cyrilzakka/clinical-trials huggingface dataset:
A Cross-Cultural Assessment of the Motivations of Healthy Participants in Phase I Research

Background:

* Individuals often participate in clinical trials to seek new therapies and free medical treatments for their illnesses or chronic conditions. However, less is known about the motivations of the healthy individuals who volunteer for research studies.
* Although many healthy volunteers participate in clinical trials for financial compensation, the particular risks involved in testing drugs that have not been tried in human clinical trials pose potential dangers for healthy volunteers in Phase I studies. More research is needed to understand the motivations of volunteers who participate in Phase I clinical trials.

Objectives:

- To evaluate the primary and secondary motivations of healthy participants in research studies.

Eligibility:

- Individuals at least 18 years of age who are healthy volunteers in selected Pfizer Phase I clinical trials.

Design:

* Individuals who express interest in participating in specific Pfizer Phase I drug studies will be asked to complete a short questionnaire after completing the standard consent session for the study.
* Those who enroll in the trial will be asked to complete a second questionnaire prior to discharge from the study.

This healthy volunteer motivation study is a sub-study of Phase I drug development studies conducted by Pfizer International. The substudy is designed to evaluate the primary and secondary motivations of healthy participants in research studies, as well as the process by which participants decide to participate, including their consideration of any risks, benefits, compensation and other factors, and the relationship of these factors to cultural and sociodemographic variables. Data will be collected via self-administered surveys at 2 possible time points, 1) after going through the consent process at the beginning of participation in the primary study, and 2) towards the end of the study participation.

Eligibility Criteria:
* INCLUSION CRITERIA:

Participants will be willing adults who have participated in an informed consent session for a designated Phase I study at a Pfizer CRU. Participants in New Haven and Singapore must be able to read and answer question in English and participants in Brussels must be able to read and answer questions either in English, French, or Flemish. Only adults (over 18 years old) who can provide their own consent will be included.

EXCLUSION CRITERIA:

Participants in Pfizer phase I studies who are unable or unwilling to complete the survey instruments.
Predictive Significance of TEG on END in Patients With Acute Ischemic Stroke

The purpose of this study is to evaluate whether Thromboelastography (TEG) parameters on admission might be predictive for early neurological deterioration in acute ischemic stroke patients, specifically for the DWI lesion evolution within the first week after stroke onset.

Early neurological deterioration (END ) is a major concern in stroke care, consistently associated with adverse clinical outcomes.END is a heterogeneous complex of pathophysiological and clinical entities. Despite some straight forward causes, DWI lesion growth is reportedly a primary underlying mechanism. Early recognition of END risk would allow for timely identification and proper intervention, improving stroke health care.

Thromboelastography (TEG) measures the coagulation process from initial clotting cascade to clot strength, providing an integrated picture of two separate but simultaneously occuring components of coagulation, thrombosis and lysis. It has been reported to be associated with short and long-term outcome in patients with trauma, coronary artery diseases , pulmonary embolism and, most recently, stroke prevention.The purposes of this study is to evaluate how effective TEG is on predicting END, by producing a range of TEG values correlated with clinical and radiological assessment.

Eligibility Criteria:
Inclusion Criteria:

* acute ischemic stroke within 24 hours after symptom onset
* first ever stroke
* give informed consent

Exclusion Criteria:

* receiving thrombolysis
* cardiogenic embolism
* contradiction to serial MRI studies
* taking hemostatic agents (warfarin, oral anticoagulants and etc. )
Biomarkers in a Candian Memory Clinic

This is a prospective, observational, case control study in a real-world cohort of patients referred by a primary care physician to a tertiary memory clinic for cognitive concerns. This study's main objective is to determine the effect of using standardized criteria (based on eligibility for disease modifying treatment (DMT)) to triage patients towards biological staging of disease with biomarker testing.


Eligibility Criteria:
Inclusion Criteria:

1. Individual with MCI (if not yet diagnosed, individuals with amnestic changes in memory as shown on MoCA)
2. MoCA score must be 18 to 28 inclusive
3. Age 55 to 80 years inclusive
4. Has a study partner that is willing to participate as a source of information and has approximately weekly contact with the subject (contact can be in-person, via telephone or electronic communication). The study partner must have sufficient contact such that the investigator feels the study partner can provide meaningful information about the subject's daily function.
5. Group A - must have a clinical memory assessment appointment scheduled at Parkwood Institute within 18 months of baseline
6. Group B - must have had a clinical memory assessment appointment at Parkwood Institute within 18 months of baseline

Exclusion Criteria:

* 1) Participants who fulfill diagnostic criteria for MCI or dementia/mild or major neurocognitive disorder suspected to be due to any etiology other than AD (eg, MCI/dementia due to frontotemporal lobar degeneration, diffuse Lewy body disease, Parkinson's disease, cerebrovascular disease, normal pressure hydrocephalus, head injury, drug or alcohol abuse/dependence, anoxic brain injury, etc).

  2) Presence of any neurological, psychiatric, or medical conditions associated with a long-term risk of significant cognitive impairment or dementia including, but not limited to, pre-manifest Huntington's disease, multiple sclerosis, Parkinson's disease, Down's syndrome, active alcohol/drug abuse or major psychiatric disorders including, but not limited to, schizophrenia, schizoaffective disorder, or bipolar affective disorder or current episode of major depressive disorder.

  3) Current or history within the past 2 years of psychiatric diagnosis or symptoms (eg, hallucinations, major depression, or delusions) that, in the opinion of the investigator, could interfere with study procedures 4) History of epilepsy, fits, or unexplained blackouts other than vasovagal syncope within 10 years before screening.

  5) Malignant neoplasms within 3 years (except for basal cell or squamous cell carcinoma in situ of the skin) 6) Women of child bearing potential and breastfeeding mothers 7) Individuals who require sedation to complete PET scan. 8) Individuals who are unable to complete assessments in the English language. 9) Individuals who cannot provide consent
A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia

This pilot study is an eight-week, randomized, double-blind, placebo-controlled, escalating dose trial of the novel vigilance-promoting drug, modafinil, added to a stable dose of clozapine in 40 patients with schizophrenia or schizoaffective disorder. Modafinil will be initiated at 100 mg/d. After 2 weeks, the study drug may be increased to 200 mg/d and after 4 weeks, study drug may be increased to a maximum of 300 mg/d. Dose escalation will be based upon persistence of sedation versus emergence of side effects.

This pilot study is an eight-week, randomized, double-blind, placebo-controlled, escalating dose trial of the novel vigilance-promoting drug, modafinil, added to a stable dose of clozapine in 40 patients with schizophrenia or schizoaffective disorder. Modafinil will be initiated at 100 mg/d. After 2 weeks, the study drug may be increased to 200 mg/d and after 4 weeks, study drug may be increased to a maximum of 300 mg/d. Dose escalation will be based upon persistence of sedation versus emergence of side effects.

1. Evaluate tolerability and safety of modafinil compared to placebo using the SAFTEE and vital signs.
2. Evaluate the effect size of modafinil compared to placebo upon wakefulness and fatigue using the Epworth Sleepiness Scale (ESS) and the Fatigue Severity Scale (FSS).
3. Evaluate the effect size of modafinil compared to placebo upon negative symptoms using the SANS total score.
4. Evaluate the effect size of modafinil compared to placebo upon cognitive functioning using a standard battery of cognitive tests.
5. Evaluate the effect size of modafinil compared to placebo upon weight, BMI, waist/hip circumference and fasting glucose and lipids.
6. Effect the variability of response in placebo and modafinil groups for each of the outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Schizophrenia, any subtype or schizoaffective disorder
* Ages 18-65 years
* Capable of providing informed consent, or capable of providing assent with a guardian who provides informed consent
* Stable dose of clozapine for at least 1 month
* Three months of stable psychotic symptoms

Exclusion Criteria:

* Serious medical or neurological illness (unstable cardiac disease, seizure disorder, malignancy, liver or renal impairment, etc.)
* Current substance abuse
* Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile.
* Unable to complete neuropsychological tests
* History of serious blood dyscrasia requiring discontinuation of clozapine
* Serious suicidal or homicidal risk within the past six months
* Current treatment with a psychostimulant
Open-label Phase IV Clinical Trial to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastases

To assess the effects of i.v. zoledronic acid 4 mg with respect to safety and tolerability


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Histological confirmed diagnosis of carcinoma of the prostate
* Current or previous evidence of metastatic disease to the bone
* Receiving currently or not, hormonal therapy
* ECOG performance status of 0, 1, or 2

Exclusion Criteria:

* Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal, or by a calculated creatinine clearance of 60 ml/minute or less.
* Corrected serum calcium concentration, adjusted for serum albumin \< 8.0 mg/dl (2.00 mmol/L).
* WBC\<3.0x10\^9, ANC \< 1500/mm3, Hb \< 8.0 g/dL, platelets \< 75 x 10\^9/L.
* Liver function tests \>2.5 ULN, serum creatinine \>1.5 ULN.
* Patients with another non malignant disease, which could confound the evaluation of primary endpoints, or prevent the patient complying with the protocol.
* Known hypersensitivity to zoledronic acid or other bisphosphonates or each of the compounds which perform the formula.

Other protocol-related inclusion / exclusion criteria may apply
Rotigotine Restless Legs Syndrome Dose Finding Trial

The objective of this trial is to demonstrate clinical efficacy of four different dosages of SPM 962 1.125 mg, 2.25 mg, 4.5 mg and 6.75 mg (corresponding to 2.5 cm2, 5 cm2, 10 cm2 and 15 cm2 patch size respectively) in RLS subjects. It is anticipated that rotigotine (SPM 936) will be more effective than placebo. The tolerability and safety of rotigotine will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Restless Leg Syndrome
* Subject has responded previously, according to medical history information, to L-Dopa therapy and/or treatment with a dopamine agonist, if pre-treated

Exclusion Criteria:

* Secondary restless legs syndrome due to, e.g., renal insufficiency (uremia), iron deficiency anemia, rheumatoid arthritis.
* Secondary restless legs syndrome associated with previous or concomitant therapy with dopamine D2 receptor antagonists, butyrophenones, metoclopramid, atypical antipsychotics (e.g., olanzapine), tri- and tetracyclic antide-pressants, mianserine, lithium or H2-blockers (e.g., cimetidine), or due to withdrawal from drugs such as anticonvulsants, benzodiazepines, barbitur-ates, and other hypnotics.
* History of sleep disturbances like sleep apnea syndrome, narcolepsy, myoclonus epilepsy observed during polysomnography (PSG) or explored in subject history.
* Clinically relevant cardiac dysfunction and/or arrhythmias (e.g., suspected conduction system dysregulations, second or third degree AV block, complete left or right bundle branch block, sick-sinus-syndrome, congestive heart failure Class III or IV by NYHA, myocardial infarction within twelve months prior to enrollment).
* Clinically relevant renal dysfunction (serum creatinine \>2.0 mg/dl)
* Clinically relevant hepatic dysfunction (total bilirubin \>2.0 mg/dl or ALT and/or AST greater than two times the upper limit of the reference range).
* QTc-interval in resting ECG \> 450 msec in males and \> 470 msec in females.
* History of symptomatic orthostatic hypotension within 28 days prior to screening visit (Visit 1), or a systolic blood pressure (SBP) less than 105mmHg at trial entry.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANX005 in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)

This study will evaluate the safety and tolerability of ANX005 in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).

After being informed of study details and potential risks, all participants who provide written informed consent will undergo an up to 6-week screening period to determine eligibility. Participants who meet the eligibility criteria will receive two once-weekly intravenous (IV) infusions of ANX005. Participants will return to the clinic weekly through Week 10 for study assessments. The total duration of individual participation in this study will be up to 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating female ≥18 years of age (no maximum age).
* Diagnosis of wAIHA at least 3 months prior to screening with a direct antiglobulin test (DAT) ≥1 positive for immunoglobulin G (IgG)±C3, or a diagnosis of mixed autoimmune hemolytic anemia (AIHA) that is DAT positive for both IgG and C3, with a presence of a cold antibody with a thermal amplitude ≥30ºCelcius.
* Hemoglobin (Hgb) level ≤10.0 grams/deciliter (pre-transfusion).
* Evidence of classical complement pathway activation.
* Evidence of active hemolysis.
* Stable use of glucocorticoids and immunosuppressants are permitted.
* Vaccinations against encapsulated bacterial organisms within 5 years prior to screening or participant must be willing to receive prophylaxis against infections with encapsulated bacteria via vaccination and/or the use of prophylactic antibiotics in accordance with local standards of practice and/or guidelines.

Exclusion Criteria:

* Elevated aspartate aminotransferase or alanine aminotransferase levels \>2.5 times the upper limit of normal.
* Platelet count \<30 X 10\^9/liter.
* History of cold agglutinin disease.
* History of solid organ, bone marrow, or stem cell transplantation.
* History of splenectomy within the 3 months prior to screening.
* Received rituximab or other anti-CD20 monoclonal antibody \<3 months prior to screening.
* Intravenous immunoglobulin (IVIg) treatment within 3 months prior to screening or plasmapheresis or immunoadsorption treatment within 60 days prior to screening.
* Clinically significant, recent, or ongoing illness or medical condition, including coexistent autoimmune disorder, malignancy, HIV, hepatitis B virus, and hepatitis C virus.
* History of meningitis or septicemia within the past 2 years.
* Treatment with an investigational therapeutic agent within 30 days prior to screening.
* Hypersensitivity to any drug product or excipients used in this study or to previous IV medication administration.
* Body weight less than 50 kilograms (kg) or greater than 100 kg
The Effect of Endurance Training in Patients With Prostate Cancer

The aim of the present study is to investigate the effect of endurance on PSA doubling time in prostate cancer patients with an elevation in PSA following radical prostatectomy for localized cancer. Furthermore, underlying mechanisms such as reduction in inflammatory markers and improvement in insulin sensitivity and body composition are investigated.


Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer patients with an increase in PSA following radical prostatectomy

Exclusion Criteria:

* severe cardiovascular disease
* severe arthritis
* severe neuropathy
* severe hypertension
* therapy with antidiabetic agents
* other treatment for prostate cancer than radical prostatectomy
Post-marketing Surveillance on the Safety of CabometyxTM in Korean Patients

The objective of this Post Marketing Surveillance (PMS) is to collect and describe safety and effectiveness profile of Cabometyx™ in real clinical practice setting, according to the approved labelling after the approval of marketing authorization.


Eligibility Criteria:
Inclusion Criteria:

* Patients who meet 'Indications' of label for Cabometyx™ as monotherapy
* Patients who are treated with Cabometyx™ for the first time according to label for Cabometyx™ as monotherapy
* Patients who are aged 18 years or older
* Patients who are willing to provide written consent after being informed of this surveillance

Exclusion Criteria:

* Patients who are contraindicated for Cabometyx™ based on Cabometyx™ label
Assessment of Early-detection Based on Liquid Biopsy in Lymphoid Malignancies

ASCEND-LYM is a prospective, multi-center, observational study aimed at detecting early stage lymphoma and constrcuting prognostic model by combined assays of cfDNA methylation and other biomarkers. The study will enroll approximately 493 participants including lymphoid malignancies and benign diseases.


Eligibility Criteria:
Inclusion Criteria for All Participants:

* Age 40-75 years at the day of consenting to the study.
* Able to provide a written informed consent.

Additional Inclusion Criteria for Cancer Participants:

* No prior cancer treatment (local or systematic) prior to blood draw.
* High suspicious or pathologically confirmed lymphoid malignancies within 42 days prior to blood draw.

Additional Inclusion Criteria for Benign Disease Participants:

* No prior radical treatment of the benign diseases prior to study blood draw
* Pathologically confirmed diagnosis of lymphoid benign diseases within 90 days prior to blood draw.

Exclusion Criteria for All Participants:

* Insufficient qualified blood samples.
* During pregnancy or lactation.
* Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
* Recipient of blood transfusion within 7 days prior to blood draw.
* Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw, such as rheumatic drugs (methotrexate, cyclophosphamide, or azathioprine), or endocrine drugs (tamoxifen).

Additional Exclusion Criteria for Cancer Participants:

* With other known malignant tumors or multiple primary tumors.
* Lymphoid malignancies unable to comfirmed by imaging tests or pathological cancer diagnosis within 42 days after the blood draw.

Additional Exclusion Criteria for Benign Disease Participants:

* With other known malignant tumors or comfirmed lymphoid malignancies.
* Lymphoid benign diseases unable to comfirmed by imaging tests or pathological cancer diagnosis within 42 days after the blood draw.
Evaluation of the Effect of Pelvic Floor Physical Therapy on Patients With 3rd and 4th Degree Obstetrical Lacerations

The purpose of this study is to determine if patients with third and fourth degree obstetric lacerations benefit from a short course of pelvic floor physical therapy in the immediate postpartum period.

The proposed study is a prospective, randomized pilot trial. We aim to answer the question: do patients with third and fourth degree obstetric lacerations benefit from a short course pelvic floor physical therapy in the immediate postpartum period?

Forty patients experiencing third or fourth degree obstetric laceration at either BIDMC or Mount Auburn Hospital will be identified and randomized in a 1:1 ratio. Half of the patients will receive a 10-12 week course of pelvic floor physical therapy at Marathon PT to begin one to two weeks postpartum. Those assigned to the control will not receive pelvic floor physical therapy which is the current standard of care. They will also agree not to seek pelvic floor physical therapy during until at least 14 weeks postpartum without discussing with study investigators. At 14 weeks postpartum they will be offered pelvic floor physical therapy. At 1-2 weeks postpartum, 6-8 weeks postpartum, and 12-14 weeks postpartum, all study subjects will complete the Pelvic Floor Impact Questionnaire - 7 (PFIQ-7), the Pelvic Floor Distress Inventory - 20 (PFDI-20), the Female Sexual Function Index (FSFI), the Patient Global Impression of Severity (PGI-S) Scale and the Patient Global Impression of Improvement (PGI-I) Scale all of which are validated surveys. Surveys will be completed online via REDCap using computers at Marathon PT for treatment group subjects and at home or in a location of their choosing for control subjects. Control patients will be given the option of beginning pelvic floor PT after 14 weeks postpartum. Should they decide to pursue pelvic floor PT at that time, they will have the option to continue to fill out periodic surveys via REDCap, but will not be required to do so.

Eligibility Criteria:
Inclusion Criteria:

* Vaginal delivery at either BIDMC or Mt. Auburn Hospital complicated by either third or fourth degree perineal laceration
* Age 18 or older

Exclusion Criteria:

* History of previous vaginal delivery after 24 weeks gestation
Assessment of Growth of Infants Fed a New Formula

The purpose of this clinical trial is to assess growth (rate of weight gain in grams per day) of infants fed an infant formula with a whey isolate enriched with lactoferrin, during the first four months of life as compared to infants fed a standard infant formula.


Eligibility Criteria:
Inclusion Criteria:

* Healthy newborn infant
* Full-term (\>37 weeks gestation)
* Birth weight between \> 2500 and \< 4500 g
* Infant's mother has elected not to breastfeed and baby has been exclusively formula fed a minimum 3 days prior to enrollment
* Tolerating a cows milk based formula for at least 3 days
* Study explained and written information provided with Parent/Caregiver demonstrating understanding of the given information
* Informed consent signed (Parent/Legal representative)
* Parent/Caregiver has a working freezer
* Lives within 45 minutes of a study site

Exclusion Criteria:

* Congenital illness or malformation that may affect infant feeding and/or normal growth
* Suspected or known allergy to cow's milk protein
* Significant pre-natal and/or post-natal disease
* Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
* Infant has received oral or intravenous antibiotic therapy in the 10 days prior to enrollment
* Infant receiving prescription medication (with exception of treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
* Infant currently participating in another clinical study
* Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol