cyrilzakka/clinical-trials huggingface dataset:
A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis

The primary objective is to provide dose-ranging data for 4 dose regimens of BI 655130 compared to placebo on the primary endpoint of percentage change from baseline in PPP ASI at Week 16. The target dose(s) will be estimated from the model by incorporating information on the minimum clinically relevant effect and accounting for safety.

Supportive dose-ranging assessments will also be done on pre-specified secondary endpoints.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years of legal age (according to local legislation) at screening.
* Diagnosis of Palmoplantar Pustulosis defined as presence of primary, persistent (\>3 months duration), sterile, macroscopically visible pustules on the palms and/or soles, without or with plaque psoriasis elsewhere on the body.
* PPP PGA of at least moderate severity (≥3) at screening and baseline.
* A minimum PPP ASI score of 12 at screening and baseline.
* Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).
* Signed and dated written informed consent in accordance with ICH GCP and local legislation prior to admission to the trial.
* Further criteria apply.

Exclusion Criteria:

* Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
* Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.
* Presence or known history of anti-TNF-induced PPP-like disease.
* Patient with a transplanted organ (with exception of a corneal transplant \>12 weeks Prior to screening) or who have ever received stem cell therapy (e.g., Prochymal).
* Known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
* Further criteria apply.
Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome

This correlative study aims to understand the pharmacodynamic effects and clonal dynamics in response to epcoritamab by obtaining and analyzing lymph node, bone marrow, and blood samples from subjects enrolled in GCT3013-03 trial sponsored by Genmab at NIH. Samples will be collected before and at multiple time points during treatment with epcoritamab. National Heart, Lung, and Blood Institute (NHLBI) investigators are experienced in testing samples treated with bsAb2,3 including epcoritamab in an ongoing pre-clinical collaboration with Genmab. Addressing the objectives of this correlative study will advance the science and clinical application of epcoritamab specifically as well as T-cell engaging bsAb in general as an emerging class of immunotherapy for cancer.

The study is enrolling by invitation only.

Study Description:

Subjects enrolled in GCT3013-03, a phase 1b/2 study of epcoritamab in R/R CLL and RS, at the National Institutes of Health (NIH) Clinical Center (CC) will be invited to simultaneously participate in this companion correlative study. Subjects will undergo percutaneous lymph node coreneedle biopsies, bone marrow biopsies, lymphapheresis, and blood draws for pharmacodynamic evaluation of tumor and immune cells in affected tissue sites and blood before and during treatment with epcoritamab.

Objectives:

Primary Objective:

-Assess the pharmacodynamic effects of epcoritamab in the tumor microenvironment.

Secondary Objectives:

* Assess the pharmacodynamic effects of epcoritamab in blood
* Investigate clonal dynamics during treatment with epcoritamab

Exploratory Objective:

-Evaluate pharmacodynamic and predictive biomarkers

Endpoints:

Primary Endpoint:

-Immunophenotype and transcriptome of T cells and tumor cells in lymph node and bone marrow

Secondary Endpoints:

* Immunophenotype and transcriptome of T cells and tumor cells in peripheral blood
* DNA sequencing of tumor cells

Exploratory Endpoints:

-Tests include, but are not limited to single cell multiomics, bulk lymph node transcriptome cytokine analysis

Eligibility Criteria:
* INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

* Must be undergoing screening for GCT3013-03
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Ability of subject to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

None
Primary Care-Based Physical Activity for Diabetic Latinas

The goal of this proposal is to test the efficacy of a primary care-delivered, print-based physical activity intervention for Latinas with type II diabetes. The investigators will test the efficacy of this intervention by randomizing 80 Latinas with type II diabetes recruited through UCSD Health System primary care to either the adapted web-based physical activity intervention or standard of care, and assessing physical activity gains at six and 12 months. The ultimate goal is to develop a print-based physical activity intervention for diabetic Latinas that could be widely disseminated through primary care.

Studies show that adoption of regular physical activity (PA) can greatly enhance diabetes management and prevention. Individuals who adopt a PA routine show significant improvements in clinical markers of diabetes, including HbA1c, glucose tolerance, insulin sensitivity, weight and waist circumference, and significant reductions in medication use, and also show reductions in cardiovascular risk factors and other related co-morbidities. Incorporation of cost-effective PA interventions into primary care for diabetes treatment could therefore enhance overall health and quality of life and significantly reduce healthcare costs. The primary aim of this study is to conduct a small randomized trial (N=80) to test the efficacy of an individually tailored culturally adapted print-based physical activity intervention integrated into primary care to increase weekly moderate-to-vigorous physical activity in Latinas with type II diabetes, compared to those receiving standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Have received a physician's diagnosis of type II diabetes and are currently being seen by a primary care physician
* Currently inactive, defined as participating in at least moderate intensity physical activity for less than 60 minutes per week

Exclusion Criteria:

* Medical condition that may make exercise unsafe, including congestive heart failure, severe musculoskeletal problems or pulmonary conditions, or other conditions determined by the referring physician to preclude unsupervised exercise
* Unable to receive mailed materials (do not have a mailing address)
* Unable to engage in physical activity for at least 30 minutes
* Have a current or planned pregnancy
* Planning to move from the area within the next year
755nm Alex Laser for Treatment of Stretch Marks

Evaluate the safety and efficacy of the bilateral treatment of striae using a 755nm Alexandrite laser.


Eligibility Criteria:
Inclusion Criteria

1. Is a healthy male or female between 18 and 85 years old.
2. Has unwanted striae and wishes to undergo laser treatments to remove or improve them.
3. Is willing to consent to participate in the study.
4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.

Exclusion Criteria

1. Is hypersensitive to light exposure.
2. Has active localized or systemic infection.
3. Is taking medication(s) for which sunlight is a contraindication.
4. Has a history of squamous cell carcinoma or melanoma.
5. Has a history of keloid scarring.
6. Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
7. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
8. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
9. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine.
10. Has any other reason determined by the physician to be ineligible to participate in the study.
Body Mass Index and Age Correlate With Antioxidant Supplementation Effects on Sperm Quality

Spermatozoa are vulnerable to lack of energy and oxidative stress as a result of elevated levels of reactive oxygen species. Therefore, it is essential that appropriate nutrients are available during maturation.

This randomized, double-blind, placebo-controlled trial investigated the effect of 6 months supplementation with carnitines and other micronutrients on sperm quality in 104 subjects with oligo- and/or astheno- and/or teratozoospermia with or without varicocele. Semen analyses were done at the beginning and end of the treatment. In addition to main analyses, post-hoc analyses for age and body mass index (BMI) were carried out. Results were interpreted by dividing the population into two age and BMI classes.


Eligibility Criteria:
Inclusion Criteria:

* men with oligo- and/or astheno- and/or terato-zoospermia
* with or without varicocele
* men aged between 18 and 50 years
* men from couples with history of difficulty conceiving for more than 12 months

Exclusion Criteria:

* subjects with known hypersensitivity to any of the treatment compound
* history of undescended testes or cancer
* endocrine disorders
* history of post-pubertal mumps
* genitourinary surgery
* obstructive azoospermia or obstructive pathology of the urogenital system
* autoimmune disease
* cystic fibrosis
* history of taking any therapy affecting fertility within last 3 months
* excessive consumption of alcohol or regular use of illicit or "recreational" drugs
* positive serology for HIV
* subjects following any special diet
* any condition which in the opinion of the investigator might put the subject at risk by participation in this study and subjects involved in any other clinical trials
Viewing Surface Electrical Stimulation on Pelvic Floor With Ultrasound

Subjects will place a surface electrode on their perineal area after a bladder-filling protocol. Transabdominal ultrasound will image the base of the bladder at rest, voluntary pelvic floor contraction, with the surface electrical stimulation and with a combined pelvic floor contraction and electrical stimulation active.


Eligibility Criteria:
Inclusion Criteria:

* Age:18-80y
* Gender: female

Exclusion Criteria:

* Moderate-severe stress incontinence\*: As determined by self-reported \>3 accidents in 24-hr period
* Currently pregnant, may be pregnant (Unsure pre and peri-menopausal women should take a pregnancy test.)
* Active urinary tract infection (UTI)
* Pelvic pain, Painful bladder syndrome, underlying neurologic/neuromuscular disorder that may impact ability to partake in the trial
* implanted cardiac device or untreated cardiac arrhythmia
* Obesity as defined by BMI \>= 30 (height, weight recorded)
* Anyone with impaired decision making, drug or alcohol dependence, or potentially suicidal.
* Anyone who lacks the capacity to consent for themselves or who requires a legal representative to give informed consent \* Stress urinary incontinence: as determined by an answer of "Yes" to a standard question (from King's Health Questionnaire): "Do you lose urine with physical activities such as coughing, sneezing, running?"
Study to Evaluate the Pharmacokinetics of Filgotinib in Participants With Impaired Hepatic Function

The primary objective of this study is to evaluate the pharmacokinetics (PK) of filgotinib and its metabolite, GS-829845, in participants with varying degrees of impaired hepatic function relative to matched, healthy controls.


Eligibility Criteria:
Key Inclusion Criteria:

* Eligible individuals will be male and nonpregnant, nonlactating females, aged 18 to 70 years (inclusive), body mass index (BMI) between 18 and 36 kg/m\^2 (inclusive), with either impaired hepatic function or normal hepatic function.
* Individuals will be current nonsmokers (no use of tobacco, nicotine-containing, or tetrahydrocannabinol \[THC\]-containing products within the last 14 days).
* Individuals with hepatic impairment will be categorized by the Child-Pugh-Turcotte (CPT) classification system indicating hepatic impairment as follows:

  * Class A (mild): CPT score 5-6
  * Class B (moderate): CPT score 7-9
  * Class C (severe): CPT score 10-15
* Hepatic impairment must have been stable during the 3 months (90 days) prior to study drug. Each individual in the control group will be matched to a individual with impaired hepatic function by age (± 10 years), gender, and body mass index (± 15%).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1128688 After Multiple Oral Administrations in Healthy Women

The objective of this trial is to investigate the safety and tolerability of BAY1128688 and to determine the concentration of this substance in blood after repeated administration by the oral route. The investigational substance will be administered in tablet form to healthy women.


Eligibility Criteria:
Inclusion Criteria:

PART A

* Postmenopausal state, revealed by

  1. Medical history. One of the following:

     * Natural menopause at least 12 months prior to first study drug administration,
     * Surgical menopause by bilateral ovariectomy at least 3 months prior to first study drug administration) or
     * Hysterectomy AND
  2. Follicle-stimulating hormone (FSH) \> 40 IU/L
* Age 45 to 68 years

PART B

* Healthy female subjects

  * Sterilized by tubal-ligation
  * Pre-treatment menstrual cycle assessed as ovulatory
* Completion of more than 3 menstrual cycles after delivery, abortion or lactation
* Age 18 to 48 years

Exclusion Criteria:

* Body mass index (kg/m2) greater or equal 32 (or less or equal 18)
* Smoking: PART A: non-smoking; PART B: less than 10 cigarettes per day
* Use of medicines including but not restricted to contraceptives and NSAIDs (details regarding previous use of medicines provided by the study center)
* Ability and willingness to adhere to restrictions regarding diet (PART A and B) and to eat standardised meals (PART A only)
* Significant diseases of the heart, gastrointestinal tract and/or liver and/or kidney and/or reproductive organs (present or in the past; details will be provided by the study center)
* Recent infectious diseases (details will be provided by the study center)
* Migraine or depression
* Thyroid disease which requires treatment
* Metabolic disorders, for example diabetes mellitus or hypertriglyceridemia
* Drug or alcohol abuse; regular consumption of more than 800 ml of beer per day (or other drinks resembling 40 g of alcohol)
Myo-inositol as Pretreatment in Hyperandrogenic PCOS Patients

A randomized controlled trial to evaluate whether pretreatment with myo-inositol can lower testosterone levels and improve clinical outcomes in hyperandrogenic PCOS patients undergoing ART


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-40 years
* PCOS phenotypes A, B and C
* Signed informed consent

Exclusion Criteria:

* Other relevant endocrine disorders
* Contraindications to the use of gonadotropins
* Endometriosis grade 3-4
* BMI \> 35
Harnessing Health IT to Promote Equitable Care for Patients with Limited English Proficiency and Complex Care Needs

This is a pragmatic trial that will measure if the use of AI to identify patients with complex care needs and language barriers, as well as active reaching out to clinicians to offer the use of interpreter services will improve the frequency of interpreter use and reduce the time to first interpreter use


Eligibility Criteria:
Inclusion Criteria:

* Adults with limited English proficiency and requiring an interpreter and having complex medical care needs (includes admitted to the ICU, prolonged hospital stay, requiring palliative care)
* Have research authorization

Exclusion Criteria:

- Do not require an interpreter
A Web-Based Dyadic Intervention for Colorectal Cancer

This clinical trial studies how well a web-based dyadic intervention works to manage psychoneurological symptoms for patients with colorectal cancer and their caregivers. Patients with colorectal cancer receiving chemotherapy experience severe and distressing psychoneurological symptoms that include fatigue, depression, sleep disturbance, pain, and cognitive dysfunction. When these co-occurring symptoms are undertreated, they negatively affect functional status, survival rates, and quality of life of patients as well as decrease health outcomes of their family caregiver. A critical need exists to develop an effective and novel intervention that focuses on patients with colorectal cancer receiving chemotherapy and their caregivers. A web-based dyadic intervention holds great promise to reduce psychoneurological symptoms burden and improve quality of life for patients with colorectal cancer receiving chemotherapy and advance intervention development and implementation in cancer supportive care and health equity.

PRIMARY OBJECTIVES:

I. To develop a web-based dyadic intervention for patients with colorectal cancer receiving chemotherapy and their caregivers (CRCweb).

Ia. Determine tailored contents by identifying needs and supports for a web-based dyadic intervention using interviews with patient-caregiver dyads (n=8); Ib. Develop a prototype of a web-based dyadic intervention program (CRCweb); Ic. Test the usability (e.g., design, navigation, structure, language) of CRCweb prototype using interviews with 4 dyads (in Aim Ia).

II. Evaluate the feasibility and acceptability of CRCweb for patients with colorectal cancer receiving chemotherapy and their caregivers in 20 dyads in a pilot clinical trial.

III. Evaluate the preliminary effects of CRCweb on the primary outcome (i.e., attrition, adherence, acceptability, fatigue, depression, sleep disturbance, pain, and cognitive dysfunction) and secondary outcomes (i.e., quality of life) for patients with colorectal cancer receiving chemotherapy and their caregivers in 20 dyads in a pilot clinical trial.

OUTLINE:

Patients and caregivers attend a CRCweb intervention over 8 weeks. Patients and caregivers complete interviews and surveys throughout the trial.

Eligibility Criteria:
INCLUSION CRITERIA

Patients:

* Age \>= 18 years
* Diagnosed with colorectal cancer
* Life expectancy \> 12 months
* Receiving active chemotherapy
* Self-reported at least two psychoneurological symptoms (based on the symptom measures' cutoff scores)
* Identified primary caregiver (i.e., family members or significant others identified by the patients as their primary source of emotional and physical support)
* Access to the Internet
* Fluent in English

Caregivers:

* Age \>= 18 years
* Primary caregiver
* Access to the Internet
* Fluent in English

EXCLUSION CRITERIA

Patients:

• Karnofsky Performance Scale \< 50

Caregivers:

• Have severe diseases (e.g., cancer, heart disease)
Impact of a Physical Activity Intervention With Motivational Support From Peers for Prostate Cancer Patients

Despite the recognized benefits of physical activity in tertiary prevention, 60-70% of prostate cancer patients are insufficiently active.

Yet 150 minutes of brisk walking per week (new WHO recommendations) is associated with a 29% reduction in cancer mortality and a 57% reduction in recurrence.

Increasing patients' adherence to regular physical activity appears to be a new challenge for personalized cancer care.

Personalized physical activity programmes (1) at home, (2) supported by health professionals, or (3) by peers have shown the effectiveness of regular physical activity.

However, these interventions last less than 6 months and do not allow for long-term sustainability of physical activity.

This study proposes to combine 3 interventions, which aim to initiate and maintain regular physical activity in prostate cancer patients:

* 1-The realization of a personalized and realistic physical activity project via physical activity support devices (sport health centers)
* 2-Coaching by a peer (a patient with the same disease who has reached the WHO recommendations for physical activity), who will provide motivational follow-up
* 3-Support by health professionals (attending physician) through the prescription of physical activity.

The feasibility of ACTI-PAIR program has been demonstrated, the investigators now wish to evaluate it effectiveness.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* Age ≥ 18 years
* Diagnosed with prostate cancer for at least 1 year
* PA practice \< 150 minutes per week (considered inactive according to WHO)
* Affiliated or entitled to a social security scheme
* Having received informed information about the study and having co-signed, with the investigator, a consent to participate in the study

Exclusion Criteria:

For patients:

* Undergoing treatment (except hormone therapy)
* Significant comorbidities contraindicating the practice of physical activity: associated cardiac pathologies, respiratory pathologies, disabling joint pathologies
* Deprived of liberty or under guardianship
Coupling Negative Pressure Wound Therapy With Instillation

The objective of this study is to compare standard negative pressure wound therapy with negative pressure wound therapy coupled with instillation for optimal skin graft take. Either the V.A.C ULTA NPWT or V.A.C. VeraFlo Therapy systems with normal saline will be applied intra-operatively to split-thickness skin grafts of upper and lower extremity wounds and kept in place for a duration of four days. Following completion of four days, the skin graft with be assessed for percentage of take/adherence and will be covered with simple gauze dressings as needed.

Past studies have investigated the use of NPWT for post-operative skin graft treatment and shown superior outcomes regarding graft take and need for repeat grafting when compared with standard gauze dressing. However, to date, no study has compared standard NPWT to NPWT coupled with instillation for post-operative treatment of extremity skin grafts. This study is designed as a randomized, controlled pilot study to compare treatment standard NPWT with NPWT coupled with instillation on skin graft take.

Patients will be selected based on inclusion criteria and randomized to either the treatment (NPWT coupled with instillation) or the control group (standard NPWT). Depending on the group to which they are randomized to, patients will have standard NPWT or NPWT coupled with instillation applied intra-operatively after application of split thickness skin graft for treatment of extremity wound.

Patients randomized to control group will receive V.A.C Ulta NPWT at 125mmHg continuous pressure for duration of four days.

Patients randomized to treatment group will receive V.A.C VeraFlo therapy. Protocol will consist of the following:

* Instillation solution: normal saline
* Dwell/soak time: 30 seconds
* Cycle Time: 4 hours
* Pressure: 125mmHg

The devices will be kept in place for four days, at which point, the wound vacs will be removed and the percentage of skin graft take will be evaluated with use of photometric analysis. The skin grafts will be subsequently dressed with gauze as appropriate. Patients will be followed up in clinic to assess outcome of skin graft take.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been offered split-thickness skin graft for treatment of an extremity wound.

Exclusion Criteria:

* Abnormal healing (diagnosed with connective tissue disorder)
* Uncontrolled diabetes mellitus (HgbA1c \>9)