cyrilzakka/clinical-trials huggingface dataset:
The Study of GW493838, an Adenosine A1 Agonist, in Peripheral Neuropathic Pain

The purpose of this study was to determine the analgesic effect of GW493838 in patients with post-herpetic neuralgia or peripheral nerve injury caused by trauma or surgery.


Eligibility Criteria:
Inclusion criteria (subjects must meet all of the following criteria in order to be eligible for this study):

* Females of non-child-bearing potential
* diagnosis of peripheral neuropathic pain as a result of: postherpetic neuralgia (PHN) from shingles for at least 3 months duration OR focal neuropathic pain related to nerve injury caused by trauma or surgery
* defined area of pain

Exclusion criteria

* discontinue agents for the treatment of neuropathic pain
* unable to refrain from alcohol and sedative use during the study
* confounding chronic pain which could not be differentiated from the peripheral neuropathic pain under study
* intractable pain of unknown origin or active infection in the area of nerve injury.
* clinically significant medical history or abnormality found on physical examination, laboratory assessment or ECG at Screening or Baseline
* severe asthma that has required oral corticosteroid use in the last 12 months or the subject had severe asthma that required, at anytime, hospitalization or mechanical ventilation support.
* clinical evidence of major depression (by medical history) except those subjects controlled by SSRIs.
* a known allergy or hypersensitivity to any of the investigational products (including rescue analgesia- acetaminophen), or pharmacological class of the investigational product (i.e. adenosine) and/or investigational product excipients.
* a clinically significant abuse of substances, defined as: Patterns of substance intake consistent with disruption of normal function in society; Past or current impairment of organ function reasonably related to substance intake; Any indication of difficulty in abstaining from substances for the duration of the study.
* had previously participated in a clinical study during the past 30 days in which the subject was exposed to an investigational or non-investigational drug or device
* currently participating in another clinical study in which the subject was exposed to an investigational or non-investigational drug or device
* prior blood reduction (450 mL or more) during the previous 30 days
* at risk of non-compliance
* a woman of childbearing potential or a woman who was lactating.
NutritiOUs fRuIts and veggieS to Improve Health: A Culinary Medicine Intervention

This study includes a 12-week culinary medicine intervention integrated within the existing YMCA Suncoast Survivorship and Wellness Program Powered by Moffitt. Members of the John Geigle YMCA will be assigned to the NOURISH intervention, which includes biweekly provision of fruit and vegetable bundles, recipe cards, and nutritional education handouts plus 30-minute culinary medicine demonstrations with skill-building training (six total demonstrations focused on fruit and vegetable recipes).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cancer.
* Able to speak and read English.
* Without documented or observable psychiatric or neurologic diagnoses that could interfere with participation (e.g., dementia, active psychosis).
* Able to provide informed consent.

Exclusion Criteria:

* Not meeting all of the above inclusion criteria.
Buprenorphine as a Treatment in Opiate Dependent Pain Patients

This study is designed to determine if different doses of buprenorphine (either tapering doses or steady doses) are effective in managing chronic, non-cancer pain in individuals who also are addicted to opiate pain medicines.

Context: Some individuals have two conditions: 1) a well-documented pain disorder and 2) clear evidence of a substance use disorder with opiate dependency. It is not known how to manage these patients. In addition to other modalities for the treatment of chronic pain, combination tablets of buprenorphine/naloxone (Suboxone) may be helpful.

Objective: The objective of this study is to determine if the addition of pharmacotherapy with Suboxone to usual care would improve clinical outcome relative to usual care alone.

Design: Randomized control trial.

Setting: The study will be conducted in the out-patient clinics of a tertiary-care teaching hospital.

Participants: The participants will be those who have: 1) a well-documented pain disorder and 2) clear evidence of a substance use disorder with opiate dependency.

Baseline data collected: Data collected at baseline will include (with examples): demographics (age, gender, race), substance use history (type of substances used, duration of use, routes of abuse), type of pain disorder (previous traumatic injury, musculoskeletal, neuropathic), co-existing medical problems (seizures, hepatitis C), prior injuries (accidents, interpersonal violence), prior mental health problems (prior treatment, diagnoses), prior substance abuse treatment (outpatient, inpatient), socioeconomic variables (educational level, occupation, employment history), criminal history (number of arrests and convictions, total amount of time spent in jail or prison), family history (first degree relatives with substance use disorders) and scores on psychometric testing (ASI).

Outcome data: Three main outcome variables will be examined relapse to substance use (as documented by toxicology), quality of life, and successful participation in the pain management program for six months, which included the completion of the study buprenorphine treatment protocols.

Data analyses: Outcome variables will be compared between the two groups using t-tests or chi-square tests as appropriate. A Kaplan-Myer survival analysis will be used to describe participant participation. Predictors of poor outcomes will be identified using a case-control design in which those with poor outcomes (the "cases") will be compared to those with successful outcomes (the "controls") using multivariate techniques (logistic regression).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic refractory pain
* Clinical diagnosis of opiate dependency

Exclusion Criteria:

* unable to pay for medication
* enrolled in a methadone maintenance program
* homelessness
* major mental illness
* pregnant women
* prisoners
* terminal cancer pain
Immunogenicity and Safety Study of a Booster Dose (5th) of Diphteria-Tetanus-Pertussis-Polio Vaccine

An open clinical trial to study the immune response and safety after giving a booster dose (5th Dose) of a combination vaccine against Diphteria-Tetanus-Pertussis-Polio to healthy adolescents 15-16 Years of age. The first three doses were given during the first year of life, according to the Norwegian child immunization program. The fourth dose was given in a previous clinical trial performed in 1998 when the children were 6-7 years old.

In 2006 there was a change in the child immunization program in Norway: a fourth dose of a Combination Vaccine Against Diphteria-Tetanus-Pertussis-Polio is given to children 6-7 years old.

This study will give us information if there is need for an additional dose (5th dose) of a combination vaccine, containing the pertussis components, before the adolescents are leaving secondary school.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adolescents who have previously received a dose of a vaccine against diphteria, tetanus, pertussis and polio in a clinical trial in 1998
* Written informed consent from the adolescent and one of his/her parents
* The family must understand norwegian

Exclusion Criteria:

* Serious chronic diseases
* Vaccination against tetanus last 12 months
* Immunization with a Diphteria vaccine component after the study in 1998
* Suspected or confirmed immune deficiency
* Immunological/immunosuppressive treatment
* Pregnancy
* Serious reactions to previous immunization with any of the vaccine components
* Acute fever (axillary temperature ≥ 38°C) at the the of vaccination. (Postpone vaccination)
Imiquimod in Preventing Cervical Cancer in Women With Cervical Neoplasia

RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development of cancer. Applying topical imiquimod before abnormal cervical cells are removed may be effective in preventing cervical cancer.

PURPOSE: Randomized phase II trial to study the effectiveness of applying topical imiquimod before abnormal cervical cells are removed in preventing cervical cancer in patients who have recurrent or persistent cervical neoplasia.

OBJECTIVES:

* Compare the chemopreventive efficacy of topical imiquimod followed by local ablative or excisional therapy vs ablative/excisional therapy alone in patients with recurrent or high-grade cervical intraepithelial neoplasia.
* Compare the toxicity of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
* Determine the safety and tolerability of imiquimod in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, disease (primary vs recurrent or persistent), severity of dysplasia (grade I vs grade II vs grade III), current tobacco use (yes vs no), planned surgical procedure (excisional vs laser vs cryotherapy vs other), and time since first abnormal Pap smear, including pathology of ascus favor dysplasia (less than 1 year vs 1-3 years vs more than 3 years). Patients are randomized to one of two treatment arms.

* Arm I: Patients undergo ablative or excisional therapy.
* Arm II: Patients have topical imiquimod applied to the cervix for 6-10 hours twice weekly for a total of 5 doses. Within 3-4 weeks after the final application, patients undergo ablative or excisional therapy.

Quality of life is assessed at baseline, after last dose of study drug (arm II only), 3-5 days after ablation or excisional therapy, at 3 months, and then annually thereafter.

Patients are followed every 3-4 months until 2 consecutive normal Pap smears or colposcopic exams, every 6 months for 2 years, and then annually until 5 years after completion of study therapy.

PROJECTED ACCRUAL: A total of 66-152 (33-76 per treatment arm) will be accrued for this study within 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed primary grade II or III cervical intraepithelial neoplasia (CIN) or persistent grade I-III CIN (dysplasia that is not new and requires treatment)
* Squamous cell lesions not involving endocervix by colposcopy OR colposcopy with negative cytobrush or endocervical curettage
* No untreated cervical or vaginal infection other than human papilloma virus
* No desire for hysterectomy as ablative therapy

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Life expectancy:

* At least 5 years

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study
* HIV negative
* No AIDS
* No known hypersensitivity to imiquimod
* No latex allergy

PRIOR CONCURRENT THERAPY:

Other:

* No concurrent immunosuppressive therapy
Troglitazone in Treating Patients With Liposarcoma

Troglitazone may help liposarcoma cells develop into normal cells. This was a single arm, open-label study with a two-stage design to evaluate troglitazone in patients with liposarcoma stratified by histologic subtype.

OBJECTIVES:

I. To evaluate the clinical activity of troglitazone in patients with malignant liposarcoma stratified by histologic subtype.

II. To perform correlative imaging, biological, and biochemical testing of patients in order to define the degree to which in vivo terminal differentiation may be promoted by this therapeutic intervention.

III. To evaluate the tolerance and safety of troglitazone in this patient population.

PROJECTED ACCRUAL:

Initially, 14 patients of each of the 5 histologic subtypes of liposarcoma will be accrued. If 1 or more patients show evidence of biological response, an additional 16 patients of each subtype will be accrued for a total of 30 patients per subtype. If 4 or more of 30 patients achieve biological response then troglitazone will be deemed promising in that histologic subtype.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven liposarcoma that is incurable by standard surgery Measurable or evaluable disease required No active CNS involvement or leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT less than 5 times upper normal limit Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No poorly controlled atrial arrhythmias, angina pectoris, or myocardial infarction within past 6 months No symptomatic congestive heart failure, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within past 3 months Other: Not pregnant or nursing Fertile patients must use effective contraception No known active retroviral disease

PRIOR CONCURRENT THERAPY: Recovered from toxic effects of all prior therapy No concurrent cytotoxic therapy Biologic therapy: Not specified Chemotherapy: Prior chemotherapy allowed Endocrine therapy: No concurrent hormonal therapy Radiotherapy: Prior radiation therapy for metastatic disease allowed No radiotherapy to sole site of measurable disease within past 6 months Surgery: Not specified
Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder (CLARITY)

To assess the efficacy of pimavanserin compared to placebo when given adjunctively to a selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant as treatment of patients with Major Depressive Disorder (MDD) and an inadequate response to antidepressant therapy


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients, aged 18 years and above
2. A clinical diagnosis of major depressive disorder (MDD)
3. Is being treated with one of the following SSRI or SNRI antidepressants as monotherapy:

   * Citalopram
   * Escitalopram
   * Paroxetine
   * Fluoxetine
   * Sertraline
   * Duloxetine
   * Venlafaxine
   * Desvenlafaxine
   * Venlafaxine XR
4. Has a history of inadequate response to antidepressant treatments

Exclusion Criteria:

1. Patient has a psychotic disorder other than MDD
2. Patient has current evidence of a serious and/or unstable neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program
3. Patient has a history or symptoms of long QT syndrome

Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
Posterior Cruciate Ligament Reconstruction Using Knot/Press-fit Technique

This study presents an arthroscopic-assisted PCL reconstruction using femoral knot/press-fit technique with a periosteum-enveloping graft in tibial tunnel. The investigators evaluated the results of patients with PCL ruptures, who undergoing PCL reconstruction using this unique technique.


Eligibility Criteria:
Inclusion Criteria:

* PCL TEAR

Exclusion Criteria:

* PL INSTBILITY
Risk Stratification Using Midregional Proadrenomedullin in the ED

Emergency departments (ED) are becoming increasingly over-crowded, with patients facing prolonged waiting times. Therefore, a safe and rapid assessment that identifies patients with low severity that could be treated as outpatients is essential for improving the workflow within the ED.

The rationale of this IDEAL+ study is to safely decrease the number of hospital admissions through identification of low risk patients with the biomarker MR-proADM. This will has already been tested in the IDEAL - pilot study and results should be confirmed with this IDEAL+ study.


Eligibility Criteria:
Inclusion Criteria:

1. Consecutive patients presenting to the ED with suspicion of infection
2. Age ≥18 years
3. Written Informed Consent obtained

Exclusion Criteria:

1. Patients with SARS-COV-2 infection
2. Recent major trauma or surgery
3. End stage renal failure requiring dialysis
4. Terminal disease and/or very severe medical co-morbidity where death has to be expected in the next 6 months, e.g. due to malignancy, cardiac, renal or hepatic failure
5. Patients whose source of infection always requires hospital admission or never requires hospital admission.
6. Patients who cannot be discharged for other than medical reasons
7. Patient participates in any other interventional clinical trial
8. Patients with active abusive drug use
9. Pregnant or lactating women
10. Patients who are institutionalized by official or judicial order
11. Dependents of the sponsor, the CRO, the study site or the investigator
68Ga-PSMA-11 PET for the Diagnosis of Biochemically Recurrent Prostate Cancer

This phase I trial studies the side effects of 68GA-PSMA-11 PET imaging in patients with prostate cancer that has come back (recurrent). Gallium (68Ga) is a radiotracer that binds to a molecule, PSMA, that is found in abundance on most prostate cancer cells. PSMA is short for 'prostate specific membrane antigen'. Diagnostic procedures, such as 68GA-PSMA-11 PET imaging, may help measure a patient's response to earlier treatment, and may help plan the best treatment for prostate cancer.

PRIMARY OBJECTIVE:

I. To provide clinical access to and assess the safety of the investigational agent Gallium Ga 68-labeled prostate specific membrane antigen (PSMA)-11 (68Ga-PSMA-11) positron emission tomography (PET) at City of Hope National Medical Center for patients co-enrolled on Institutional Review Board (IRB) 18517 treatment trial.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over less than 1 minute, and then undergo PET over 60 minutes.

After completion of study, patients are followed up at 1-3 days, and then at 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Biochemical recurrent prostate cancer
* Karnofsky performance status of \>= 50
* The effects of 68Ga-PSMA-11 on the developing fetus are unknown. For this reason, subjects must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation when having sex with a pregnant female or with a female partner of childbearing potential
* Co-enrollment on IRB 18517
* Documented informed consent of the patient. All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Patients should not have any uncontrolled illness including ongoing or active infection
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga-PSMA-11
* Use of another concomitant investigational therapy (with the exception of the investigational treatment given in IRB 18517) for prostate cancer within 7 days of scheduled 68Ga-PSMA-11 PET scan
* Unable to tolerate PET scan (i.e. if the patient is claustrophobic or unable to lie still for 30-60 minutes)
* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children With Achondroplasia

To Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children with Achondroplasia


Eligibility Criteria:
Inclusion Criteria:

* 2-10 years old;
* In Tanner I stage;
* ACH, documented and confirmed by genetic testing;
* Short stature;
* Ambulatory and able to stand or walk without assistance;
* Parent(s) or guardian(s) consent；
* Had never been treated with growth hormone

Exclusion criteria:

* Short stature condition other than ACH;
* Evidence of growth plate closure (proximal tibia, distal femur);
* Had a fracture of the long bones within 6 months prior to screening;
* Planned or expected bone-related surgery;
* Chronic diseases condition that affect bone metabolism and weight;
* Severe intracranial hypertension
Psychosocial Intervention in Assisted Reproduction Treatments

The aim of the study was to evaluate and compare different strategies of psychosocial intervention for patients undergoing IVF treatment in a private fertility clinic. Recruited patients were assigned to one of three groups: group intervention, couple intervention or no intervention (control group). Three main variables were assessed: depression, anxiety and life quality.

A total of 87 couples have participated in this study. All couples were about to start an assisted reproduction treatment (artificial insemination or in vitro fertilization). Couples were assigned to one of three study groups: group intervention, couple intervention or no intervention (control group). Patients in the first group (group intervention) attended six group psychotherapy sessions. Patients in the second group attended six psychotherapy sessions (particular sessions in this case). The patients in the third group received no psycho-social intervention. Assignation to each group was not randomized, it depended on scheduling availability of the patients. Patients attended one session every week or 15 days. Each session lasted 90 minutes. Sessions were designed to minimize the possible negative psycho -social impact of infertility and its treatment. Different aspects were approached in these sessions including emotion expression, social coping, communication skills, emotion management in different social situations, identification of dysfunctional thoughts, cognitive restructuring, and cognitive distortions. The outcomes measured were: anxiety, depression, life quality, coping and perceived social support. These variables were assessed before ART, after ART and in a follow-up performed six months after ART. Psychological variables were assessed using different well-recognized inventories.

Eligibility Criteria:
Inclusion Criteria:

* Childless couples
* About to undergo an ART treatment

Exclusion Criteria:

* Undergoing ART treatment when signing the informed consent of the study
* Pregnant when signing the informed consent of the study