cyrilzakka/clinical-trials huggingface dataset:
Study of AVE1642 Anti-IGF1R Monoclonal Antibody in Patients With Advanced Multiple Myeloma

Primary Objectives:

Study Part 1: Determine the selected dose of AVE1642 administered every 3 weeks based on pharmacokinetic (PK) (Clearance of AVE1642), pharmacodynamic (PD) (insulin-like growth factor 1 \[IGF-1\] serum level) parameters, and eventual dose limiting toxicities (DLTs) in patients with recurrent, refractory multiple myeloma (MM).

Study Part 2: Assess the safety of the combination of the selected dose of AVE1642 with the recommended dose of Velcade®.

Secondary Objectives :

Study Part 1:

* To assess the safety profile: type, incidence and intensity of drug related adverse events (AEs)
* To assess the biological activity of AVE1642 (saturation of the receptors and down-regulation) on malignant plasma cells and on peripheral blood mononuclear cells (PBMC) and granulocytes
* To assess the biological activity of AVE1642 on the signalization pathway of the IGF-1 system (phosphorylated akt \[pAkt\], phosphorylated erk \[pErk\]) on malignant plasma cells when technically possible
* To define PK profile of AVE1642, and its PD effects on serum IGF 1, GF 2 and IGFBP-3
* To assess clinical efficacy (complete response \[CR\], partial response \[PR\], minimal response \[MR\] and stabilization) based on the European group for Blood and Marrow Transplantation (EBMT) criteria, when possible
* To assess potential immunogenicity by detection of human antihumanized antibodies (HAHA) anti-AVE1642

Study Part 2:

* To detect any PK or PD interaction between AVE1642 and Velcade®
* To assess clinical efficacy (CR, PR, MR, no change \[NC\]) according to EBMT criteria when appropriate
* To assess biological activity of AVE1642 in combination with Velcade® on malignant plasma cells collected from bone marrow aspirates: saturation and down-regulation of the insulin-like growth factor 1 receptor (IGF-1R) and activity on the signalization pathway of the IGF-1 system (pAkt, pErk) when feasible
* To detect immunogenicity reaction (HAHA)
* To characterize PK and PD profile of a low dose (0.5 mg/kg) of AVE1642 expected to be non biologically active


Eligibility Criteria:
Inclusion Criteria:

* Multiple myeloma confirmed by bone marrow aspirate or biopsy
* Patient had to have relapsed and/or refractory multiple myeloma after at least 1 standard therapy, and have demonstrated disease progression
* Previous exposure to Velcade was allowed, provided no DLTs of Grade 3 or above had been observed during previous treatment (for Part 2 of the study only)

Exclusion Criteria:

* Prior therapy with any IGF-1 system targeting compound
* History of allogenic stem cell transplantation in case of concomitant immunosuppressive therapy within 6 months before study entry. Patients having undergone autologous stem cell transplantation(s) may have been included in the study
* History of organ transplant and any patient receiving long term systemic immunosuppressive therapy

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Resistance Training in Type 1 Diabetes Mellitus

The purpose of this study is to learn how different resistance training programs affects blood sugar in young athletes with T1DM.

Strength and condition training to improve sport performance has been greatly emphasized over the past 20 years. Formal strength and conditioning (S\&C) programming is performed by S\&C coaches who are educated in the field of exercise program with the intentions to bring about particular athletic adaptations through exercise. S\&C programs, previously limited to programs at the college and professional level, are now commonly seen in secondary school athletic programs. With such broad adoption, many athletes that manage chronic diseases, such as type 1 diabetes mellitus, are exposed to elements of these programs.

Diabetes mellitus impacts more than 10% of the United States population. Of these, 5.2% have identified type 1 diabetes mellitus (T1DM) which includes approximately 210,000 individuals under the age of 20. In addition to insulin and dietary management, exercise and physical activity is recommended as an important therapeutic tool for most patients with T1DM. Physical activity has been shown to significantly improve glycemic control in individuals with diabetes. Additional benefits of exercise include improved cardiovascular fitness, muscle strength, insulin sensitivity and blood glucose control. S\&C programs offer benefits to those living with T1DM as different exercises can be tailored to preserve health. However, there are no exercise prescription or guidelines specifically for adolescent athletes diagnosed with type 1 diabetes participating in strength and conditioning programs. Furthermore, there is no available data that states the predictability of glucose response and insulin needs to any of the specific strength and conditioning goals.

Objective: To assess the impact of different strength and conditioning programming on glycemic control in athletes with T1DM.

Primary Aim: Assess glucose response to different resistance training methods. Secondary Aims: To assess for correlation between lactate and glucose using different resistance training methods.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 13 years of age
* ≥2 years from date of T1DM diagnosis
* Prior exposure to strength and conditioning
* HbA1C ≤ 10%
* Actively utilizing continuous glucose monitoring for diabetes management

Exclusion Criteria:

* Physical limitation that may impede ability to complete study procedures
* Non-English-speaking individual
Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis

This study will investigate if the drug zoledronic acid given once yearly is safe and has beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

• Osteoporosis as defined by very low bone mineral density in the hip and spine or low bone mineral density in the hip combined with presence of 1-3 mild or moderate fractures of the vertebrae

Exclusion Criteria:

* Low Vitamin D
* Renal insufficiency
* Previous treatment with certain anti-osteoporotic therapies (except after certain washout periods): calcitonin, bisphosphonates, parathyroid hormone (PTH), sodium fluoride, strontium ranelate,
* Previous treatment with testosterone, anabolic steroids or growth hormone
* Chronic use of systemic corticosteroids (oral or i.v.) within the last year
* History of any cancer or metastases within the last 5 years
* History of brittle bone disease, multiple myeloma, or Paget's disease, or any other metabolic bone disease, except osteoporosis
* Bilateral hip replacements

Other protocol-defined inclusion/exclusion criteria may apply
PMCF Study of the AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair

This is a Post Market Clinical Follow Up Study in Orthopaedics, it will verify the long-term safety and performance of the device in the intended patient population, when indicated for the acute repair of the Achilles tendon.

The Medical Device in this study AchilloCordPLUS is a Class IIb UKCA-Marked device manufactured by Xiros Ltd.

This is a Post Market Clinical Follow Up Study in Orthopaedics, it will verify the long-term safety and performance of the device in the intended patient population, when indicated for the acute repair of the Achilles tendon.

The Medical Device in this study AchilloCordPLUS is a Class IIb UKCA-Marked device manufactured by Xiros Ltd.

AchilloCordPLUS is a single-use device, indicated for patients with acute Achilles tendon ruptures. It is particularly suited to active patients where an extended period of postoperative immobilisation is undesirable.

This study is a prospective, single-centre, consecutively recruited non-randomised study. The total length of the study is expected to be 3 years. This includes a recruitment period of approximately 12 months and a 2-year follow-up.

This study has now closed to follow-up, with a recruitment of 19 participants. Follow up is at 2,4,6,8 and 12 weeks, 6 months and 1 and 2 years. All subjects treated with the AchilloCordPLUS for acute Achilles tendon repair will be consecutively recruited into the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be skeletally mature and be 18 years old or above.
* Patients requiring end to end repair for acute Achilles tendon rupture.
* Patient is willing to participate in the study and have been informed of the nature of the study, agree to its follow-up and has provided written informed consent as approved by the Research Ethics Committee (REC).

Exclusion Criteria:

* Patients with chronic ruptures of the Achilles tendon.
* Patients with bilateral ruptures.
* Patients with known hypersensitivity to implant materials. Appropriate tests should be carried out on patients with suspected material sensitivity prior to implantation.
* Patients with infections or any structural or pathological condition of the bone or soft tissue that would be expected to impair healing or prevent secure fixation.
* Patients who are unable or unwilling to restrict activities to prescribed levels or to follow the rehabilitation instructions during the healing period.
Anti-Oxidant Effect on Peritoneal Membrane in Peritoneal Dialysis (PD) Patients

Peritoneal fibrosis is one of the major causes of technical failure in patients on peritoneal dialysis (PD) for long period of time. Although the exact mechanisms of peritoneal damage during PD still remain unclear, generation of reactive oxygen species may be responsible for progressive membrane dysfunction. N-acetylcysteine (NAC)is a powerful antioxidant shown to protect peritoneal fibrosis in peritoneal dialysis animal model. In this study the researchers investigated the hypothesis that NAC protect peritoneal membrane damage.

N-Acetylcysteine (NAC) is known to be relatively safe and beneficial in peritoneal dialysis patient at a dose of 1200 mg per day. Patients will be randomly assigned to NAC and control group and prescribed according to the protocol. At 2 and 6 month, Peritoneal equilibrium test (PET) will be performed with blood sampling.

Eligibility Criteria:
Inclusion Criteria:

* Maintenance peritoneal dialysis at least 3 months
* Patients who are able and willing to understand, sign and date an informed consent document, and authorize access to protected health information

Exclusion Criteria:

* Episode of peritonitis at least 3 months
* Episodes of admission due to other disease at lease 3 months
* Liver disease
* Allergic history with N-acetylcysteine
Reducing Self-Stigma Among Individuals with History of Childhood Maltreatment: a Cross-Cultural Lens

Individuals who report experiencing any kind of abuse during childhood report shame and self-blame, often leading to self-stigma and a reluctance to reveal their experiences and seek help. Such stigma may aggravate the mental health consequences of child maltreatment (CM).

The investigators hypothesize that:

1. The brief video-based intervention will have the immediate and repeated effect of reducing self-stigma among CM survivors compared with the control condition.
2. The brief video-based intervention will increase seeking treatment compared with the control condition.
3. The brief video-based intervention will show similar effects in reducing self-stigma across multiple countries.

Prior research suggests that social contact-based interventions are the most efficient way of reducing stigma. This study aims to address self-stigma and empower individuals who self-reported experiencing any kind of abuse during childhood and increase their openness to seeking help, if needed.

Four hundred participants with self-reported experience of any kind of childhood abuse will be recruited to participate in a Randomized Controlled Trial (RCT) testing the efficacy of the intervention. Participants will be randomized into one of two arms: 1) A 2-minute video intervention in which a CM survivor (presented by an actor) shares their personal CM experience and describes how they were able to overcome feelings of shame and self-blame to seek mental health care; or 2) A 2-minute control video using the same actor, but without a personal narrative of CM experience. Both videos will be preceded by and immediately followed by questionnaires assessing self-stigma and openness to seeking treatment. An additional assessment of emotional engagement will be added immediately following intervention delivery. Following the intervention, there will be a 30- day follow-up to examine potential long-term effects.

The results will be analyzed alongside results from parallel protocols being conducted by partner sites in other countries (Switzerland, Sweden, Japan, Peru, India, Australia, Turkey, South Africa, and Israel). Each site will conduct the study under their own university's purview and with their own protocol, and only deidentified data will be shared for analysis.

All study procedures will be conducted remotely via CloudReseach and Mechanical Turk, which is a crowdsourcing platform. The study survey will be hosted by Qualtrics.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* US resident
* Individuals who endorse yes to one of the following items: physical aggression in family or household, emotional or verbal abuse in family or household, sexual abuse or inappropriate sexual experiences, negligence - physical or emotional, mental illness or substance abuse at home, incarceration of family member
* Fluent in English and able to give informed consent

Exclusion Criteria:

- N/A
The Combination of Terbutaline and Danazol as the Treatment of Corticosteroid-resistant/Relapse Immune Thrombocytopenia

A randomized, open-label, multicenter study to compare the efficacy and safety of terbutaline plus danazol compared to danazol monotherapy for the second-line treatment of adults with corticosteroid-resistant or relapsed primary immune thrombocytopenia (ITP).

The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 228 adults with ITP in China. Patients were randomized to terbutaline plus danazol compared to danazol monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Eligibility Criteria:
Inclusion Criteria: Patients \>18 years old with corticosteroid-resistant or relapsed ITP who had either a platelet count of \<30×10\^9/L or a platelet count of \<50×10\^9/L and clinically significant bleeding.

1. Not achieving a sustained response to therapy with full-dose corticosteroids for a duration of at least 4 weeks or relapsed during the process of corticosteroid tapering or discontinuation;
2. Platelet counts \<30×10\^9/L or platelet counts \< 50×10\^9/L and significant bleeding symptoms (WHO bleeding scale 2 or above);
3. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Secondary ITP (have a known diagnosis of connective tissue diseases, malignancy, active infection, HIV infections or hepatitis B virus or hepatitis C virus infections);
3. Received drugs affecting the platelet counts within 6 months before the screening visit (e.g., chemotherapy, anticoagulants, etc);
4. Severe medical condition (lung, heart, hepatic or renal disorder);
5. Patients who are deemed unsuitable for the study by the investigator.
6. Patients who had hypertension, diabetes mellitus, hyperthyroidism or coronary heart disease.
Using Question Prompt Lists During Pediatric Asthma Visits to Increase Adolescent Involvement

The purpose of this study is to conduct a randomized controlled trial with English and Spanish-speaking adolescents to compare the effectiveness of an adolescent "asthma question prompt list" with a supportive educational video intervention with usual care.

The hypothesis of this study is that by showing the parents and adolescents the educational video and then providing the adolescents with the one-page "asthma question prompt lists" to use during their visits will improve: (a) asthma control, (b) adolescent self-efficacy in managing asthma, and (c) adolescent quality-of-life.

The study uses a randomized controlled trial design stratified by provider to assess the impact of an adolescent "asthma question prompt list" combined with a supportive educational video emphasizing the importance of adolescent involvement and question-asking on communication during pediatric visits. This application is based on Social Cognitive Theory. Self-confidence or self-efficacy is a central component of Social Cognitive Theory (SCT) Application of Social Cognitive Theory (SCT) in asthma populations has shown that technical advice from providers is one external factor that can improve asthma management self-efficacy. Additionally, personal beliefs, such as outcome expectations, and family factors, such as parent and adolescent responsibility for asthma self-management, have been shown to affect adolescent self-efficacy and disease management outcomes. Prior work has found that adolescent self-efficacy in asthma management correlates strongly with health status, adherence, asthma medication device technique, asthma symptoms, and impact of illness on the family.

All adolescents will have their medical visits audio recorded. The adolescent will be interviewed after his/her medical visit while his/her caregiver/parent completes a survey at the time of study enrollment. This same procedure will be used when the adolescent and caregiver/parents return for the 6- and 12-month follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* ages 11 to 17 years;
* speak and read English or Spanish;
* have persistent asthma;
* are present for an acute or follow-up asthma visit or a well-child visit;
* and have previously visited the clinic at least once for asthma.

Adolescents' parents will be eligible if they are at least 18 years of age, speak and read English or Spanish, and are the legal guardian of the adolescent.

Exclusion Criteria:

* present for gastrointestinal complaints or other non-asthma related acute illness.
Young Adult Smoker's Treatment Demand

The purpose of this study is to determine whether tailored online advertisements will drive young adult smoker's (18 to 26 years old), who are motivated to quit, to use Internet-based cessation treatment.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 30 years old
* smoke on some days or everyday
* enrollment in specified online cessation program
COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction

This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market setting.

The study is a prospective, non-randomized, multi-center clinical study to assess the safety and effectiveness of pulmonic implantation of the SAPIEN THV in patients with dysfunctional RVOT conduits requiring treatment for moderate or severe pulmonary regurgitation (PR) by transthoracic echocardiography (TTE) and/or RVOT conduit obstruction with a mean gradient of ≥ 35 mmHg by TTE.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has a dysfunctional, non-compliant RVOT conduit.
2. The patient/patient's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

1. Inability to tolerate an anticoagulation/antiplatelet regimen
2. Active bacterial endocarditis
Study to Assess the Cosmetic Changes in the Facial Skin After Use of a Topical Retinoid Product in Participants With Moderate to Severe Photodamage

This study will assess the cosmetic changes of a cosmetic topical retinoid product in participants with moderate to severe photodamage utilizing non-invasive in vivo skin imaging instrumentation.


Eligibility Criteria:
Inclusion Criteria:

* Participants with Fitzpatrick skin type I-IV
* Presence of moderate to severe facial photodamage
* Participants taking hormone replacement or hormones for birth control, willing to stop or change this medication for the duration of the study
* Willingness to cleanse the face and remove all makeup at least 15 minutes prior to each scheduled clinic visit
* Willingness to not use any other products, including self-tanners on their facial skin during the study
* Willingness to avoid as much as possible, direct and prolonged sun exposure for the duration of the study (including tanning beds), especially from 10 AM to 2 PM. Participants are asked to wear protective clothing prior to and during exposure.

Exclusion Criteria:

* Individuals with active symptoms of allergy, cold sore or warts, active psoriasis or eczema, rosacea, sunburn, open wounds, neurotic excoriations, excessive scarring, tattoos, or other skin conditions in the test areas that would interfere with the assessments of this study
* Individuals who are nursing, pregnant, or planning to become pregnant during the study
* Individuals with uncontrolled disease such as diabetes, hypertension, hyper or hypothyroidism, active hepatitis, immune deficiency, or autoimmune
* Individuals who have a pre-existing or dormant dermatologic condition (e.g., psoriasis, atopic dermatitis, rosacea, skin cancer, etc.)
* Individuals who require electrolysis, waxing, or use depilatories on the face during the study
* Chemical peel or microdermabrasion within 4 weeks of study start
* Retin-A®, Retin-A Micro®, Renova®, Avita®,Tazorac®, Avage® or Differin® or other similar prescription drugs within 3 months of study start
* Cosmetic injections (filler and/or toxins, i.e. Juvederm, Radiesse, Botox, etc.), non-ablative laser or fractional laser resurfacing
* Accutane® or other oral retinoid, Ablative procedures (i.e. laser, chemical, cosmetic surgeries) within 12 months of study start
* Participants who have planned surgeries or procedures.