cyrilzakka/clinical-trials huggingface dataset:
Dinoprostone Vaginal Insert Versus Double Balloon Catheter for Preinduction Cervical Ripening

Effıcacy of dinoprostone vaginal insert versus double- balloon catheter among women in the induction of labor

The study will be conducted in the Department of Obstetrics and Gynecology at Kanuni Sultan Süleyman Education and Research Hospital ,İstanbul, Turkey, with approval of the local institutional review board. All the participants will give informed consent before beginning of the study. Women who agree to participate will be first stratified into nulliparous and multiparous groups. Randomisation will be carried out by using sealed opaque envelopes with a piece of paper inside marked 'PGE2 vaginal insert' or 'Double-balloon catheter'. Envelopes will be prepared in blocks of 20 (10 PGE2 vaginal insert and 10 double-balloon catheters) for each stratified group. Envelopes will be then shuffled and placed in boxes marked 'nulliparous' and 'multiparous'. The investigator is not blinded to the allocation procedure. The allocated envelope will be opened by the clinician performing the initial vaginal examination just prior to that examination.

In the group assigned to mechanical ripening , a double- balloon catheter (Cook Cervical Ripener Balloon,Cook OB/GYN,Spencer IN) is inserted into cervical canal under direct visualisation during a sterile speculum examination. Once both balloon enter the cervical canal, the first balloon is filled with 40 ml saline above the level of the internal os. The second (vaginal) balloon is the inflated with 20 ml of saline.Then both of them are filled with 60 ml of saline. The external end of the device is taped without traction to the medial aspect of the woman's thigh. After completion of the device placement, patients undergo continous fetal heart rate monitoring for 30 min then are allowed to ambulate.The double ballon is placed for 12 hours .

In the group randomly assigned to vaginal insert is placed high in the vaginal fornix, the patients are monitored at least 1 hour for fetal heart rate and uterine activity and they are allowed to ambulate.

After 12 hours oxytocin isadministered using a standard dose regimen to all patients.

Primary and secondary outcomes are measured.

Eligibility Criteria:
Inclusion Criteria:

* Eligible women have obstetric or medical indications for labor induction with intact membranes
* singleton pregnancies,
* vertex presentations
* low Bishop scores ≤6
* gestational age ≥34 w
* reassuring fetal heart tracing on admission.

Exclusion Criteria:

* Exclusion criteria are placenta previa
* unexplained vaginal bleeding
* nonvertex presentation
* intrauterine fetal death
* prior cesarean delivery
* any scarred uterus
* any other contraindications for vaginal delivery.
Relative Bioavailability of Intravenous GTX-104 Compared to Oral Nimodipine Capsules in Healthy Subjects

This is a Phase 1, single center, randomized, two-period crossover study in healthy male and female subjects designed to evaluate the relative bioavailability (BA) and safety at steady state of two formulations of nimodipine: GTX 104 (nimodipine for intravenous \[IV\] infusion; test formulation) and nimodipine oral capsules, RS (reference formulation).


Eligibility Criteria:
Inclusion Criteria:

* Subject had a body mass index between 18 and 32 kg/m2, inclusive.
* Subject was in good general physical health as determined by absence of clinically significant (CS) medical or psychiatric history, physical examination findings, vital signs, clinical laboratory evaluations, and 12-lead ECG measurements.

Exclusion Criteria:

* History or presence of clinically significant medical illness, including, but not limited to, cardiovascular, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, psychiatric, renal, hepatic, chronic respiratory, or gastrointestinal disease, that could have interfered with the interpretation of the study.
* Had current or recent (within 6 months) history of gastrointestinal disease or any surgical or medical condition (eg, Crohn's or liver disease) that could potentially alter the absorption, metabolism, or excretion of the study drug.
Pharmacokinetic Study of Buparlisib in Subjects With Renal Impairment.

To characterize the pharmacokinetics and safety of buparlisib following a single 50 mg oral dose in subjects with moderate and severe renal impairment.


Eligibility Criteria:
Inclusion Criteria:

* Other than renal impairment, subjects should be in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, (except for additional inclusion criteria for renal impaired patients).
* Subjects must have a BMI between 18 kg/m2 and 34 kg/m2 and weight at least 50 kg and no more than 120 kg.

  * Additional criteria for renal impaired subjects: - Subjects must have stable renal disease without evidence of renal progressive disease defined as moderate renal impairment (eGFR 30-59 mL/min/1.73m2) or severe renal impairment (eGFR 15-29 mL/min/1.73m2).
  * Additional criteria for matched healthy control subjects: - Matched to at least one renal impaired subject by gender, race, age (± 10 years), and weight (± 20%).
* An estimated GFR as determined by MDRD equation within normal range as determined by eGFR ≥ 90 mL/min/1.73m2

Exclusion Criteria:

* Significant illness, including infections, or hospitalization within the 2 weeks prior to dosing, except for the renal impaired subjects who due to their renal disease may be affected by significant medical problems which require frequent hospitalizations.
* Any surgical or medical condition that may significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study
* Subject has a medical history of cardiac disease and/or clinically significant ECG abnormalities within 6 months prior to screening.
* Subject has an active or a history within 6 months prior to screening of clinically significant hematologic, endocrinologic, pulmonary, cardiovascular, hepatic, or allergic disease, medically documented (other than clinical conditions associated with renal impairment for the renal impaired subjects only).
* - Additional exclusion criteria for renal impaired subjects: - Severe albuminuria \> 300 mg/day.
* Subjects undergoing any method of dialysis.
* Subjects with renal impairment due to hepatic disease (hepatorenal syndrome).
* Subjects with clinically significant abnormal findings, not consistent with clinical disease, upon physical examination, ECG or laboratory evaluation.
* Use of any prescription or non-prescription medication that has the potential to interact with buparlisib within two weeks prior to dosing or during the study.
* - Additional criteria for matched healthy control subjects: - Use of any prescription or non-prescription medication or vitamins during 14 days prior to dosing.

Other protocol-defined inclusion/exclusion criteria may apply.
Hypothermia for Encephalopathy in Low Income Countries-Feasibilty

Whole body cooling improves survival with normal neurological outcome after neonatal encephalopathy in high-income countries. However, cooling equipments used in the high-income countries are expensive and unsuitable for wider use in low and middle-income countries (LMIC). We had previously conducted a randomised controlled trial of whole body cooling using phase changing material in south India. Although cooling was provided, there were wide temperature fluctuations.

Aim: To examine efficacy of the low technology cooling equipment (Tecotherm-HELIX) in administering effective and stable whole body cooling in encephalopathic infants.

Methods: After informed parental consent (and ethical approvals), we will administer 72 hours of whole body cooling (rectal temperature 33 to 34C) to a total 50 encephalopathic infants (aged \<6 hours) admitted to the neonatal units at Calicut Medical College and Madras Medical College, over a six month period. To induce cooling, the infants will be kept on the cooling mattress. Temperature will be continuously measured for 80 hours using a rectal probe connected to a digital data logger.

The primary outcome will be the effective cooling time i.e. percentage of time (95% CI) for which the temperature remains between 33 to 340C during the intended cooling period.


Eligibility Criteria:
Inclusion Criteria:

1. Age \< 6 hours, Birth-weight \>1.8, Gestation \>36 weeks
2. Need for resuscitation at birth and 5 minute Apgar score \<6 (in born babies) or Lack of cry by 5 minutes of age (for out-born babies)
3. Evidence of encephalopathy on clinical examination

Exclusion Criteria:

* Infants in moribound condition, where death is imminent
* Absent heart rate at 10 minute of age
* Major life threatening congenital malformation
* Lack of cooling equipment
* Lack of parental or physician consent
Consolidation Therapy with Cladribine in Relapsing Multiple Sclerosis Patients

To investigate the impact on IgG and IgM concentration, infection risk and effectiveness of switching from anti-CD20 to cladribine compared to continued anti-CD20 treatment over 2 years in relapsing MS patients.


Eligibility Criteria:
Inclusion Criteria:

* Relapsing MS according to Lublin \[23\]

EDSS ≤7.0 - Male and female patients with age \>18 years - Treatment with ocrelizumab or rituximab for ≥12 months and/or having received ≥ 1.2 / 1.0 gr, respectively - For CLAD_GROUP: Planning to switch to cladribine because of concerns about increased risk of infections related to long term anti-CD20 therapies, defined as at least 3 infectious events/year or a serious infection under anti-CD20 and/or a documented decrease of ≥ 5% IgG and/or a level of IgG below 7 gr/L compared to pre- anti-CD20 therapy (will be considered as CLAD_GROUP)

- For OCR_GROUP and RTX_GROUP: continuing anti-CD20 therapies (considered as OCR_GROUP and RTX_GROUP with ocrelizumab with rituximab treatment, respectively)

- Anti-CD20 and Cladribine are prescribed according to Swiss and European SmPC.

Exclusion Criteria:

* Non-relapsing MS

Pregnancy or lactation - Contraindication to receive cladribine or to continue anti-CD20 therapies according to local label - Inability to complete an MRI - Known presence of other neurological disorders which may mimic MS including but not limited to: neuromyelitis optica, Lyme disease, untreated vitamin B12 deficiency, neurosarcoidosis and cerebrovascular disorders - Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study

- Significant or uncontrolled somatic disease or any other significant disease that may preclude patient from participating in the study

- Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds Infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks prior to baseline visit or oral antibiotics within 2 weeks prior to baseline visit

- History of progressive multifocal leukoencephalopathy (PML)

- Active malignancy, including solid tumors and hematological malignancies, except basal cell carcinoma, in situ squamous cell carcinoma of the skin, and in situ carcinoma of the cervix of the uterus that have been previously completely excised with documented, clear margins

- History of alcohol or drug abuse within 24 weeks prior to baseline

- Lymphocyte count \< 1000 /μL

- AST/SGOT or ALT/SGPT ≥ 3.0 Upper Limit of Normal (ULN)
Healthcare Worker Exposure Response and Outcomes (HERO) Registry Study, COVID-19

The HERO Registry provides a resource for collecting information on Healthcare Workers (HCWs) currently working in the United States, and their families and communities. The overall goal of the Registry is to develop the infrastructure necessary to create and engage a community of people who may be eligible for participation in future research studies, including those of COVID-19 prophylaxis and treatment.

The HERO Registry provides a resource for collecting information on Healthcare Workers (HCWs) currently working in the United States, and their family members and communities. The overall goal of the Registry is to create and engage a community of HCWs and their families and communities who may be eligible for participation in future research studies, including those of COVID-19 prophylaxis and treatment. The HERO registry will create a repository of adults interested in COVID-19 research that can be eligible for future research studies. The main objectives of the study are 1) create a virtual community of adult HCWs in the United States, and their families and communities, 2) Identify adults interested in engaging in upcoming research studies, including those related to COVID-19, and 3) Create a dataset of health related measurements, risk factors, and outcomes for future analysis. The population of interest is adult healthcare workers in the United States, and their families and communities.

All analysis of the HERO Registry will be exploratory in nature. Analysis may include descriptive statistics of the cohort, statistical associations between variables of interest, and predictive modeling for health outcomes and behaviors. Analyses may be conducted on all participants in the HERO Registry or may be conducted on subpopulations defined based on clinical, demographic or other factors.

There is no direct benefit to the participants for their participation in this study, but the information obtained will be used in scientific research and may be helpful to the participant or others in the future. Participants may experience indirect benefits such as learning about their own health, access to health data, and opportunities to participate in future research.

Eligibility Criteria:
Inclusion Criteria:

* A member of one of the following three groups:

  * Individual currently works in a setting where individuals receive healthcare ("healthcare worker") (including emergency medical services), OR
  * A family member of a healthcare worker, OR
  * A member of a healthcare worker's community
* Age ≥ 18
* Able to speak and read English or Spanish

Exclusion Criteria:

\* There are no specific exclusion criteria for this study. Participants must meet inclusion criteria.
Evaluation of Post Operative Pain After Sonic Activation and Different Irrigation Needles During Root Canal Treatment

The study compares the post operative pain after root canal therapy, after using different irrigation protocols. The subjects are divided into 3 groups and different irrigation protocol is used in each group. One group undergoes final irrigation after root canal therapy with a sonic activation device, and in the other two groups, side-vented and open-ended needles are used. Post operative pain is then compared at 8, 24, and 48 hour intervals.

Root canal therapy is a procedure in which inflamed pulp tissue and microorganisms are removed from root canals and pulp chamber, in order to eradicate infection and symptoms. Irrigation is a crucial step of an endodontic therapy and different methods and protocols are used to enhance the efficacy of irrigation. Sonic activation of root canal irrigation agent is one of the effective methods that enhance the outcomes and success rate of endo therapies. It removes the smear layer, bacterial biofilms and debris by acoustic streaming and agitating the irrigant inside root canals. Similarly, irrigation needles also play an important role in endodontic therapy, particularly by improving the delivery of irrigation agent to the apex of a root canal. conventionally, open ended needles have been used for irrigant delivery inside root canal but is not deemed very efficacious as they cannot penetrate deep into canals and cause extrusion of debris beyond the apex. This problem is solved by using side vented needles of smaller gauge (30 G) that leads to better irrigation and prevent extrusion of chemicals and debris outside the root apex.

In this study, the efficacy of all three different irrigation protocols will be compared and assessed based on post-operative pain, measured by Visual Analog Scale (VAS).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with unremarkable/ noncontributory medical history
2. Healthy persons between the ages of 18 and 60 years
3. Maxillary and mandibular molar teeth diagnosed with symptomatic irreversible pulpitis.
4. Patients not having taken any medication for 12 hours before treatment
5. No allergies to the drugs or dental material being used in the treatment

Exclusion Criteria:

1. Patients who had taken analgesics on anti-inflammatory drugs within the last 12 hours
2. Pregnant women and patients with immunocompromised health state
3. Patients having severe malocclusion associated with traumatic occlusion
4. Teeth with calcified canals
5. Teeth with periapical radiolucency
6. Teeth with root resorption
7. Teeth previously undergone root canal treatment
Anti PD-1 Antibody With Radiation Therapy in Patients With HER2-negative Metastatic Breast Cancer

The aim of this study is to evaluate the safety and efficacy of anti PD-1 antibody with radiation therapy in patients with HER2-negative metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

- Cohort A

1. Documentation of ER-positive and/or PR-positive tumor (\>=1% positive stained cells) .
2. Patients must satisfy the following criteria for prior therapy:

   - Progressed during treatment or within 12 months of completion of adjuvant hormone therapy.

   or Progressed while prior hormone therapy for advanced/metastatic breast cancer. Two previous line of hormone therapy for advanced/metastatic disease is allowed.
3. Patients who have hormone therapy that can be expected for advanced /metastatic disease.

   Cohort B
4. Patients who have come to be non-responsive more than two line of chemotherapy
5. Prior chemotherapy with anthracycline and taxane agent

   Cohort A and B
6. Female patients who are histologically or cytologically confirmed to have breast cancer
7. Patients who have distant metastatic lesion as follow

   - More than one bone lesion for radiation therapy
8. Patients with cancer confirmed to be HER2-negative.（
9. Patients with a measurable lesion based on RECIST 1.1.
10. Patients aged \>= 20 years at informed consent
11. Patients with ECOG PS of 0 to 1.
12. Patients without any severe disorder in the major organs.
13. Patients expected to survive for ≥ 90 days.
14. Patients of childbearing potential must be using an acceptable method of contraception to avoid pregnancy and must not be breastfeeding for 18 weeks after the last dose of investigational product
15. Patients who have provided written informed consent themselves.

Exclusion Criteria:

-

Exclusion Criteria:

1. Patients who have neuropathy (more than Grade 2)
2. Patients with any active autoimmune disease or a history of known autoimmune disease.
3. Patients who has a history of pneumonitis or interstitial lung disease.
4. Active, untreated central nervous system metastasis.
5. Patients with pericardial effusion, pleural effusion or ascites requiring treatment
6. Patients with uncontrolled diabetes mellitus
7. Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 28 days of the enrollment.
8. Patients who has received radiotherapy within 28 days of study registration, or radiotherapy for thorax within 56 days of the enrollment.
9. Pregnant or breast-feeding women.
10. Prior therapy with Nivolumab, anti CTLA-4 antibody therapies, any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
11. Patients considered ineligible for participation in this study by their attending physicians
Factors Associated With Success of NIPPV in ALS Patients

This is a retrospective cohort study to assess the factor associated with success of non-invasive positive ventilation in ALS patients.

Patients with ALS who were admitted to a tertiary hospital for initially applying non-invasive positive pressure ventilation (NIPPV). The objective of this study was to investigate factors associated with optimal NIPPV initiation and adherence, and to assess the long-term effects of NIPPV adherence in ALS patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilling the El Escorial World Federation criteria for probable, or definite ALS
* Aged ≥ 19 years
* Patients who performed blood gas analysis including venous blood gas and arterial blood gas before NIPPV application.

Exclusion Criteria:

* Patients who had experience in applying the NIPPV or currently using NIPPV
* Patients who applied in outpatient settings
* Patients who did not perform blood gas analysis before NIPPV application
* Patietns who had a history of asthma or COPD,
* Patients who didn't have any record of NIPPV application time
PEERS Plus mHealth Enhanced Peer Support

The goal of this intervention study is to design and learn whether peer support that is delivered through video chats and texting can decrease depression among older adults. Participants will be assigned to a peer support program where they will receive 8 video chats with a peer mentor who provide social support and supportive texts over 8 weeks.

PEERS plus is a psychosocial intervention being developed to reduce depression among older adults. In this intervention peer mentors who are also 50 years of age and older and who have experiential knowledge of depression provide depression care. Older adults with depression will be recruited and assigned to the peer support program. This will consist of 8 weekly peer mentor - older adult video chats that provide emotional support and sharing of self-care skills for depression. Supportive texts will be sent on a weekly basis to older adults by peer mentors. These texts will provide encouragement, affirmations and information about mental health resources. Peer mentors are trained and supervised by a mental health professional during the 8 week period. We will assess at baseline, post study and 3 months after the intervention.

Eligibility Criteria:
Inclusion Criteria:

1. 50 years and older
2. PHQ-9 score \> 5,
3. on the same antidepressant dose for at least 3 months
4. if receiving psychotherapy, frequency is a most once a month
5. able to communicate in English
6. able to give informed consent.

Exclusion Criteria:

1. meet diagnostic criteria for mania or hypomania
2. active suicidal ideation, 3) meet diagnostic criteria for psychotic syndrome
3. meet diagnostic criteria for substance abuse or dependence
4. a score on the Mini mental state exam (MMSE) \< 24.
Expanding Reach of Evidence-based Psychotherapy for Veterans With Co-occurring Anxiety and Substance Use Disorders.

The current study seeks to better understand how to improve access to evidence-based psychotherapy (EBP) for rural Veterans with co-occurring anxiety and substance use disorders (SUD) using a web-based cognitive behavioral therapy tool (VA Coordinated Anxiety Learning and Management, Substance Use Version; VA CALM-S).


Eligibility Criteria:
Inclusion Criteria:

* current anxiety disorder diagnosis
* current SUD

Exclusion Criteria:

* current substance withdrawal such that medically supervised detoxification is necessary (determined by evaluation of substance use history and report of current symptoms),
* acute suicidality
* current delusions/hallucinations.