cyrilzakka/clinical-trials huggingface dataset:
A Study of Nasal PYY3-36 and Placebo for Weight Loss in Obese Subjects

The purpose of this study is to determine the effect of nasal PYY3-36 on weight loss post 24 weeks of treatment.

This is a multi-center, Phase 2 double-blind, randomized, placebo-controlled trial in healthy obese patients. The primary objective of the study is to evaluate the effect of increasing nasal PYY3-36 dosing on weight loss post 24 weeks of treatment.

Secondary Objectives:

* To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo
* To compare the weight loss post 12 and 24 weeks of treatment for each of the three nasal PYY3 36 dose groups versus the nasal placebo group
* To compare the proportion of patients who lose at least 5% and 10% of the baseline body weight post 12 and 24 weeks of therapy for each of the three nasal PYY3 36 dose groups versus the nasal placebo group
* To compare the weight loss and proportion of patients who lose at least 5% of the baseline body weight post 12 and 24 weeks of treatment with sibutramine versus capsule placebo
* To compare the weight loss and proportion of patients who lose at least 5% of the baseline body weight post 12 and 24 weeks of treatment with nasal placebo versus capsule placebo
* To compare the weight loss and proportion of patients who lose at least 5% of the baseline body weight post 12 and 24 weeks of treatment with sibutramine versus the nasal PYY3 36 dose groups
* To evaluate the effect of 12 and 24 weeks of treatment with nasal PYY3 36 and sibutramine on fasting lipid profile, plasma glucose, insulin, blood pressure and pulse, waist circumference and BMI
* To evaluate the effect of 24 weeks of treatment with nasal PYY3 36 and sibutramine on HbA1c levels

Eligibility Criteria:
Inclusion Criteria:

* Male or Female patients 18 and 65 years, inclusive;
* BMI 30-43 kg/m2, inclusive;
* In good health, determined by medical history and physical examination, as well as normal 12-lead ECG and vital signs;
* Non-smoker and no use of tobacco or nicotine products for at least 3 months;
* Females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile (including tubal ligation, hysterectomy) for at least 3 months, until 30 days following Study Completion be willing to use an approved method of contraception;
* Has normal nasal mucosa.

Exclusion Criteria:

* Previous surgical treatment for obesity;
* Serious Medical Condition
* Serious Psychiatric illness
* Organic causes of obesity (e.g. untreated hypothyroidism)
* Type 1 or Type 2 Diabetes;
* Presence of uncontrolled hypertension
* On prohibited concomitant medication
Evaluation of The Vaginal Renewal™ Program in Gynecologic Cancer Patients Experiencing Sexual Dysfunction

This is a randomized controlled trial designed to evaluate the effect of the Vaginal Renewal™ Program (VRP), consisting of the use of a vibrating vaginal wand, manual massage and a water based lubricant, on sexual dysfunction, compared to the current standard care for women with no evidence of disease after treatment for gynecologic cancers.

In the University of Wisconsin gynecologic oncology and radiation oncology clinics, patients are generally asked about sexual function. Those women who report sexual dysfunction will be given the option to enroll in the study. After enrollment, the Female Sexual Function Index (FSFI) and other quality of life surveys will be administered at baseline. The participants will be randomized to either the control arm, composed of standard of care therapy for the physical components of sexual dysfunction, or the experimental arm (VRP).

Throughout the study, the participants will undergo physical exams to assess the rate of improvement in their comfort with pelvic exams and changes in vaginal length. They will also be evaluated with the FSFI, Marinoff Scale for Dyspareunia, and Functional Assessment of Cancer Therapy-General (FACT-G) surveys at the end of the study to assess the magnitude of improvement in sexual function and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* History of a gynecologic cancer
* No evidence of disease at time of inclusion in the study
* Postmenopausal (either surgical or natural menopause)
* Self report of sexual dysfunction that did not predate cancer diagnosis
* Suspected physical component to sexual dysfunction with the participant, not sexual partner
* Desire to improve sexual function
* ECOG Performance status score of 2 or better
* Six months or greater from last surgical and/or radiation treatment

Exclusion Criteria:

* History of sexual reassignment
* Presence of vaginal fistula
* Does not desire to improve sexual function
* Already using the vaginal renewal program
* Not fluent in English
* Incarceration
Lidocaine Injection Versus Sham Needling in Treating Whiplash Associated Disorder

To determine the efficacy of lidocaine injection of trigger points versus subcutaneous injection in patients with subacute whiplash associated disorder following injury.

This is a double-blind, randomized controlled trial to determine the efficacy of lidocaine injection of trigger points versus subcutaneous injection in patients with subacute whiplash associated disorder following injury. Outcomes include pain, objective assessment, self-report function recovery, impact on work performance and globe perceived effects which will be assessed 5 minutes, 2 and 6 weeks following injection.

Eligibility Criteria:
Inclusion Criteria:

* fulfill the Grade II Quebec Task Force classification of WAD,
* with identifiable myofascial trigger points ( which occur with or without a taut band),
* reproduction of recognizable pain with sustained pressure ( up to 10 seconds) on trigger points
* aged 18 to 70
* a good understanding of informed consent and willing to attend this trial.

Exclusion Criteria:

* have serious injury such as fracture and internal bleeding
* suspicion of upper cervical instability or neurological deficits
* clinical evidence of radiculopathy
* a history of active cancer, central nerve disorder, blood clotting disorders, needle phobia
* anticoagulant medication user
* previous experience with any type of needling for myofascial pain
Bioequivalence Study of Metformin Component of Fixed Dose Combination (FDC) Immediate Release (IR) Tablet of Canagliflozin and Metformin Compared to Metformin IR Tablet Co-administered With Canagliflozin in Healthy Fed and Fasted Participants

The purpose of this study is to evaluate the bioequivalence of metformin component of the canagliflozin and metformin immediate release (IR) fixed dose combination (FDC) tablet compared with the metformin IR tablet co-administered with canagliflozin in healthy fed and fasted participants.

This is a randomized (study medication assigned to participants by chance), open-label (identity of study drug will be known to volunteer and study staff), single-center, single-dose, 4-treatment, 4-way crossover (method used to switch participants from one study group to another in a clinical trial, like the flip of a coin) study in healthy adult participants. The study will have 3 phases: Screening Phase (approximately 3 weeks, Day -22 to Day -2), Open-Label Treatment Phase (consisting of 4 single-dose treatment periods of 3 days each \[Day -1 to Day 2\], each separated by a washout period of 7 days) and Follow-up Phase (5 to 7 days after last study-related procedure on Day 2 of treatment period 4). All the eligible participants will be randomly assigned to 1 of 4 treatment sequences and will receive 2 treatments under fasting and 2 treatments under fed conditions. Blood samples will be collected for evaluation of pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) at pre-dose and post-dose of study treatment. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.5 and 30 kilogram per square meter (kg/m\^2) (inclusive) and a body weight of not less than 50 kg

Exclusion Criteria:

* History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator
The Use of Propranolol to Block Memory Reconsolidation in PTSD

The purpose of this investigation is to see if propranolol will reduce the psychophysiological hyperactivation associated with memories of combat stress in Veterans with Posttraumatic Stress Disorder.

The goal of this translational research project is to generate a pilot sample of data from an investigation of a novel therapeutic approach to post traumatic stress disorder (PTSD). Current treatments for PTSD include exposure and other aspects of cognitive therapy as well as drug therapies based on serotonin-reuptake inhibiting antidepressant agents. However, these treatments are often unsuccessful, and symptoms in affected individuals may persist for decades. The central hypothesis guiding this research project posits that acquired fear responses, such as those in PTSD, when reactivated by recall become sensitive to noradrenergic modulation and thus may be permanently attenuated by blocking noradrenergic transmission. Further, we predict that this attenuation will facilitate subsequent therapy. In the current study, we will be investigating this model in three groups of Veterans of either Operation Iraqi Freedom or Operation Enduring Freedom (OIF/OEF) with PTSD: 1) Individuals who receive propranolol following recall of a traumatic memory (Propranolol-trauma); 2) Individuals who receive a placebo following recall of a traumatic memory (Placebo-trauma), and; 3) Individuals who receive propranolol following recall of an affective neutral memory (Propranolol-neutral). In addition, traumatic memory recall will be psychophysiologically assessed by measuring Veterans' facial corrugator electromyography (EMG), skin conductance, blood pressure and cardiovascular inter-beat interval responses pre- and one month post-medication administration.

Eligibility Criteria:
Inclusion Criteria:

* Participants will meet the clinical criteria of PTSD (DSM IVTR) secondary to combat exposure.

Exclusion Criteria:

* Current illicit substance use or alcohol consumption, as determined by urine toxicology and alcohol breath test.
* Any diagnosis of current comorbid psychotic disorders, bipolar disorder, or illicit substance or alcohol abuse or dependence.
* Any current prescription medication usage or supplement (dietary or herbal) usage that is contraindicated with propranolol.
* Active enrollment into any psychiatric or psychological treatment.
* Any condition that contraindicates the use of propranolol, such as:

  * history of bronchial asthma.
  * heart block.
  * sinus bradycardia.
  * congestive heart failure.
  * insulin-dependent diabetes.
  * initial systolic blood pressure \< 100 mmHg.
  * Hyperthyroidism.
  * Thyroid disease.
  * Renal or liver impairment.
Re-Evaluation of Tumor Samples From Women With Breast Cancer With the in Vitro Diagnostic Kit "MammaTyperTM"

This is a prospective examination of tumor material of breast cancer patients randomized into the FinHer-trial (= (= Comparison of vinorelbine and docetaxel and trastuzumab as adjuvant treatments of breast cancer patients wirh a high risk of cancer recurrence).

The formalin-fixed, paraffin-embedded tissue samples will be analysed for Estrogen receptor 1 (ESR1), progesterone receptor (PgR), Human epidermal growth factor receptor 2 (HER2) and Antigen Ki-67 (Ki-67) with the molecular in vitro diagnostic kit MammaTyper™.

According to the new subtyping the 5 year Distant disease free survival (DDFS) and Overall survival (OS) will be re-evaluated.

Despite the fact that reliable measures for the markers ESR1, PgR, HER2, Ki-67 are necessary with the currently used methods up to 20% of determinations are inaccurate and especially Ki67- measures are not very reproducible. Therefore new evaluation systems or new methods are necessary to improve diagnostic.

At least 4 subtypes can be distinguished to date depending on the expression of ESR, PgR, Her2 and Ki-67:

* Luminal A-type
* Luminal B-type
* Her2-type
* Triple-negative-type

MammaTyper™ uses a new approach. Instead of detection of the marker proteins, the messenger ribonucleic adic (mRNA) of marker proteins is quantitated. This prospectively planned diagnostic study will investigate the potential of subgrouping of patients at baseline according to results of MammaTyper™ methodology for predicting survival.

Patients will be subgrouped according to the new marker determination and the DDFS and OS will be evaluated and compared to the DDFS and OS of subgrouping with former marker determination.

Eligibility Criteria:
Inclusion Criteria:

* Invasive breast cancer verified in a histological biopsy
* Age 65 or younger
* Estrogen receptor (ER), PgR and HER2 expression have been determined
* No distant metastases present (M0)
* The patient provides a written informed consent for study participation
* The estimated risk of breast cancer recurrence is high (25% or higher within the first 5 years from the date of the diagnosis, over \>35% within the first 10 years from the diagnosis)

Exclusion Criteria:

* Patients with breast cancer with "a special histological type" (mucinous, papillary, medullary, or tubular type of breast cancer) when no metastases are present in the ipsilateral axillary lymph nodes
* The WHO performance status is moderate/poor, Z \>1
* The peripheral blood leukocyte count is less than 3.0 x 109/L, the blood granulocyte count is less than 1.5 x 109/L, or the blood thrombocyte count is less than 120 x 109/L
* Any physical or mental disorder that is considered to prohibit administration of chemotherapy
* Cardiac failure; severe cardiac arrythmia requiring regular medication
Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD

Autism spectrum disorder (ASD) consists of deficits in social, communication, and cognitive development, repetitive and stereotypic behaviors. Many ASD patients show notably high levels of irritability, including verbal and physical aggression, self injury, and/or property destruction. Autistic infants tend to avoid eye contact and show little interest in others. This study will assess how safe and effective cariprazine is in treating pediatric participants (5 to 17 years of age) with ASD. Adverse events and change in disease activity will be assessed.

Cariprazine is an investigational drug being developed for the treatment of irritability due to ASD. This study is double-blinded means that neither the participants nor the study doctors will know who will be given cariprazine and who will be given placebo (does not contain treatment drug). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Approximately 152 participants diagnosed with ASD will be enrolled in approximately 40 sites globally.

Participants will receive oral capsules or oral solution of cariprazine or placebo once daily for 8-weeks and will undergo a 4-week safety follow-up period.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Participants at the time of screening must have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of ASD, confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime (K-SADS-PL) administered at screening (Visit 1) by a trained clinician.
* Participants must have an Aberrant Behavior Checklist, 2nd edition - Community Version - Irritability (ABC-I) subscale score ≥ 18 (Visits 1 and 2).
* Participants must have a Clinical Global Impressions - Severity - Irritability (CGI-S Irritability) score ≥ 4 at screening (Visits 1 and 2).

Exclusion Criteria:

* Participants with diagnosis of intellectual disability (Intelligence quotient \< 25).
* No history of major depressive disorder, bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition, as excluded by administration of Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime (K-SADS-PL).
* History of ASD that is associated with Rett Disorder, Fragile-X Syndrome, or Childhood Disintegrative Disorder.
A Study of LY2127399 in Rheumatoid Arthritis

This study will investigate how LY2127399 works in participants with rheumatoid arthritis (RA) who are not adequately responding to methotrexate. Participants will receive LY2127399 via an injection(s) under the skin at 4 week intervals for up to 52 weeks. Key study procedures include biopsies of the lining of an inflamed joint and blood tests to measure RA activity.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of adult onset RA disease according to revised 1987 American Rheumatism Association (ARA) criteria and currently have a documented history of positive for rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide antibody (anti-CCP Ab) and have moderately to severely active RA despite ongoing methotrexate (MTX) therapy
* Have active RA defined as the presence of at least 8/68 tender and at least 8/66 swollen joints, as determined by the tender joint count and swollen joint count assessment forms
* Have a screening C-reactive protein (CRP) measurement greater than 1.2 times upper limit of normal or erythrocyte sedimentation rate (ESR) greater than 28 millimeters/hour (mm/hr)
* Have a clinically inflamed joint suitable for synovial biopsy procedure

Exclusion Criteria:

* Have used an unstable dose of non-steroidal anti-inflammatory drugs (NSAIDs) within 6 weeks prior to baseline
* Have used oral corticosteroids at average daily doses of \>10 milligrams/day (mg/day) of prednisone or its equivalent within 6 weeks prior to baseline
* Have received any parenteral corticosteroid injection within 6 weeks of baseline
* Have used other disease-modifying anti-rheumatic drugs (DMARDs) other than MTX, hydroxychloroquine, and/or sulfasalazine in the 8 weeks prior to baseline
Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects

The purpose of OM6 is to evaluate efficacy and safety of Lovaza (omega-3-acid ethyl esters) \[formerly known as Omacor\] combined with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HDL-C) in subjects with persistent high triglycerides despite statin therapy.

Additionally, a two-year extension trial (LOV111818/OM6X) is posted on NCT00903409.

Two studies comprise this OM6 Program. Study OM6 / LOV111858 (double-blind study) and is not required to post results based on FDAAA. Study OM6X / LOV111818 (open-label extension) is posted on NCT00903409.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18-79 years, inclusive
* Current therapy with a statin drug
* Triglyceride levels between 200 and 499 mg/dL
* Normally active and in good health on the basis of medical history, brief physical examination, electrocardiogram, and routine laboratory tests
* Provide written informed consent and authorization for protected health information disclosure

Exclusion Criteria:

* Sensitivity to statin drugs or omega-3 fatty acids
* Lipoprotein lipase impairment or apo C-2 deficiency or type III hyperlipidemia
* Unexplained muscle pain or weakness
* History of pancreatitis
* Recent history of certain heart, kidney, liver, lung, or gastrointestinal diseases, or cancer (except non-melanoma skin cancer)
* Poorly controlled diabetes, or receiving insulin therapy
* Pregnant or lactating females. Women of childbearing potential who are not using a medically approved method of contraception.
* Use of certain types of hormones, anticonvulsant drugs, immunologic drugs, antibiotic, antifungal and antiviral drugs, and cardiac drugs
* Use of warfarin (Coumadin)
Effects of a Mulligan Mobilisation in the Lumbar Flexion Range of Asymptomatic Subjects

Mulligan's mobilisation techniques are believed to increase the range of movement (ROM) in patients with low back pain. The primary aim of this study was to investigate the mechanical effects of Mulligan's "SNAG" technique on lumbar flexion ROM. The secondary aim was to measure the intra- and inter-day reliability of lumbar ROM employing the same procedure, and utilising a 3-D motion analysis system for measuring range of motion (ROM).

The primary aim of this study was to investigate the mechanical effects of Mulligan's "SNAG" technique on lumbar flexion ROM. The secondary aim was to measure the intra- and inter-day reliability of lumbar ROM employing the same procedure. For the interventional component of the study, 49 asymptomatic volunteers participated in it. Subjects were randomly assigned into either a treatment (SNAG) group (n=25), or a placebo (SHAM) group (n=24). The "SNAG" technique was applied on L3 and L4 spinal levels by an experienced manual therapist. SNAGs were performed with active flexion in sitting, 10 times at each level. The placebo-SHAM was similar to the SNAG without however applying the appropriate direction or force. Lumbar ROM was measured by a three dimensional electronic goniometer (Zebris CM20), before and after each technique. For the reliability component, five measurements in two different days (one week apart) were performed in 20 healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* asymptomatic
* health individuals

Exclusion Criteria:

* Low back pain
* spinal pathology
* vascular or heart problems
* subjects taking anticoagulants