cyrilzakka/clinical-trials huggingface dataset:
Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women

Physicians might be concerned that Adempas may have a metabolic interaction with oral contraceptives (OC) that could decrease the contraceptive efficacy of the OC. The information regarding lack of potential pharmacokinetic interaction has been communicated; there is a need for more re-assurance and further data that there is no interaction between Adempas and OCs. A drug-drug interaction study of riociguat with an OC such as Microgynon in the least vulnerable population for these purposes, i.e. healthy postmenopausal women, is considered adequate to inform about safe use of Adempas with OCs.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subject
* Non-smokers of at least 3 month before screening
* Age: 52 to 65 years (inclusive) at the first screening examination
* Ethnicity: white
* Body mass index (BMI)\>=20 and \<=32 kg/m2
* Postmenopausal state, defined as
* Medical history, if applicable (natural menopause at least 12 months before the first study drug administration and hormone analyses in serum
* Age\<60 years: follicle-stimulating hormone (FSH) \>40 IU/L in plasma
* Age \<60 years: estradiol (E2) \<20 ng/L (\<73 pmol/L) in plasma

Exclusion Criteria:

* History of coronary artery disease, Symptomatic postural hypotension, History of bronchial asthma, known hypersensitivity to the study, relevant diseases within 4 weeks before study drug administration,
* Presence or a history of venous or arterial thrombotic / thromboembolic events or cerebrovascular accident, a high risk for venous or arterial thrombosis,
* Use of systemic or topical medicines or substances which oppose the study objectives, smoking, use of sex hormones in any forms
* Clinically relevant findings in the ECG, systolic blood pressure below 110 or above 145 mmHg, heart rate below 50 or above 95 beats per minute
* Clinically relevant findings in the gynecological examination,
* Participation in another clinical study
Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men

The purpose of this study is to explore diazoxide efficacy in treatment of obese men and assessment of maximal insulin suppression in obese men without hyperglycaemia.

Obesity is associated with markedly elevated plasma insulin levels throughout the day. The concept is that obese subjects predominantly develop lean tissue resistance against the glucoregulatory actions of insulin, but remain relatively sensitive to the lipogenic and antilipolytic effects of insulin in adipose tissue. According to this theory, suppression of hyperinsulinism by diazoxide, a well known inhibitor of glucose stimulated insulin secretion, might be useful to treat obesity because it will help to reverse the process of lipid storage.

The purpose of this study is to explore diazoxide efficacy in treatment of obese men and assessment of maximal insulin suppression in obese men without hyperglycaemia.

Study design:

This study is an open-labelled, non-randomized, phase IIa study.

Treatment:

During a 6 month period, the dosage of Diazoxide will be raised gradually until a maximum of 900 mg/day, under control of bloodpressure and glucose levels.

Endpoints, monthly determined:

* body weight
* abdominal circumference
* body composition measured by Dual Energy X-ray Absorptiometry
* glucose tolerance

Eligibility Criteria:
Inclusion Criteria:

* fasting glucose \< 7.0 mmol/L
* fasting C-peptide plasma level \> 1.0 nmol/L
* HbA1c of 6.0% or lower
* Absence of comorbidity
* Absence of medication use

Exclusion Criteria:

* Plasma Creatinine \> 120 micromol/L
* Liverenzymes \> 2 times the upper normal limit
* Gout
* Alcohol use \> 2 units/day
* Illicit drug use
* Quit smoking less than 6 months ago
A Clinical Study Using MEDI-551 in Adult Participants With Relapsed or Refractory Advanced B-Cell Malignancies

The purpose of this study is to determine the maximum tolerated dose of this drug (MEDI-551) in participants with advanced B-cell malignancies. Expansion to occur at maximum tolerated dose (MTD), or if not reached, at optimal biologic dose (OBD).

To determine the MTD or OBD of MEDI-551 in participants with relapsed or refractory advanced B-cell malignancies.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed CLL, DLBCL, FL, or MM;
* Karnofsky Performance Status \>= 70;
* Life expectancy of \>= 12 weeks;
* Prior radiation therapy provided exposure does not exceed an area of 25% of marrow space
* Adequate hematological function
* Adequate organ function

Exclusion Criteria:

* Any available standard line of therapy known to be life-prolonging or life-saving;
* No concurrent therapy or therapy within six weeks of first dose of MEDI-551 for treatment of cancer
* Previous therapy directed against CD19
* Vaccination (other than experimental cancer vaccine therapy) within 28 days prior to receiving the first dose of MEDI-551;
* History of other invasive malignancy within 5 years except for cervical carcinoma in situ (CIS), non-melanomatous carcinoma of the skin or ductal carcinoma in situ (DCIS) of the breast that have been surgically cured;
* Active infection requiring treatment
* Autologous stem cell transplantation within 4 months prior to study entry;
* Allogeneic stem cell transplantation or any other organ transplant;
* Ongoing \>= Grade 2 toxicities from previous cancer therapies unless specifically allowed in the Inclusion/Exclusion criteria.
* Use of immunosuppressive medication other than steroids within 28 days before the first dose of MEDI-551;
* Use of immunosuppressive medication other than steroids within 28 days before the first dose of MEDI-551 (inhaled and topical corticosteroids are permitted);
* Documented current central nervous system involvement by leukemia or lymphoma;
* Pregnancy or lactation;
* Clinically significant abnormality on ECG.
Effects of Lumbar Traction on the Straight Leg Raise Test and Pain

Disc prolapse causes impairment of function by nerve root compression compelling the patient to seek medical advice for low backache. Traction is one of the physical modalities frequently used for the treatment of lumbar disc herniations. So the purpose of the study is to determine the effect of one-fifth, one-half, and one-third of body weight traction on the straight leg raise test and pain.

A total of 45 patients suffering from lumbar PIVD and having neurological symptoms will be selected for the study. Lumbar PIVD will be confirmed from MRI. Participants will be divided into three groups with 15 participants in each group. group A. for one-fifth of body weight traction, group b for one-third of body weight traction, and group C for one-half of body weight traction. SLR and pain will be measured before traction and after traction. A goniometer will be used to measure SLR and VAS will be used to measure pain.

Eligibility Criteria:
Inclusion Criteria:

* Back pain for less than 3 months
* Positive unilateral Straight Leg Raise test which includes reports of back and leg pain or paraesthesia below 45-degree hip flexion
* At least one additional neurological sign should be present including- (a) Diminished Achillis/Hamstring tendon reflex, tested in the supine position or (b) Hyposthesia in any of the L4-S2 dermatome, or (c) Muscle weakness in any of the L4-S2 myotome.
* MRI evidence of L-4-L5 or L5-S1 disc prolapse or both.

Exclusion Criteria:

* Malignancy, Tuberculosis, Osteoporosis, Osteomyelitis of the vertebral column
* Cord compression, Pregnancy, Hypertension, Cardiovascular disease, Joint hyper mobility
* Subjects who could not tolerate the traction force secondary to being in an acute stage of back pain.
* Subjects who have taken previous physiotherapy treatment in the last three months for back pain.
Costs & Outcomes of Hospitalization/Treatment With Levalbuterol & Albuterol in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Subjects

An analysis of the costs and outcomes associated with hospitalization and treatment of Levalbuterol versus Racemic Albuterol in subjects with Asthma and COPD.

This was a randomized, open-label study evaluating clinical and pharmacoeconomic outcomes in hospitalized patients with asthma or COPD who have been admitted due to an exacerbation of their disease and required further treatment with a beta2-adrenergic agonist. Approximately 430 patients were randomized and enrolled. Patients were then followed during their hospitalization. Once discharged, patient status was assessed via telephone interview 30 days after discharge. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects must be at least greater than or equal to 18 years of age at the time of consent.
* Subjects must have history of asthma or COPD for at least 6 months prior to hospitalization.
* Subjects must have been hospitalized due to an exacerbation of their disease and required further treatment with a nebulized beta2-adrenergic agonist.
* Subjects must have an oxygen saturation level greater than or equal to 90% with greater than or equal to 40% face mask supplemental oxygen.

Exclusion Criteria:

* Subjects who are likely to be in the Intensive Care Unit (ICU) or Critical Care Unit (CCU).
* Based upon history or physical exam in the ED or Clinic, subjects with known or suspected cause of pulmonary symptoms other than asthma or COPD, such as pneumonia, pulmonary embolism, cystic fibrosis, or angioedema. Subjects with CHF that are admitted with a primary admission diagnosis of COPD are not excluded.
* Female subjects who are pregnant or breast feeding.
* Subjects who have participated in an investigational drug study within 30 days of study entry or have previously participated in the current trial.
* Subjects who are planning to receive elective surgical procedures during the 30 day period after hospital discharge.
Multiple Ascending Dose Study of HM12460A in Type 2 Diabetes Mellitus

This is a phase 1 multiple ascending dose (MAD) study, conducted in subjects with Type 2 Diabetes Mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Female subjects must be non-pregnant and non-lactating

Exclusion Criteria:

* Recurrent severe hypoglycemia or hypoglycemic unawareness or recent severe ketoacidosis, as judged by the Investigator
* Pregnant or lactating women
* Participation in an investigational study within 30 days prior to dosing
Comparison of Targeting Methods for Transcranial Magnetic Stimulation Treatment of Depression

We aim to learn whether use of a mixed reality device for transcranial magnetic stimulation (TMS) targeting can improve treatment outcomes compared to targeting through scalp measurements or a commercial neuronavigation system. Prior studies indicate that neuronavigation can lead to improved treatment outcomes compared to scalp measurements, but neuronavigation adaption has been lacking due to the increased burden of the neuronavigation setup on the TMS operator. We will assess whether use of a mixed reality device can decrease that burden and speed up the neuronavigation process and is feasible to be used in a clinical setting.

Prior studies suggest that treatment efficacy for TMS treatment of depression is affected by the targeting method used to guide TMS coil placement. We will compare the treatment outcome for three patient groups. TMS coil placement is guided for group 1) with simple scalp measurement targeting, for group 2) with a mixed reality neuronavigation system.

The treatment schedule for the medically prescribed TMS treatment for each patient are 30 daily weekday repetitive TMS treatments for 6 weeks with an additional 6 treatments tapered over 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects ages 18-75.
2. MRI scanning eligibility, including no evidence of any form of metal embedded in the body (e.g., metal wires, nuts, bolts, screws, plates, sutures), as these produce artifacts when brain imaging. All potential subjects for the MRI component will need to successfully complete the screening forms at the Stanford Center for Cognitive and Neurobiological Imaging (CNI) or the Lucas Center. Those subjects who present no contraindications to being scanned will be allowed to participate.
3. Healthy subjects with no history of any Axis I psychiatric disorder, are taking psychotropic medication, or use illicit drugs.
4. Clinical subjects with a diagnosis of treatment resistant depression and prescribed a clinical course of treatment with rTMS.

Exclusion Criteria:

1. Any contraindication to being scanned in the 3.0T scanner at the Lucas Center or CNI such as having a pacemaker or implanted device that has not been cleared for scanning at 3.0 Tesla.
2. History of neurological disorders including but not limited to brain surgery, deep brain stimulation, radiation treatment, brain hemorrhage or tumor, stroke, seizures or epilepsy, head trauma.
Cognitive Behavior Therapy for Insomnia Delivered by a Therapist or on the Internet

Background: Insomnia is a highly prevalent and disabling disorder where Cognitive Behavior Therapy for Insomnia (CBT-I) is established as the best available treatment. Still, only a negligible number of patients with insomnia receive this treatment. One potential way of improving the dissemination of CBT-I is by using online adaptations of CBT-I. This is a new method for delivering CBT-I and it is not known how effective online treatment is compared to face-to-face CBT-I. This trial's purpose is to compare face-to-face CBT-I with online CBT-I. Because of the great advantage of online treatment in both availability and cost, the trial is designed as a noninferiority trial.

Aim: To test if online CBT-I is noninferior in reducing insomnia complaints compared with CBT-I as delivered face-to-face by a therapist.


Eligibility Criteria:
Inclusion Criteria:

* meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnostic criteria for insomnia disorder

Exclusion Criteria:

* a condition that renders the patient incapable of understanding the treatment (e.g. actively psychotic, mental retardation, dementia or others
* an ongoing substance abuse problem
* other organic sleep disturbances or circadian sleep disturbance
* an ongoing medical condition where treatment of insomnia is not indicated (e.g. an attack phase of multiple sclerosis)
* working night shifts and being unable to discontinue this work pattern
* not being sufficiently fluent in Norwegian to understand the assessments or treatment
* not having the necessary computer skills needed to log on to the web based program
Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in Zambia

With the advent of universal eligibility for HIV treatment ("treat all") and same-day and community-based antiretroviral therapy (ART) initiation, retention in care after a patient has started ART remains the main challenge to achieving optimal outcomes in HIV treatment programs. Consistently across both time and geography, the highest risk for loss from care is during a patient's first six months after ART initiation, with about quarter of all patients not retained by the end of month 6.

One of the reasons for the high attrition from care in this early retention period is that the model of care offered to most newly-initiating and re-initiating patients has barely evolved from its original outlines. Patients in their first six months on ART are generally not eligible for lower-intensity, patient-centered "differentiated service delivery" models that make remaining in care easier for experienced patients. Instead, most early patients must still make multiple clinic visits that include clinical consultations with providers, and most can receive only 1-2 month supplies of medications at a time.

This protocol is for the PREFER-Zambia study, an activity of the Retain6 project. Retain6 aims to develop new models of care for patients' first six months on ART. PREFER-Zambia will collect data on patients' characteristics, clinical and non-clinical needs, and preferences for different types of services during their first six months after initiating ART. The investigators will conduct an observational, prospective cohort survey of newly-initiated or re-initiated adult ART patients at a selected set of 12 healthcare facilities in Zambia. Results are expected to inform the design of better models of service delivery for the early treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Living with HIV and on ART for 0-6 six months at the study site
* ≥ 18 years old (18 and older considered adult for research purposes in Zambia)
* Presented at the study site for routine HIV-related care
* Provide written informed consent to participate.

Exclusion Criteria:

* Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
* Not physically, mentally, or emotionally able to participate in the study, in the opinion of the investigators or study staff
* Unwilling to take the time required to complete the questionnaire on the day of consent
Targeting Collagen VII Antibodies with IV IgG in Dystrophic Epidermolysis Bullosa

The study objective is to see if IV IgG treatment in Recessive Dystrophic Epidermolysis Bullosa (RDEB) skin in conjunction with VYJUVEK treatment improves wound healing and affects the levels of C7 and HSV-1 antibody levels in serum.

Fewer wounds, more rapidly healing wounds, and decreased C7 and HSV-1 antibodies could improve quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations.
2. Diagnosis of EBA demonstrated by the presence of levels of serum C7 antibodies above the normal ELISA range
3. Baseline skin blistering greater than 5% total body surface area
4. 1 wound at least 20 cm\^2 able to be entirely treated with Vyjuvek weekly
5. 1 wound at least 20 cm\^2 that has never been treated with Vyjuvek
6. Ongoing VYJUVEK treatment.

Exclusion Criteria:

1. History of thrombotic event(s)
2. History of cardiac failure
3. History of renal failure
4. IgA deficiency
The Pathophysiology of Orthostatic Hypotension

The purpose of this study is to determine the cause of low blood pressure in selective patients who have problems with their involuntary (autonomic) nervous system. These patients frequently have had symptoms throughout their life, and their disorder might have a genetic basis. The biochemical, physiological and pharmacological procedures in this study should help us define the problem and perhaps lead to more effective treatment.


Eligibility Criteria:
Inclusion Criteria:

* severe orthostatic hypotension and other autonomic symptoms but do not meet criteria for standard diagnosis
* non-smokers
* drug-free
* able to give informed consent
* free of pulmonary, renal, hematopoietic, hepatic and cardiac disease

Exclusion Criteria:

* medications affecting the autonomic nervous system
* any chronic illness
* anemia (Hct\<30)
* women of childbearing age who are pregnant or nursing
* smokers
3D Printed PEEK Implants for Cranioplasty

This study is a non-randomised and single center study with patients needing an artificial skull bone eg cranioplasty. 40 patients will be implanted with in house manufactured polyether ether ketone (PEEK) implants using a fused filament fabrication 3D printer. The primary aim is to ascertain safety and feasibility of the procedure. The secondary aim is to compare complication rates with conventional methods such as autologous bone and polymethylmetacrylate (PMMA).

Cranioplasty is the surgical repair of a congenital or cranial defects after head trauma, infection or decompressive craniectomy. Although some patients can tolerate cranial defects for varied periods of time, cranioplasty is mostly indicated due to the increased risk of additional brain trauma, local pain or impaired CSF circulation but also aesthetic and psychological issues. The gold standard for repair since many years is cranioplasty with autologous bones . However, sometimes it not feasible to use the patient's autologous bone due to infections, trauma, bone graft resorption and donor-site morbidity. To replace the autologous bone grafts several different materials have been used, or are in use, as titanium meshes, hydroxyapatite cement and plastic resins as polymethyl methacrylate (PMMA) and porous polyethylene. Some of these have gathered increased interest due to advancements in technology for manufacture of these materials, and also the possibility to create custom made implants or moulds.

The present study aims to assay safety and feasibility of in house 3D printed medical grade PEEK implants in research persons with acquired skull defects.

The implants will be manufactured after 3D rendering from CT images of the skull defects, sterilised and aseptically inserted in the defects by means of a surgical intervention.

A safety interim analysis will be performed after inclusion of 10 patients.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for cranioplasty
* Informed consent

Exclusion Criteria:

* No informed consent
* Implant size greater than 12x12 cm
Evaluation of the Role of Propionibacterium Acnes in the Inflammatory Lesions Associated With Acne Vulgaris

The purpose of this study is to determine the response of acne patients and healthy control patients to the P. acnes bacteria. Half a tube of blood will be drawn from all participants to determine whether or not they have antibodies to the P. acnes bacterium. Anywhere from 1 to 4 skin biopsies of acne pimples or normal control skin will be taken from all subjects for further analysis in the lab to determine whether the inflammation in these pimples can be reduced using anti-P.acnes antibodies.


Eligibility Criteria:
Inclusion Criteria:

* Fits into one of the following diagnostic groups:

  1. Healthy subject with no active skin disease or history of skin disease
  2. Diagnosis of moderate-to-severe truncal acne diagnosed clinically and confirmed using the modified Leeds criteria with no reported use of topical acne treatments within the past 2 weeks prior to enrollment in the study, and no reported use of oral acne treatments during the past 4 weeks prior to enrollment in the study
  3. Diagnosis of moderate-to-severe truncal acne diagnosed clinically and confirmed using the modified Leeds criteria who has used any topical acne treatments in the 2 weeks prior to enrolling in the study, or who has used any oral acne treatments during the 4 weeks prior to enrolling in the study 2. Age 18-60 years 3. Male or female of any race and ethnicity 4. Subject agrees to comply with study requirements

Exclusion Criteria:

1. Subjects with severe medical condition(s) that in the view of the investigator prohibits participation in the study
2. Subject has Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
3. Pregnant or nursing females
4. Immunocompromised subjects (e.g., lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome), or with a history of active or malignant disease (excluding non-melanoma skin cancer) as determined by the participant's medical history.
5. Subjects with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol
6. Subjects with significant concurrent medical condition(s) at screening that in the view of the investigator prohibits participation in the study (e.g., severe concurrent allergic disease, condition associated with malignancy, and condition associated with immunosuppression)
7. Active viral or fungal skin infections at the target areas
8. Are currently receiving lithium now or within the last 4 weeks.
9. Ongoing participation in an investigational drug trial
10. Use of any systemic immunosuppressive therapy less than four weeks prior to screening.
11. Subjects with diabetes
12. Injured, broken skin that, per the investigator, may lead to poor wound healing
13. Subjects with allergies to anesthetic medications