cyrilzakka/clinical-trials huggingface dataset:
Parkinson's Disease Biomarker Program

The primary objective of this study is to obtain detailed clinical information and biologic specimens from subjects with PD toward the ultimate end of identifying a biomarker of PD. Because of the inherent difficulties of using clinical outcome measures to assess disease modification, the identification of biomarkers of PD is of paramount importance. The ideal PD biomarker would be one that is easily assayed in a convenient biological sample, varies proportionally with disease severity, is abnormal during the pre-symptomatic phase of the illness, and is unaffected by drugs or other interventions used to treat PD. The existence of a sensitive biomarker with these properties would enable much more effective disease modifying research that would likely be able to take advantage of smaller and potentially shorter trials.

Subjects will be asked to attend study visits every 6 months for up to 5 years of follow up. Each visit will consist of patient outcomes questionnaires, neurological exams, computerized assessments of gait and balance, a video recorded motor exam, and biological specimen collection for biomarker discovery.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of idiopathic PD meeting UK PD Society Brain Bank Criteria (Step 1, Step 2, and 2 items present from step 3).1
* Male or female age 30 years or older at time of PD diagnosis, Hoehn \& Yahr (H\&Y) stage I-IV.
* Confirmation from I-123 Ioflupane SPECT (DatScan®) of dopamine transporter deficit for de-novo, untreated patients.
* Clinical evidence of response to dopaminergic medication (MAO-B inhibitors, dopamine agonists, levodopa, or combinations) in patients on treatment for PD.
* Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.
* Able to make visits to UT Southwestern every 6 months for up to 5 years without undue hardship.

Exclusion Criteria:

* Idiopathic PD, H\&Y stage 5, as these will be unable to participate in gait assessments.
* Confirmed or suspected atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases.
* Presence of definite dementia (MoCA \< 17)2.
* For de-novo subjects: received any of the following drugs that might interfere with dopamine transporter SPECT imaging: neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of screening.
* For the prospective CSF cohort: current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
* For the prospective CSF cohort: any condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or known clinically significant coagulopathy or thrombocytopenia.
* Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
Education Nutritional Video for Gestational Diabetics

The purpose of this research study is to find out if watching an educational video about nutrition helps participants learn about how different foods affect their blood sugar and how Gestational Diabetes affects pregnancy.

* Patients diagnosed with gestational diabetes receive standard nutritional counseling at their first high risk clinic visit. All patients agreeing to participate in the study will at this visit fill out a knowledge questionnaire prior to receiving counseling.
* Patients will be randomized into standard counseling or standard counseling plus educational video using block randomization that has been integrated into the Redcap Survey. Once the Initial survey is completed the RedCap program will inform the patient whether they are randomized to Video or NO Video.
* Patients randomized to Video will watch the video will watch the video on a clinic designated computer. Patients randomized to no Video will not watch a video.
* At the next High risk clinic visit one to two weeks later all patients will fill out the same fill out the same questionnaire in addition to the The Problem Areas In Diabetes (PAID) questionaire.
* English-speaking patients will view the English version of the video, and Spanish-speaking patients will view the Spanish version of the video in either English or the dubbed Spanish version.
* A Spanish version of the patient hand-out will be provided in an amendment, prior to their use with Spanish- speaking patients.

Eligibility Criteria:
Inclusion Criteria:

* Any diagnosis of Diabetes in Pregnancy
* Received at least one session of nutritional counseling from the registered dieticians

Exclusion Criteria:

* Age \< 18
* Patients without diagnosis of diabetes
Anti-PD-1 in Combination With Chemotherapy as First-Line Treatment to Lung Cancer

This is a Phase II, open-label, 4-cohort study of the monoclonal antibody BGB-A317 in combination with standard platinum-based chemotherapy in participants with advanced NSCLC or SCLC. The 4 cohorts will be enrolled concurrently including non-squamous NSCLC Cohort, squamous NSCLC Cohort A, squamous NSCLC Cohort B and SCLC Cohort. Participants with a mixed adenocarcinoma and squamous cell NSCLC will be allocated to one of the NSCLC cohorts based on the predominant histopathological profile. (e.g., participants with adenocarcinoma component accounting for \> 50% will be allocated to non-squamous NSCLC cohort.). Participants with squamous NSCLC will be sequentially enrolled into either of the 2 squamous NSCLC cohorts by the trial stage i.e. the sequence of the enrollment for the squamous NSCLC cohorts will be as Cohort A safety run-in Stage, followed by Cohort B safety run-in Stage, Cohort A dose-expansion stage and Cohort B dose-expansion Stage.


Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female, aged 18-75 years on the day of signing informed consent.
2. Have histologically or cytologically confirmed locally advanced or metastatic non-squamous NSCLC, squamous NSCLC, or extensive-stage SCLC.

   Note: Participants with mixed adenosquamous carcinoma may also be enrolled on a case-by-case basis after discussion with the medical monitors.
3. Have had no prior systemic therapy for advanced or metastatic disease. Prior neoadjuvant/adjuvant therapy or chemoradiation therapy with curative intent should have been completed at least 6 months prior to documentation of recurrence of disease.
4. Participants must be able to provide fresh or archival tumor tissues (formalin-fixed paraffin-embedded \[FFPE\] blocks or at least 10 unstained FFPE slides) with an associated pathological report.

Key Exclusion Criteria:

1. Participants with a sensitizing mutation in EGFR gene or an ALK fusion oncogene (specifically for participants with non- squamous NSCLC). Participants with unknown mutation/fusion status of EGFR and/or ALK must take the respective test at the investigational sites (or other designated sites) prior to enrolment.
2. Prior malignancy active within the previous 2 years exceptions include the tumor under investigation in this trial, and locally recurring cancers that have undergone curative treatment, such as resected basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast
3. Prior therapies targeting PD-1, PD-L1 or PD-L2

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry II

To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of treatment in patients with Chronic Obstructive Pulmonary Disease.


Eligibility Criteria:
Inclusion criteria:

1. Signed informed consent prior to participation.
2. Diagnosis of chronic obstructive pulmonary disease and post-bronchodilator FEV1(Forced Expiratory Volume in 1 sec) \<80% of predicted normal and post-bronchodilator FEV1(Forced Expiratory Volume in 1 sec)/FVC of \< 70% at Visit 1.
3. Male or female between 40 and 75 years of age.
4. Current or ex-smokers with smoking history of more than 10-pack years.
5. Able to perform technically acceptable pulmonary function tests, multiple exercise tests and able to maintain records.
6. Able to inhale medication in a competent manner from a metered-dose inhaler and Respimat inhaler.

Exclusion criteria:

1. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT \>x2 ULN, SGPT \>x2 ULN, bilirubin \>x2 ULN or creatinine \>x2 ULN.
2. Patients with a history of asthma and/or total blood eosinophil count of 600 cells/mm3.
3. Patients with thyrotoxicosis, paroxysmal tachycardia (\>100 beats per minute).
4. Patients with a history of myocardial infarction within 1 year of screening visit, unstable or life-threatening cardiac arrhythmia, hospitalization for heart failure within the past year, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, life-threatening pulmonary obstruction, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse or contraindications to exercise.
5. Patients who have undergone thoracotomy with pulmonary resection.
6. Patients being treated with oral beta-adrenergics or oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
7. Patients who regularly use daytime oxygen for more than one hour per day.
8. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit or patients who are currently in a pulmonary rehabilitation program.
9. Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnea.
10. Pregnant or nursing women.
11. Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).
Effects of Intrauterine Administration of Autologous PBMC on the Endometrial Cells Populations

The behaviour of the endometrium during its receptive phase is highly dependent on the endometrial cell type composition. Each cell type has its role in the endometrial preparation for the invading embryo. Alteration in the immune cells dialogue could be the main reason for unsuccessful implantation in certain patients. Immune cell homeostasis is often improved by intrauterine administration of autologous PBMC.

There have been numerous reports on the positive effects of the intrauterine administration of autologous PBMC on the IVF outcomes (embryo implantation and ongoing pregnancy success). However, there is little data on the direct effect of the PBMC administration on the cell composition of the endometrium. This study will focus on the changes in the endometrial cell populations by PBMC treatment that could lead to IVF outcome improvement.

The aim of this project is to analyze the effect of intrauterine administration of autologous PBMC on the endometrial cell populations and on the IVF outcome parameters (implantation and ongoing pregnancy success as IVF outcome variables).


Eligibility Criteria:
Inclusion Criteria:

* Participating in Assisted Reproduction Treatment
* Presenting altered endometrial immune profile
* Having primary infertility
* Having regular menstrual cycles
* Embryo transfer of euploid embryos

Exclusion Criteria:

* Uterine pathologies
* Endometrial Bacterial infections
* Active endometrial inflammation
* Polycystic ovary syndrome
* Presence of auto anti-bodies such as anti-TPO, anti-TG, ACA, APA, ANA, and anti-dsDNA
* Presence of mutations involving the coagulation system such as deficiency of factor XII, Pro C, Pro S
* Cancer diagnostics
* Positive HIV, HCV or HBV tests
Caring for Frail Patients Through Vaccination

The CareVax project aims to find frail patients at Fondazione Policlinico Universitario 'A. Gemelli' IRCCS who could benefit from vaccinations against pneumococcal, Zoster, flu, HBV and SARS-CoV-2. This will reduce hospital stays, long-term effects, and deaths related to these diseases, as outlined in the PNPV (National Plan for Vaccine Prevention) 2017-2019 and Ministry of Health circulars from September, October, December 2022, and January 2023. Eligible patients, upon consent, will be identified by applying an automated algorithm to the patient's electronic health record and vaccination history contained in the regional vaccination registry. Identified patients will be contacted either directly if they are admitted to the inpatient wards of the Fondazione Policlinico Universitario "A.Gemelli" IRCCS (FPG) Hospital, or by messaging or e-mail in the case of access to the FPG for follow-up or routine visits or day hospital or day surgery service. Patients contacted, depending on their frail condition, will be booked for vaccination at an hospital vaccine clinic (extremely vulnerable patients) or a Local Health Unit (ASL Roma1) vaccine clinic respectively (frail patients).

The project envisages a validation phase of the algorithm, through the evaluation of its concordance with the judgement of a blinded clinician on a small group of patients Patients' engagement and a proper communication system with them will be carried through an interoperable digital system aimed at booking the new vaccination appointment, reminding it and providing patients with all the information needed.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or more,
* Patients who have accessed one of the enrolled departments (Dermatology, Oncological gynaecology, Geriatry, Nephrology, Gastroenterology),
* Medical residence in Lazio Region

Exclusion Criteria:

- Patients who do not fulfill 1 or more inclusion criteria
Evaluation of Pregnancy Associated Plasma Protein A (PAPPA) as a Biomarker in Breast Cancer.

This work aims to:

1. Evaluation of the role of pregnancy associated plasma protein A( PAPPA ) in diagnosis \& early detection of breast cancer.
2. Evaluation of the relationship between ( PAPPA ) levels and stages of breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* female patients with breast cancer who were diagnosed by histopathological studies and did not receive any treatment.

Exclusion Criteria:

* Patients who received chemotherapy or radiotherapy.
* Patients with known other organ malignancy.
Treating Psychosocial Distress in Glaucoma

In this study, using three phases, the investigators will use an iterative development approach to refine a behavioral intervention for managing concomitant psychosocial distress in glaucoma. Phase 1: The investigators will begin by developing a baseline intervention using strategies from Acceptance and Commitment Therapy (ACT), and delivered using a mobile application. Phase 2: The investigators will refine the baseline intervention for glaucoma patients using qualitative interviews conducted with primary open-angle glaucoma (POAG) patients with psychosocial distress (N=20), and health professionals (N=5). Phase 3: Finally, the investigators will measure acceptability and feasibility of the refined intervention through a single-armed pilot study (N=25). The investigators hypothesize that the refined intervention will yield an acceptable and feasible intervention in a POAG patient population, setting the stage for a future efficacy study.


Eligibility Criteria:
Inclusion Criteria:

* be diagnosed with primary open-angle glaucoma,
* be scheduled for a glaucoma clinic encounter to the Duke Eye Center main or satellite site in the succeeding two months,
* have a previous encounter to a Duke glaucoma clinic and at least one-year of follow-up,
* be at least 18 years of age,
* be able to understand, speak, and read English, and
* be able to provide informed consent.

Exclusion Criteria:

* a glaucoma surgery (e.g., trabeculectomy) within the past 6-months,
* reported or suspected cognitive impairment indicated by provider or chart review,
* presence of untreated serious mental illness (e.g., schizophrenia) indicated by provider or chart review, and
* legal blindness as indicated by provider or chart review.
Evaluation of Root Resorption Following Different Mandibular Incisors Intrusive Mechanics

Evaluation of root resorption following different mandibular incisors intrusive mechanics : A randomized clinical trial


Eligibility Criteria:
Inclusion Criteria:

* Patient will be included in this study if has:

  * An age range between 12 and 16 years.
  * Deep overbite with excessive curve of Spee of more than 5mm
  * Over erupted lower incisors.
  * Permanent teeth are all present (except for third molar).
  * No previous orthodontic treatment.
  * No indications or symptoms of periodontal disease in the past or present, as determined by clinical and radiographic examination

Exclusion Criteria:

* Patients who needed surgery to fix skeletal problems.
* Any previous trauma or root canal therapy
* Missing lower incisor.
* Patients with congenital dentoskeletal disorders
A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Orthofix Spine Devices

This protocol is designed to study Orthofix regulatory approved and commercially available spine devices to generate Real World Evidence (RWE) of device safety and performance in the treatment of patients with spine injuries and/or disorders following the local medical standard of care. The clinical data generated from this study will support compliance to global regulatory requirements including but not limited to the European Medical Device Regulation (EU MDR) for the applicable devices.


Eligibility Criteria:
Inclusion Criteria:

1. Patient diagnosed with a spine injury/disorder and undergoing or has undergone spine procedure at the participating investigative centers utilizing Orthofix Spine devices.
2. Patient is 18 years or older at the time of surgery.
3. Patient is capable of understanding the content of the patient information / Informed Consent Form (ICF) for the prospective segment of the study.
4. Patient is willing and able to participate in the prospective data collection protocol and comply with the required data collection.

Note: For retrospective segment of the study: A waiver of consent for retrospective data collection is in place OR an informed consent is obtained from the participating patient prior to data collection as required by local regulations.

Exclusion criteria:

1. Patient may be excluded from study participation if there are other concurrent medical or other conditions (chronic or acute in nature) that in the opinion of the participating investigator may prevent participation or otherwise render patient ineligible for the study.
Comparison of Intermittent Fasting and Caloric Deficit for Weight Loss in Women With Polycystic Ovarian Syndrome

Time restricted feeding (TRF) has been emerging as a potential weight loss strategy that avoids major dietary changes but achieves strong effects. It also improves insulin sensitivity through increased human growth hormone. This effect helps to improve the root cause of weight gain and has additional benefits for women with PCOS.


Eligibility Criteria:
Inclusion Criteria:

* PCOS as described by Rotterdam's criteria

Exclusion Criteria:

* endocrine disorders
* diabetic
* hypertensive
* Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
* The body weight fluctuated more than 5% in recent 3 months.
* Liver and kidney dysfunction: renal impairment, creatinine clearance rate \< 30 mL/min/1.73 m2, transaminase increased, more than three times higher than the normal limit;
* History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
* History of thyroid diseases;
* pregnant
* Currently participating in weight loss programs or weight change in the past 3 months (\> 5% current body weight)
* Patients who cannot be followed for 16 months (due to a health situation or migration)
* Patients who are unwilling or unable to give informed consent
Deep Friction Massage in Children With Spastic Cerebral Palsy

The aim of this clinical trial is to determine whether deep friction massage and stretching reduce muscle contraction in the calf muscle. The primary questions it seeks to answer are:

* Does deep friction massage or stretching reduce muscle contraction?
* Does deep friction massage or stretching improve walking?
* Does deep friction massage or stretching increase ankle joint range of motion?

Participants:

Participants will undergo either deep friction massage or stretching exercises for 10 minutes, three days a week, over a period of six weeks.


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of spastic diplegic or hemiparetic CP
* aged between 3 and 18 years
* classified as level I, II, or III according to the Gross Motor Function Classification System (GMFCS)
* possessing sufficient cognitive function to cooperate.

Exclusion Criteria:

* Botulinum toxin (BoNT) injections to the lower extremity muscles within the last six months
* undergoing any surgery such as muscle lengthening or joint contracture within the last six months
* non-participation in two consecutive exercise sessions
* experiencing illnesses such as infections or musculoskeletal injuries during the study period.
Defibrillation Testing During Implantable Cardioverter Defibrillator (ICD) Replacement

This study will evaluate safety and clinical outcomes of a systematic defibrillation threshold testing in patient with indication for defibrillator replacement.

Implantable cardioverter defibrillators (ICD) are strongly recommended in patients with left ventricular systolic function ≤35% or selected patients with channelopathies and cardiomyopathies.

Defibrillation threshold testing (DFT) defines the minimal energy required to successfully terminate a ventricular arrhythmia by an ICD. It remains the gold standard to evaluate the electrical integrity of the device. However inherent complications of this procedure have been registered, such as refractory ventricular fibrillation, and the need for this practice during implant and/or replacement of ICD has recently been questioned.

If several studies have led to abandonment of the DFT during initial ICD implant, its interest during replacement is still controversial. Indeed, the leads essential for the device electrical integrity are older, more fragile, and the ICD replacement may damage it.

Device replacement is indicated when battery reaches the point of Elective Replacement Interval (ERI).

Patients over 18 years old with indication for replacement of defibrillator will be included. Patient's informations (comorbidities, medical history and events during hospitalization or follow-up) and device characteristics will be collected. Procedure will be realized under local or general anesthesia and prophylactic antibiotic will be administrated. Leads will be tested before and after the implantation of the new device. After connexion of the new implanted device to the leads a DFT will be performed. Protocol of DFT will be decided by the physician who will chose between induction of ventricular fibrillation or R-wave synchronized shock. Patients will be followed for 6 and 12 months from the date of defibrillator replacement.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an ICD (VR or DR) or CRT-D undergoing generator replacement.
* Consent for participation
* Affiliation to the French social security system

Exclusion Criteria:

* Atrial Fibrillation without effective anti-coagulation treatments.
* Severe Aortic valve stenosis
* Stroke occurred in the previous month
* Hemodynamic instability contraindicating the high energy shock
* Contraindication for anesthesia
* Pregnant or breastfeeding women
* Communication difficulties or neuropsychiatric disorder
* Patients under protection of the adults (guardianship, curators or safeguard of justice)