cyrilzakka/clinical-trials huggingface dataset:
Weight Management Counseling in Medical Schools

Eight U.S. medical schools will be participating in the study: Weight Management Counseling in Medical Schools, also known as MSWEIGHT. This is a five-year randomized controlled trial (RCT) designed to compare the efficacy of two approaches to learning weight management counseling: 1)traditional education (TE) and; 2) multi-modal educational intervention (MME).

The study aims are to refine and compare the efficacy of MME to TE on observed student weight management counseling skills measured through the primary outcome, the Objective Structured Clinical Examination (OSCE).

Eight U.S. medical schools are matched and then randomized to one of two educational interventions, MME or TE.

Schools randomized to TE represent "usual care" and will continue the current curriculum. The MME arm will build upon the traditional usual curriculum at the medical school. The MME is a multi-modal educational intervention of a series of interactive learning components focused on integrated weight management counseling. This MME intervention for weight management counseling uses the 5As model based on the updated American Heart Association (AHA) /American College of Cardiology (ACC) /The Obesity Society (TOS) and updated NHLBI guidelines.

Eligibility Criteria:
Inclusion Criteria:

The medical school has:

* Interest in WMC medical education reform.
* Curricula resources (e.g. academic computing) to facilitate web-course training and a system to maintain student contact.
* The willingness and ability to incorporate all components of MSWEIGHT into the medical school curriculum, require or strongly encourage students to participate, and award credit for completion.
* The willingness and ability to offer the WMC OSCE for third year medical students upon completion of the Family or Internal Medicine clerkship rotation.

Exclusion Criteria: The medical school does not have:

* The ability to incorporate all components of MSWEIGHT into the medical school curriculum.
* The ability to offer the WMC OSCE for third year medical students upon completion of the Family or Internal Medicine clerkship rotation.
Safety and Modulation of Adaptive Immunity by Iscador® Qu Viscum Album Extract in Patients With Advanced, Recurrent or Metastatic Cancers Treated With Immune Checkpoint Inhibitors

The main objective of this study is to test if adding the mistletoe extract Iscador® Qu to regular cancer treatment with immune checkpoint inhibitors affects:

* The immune system's ability to fight cancer
* Safety of the treatment
* How well the treatment performs against cancer
* How the patient feels during treatment

Researchers will compare patients treated with immune checkpoint inhibitors plus Iscador® Qu with patients treated with imune checkpoint inhibitors only.

The impact of mistletoe preparations - that are claimed to have immunostimulatory properties - on cancer treatment with immune checkpoint inhibitors remains unclear. To address this knowledge gap, the current study aims to investigate the modulation of adaptive immunity through the combination of Iscador (a specific mistletoe preparation) and immune checkpoint inhibitors. Additionally, researchers will evaluate the safety profile of this combination therapy in patients with locally advanced non-operable or metastatic cancers except for skin cancers. By examining the modulation of adaptive immunity and safety of this treatment approach, researchers aim to provide valuable insights for clinicians and patients in the context of advanced cancer care.

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced non-operable or metastatic solid tumor, except for skin cancer
* Eligible for routine (standard) treatment with immune checkpoint inhibitor (+/- chemo/targeted therapy) as per the discretion of the local investigator
* Subjects must be eligible for treatment with mistletoe preparations (controlled brain metastases, prednisolone equivalent below 10mg, no known hypersensitivity)
* ECOG (Eastern Cooperative Oncology Group) performance status score of 0-2
* Males and Females at least 18 years of age; no subjects under tutelage
* No previous mistletoe treatment

Exclusion Criteria:

* Contraindications to Iscador® Qu or immune checkpoint inhibitors, e.g. hypersensitivity, active autoimmune disorder
* Patients with skin cancer
* Participation in another study with investigational drug within 30 days prior to enrolment (participation in observational studies or diagnostic studies without a particular drug intervention are allowed)
* Enrolment of the investigator, his/her family members, employees and other dependent
Camrelizumab Plus Apatinib and Temozolomide as Neoadjuvant in High Risk Acral Melanoma

Neoadjuvant therapy is feasible in stage Ⅱ-Ⅲ melanoma, Carrelizumab combined with apatinib and temozolomide has synergistic antitumor effects and may improve pathological response.

Patients with resectable melanoma can benefit from neoadjuvant therapy, including improved surgical outcomes, precise management of patients based on neoadjuvant response, and analysis of resistance mechanisms through histological sections for subsequent treatment. At present, there have been a number of clinical trials exploring the effect of neoadjuvant regimens for melanoma, and some published results have shown that neoadjuvant therapy can lead to a higher pathological response rate, thereby improving the RFS of patients.

In the past, this site has carried out a clinical study of Camrelizumab combined with Apatinib and Temozolomide for first-line treatment of unresectable acral melanoma, with a high preliminary clinical response rate and safety. Based on this, this study intends to evaluate the neoadjuvant treatment of completely resectable melanoma with Camrelizumab combined with Apatinib and Temozolomide in patients with stage III and IIB, IIC high-risk melanoma. To comprehensively evaluate the short-term and long-term benefits of neoadjuvant therapy and provide an important reference for neoadjuvant treatment strategies in the acral melanoma population.

Eligibility Criteria:
Inclusion Criteria:

1. age:18-75 years, male or female.
2. Histopathologically confirmed acral melanoma (stage Ⅱ/Ⅲ).
3. Has not received any systematic anti-tumor drug treatment.
4. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
5. ECOG 0-1.
6. Adequate organ function.
7. Life expectancy of greater than 12 weeks.
8. Patient has given written informed consent.

Exclusion Criteria:

1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
2. Known history of hypersensitivity to any component of apatinib, temozolomide, Camrelizumab.
3. Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
4. Subjects with any active autoimmune disease or history of autoimmune disease
5. Patients with any unstable systemic disease, including but not limited to: serious infection, uncontrolled diabetes, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, myocardial infarction, congestive heart failure, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease;
6. Received a live vaccine within 4 weeks of the first dose of study medication.
7. Pregnancy or breast feeding.
8. Decision of unsuitableness by principal investigator or physician-in charge.
The Metabolic and Circadian Effects of Shift Work

In an exploratory observational pilot study, the investigators will focus on the effects of short-term circadian misalignment induced by shift work on multidimensional measurements including glucose excursion, metabolic health, circadian rhythms (measured in vitro and in vivo), sleep/wake cycles and ambient light, eating and activity patterns, well-being and attention.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Age 20-50 years
* Working ≥ 80% full-time equivalent over the previous month and during the study
* Working night shifts (i.e. shifts that comprise working hours between 23h and 06h) in rotation with day shifts (i.e. shifts that comprise working hours between 06h and 20h)
* Planned to work at least 3 consecutive night shifts during the study preceded by at least a day off or day shift
* Planned to work at least 3 consecutive day shifts during the study
* Confident use of a smartphone compatible with the study application (iOS, Android) and able to regularly take pictures of consumed food/drinks
* Able to give a fully informed consent and follow the study procedures

Exclusion Criteria:

* Planned or current pregnancy during the study
* Menopausal women
* Major illness or hospitalization over the previous month
* Carries a pacemaker, pump or other medical device that can be disabled by a magnet
* Major mental illness
* Trip to a different time zone (≥ 2-hour time difference) over the previous month or planned during the study
* Enrolled in an interventional clinical trial (potentially interfering with the main outcomes) over the previous month or planned during the study
Heart Rate Variability and Cardiorespiratory Complications During Ophthalmic Arterial Chemotherapy for Retinoblastoma

A patient undergoing ophthalmic arterial chemosurgery may experience a sudden, profound decrease in lung compliance when the microcatheter is in the ICA or ophthalmic artery. However, underlying pathophysiology of the respiratory complication is unknown. In this study, the investigators are going to investigate the relation between underlying balance of parasympathetic and sympathetic tone and the respiratory complications by analyzing heart rate beat-to-beat variability.

A patient undergoing ophthalmic arterial chemosurgery may experience a sudden, profound decrease in lung compliance when the microcatheter is in the ICA or ophthalmic artery. However, underlying pathophysiology of the respiratory complication is unknown. In this study, the investigators are going to investigate the relation between underlying balance of parasympathetic and sympathetic tone and the respiratory complications by analyzing heart rate beat-to-beat variability. Also, the investigators are going to investigate whether baseline heart rate variability can predict respiratory complications during the procedures.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing ophthalmic arterial chemotherapy

Exclusion Criteria:

* None
Evaluation of the Efficacy of Allograft Versus Tenting Technique in Open Sinus Lifting With Immediate Implant Placement

Implant placement in deficient posterior maxilla is a challenging clinical situation that necessitates appropriate treatment options to restore this area.

-Aim of the study: To compare allograft vs tenting technique in terms of implant stability and bone height.

Rationale for carrying out the trial:

The research population will be divided into two groups. Group1 will be treated by allograft with immediate implant technique, Group2 will be treated by tenting technique with immediate implant technique. Allograft has been effective in augmenting bone growth and has been proven to be a vital asset in sinus lifting.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with missing upper pre molar , molar teeth
2. Patients in need of bone grafting of the maxillary sinus to house an implant.
3. Patients with residual alveolar crest of at least 3-4mm in height and 5mm in width distal to the canine as measured on CBCT scan
4. Patients with adequate inter-arch space

Exclusion Criteria:

1. Patients suffering from any sinus pathosis.
2. Patients who are heavy smokers (\>10 cigarettes/day).
3. Patient under psychiatric therapy or unrealistic expectations
4. Patients of systemic conditions that may interfere with carrying out the surgical procedure.
5. Lack of opposite occluding dentition/prosthesis in the area intended for implant placement
6. Severe bruxism or clenching
7. Poor oral hygiene (full mouth bleeding on probing and full mouth plaque index \>25%)
FARAPULSE Workflow Assessment Registry

The study is designed to determine the best practices in the patient pathway, and to analyze pre-procedural, procedural and follow-up workflow data related with ablation of atrial fibrillation where the FARAPULSE™ Pulsed Field Ablation System is used in a commercial and standard of care setting. Workflow-related variables, inclusive of pre-procedural imaging, methods of transseptal access, anesthesia/sedation technique, intracardiac mapping, ablation settings, dosing strategy, lesion sets and general procedure management, will be used to identify predominant workflow schemes that will be associated with patient demographics, procedure-related complications (safety parameters), and one-year effectiveness parameters.

The study data can be used for procedural workflow optimization when using Pulsed Field Ablation for the ablation treatment of Atrial Fibrillation based on patient demographics, cardiac anatomy and arrhythmia characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Subjects are prospectively planned and intended to be treated with the FARAPULSE™ Pulsed Field Ablation system for cardiac tissue ablation, per physician's medical judgement, and as per hospitals' standard of care
* Subjects who are willing and capable of providing informed consent
* Subjects who are willing and capable of participating to this Registry at an approved clinical investigational center
* Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law

Exclusion Criteria:

* Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study. Exceptions are when the subject is participating in a mandatory governmental registry, or a purely observational registry, that do not interfere with the current study
* Prior Left Atrium Ablation
Safety and Feasibility of Autologous Endothelial Progenitor Cells Transplantation in Patients With Idiopathic Pulmonary Arterial Hypertension

Recent researches indicate that impairment of vascular and endothelial homeostasis plays a major role in the initiation and development of IPAH.We have recently reported the safety and feasibility data for autologous endothelial progenitor cells (EPCs) injection in patients with IPAH. Yet many questions remain unanswered: what is the ideal quantity of EPCs for therapy, the duration of the therapeutic effect, and moreover, the potential toxicity of such therapy. To help answer these questions, we designed the one year follow-up to investigate the safety and efficacy of autologous EPCs injection in patients with IPAH.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria included a base-line six minute walking distance between 100 and 450 m
* A resting mean pulmonary-artery pressure greater than 30 mm Hg
* A pulmonarycapillary wedge pressure of less than 15 mm Hg
* Pulmonary vascular resistance greater than 240 dyn•sec•cm-5
* 18-60 years old

Exclusion Criteria:

* The exclusion criteria included secondary pulmonary hypertension as a result of heart disease
* Pulmonary disease
* Sleep-associated disorders
* Chronic thromboembolic disease
* Autoimmune or collagen vascular disease
* HIV infection
* Liver disease
* New York Heart Association functional class IV
* Major bleeding requiring blood transfusion
* Diabetes
* Renal dysfunction
* Evidence for malignant diseases were excluded
Comparison of Conventional and Custom Photorefractive Keratectomy (PRK)

The study objective is to compare the clinical outcomes using wavefront guided PRK with iris registration and conventional laser PRK using FDA-approved laser technology on the same patient.

Patients undergoing bilateral PRK on the same day will have one eye randomly assigned to custom wavefront guided PRK and the fellow eye treated with conventional PRK.

Eligibility Criteria:
Inclusion Criteria:

* Patients deemed to be suitable candidates for bilateral PRK

Exclusion Criteria:

* Patients desiring monovision correction rather than bilateral distance correction
Assessment of Endometrial Changes in Postmenopausal Women With Breast Cancer in Adjuvant Treatment With Anastrozole

To investigate the global incidence of the endometrial changes in postmenopausal women receiving Anastrozole for the adjuvant treatment of hormone receptors positive breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Provision of Informed Consent
* Resectable breast cancer patients, with histological confirmation
* Patients eligible to receive hormonal adjuvant treatment with Anastrozole
* They are allowed patients treated with adjuvant chemo or radiotherapy concurrently
* Patients previously treated with Tamoxifen that had to withdraw treatment due to other reason than endometrial changes are allowed
* Postmenopausal patients(aged 50 years or over/ without menses in the last months/ FSH level \>40UI/L / women under 50 years with FSH levels\>40UI/L).
* Women showing progesterone and/or estrogen receptors positive.

Exclusion Criteria:

* Patients with evidence of metastatic disease
* Patients unsuitable to receive the medication according the Anastrozole label
* Patients not giving their Informed Consent
PTG-100 for Patients With Celiac Disease

The goal of this study is to learn whether or not the drug PTG-100 can reduce or prevent inflammatory injury to the small intestine that occurs when people with celiac disease eat food products containing gluten.

This is a clinical research study to determine the safety and efficacy of PTG-100 in preventing gluten-induced inflammatory injury to the small intestine in patients with celiac disease. 30 patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days. They will also receive a gluten challenge twice daily in the form of a cookie or equivalent. An upper gastrointestinal endoscopy and exam including small bowel mucosa biopsy will be performed at the start of the treatment period and again at the end. Blood samples will be routinely taken to evaluate safety and the drug's mechanism of action throughout the study, and symptoms will be recorded using the celiac symptoms index (CSI) survey.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of celiac disease

Exclusion Criteria:

* Active GI disease or history of clinically significant diseases
* Diagnosis of Crohn's disease or ulcerative colitis.
Does The Addition Of Divalproex Sodium ER To An Atypical Antipsychotic Drug (APD) Improve Cognition And Psychopathology In Outpatients With Schizophrenia (SCH) Or Schizoaffective Disorder (SAD)?

The major objective of this proposal is to test the hypothesis that the addition of divalproex sodium to an atypical antipsychotic drug other than clozapine will significantly improve: a) cognition; and b) psychopathology (positive, negative, and mood symptoms) in a double-blind, randomized trial of 6 weeks duration in patients with schizophrenia or schizoaffective disorder.

Cognitive function is one of the most critical deficits in schizophrenia and schizoaffective disorder. It has been found that cognitive dysfunction may be even more important than positive or negative symptoms in predicting functional outcomes such as community adjustment, ability to work, social interactions, and caretaker burden. Preclinical data from our laboratory provided the rationale for a clinical trial to test whether divalproex sodium ER can improve cognitive impairment in patients.

The major objective of this proposal is to test the hypothesis that the addition of divalproex sodium to an atypical antipsychotic drug other than clozapine will significantly improve: a) cognition; and b) psychopathology (positive, negative, and mood symptoms) in a double-blind, randomized trial of 6 weeks duration in patients with schizophrenia or schizoaffective disorder.

Eligibility Criteria:
Inclusion criteria

* Male or female, age 18-65
* DSM-IV diagnosis of schizophrenia or schizoaffective disorder
* Treated with olanzapine, aripiprazole, ziprasidone, quetiapine or risperidone monotherapy for at least three months prior to enrollment
* Able to provide written consent

Exclusion criteria

* Primary DSM-IV diagnosis other than schizophrenia or schizoaffective disorder
* Treatment with any antipsychotic other than olanzapine, aripiprazole, ziprasidone, quetiapine or risperidone in the past three months
* Treatment with a mood stabilizer or an antidepressant continuously in the past three months. Patients who have had it for less than two weeks continuously will be permitted to enter.
* Pregnant or lactating females
Maternal and Infant Growth Study

Rapid growth early in infancy is a risk factor for obesity and cardiovascular disease later in the lifespan. Evidence is limited, but both pre- and postnatal factors are associated with early rapid growth, and include high maternal BMI prior to pregnancy and excessive gestational weight gain. This research focuses on aspects of early feeding as potentially modifiable factor affecting early infant weight gain. Formula feeding mothers are randomized to receive either 5 oz of 8 oz bottles to use in feeding their infants from 2- to 16 weeks postpartum. In addition, a reference group of exclusively breastfeeding mother-infant dyads are also included. The hypothesis is that differences in feeding practices will be associated with differences in growth and that infants randomized to be fed from smaller bottles will grow more slowly that those randomized to larger bottles. Growth patterns of formula fed infants will also be compared to those of exclusively breastfed infants.

Mothers complete feeding logs, questionnaires on health history, demographics, feeding attitudes and practices. Infant growth and body composition are measured via PEA POD, and maternal anthropometrics and body composition are measured in BOD POD the laboratory at 2, 8, and 16 weeks postpartum. Primary outcome is change in weight-for-age z-scores.

Eligibility Criteria:
Inclusion Criteria:

* pregnant or newborn aged 28 days or younger

Exclusion Criteria:

* gestational diabetes, hypertension, pregnancy/delivery complications, premature birth, low birth weight
Retention Rate of Acalabrutinib in a Non-interventional Setting

Retention rate of acalabrutinib in a non-interventional setting. This is a prospective, multicentre, non-interventional study to collect real-world data on retention rates of CLL patients prescribed with acalabrutinib in Germany.

This observational study will prospectively assess acalabrutinib therapy retention of CLL patients one year and 2 years after treatment initiation with acalabrutinib in routine clinical practice. Furthermore, therapy adherence, treatment efficacy, overall survival, and QoL to analyse the possible influence of psychological aspects of the patient-based disease perception, a four-group-segmentation for acceptance and perceived control of the health state will be conducted. Finally, disease-, treatment-, and patient-specific factors possibly affecting therapy retention will be analysed: sociodemographic factors, disease and treatment characteristics, comorbidities, therapy adherence, treatment effectiveness, safety, QoL, and psychological segmentation.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of CLL
* Ability to understand the study concept and to regularly complete patient questionnaires from physical, mental, and linguistic perspectives
* Decision to start therapy with acalabrutinib according to the current SmPC. For previously untreated patients as continuous therapy with or without obinutuzumab. OR For patients with at least one prior CLL therapy as continuous monotherapy.
* Provision of signed informed consent form

Exclusion Criteria:

* Current or planned participation in an interventional clinical trial
* Contraindications to treatment with acalabrutinib according to the current SmPC
* Pregnancy or breast feeding
* Disease progression on prior BTKi therapy
* Start of acalabrutinib therapy more than 28 days prior to enrolment