cyrilzakka/clinical-trials huggingface dataset:
Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary Insomnia

This study is designed to find the optimal (best) doses of GW679769 that could be given daily to promote sleep onset and maintain sleep during the night without significant next-day thinking impairment and drowsiness in subjects with primary insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Difficulty going to sleep and/or staying asleep for at least the past 3 months.
* Insomnia must result in significant distress or impairment in functioning at home, socially or at work.
* Otherwise good health with no significant or unstable medical disorder including psychiatric, neurological, endocrine, heart, lung or gastrointestinal disorders, drug/alcohol abuse, cognitive impairment, cancer or chronic pain conditions such as arthritis.

Exclusion Criteria:

* History of other sleep disorders such as sleep apnea or restless leg syndrome.
* Regular sleep habits, including bedtime between 9 PM and midnight.
* No nightshift/rotating shift work, frequent napping or planned travel across \>2 time zones.
* Use of nicotine, caffeine and alcoholic products.
SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study

This is a phase 2a, proof-of-concept, 26-week, double-blind, multicenter, randomized, parallel group, placebo-controlled study to compare the efficacy and safety of treatment with SUVN-502 to placebo treatment in subjects with moderate Alzheimer's disease receiving stable doses of donepezil HCl and memantine HCl.

This is a phase 2a, proof-of-concept, 26-week, double-blind, multicenter, randomized, parallel group, placebo-controlled study to compare the efficacy and safety of treatment with SUVN-502 to placebo treatment in subjects with moderate Alzheimer's disease receiving donepezil HCl (10 mg qd) and either memantine HCl (10 mg twice daily \[bid\]) or Namenda XR® (Extended Release, 28 mg qd) or the combination therapy, Namzaric™

The primary objective of the study is to evaluate the efficacy of a serotonin receptor subtype 6 (5-HT6) antagonist, SUVN-502, compared to placebo, as adjunct treatment in subjects with moderate Alzheimer's disease (Mini-Mental State Examination \[MMSE\] score of 12 to 20) currently treated with the acetylcholinesterase inhibitor, donepezil hydrochloride (HCl), and the N-methyl-D-aspartic acid (NMDA) antagonist, memantine HCl. Efficacy will be assessed by the 11-item Alzheimer's Disease Assessment Scale for Cognitive Behavior (ADAScog-11) after 26 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of probable Alzheimer's disease based on the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria at least 1 year prior to the screening visit.
* Has a score between 12 and 20 inclusive on the MMSE at the screening and baseline visits.
* Has a MRI or CT scan performed within 12 months prior to screening with findings consistent with the diagnosis of dementia due to Alzheimer's disease without any other clinically significant comorbid pathologies.
* Must be receiving treatment with stable doses of donepezil HCl and memantine HCl for at least 3 months prior to the screening visit
* Availability of an eligible and reliable caregiver
* Must be living in the community or an assisted living facility.
* Must be ambulatory or ambulatory aided (use of cane or walker).
* Is not pregnant or planning to become pregnant during the study.
* Subject (or subject's legally acceptable representative) and caregiver must sign an Informed Consent to participate in the study.

Exclusion Criteria:

* Has a diagnosis of dementia due to other than Alzheimer's Disease
* Is taking cholinesterase inhibitors other than donepezil HCl or taking doses of donepezil HCl other than 10 mg
* Is taking doses of memantine HCl other than 10 mg bid or Namenda XR® 28 mg qd.
* Has uncontrolled cardiac disease or hypertension.
* Has clinically significant renal or hepatic impairment.
* Has cancer or a malignant tumor, untreated thyroid disorder or has a history of seizure disorder
* Is treated or likely to require treatment during the study, with any medications prohibited by the study protocol.
Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program

The goal of this clinical trial is to the efficacy of the Building a Strong Identity and Coping Skills intervention within a sample of low-income and minoritized youth aged 11-14 who are seeking mental health treatment and have been placed on a waitlist to receive services.

The aims of this study are to: (1) confirm the efficacy of BaSICS by replicating previous findings, (2) Examine the changes of coping mechanisms and symptom change over the course of the BaSICS intervention, and (3) test models of physiologic stress reactivity and regulation to capture biological "risk" and recalibration.

Cohorts of 20 participants will randomly be enrolled in either the intervention (10) or control (10) groups. Participants enrolled in the intervention group will complete the BaSICS program and participants enrolled in the no intervention group will not be enrolled in the intervention program. The BaSICS program is designed to help treat anxiety, depression, and post-traumatic stress symptoms and disorders and have direct effects on physiologic stress response systems (hypothalamic-pituitary-adrenal (HPA) axis). Researchers will compare the intervention and no intervention groups to see if there is a difference in the reduction of markers for anxiety, depression, and suicide scores, changes in coping mechanism, and HPA reactivity profiles


Eligibility Criteria:
Inclusion Criteria:

* Children ages 11-14 at intake
* Family income at or below 200% federal poverty level
* Child speaks English
* Parent speaks English or Spanish

Exclusion Criteria:

* Intellectual disability
* Autism spectrum disorder
* High suicidal risk (score of 17 or more on the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-Kid))
* Severe depression (score of 19 or more on Patient health questionnaire (PHQ).
Prospective Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine

The purpose of this study is to compare the incidence of stomatitis when treating with amifostine before radiation treatment.


Eligibility Criteria:
Inclusion Criteria:

1. 18-70 years old, male or female
2. Primary treatment of phase I-IVA head and neck cancer patients, identified by histological and pathological diagnosis
3. Postoperative patients should receive radiation treatment in 12 weeks
4. ECOG \<2
5. Expected lifetime ≥6months
6. No severe complications (hypertension, CHD, diabetes and psychiatric history, etc.)
7. Not involved in other clinical trials
8. Sign ICF

Exclusion Criteria:

1. ECOG \>2
2. Suffered other cancers in the past 5 years
3. Received amifostine treatment in the past 4 weeks
4. Unable to complete treatment or sign ICF because of medical or physical reasons
Active Your Health: A Workplace Healthy Lifestyle Program

Currently there are very few studies that integrate classical interventions (screening clinics) and online tools in order to obtain sustainable lifestyle changes in workers efficiently. The current project aims to evaluate the efficiency of a combined approach versus the more traditional approach. Health Data collected by CAPSANA in the workplace between 2012 and 2014 showed that, out of 4231 workers, 69% should aim to do more active lifestyle and 74% to a better nutrition profile. In addition, 53% of the sampled population were overweight. In this context, the current project aims to motivate aims to motivate and follow individuals towards a healthier lifestyle. To do so, the Activate Your Health will be implemented and tested using various options (limited to more complete) in several companies.

Currently, lifestyle habits of workers does not only represents a personal concern, but also a concern of the company. Currently there are very few studies that efficiently integrate classical interventions (screening) and online tools in order to obtain sustainable lifestyle changes in workers. The current project aims to evaluate efficacy of a combined approach versus more traditional approaches. Health Data collected by CAPSANA in the workplace between 2012 and 2014 showed that, out of 4231 workers, 69% should aim at a more active lifestyle and 74% at a better nutritional profile. In addition, 53% of the sampled population were overweight.

In this context, the current project aims to motivate and follow individuals towards a healthier lifestyle. To do so, the Activate Your Health will be implemented and tested using various options (limited to more complete) in several companies. It is planned to compare to a control group receiving no intervention to the other groups containing little to complete set of interventions. The content of the interventions involves health assessment, electronic tools (SOScuisine and social media platform), health screening, activity monitor tool and closing events. The companies had to pick which option they would like to provide their employees. It is anticipated that the complete option will yield better results for the activity profile and other lifestyle habits. For example, changes in eating habits toward better habits are expected.

Eligibility Criteria:
Inclusion Criteria:

* French Speaking, work in the participating company.

Exclusion Criteria:

* pregnant women.
Effects Of Spinal Mobilization With Leg Movement on Pain And Disability in Patients With Lumbar Radiculopathy

This study will be a Randomized Control Trial in which Both Genders with Age between 20 to 50 Years who had diagnosed with lumbar radiculopathy will be recriuted in to two groups.group A will be recieving spinal mobilzation with leg movement along with TENS \& hot pack.whie group B will be given only spinal mobilization with TENS \& hot pack.before and after the introduction of interventions pain,disabaility,speed of gait,cadence and SLR will be checked before and after the treatment

Lumbar Radiculopathy is a medical condition that occurs when one or more nerve roots in the spinal cord are compressed or damaged, leading to pain, weakness, numbness or tingling sensations in the affected area of the body. This condition can be caused by herniated discs, spinal stenosis, Degenerative disc disease, tumors and infections.This study will be a Randomized Control Trial.The study will be conducted in district Swabi. We will recruit the data from NCS University Rehabilitation Centre Swabi.oswestry disbaility index will be given at the start of study and NPRS to check their pain and disbaility levels.SMWLM will be given to experimental group.Participants will be given Hot pack for 15 minutes, TENS for 10 minutes.The patient receives a set of three repetitions, then three sets of six repetitions, with a 30-second break in between each set of treatments. In this session, a progression was also provided as free SLR overpressure. A total of 6 sessions will be given thrice a week on alternate days for 2 consecutive weeks. The treatment will be given with 5 repetitions of SMWLM and 10 repetitions of spinal mobilization with three sets of transverse glide. Total time duration of the treatment will be around 25-35 minutes§ Pre assessment will be conducted at baseline followed by intervention for 3 days per week for 6 consecutive weeks.Final assessment will be conducted at the end of 6 weeks of intervention

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with lumbar Radiculopathy with unilateral radiating leg pain.
* Both Genders with Age between 20 to 50 Years.
* Patient willing to participate and complete their follow-ups.
* Pain from (0-35 degrees) in Straight Leg Raise(Dural Pain).
* Positive neurodynamic test i.e. SLR test(35-70 degrees),which indicate sciatica)
* Pain more 3-5 or More on NPRS.

Exclusion Criteria:

* Spinal stenosis.
* Cauda equina syndrome.
* Patients having Somatic referred pain.
* Specific diseases of spine like ankylosing spondylitis, ,vertebral collapse, Rheumatoid arthritis, and Spondylolisthesis.
* Tb spine, intermittent claudication,diabetic neuropathy.
* Recent infection.
* Mental retardation.
* Previous spinal Surgery.
* Pelvis Fracture.
VS-Sense Result Reading Clarity

This study is designed to demonstrate the result reading clarity of the VS-SENSE is substantially equivalent to the result reading clarity of the Nitrazine pH Paper test for vaginal secretions.

Once informed consent has been signed, the clinician will perform the following:

Record baseline variables in the CRF. The 1st clinician will obtain a vaginal secretion sample by using the VS-SENSE swab. The 1st clinician will obtain the specimen by separating the labia to expose the vagina. The yellow tip of the VS-SENSE swab will be inserted into the vagina approximately 5 cm/ 2". The 1st clinician will use the VS-SENSE according the instructions for use - attachment 1 to the protocol.

The 1st clinician will read the VS-SENSE results and record them on the designated form (Clinician Report - VS-SENSE Result form), and fill out the table regarding the VS-SENSE reading clarity on the same form.Vaginal examination (including speculum examination) - will be performed by a 2nd clinician, masked from the results of the 1st clinician test.

The 2nd clinician will use a vaginal swab for pH measurement by Nitrazine pH Paper test. The Nitrazine pH Paper test will be performed according to strict manufacturer's instruction.

The 2nd clinician will read the results of the Nitrazine pH Paper test result, document it on the Clinician Report - pH Test Result form, and fill out the table regarding the pH test reading clarity on the same form.

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic women, ages 18 and above.
2. Subjects willing and able to sign the informed consent form.

Exclusion Criteria:

1. Subjects are unable or unwilling to cooperate with study procedures.
2. Subjects are currently participating in other clinical study that may directly or indirectly affect the results of this study.
3. Women with blood present in their vaginal secretion.
4. Subjects that have had sexual relations or applied vaginal douched within the previous 12 hours.
5. Subjects that applied vaginal medications within the last 3 days.
6. Subjects with symptoms and signs of pelvic inflammatory disease.
Safety and Immunogenicity Study of SeV-G(NP) HIV Vaccine Administered Intranasally and Ad35-GRIN HIV Vaccine Given Intramuscularly in Prime-Boost Regimens in HIV-Uninfected Volunteers

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of Sendai HIV vaccine SeV-G(NP) given intranasally and Ad35-GRIN administered intramuscularly in prime-boost regimens in HIV-uninfected, healthy adult volunteers.

The study is a randomized, double-blind, placebo-controlled, dose-escalation trial assessing the safety, tolerability, and immunogenicity of SeV-G(NP) given intranasally by drops and Ad35-GRIN administered intramuscularly in each of four prime-boost regimens.

Volunteers will be screened up to 42 days before the 1st vaccination and will be followed for 12 months after the last vaccine administration (16 months after the first vaccination). It is anticipated that it will take approximately 6 months to enroll the study. Approximately 64 volunteers (48 vaccine and 16 placebo recipients) will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* healthy male or female adults,
* 18 to 50 years of age (21 to 50 years of age for volunteers in Rwanda),
* who do not report high-risk behaviour for HIV infection,
* who are available for the duration of the trial,
* who are willing to undergo HIV testing,
* use an effective method of contraception, and
* who, in the opinion of the principal investigator or designee, understand the study and who provide written informed consent.

Exclusion Criteria:

* confirmed HIV infection,
* pregnancy and lactation,
* significant acute or chronic disease,
* clinically significant laboratory abnormalities,
* recent vaccination or receipt of a blood product,
* previous receipt of an HIV vaccine, and
* previous severe local or systemic reactions to vaccination or history of severe allergic reactions.
Pre-hospital Agitation and Sedation Trial: A Randomized Controlled Trial of Haloperidol Versus Midazolam for the Sedation of the Agitated Patient

PREHOSPITAL AGITATION AND SEDATION TRIAL (PHAST)

* The goal of the PHAST is to demine whether haloperidol is superior to midazolam for the sedation of agitated patients in the prehospital environment
* The primary outcome is the time to a Richmond Agitation and Sedation Scale (RASS) ≤1

  o The RASS is a well validated standardized score to measure a patient's agitation
* The secondary outcomes are

  * Time until RASS returns to 0 or 1 if RASS \<0
  * Need for additional sedation
  * Adverse effects (need for intubation, arrhythmia)
* Mercy EMS will be the only EMS agency in the Commonwealth of Pennsylvania carrying haloperidol
* Identification of potential study patients will be per state protocols
* Exclusion Criteria for the study
* Age \<18
* Pregnant
* Allergic to study medication
* Transport to hospital other than Mercy Fitzgerald Hospital
* Unable to reach medical command prior to giving medication
* When a paramedic identifies a possible study candidate, the paramedic will consult medical command to see if the patient is appropriate for the study
* If the medical command agrees the patient is appropriate for the study, patients will be randomized to
* Odd days: Haloperidol 5mg IM (age \<65) or haloperidol 2.5 mg IM (age ≥65)
* Even days: Midazolam 0.05 mg IM to maximum of 5mg IM (age \<65) or maximum of 2.5mg (age ≥65)
* The RASS will be documented by the prehospital providers every 5 minutes until arrival at the hospital
* Once the patient arrives at the ED, the RASS will be documented in PICIS® by the emergency department nurse at the time of triage and at a minimum of hourly until the RASS =0 or 1 for 2 consecutive hours
* Questions may be directed to Dr. Isenberg at disenberg@mercyhealth.org or at (267) 205-6453

Richmond Agitation Sedation Scale

RASS RASS Description

* 4 Combative, violent, danger to staff
* 3 Pulls or removes tube(s) or catheters; aggressive
* 2 Frequent non-purposeful movement
* 1 Anxious, apprehensive, but not aggressive 0 Alert and calm

  * 1 Awakens to voice (eye opening/contact) \>10 sec
  * 2 Light sedation, briefly awakens to voice (eye opening/contact) \<10 sec
  * 3 Moderate sedation, movement or eye opening. No eye contact
  * 4 Deep sedation, no response to voice, but movement or eye opening to physical stimulation
  * 5 Unarousable, no response to voice or physical stimulation


Eligibility Criteria:
Exclusion Criteria:

* Age \<18
* Pregnant
* Allergic to study medication
* Transport to hospital other than Mercy Fitzgerald Hospital
* Unable to reach medical command prior to giving medication
Study of Optimizing Neoadjuvant Regimens in Subtypes of Breast Cancer

There are no standard neodjuvant regimens adapted according to the different subtypes of breast cancer. This is a phase 2, randomized study to evaluate several regimens in different subtypes of breast cancer.

Breast cancer is a heterogenous disease with at least 4 intrinsic subtypes including Luminal A, Luminal B, HER2 enriched, Basal-like and normal breast like. Different subtypes have different prognosis and treatment sensitivity. Thus, it would be more suitable to administer different chemo-regimen in different subtypes. This is especially true in neoadjuvant chemotherapy setting where no standard regimen has ever been established. Therefore, we designed this phase 2 randomized clinical trial to explore potential effective regimens in variable subtypes of breast cancer in neoadjuvant treatment. Patients were first classified into Luminal type, Her2 positive type and triple-negative type by immunohistochemistry exam of ER/PR/HER2 in core needle biopsy and then randomized to received either dose dense paclitaxel in Luminal type or dose dense paclitaxel plus carboplatin with or without trastuzumab in HER2 positive type or dose dense paclitaxel plus carboplatin in triple-negative type.The control groups in each subtype all receive paclitaxel plus epirubicin every 3 weeks. The duration of treatment is 4-6 cycles. Primary endpoint is the pathological CR rate in each subtypes. Secondary endpoints include disease free survival, objective response rate, safety. Tissue samples and blood samples will be collected at baseline and during treatment. There will be exploratory biomarkers analyses to identify predictive markers for efficacy in every subtypes.

Eligibility Criteria:
Inclusion Criteria:

* Stage IIa-IIIc breast cancer patients plan to receive neoadjuvant chemotherapy
* Patients have enough tissue sample to do IHC test for subtype classification
* Patients have at least one measurable lesion according to RECIST1.1
* KPS≥80
* No prior treatment for breast cancer
* Adequate bone marrow (neutrophil count ≥1500 ml and platelet count ≥100,000 ml), renal (serum creatinine \<1.5 times the upper limit of normal \[ULN\] or a creatinine clearance of ≥60 ml/minute), hepatic (total bilirubin ≤1.5 ULN; alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase ≤2.5 ULN), and cardiac function (assessed by electrocardiogram or thoracic radiography) were required.

Exclusion Criteria:

* Fertile women were excluded if pregnant or lactating or if they were not using adequate contraception.
* Previous chemotherapy for breast cancer.
* history of other serious illness (e.g. congestive heart failure, angina pectoris, uncontrolled hypertension or arrhythmia, clinically significant neurologic or psychiatric disorders, uncontrolled serious infection, AIDS), had an organ allograft, severe gastrointestinal disorder, or other neoplasias (except for in situ cervical cancer, non-melanoma skin cancer, or previous diagnosis of cancer with no evidence of disease for \>10 years).
Cross-over Study to Investigate Retinal Function Following Administration of a Single Dose of AZD9056

The purpose of the study is to determine whether treatment with a single 800mg dose of AZD9056, a medication which has been developed as a possible treatment for Rheumatoid Arthritis, has an effect on the function of the retina


Eligibility Criteria:
Inclusion Criteria:

* Volunteers must be able to undergo the Electroretinography assessments
* Volunteers must have an intra ocular pressure of less than 25mmHg and 6/6 vision

Exclusion Criteria:

* Volunteers must pass a test that assesses whether they are at risk of narrow angle glaucoma
* Volunteers must not a family history of colour blindness, they must also pass a colour blindness test
* Volunteers must not have a history or current neurological or opthalmological (eye) disease