cyrilzakka/clinical-trials huggingface dataset:
Multiple Dose Escalation Trial Of PF-04603629 Given To Subjects With Type 2 Diabetes Mellitus

PF-04603629 is being investigated for the treatment of Type 2 diabetes mellitus (T2DM). Specifically, PF-04603629 is a protein that is a combination of exendin-4 (a glucagon-like peptide-1 (GLP-1) mimetic currently marketed as Byetta®) fused to human transferrin (a naturally occuring protein) in order to increase the concentration of exendin-4 in the blood. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04603629 following multiple escalating subcutaneous doses in adult subjects with T2DM.

B0571002 was terminated August 19 2008 due to the decision to discontinue development of PF-04603629 after observing (in both B0571001 and B0571002) a trend for a reversible increase in heart rate within the normal range, which occurred at efficacious doses. Thus, the compound was primarily terminated due to safety concerns, although there was no immediate safety risk to any subject in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus who are not taking any treatment or are taking metformin (with no change in the treatment, including dose, over the past 2 months). Subjects previously treated with a sulfonylurea in combination with metformin may be eligible if switched over to metformin only for a minimum of 4 weeks before dosing.
* Male and/or female subjects (females will be women of non-childbearing potential) between the ages of 18 and 70 years, inclusive.
* Body Mass Index (BMI) of approximately 22 to 40 kg/m2
* Fasting C-peptide test result must be \>0.4 nmol/L.
* HbA1c ≥7% and ≤11%. If the subject requires to be washed off a sulfonylurea, the HbA1c limits will be ≥7% and ≤9.5%.

Exclusion Criteria:

* Screening fasting blood glucose, ≤60 or ≥270 mg/dL. One repeat screening fasting blood glucose will be allowed.
* Previous treatment with an approved or investigational GLP-1 mimetic.
* Have a known allergy to yeast, yeast-derived or yeast containing products.
Single-Session Psychotherapy for Young Kids Through Patient Engagement Techniques

The goal of this clinical trial is to compare outcomes between participants in the single-session psychotherapy for young kids (SPYKids) conditions and participants in the services as usual (SAU) condition. The main questions it aims to answer are:

* What is the feasibility and acceptability of SPYKids compared to services as usual?
* What are the changes in child mental health between the SPYKids group compared with the SAU group?

Participants will

* Fill out questionnaires at baseline, immediately post-program, approximately one month after the baseline assessment, and three months after the baseline assessment
* Meet with a parent coach in a virtual 90-minute session to discuss coping strategies relevant to their identified concerns

Researchers will compare participants in the SPYKids group with participants in the Services as Usual group to see if there are changes in child well-being, parent well-being, and parent self-efficacy.

The coronavirus disease of 2019 (COVID-19) pandemic has contributed to elevated stress experienced by parents and caregivers of children with neurodevelopmental disorders (NDDs) resulting in increased demand for relevant specialized services. Current waitlists for NDD assessments following referral are approximately 12 months in Manitoba, with similar lengths of 6-30 months across Canada, which can result in children aging out of some early intervention services. The SPYKids program aims to provide families with help, encouragement, and motivation to cope with family stressors while on waitlists at local organizations through a single-session consultation model. A single-session intervention (SSI) is designed to increase parental ability to understand and address emergent mental health problems by teaching parents how to support children's emotional development and impulse control to reduce mental health problems, while reducing high-conflict parenting that can worsen mental health over time. The present study aims to test the feasibility and value of SSIs in a 2-arm randomized control trial which will include one 90-minute consultation with psychoeducation, identification of a primary mental health issue, an opportunity to practice the skills, and an action plan for the family to apply the skills independently. The long-term goal is to create an evidence-based accessible and rapidly deployable intervention to promote well-being for children with NDDs and their families.

Eligibility Criteria:
Inclusion Criteria:

* Manitoba resident with a Manitoba IP address
* Caregiver must be at least 18 years old
* Primary caregiver of 2-5-year-old child
* Must be on a waitlist for neurodevelopmental services in Manitoba

Exclusion Criteria:

* Living outside of Manitoba and/or internet protocol (IP) address outside of Manitoba
* Child is outside of the 2-5-year-old age range
* The caregiver is younger than 18 years old
* Not on a waitlist for neurodevelopmental services
Pharmacokinetic of Tadalafil Co-administered With Tipranavir/Ritonavir to Healthy Male Volunteers

Study to assess the effects of single-dose and steady-state tipranavir/ritonavir 500 mg/200 mg on the single-dose pharmacokinetics of tadalafil 10 mg


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Healthy male subjects aged between 18 years and 55 years inclusive
3. Weighing at least 40 kg
4. Volunteers must be hospitalized on day of pharmacokinetic assessments for each regimen
5. Volunteers must be willing to complete all study-related activities
6. Each volunteer must have a valid social security regimen
7. Each volunteer must have acceptable medical history, physical examination and laboratory test
8. Volunteers with negative HIV serology

Exclusion Criteria:

1. History or presence of allergy to the study drugs or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation. (If heparin is used during pharmacokinetic (PK) sampling, subjects with a history of sensibility to heparin or heparin-induced thrombocytopenia should not be enrolled)
2. Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, haematological, oncological or hormonal disorders
4. Known elevated liver enzymes in past clinical trials with any compound (experimental or marketed)
5. Clinically relevant laboratory abnormalities and all abnormal laboratory values \>Grade 1, based on the Division of AIDS Grading Scale
6. Subjects with a history of any illness or allergy that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering tipranavir, ritonavir or tadalafil to the subject
7. Volunteers who are using any form of organic nitrate, either regularly and/or intermittently (contraindication to use tadalafil)
8. Hypersensitivity to tadalafil, tipranavir, ritonavir or their excipients
9. Concurrent treatment with other experimental compounds
10. Inadequate venous access
11. Contraindications to tadalafil: Volunteers with mild or moderate hepatic impairment, Renal insufficiency or Cardiovascular disease (patients with a myocardial infarction within the last 90 days, unstable angina or angina occurring during sexual intercourse, patients with New York Heart Association Class 2 or greater heart failure in the last 6 months, patients with uncontrolled arrhythmias, hypotension (\<90/50 mm Hg), or uncontrolled hypertension (\>170/100 mm Hg), and patients with a stroke within the last 6 months)
12. Clinically unacceptable result at the screening physical examination
13. Use of investigational medications within 30 days before study entry
14. Patients hospitalized in a medical or social establishment, for any other reason than research
15. People deprived of judicial or administrative freedom.
The Safety and Effectiveness of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Who Have Had PCP Before

To evaluate and compare the safety, tolerability, and efficacy of biweekly administration of 1 of 3 doses of aerosol pentamidine when used as a prophylactic agent in patients who have recovered from their first episode of AIDS-associated Pneumocystis carinii pneumonia (PCP).


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Zidovudine (AZT).

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those with either of the following AIDS-defining O.I.'s prior to entry:
* Toxoplasmosis.
* Cryptococcosis.
* Transfusion dependent (requiring blood transfusion more than once per month). The last transfusion cannot have been given within 7 days of study entry.
* Pulmonary Kaposi's sarcoma (KS).
* Asthma requiring medication.
* Active therapy for tuberculosis.

Concurrent Medication:

Excluded:

* Active therapy for tuberculosis.

Patients with the following are excluded:

* Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those with either of the following AIDS-defining O.I.'s prior to entry:
* Toxoplasmosis.
* Cryptococcosis.
* Transfusion dependent (requiring blood transfusion more than once per month). The last transfusion cannot have been given within 7 days of study entry.
* Pulmonary Kaposi's sarcoma (KS).
* Unwilling to sign informed consent.
* Cannot cooperate with study procedures.
* Asthma requiring medication.

Prior Medication:

Excluded within 30 days of study entry:

* Antiretrovirals other than zidovudine (AZT).
* Immunomodulating agents.
* Corticosteroids.

Patients must:

* Have AIDS and recovered from their first episode of cytologically or histologically proven Pneumocystis carinii pneumonia (PCP).
* Be at least 2 weeks and no more than 24 weeks status post therapy for acute PCP.
* Have positive antibody to HIV by any federally licensed ELISA test kit, or confirmed Western blot test.
* Have adequate pulmonary function (vital capacity = or \> 80 percent of predicted; forced expiratory volume (FEV), 1 s = or \> 65 percent of total FEV; and corrected pulmonary diffusion capacity \> 60 percent of predicted).
* Free of acute medical problems.

Active substance abuse.
Study Evaluating Novel Biomarkers of AKI (Acute Kidney Injury) in Post-operative Patients

To validate the use of \[TIMP-2\]●\[IGFBP-7\] to predict AKI in patients undergoing major intra abdominal surgery.

A prospective pilot single center study to investigate the potential of \[TIMP-2\].\[IGFBP-7\] to predict AKI (Acute Kidney Injury) in patients undergoing major abdominal surgery. The investigators will measure the biomarker once preoperatively and 4-times postoperatively starting at arrival on PACU (post anesthesia care unit).The primary endpoint of this study is the development of AKI stage 2 or 3 within the first 72 postoperative hours.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* High risk patients: General Surgery AKI Risk Index Class III, IV or V
* Major abdominal surgery

Exclusion Criteria:

* Ongoing acute kidney injury Stage 2/3
* History of kidney transplant
Circle of Life. Improving Capacity of Swampy Cree Community Members to Recognize People at Risk for Suicide

Primary Hypothesis: Participants in the Applied Suicide Intervention Skills Training (ASIST) gatekeeper training will be significantly more likely to have increased knowledge and preparedness to help people with suicidal ideation than participants who receive the resilience retreat.

Secondary Hypotheses:

1. Participants in ASIST gatekeeper training will not have higher levels of post-intervention distress or suicidal ideation compared to the resilience retreat.
2. High levels of distress, grief, and alcohol abuse will significantly impact on the learning and retention of suicide intervention skills.

Inclusion criterion: All members of the Swampy Cree Tribal communities who are currently residing on the reserves will be eligible to participate in the study.

Exclusion criterion: Exclusion criteria for the study include being less than 16 years of age, prior training in SafeTALK or ASIST, being an elected official in a First Nations community, and inability to read or write.

Primary outcome: Skills in Suicide Intervention: Suicide Intervention Response Inventory.The Suicide Intervention Response Inventory (SIRI) will be used to detect enhancement of intervention skills in participants. The SIRI is a self-administered test that was designed to measure competence in choosing appropriate response to a series of clinical scenarios with suicidal individuals. Research on the SIRI has shown its good psychometric properties, freedom from social desirability effects, and responsiveness to training in suicide prevention. It contains 25 items, each of which consists of a "client" remark and two "helper" responses. Responses are judged based on response options made by highly expert suicidologists. The SIRI has shown good internal consistency with alpha of 0.834, and good test-retest reliability.

Secondary Outcomes:

* Knowledge about suicide, attitudes toward suicide, and self-reported preparedness to intervene with suicidal behavior will be measured by a series of questions that were developed by LivingWorks Inc.
* Gatekeeper behaviors will be measured similar to questions utilized by Wyman in the school-based study that assess how many people had the person asked others about suicide.

Eligibility Criteria:
Inclusion Criteria:

* All members of the Swampy Cree Tribal communities who are currently residing on the reserves will be eligible to participate in the study.

Exclusion Criteria:

* being less than 16 years of age
* prior training in SafeTALK or ASIST
* being an elected official in a First Nations community
Comparing IVF/ICSI Cycle Outcomes of Post Ovulation Ovarian Stimulation Protocol with Elonva Without GnRH Antagonist to Follicular Phase Day 2 Stimulation Fixed Day 5 Antagonist Protocol

There are several approaches to the timing of antagonist administration in IVF/ICSI cycles. The primary goal is indeed to prevent premature ovulation, which could jeopardize the success of the cycle There is an emerging concept that suggests that the progesterone produced by the corpus luteum (formed after ovulation) might be sufficient to prevent further ovulation, obviating the need for antagonist or exogenous progesterone administration. This hypothesis relies on the natural regulatory mechanisms of the menstrual cycle to maintain a progesterone-dominated environment post-ovulation. We hypothesized that this approach would minimize treatment costs /burden without having an impact on the outcome.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 38 years old.
* Normal Menstrual cycle of 25-35 days.
* Body Weight 60to90 kg
* AMH\>1.3 - \<3 ng/m (Ferraretti and Gianaroli, 2014; Calzada et al., 2019) an antral follicle count (AFC) of \>5 on menstrual cycle days 2-3,

Exclusion Criteria:

* History of premature ovulation
* Azoospermia
* PCOS
* Endometriosis AFS ¾
* Endometrioma
* Known chromosomal abnormalities
Perioperative Local Anesthesia Block in Spine Surgery

The purpose of the this study to evaluate the feasibility, safety, and efficacy of a fluoroscopically-guided dorsal ramus block placed by the operative neurosurgeon prior to lumbosacral surgery. The study will consist of a retrospective analysis of a cohort of patients who underwent lumbosacral surgery patients between June 2018 and March 2021 with or without a preoperative fluoroscopically-guided dorsal ramus (DR) block placed by the operative neurosurgeon.

Spine surgery poses unique challenges in postoperative pain management. Local anesthetic blocks, namely the erector spinae plane and thoracolumbar interfacial plane blocks, placed by anesthesia under ultrasound guidance have been shown to reduce postoperative pain after spinal surgery and decrease perioperative opioid requirements by as much as 50%. Nonetheless these procedures are not routinely performed, likely due to logistical hurdles and lack of widespread knowledge of the procedure by anesthesiologists. A preoperative dorsal ramus block performed by the operative neurosurgeon under fluoroscopy shows promise as an alternative approach to perioperative pain control. The objective of this retrospective observational study is to evaluate the feasibility, safety, and efficacy of a dorsal ramus block block performed by a neurosurgeon under x-ray guidance prior to lumbar surgery. The study will include a cohort of patients who have undergone lumbar spine surgery with or without the x-ray guided dorsal ramus block. A retrospective chart review of these patients will be performed to assess for postoperative pain control, postoperative opioid requirements, time to block completion, length of stay, and adverse events. Descriptive and comparative statistics will be performed. No new data will be gathered from the subjects beyond pre-existing data within the medical record, and no new procedures will be performed as part of the study. If the current study suggests that a dorsal ramus block performed by the operative neurosurgeon is feasible, safe, and effective, it will serve as a foundation for a randomized clinical trial of such a block among patients undergoing lumbar surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older
* Patients undergoing lumbar spine surgery at any spinal level from L1 to sacrum (including decompression, discectomy, posterior fusion, interbody fusion, wound revision or washout, intradural tumor resection, treatment of vascular spinal lesion, tethered cord release, repair of cerebrospinal fluid (CSF) leak, hardware removal)

Exclusion Criteria:

* Patients undergoing surgery that includes thoracic levels
* Patients from whom pain scores could not be elicited in the immediate postoperative period due to mental status (e.g. prolonged intubation requirement, etc.)
Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries

Multilevel decompression and bone graft fusion is a most effective measure for treating degenerative lumbar spinal diseases. Yet, the surgery is commonly associated with large amount of perioperative blood loss and high demand for homologous blood transfusion. Tranexamic acid (TXA) has been proved as efficient in reducing the gross blood loss in various kinds of surgeries. However, high quality evidence of its efficacy and safety is still lacking in lumbar spinal surgeries. Besides, systemic use of TXA carries the risks of thromboembolic complications such as deep venous thrombosis and pulmonary embolism, thus the optimal drug delivery route of TXA remains undetermined. The aim of this study is to test the non-inferiority of topical TXA application to its intravenous use in multilevel decompression and bone graft fusion surgeries. A prospective, randomized, double-blind, head-to-head comparison study design will be adopted.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists(ASA)classification of physical status I-II.
* Aged over 50yrs.
* Patients suffering from spinal stenosis or intervertebral disc displacement and require multilevel decompression and bone graft fusion surgeries.
* Written informed consent.

Exclusion Criteria:

* ASA III-IV.
* Age≤ 50yrs.
* History of chronic renal dysfunction (preoperative blood creatinine\> 120mmol/L), liver dysfunction (preoperative blood aspartate or alanine aminotransferase\> 50 units/L) or history of coronary artery disease with stent placement.
* Abnormal preoperative coagulation profile (preoperative prothrombin time elongation\> 3s, activated partial thromboplastin time elongation\> 10s, platelet counts\< 100\*10\^9/L or \>400\*10\^9/L, or INR\> 1.4).
* Pre-existing anemia (male\< 12g/dL, female\<11g/dL).
* Long-term medications of aspirin and/or other anticoagulants.
* Patients known as allergic to TXA.
* Patients who have religious and/or other beliefs limiting blood transfusion.
* Dura mater laceration and/or unexpected massive bleeding during operation.
* Cell saver application during operation.
Deep Electrical Neuromodulation in Obsessive-compulsive Disorder

Obsessive-compulsive disorder (OCD) is a neuropsychiatric disease characterised by intrusive, recurrent and persistent thoughts, urges or images (obsessions) and the resulting excessive repetitive behaviours or mental acts according to rigid rules unrealistically aimed at reducing distress (compulsions).

Its lifetime prevalence in the general population is usually estimated between 1 - 3% (Ruscio, Mol Psychiatry, 2010). Despite appropriate pharmacological and cognitive-behavioural treatments, it is commonly estimated that 10% of patients are therapy-refractory and that among improved or recovered patients, sustained efficacy is uncertain.

For treatment refractory OCD patients, a neurosurgical treatment by deep brain stimulation (DBS), has emerged in the late 1990s as a new therapeutic option (Nuttin et al, Lancet, 1999).

The objective of the current study is to report the long-term treatment effects (safety and effectiveness) of DBS from the cohort of six severe and therapy-refractory OCD patients implanted at the French university hospital of Montpellier since 2003.

The data needed to carry out the study will be extracted from the medical files of the 6 patients concerned.

The following data will be collected:

* Age, sex
* Medical, surgical and psychiatric history
* History of pharmacological treatments
* Elements from clinical examination
* any reported adverse effect
* scores of the various questionnaires completed throughout the follow-up (including Y-BOCS and GAF)
* results of biological, morphological, neuropsychological tests
* Stimulation parameters applied since implantation.

Eligibility Criteria:
Inclusion criteria:

* all patients with severe and refractory OCD according to DSM-IV criteria, confirmed by experienced psychiatrist
* treated by DBS at the CHU of Montpellier

Exclusion criteria:

- already enrolled in a study protocol at time of implantation
Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in TKI-Treated Advanced Digestive Tumors

This study is a prospective, observational clinical study aimed at evaluating the efficacy of Megestrol Acetate for cachexia in patients with advanced digestive system tumors receiving TKI-based therapy.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily sign a written informed consent (ICF).
* Age ≥ 18 years at enrollment.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Life expectancy ≥ 3 months.
* Histologically or cytologically confirmed locally advanced or metastatic digestive system tumors that are not amenable to curative treatment, according to the 8th edition TNM staging classification.
* Not benefiting from local anticancer therapies such as surgery, local ablation, or chemoembolization, and planned to receive TKI-based anticancer treatment, which may be combined with chemotherapy or immunotherapy).
* Meet the diagnostic criteria for pre-cachexia or cachexia (based on Fearon diagnostic criteria).
* Good organ function determined

Exclusion Criteria:

* Gastrointestinal obstruction.
* Anorexia due to difficulty in eating caused by neurosis, mental illness, or pain.
* Comorbidities such as severe cerebrovascular, cardiac, renal, or liver diseases.
* Major surgery or trauma within the last month.
* Allergy to any component of the investigational drug.
* Other conditions deemed unsuitable by the investigator.