cyrilzakka/clinical-trials huggingface dataset:
Clinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache

The purpose of this multi-center study is to assess the efficacy of headache relief of new paracetamol/caffeine formulation compared to placebo and ibuprofen in episodic tension-type headache (ETTH).


Eligibility Criteria:
Inclusion Criteria:

* Participants in good general health, and with diagnosis of ETTH with following conditions:

  1. number of days with the condition is historically greater than or equal to two per month;
  2. severity of headaches is historically at least moderate;
  3. duration of headaches is historically more than or equal to 4 hours, if untreated.

     Exclusion Criteria:
* Participant with known or suspected hypersensitivity, allergy, intolerance or contraindication to the use of any of the study medications
* Participant has chronic tension type headache, psychiatric disease or a significant cognitive disorder, or any chronic pain disorder.
* Participant currently taking or has taken medications or herbal supplements within the three months that are likely to interfere with the validity of subject-rated assessments.
Voice Biomarkers Predictive of Depression and Anxiety

The objective of this study is to collect data to improve the sensitivity and specificity of Kintsugi Voice's (formerly KiVATM) predictions on audio files. A web-based audio recording tool will be used to record voice sample and ask participants the PHQ-9 and GAD-7 questions. A voluntary subset of participants will then be assessed by mental health professionals with the Hamilton Depression Rating Scale (HAM-D) and Hamilton Anxiety Rating Scale (HAM-A) scores.

Participants will be recruited via various online mediums to participate in a voluntary observational study. Completing the consent and survey on their smart-phone, tablet, or computer, the participant will be asked to provide a 1-minute response to an audio prompt "How was your day?" After recording their response, the participant will be asked to complete the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 measures independently.

In a second voluntary phase of the study, participants who indicated a score higher than 20, will be contacted by the research team via email to determine if they are interested in a voluntary follow-up to their initial study participation. Participants who would like to take part in the additional survey will complete additional voice recording responses to prompts and complete the Patient History Questionnaire and Generalized Anxiety Disorder-7. These participants will be contacted by a Mental Health Professional to discuss seeking mental health resources and clinicians, as well as, complete the Hamilton Depression Rating Scale and Hamilton Anxiety Rating Scale via the telephone.

Eligibility Criteria:
Inclusion Criteria:

* Adult males and or females over the age of 18 at the time of informed consent. Adults with a known history of depression and/or anxiety and adults without a known history of depression and/or anxiety will be included in this study.
* Access to a laptop, smart-phone or tablet with a functioning microphone
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Fluency in English

Exclusion Criteria:

* Visual impairment that would make it difficult for the participant to see the web-based survey
* Motor impairment that would make it difficult for the participant to use the web-based survey
Diagnostic Accuracy and Performance of 18F-PSMA-1007

Whereas 18F-PSMA-1007 has rapidly established itself as a radiotracer for the investigation of prostate cancer, there are no studies confirming its diagnostic performance. The purpose of this study is to determine the diagnostic performance for this radiotracer.

In this prospective, single-armed diagnostic imaging study men undergoing standard-of-care PSMA PET/CT using \[18F\]PSMA-1007 shall be studied. The primary objective is to confirm the positive predictive value (PPV) of this tracer at a patient-based level by recruiting until 53 patients with follow-up to a composite reference standard are available. Secondary outcomes shall include patient based rate of pathological-scans stratified by PSA, the PPV stratified by region , interrelate agreement, frequency of indeterminate lesions and the safety and tolerability of the examination.

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients referred for investigation of recurrent PC by PSMA PET/CT.
* Patients with known biochemical recurrence of a histologically confirmed primary prostate cancer, defined as:

Post prostatectomy: two consecutive PSA \> 0.2 ng/ml Post-radiotherapy: a rise of 2ng/mL \> post-therapy nadir (ASTRO consensus definition)

* Male patients \>18 years old
* PSA measured ± 4 weeks of the PSMA-PET/CT
* Patients willing and able to consent to the informed consent document

Exclusion Criteria:

* Patients with ADT within 6 months prior to the PSMA-PET/CT
* Inability to provide informed, written consent
* Patients undergoing active treatment for a second non-prostatic malignancy
The Effects Of Probiotics On Stress Among Healthy Adults From Umm Al-Qura University At Makkah

The goal of this clinical trial is to study the effects of probiotic supplementation on stress levels and bowel habits in healthy Saudi adults for both males and females.

The main questions it aims to answer are:

Does probiotic supplementation decrease stress levels? Does probiotic supplementation improve bowel habits?

Researchers compared between the intervention group receiving probiotic supplements with high stress levels with a control group not receiving probiotics with high stress levels to see if probiotics decreases stress levels.

Participants were required to

1. Attend a visit to the nutrition clinic at Umm AL-Qura University to assess for eligibility.
2. Eligible participants were asked to sign a consent form and anthropometrics, stress, bowel habits, food records and knowledge on probiotics were collected
3. Participants were randomized based on lottery based method to an interventional or control group
4. Intervention group received 30 capsules of probiotics (Lactobacillus rhamnosus GG, 6x10\^9 cpu) to be taken once daily
5. After 30 days, all participants had to attend a second visit at the nutrition clinic at Umm Al-Qura University to assess stress levels, bowel habits and receive their incentives (discount voucher of restaurants).

Eligibility Criteria:
Inclusion Criteria:

* Students at Umm Al-Qura University
* Age ≥ 18 years
* Healthy individuals
* Both genders
* Saudi nationality

Exclusion Criteria:

* Diagnosed with chronic illness or/and psychiatric condition
* Consumption of medications or supplements in the previous 3 months
* Pregnant and breastfeeding
* Smoker
Diabetes and Risk of Ischemic Stroke.

Diabetes in an independent risk factor for ischemic stroke, whose associated mortality rate is higher and sequelae more serious than for nondiabetics. Diabetes increases the risk of stroke or death after surgical carotid revascularization or endoluminal angioplasty. It is, with contralateral ICA occlusion, 1 of the 7 factors doubling the stroke risk after carotid endarterectomy. Diabetes also enhances the cerebral hemorrhage risk associated with carotid surgery, thrombectomy or thrombolysis revascularization of the cerebral arteries.

This study was undertaken to examine whether the hemodynamic cerebral ischemia (HCI) frequency, which increases stroke severity, is higher in diabetics than nondiabetics and, if diabetes carries an excess HCI risk, whether it is independent of contralateral ICA occlusion.

Embolic and hemodynamic mechanisms are the main causes underlying ischemic strokes of carotid origin. The hemodynamic cerebral ischemia (HCI) risk depends on the contribution of the contralateral internal carotid artery (ICA) and vertebral arteries via the circle of Willis, the ipsilateral external carotid artery via the ophthalmic artery and the leptomeningeal arteries. During carotid surgery, impaired collateral flow is associated with the need for shunt insertion.

When HCI is present, cerebral perfusion is initially maintained by vasodilation of precapillary arterioles and the increased extraction coefficient of oxygen. Secondarily, vascular reserve exhaustion by degradation of arterial lesions engenders a loss of cerebral autoregulation, ischemic penumbra and cerebral infarction.

Carotid revascularization with an incomplete circle of Willis enhances the postoperative ischemic stroke risk. The loss of cerebral autoregulation, attributable to HCI combined with ipsilateral carotid tight stenosis, heightens the risk of hyperperfusion and cerebral hemorrhage.

Carotid occlusion is the primary cause of HCI. Carotid occlusions and tight stenoses lead to loss of cerebral autoregulation and cerebrovascular reserve, and have been associated with a 4-fold-increased stroke risk.

Diabetes in an independent risk factor for ischemic stroke, whose associated mortality rate is higher and sequelae more serious than for nondiabetics. Diabetes increases the risk of stroke or death after surgical carotid revascularization or endoluminal angioplasty.It is, with contralateral ICA occlusion, 1 of the 7 factors doubling the stroke risk after carotid endarterectomy. Diabetes also enhances the cerebral hemorrhage risk associated with carotid surgery, thrombectomy or thrombolysis revascularization of the cerebral arteries.

This study was undertaken to examine whether the HCI frequency is higher in diabetics than nondiabetics and, if diabetes carries an excess HCI risk, whether it is independent of contralateral ICA occlusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clamping test during carotid surgery.

Exclusion Criteria:

* Patients without clamping test during carotid surgery.
A Study of Minirin Melt in Japanese Patients With Central Diabetes Insipidus (CDI).

This is an open-label dose-titration study in Japanese Central Diabetes Insipidus (CDI) patients designed to demonstrate the efficacy and safety of orally-disintegrating tablet of desmopressin.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be documented to have Central Diabetes Insipidus (CDI) by at least two of the following four criteria (a-d):

  1. Failure to increase urine osmolality above 300 mOsm/kg during a period of fluid deprivation sufficient to raise plasma osmolality and sodium above the upper limit of normal level for the reference laboratory (usually 295 mOsm/kg and 148 mEq/l, respectively)
  2. Complete and continuous control of the DI by desmopressin therapy without "breakthrough" diuresis, hypernatremia, hyponatremia, or symptoms or signs of water intoxication.
  3. A deficient plasma vasopressin response to osmotic or non-osmotic stimulation.
  4. Absence of the posterior pituitary bright spot on T-1 weighted midsagittal magnetic resonance imaging (MRI) of the brain.
* Given written informed consent prior to any trial-related procedure is performed
* 24 hour urine volume (mL), urine osmolality (mOsm/kg), urine specific gravity, and serum sodium (mEq/L) maintained at a normal level by desmopressin nasal administration
* Outpatient
* The participant is, in the investigator's opinion, otherwise healthy
* Be willing and able to comply with the protocol requirements including restriction of water intake

Exclusion Criteria:

* Presence or a history of nephrogenic diabetes insipidus or diabetes mellitus
* Presence of uncorrected hypothyroidism, hypoadrenalism or hypogonadism
* Abnormalities or disease of the oral cavity that might affect the release and absorption of drug
* Unable to be placed on water-intake restriction starting from two hours before bedtime
* Presence of a hypothalamus abnormality leading to thirst disorder
* Evidence of hepatic, renal, cardiac, or pulmonary dysfunction
* Uncontrolled hypertension
* Treatment with another investigational product within the past 3 months
* Concurrent treatment with diuretics, chlorpropamide, tricyclic antidepressants, indomethacin, carbamazepine
* Alcohol dependency or drug abuse
* Breastfeeding, pregnant, or likely to become pregnant
* A mental condition, the lack of decision-making ability, dementia or a speech handicap
* Any other reason that the Investigator believes inappropriate
Study Assessing High-Frequency Chest Wall Oscillation (HFCWO) in Preventing Pulmonary Exacerbations

To asssess efficacy of airway clearance provided by Vest therapy (HFCWO) in the reduction of respiratory exacerbations requiring hospitalization or antibiotic utilization in patients with muscle weakness and restrictive lung disease.

This non-randomized home based pre-post intervention study. The study will compare the efficacy of Vest® therapy (HFCWO) for mucus secretion clearance in a population of patients with muscle weakness and restrictive lung disease with frequent pulmonary exacerbations. Enrolled subjects with a tracheostomy will be evaluated for microbial load and inflammatory status as a pilot evaluation of microbial load and inflammatory status outcomes.

The total number of evaluable subjects to be recruited is estimated at 40. Subjects will be considered evaluable if they have completed at least 6 months of follow up.

Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 months old.
* Subject has a chest circumference of greater than 19 inches.
* Subject has a diagnosis of muscle weakness and restrictive lung disease.
* Ability to provide Informed consent from legal guardian.
* Subject has had 2 or more exacerbations requiring either hospitalization or antibiotics (IV or oral) in the past 12 months
* If inhaled Tobramycin has been prescribed prophylacticly, subjects must discontinue the medication at least 2 weeks prior to study enrollment

Exclusion Criteria:

* Subject has a diagnosed allergy with a respiratory trigger.
* Participation in another clinical trial.
* Unstable head or spinal injury.
* Unresolved pneumothorax or pneumomediastinum present
* Unresolved hemorrhage
* Hypotension requiring vasopressors or positioning
* Bronchopleural fistula
* Gross hemoptysis within the past eight hours
* Pulmonary embolism or history of pulmonary embolism within the past two months
* Burns, open wounds and skin infections on the thorax
* Osteomyelitis of the ribs
* Osteoporosis with history of fractures.
Cervical Cancer Screening Among Hispanic Women

In this study, 400 Hispanic women will be recruited and randomized to one of three interventions:

1. Control (no change);
2. A low-intensity information program, consisting of a video approach educating women on the importance of cervical cancer screening;
3. A higher intensity program consisting of the video plus a 'promotora' or lay-community health educator led intervention at the participant's home to encourage cervical cancer screening.

The investigators will compare which intervention is most effective in encouraging Hispanic women to undergo cervical cancer screening (Pap test)


Eligibility Criteria:
Inclusion Criteria:

* Female
* 21 - 64 years of age
* Hispanic or Latina
* Resident of the Yakima Valley, WA, USA
* No hysterectomy
* Last PAP test (cervical screening) more than 3 years ago
* Last seen at the local clinic less than 5 years ago

Exclusion Criteria:

* Less than 21 or greater than 64 years of age
* PAP test less 3 years ago
* Prior hysterectomy
Cohort Construction for Preterm Infants With Growth Retardation and Its Influencing Factors

In this cohort, prospective clinical cohort study was used to establish a follow-up cohort of preterm infants with different gestational ages. The regular monitoring indexes of physical development and neuropsychological development of preterm infants from birth to 3 years after birth were collected. The influencing factors of preterm infants' development at different stages were recorded, and the high-risk factors leading to different stages of preterm infants' growth retardation were analyzed.

Preterm infants are at high risk of stunting due to premature birth, insufficient intrauterine nutrient reserves, burden of various diseases after birth, and persistent nutrient liabilities. The growth retardation of premature infants at different developmental stages has an important impact on both short-term survival and long-term health. The growth and development data of premature infants during hospitalization and after discharge are very limited in foreign countries. Domestic researches on growth retardation of preterm infants only involve retrospective cross-sectional studies during hospitalization, and lack of prospective follow-up study data on growth and development data of premature infants during hospitalization and after discharge.

In this cohort, prospective clinical cohort study was used to establish a follow-up cohort of preterm infants with different gestational ages. The regular monitoring indexes of physical development and neuropsychological development of preterm infants from birth to 3 years after birth were collected. The influencing factors of preterm infants' development at different stages were recorded, and the high-risk factors leading to different stages of preterm infants' growth retardation were analyzed. In order to provide a strong scientific basis for the development evaluation and intervention of premature infants in China, a systematic and scientific clinical cohort study method was explored to improve the overall medical quality and medical level of the Department and further promote the development of the discipline.

Eligibility Criteria:
Inclusion Criteria:

* All preterm infants born less than 37 weeks during the study period

Exclusion Criteria:

* Congenital malformations or genetic diseases Various surgical treatments during the newborn period Interrupted treatment or discharged automatically
A Randomized, Placebo-Controlled Trial to Examine the Efficacy of Oral Donepezil in Subjects With MCI

To purpose of this study is to estimate the effect of donepezil on Neuropsychological Testing (NPT) and brain Proton Magnetic Resonance Spectroscopy.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females ages 55-90 inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12-lead ECG and clinical laboratory tests)
* Body Mass Index (BMI) between 18 to 34 kg/m2, inclusive; and a total body weight
* Subjects with mild cognitive impairment (MCI) must have a reliable informant who has an average of 10 hours per week or more contact with the subject.
* Memory complaints and memory difficulties, which are verified by an informant
* Mini-mental status exam (MMSE) score of 24-30

Exclusion Criteria:

* Subjects with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives
* Insulin-requiring diabetes or uncontrolled diabetes mellitus
* Subjects with a current diagnosis of depression or other psychiatric illnesses
SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)

The purpose of this study was to compare the efficacy of a single dose of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC), as measured by the duration of severe neutropenia (DSN) in Cycle 1.

This was a Phase 3, randomized, open-label, active-controlled, multicenter study to compare the efficacy and safety of SPI-2012 vs pegfilgrastim in participants with breast cancer treated with TC chemotherapy.

Each cycle was 21 days. Four cycles were evaluated in this study. On Day 1 of each cycle, participants received TC chemotherapy. On Day 2 of each cycle, participants received study drug (SPI-2012 or pegfilgrastim).

Eligibility Criteria:
Key Inclusion Criteria:

* New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer
* Candidate for adjuvant or neoadjuvant TC chemotherapy
* Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
* Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L
* Platelet count ≥ 100×10\^9/L
* Hemoglobin \> 9 g/dL
* Creatinine clearance \> 50 mL/min
* Total bilirubin ≤ 1.5 mg/dL
* Aspartate Aminotransferase per Serum Glutamic-Oxaloacetic Transaminase (AST/SGOT) and Alanine Aminotransferase per Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) ≤ 2.5× Upper Limit of Normal (ULN).
* Alkaline phosphatase ≤ 2.0×ULN

Key Exclusion Criteria:

* Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease
* Locally recurrent or metastatic breast cancer
* Known sensitivity to E. coli -derived products or to any products to be administered during dosing
* Concurrent adjuvant cancer therapy
* Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 12 months prior to the administration of study drug
* Active infection, receiving anti-infectives, or any serious underlying medical condition that would impair ability to receive protocol treatment
* Prior bone marrow or stem cell transplant
* Use of any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study
* Radiation therapy within 30 days prior to enrollment
* Major surgery within 30 days prior to enrollment
Post-Surgery Extracorporeal Life Support

Extracorporeal Life Support (ECLS) may provide pulmonary and circulatory support for patients with acute heart failure refractory to conventional medical therapy. However, indications and effectiveness of ECLS engagement post-surgery remains a concern. The investigators sought to analyze indications, modality and outcomes of PS-ECLS, to identify predictors of early and midterm survival after PS-ECLS. The investigators have recorded prospectively, and analysed data of 209 consecutive PS-ECLS patients between January 2004 and December 2018. Demographic and clinical data before, during and after PS-ECLS were collected and their influence on hospital mortality and outcomes (early and midterm) will analyse. Multivariate analysis of pre PS-ECLS implantation factors (as age, female sex , insulin-dependent diabetes, pulmonary hypertension, STS, type of surgical procedure data, pre-ECLS blood lactate level) will be made for identify prognostic risk factors of in-hospital mortality. Overall survival will be analysed, at 6 months,1-year and 5-years, respectively and the factors influencing mild/term outcome will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Patients underwent cardiac surgery

Exclusion Criteria:

* Age \< 18 years