cyrilzakka/clinical-trials huggingface dataset:
Trial of the Families Moving Forward (FMF) Connect Mobile Health Intervention

The purpose of this study is to test a new smartphone "app" for parents/caregivers of children with fetal alcohol spectrum disorder (FASD). The app is called Families Moving Forward (FMF) Connect. The goal of the app is to provide parents/caregivers with useful information to help manage their children's condition and obtain peer support.


Eligibility Criteria:
Inclusion Criteria:

* Biological parent or other primary caregiver (e.g., foster or adoptive parent, relative, legal guardian) of a child with FASD or prenatal alcohol exposure (PAE)
* The parent/caregiver must be at least 18 years old
* The child must between the ages of 3 and 12 years old
* The child has a diagnosis of FASD or has confirmed PAE
* The child has lived with the parent/caregiver for at least 4 months and is expected to remain in the home for at least 1 year
* The parent/caregiver lives in the United States
* The parent/caregiver has a smartphone with iOS or Android operating system

Exclusion Criteria:

* The parent/caregiver is not fluent in English (the FMF Connect app and pre-post measures are currently only available in English)
* There is another parent/caregiver of the same child or living in the home that is already enrolled in the study (couples are excluded to prevent dependence in the data)
* The family has previously received or is currently receiving the therapist-led Families Moving Forward (FMF) Program
Human Mass Balance Study With Bilastine

The primary objective of the study is to define the absorption and excretion kinetics of bilastine in man following oral administration, and to investigate the nature of the metabolites present in plasma and excreta. The secondary objective of the study is to assess the safety and tolerability of bilastine

Primary Endpoints are: Whole blood and plasma concentrations of total radioactivity and parent drug. Urine and faecal recovery of total radioactivity. Characterisation and identification of metabolites in plasma, urine and faeces.

Eligibility Criteria:
Inclusion Criteria:

* No clinically important abnormal physical findings.
* No clinically significant abnormalities in the results of laboratory evaluation.
* Normal ECG.
* Normal supine blood pressure and heart rate.
* Body weight between 50 and 100 kg and body mass index between 18 and 30 kg/m2.
* Able to communicate well with the investigator and to comply with the requirements of the entire study.
* Provision of written informed consent to participate.
* Subjects must agree to use an adequate method of contraception during the study and for 12 weeks after dosing.
* Subjects must have a negative urine screen for drugs of abuse.
* Subjects must have a regular bowel habit.

Exclusion Criteria:

* Administration of any IMP within 12 weeks before entry to the study.
* Use of any prescribed medication or St John's Wort within 14 days or OTC medication within 5 days of dosing.
* Existence of any surgical or medical condition which, in the judgement of the investigator, might interfere with the absorption, distribution, metabolism or excretion of the IMP.
* History of any drug or alcohol abuse in the past 2 years, or alcohol consumption greater than 21 units per week.
* Presence or history of allergy requiring treatment.
* Hayfever is allowed unless it is active or has required treatment within the previous 2 months.
* Donation or loss of greater than 400 mL of blood within 12 weeks before entry to the study.
* Serious adverse reaction or serious hypersensitivity to any drug.
* Presence of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) or HIV 1 or HIV 2 antibodies at screening.
* Administration of radiolabelled substances or exposure to significant radiation (eg serial x-ray or CT scans, barium meal etc) within the past 12 months.
* Any ECG abnormality at screening (including QTc intervals of \>430 ms).
* Past medical history of clinically significant ECG abnormalities, or a family history of a prolonged QT interval syndrome.
* Abnormal diet or substantial changes in eating habits within 30 days prior to study initiation.
* Treatment with any known enzyme altering agents (barbiturates, phenothiazines, cimetidine, etc.) within 2 months prior to or during the study.
F-18 FDOPA PET/CT Versus I-123 MIBG Scintigraphy With SPECT/CT for the Diagnosis of Pheochromocytoma and Paraganglioma

Pheochromocytomas and paragangliomas (PPGLs) are chromaffin cells-derived tomours that originate from the adrenal medulla (80\~85%) and the extra-adrenal sympathetic paraganglia in thorax, abdomen and pelvis (15\~20%) or parasympathetic paraganglia in the head and neck region (\~1%), respectively. Functional imaging, such as 123I-Meta-Iodobenzylguanidine (MIBG) scintigraphy with single photon emission computed tomography with a CT (SPECT/CT), offers high specificity for PPGL but necessitates 24-hour delayed imaging, pre-processing thyroid protection with a potassium iodide solution, and medication reconciliation to prevent the inhibition of 123I-MIBG uptake. Conversely, 18F-L-dihydroxyphenylalanine (FDOPA), a radiopharmaceutical for positron emission tomography (PET) imaging, is specifically absorbed and accumulated by chromaffin cells, offering better image quality and convenience compared to 123I-MIBG scintigraphy. 18F-FDOPA PET/CT has been approved for the localization, staging, and detection of PPGL recurrences in European and other countries. Therefore, the aim of this study was to compare prospectively the diagnostic performances of 18F-FDOPA PET/CT and 123I-MIBG scintigraphy with SPECT/CT in patients with PPGL.


Eligibility Criteria:
Inclusion Criteria:

1. suspected PPGL based on a biochemical screening, including 24-hour urinary total normetanephrine, metanephrine, norepinephrine, and epinephrine, along with plasma free concentrations of normetanephrine and metanephrine conducted within the past 6 months
2. an adrenal incidentaloma, suggestive of PPGL on anatomical imaging (CT or MRI) performed within the past 6 months
3. characteristic symptoms and signs of PPGL
4. suspected of recurrence or metastases of known PPGL.

Exclusion Criteria:

* pregnant and lactating women
* individuals aged less than 15 years
* patients with a serum creatinine level greater than 3 mg/dL due to chronic renal failure
* patients with a second primary cancer that was not in complete remission
Mass Balance Study of JTZ-951 in Subjects With End-stage Renal Disease on Hemodialysis

A mass balance study to determine the routes and rates of elimination of radioactivity, to determine total radioactivity in plasma and whole blood over time and compare levels to JTZ-951 and drug-derived entities in plasma and to determine pharmacokinetic (PK) parameters of JTZ-951 and its metabolite(s).


Eligibility Criteria:
Inclusion Criteria:

* Subjects with end stage renal disease on hemodialysis
* Post-dialysis body weight \>45.0 kg
* BMI between 18.0 and 40.0 kg/m2 (inclusive)

Exclusion Criteria:

* Subjects with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.0 × upper limit of normal (ULN), or total bilirubin \>1.5 × ULN at the Screening Visit
* Subjects who have hepatobiliary disease or condition (such as biliary cirrhosis)
* Subjects with positive test results for HBsAg (hepatitis B surface antigen), HCV antibody or HIV antibody
* Subjects with known history of liver failure or liver surgery
* Subjects with a history or current clinically significant chronic or acute blood loss
Long-Term Dopamine Transporter Imaging and Clinical Assessment of Parkinson's Disease Progression

The purpose of this project is to assess the change in dopamine transporter density in Parkinson's disease subjects during a sixty month period including a nine month treatment trial of levodopa. Dopamine transporter will be assessed using \[123I\]ß-CIT SPECT (single photon emission computed tomography) imaging, a marker of dopamine terminal integrity and of clinical disease state.

All subjects will be imaged at the Institute for Neurodegenerative Disorders.

Subjects will be evaluated sequentially with \[123I\]ß-CIT SPECT and standardized clinical rating scales during a sixty month period. The subjects involved in this study will have had \[123I\]ß-CIT and SPECT scans at baseline and return for scanning at week 40 following the start of their participation in the ELLDOPA study.

Before each SPECT procedure subjects will be tested to ensure eligibility for the study. They will also have a neurological evaluation including tests of motor function, thinking, memory and handwriting. Some of these tests will be given with the aid of a computer.

On the first day participants are injected with \[123I\]ß-CIT, an investigational radioactive material that localizes in the brain. Study participants will also have a thorough neurologic examination and standard neuropsychological testing, including testing of memory, concentration, abstraction and visual spatial functions.

Twenty-four hours later study participants return to the Institute for Neurodegenerative Disorders where an investigational scanning procedure will be used to obtain SPECT (single photon emission computed tomography) images of the brain.

Eligibility Criteria:
Inclusion Criteria:

* Prior participation in the study titled Dopamine Transporter Imaging Assessment of Parkinson's Disease Progression (DAMD17-99-1-9472) \[123I\] B-CIT and Spect in Vivo Imaging Assessment of Dopamine Transporter Density in Subjects With Early Parkinson's Disease Participating in Earlier Vs. Later Levodopa in Parkinson's Disease (ELLDOPA)\].

Exclusion Criteria:

* Inability to sign informed consent and participate in all study procedures.
* Mini mental status exam \< 25.
* Pregnancy
Dilapan-S®: A Multicenter US E-registry

Objective of this registry is to collect a representative set of real world data on the use of Dilapan-S® for pre-induction cervical ripening in daily clinical practice. Upon completion of the registry, relevant collected data will be analyzed and published.

In the US, 23% of pregnant women undergo labor induction. A recent randomized controlled trial showed that elective labor induction at term in low-risk nulliparous women is associated with a lower risk of cesarean delivery and preeclampsia, with no increase in adverse perinatal morbidities. Hence, one can assume that labor induction rates will increase. The majority of women undergoing induction have unfavorable cervixes and require cervical ripening agents. Dilapan-S®, a hygroscopic cervical dilator made from a patented hydrogel (AQUACRYL), has been used in the past for cervical ripening for early gestation uterine evacuation. Dilapan-S® was approved by the FDA for cervical ripening in the third trimester in 2015.

The Dilapan-S® rods are inserted into the cervical canal, are contained within the vagina, and do not require tension. Dilapan-S® works by absorbing fluid from cervical canal cells, resulting in reversible cell membrane dehydration and softening. In addition, the increase in the rod's volume creates a mechanical stretch and leads to the release of endogenous prostaglandins, causing cervical ripening. Recently, a multicenter prospective cohort study showed that Dilapan-S® is a safe and effective method for cervical ripening in term gestations. Lastly, our group performed non-inferiority randomized clinical trial comparing Dilapan-S® to Foley balloon for cervical ripening in term pregnancies and found that Dilapan-S® is non-inferior to Foley balloon for pre-induction cervical ripening at term.

The Dilapan-S® rods are inserted into the cervical canal, are contained within the vagina, and do not require tension. Dilapan-S® works by absorbing fluid from cervical canal cells, resulting in reversible cell membrane dehydration and softening. In addition, the increase in the rod's volume creates a mechanical stretch and leads to the release of endogenous prostaglandins, causing cervical ripening. Advantages of Dilapan-S® over Foley include FDA approval, safe profile, no protrusion from the introitus, no need to keep under tension and better patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman whose plan of care is induction of labor
* Maternal age ≥ 18 years
* Gestational age ≥ 37 +0/7 weeks
* Dilapan-S® used for cervical ripening

Exclusion Criteria:

* Data not available for extraction
MBCT and CBT for Depression in Patients After Cancer: a Randomized Controlled Trial

The purpose of this study is to determine whether mindfulness-based cognitive therapy (MBCT) and cognitive behavioral therapy (CBT) are effective in reducing depressive symptoms in patients after cancer

Cancer patients are prone to develop depressive symptoms, even after curative treatment. Conventional therapies such as cognitive behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT) are frequently used for reducing these depressive symptoms in patients with medical conditions. However, until now evidence from proper designed randomized controlled trials regarding the effectiveness of both interventions in cancer survivors, is lacking. Therefore, our longitudinal study aims to investigate the effectiveness of CBT and MBCT in reducing depressive symptoms in cancer survivors. In addition, potential moderators and mediators of each intervention will be explored.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Completion of curative cancer treatment (for primary diagnosis of cancer or possible recurrence of cancer) at least one year ago and no longer than five years ago.
* Currently no active cancer.
* ≥ 18 at the time of diagnosis of cancer and ≤ 75 at inclusion.
* Depressive symptoms as assessed by a Patient Health Questionnaire (PHQ-9) score ≥ 10 (indicating presence of at least mild depressive symptoms).
* Being able to read, write, and speak Dutch.

Exclusion Criteria:

* Severe psychiatric co-morbidity (i.e. acute suicidal ideations or behavior, recently experienced psychosis, diagnosis of schizophrenia, bipolar disorder, drug abuse or substance dependence, serious cognitive or neurological problems).
* Receiving psychological treatment for depressive symptoms, currently or less than two months prior to study participation.
* Unstable antidepressant medication regimen two months prior to inclusion of the study
Procarbazine and Isotretinoin in Treating Patients With Recurrent Primary Malignant Gliomas

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether giving procarbazine alone or with isotretinoin is more effective for recurrent primary malignant glioma.

PURPOSE: Randomized phase III trial to compare the effectiveness of procarbazine alone or with isotretinoin in treating patients with recurrent primary malignant gliomas.

OBJECTIVES: I. Determine whether the combination of isotretinoin and procarbazine can improve time to progression and survival compared to procarbazine alone in patients with recurrent malignant gliomas. II. Document the toxicity of these two regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to receive procarbazine alone or in combination with isotretinoin. Arm I: Patients receive oral procarbazine once daily on days 1-14 every 28 days. Oral isotretinoin is administered every 12 hours on days 15-28 every 28 days. Patient receive 6 courses of combined therapy, then continue with oral isotretinoin alone on days 15-28 of each 28 day course, until disease progression or unacceptable toxicity. Arm II: Patients receive procarbazine by mouth once daily on days 1-14 followed by 2 weeks of rest. Patients receive a total of 6 courses of treatment in the absence of disease progression and unacceptable toxicity. Patients are followed until death.

PROJECTED ACCRUAL: This study will accrue a total of 194 patients (97 per treatment group).

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven primary malignant gliomas including the following: Glioblastoma multiforme Gliosarcoma Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic infiltrating glioma Mixed malignant gliomas Must show evidence of tumor recurrence or progression on at least 2 serial enhanced MRI scans Must have measurably enhancing residual disease on MRI or CT scan of brain

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 60-100% Life expectancy: Greater than 8 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGPT less than 2 times institutional normal Alkaline phosphatase less than 2 times institutional normal Bilirubin less than 1.5 mg/dL Renal: BUN less than 1.5 times institutional normal OR Creatinine less than 1.5 times institutional normal Other: No active infection Not pregnant or nursing Fertile patients must use effective contraception 1 month before, during, and 1 month after study No other disease that will obscure toxicity or alter drug metabolism No other concurrent medical illness

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior procarbazine No prior isotretinoin At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: Not specified Other: No concurrent tetracyclines
Sayana® Press Self-injection Study in Malawi

The feasibility of Sayana Press self-injection and the potential for this practice to increase contraceptive continuation has never been assessed in family planning programs in low-resource settings. The Malawi Ministry of Health (MOH) and the United States Agency for International Development (USAID) Malawi Mission requested the Advancing Partners and Communities (APC) project to assess self-injection of Sayana Press to inform their decision-making for procurement of Sayana Press and distribution through the health system in Malawi.

Sayana® Press is a subcutaneous formulation of depot medroxyprogesterone acetate (DMPA) in a prefilled, auto-disabled injection system called Uniject (Pfizer, Inc., USA). Sayana Press was registered with the Medicines and Health Care Products Regulatory Agency (MHRA) and several other national regulatory agencies. The addition of this method is anticipated to aid in improving provision of family planning services in low-resource settings. As such, Sayana Press could be particularly useful in a country such as Malawi where injectable contraception is the most common method used. DMPA clients and providers are ready to explore the potential of self-injection of Sayana Press. A study conducted in a large family planning clinic in Edinburgh, Scotland found self-administration of DMPA-SC feasible and associated with similar continuation rates and satisfaction to clinician-administered DMPA-IM. A non-comparison study conducted in Planned Parenthood clinics in Florida found continuation of self-injected DMPA-SC high (74%) at the fourth injection. Participants in this study reported the injection to be easy and convenient and were likely to recommend self-administration to other women. Moreover, on September 29, 2014 Pfizer submitted a request to the MHRA to change the Sayana Press label to include self-injection.

If self-injection is found feasible, the results from this research will inform self-injection training materials, messages for providers and clients, and future scale-up efforts in Malawi and elsewhere in sub-Saharan Africa.

Eligibility Criteria:
Inclusion Criteria:

Age 18-40, inclusive

* In general good health (participant verbally reports she feels well)
* Able to understand and willing to sign an informed consent document
* Willing to give contact information for follow-up
* Agree to have follow-up visits/interviews
* Willing to be randomized to the self-injection arm or provider-administered injection arm
* Menstrual period started within the past 7 days (for new DMPA users)
* Meet eligibility criteria for receiving DMPA per WHO Medical Eligibility Criteria (MEC)

Exclusion Criteria:

Pregnancy

* Plans to become pregnant in the next 12 months
* Plans to relocate outside the study area in the next 12 months
* Any condition (social or medical) which in the opinion of the investigator would make study participation unsafe or would interfere with adherence to study requirements or complicate data interpretation
Understanding Host-pathogen Interaction in the Respiratory Mucosa During Pregnancy

The clinical presentation of the ongoing coronavirus disease-19 (COVID-19) pandemic in pregnant women is unique with more asymptomatic infection, higher morbidity when symptomatic, yet without a difference in mortality rate. This is strikingly different from the high mortality observed during the past influenza A pandemics. Though both influenza A virus (IAV) and SARS-CoV-2 are single-stranded RNA viruses, the exquisite vulnerability of pregnant women to influenza A but not COVID-19 remains a mystery. Our objective, therefore, is to determine the mechanisms that predispose pregnant women to severe influenza A but confer protection against SARS-CoV-2 infection by examining the viral entry factors and innate immune response mechanisms in the nasal epithelium of pregnant vs. non-pregnant age-matched women.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, uncomplicated pregnant subjects in the third trimester ((≥ 28 ≤ 41 weeks' gestation)
* Healthy non-pregnant adult female volunteers between the ages of 18 - 45 years.
* Between 18-45 years old
* Able to provide consent

Exclusion Criteria:

* Patients in labor
* Critically ill patients needing intubation and mechanical ventilation
* Patients with fever or influenza-like illness
* H/o epistaxis or rhinosinusitis
* Nasal polyposis and deviated nasal septum
* Preeclampsia and chronic hypertension
* Use of anti-hypertensives
* Ongoing seasonal allergy
* H/o asthma
* Recent recovery from SARS-CoV-2 or influenza A infection (≤ 4 weeks)
* Recent receipt of either COVID-19 or influenza A vaccine (≤ 4 weeks)
* Use of immunosuppressive medications
* Use of inhaled corticosteroids
* Use of hormonal contraceptives in non-pregnant population
* Allergy to local anesthetic
Investigation of Change in The WHO-5 Well-Being Index During a Year in a Community Psychiatry in Denmark

Patient reported quality of life was measured using the WHO-5 Well-Being Index in a group of outpatients in the Community Psychiatry in Holbaek, Denmark.

Methods

The first and last answer were compared and significance of change in various subgroups of patients was estimated using the PSPP statistical program.

Investigation of the change of The WHO-5 Wellbeing Index during a year in a Community Psychiatry in Denmark.

Introduction

In the Community Psychiatry of the town Holbaek part of Region West of The Region Sjaelland in eastern Denmark the WHO-5 Well-Being Index has for 5 years been used in order to obtain the patients personal evaluation of their actual quality of life. That has given the possibility of following changes during the treatment. The questionnaire is easy to understand and to use as part of a consultation. The patients will answer the 5 questions in a few minutes. The WHO-5 questionnaire is thoroughly evaluated internationally and described and used in many clinical situations also outside of psychiatry and fulfill measures of psychometric quality. With this work the intention was to try to answer often critical questions from our administration and from the press and in the society. There was no funding for the work.

Eligibility Criteria:
Inclusion Criteria:

* all patients able and willing to participate

Exclusion Criteria:

* patients with mental conditions making them unable to answer simple questions about their daily life (in general severe psychosis and severe organic mental disorders)