cyrilzakka/clinical-trials huggingface dataset:
The Safety and Effectiveness of Indinavir Sulfate Plus Efavirenz

To estimate the differences in parameters of antiviral activity and safety between a control regimen of indinavir in combination with DMP 266 and an experimental regimen of higher-dose indinavir in combination with lower-dose DMP 266 after sixteen weeks of dosing, in protease inhibitor- and non-nucleoside reverse transcriptase inhibitor-naive, HIV-1 seropositive patients.

It is hypothesized that after 16 weeks of randomized treatment with either the control or experimental regimen that:

1. The observed proportion of patients with serum viral RNA \< 400 copies/ml in the experimental and control regimen will be similar and will continue to be so after 48 weeks.
2. The safety profiles of the two groups will be similar, judged by the incidence of serious, drug-related adverse experiences and the incidence of events of specific interest (e.g., nephrolithiasis, hyperbilirubinemia, nausea/vomiting, rash, and CNS-related symptoms) and will continue to be so after 48 weeks.
3. The two groups will be similar with respect to changes from baseline in serum viral RNA and CD4 counts and will continue to be so after 48 weeks.

It is hypothesized that after 16 weeks of randomized treatment with either the control or experimental regimen that:

1. The observed proportion of patients with serum viral RNA \< 400 copies/ml in the experimental and control regimen will be similar and will continue to be so after 48 weeks.
2. The safety profiles of the two groups will be similar, judged by the incidence of serious, drug-related adverse experiences and the incidence of events of specific interest (e.g., nephrolithiasis, hyperbilirubinemia, nausea/vomiting, rash, and CNS-related symptoms) and will continue to be so after 48 weeks.
3. The two groups will be similar with respect to changes from baseline in serum viral RNA and CD4 counts and will continue to be so after 48 weeks.

Patients are randomized to one of two regimens: a control regimen of indinavir plus DMP 266 or an experimental regimen of indinavir plus DMP 266, each at different doses than in the control regimen.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV-1 seropositive status.
* CD4 count \>= 100 cells/mm3.
* Serum viral RNA levels \>= 10,000 copies/ml.

Exclusion Criteria

Prior Medication:

Excluded:

* Prior protease inhibitor therapy.
* Prior non-nucleoside reverse transcriptase inhibitor therapy.
Parents as Friendship Coaches for Children With ADHD

Many children with Attention-Deficit/Hyperactivity Disorder (ADHD) have problems with making and keeping friends. The current study compared the efficacy of two 10-week behavioral interventions for improving the friendships of children with this disorder. Participants were children ages 6-11 with ADHD and their families, who were experiencing friendship problems. Outcome measures assessed friendship quality and friendship behaviors at baseline (pre-treatment), post-treatment, and 8-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Children who meet diagnostic criteria for ADHD
* Children who are have peer relationship problems

Exclusion Criteria:

* Children with autism spectrum disorder, psychosis, or active suicidality (requires other interventions
* Children with intellectual disability (may not benefit from the interventions offered)
* Children who are not on a stable dose of medication (this treatment may affect outcome measures)
* Children who are receiving other behavioral treatment or treatment for social problems (these other treatments may affect outcome measures).
NT-814: Evaluation of Its Ability to Alter the Abuse Liability of Oxycodone in an Exploratory Clinical Study

Healthy adult men who abuse opioids and are physically dependent on them will be invited to participate in a study to examine the ability of NT-814, a neurokinin (NK) antagonist at the 1 and 3 receptor subtypes, to alter the abuse liability of oxycodone.

After completing the screening process, participants will be scheduled for admission onto the General Clinical Research Unit on 5-South for a 13-week study. During Week 1, participants will be detoxified from opioids. During Week 2 after the detoxification period, participants will be randomized to receive one of four maintenance doses of NT-814. During Weeks 3-4 participants may receive oxycodone during laboratory sessions and will complete a cue exposure session involving presentation of neutral and drug cues. Participants then will have the opportunity to self-administer drug by making clicks on a computer mouse. Weeks 2, 5, 8, and 11 will be medication stabilization weeks following by testing during Weeks 3-4, 6-7, 9-10, and 12-13. At the conclusion of the study, participants will be given an exit interview during which the study will be described. Those who are interested in treatment for their drug use at the end of the study will be offered referrals to studies at our Substance Treatment and Research Service or other treatment providers.

Eligibility Criteria:
Inclusion Criteria:

* DSM V criteria for Opioid Use Disorder moderate-severe (304.00)
* Physically healthy
* Able to perform study procedures
* Normal body weight (BMI \<30 and \>17.5), and total body weight \>50 kg (110 lbs)
* Total testosterone in the laboratory normal range (250-1100 ng/dl)
* Current or history of intranasal opioid use.
* Must be willing to use adequate forms of contraception (e.g. condoms in combination with spermicide) for the duration of the study and a specified amount of time after participation.

Exclusion Criteria:

* On parole or probation
* Elevated liver function (i.e. AST and ALT \>2 times the upper limit of normal) or impaired renal function (creatinine within normal limits)
* 12-lead ECG-based repeated demonstration of QTcF \> 450 msec at screening
* HIV positive
* Any physical disorders that might make participation hazardous
Pediatric Boot Camp Program

An intensive 13 weeks program that aims to improve glucose control in children with type 1 diabetes.

Our new PeDi-BoCa Program aims to help children with type 1 diabetes achieve better diabetes control by interacting weekly with their doctor/nurse practitioner (NP) and also by using a "smart pen" that can facilitate the burden of daily calculations with the use of an app on the phone.

Your child's doctor/NP will be able to remotely monitor your child's glucose every week (Dexcom) and make recommendations for changes, discuss solutions to possible obstacles and offer intensive diabetes education.

Eligibility Criteria:
Inclusion Criteria:

1. Age 11-18 years old
2. HbA1c \> 8.5%
3. Duration of type 1 diabetes \>1 year
4. Child uses Dexcom and has a phone that is compatible with the InPen app and Dexcom Clarity app.

Exclusion Criteria:

Not able to attend telehealth visits
Portable Oxygen Concentrator to Improve Quality of Life in Chronic Obstructive Pulmonary Disease

* Evaluate subjects in an prospective observational study
* Subjects will be administered scientifically validated questionnaires
* Determine the affect of the Portable Oxygen Concentrator (POC) on improvements in:

  1. Exercise capability, dyspnea and quality of life as primary endpoints
  2. Utilize:

     1. Baseline Dyspnea Index (BDI)
     2. Transitional Dyspnea Index (TDI)
     3. Chronic Respiratory Disease Questionnaire (CRQ)
     4. Six minute walk test (6MWT)
     5. Epworth Sleepiness Scale (ESS)
* The secondary endpoints will be:

  1. Rate of exacerbations, sleep quality
  2. Health care utilization (emergency room encounters, hospital admissions)

Evaluate subjects in an prospective observational study in which subjects will be screened and administered scientifically validated questionnaires at study entry and during the observation period at specified intervals to determine the affect of the Portable Oxygen Concentrator on improvements in exercise capability, dyspnea and quality of life as primary endpoints, utilizing the Baseline Dyspnea Index (BDI), Transitional Dyspnea Index (TDI), the Chronic Respiratory Disease Questionnaire (CRQ) and six minute walk test (6MWT). The secondary endpoints will be rate of exacerbations, sleep quality (reported as number of hours sleep improvement; utilize Epworth Sleepiness Scale \[ESS\]), and health care utilization (emergency room encounters, hospital admissions).

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of chronic obstructive pulmonary disease (COPD)
* Clinically stable disease at the time of consent
* Current prescription of oxygen; with previous or current oximetry suggesting desaturation at rest or during exercises (oxygen saturation ≤88% on at least one occasion)
* Highest measured FEV1, 70% predicted; and
* Highest measured FEV1/FVC, 70% predicted
* Capable of giving informed consent
* Currently using oxygen system that is either a portable tank; liquid or other Portable Oxygen Concentrator (POC)
* Mobility without a walker, cane or rollator
* Spo2 ≥ 92% on Portable Oxygen Concentrator (POC) at rest and activity
* Non-smoker at time of consent

Exclusion Criteria:

* Cardiovascular disease as defined in New York Heart Association Functional Class III
* Degenerative bone or joint disease that limits mobility and ability to perform activities of daily living and/or exercise
* Current homeless persons
* Active drug/alcohol dependence
* Recent abuse history within the past two years
* Clinically unstable at the time of consent
* Currently a tobacco smoker
Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Acute Heart Failure

Background:

Acute heart failure is a potentially life-threatening condition, reaching mortality rates of up to 50% in advanced cases. The investigators have shown that infusion of ketone bodies increase cardiac output by 40% in stabile patients with chronic heart failure. However, there are no data showing the effects of ketone on patients with acute heart failure

Objectives:

To investigate the effect of ketone supplementation in patients with acute heart failure and cardiogenic shock, using two different types of oral ketone supplements.

Methods:

The investigators will conduct four randomized placebo-controlled studies, to investigate the hemodynamic effect of exogenous ketones in acute heart failure and cardiogenic shock.

Perspectives:

The present study will determine the potential beneficial effects of ketone supplements in patients with acute heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized with worsening HF or de novo diagnosis of HF
* LVEF \< 50%
* Treatment with intravenous loop diuretics during the hospitalization and/or increased dosage of oral diuretics.

Exclusion Criteria:

* Cardiogenic shock
* Systolic Blood Pressure \<85 mmHg
* Acute myocardial infarction other than type II \<5 days prior to randomization \*
* Severe uncorrected cardiac valve disease
* Expected or possible need for hemodialysis as judged by the investigator
* Ongoing inotropic treatment
* Possible need for advanced heart failure treatment (LVAD, heart transplantation) as judged by the investigator.
* Ongoing, severe infection
* Severe respiratory distress (SAT\<90% or RF\> 24/min or receiving more than 2 l O2/min or intubated)
* Atrial Fibrillation with heart \>120 beats per minute
* Inability to cooperate to or accept oral intake of food, including presence of major gastrointestinal discomfort.

  * If suspected or confirmed acute myocardial infarction as cause of acute heart failure, patients can be recruited 5 days after hospitalization in the absence of malignant arrhythmias (e.g. ventricular tachycardia) or clinically significant residual angina pectoris.
Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other Examinations

This is a prospective cohort study. The investigators enroll subjects with pancreatic ductal adenocarcinoma (PDAC), individuals at high risk for PDAC, patients with other pancreatic diseases, patients with CA19-9 elevation and controls without pancreatic disease. This study aims to establish a diagnostic prediction model by using elastase 1, common clinical serological examinations, and imaging examinations including endoscopic ultrasonography (EUS), and to explore the diagnostic ability of the model in the high-risk population of PDAC. Besides, the investigators search for new biomarkers by multi-omics studies of serum and pancreatic tissues to further improve the diagnostic performance of this model. In conclusion, this study seeks a robust diagnostic prediction model to diagnose PDAC, especially early resectable PDAC.


Eligibility Criteria:
Inclusion Criteria:

Case groups (matching any of the following):

1. Patients with pancreatic cancer with recognized diagnostic criteria or conclusions.
2. Patients who are the high-risk group of pancreatic cancer.
3. Patients with solid pseudo papilloma and neuroendocrine tumors of pancreas with recognized diagnostic criteria or conclusions.
4. Patients with other diseases with abnormally elevated CA19-9.

Control group:

(1) Patients without pancreatic disease assessed by laboratory tests and imaging examinations have no CA19-9 elevation.

Exclusion Criteria:

1. Patients who are younger than 18 years of age.
2. Patients with suspected pancreatic malignant lesions but has no confirmed imaging or pathological diagnosis.
3. Patients who have not signed informed consent.
Coping Skills Training in Individuals With Migraine

This study was planned to investigate the effects of coping skills training on pain, quality of life, disability level, and coping skills in individuals with migraine.

Migraine is a type of headache that lasts 4-72 hours, and it is characterized by throbbing pain on one side of the head, and recurrent attacks, making routine daily activities and movements difficult. Also, nausea and vomiting may accompany migraine, and sensitivity to both light and sound may increase. The World Health Organization (WHO) lists migraine as the disease that causes the most disability.

Approaches to the treatment of migraine consist of pharmacological and non-pharmacological treatments. Within the scope of non-pharmacological approaches, it is aimed to increase the coping skills of the individual by using methods such as exercise, stress management, and cognitive behavioral therapy, which include physical, mental, and cognitive interventions. Although these approaches are effective respectively, since migraine affects the whole life of the individual, there is a need for applications in which the approaches are applied with a combined and individual perspective. It has been shown that coping skills training improves both the physical and mental health and well-being of individuals with chronic headaches. It is known to cause a decrease in pain intensity, migraine attacks, and drug use. At the same time, it is aimed to adapt the individual to live efficiently. Despite these positive effects, there is a limited number of studies examining the effect of migraine coping skills training on individuals' disabilities and coping skills. Therefore, within the scope of this study, the effects of client-centered coping skills training on pain, disability, coping skills, and quality of life were examined.

Eligibility Criteria:
Inclusion Criteria:

* have a diagnosis of migraine meeting the International Headache Society diagnostic criteria (ICHD-3 beta International Classification of Headache Disorders),
* to be between the ages of 18-65,
* to have a migraine onset age younger than 50 (migraine onset age shouldn't be 50 years or more because being above is usually a secondary reason)
* to be literate.

Exclusion Criteria:

* have psychotic disorders, organic brain damage, other types of headaches, a history of traumatic head injuries, neck pain, any pathology causing headaches in the head and neck,
* alcohol or substance use,
* pregnancy
A Proof of Concept Study of Serum Progesterone Levels for IVF/ICSI Following HCG Trigger for Oocyte Maturation

This study will determine the rise of progesterone levels after human chorionic gonadotrophin (hCG) trigger in stimulated cycles IVF/ICSI

Studies have suggested that controlled ovarian hyperstimulation adversely affects endometrial receptivity. In ovarian stimulation cycles with exogenous gonadotrophins there is an ongoing debate regarding the effect of a late follicular phase progesterone level on reproductive outcomes. It is not yet clarified if an elevated serum progesterone level in the late follicular phase is a symptom or cause of an adverse effect on reproductive outcomes. A new hypothesis is evolving and gaining momentum providing a novel explanation for the association between late follicular phase progesterone rise and reproductive outcome. It is proposed that exogenous FSH (Follicle-stimulating hormone) administration results in supraphysiological levels of FSH, which induce an abundance of LH (luteinizing hormone) receptors on granulosa cells causing the follicles to become hypersensitive to LH-like activity (ie hCG trigger). Based on this hypothesis, the focus should be placed on the hCG trigger rather than on the late follicular phase progesterone rise.

Eligibility Criteria:
Inclusion Criteria:

* Females aged 18 to 42 years with regular menstrual cycles of 26-34 days
* Undergoing ovarian stimulation for IVF/ICSI \& PGS.
* Receiving recombinant FSH for stimulation
* hCG 5000iu IM as trigger injection for oocyte maturation.
* Ovarian stimulation in GnRH-antagonist protocols
* BMI 18- 35 kg/m2
* Having 1 or 2 euploid embryos for transfer in spontaneous natural cycles.

Exclusion Criteria:

* Poor ovarian reserve as defined by Bologna criteria
* PCOS in accordance with Rotterdam criteria
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants

This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy term 2-month-old infants for whom a parent/legal representative has given written informed consent.

Exclusion Criteria:

* Subjects with a previous or suspected disease caused by Neisseria meningitidis, Corynebacterium diphtheriae, Clostridium tetani, Poliovirus, Hepatitis B, Haemophilus influenzae type b (Hib), Pneumococcus or Bordetella pertussis; previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) or prior vaccination with Diptheria, Tetanus, Pertussis (acellular or whole cell), inactivated polio vaccineIPV or oral polio vaccineOPV, H. influenzae type b (Hib) or Pneumococcus; who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W-135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth; Any serious acute, chronic or progressive disease
Lowering Caloric Density of the Diet

For weight loss to occur, energy intake needs to be reduced to incur an energy deficit. One dietary strategy that may facilitate reducing energy intake and enhancing weight loss is consuming a diet low in dietary energy density (ED). The ED of a given food, defined as the ratio of energy of the food to the weight of the food (kcal/g), is largely determined by water content, but is also affected by fat and fiber. Although the 2010 Dietary Guidelines encourage an eating pattern low in energy density (ED) to manage weight, it is currently not known what the best strategy is for reducing ED in the diet. Eating a greater number of foods low in ED or reducing the number of foods high in ED may reduce overall dietary ED. As ED is believed to reduce intake by allowing a greater weight of food relative to total energy consumed assisting with enhancing feelings of fullness, it is anticipated that either increasing consumption of low-ED foods in the diet alone or combining an increase in consumption of low-ED foods with a decrease in consumption of high-ED foods may be the best strategies for reducing overall dietary ED for weight loss.


Eligibility Criteria:
Inclusion Criteria:

* 1) age between 18 and 65 years and 2) a body mass index (BMI)7 between 27 and 45 kg/m2.

Exclusion Criteria:

1. report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q)8 (medical conditions that could limit exercise for safety reasons will be required to obtain written physician consent before participating in the investigation)
2. report being unable to walk for 2 blocks (1/4 mile) without stopping
3. are currently participating in a weight loss program and/or taking weight loss medication or lost \> 5% of body weight during the past 6 months
4. report major psychiatric diseases or organic brain syndromes
5. have had bariatric surgery or are planning to have bariatric surgery within the next 4 months
6. intend to move outside of the metropolitan area within the time frame of the investigation
7. are pregnant, lactating, \< 6 months post-partum, or plan to become pregnant during the investigation.
A Pilot Study to Assess the Effectiveness of BehaviouRal ActiVation Group Program in Patients With dEpression: BRAVE

The study's primary goal is to assess the effectiveness of behavioural activation in reducing depressive symptoms and re-integrate patients with depression into their personal and professional lives thus improving quality of life and helping in attaining and maintaining remission of depression. It is aimed at helping patients re-engage with several life areas that they may have lost in the course of depressive illness. The intervention is centred on behavioural activation (BA) with complementary interventions including recreation activities, and behavioural modifications. The study question is: in patients with depressive disorder attending a specialized hospital based mood disorders clinic, does the addition of behavioural activation program delivered in a group format improve depressive symptoms and quality of life compared to treatment as usual after 18 weeks of treatment? Study investigators hypothesize that behavioural activation is an effective treatment for depressive disorder in patients with depression.

This is a pilot study, a mixed-methods design including an open label pragmatic randomized trial and a qualitative grounded theory approach. Participants will be randomized to Behavioural Activation (BA) (intervention) or support group (control) in addition to treatment as usual. The qualitative component will be used to gather participant's experiences, beliefs and opinions about two topics: 1) the experience of participating in the behavioural activation program and 2) their evolving perceptions of their individual depressive illness and quality of life. Based on the analysis of qualitative data pertaining to the first topic, the behavioural activation program may be modified for the main trial, to respond to patient needs and feedback, in the spirit of delivering truly patient centered care. The qualitative study will involve multiple interviews and focus groups which will take place before, during, and after the pilot intervention period.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Major Depressive Disorder
* Must be able to provide written informed consent
* Must be able to attend program sessions

Exclusion Criteria:

* Inability to understand written and spoken English
* Primary diagnosis other than Depressive Disorder