cyrilzakka/clinical-trials huggingface dataset:
A Safety Study of LY3462817 in Healthy Participants

This study is being conducted to determine how safe and how well tolerated LY3462817 is when given intravenously (IV) (into a vein) and subcutaneously (SC) (just under the skin) to healthy participants. Blood tests will be done to check how much LY3462817 is in the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive 1 dose of LY3462817 or placebo. The study will last about 16 weeks, including screening.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy male or a female who cannot get pregnant
* Have a body mass index (BMI) of 18 to 32 kilogram per square meter (kg/m²), inclusive, at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
* Weight at least 45 kilograms (kg)

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously participated or withdrawn from this study
* Have cancer or a malignant disease in the past 5 years
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Are unwilling to receive study drug administration by injections or through the veins
ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen

A multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and Tolerability of Two Dosing Regimens of AllerT, a Combination of Contiguous Overlapping Peptides Derived from Bet v 1, in Adults with Birch Pollen Allergic Rhinitis/Rhinoconjunctivitis


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects 18 to 65 yrs old, male or female
* moderate to severe allergic Rhinitis/Rhinoconjunctivitis to birch pollen during the two preceding birch pollen seasons
* positive Skin Prick Test (SPT) to birch pollen extract
* positive specific IgE CAP to Bet v1.

Exclusion Criteria:

* persistent non-controlled asthma (Forced Expiratory Volume, FEV1 \< 85% of predicted),
* previous specific immunotherapy (SIT) to tree pollens,
* previous SIT to any allergen within 5 years,
* previous history of severe anaphylactic reaction,
* perennial allergic Rhinitis/Rhinoconjunctivitis,
* other disorder possibly influencing the trial outcomes,
* pregnancy,
* any severely debilitating disease,
* primary or secondary immunodeficiency or treatment with immunosuppressor drugs within one month prior to randomization (oral steroids, other immunosuppressors).
The Use of Chaperone in Routine Anorectal Examination

Background and aim: The use of chaperone in routine anorectal examination of women attending to Coloproctology clinics has not been studied to this date. The aim of this study is to compare the patients' perception and preference regarding the presence of a chaperone during their first anorectal examination. Patients and methods: adult women will be randomly selected to be examined with or without the presence of a female chaperone. After that, they will answer a questionnaire form about how they feel during the examination and whether or not they would prefer having or not a chaperone present in that clinical situation. The patients will prospectively enrolled in one of the two groups of this randomized trial during a period of two years.

The use of chaperone in routine anorectal examination of women attending to Coloproctology clinics has not been studied to this date. However, there are some guidance saying says that doctors should offer the patient the option of a chaperone wherever possible before conducting an intimate examination. The aim of this study is to compare the female patients' perception and preference regarding the presence of a chaperone during their first anorectal examination conduct by a male physician. Adult women will be investigated during their first visit to a Coloproctology Clinic at University Hospital. Only senior professionals will be examining the patients. This will be a prospectively randomized trial. Patients will be selected to be examined with or without the presence of a female chaperone. After that, they will answer a questionnaire form about how they feel during the examination and whether or not they would prefer having or not a chaperone present during the anorectal examination. The enrollment period will be two years from July 2018. Sample size estimated for the study is 188 patients (94 in each study group).

Eligibility Criteria:
Inclusion Criteria:

* adult female patients;
* first visit to our Coloproctology clinic;
* signed consent form

Exclusion Criteria:

* patients previously submitted to anorectal examination;
* refusal of participation.
Biological Effects of Citrate-buffered Solutions on Dialysis Efficiency and Systemic Inflammation

In this study 45 patients undergoing weekly dialysis for chronic end stage renal disease will be enrolled. The patients will be treated with a standard dialysis solution, containing acetate buffer, for 3 months; subsequently the acetate will be substituted with citrate anion for the 3 following months and then, the last 3 months, the standard acetate-solution will be restarted. The aim of the study is to assess if acetate-to-citrate switch in the dialysis solution influences dialysis efficiency and patient inflammatory state.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* creatinine clearance \<5ml/min
* treatment with bicarbonate HD (BIC-HD) or on-line hemodiafiltration (OL-HDF) 3 times per week for at least 6 months prior to study start
* treated at Dialysis unit of: Città della Salute e della Scienza University Hospital, Torino, Italy

Exclusion Criteria:

* known neoplastic disease
* active chronic inflammatory disease
* active acute inflammatory disease
CHORUS - Comprehensive HHT Outcomes Registry of the United States (Formerly OUR HHT Registry)

The goal of this study is to better understand HHT, the symptoms and complications it causes ("outcomes") and how the disease impacts people's lives. The investigators are aiming to recruit and gather information together in the Registry from 1,000 HHT patients from four HHT Centres of Excellence in North America. The Investigators will collect long-term information about the people in the Registry, allowing the investigators to understand how the disease changes over time, and what factors can influence those changes. Ultimately, this should help improve treatments for the disease.

Background and Rationale HHT has an estimated prevalence of 1 in 5000, affecting children and adults, in multiple organs. The disease is characterized by the presence of vascular malformations (VMs), including arteriovenous malformations (AVMs) of the lung, liver, brain, spinal cord and smaller mucosal lesions (telangiectasia) of the nose, mouth and GI tract. These lesions lead to acute and chronic bleeding, stroke, heart failure and death. Treatments are currently mostly limited to managing complications, while approximately 90% of adults have ongoing symptoms, despite best surgical and medical therapies. With recent drug development related to angiogenesis, there is hope for effective novel therapies. Investigators, experts, the International HHT Guidelines, Pharma representatives, the CDC and HHT patient advocates (curehht.org) all agree that there is an urgent need for natural history data in this disease, with characterization of clinical outcomes, to allow patients to benefit from the explosion of drug development in the field.

As of August 27, 2023, the OUR HHT Registry has transitioned to the CHORUS platform (Studytrax) for ongoing data collection. Only select CHORUS-funded sites are currently enrolling. The Toronto site has completed enrollment but remains active with REB approval.

Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with HHT by the Curacao criteria (either 3+ clinical diagnostic criteria or genetic diagnosis).
* Capable of giving informed consent in person or via a substitute decision maker
* \>18 years

Exclusion Criteria:

* Participants unable to give informed consent either in person or with a substitute decision maker
The Impact of Medication Belief on Adherence to Infliximab in Patients With Crohn's Disease

The IFX adherence to CD in China was not high. Medicine concerns may be predictive factor of adherence. By enhancing knowledge and relieving medicine concerns, we may increase patients' adherence to IFX.

Crohn's disease (CD) is an incurable chronic disease that requires long-term treatment. As an anti-tumor necrosis factor (TNF) agent, Infliximab (IFX) is widely used in the treatment of Crohn's disease, while the adherence is not high. The purpose of this study was to investigate the adherence to IFX among CD patients in China and evaluate the association between medication belief and IFX adherence.

Eligibility Criteria:
Inclusion Criteria:

* patients with a confirmed diagnosis of CD; were treated with infliximab for at least 12 weeks; were informed consent.

Exclusion Criteria:

* The exclusion criteria were received treatment from mental health professionals due to any mental or cognitive impairment; suffered from other serious diseases, such as heart, brain, lung, liver and kidney dysfunction; severe infection, anemia, cachexia or other serious complications were found.
IMPACT Non Hodgkins Lymphoma (NHL) Study

This is multi-center, international observational study of subjects receiving CHOP-14 or CHOP-21 (with or without Rituximab) for the treatment of NHL. Approximately 100-150 sites will contribute information on subjects treated at their institution.

This is a multi-center, international observational study of subjects receiving CHOP-14 or CHOP-21 (with or without Rituximab) for the treatment of NHL. Approximately 100-150 sites will contribute information on subjects treated at their institution.

To avoid geographical bias, sites will be selected to represent the spread of subjects in each country. Each site will be initially limited to 5 retrospective subjects and 10 prospective subjects (15 subjects per site) but sites may be asked to contribute further subjects to approximately 10 retrospective subjects and 20 prospective subjects.

Retrospective subjects may include any subject that has completed all cycles of chemotherapy treatment prior to date of site initiation. Prospective subjects which may be considered for the study are any subject planned for CHOP-14 or CHOP-21 (with or without Rituximab) treatment after the site initiation visit.

Eligibility Criteria:
Inclusion Criteria:

* Subjects greater than or equal to 18 years old
* Subjects diagnosed with any histological type of NHL (including both chemotherapy naïve and pre-treated subjects)
* Subjects planned to receive a minimum of 3 cycles of CHOP-14 or CHOP-21 with or without Rituximab (for subjects enrolled retrospectively, eligibility should be assessed on the profile at time of planning treatment, where treatment initiates on or after 01 Jan 2005, with specific focus on planned chemotherapy and not outcome or number of delivered cycles)
* Before any study-specific procedure, the appropriate written informed consent must be obtained for countries where this is required

Exclusion Criteria:

* Subjects receiving CHOEP ((CHOP = Cytoxan, Hydroxyrubicin (Adriamycin), Oncovin (Vincristine),Etoposide, Prednisone Chemotherapy )or CNOP (Cytoxan, Novantrone, Oncovin (Vincristine),Etoposide, Prednisone) chemotherapy are not eligible for inclusion in this study
Evaluation of Cholesterol Education for At-Risk Children

To evaluate two educational programs that promoted the role of pediatric practices in lowering LDL cholesterol levels in 4-10 year old hypercholesterolemic children through dietary modification.

BACKGROUND:

Outcomes of the study provided valuable guidance for pediatricians who wanted to become more actively involved in identifying and treating children with elevated blood lipids.

DESIGN NARRATIVE:

Pediatricians in five practices in Abington, Pennsylvania conducted a cholesterol screening program (capillary bloodsample) for 4-10 year old children in their care. Children who tested positive (total cholesterol \>176 mg/dl) were offered follow-up evaluations (two fasting venous blood samples) to confirm the positive initial test. Those with mean LDL cholesterol levels between the 80th and 98th percentiles for age/sex (107-164 mg/dl for boys and 112-164 mg/dl for girls) and who met other entry criteria were invited to join the study. Children with parental permission to participate were randomized to one of three groups: two that received dietary education, and a comparison group that received no dietary education. One educational program used face-to-face counseling with a registered dietitian and the other used a home-based, parent-child autotutorial approach. In addition, a random sample of non-hypercholesterolemic children with total plasma cholesterol levels between the 40th and 60th percentiles for age/sex were invited to join the study as a second comparison group. Prior to the education period (baseline) and three times thereafter (3, 6 and 12 months post-baseline), all four groups were assessed for consumption of total fat, saturated fat, and cholesterol, and their growth and pertinent cognitive psychosocial factors. Also, the plasma LDL cholesterol levels of the three hypercholesterolemic groups were assessed at all four time points along with blood indicators of iron status at baseline and twelve months.

To assess the educational programs' effectiveness, changes were compared in assessed variables of the hypercholesterolemic groups who did and did not receive dietary education. Also, changes in diet, growth, and cognitive/psychosocial factors in these groups were compared with those of the non-hypercholesterolemic group that had neither a positive diagnosis of elevated blood lipids nor dietary education. Additionally, the cost-effectiveness of the two dietary education programs was evaluated.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3474 Injection

This is a study to evaluate the tolerance, dose-limiting toxicity (DLT), phase II recommended dose (RP2D), and maximum tolerated dose (MTD) of single and multiple oral doses of TQB3474 in patients with advanced malignant tumors.


Eligibility Criteria:
Inclusion Criteria:

1.18 and 70 years old.

2. Histologically or cytologically confirmed advanced solid tumors.

3. Has the surgery more than 4 weeks before the first dose.

4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.

5. Life expectancy ≥12 weeks.

6. Adequate organ system function.

7. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study.

8. Understood and signed an informed consent form.

Exclusion Criteria:

1. Has received chemotherapy or radiotherapy within 4 weeks before the first dose.
2. Hypersensitivity to TQB3474 or its excipient.
3. Has factors that impact on intravenous infusion of drugs and venous blood collection.
4. Has severe gastrointestinal disease within 4 weeks before the first dose.
5. Has severe eye disease.
6. Breastfeeding or pregnant women.
7. Has brain metastases.
8. HCV antibody and HCV-RNA positive; Syphilis positive; HBsAg positive and HBV DNA positive (≥1000 copies /mL).
9. Has infection that need systemic treatment during screening.
10. Has participated in any other clinical trial within 4 weeks before the first dose.
11. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Vitamin D Effects in Overweight Patients

The purpose of the study is to investigate in overweight patients who are on a telemedically guided weight loss program the influence of a daily vitamin D supplement on

* weight loss and body composition,
* selected inflammation markers and biochemical parameters of lipid and glucose metabolism .
* selected clinical parameters such as blood pressure, heart rate

Obese patients are known to have low levels of vitamin D metabolites. There is some evidence that vitamin D and/or dietary calcium may influence energy metabolism and body weight. We therefore perform a prospective controlled trial with 200 overweight (Body mass index 27-29.9 kg/m2) and obese subjects (Body mass index \>= 30 kg/m2) who are on a telemedically guided weight loss program. Subjects randomly receive a daily vitamin D supplement or a placebo for 1 year. Participants have to send their body weight data to the study office weekly. In addition, a nutritionist at the study office has to be contacted weekly to receive further support concerning the weight loss program. Dietary records have to be completed monthly. Clinical parameters and blood samples are collected at baseline, and after 6 and 12 months. It is the aim of the study to investigate the vitamin D effects on weight loss and body composition. In addition, possible vitamin D effects on clinical and selected biochemical parameters should be assessed. These parameters include heart rate, blood pressure, inflammation markers, and parameters of lipid and glucose metablolism.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index \> 27 kg/m2

Exclusion Criteria:

* pregnant and lactating women
* vegetarians
* patients with renal insufficiency (creatinine \> 1.5 mg/dl)
* History of renal stones and gallstones
* patients with insulin dependent diabetes mellitus
* parallel participation in another clinical study
* missing informed consent
* subjects with pacemaker implantation
Training Educators to Conduct Functional Behavior Assessment Via Telehealth

This study evaluates the effects of delivering training services via telehealth to educators in rural schools. The investigators hope to increase the accuracy with which educators implement functional behavior assessments in schools. During the study, participants will receive training on functional behavior assessments at different periods. When one school is receiving training, other schools will not be receiving training. The purpose will be to show increased accuracy of functional behavior assessments only occur following training.

Training services for educators typically occurs in-vivo with experts providing immediate feedback and modeling to shape behavior. These types of training experiences may not be accessible for all educators though. The current study will evaluate delivering behavioral skills training (e.g., feedback and error correction) via telehealth for educators conducting functional behavior assessments. The components of the functional behavior assessment that will be targeted are open-ended interviews, stimulus preference assessments, direct observations of problem behavior, and a functional communication training program. With at least three different schools, the investigators will introduce training delivered via telehealth one at a time to show that increases in acquisition of the various components of the functional behavior assessment only occur following telehealth-based training.

Eligibility Criteria:
Inclusion Criteria:

* Must be an educator who conducts functional behavior assessment.
* Must be training to become a registered behavior technician.

Exclusion Criteria:
Comparison Between Two Operational Techniques for Total Knee Replacement

Advance Knee osteoarthritis is treated by Total knee replacement. Since the first TKR in 1973 there has been continuous advance in implant technology as well as operative technique, yet current patient satisfaction after the procedure is accepted to be about 80%.

There are a few operative techniques to perform TKR. Until recently the most common technique is the anterior approach to the knee and then using mechanical instrumentation to make the bone cuts for the femur and tibia. A second popular technique is the anterior approach to the knee and then using a kinematic alignment to make the bone cuts.

The investigators wish to compare short term results of the two operative techniques as evidenced in patient objective functional scores and also by evaluating the gait of the patients by using the REHAGAIT ANALYZER PRO by HASOMED inc. Magdeburg Germany.


Eligibility Criteria:
Inclusion Criteria:

- Patients after total knee replacement which was performed in our ward.

Exclusion Criteria:

* Less than 6 months have passed after the procedure
* Inability to understand and fill out PROMS questionnaires.
* Inability to walk without aids for at least 20 meters.
A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers

The Purpose of a randomized, double-blind, placebo-controlled, single-dose, dose-escalation clinical trial is to explore investigate the safety, tolerability, pharmacokinetics, and food effect of PMK-S005 after oral administration in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Male 20 year ≤ age ≤ 40 year.
* Weight ≥ 55kg, IBW ±20%.
* Patients with normal hematology, biochemistry, urinary result.
* Patients who have not congenital or chronic disease.
* Provision of written informed consent voluntarily.

Exclusion Criteria:

* Patients having known hypersensitivity to any component of the study drug.
* Patients with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, muscloskeletal, immune, the nose and ears, psychiatry, stomach system.
* Patients with any gastrointestinal disorders.
* Systolic blood pressure ≥ 150 or ≤ 90 mmHg, Diasolic blood pressure ≥ 95 or ≤ 50 mmHg.
* Drug abuser, alcoholic.
* Patients taking ETC medication within 14 days, OTC within 7 days.
* Patients taking other investigational product within 60 days prior to the participation in the study.
Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy

The purpose of this study is to characterize the pharmacokinetic (PK) profile of a single dose of EXPAREL (133 mg/10 mL) administered intraoperatively per normal infiltration for prolonged analgesia in 12 adult subjects undergoing tonsillectomy with or without removal of the adenoids.

Blood samples for bupivacaine PK analysis will be obtained from subjects at baseline (within 30 minutes prior to EXPAREL infiltration), 15 minutes, 30 minutes, and 1, 2, 4, 8, 12, 24, 36, 48, and 72 hours after the beginning of EXPAREL infiltration, and on Day 7.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, ≥18 years of age at the Screening Visit.
* Subjects undergoing tonsillectomy with or without removal of the adenoids.
* Able and willing to comply with all study visits and procedures.
* Willing and capable of providing written informed consent.

Exclusion Criteria:

* History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics.
* Received any investigational drug within 30 days prior to EXPAREL administration, and/or has planned administration of another investigational product or procedure while participating in this study.
* Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after EXPAREL administration. Female subjects must be surgically sterile, at least 2 years postmenopausal, or using an acceptable method of birth control. If of childbearing potential, must have a documented negative pregnancy test within 24 hours before EXPAREL administration.
* Subjects with significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to EXPAREL and/or procedures, or cause inability to comply with the study requirements.