cyrilzakka/clinical-trials huggingface dataset:
A Phase I Study of AK159 in Healthy Postmenopausal Women

The objective of this study is to investigate the pharmacokinetics, safety, and tolerability of AK159 administered to healthy postmenopausal women.

This study consists of two parts: Part 1 and Part 2. The Part 1 is a single-center, randomized, 2-way crossover study that investigates the pharmacokinetics, safety, and tolerability of teriparatide after a single dose of AK159 (5 levels) and estimates the relative bioavailability of AK159 with subcutaneous teriparatide acetate in healthy post-menopausal women.

The Part 2 is a multiple-center, randomized, double-blind, positive- and placebo-controlled, parallel study that compares the pharmacokinetics, bone makers, safety, and tolerability of teriparatide after a weekly doses of AK159 (4 levels) for 6 weeks with placebo and a weekly doses of subcutaneous teriparatide acetate in healthy post-menopausal women.

Eligibility Criteria:
Inclusion Criteria:

* Healthy postmenopausal ethnic Japanese women
* At least 45 years of age at the time consent is obtained
* Give voluntary consent in writing with a sufficient understanding of the study.

Exclusion Criteria:

* Clinical abnormality identified in the laboratory tests
* Weight \< 40.0 kg
* Body mass index \< 17.5 or \>=30.5
* History of disease of the kidneys, liver, heart, brain, or other organ that makes them ineligible as subjects
* Previously received radiation treatment potentially affecting bone
* Clinical abnormality identified in the 12-lead ECGs performed at the study center during the screening period
* Systolic blood pressure \< 90 mmHg
* Serum calcium level exceeding 10.4 mg/dL
* History of contact dermatitis or skin disease potentially compromising study evaluation
* Used drugs which impact bone metabolism in the 8-week period preceding investigational product administration
* Used a bisphosphonate
* Used a teriparatide product
Effectiveness and Implementation of mPATH-CRC

Study Investigators are conducting this study to learn how to best implement a new iPad program in clinical practice.

The study team has developed mPATH-CRC (mobile PAtient Technology for Health-Colorectal Cancer), a patient-friendly iPad program used by individuals immediately before a routine primary care visit. mPATH-CheckIn is a module that is used in conjunction with mPATH-CRC that consists of questions asked of all adult patients at check-in. mPATH-CRC is a module specific for patients due for CRC screening.

To fully realize mPATH-CRC's potential to decrease CRC mortality, the program now must be implemented in primary care practices in a way that encourages routine and sustained use. However, while hundreds of mobile health (mHealth) tools have been developed in recent years, the optimal strategies for implementing and maintaining mHealth interventions in clinical practice are unknown. This study will compare the results of a "high touch" strategy to a "low touch" strategy using a Type III hybrid design and incorporating mixed methods to evaluate implementation, maintenance, and effectiveness of mPATH-CRC in a diverse sample of community-based practices.

The study will be conducted in three phases: 1) in a cluster-randomized controlled trial of 22 primary care clinics, the study team will compare the implementation outcomes of a "high touch" evidence-based mHealth implementation strategy with a "low touch" implementation strategy; 2) in a nested pragmatic study, the study team will estimate the effect of mPATH-CRC on completion of CRC screening within 16 weeks of a clinic visit; and 3) by surveying and interviewing clinic staff and providers after implementation is complete, the study team will determine the factors that facilitate or impede the maintenance of mHealth interventions.

Eligibility Criteria:
This study will include three distinct populations of participants: 1) healthcare providers and staff at primary care practices, 2) patients aged 18 and older seen in the participating study sites, and 3) patients aged 50-74 seen in the participating study sites who are eligible for CRC screening

Patient Inclusion Criteria:

Due for routine CRC screening, defined as:

* No colonoscopy within the prior 10 years
* No flexible sigmoidoscopy within the prior 5 years
* No CT colonography within the prior 5 years
* No fecal DNA testing within the prior 3 years
* No fecal blood testing (guaiac-based test with home kit or fecal immunochemical test) within the prior 12 months

Patient Exclusion Criteria:

* Personal history of CRC
* First degree relative with CRC
* Personal history of colorectal polyps
Zebutinib Combined With Immunochemotherapy in the Treat of Newly Treated CLL Patients Without 17p-/TP53 Mutation

To investigate limited course of treatment of Zebutinib combined with immunochemotherapy for patients with newly treated chronic lymphocytic leukemia without 17p-/TP53 mutation


Eligibility Criteria:
Inclusion Criteria:

* CLL patients with indications for treatment according to iwCLL;
* CT/MRI shows measurable lesions;
* ECOG score is 0-2;
* No pregnancy plans during treatment

Exclusion Criteria:

* Richter transformation;
* 17p-/TP53 amplification ≥20% (FISH);
* Received steroids within 7 days before starting treatment;
* Have previously received treatments for chronic lymphocytic leukemia;
* Vaccine live attenuated vaccine within 4 weeks of randomization;
* Any life-threatening disease;
* Central nervous system leukemia;
* Apoplexy, history of intracranial hemorrhage;
* HIV or HCV or HBVpositive
Progesterone Supplementation in Threatened Abortion

To decide whether progesterone supplementation in threatened abortion is a sound practice.

This study was conducted at Obstetrics and Gynecology Department, Tanta University in the period from January 2018 to December 2018. Patients: Eligible patients (n=190) were randomly allocated into 2 groups; study group who will receive progesterone supplementation (Prog.group) and control group who will receive no treatment (place.group).

Eligibility Criteria:
Inclusion Criteria:

* threatened abortion diagnosed by history and ultrasound examination
* singleton
* viable fetus
* gestational age \< 20 weeks
* closed normal length cervix.

Exclusion Criteria:

* short cervix \<2 cm Multiple pregnancy
* dead fetus
* open cervix ≥ 2cm
* history of cervical surgery
* refusal to participate.
The PRECIOUS Study: Predicting Crohn's & ColitIs Outcomes in the United States

A multi-center observational study based at referral centers and community hospitals within the US. Patients' blood will be collected at enrollment for testing with PredictSURE IBD™, which will occur at a later date. Patients will be prospectively followed up for 12 months with clinicians treating according to local standard of care, with a step-up or accelerated step-up regimen. Clinicians and patients will be blinded to the biomarker results.

This is a multi-center, observational study of newly diagnosed IBD (CD or UC) patients. The Study aims to assess whether a prognostic biomarker can stratify IBD patients in the US.

Eligibility Criteria:
Inclusion Criteria:

* Active UC or CD with typical symptoms in conjunction with at least one objective measure of disease activity: elevated CRP, calprotectin, endoscopic evidence.
* Not currently receiving systemic therapy\* with steroids, immunomodulators or biologics, and at least 7 days since the last steroid dose.
* Due to be managed using a "step-up" or "accelerated step-up" approach (so will not receive biologics as first line therapy).
* Aged 16-80 years old.

Note, the ideal patients for this study are newly diagnosed patients who are treatment-naïve.

Exclusion Criteria:

* The presence of any of the following will preclude patient inclusion:
* Patients with fistulating peri-anal Crohn's disease or active perianal sepsis.
* Obstructive symptoms and evidence of a fixed stricture on radiology or colonoscopy.
* Patients who are scheduled to start on "top-down" therapy or receive biologics as a first line therapy
Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients

The overall objective of the study is to determine which treatments (e.g. immune modulator drugs) have the most favorable benefit-risk in adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation.

The specific aims of this Covid19 cohort are to collect observational data at regular intervals on an ongoing basis in order to embed a series of randomized controlled trials evaluating a various set of interventions for patients with COVID-19 pneumonia. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design.


Eligibility Criteria:
Inclusion Criteria:

* Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen \< 72 hours and/or CT Scan prior to randomization (Following typical radiological findings (ground glass abnormalities, and absence of lymphadenopathy, pleural effusion, pulmonary nodules, lung cavitation)
* Hospitalized patients
* Illness of any duration and severity (mild, moderate, severe, critical, see annexe 1), with symptoms (fever, cough, respiratory difficulties, shortness of breath), and at least one of the following:
* Radiographic infiltrates by imaging (CT scan)
* Clinical assessment (evidence of rales/crackles on exam or respiratory rate \>25/min) AND SpO2≤94% on room air
* SpO2≤97 % with O2 \> 5L/min or Respiratory rate\>=30/min
* Requiring mechanical ventilation
* With any comorbidities (TBD such as acute kidney injury, cardiovascular condition, pulmonary disease, obesity, high blood pressure, diabetes, chronic kidney diseases, haematological diseases, sickle cell diseases, autoimmune and auto-inflammatory, pregnant women, HIV infected, etc)
* Male or female adult ≥ 18 years of age at time of enrolment
* Patients must be able and willing to comply with study visits and procedures.
* Patient agrees to the collection of oropharyngeal and nasal swabs and venous blood per protocol Written informed consent provided by the patient or alternatively by next-of-kin prior to any protocol-specific procedures.

Exclusion Criteria:

* Patients with any condition that the physician judges could be detrimental to the patient participating in this study; including any clinically important deviations from normal clinical laboratory values or concurrent medical conditions (active infection diseases such as severe bacterial infections, aspergillosis, tuberculosis, depending on the tested medication).
* Absence of Health Insurance
* Subject protected by law under guardianship or curatorship
CemiplimAb Survivorship Epidemiology

The objectives of the study are:

* To describe the effectiveness of cemiplimab 350 mg administered every 3 weeks (Q3W) for treatment of patients with advanced (defined as locally advanced or metastatic \[nodal or distant\]) cutaneous squamous cell carcinoma (CSCC) and patients with advanced (defined as locally advanced or metastatic \[nodal or distant\]) basal cell carcinoma (BCC) in real-world clinical settings
* To evaluate the safety of cemiplimab based on incidence of treatment related immune-related adverse events (irAEs), infusion related reactions (IRRs), and treatment related serious adverse reactions (TSARs) in patients with advanced CSCC and patients with advanced BCC receiving cemiplimab treatment in real world clinical settings
* To describe patient experience, including patient reported quality of life (QOL) and functional status, and clinician reported performance status in a real-world setting for patients with advanced CSCC and patients with advanced BCC
* To describe baseline characteristics that could potentially be associated with health-related outcomes for patients with advanced CSCC and patients with advanced BCC undergoing treatment with cemiplimab
* To describe patients who receive cemiplimab as treatment for CSCC or BCC in a real-world setting
* To describe real-world use patterns of cemiplimab for CSCC and BCC
* To investigate the long-term effects and effectiveness of cemiplimab in patients with advanced CSCC or advanced BCC
* To describe the effectiveness of cemiplimab in immunosuppressed and immunocompetent patients with advanced CSCC or advanced BCC, regardless of etiology, per available data
* To describe the effectiveness of cemiplimab after prior exposure to radiation therapy for CSCC per available data
* To describe the effectiveness of cemiplimab as a first-line (1L) or later systemic treatment in patients with advanced CSCC, regardless of etiology, per available data
* To describe the effectiveness of cemiplimab in patients with advanced BCC based on treatment patterns (reason for discontinuation, treatment exposure, etc) of prior Hedgehog inhibitor (HHI) usage


Eligibility Criteria:
Key Inclusion Criteria:

* Eligible for treatment with and prescribed cemiplimab for advanced CSCC or advanced BCC in accordance with approved prescribing information as described in the protocol

Key Exclusion Criteria:

* Receiving cemiplimab for an indication other than advanced CSCC or advanced BCC
* Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study
* Patients concurrently participating in any study including administration of any investigational drug (including cemiplimab) or procedure (including survival follow up)

Note: Other protocol defined Inclusion/Exclusion Criteria apply
Atypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder

The purpose of this study is to reassure the clinical study data on atypical antipsychotics effect on quality of life in Korean Bipolar patients.


Eligibility Criteria:
Inclusion Criteria:

* The patient and the patient's legal representative (if any) must understand the nature of the study and must have given written consent.
* Meet DSM-IV-TR criteria for bipolar disorder (bipolar I disorder, bipolar II disorder) at the time of baseline.

Exclusion Criteria:

* Serious or unstable, medical illness. Subjects with chronic illness may be included but must be stable and otherwise physically healthy on the basis of a physical examination, medical history.
* Known intolerance for or lack of response to atypical antipsychotics , as judged by the investigator.
Circulating Tumor Mitochondrial DNA (ct-mtDNA) As a Biomarker for Biliary Tract Cancer Recurrence Surveillance

This is a prospective, observational, single-center study. The purpose of this study is to evaluate the efficacy of circulating tumor mitochondrial DNA (ct-mtDNA) in plasma as a biomarker for minimal residual disease (MRD) assessment and recurrence monitoring in patients with biliary tract cancer.

Biliary tract cancer (BTC) encompasses a range of malignancies including intrahepatic, perihilar, and distal cholangiocarcinomas, as well as gallbladder cancer. While relatively rare in many high-income countries, it poses a significant health challenge in certain regions, with a rising incidence of intrahepatic cholangiocarcinoma globally. Despite recent therapeutic advancements, BTC remains an aggressive disease with a grim prognosis, characterized by a median overall survival of less than one year and a 5-year survival rate below 5%. The primary objective of this study is to evaluate the effectiveness of plasma tumor mitochondrial mutations as a biomarker for MRD assessment and recurrence monitoring in patients with BTC. The study hypothesizes that the presence and dynamics of tumor mitochondrial mutations in plasma are associated with the risk of recurrence and overall survival in BTC patients. This is a prospective, observational, single-center study conducted by the Chinese Cooperative Group of Liver Cancer (CCGLC) under the auspices of the Chinese Chapter of International Hepato-Pancreato Biliary Association. The study will involve the collection and analysis of plasma samples from patients with BTC to detect ct-mtDNA mutations before and after treatment. The primary clinical endpoint is the impact of MRD status on progression-free survival (PFS). Secondary endpoints include the influence of treatment on MRD markers, the correlation between post-treatment residual tumor molecular burden and PFS, and the ability of MRD detection to predict recurrence earlier than traditional tumor markers or imaging methods. This study seeks to contribute to the field of BTC management by providing a more precise and personalized approach to MRD assessment and recurrence monitoring. The findings have the potential to improve long-term treatment outcomes and quality of life for patients with BTC.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed biliary tract cancer (BTC);
* Expected survival time of 12 weeks or more;
* Signed informed consent form and ability to comply with the study visits and related procedures as stipulated in the protocol.

Exclusion Criteria:

* Patients with other active tumors or severe complications;
* Insufficient tumor tissue for MRD detection.
Fit Moms in Partners, Children, and Other Members

The purpose of this ancillary study is to determine whether a behavioral weight loss intervention for postpartum mothers (5R01DK087889-02, PI Phelan; Co-I Tate) has a positive "ripple" effect on weight and health of partners and children/offspring.

Lifestyle interventions targeting overweight/obese individuals can produce positive "ripple" effects on untreated overweight partners in the home. Interestingly, ripple effects on partners' weight appear most pronounced when the interventions target women. Women, and mothers in particular, remain the primary "nutritional gatekeepers" of the home. Despite widespread recognition that motherhood is a powerful motivator for behavior changes, no study to date has examined the "ripple" effects of a postpartum Internet-based lifestyle intervention that target mothers' weight. The purpose of this ancillary study is to determine whether a behavioral weight loss intervention for postpartum mothers (5R01DK087889-02, PI Phelan; Co-I Tate) has a positive "ripple" effect on weight and health of partners and children/offspring. The proposed study is ancillary to an ongoing clinic-randomized trial examining the efficacy of an innovative multicomponent (online, face-to-face, mobile phone) postpartum behavioral weight loss intervention in 408 low-income women in the Women, Infants, and Children program. The proposed study will determine whether partners of women randomized to the postpartum BWL intervention have greater weight losses and greater improvements in health outcomes than partners of women in standard WIC. Similar to the parent grant, assessments will occur at study entry, 6 months, and 12 months. This project is highly innovative, as it capitalizes on existing funded research and is the first study to examine ripple effects of multicomponent Internet-based intervention in low-income individuals. The project also has high impact, as the postpartum period is a powerful motivator for behavior and environmental changes in the home; and, if positive ripple effects occur, the field of obesity treatment and prevention could move beyond focus on individual level to the often, unrecognized interpersonal effects of lifestyle interventions. PUBLIC HEALTH RELEVANCE: This research project will examine whether a postpartum weight-loss intervention has a positive "ripple" effects on weight and health of untreated partners and offspring/children in the home.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman who self-identifies as sharing an intimate relationship and cohabitating in the home with the postpartum woman (enrolled in the parent grant) for the previous 3 months or recently been married and living in the home
* ≥18 years
* willing to provide informed consent

Exclusion Criteria:

* None
Effect of Cognitive-behavior Therapy on Fear Responses to Body Symptoms in Patients With Panic Disorder

The present study aims to investigate a potential mechanism of successful CBT for panic disorder, i.e., the reduction of excessive anxious apprehension and fear responses to panic-related body symptoms in the context of CBT treatment. In the present non-randomized interventional study, effects of cognitive behavior therapy on reported symptoms and fear responses to panic-related body symptoms are investigated. It is expected that symptom improvement during CBT is associated with a decrease in the activation of the brain's fear network to panic-related body symptoms.

Changes in fear responses to body symptoms in the course of CBT are investigated in patients with PD by applying a highly standardized hyperventilation task (provoking panic-related body symptoms) prior to and after a manualized CBT or a waiting period. Activation of the brain's fear network (defensive activation) is indexed by the potentiation of the startle eyeblink response.

Eligibility Criteria:
Inclusion Criteria:

* current primary diagnosis of panic disorder (with or without agoraphobia) as defined by the criteria of the diagnostic and statistical manual, fourth revision/text revision (DSM-IV-TR) (determined using the Composite International Diagnostic Interview and verified by a certified psychotherapist)
* age 18 - 65 years

Exclusion Criteria:

* current suicidal intent
* any psychotic or bipolar disorder
* borderline personality disorder
* a medical condition that could explain patients' symptoms
* physical contradictions regarding application of exposure-based CBT (e.g., neurological disease)
* Patients has to be on a stable psychopharmacological medication schedule prior to study entry for at least 12 weeks
* Intake of benzodiazepines
Targeting Cervical Epidural Spinal Cord Stimulation for Functional Recovery

The proposed study seeks to understand how the cervical spinal cord should be stimulated after injury through short-term physiology experiments that will inform a preclinical efficacy trial. The purpose of this study is to determine which cervical levels epidural electrical stimulation (EES) should target to recruit arm and hand muscles effectively and selectively in spinal cord injury (SCI).

For people with cervical spinal cord injury (SCI), regaining hand and arm function is their highest priority. Epidural stimulation enables recovery of walking and autonomic function in people with chronic SCI, but how the spinal cord should be stimulated to restore arm and hand function is not known. This project seeks to advance our understanding of how best to apply epidural electrical stimulation (EES) after cervical SCI using complementary experiments in humans and rats. This improved understanding will be used to conduct a preclinical study of the efficacy of different sites of cervical spinal cord stimulation.

Eligibility Criteria:
Inclusion Criteria:

•Clinical indication for cervical spine surgery.

Exclusion criteria:

•Stimulation devices in the neck or chest (e.g., vagal nerve stimulation, cardiac patients with pacemakers)