cyrilzakka/clinical-trials huggingface dataset:
Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy

Marijuana is by far the mostly commonly used illicit drug during pregnancy, and prenatal exposure to marijuana can have lasting negative effects. However, current answers to this problem are failing to reach most women who use marijuana while pregnant. This project will develop and begin testing two technology-based, highly practical interventions that could reduce the number of children who are prenatally exposed to marijuana.

There are at present no evidence-based interventions for marijuana use during pregnancy, despite its being by far the most commonly used illicit drug during pregnancy (particularly among African-American women), and despite growing evidence that it may have a range of long-term cognitive and neurobehavioral consequences. This R34 clinical trial planning grant therefore proposes the development and preliminary validation of two high- reach and mutually compatible technology-based interventions for marijuana use during pregnancy. The first, a theory-based, synchronous, and highly interactive computer-delivered brief intervention, will be based on an emerging knowledge base regarding key elements of efficacious technology-delivered interventions. The second intervention, a series of tailored text messages, will build on the rich literature regarding key tailoring elements. These interventions will be developed and refined with input from pregnant women who report active use of marijuana, as well as from health care providers. They will subsequently be tested-alone and in combination-in a pilot randomized trial involving 80 women actively using marijuana during pregnancy. This Stage I pilot work would set the stage for a confirmatory Stage II trial. It would also produce the first high-reach brief interventions for marijuana use during pregnancy. If effective, these approaches could have a substantial population impact on marijuana use among pregnant women, with potential for lifelong improved outcomes for both mother and child.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 40 years of age
* 20 weeks or less gestation
* intention to carry pregnancy to term
* self-reported marijuana use in month before pregnancy
* own a cell phone and willingness to receive text messages
* gives consent to access medical records for collection of birth outcome data

Exclusion Criteria:

* frank cognitive impairment or psychosis
* not able to communicate in English
* not planning to deliver at a Detroit Medical Center (DMC) hospital
* previous or current participant in a study conducted by Dr. Ondersma
* Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Perinatal Research Branch participant.
Efficacy and Safety of Valsartan/Amlodipine Combination in Hypertensive Patients Not Controlled With Amlodipine Alone

This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication


Eligibility Criteria:
Inclusion Criteria:

* Patients with uncomplicated, essential hypertension

Exclusion Criteria:

* Severe hypertension
* History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
* Liver, kidney, or pancreas disease
* Insulin dependent diabetes
* Allergy to certain medications used to treat high blood pressure

Other protocol-defined exclusion criteria may apply.
Assessment of CSF Shunt Flow With Thermal Measurements A

This study evaluates the performance of a non-invasive thermal measurement device for assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction will be evaluated with the study device.

Patients with an existing implanted ventriculoperitoneal (VP) shunt and who are experiencing shunt malfunction symptoms will be recruited by the clinical investigators at each investigational site in accordance with the inclusion and exclusion criteria. Assessment of shunt flow will be performed non-invasively with the study device; physician and clinical staff will be blinded to the device result. Standard-of-care assessment of shunt function will be performed and surgical intervention will occur based on the judgement of the treating neurosurgeon without the use of study device data. This trial will evaluate the ability of the study device to identify shunt malfunctions.

Eligibility Criteria:
Inclusion Criteria:

* Existing ventriculoperitoneal CSF shunt
* At least one symptom of shunt malfunction as determined by the investigator, including seizure, fever, headache, vision problems, dizziness, disorientation, confusion, vomiting, lethargy, irritability, difficulty waking or staying awake, swelling along shunt tract, enlargement of head, loss of balance, gait disturbance, and loss of sensory or motor function
* Suspicion of shunt obstruction warrants the performance of a test for this condition in the investigator's judgement
* Region of intact skin overlying an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
* Available for follow-up for up to fourteen days
* Signed informed consent by patient or a parent, legal guardian, health care agent, or legally authorized representative.
* Verbal assent by minors four years of age and older who are able to understand the study and communicate their decision

Exclusion Criteria:

* Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction
* Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed
* Presence of an interfering open wound or edema over any portion of the shunt
* Patient-reported history of adverse skin reactions to adhesives
* Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
* Participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject
* Prior enrollment in this study (multiple enrollments of the same patient are disallowed)
* Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
Phase II Study of Tipifarnib in Squamous Head and Neck Cancer With HRAS Mutations

Phase II study to investigate the antitumor activity in terms of objective response rate (ORR) of tipifarnib in subjects with advanced tumors that carry HRAS mutations and for whom there is no standard curative therapy available.

This Phase II study will investigate the antitumor activity in terms of ORR of tipifarnib in subjects with locally advanced, unresectable or metastatic, relapsed and/or refractory tumors that carry HRAS mutations and for whom there is no curative therapy available. Subjects with information available on tumor HRAS status previously generated are eligible. All subjects must consent to provide at least 10 tumor slides from a prior diagnostic biopsy for a retrospective testing of HRAS gene status at a central facility.

Subjects will be enrolled into three nonrandomized cohorts:

* Cohort 1: Malignant thyroid tumors with HRAS mutations.
* Cohort 2: Squamous Cell Carcinoma Head and Neck Cancer with HRAS mutations.
* Cohort 3: Squamous Cell Carcinoma (SCC) with HRAS mutations other than HNSCC.

Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically confirmed diagnosis of thyroid cancer (cohort 1) or Squamous Cell Carcinoma head and neck cancer (cohort 2) or Squamous Cell Carcinoma other than HNSCC (cohort 3) for which there is no curative therapy available.
* tumor that carries a missense HRAS mutation ith a variant allele frequency (VAF) \> 20%.
* Subject consents to provide at least 10 unstained tumor slides for retrospective testing of HRAS gene tumor status
* Subject has measurable disease according to RECIST v1.1 and has relapsed or is refractory to prior therapy.
* At least 2 weeks since the last systemic therapy or radiotherapy regimen prior to enrolment
* ECOG PS 0 or 1
* Acceptable liver function
* Acceptable renal function
* Acceptable hematologic status • Serum albumin ≥ 3.5 g/dL. Subjects with tumors potentially highly sensitive to tipifarnib (HRAS mutant VAF ≥ 35%) may be enrolled despite a serum albumin \< 3.5 g/dL.

Exclusion Criteria:

* Prior treatment with an FTase inhibitor
* History of relevant coronary heart disease or myocardial infarction within last 3 years, NYHA Grade III or greater congestive heart failure, cerebro-vascular attack within the prior year, or serious cardiac arrhythmia requiring medication except atrial fibrillation.
* Known uncontrolled brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 4 weeks prior to Cycle 1 Day 1). Controlled brain metastases that require continuous high dose corticosteroid use within 4 weeks of Day 1.
* Non-tolerable \> Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks first dose
* Major surgery, other than diagnostic surgery, within 4 weeks prior to first dose, without complete recovery.
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Known infection with HIV, or an active infection with hepatitis B or hepatitis C
Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg in Korean Patients With Seasonal Allergic Rhinitis

The objective of the study was to determine the efficacy and tolerability of 20 mg of Bilastine, compared to Desloratadine and placebo for the treatment of Seasonal Allergic Rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* The study disease was diagnosed on the basis of clinical criteria: Nasal symptoms (presence of nasal blockage, sneezing, nasal itching and rhinorrhea) and non-nasal symptoms (ocular itching, lacrimation, itching of ears and/or palate and ocular redness), as well as the skin prick test performed at the time of selection or within the year prior to entering.
* Patients with history of Seasonal Allergic Rhinitis, positive skin prick test and symptoms were included if they were between 12 and 70 years old, gave their informed consent, attended the required visits scheduled and also underwent a complete medical examination..

Exclusion Criteria:

* Patients were excluded if they had a significant nasal abnormality which could interfere with the aim of the study, acute or chronic sinusitis, asthma or any condition, disease or hypersensitivity that could be harmed.
* Patients were not allowed to take forbidden medications or not comply the study requirements.
* Patients who were currently participating in or had participated in another clinical trial within the previous three months or were planning to travel outside of the study area during the course of the study were excluded.
* Pregnant or breast-feeding women were also excluded.
* Women of childbearing potential had a pregnancy test done
Continuum of Care for Frail Elderly People

The present study "Continuum of care for frail elderly people" form part of the research programme "Support for frail elderly persons - from prevention to palliation" (www.vardalinstitutet.net) which comprises research into three interventions. The program comprises interventions addressing frail elderly people in different phases of the disablement process, from elderly people who are beginning to develop frailty to very frail elderly people receiving palliative care.

The intervention "Continuum of care for frail elderly people" addresses elderly people who are frail and that have a great risk of high health care consumption. The hypothesis is that an intervention program for frail elderly people can reduce the number of visits to the emergency department, increase the life satisfaction and maintain the functional ability. The intervention, including an early geriatric assessment at the emergency department, early family support, a case manager in the community with a multi-professional team and active follow-up by the case manager, contributes to early recognition of the elderly people's need of information, care and rehabilitation and of informal caregivers' need of information. It enhances the transfer of information and integrates the care between different caregivers and different care levels, thereby better recognize frail elderly people's needs. Specifically, this study is expected to show that the intervention has a positive effect on the frail elderly person's functional ability, life satisfaction, satisfaction with health and social care, and health care consumption.


Eligibility Criteria:
Inclusion Criteria:

* 80 years and older or 65 to 79 years and having at least one chronic disease and being dependent in at least one activity of daily living

Exclusion Criteria:

* acute severely sick who immediately needs the assessment of a physician (within ten minutes)
* those with diagnosis of dementia (or severe cognitive impairment)
* patients in palliative care
GLP-1 Signaling in Truncally Vagotomized Subjects

Investigation of the importance of vagal signaling for the glucohomeostatic effects of GLP-1. The study will include physiological studies of truncally vagotomized participants and matched controls.


Eligibility Criteria:
Truncally vagotomized individuals:

Inclusion Criteria:

* Normal fasting plasma glucose
* Normal haemoglobin concentration
* Cardiaresection with a pyloroplasty
* Informed consent

Exclusion Criteria:

* Diabetes mellitus
* Disposition for diabetes mellitus
* Intestinal disease (apart from cardia resection+pyloroplasty)
* Disposition of inflammatory bowel disease
* Intestinal resection (apart from cardia resection+pyloroplasty)
* Body mass index (BMI) \> 27,5 kg/m2
* Tobacco use
* Nephropathy (se-creatinine\> 130 µM and/or albuminuria)
* Liver disease (ALAT and/or ASAT \>2 × refference value)
* known heart condition
* medicinal use, that may not be paused for 12 hours
* Obstipation
* swallowing difficulties
* previous problems with intestinal tube placement
* Latex allergy
* Fructose malabsorption
* Known diseases in the pharynx
* Previous facial or cranial fractures
* Sinusitis
* Bleeding diathesis

Matched controls:

Inclusion Criteria:

* Normal fasting plasma glucose
* Normal haemoglobin concentration
* Informed consent

Exclusion Criteria:

* Cardiaresection with a pyloroplasty
* Diabetes mellitus
* Disposition for diabetes mellitus
* Intestinal disease (apart from cardia resection+pyloroplasty)
* Disposition of inflammatory bowel disease
* Intestinal resection tarmresektion (apart from cardia resection+pyloroplasty)
* Body mass index (BMI) \> 27,5 kg/m2
* Tobacco use
* Nephropathy (se-creatinine\> 130 µM and/or albuminuria)
* Liver disease (ALAT and/or ASAT \>2 × refference value)
* known heart condition
* medicinal use, that may not be paused for 12 hours
* Obstipation
* swallowing difficulties
* previous problems with intestinal tube placement
* Latex allergy
* Fructose malabsorption
* Known diseases in the pharynx
* Previous facial or cranial fractures
* Sinusitis
* Bleeding diathesis
A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)

This study is to evaluates the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease.

The purpose of this study is to evaluate the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease. These patients will be switched to Zerenex™ from their current high dose of phosphate binder and, based on their serum phosphorus levels, will be titrated up from 3.4g/day of Zerenex™ to maximum tolerated and safe doses of Zerenex™. Doses will be adjusted weekly, based on serum phosphorus levels, with the maximum dose administered being approximately 12g/day.

Eligibility Criteria:
Inclusion Criteria:

* Males and non-pregnant, nonlactating females
* Age \> 18 years
* On thrice weekly hemodialysis for at least the previous 3 months prior to randomization
* Phosphorous levels ≥3.5mg/dL at Screening Visit
* On at least 12 tablets/capsules/day of calcium acetate (667mg), calcium carbonate (500mg), lanthanum carbonate (500mg), sevelamer hydrochloride (800mg or two 400mg tablets), or any combination of these agents
* Serum ferritin \<1000micrograms/L and Transferrin Saturation (TSAT) \<50%
* Willing to be discontinued from current phosphate binder(s) and initiated on Zerenex
* Willing and able to give informed consent

Exclusion Criteria:

* Parathyroidectomy within 6 months prior to Screening
* Actively symptomatic GI disease such as peptic ulcer disease, gastro esophageal reflux, diverticulosis, irritable bowel syndrome (treated asymptomatic is permitted)
* History of documented inflammatory bowel disease or erosive esophagitis
* Serum Phosphorus levels \>10.0 mg/dL documented in the 3 monthly laboratories (done routinely in the dialysis unit) in the 3 months prior to the Screening Visit
* History of multiple drug allergies
* History of malignancy in the last 5 years (treated cervical or skin cancer may be permitted if approved by CCC)
* Previous intolerance to oral ferric citrate
* Absolute requirement for oral iron therapy
* Absolute requirement for Vitamin C (multivitamins \[Neprocaps, Renaphro, etc.\] allowed)
* Absolute requirement for calcium, magnesium, or aluminum containing drugs with meals
* Psychiatric disorder that interferes with the patient's ability to comply with the study protocol
* Inability to tolerate oral drug intake
* Planned surgery or hospitalization during the study (scheduled outpatient access surgery allowed)
* Any other medical condition that renders the patient unable to or unlikely to complete the study or that would interfere with optimal participation in the study or produce significant risk to the patient
* Receipt of any investigational drug within 30 days of randomization
* Inability to cooperate with study personnel or history of noncompliance
Dialectical Behavior Therapy for Adolescents at Rutgers University

This project expands our existing psychological services clinic (the Dialectical Behavior Therapy Clinic at Rutgers University; DBT-RU) to include an adolescent treatment arm. Adolescents aged 13-20 and at least one caregiver will be recruited to participate in a six-month treatment study. Adolescents will be eligible to participate if they meet at least 3 criteria for borderline personality disorder, with one of those criteria being either impulsive behavior or recurrent self-harm behavior. Participants will be assessed at baseline, three-months (mid-treatment), six-months (post-treatment, and three-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Age 13-17 years or 18-20 if still living at home with parent.
* Agreement of at least one responsible adult parent/caregiver to participate in treatment.
* Agreement to take part in assessments, videotaping/audiotaping and coding of their sessions by research personnel.
* Agreement to pay for mental health services at the DBT- RU on a sliding scale, and to participate in research assessments as volunteers.
* Residence within commuting distance of clinic (\< 45 minutes).
* Agreement to discontinue other forms of talk therapy for duration of DBT program (does not refer to AA/NA programs or psychotropic medication management).
* Exhibits dysregulation within the past six months as evidenced by 1) intentional self-injury and/or suicide attempt and/or 2) substance use disorder.
* Meets two additional criteria for borderline personality disorder (BPD).

Exclusion Criteria:

* Clients who need mental health services not available at the DBT- RU, such as treatment for schizophrenia or life-threatening anorexia, or who are currently obtaining optimum professional treatment that should not be ended.
* Non-English speaking.
* IQ \< 70.
* Unable to understand research consent forms.
* Court-ordered to participate in treatment.
The Effect of Problem Solving and Decision Making Training Given to Nurses Managers

This research was conducted to evaluate the impact of the Problem Solving and Decision Making Training program, which was developed to enhance the problem-solving and decision-making skills of nurse managers at the lower, middle, and upper levels, by the subordinates and superiors of nurse managers. To assess the problem-solving and decision-making skills of nurse managers as perceived by their subordinates, the Problem-Solving Inventory-Managerial Version (PSI-MV) and Decision-Making Styles Scale-Managerial Version (DMSS-MV) underwent adaptation, validity, and reliability studies. These studies aimed to enable the evaluation of nurse managers' problem-solving and decision-making abilities from the perspective of their subordinates.

This research was conducted to evaluate the impact of the Problem Solving and Decision Making Training program, which was developed to enhance the problem-solving and decision-making skills of nurse managers at the lower, middle, and upper levels, by the subordinates and superiors of nurse managers. To assess the problem-solving and decision-making skills of nurse managers as perceived by their subordinates, the Problem-Solving Inventory-Managerial Version (PSI-MV) and Decision-Making Styles Scale-Managerial Version (DMSS-MV) underwent adaptation, validity, and reliability studies. These studies aimed to enable the evaluation of nurse managers' problem-solving and decision-making abilities from the perspective of their subordinates. The study was carried out using a systematic and randomized controlled design, incorporating elements such as pre-test-post-test, experimental, and control groups. In the initial phase of the research, the target population comprised 2,108 nurses employed at a city hospital in Istanbul, while the actual sample included 328 nurses. The validity and reliability studies of PSI-MV and DMSS-MV were carried out. In the scale analyses, psycholinguistic and psychometric properties were examined. In the second part of the research, a sample of 300 nurses, including 60 nurse managers and their subordinates (30 in the experimental group and 30 in the control group), was included using G\*Power analysis for sample calculation.

Eligibility Criteria:
Inclusion Criteria:

The criteria for inclusion in the sample for nurse managers were determined as follows:

* Working as a nurse manager,
* Working in a managerial position for at least six months,
* Volunteering to participate in the research,
* Ensuring full-time participation in the training program to be held within the scope of the research for the experimental group.

Inclusion criteria for subordinate nurses or nurse managers were determined as follows:

* Working under a nurse manager in the experimental or control group,
* Working with the nurse manager he/she evaluated for at least six months,
* Volunteer to participate in the research.

Exclusion Criteria:

* Not meeting the sampling inclusion criteria,
* Filling the data collection tools incompletely.