cyrilzakka/clinical-trials huggingface dataset:
Predictors of Depression Treatment Response to Exercise

50 subjects with Major Depressive Disorder who are not currently receiving treatment will be enrolled in a 12-week exercise program, supervised by a trained exercise interventionist.

50 subjects with Major Depressive Disorder who are not currently receiving treatment will be enrolled in a 12-week exercise program, supervised by a trained exercise interventionist. Blood samples will be collected at baseline for analysis of inflammatory cytokines, as well as other potential biological predictors of treatment outcomes (i.e., BDNF). Assessments will gather data on potential clinical predictors of treatment outcomes (anxiety, stress, sleep). Assessments and sample collection will also occur at 3 time points during the treatment period (Weeks 4, 8, and 12) to identify mediators and correlates of treatment effects.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with MDD
2. Ages 18-65 will be included.
3. Ability to understand and willingness to provide written informed consent.
4. Willing to provide contact information.
5. Medical clearance with protocol-defined stress testing (in accordance with American College of Sports Medicine (ACSM) guidelines) from protocol approved medical personnel. Details of guidelines and related testing protocol are provided in the study Manual of Procedures.
6. Able to comprehend and communicate in English.

Exclusion Criteria:

1. Have a medical condition contraindicating exercise participation
2. Are currently physically active - defined as moderate intensity physical activity on 3 or more days per week for the last month
3. Currently receiving antidepressant medication treatment
4. Currently considered a high suicide risk and/or high risk for being unable to complete the study due to the need for psychiatric hospitalization, suicide attempts or suicidality, significant self-mutilation, or other self-injurious or destructive behavior based on the judgment of the site PI, medical personnel, or designee.
5. Pregnancy.
6. Current psychotic disorder. Other comorbid psychiatric diagnosis that, in the investigator's judgment, will pose a safety issue or make it difficult for the participant to understand or complete the intervention.
7. Anticipated circumstances over the 6-month course of the trial that would render the participant unlikely to complete the study in the judgment of the PI or designee.
8. Any reason not listed herein yet, determined by the PI, medical personnel, or designee that constitutes good clinical practice and that would in the opinion of the PI, medical personnel, or designee make participation in the study hazardous.
9. Are currently enrolled in another research study, and participation in that study contraindicates participation in the current study
D-chiro Inositol in Prevention of Gestational Diabetes Mellitus in China

Inositol is a type of food additives, which plays an important role in insulin signal pathway and is related to insulin sensitivity. Our randomized, double-centered, placebo-controlled study is planned to recruit 360 pregnant women who is in high risk for gestational diabetes. They will be assumed randomly 1 g of D-chiro inositol per day or placebo from 12-16th gestational weeks until Oral Glucose Tolerance Test (OGTT) at 24-28th gestational weeks. Perinatal outcomes about delivery time, neonatal weight will be registered.


Eligibility Criteria:
Inclusion Criteria:

* During 12-16 weeks gestation
* Meet any of the following: prepregnancy BMI \> 24, family history of diabetes (type 1 or 2), GDM history, history of delivering macrosomia, gestational history of stillbirth;
* Willing to participate

Exclusion Criteria:

* Type 1 or type 2 diabetes mellitus diagnosed before pregnancy
* Multiple gestation
* Mental or cognitive impairment cannot complete the study
A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS

To evaluate the safety and tolerance of long-term ganciclovir (DHPG) therapy for newly diagnosed macular threatening Cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate the clinical response to a 52 week course of intravenous DHPG therapy. To evaluate the safety and tolerance of long-term DHPG with concurrent treatment with zidovudine (AZT). (Patients utilizing treatment with other anti-retroviral drugs will be considered for study entry on a case by case basis.) To determine survival in this group of patients with AIDS and CMV retinitis.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Topical acyclovir.
* Selected cytokines.
* Allowed after the first 4 weeks of ganciclovir:
* Zidovudine (AZT) at a reduced dose (500 mg/day) in patients who have tolerated ganciclovir without grade 3/4 hematological toxicity.
* Other anti-retrovirals after consultation with the Syntex study monitor.

Patients must have the following:

* AIDS and newly diagnosed Cytomegalovirus (CMV) retinitis.
* An understanding of the nature of the study, agreement to its provisions, and willingness to sign the informed consent approved by the appropriate institutions review board, and Syntex.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Have only peripheral CMV retinitis (defined as a lesion outside the major temporal vascular arcades, greater than 1500 microns from the optic disk, or greater than 3000 microns from the fovea).
* Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment.
* Ocular conditions requiring immediate surgical correction (eg:
* retinal tear or detachment).
* Demonstrated hypersensitivity to acyclovir or ganciclovir.
* Dementia, decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the patient to comply with the protocol.

Concurrent Medication:

Excluded:

* Antimetabolites.
* Alkylating agents.
* Nucleoside analogs (excluding selected anti-retroviral agents).
* Imipenem-cilastatin.
* Interferons.
* Selected cytokines.
* Acyclovir (except topical acyclovir).

Patients with the following are excluded:

* Have only peripheral CMV retinitis (defined as a lesion outside the major temporal vascular arcades, greater than 1500 microns from the optic disk or greater than 3000 microns from the fovea).
* Concomitant conditions or diseases described in Exclusion Co-Existing Conditions.

Prior Medication:

Excluded within 1 month of study entry:

* Previous treatment with anti-cytomegalovirus therapy (e.g., ganciclovir, foscarnet or CMV hyperimmune globulin).
Entospletinib (ENTO) as Monotherapy and in Combination With Chemotherapy in Japanese Adults

The primary objective of this study is to evaluate the safety and tolerability of entospletinib (ENTO) monotherapy and in combination with chemotherapy in Japanese participants.


Eligibility Criteria:
Key Inclusion Criteria:

* ENTO monotherapy (Group A): relapsed or refractory hematologic malignancies by World Health Organisation (WHO) criteria and who are not eligible to receive standard of care
* ENTO + cytarabine + daunorubicin (Group B): previously untreated AML by WHO criteria, who are deemed fit for cytarabine and daunorubicin (7+3) induction chemotherapy and are able to undergo up to 2 cycles of induction chemotherapy, as determined by the treating physician
* Must have been born in Japan and must not have lived outside of Japan for a period \> 1 year in the 5 years prior to Day 1 of study treatment
* Must be able to confirm the Japanese origin of their maternal and paternal ancestry

Key Exclusion Criteria:

* Known active central nervous system or leptomeningeal leukemic involvement
* Ongoing liver injury, or known infection with chronic active hepatitis C virus (HCV) or chronic active hepatitis B virus (HBV)

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
AZD2115 Single Ascending Dose Study

AZD2115 Single Ascending Dose Study


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged 18 to 45 years with suitable veins for cannulation or repeated venepuncture
* Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the day of dosing until 3 months after dosing with the investigational product.
* Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
* Be able to inhale from a Spira nebuliser according to given instructions

Exclusion Criteria:

* Prolonged QTcF \>450 ms or shortened QTcF \<340 ms or family history of long QT syndrome
* Any clinically important abnormalities in heart rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes. This includes subjects with any of the following:

  * PR (PQ) interval prolongation \>200 ms (first degree AV block)
  * Intermittent second or third degree AV block (based on screening or pre-dose ECG)
  * Incomplete, full or intermittent bundle branch block (QRS \<110 ms with normal QRS and T wave morphology is acceptable if there is no evidence of left ventricular hypertrophy)
  * Abnormal T wave morphology, particularly in the protocol defined primary lead
  * Dropped beats
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD2115 and/or excipients
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Serum potassium concentration of \<3.80 mmol/L on admission (Day -1)
Impact of Visceral Osteopathic Treatment on Meconium Evacuation in Preterm Infants

Timing of the first and last meconium stool is critical for oral feeding tolerance and proper gastrointestinal function. The time until premature infants pass their first meconium ranges from 1 hour to 27 days (median: 43 hours). Obstruction of the gastrointestinal tract by tenacious, sticky meconium frequently leads to gastric residuals, a distended abdomen and delayed food passage Recent data support the concept that complete rapid evacuation of meconium plays a key role in feeding tolerance . If duration to full enteral feedings is extended, the probability to acquire infections due to intravenous access for parenteral nutrition increases and hospital stay of the infant prolongates. Previously two prospective trials focusing on the problem of delayed meconium evacuation in preterm with different therapeutic pharmacological approaches were published by our group. None of the applied therapies appeared to be effective or had a beneficial effect- quite the contrary one agent (Gastrografin) was supposed to have severe negative side effects. Therefore we were looking for an alternative, non-invasive, holistic solution for the problem of delayed meconium excretion. Osteopathic treatment with the emphasis on the relationship of the structural and functional integrity of the body and with its variety of therapeutic manual techniques seemed to be remedy. Treating the abdomen of premature infants with visceral osteopathic techniques might be more effective to mobilize meconium from small bowel and deep parts of the colon. Therefore we hypothesized that repeated visceral osteopathic treatment accelerates meconium evacuation in premature infants, and thereby enhances feeding tolerance in this population.


Eligibility Criteria:
Inclusion Criteria:

* premature infants with a birthweight 1500 gram

Exclusion Criteria:

* major congenital malformations
* known gastrointestinal abnormalities
A Clinical Observation on Neuropsychology and Electrophysiology in Headache Patinets With Myofascial Trigger Points

To study the clinical characteristics of headache patients with pericranial myofascial trigger points(MTrPs),and to explore the possible pathogenesis of MTrPs,investigators hope to find the possible electrical biomarkers for clinical diagnosis and treatment, and to improve the effect of headache treatment.

A series of neuropsychological test scale including Mini-mental State Examination(MMSE),Hamilton Anxiety Rating Scale(HAMA) and Hamilton Depression Rating Scale (HMAD) were evaluated among all patients.The needle pole electromyography (EMG) inspection were practiced on subjects with myofascial trigger points ,for analysing those electrophysiological characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Primary headache patients with pericranial myofascial trigger points.

Exclusion Criteria:

* Cranial weeks muscle infection or trauma, medical history, physical examination, laboratory and imaging studies suggest secondary headache patients except cervicalheadache.
Low Intensity Ultrasound in Patients With Carpal Tunnel Syndrome

To investigate the influence of low intensity pulsed ultrasound on Pain level, pinch grip strength, sensory distal latency of the median nerve, motor distal latency of the median nerve and hand function in patients with chronic carpal tunnel syndrome

Carpal tunnel syndrome (CTS) is an entrapment neuropathy caused by compression of the median nerve as it travels through the wrist's carpal tunnel. It is the most common nerve entrapment neuropathy, accounting for 90% of all neuropathies. Early symptoms of carpal tunnel syndrome include pain, numbness, and paresthesia. These symptoms typically present, with some variability, in the thumb, index finger, middle finger, and the radial half (thumb side) of the ring finger. Pain also can radiate up the affected arm. With further progression, hand weakness, decreased fine motor coordination, clumsiness, and thenar atrophy can occur.

Low-intensity ultrasound (LIU) and low-intensity pulsed ultrasound (LIPUS) are known to have positive effects on dentin genesis, cell proliferation, protein synthesis, collagen synthesis, membrane permeability, and integrin expression and to increase cytosolic calcium levels.

Eligibility Criteria:
Inclusion Criteria:

1. 26 male and 26 female patients have unilateral with mild to moderate CTS in dominant hand diagnosed and referred by physician.
2. Age will be ranged from 30-50 years
3. All patients have body mass index between 18.5 and 24.9 kg/m2
4. Median nerve sensory distal latency \> 3.5 millisecond but not more than 4.5 millisecond, motor distal latency longer than 4.2 millisecond but not exceed 6.5 millisecond.
5. Positive clinical manifestation (pain, paresthesia in the distribution of the median nerve for 6 months, positive Tinel's and Phalen's sign)

Exclusion Criteria:

1. Patients with diabetes mellitus ( type I or type II),
2. Patients with hypothyroidism
3. Patients with rheumatoid disease
4. Patients with renal disease
5. Patients with polyneuropathy
6. patients with cervical radiculopathy
7. Patients with wrist arthritis , wrist fracture and acute trauma
8. Patients with Carpal tunnel release surgery
9. Patients with outlet syndrome
10. thenar muscle atrophy -
University of Washington Reading & Dyslexia Research Program

Subjects are recruited for a pre-kindergarten education program focusing on early literacy skills. Primary outcomes are improvement in letter knowledge and changes in brain response to text.


Eligibility Criteria:
Inclusion Criteria: Typically developing children enrolled before kindergarten.

* Typically developing child between 60 and 72 months of age
* Has not yet begun Kindergarten

Exclusion Criteria:

* Reported neurological or psychiatric condition.
* Claustrophobia. ADHD
Fluciclovine (Axumin) PET/CT vs. NaF PET/CT in Prostate Cancer Osseous Metastatic Disease

The purpose of this study is to look at whether F-18 Fluciclovine (i.e. Axumin) is better or as good as F-18 Sodium Fluoride (F-18 NaF) when looking at bone disease from prostate cancer. Axumin is a radioactive agent used on a positron/computed tomography (PET/CT) camera to look for prostate cancer in general.

The study will assess the diagnostic performance of \[F-18\] fluciclovine PET/CT compared to \[F-18\] NaF PET/CT as the reference standard. Each bone lesion identified on \[F-18\] NaF PET/CT will be compared with the level of \[F-18\] fluciclovine uptake

The primary objective is to assess \[F-18\] fluciclovine efficacy in the evaluation of osseous metastatic disease in prostate cancer on a lesion-by-lesion comparison with \[F-18\] NaF as a the reference standard.

Eligibility Criteria:
Inclusion Criteria:

* Referred for initial staging or restaging of prostate cancers with clinical suspicion of bone metastases.
* Must understand and voluntarily sign an Informed Consent Document

Exclusion Criteria:

-Cannot tolerate imaging up to 60 minutes of total imaging
Influence of Probiotics on Atopy, Immunological Responses and Gut Microflora - Follow-up to 5 Years

The investigators had conducted a double-blind, randomized placebo-controlled clinical trial studying the effects of 6 months probiotics supplementation from birth on allergic disease and sensitization up to 2 years of age. This follow-up study will extend a further 3 years to 5 years of age for assessing the longer term beneficial effects of this form of probiotics intervention on the incidence of allergic disease and sensitization at 5 years of age.

Probiotics are helpful bacteria of healthy gut and have shown potential in reducing allergy. A double-blind, randomized placebo-controlled clinical trial studying the effects of 6 months probiotics supplementation from birth on allergic disease and sensitization up to 2 years of age had been conducted. This study aims to assess the longer term beneficial effects of this form of intervention on the incidence of allergic disease and sensitization at 5 years of age by extending the follow-up period.

All children (from original cohort of 253) who completed the initial 2-year visit has been invited to participate. They will be evaluated with monthly phone calls and yearly clinic visits. Allergic sensitization will be assessed with skin prick tests to a panel of allergens.

This project will provide insights into the role of early supplementation of probiotics on the development of the immune system and its effect on allergy. The additional follow-up period is critical for the evaluation of respiratory allergies in the form of clinical asthma, allergic rhinitis and sensitization to inhalant allergens, which tend to develop after 2 years of age.

Eligibility Criteria:
Inclusion Criteria:

* Parents agree to the subject's participation in the study and informed consent has been obtained.
* The subject has been a participant in the Phase I double-blind, randomized placebo-controlled study and had taken either normal infant formula or formula supplemented with probiotics postnatally for 6 months.
* The parents are willing to comply with study procedures and are able to keep to scheduled clinic visits.

Exclusion Criteria:

* The parent is unable /unwilling to comply with procedures.
A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider

The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of treatment).


Eligibility Criteria:
Inclusion Criteria:

* Smokers aged 18 years or above and wanting to stop smoking
* Smokers who have smoked an average of at least 10 cigarettes per day over the last 4 weeks
* Smokers who have tried before to stop smoking at least once with varenicline, and who took varenicline for at least 2 weeks
* The last attempt to stop smoking must be at least 3 months before entering the study

Exclusion Criteria:

* Individuals who have not tolerated varenicline well previously, or who have a current or prior medical or psychiatric history that would make entry into the trial inadvisable
* Individuals who have previously participated in clinical trials of varenicline
* Individuals who have been participating in another smoking cessation trial within the last 3 months, or other drug trial within the last 30 days
A Comparison of the Laryngeal Mask Airway (LMA) - Unique and LMA-Supreme in Children

The aim of this randomized prospective study is to compare two single-use laryngeal mask airways the LMA Unique and the LMA Supreme, in pediatric patients. The investigators hypothesize that airway leak pressures with the LMA Supreme will be superior to the LMA Unique.

The goal of this study is to compare the LMA Unique and LMA-Supreme in children undergoing anesthesia. The investigators hypothesize that airway leak pressures with the LMA Supreme will be superior when compared with the LMA Unique at two different standardized intracuff pressures (40 and 60 cm H20). Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement, fiberoptic grade of laryngeal view, feasibility of use, and complications will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Children undergoing general anesthesia using a supraglottic airway device

Exclusion Criteria:

* ASA class IV, V, Emergency procedures
* active respiratory infection
* known history of difficult mask ventilation
* a diagnosis of a congenital syndrome associated with difficult airway management
* airway abnormalities (e.g., laryngomalacia, subglottic stenosis)
* active gastrointestinal reflux
* coagulopathy
* clinically significant pulmonary disease(s)
Safety and Efficacy of Immages System in Patients Recieving IV Therapy

The study will evaluate the functionality of IMMAGES , an intravenous infusion device system, in patients hospitalized in Bait Balev hospital. The study will aim to determine how the IMMAGES system integrates within IV infusion therapy regime and what are the advantages and disadvantages, if any, of using this system within the prescribed setting.

Using the IMMAGES system in patients recieving IV therapy will provide the nursing teams on-line information regarding the infusions and will allow them to monitor and manage the treatments in real-time, providing better and safer care for the patients.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria:

  1. Patients requiring infusion therapy
  2. Patients receiving infusion therapy by gravity flow or by pump
  3. patients are scheduled to receive at least once a day an infusion therapy
  4. Patients are scheduled to receive an infusion therapy for at least 3 days
  5. Adult over age of 18 years
  6. Informed consent form signed by patient.

     Exclusion Criteria:

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  1. Informed consent form not signed
  2. Patients are scheduled to receive less than once a day an infusion therapy
  3. patients to receive less than 3 days of infusion therapy
  4. patients not hospitalized in a ward that is participating in the study.
  5. patients participating in another clinical study or clinical field test
  6. Patients require isolation treatment
Safety, Toleration and Efficacy of CP-741,952 for the Treatment of Obesity

The purpose of this study is to determine whether CP-741,952 is effective in the treatment of obesity and to determine 12 week safety and toleration.

Following review of the preliminary data from completed study A7081004, the development program for CP-741,952 was terminated on 15 March 2007. Primary reasons for program termination included a lack of significant efficacy at all doses investigated and an increased incidence of mild to moderate elevations in serum transaminases, primarily alanine aminotransferase (ALT), and liver fat content, in treated compared to placebo subjects. A synopsis will be created and will include greater detail on these findings.

Eligibility Criteria:
Inclusion Criteria:

* BMI of 30-40 kg/m2

Exclusion Criteria:

* Women of childbearing potential