lift surgery and previous eradictive maxillary sinus surgery
* Simultaneously bilateral sinus lift
* Legal incompetence or restricted legal competence
* Alcoholism, drug dependency, smoking
* Acute or chronic infection at the application site, e.g., sinusitis
* Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
* Severe allergic rhinitis which requires permanent medication (Rosenlicht 1999)
* Known intolerance of or hypersensitivity to beta-TCP or rhGDF﷓-5
* Presence of local or systemic malignant disease or history of local or systemic malignant disease in the past 5 years
* Patients requiring chemo- or radiotherapy
* Previous or current radiotherapy of the head
* Chronic liver disorder
* Impaired renal function
* Uncontrolled, insulin-dependent diabetes mellitus
* Clinically relevant symptoms of thyroid dysfunction
* Severe hypertension (RRdiast \> 110 mmHg);
* Clinically relevant cardiovascular disease
* Systemic bone disease or illness having influence on bone metabolism,
* Clinically relevant blood coagulation disorder,
* Leukopenia \< 3.500 leukocytes/µL
* Previous or current treatment with systemic corticosteroids
* Previous or current therapy with drugs having any influence on bone metabolism
* Previous or current treatment with immunosuppressant medication