cyrilzakka/clinical-trials huggingface dataset:
Transdermal Delivery of Glucosamine to the Synovial Fluid of Male and Female With Knee Osteoarthritis

Glucosamine is commonly used as a treatment for Osteoarthritis (OA). While oral administration remains the most commonly used route, topical administration could offer numerous advantages such as targeted delivery to affected joints and overcoming the negative effects of the passage of the drug through the digestive system. The objective of this study is to assess the bioavailability of glucosamine in the synovial fluid of osteoarthritic joints, following the topical application of a commercially available transdermal glucosamine cream. Joint fluid samples will be collected from 2 groups of participants with knee OA: the Control group will not be subjected to any treatment while the Test group will apply 2g of transdermal glucosamine cream 1 to 3 hours before the joint fluid collection. Glucosamine concentration will be determined and the results obtained from both groups will be compared. This trial will potentially provide data to support that glucosamine can cross the skin and be delivered to the affected joint fluid when formulated in a transdermal cream base.


Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant female human subjects
* 21 to 80 years old
* Subjects who need to undergo arthrocentesis (prescribed during prior medical assessment)
* Willingness to follow the protocol requirements

Exclusion Criteria:

* Known allergy to shellfish
* Known history of hypersensitivity to Glucosamine or related drugs.
* Known history of hypersensitivity to Capsaicin (Capsicum extract)
* Known history of skin sensitivity
* Subjects who have taken any kind of glucosamine during the last 24 hours
* Subjects who have taken any kind of treatment for joint pain during the last 24 hours
* Subjects having scars/cut/dermatological abnormality at application site
* Pregnant or nursing women
Multiple Ascending Dose Study of HM12470 in Type 1 and Type 2 Diabetes Mellitus

This is a phase 1 multiple ascending dose (MAD) study, conducted in subjects with Type 1 and Type 2 diabetes mellitus


Eligibility Criteria:
Inclusion Criteria:

* T1DM or T2DM
* Female subjects must be non-pregnant and non-lactating

Exclusion Criteria:

* Pregnant or lactating women
* Participation in an investigational study within 30 days prior to dosing
Orthostatic Hypotension Among Veterans

Orthostatic hypotension (OH) is defined as a fall in blood pressure when standing. Several different underlying diseases, conditions, or combinations of medicines may contribute to OH; therefore the cause of the condition varies among individuals. Some studies have shown that OH is associated with an increase in the rate of death, but it is not clear what role OH plays in increased morbidity. By studying what the prevalence of OH is in a generalized veteran population we expect increase clinical awareness of the degree of the problem so that patient care might be improved.


Eligibility Criteria:
Inclusion Criteria:

* Veterans
* Between the ages of 18 and 89

Exclusion Criteria:

* Current illness/infection
* Pregnant
Intravenous Iron Metabolism in Restless Legs Syndrome

To determine the effects of high-dose infusions of iron on Restless Legs Syndrome (RLS) symptoms and brain concentrations of iron.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Restless Legs Syndrome (RLS).
* Presence of increased PLMS before receiving treatment.
* Patient sleep times are between 9pm and 9am.
* Patient's RLS symptoms would occur daily if you were not on medication.

Exclusion Criteria:

* RLS secondary to other medical disorders as determined by history and physical/neurological examination.
* On a treatment (e.g., psychiatric medication) that might significantly alter RLS symptoms or study results and who cannot discontinue medication for the extended period of the study.
* History of multiple adverse drug reactions or specifically an allergy to IV iron.
* Currently experiencing a serious medical condition (chronic organ failure, active inflammation or infection, congestive heart failure, etc.) that might alter iron metabolism, would place them at risk, or interfere with study participation.
* An MRI is not possible because of medical reasons (Pacemaker; loose iron in the tissue) or concern about severe claustrophobia.
* Any condition that is likely to increase iron loss (chronic bleeding, excluding menstruation; medically necessary phlebotomy) or consumption (pregnancy).
* Serum ferritin \>300mg/L or percent iron saturation \>50%. This is to exclude subjects with probable hemochromatosis.
* Significant medical (e.g., inflammatory bowel syndrome; bowel dysmotility syndromes) or surgical (e.g., gastrojejunal bypass, colectomy) GI tract problems; and active chronic inflammatory processes (e.g., active hepatitis, rheumatoid arthritis, SLE). This is to exclude conditions which will potentially alter iron metabolism.
Sustaining Remission From PTSD Using Tuned Vibroacoustic Stimulation (TVS) Following MDMA-Assisted Psychotherapy

The purpose of this research is to examine a wearable device called Apollo that emits gentle vibrations found to benefit mood, energy, and focus. We want to understand how it affects outcomes related to MDMA-assisted psychotherapy for PTSD including depression, anxiety and emotion regulation.

This study will test whether regular use of the Apollo wearable improves rates of sustained symptom remission in PTSD following MDMA-assisted psychotherapy over the course of two years

The study examines the effect of the Apollo wearable on its users after undergoing MDMA-assisted psychotherapy. There will be no study specific modification to the MDMA-assisted psychotherapy that participants receive. All study participants will have previously consented to MAPS MDMA-assisted psychotherapy for PTSD clinical trial before enrolling in this protocol. Once they have been identified as people who have been consented to the MAPS trial regardless of this research, they will be approached about the study, and screened/consented/enrolled accordingly.

Participants will receive the Apollo wearable device via mail upon consenting to participate in this study. They will be provided an instruction manual with guidelines on how to best use the device and will be asked to continue to use the Apollo device in their everyday life following MDMA-assisted psychotherapy.

Participants in the study will be asked to complete monthly online questionnaires for the duration of the two year study.

Please note: this study is not affiliated with the MAPS organization who is running the MDMA-assisted psychotherapy research study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over
* Completion of the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial (treatment cohort)
* completion of the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial (placebo cohort)
* enrolled in the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial, but dropped out

Exclusion Criteria:

* Unable to give adequate informed consent
* Have any current problem which, in the opinion of the investigator might interfere with participation
* Are unable to complete questionnaires written in English
A Study of LY3848575 in Healthy Participants

The main purpose of this study is to evaluate the safety and tolerability of LY3848575 when administered either intravenously or subcutaneously in single ascending or multiple doses in healthy non-Japanese and first generation Japanese participants. The study will also assess how fast LY3848575 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 142 days excluding the screening period of 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation
* Have body weight of at least 50 kilograms (kg) for males and 40 kg for females, and body mass index of 18 to 30 kilograms per meter squared (kg/m²), inclusive
* For cohorts with Japanese participants: To qualify as a participant of the first-generation Japanese origin, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan

Exclusion Criteria:

* Are currently enrolled in any other clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study.
* Have participated, within the last 3 months, in a clinical study involving an IP.
Emulsion Droplet Physical State on Postprandial Lipemia and Satiety

The purpose of this study is to compare the changes in blood lipids and feelings of satiety after consumption of oil-in-water emulsions in which the droplets are in either the liquid or solid (i.e. crystalline) states.

A double blinded randomized cross-over acute meal study will be carried out in which 15 healthy male participants will attend two study visits, separated by at least one week. On each study visit, fasted participants will consume either the solid or the liquid emulsion, in a randomized order. Both emulsions tested will have the exact same composition only differing in the physical state of the lipid emulsions, in order to isolate the impact of physical state, specifically, on metabolic response. Postprandial lipemia and satiety will be measured for 6 hours after consumption of the test beverage. The study meals will include crushed acetominophen, the appearance of which will be measured in plasma as a measure of liquid content gastric emptying. Participants will be asked to maintain their usual lifestyle habits throughout the study, with some changes in the 48 hour period leading up to each of the two visits.

Eligibility Criteria:
Inclusion Criteria:

* BMI of 18 - 26 kg/m2
* generally healthy
* non-smoking
* non to moderate alcohol drinkers
* fasting plasma cholesterol level \<5.2 mmol/L
* plasma triacylglycerol level \<1.7 mmol/L
* plasma glucose level \<5.6 mmol/L

Exclusion Criteria:

* History of major medical conditions
* taking prescription medications/ over the counter medications
* taking natural health products/ dietary supplements (other than a multivitamin)
* oral antibiotic use in the previous 3 months
* planning to take oral antibiotics in the next 3 months
* food allergy/anaphylactic/life-threatening allergy
* smokers/ regular users of recreational drugs
* elite/ training athletes
* significant weight loss/ gain during the past 3 months
* previous reaction/ sensitivity to acetaminophen
* inability to avoid taking acetaminophen for 48 hours
* sensitivity to the artificial sweetener Sugar Twin® Sucralose and artificial vanilla extract
* not willing to consume Sugar Twin® Sucralose or Artificial vanilla.
Sepsis in Oncology Patients

The overall objective of this prospective observational study is to address the significant knowledge gap that exists around the impact of immune dysfunction on the development and survival from sepsis in patients with cancer. This proposal primarily focuses on establishing the transcriptomic immune profiles of sepsis patients with a background of cancer. This analysis will be complemented with in vitro functional analyses, and in addition will commence a collection of genome-wide data, including a focus on predicting white cell number and function in health. Uniquely, the investigators propose to establish a robust link between these analyses: transcriptomic, in vitro, and genome-wide, to enable them to comprehensively explore septic oncology patient 'immune phenotypes' and effectively identify novel exploitable therapeutic pathways.

To this end, this project will collect, analyse and/or sequence DNA, RNA, leukocytes and soluble materials from a cohort of oncology patients presenting to intensive care with sepsis. This cohort will include all-comers with an oncological background but will also focus on two core groups at high risk of sepsis where baseline samples can also be sought prior to major immunosuppressive events in the cancer pathway. These are:

1. Oesophageal/upper gastrointestinal (GI) cancer patients prior to systemic anticancer therapy initiation or surgery
2. Haematological malignancy patients prior to stem cell transplantation.

These sub-cohorts will provide a previously unexplored unique insight into the role of pre-existing patient transcriptomic phenotypes.

The specific aims will be to perform multi-modal parallel immune phenotyping to determine:

* The transcriptomic (RNA) phenotypes (or 'signatures') of cancer patients with sepsis
* The association of these transcriptomic phenotypes with:

  1. Leukocyte function in sepsis, as quantified by cell surface and functional assays and plasma soluble mediator content
  2. Pre-existing genomic determinants such as leukocyte numbers
  3. Severity of, and outcome from, sepsis in oncology patients

Eligibility Criteria:
Sepsis cohort: Inclusion Criteria:

* Patients admitted to ICU with a diagnosis of sepsis as per 'Sepsis-3' definitions with a SOFA score \[REF\] ≥2 secondary to infection from any source
* ≥18 years of age
* Written consent from patient, personal or professional consultee, or deferred consent if none of the above available at admission

Sepsis cohort Exclusion Criteria:

• Death deemed imminent by the clinical team

Elective cohort inclusion criteria

* Patients undergoing elective major upper GI surgery (oesophago+/-gastrectomy) or stem cell transplant for haematological malignancy
* ≥18 years of age
* Written consent from patient

Elective cohort exclusion criteria

• Limitations in place regarding provision of treatment and/or organ support e.g., palliative patients
A Study of JNJ-64619178, an Inhibitor of PRMT5 in Participants With Advanced Solid Tumors, NHL, and Lower Risk MDS

The purpose of the study is to identify the maximum tolerated dose (MTD) of JNJ-64619178 in participants with relapsed/refractory B cell non-Hodgkin lymphoma (NHL) or advanced solid tumors and also to identify the recommended Phase 2 dose(s) (RP2Ds) of JNJ-64619178 for NHL and advanced solid tumors (Part 1) and to confirm the tolerability of JNJ-64619178 in participants with lower risk myelodysplastic syndromes (MDS) (Part 2).

The study is designed to determine the maximum tolerated dose (MTD) of JNJ-64619178, and to select a dose(s) and regimen(s) that may be used in future clinical development. Study evaluations will include safety, pharmacokinetics, biomarkers and efficacy evaluations (Disease Assessments). Adverse events will be evaluated throughout the study. The study is divided into 4 periods: a screening phase, a pharmacokinetic run-in phase, a treatment phase, and a post treatment follow-up phase. An end-of-treatment visit will be completed less than or equal (\<=) 30 days (+7 days) after the last dose of study drug or prior to the start of a new anticancer therapy, whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

* B cell non-Hodgkin lymphoma (NHL) or solid tumors, or lower risk MDS
* At least 1 measurable site of disease for B cell-NHL and solid tumors
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Adequate organ function
* Women of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and prior to the first dose of study drug. Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 90 days after receiving the last dose of study drug

Exclusion Criteria:

* History of, or known, central nervous system (CNS) involvement
* Prior solid organ transplantation
* Either of the following: a) Received an autologous stem cell transplant less than or equal (\<=) 9 months before the first dose of study drug B) Prior treatment with allogenic stem cell transplant
* History of malignancy (other than the disease under study) within 3 years before the first administration of study drug. Exceptions include squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years
* Known allergies, hypersensitivity, or intolerance to JNJ-64619178 or its excipient
The Effects of Family Centered Intervention Program on Preterm Infants

Infant born preterm have an increased risk of adverse long-term developmental outcomes.The risk associated with preterm birth increase as gestational age decreases, and vulnerability remains in moderate and early preterm (\<34 weeks) and late preterm (\>34 weeks). There are many studies in the literature showed that the prevalence of developmental delay increases with premature birth. However, there is no study in the literature investigates effect of early intervention program motor performance in subgroups of preterm infants. Hence the aim of this study is to evaluate the differences in effects of early intervention program on motor development in early and moderate (\<34 weeks) and late preterm infants.

Fifty-two preterm infants corrected age less than 6 months included in this study. They were separated by their birth weeks. Babies with gestational ages between 34-36 weeks and 6 days (including the given days) are categorized as late preterm, while those born before 34 weeks are grouped as moderate and early preterm. Each group contains 26 infants.

First, sociodemographic information and histories of babies are obtaining. Ages and contact information of the parents are recording. Prenatal and natal risk factors of the mothers are querying. Gestational ages and height, weight, and head circumferences of babies at birth are recording. Number of pregnancies, live births and abortions, type of delivery, multiple pregnancies for mothers as well as consanguinity between parents are asking.The Alberta Infant Motor Scale is using to evaluate spontaneous motor movements of the baby. After the detailed examination, intervention program set up for infants. Both groups receive 3 months family based intervention program.

After the intervention program, both groups re-examined.

Eligibility Criteria:
Inclusion Criteria:

* Born before 37 gestational weeks,
* Accepting to join the study
* Corrected age 6 months or less

Exclusion Criteria:

* Having high risk factors (e.g. grade 3 or more intraventricular hemorrhage, PVL, serious seizure)
* Born after 37 weeks
* Corrected age greater than 6 months
SBRT for Extra-cranial Oligorecurrent Tumor

Clinical experience has shown that metastasis can often be limited in number and location, and thus amenable to local treatment. The term oligometastasis describes an intermediate state of cancer spread between localized disease and widespread metastasis. The implication of such an intermediate state is that the disease can be cured by using metastasis-directed therapy. Historically, in some patients with oligometastases in the liver or lungs, surgical resection was often indicated, as abundant evidence suggested it could improve progression-free or overall survival. Recently, several studies have reported promising outcomes of \>80% local control with Stereotactic Body Radiotherapy (SBRT) in patients with lung or liver oligometastases. Nonetheless, very few studies have focused on non-liver, non-lung extracranial oligometastatic lesions treated with SBRT, and such studies have limitations of a retrospective nature and small sample sizes.Because allmost studies are based on single-arm studies without appropriate controls, the level of evidence to support SBRT is weak. Randomized trials are therefore necessary to establish the utility of SBRT for oligometastatic disease.

This study is designed as a randomized phase II study. Patients will be randomized between current standard treatment (Arm 1) versus standard treatment +SBRT (Arm 2) to all known disease.


Eligibility Criteria:
Inclusion Criteria:

* age \<18 years old
* ECOG score: 0-2
* number of distant metastases: 1-5
* all cancers (except lymphoma, myeloma, and germ cell tumor)
* status of primary lesion: cured
* pathologically confirmed cancer
* life expectancy: over 6 months

Exclusion Criteria:

* recurrent lesion which had been treated by radiotherapy
* complete response after systemic therapy
* patients who cannot be treated with SBRT due to any reason.
* pregnancy or breast-feeding
* malignant pleural effusion
Implementation and Evaluation of a Family-based Intervention Program for Children of Mentally Ill Parents

In order to identify psychological stress in children and adolescents of mentally ill parents as early as possible, a special intervention program (CHIMPs = Children of mentally ill parents) was developed. The study at hand will implement this intervention program at five sites in Germany and will further evaluate its effectiveness. The CHIMPs intervention is assumed to reduce children's psychopathology and enhance their health related quality of life.

The main purpose of this study is to implement the manualized family intervention CHIMPs (Children of mentally ill parents) for children and adolescents of psychiatrically ill parents aged between 3 and 19 years at the seven participating centres in regular care. The intervention aims at reducing children's psychopathology and enhancing their quality of life in a sustainable way and, moreover, aims at introducing especially remarkable children and adolescents to an early intervention.

The study represents a prospective, randomized and controlled multicenter study (RCT), contrasting one intervention group and one control group (TAU = Treatment as usual) by measurements at baseline and after six, 12 and 18 months. Within the data collection, the perspective of the psychiatrically ill parent, the partner, each child and the therapist will be considered. Children between 3 and 9 years of age will be evaluated only by the parents and the therapist, from 10 years on, an additional self-report form will be filled out by the child. The measurement will be ruled out indirectly (for the pre-post-measurement) as well as directly (at the end of treatment).

For each endpoint, one comprehensive mixed model will be fitted to the data containing the baseline value and further relevant patient characteristics as covariates, the random group as factor and cluster (center, therapy group, family) as random effect. Missing values will be treated by direct imputation to allow an intention-to-treat analysis.

Eligibility Criteria:
Inclusion Criteria:

* Family with at least one psychiatrically ill parent and at least one child between the age of 3 and 19 years
* Consent to participate in the study
* Sufficient knowledge of the German language of parents and children

Exclusion Criteria:

* Severe psychiatric disorders and impairments with acute symptoms such as suicidal tendencies, massive self-injurious behaviour, acute psychotic symptoms etc., making a stationary treatment inevitable and making a ambulatory intervention appear contraindicated (These patients are placed in stationary treatment)
* Children with severe symptoms in the control group will be placed at a participating psychotherapist. Nevertheless, they stay in the control group (as TAU).