cyrilzakka/clinical-trials huggingface dataset:
Setmelanotide in a Single Patient With Partial Lipodystrophy

The objective of this single patient study is to assess the safety and efficacy of setmelanotide as a treatment of severe metabolic abnormalities resulting from LD, especially refractory hypertriglyceridemia leading to recurrent bouts of pancreatitis.

This is a single-patient study to assess the safety and efficacy of setmelanotide in a unique patient with partial LD and severe metabolic abnormalities, most notably refractory hypertriglyceridemia leading to recurrent pancreatitis despite ongoing plasmapheresis treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent
2. Ability to comply with visits and procedures required by program.
3. Has physician-confirmed partial lipodystrophy and the following characteristics:

   * Has atypical lipodystrophy.
   * Has presence of neutralizing antibody to metreleptin
   * Patient has life threatening hypertriglyceridemia and has had \>8 episodes of pancreatitis, requiring weekly plasmapheresis
   * Has Type 1 diabetes mellitus with HbA1c \> 10%.
4. Female, under the age of 18 years

Exclusion Criteria:

1. Diagnosis of schizophrenia, bipolar disorder, personality disorder or other Diagnostic and Statistical Manual of Mental Disorders (DSM-III) disorders that the investigator believes will interfere significantly with study compliance. Neurocognitive disorders affecting ability to consent will not be disqualifying as long as an appropriate guardian able to give consent has been appointed.
2. History or close family history (parents or siblings) of skin cancer or melanoma, or patient history of ocular-cutaneous albinism.
3. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions, determined as part of a screening comprehensive skin evaluation performed by a qualified dermatologist.
4. Significant hypersensitivity to study drug.
5. Inability to comply with QD injection regimen.
The Global Prevalence of Infections in Urology Study

Urology departments from all over the world are invited to join the Global Prevalence Study on Infections in Urology (GPIU-study) and the GPIU Prostate Biopsy Side Study. The GPIU study is taking part annually in November since 2003. European urologists were the first group of specialist to register hospital acquired infections on an international level. More than 20.000 patients have been screened and more than 2000 patients are currently listed in this database.

Why? Infectious complications after urological procedures, such as prostate biopsy and increasing antimicrobial resistance are posing significant threats to modern urology The GPIU-study is a combined quality improvement initiative and a scientific study. Once the participating departments have filled in the report forms they will get access to statistics showing the accumulated results for all participating hospitals. The participants can anonymously compare their own results with hospitals from all over the World. The GPIU-study application has been designed as an instrument to ongoing follow-up of the development of important factors related to infection on international, national and local levels.

Take responsibility for the future of urology - join the GPIU-studies! http://gpiu.esiu.org

Prof. Dr. Florian M.E. Wagenlehner, MD, PhD Clinic for Urology, Pediatric Urology and Andrology University Clinic Giessen, Germany GPIU study coordinator

Prof. Truls E. Bjerklund Johansen, MD, PhD Urology Department, Oslo University Hospital, Chairman ESIU Oslo, NO GPIU Study coordinator

Zafer Tandogdu University College London (UCL), UK

Dominic Althaus Software engineer Giessen, Ger


Eligibility Criteria:
* On the chosen single study day at 08:00 AM local time all patients present on the ward of the participating institution are included
* The presence of urinary tract infections (UTI) according to the CDC definitions during their entire hospital stay are documented and audited and the patients are categorized as having or not having a UTI and/or
* The presence of surgical site infection (SSI) according to the CDC definitions during their entire hospital stay are documented and audited and the patients are categorized as having or not having a SSI
Bedtime Administration of Amlodipine Versus Lisinopril

This study seeks to compare the differences in effectiveness among individual patients treated at for hypertension with bedtime administration of amlodipine versus lisinopril. There will be an analysis of whether one medication was more effective than another and whether specific patient factors could predict who responded better to which one.


Eligibility Criteria:
Inclusion Criteria:

* Age 40 to 80
* Newly diagnosed hypertension based on 24 hour ambulatory blood pressure monitor criteria.
* Minimum Asleep SBP mean of ≥ 120mmHg for inclusion.

Exclusion Criteria:

* Current antihypertensive medication use
* Baseline GFR \< 45
* Preexisting macroproteinuria
* Chronic congestive heart failure
* History of CVA
* Diabetes Mellitus
* Pregnancy
* Night-shift work
* Other preexisting contraindication to amlodipine or lisinopril
Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma

The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin (CMC-544) in subjects with indolent Non-Hodgkins lymphoma (NHL) that is refractory or has relapsed after multiple therapies including rituximab or radioimmunotherapy. The investigational drug will be given to subjects with indolent NHL by intravenous infusion at a dose of 1.8 mg/m2, every 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone, or small lymphocytic lymphoma) that has progressed after 2 or more prior systemic therapies.
* Previous anticancer treatment given must have contained rituximab and chemotherapy, or anti CD20 Radio Immuno Therapy. Subjects must have exhibited no response or have progressed within 6 months from the completion of the most recent rituximab or rituximab containing therapy or within 12 months of the completion of Radio Immuno Therapy.
* Measurable disease with adequate bone marrow function, renal and hepatic function

Exclusion Criteria:

* History of, or suggestive of, veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS) or history of chronic liver disease (eg, cirrhosis) or suspected alcohol abuse.
* Prior allogeneic hematopoietic stem cell transplant (HSCT).
* Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma.
Safety and Efficacy Study of LIPO-202 for the Reduction of Central Abdominal Bulging in Obese Subjects

This is a multi-center, randomized, placebo-controlled, double-blind study evaluating the safety and efficacy of LIPO-202 for the reduction of central abdominal bulging in obese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non-pregnant female subjects
* Capable of providing written consent
* BMI \> 30 kg/m2 but \< 40 kg/m2
* Stable diet and exercise routine
* At least "Slightly Dissatisfied" with their abdominal bulging on the Abdominal Contour Questionnaire (ACQ)

Exclusion Criteria:

* BMI \> 40 kg/m2
* Have had any treatment of the fat around your abdomen, including surgical procedures (tummy tuck, liposuction), injections for fat loss or treatments with devices to reduce fat in your abdomen.
* Plan on starting a weight loss or exercise program during the study
* Known hypersensitivity to study drugs
* Have any medical condition that might complicate study procedures
Pilot Study on the Use of Acupuncture for Postpartum Depression

The proposed study is a randomized controlled trial to examine the efficacy and safety of active acupuncture versus placebo acupuncture for the treatment of postpartum depression. The investigators hypothesis is that active acupuncture would be superior to placebo acupuncture in the short-term treatment of postpartum depression.

This study will be a randomized, controlled, subject- and assessor-blind trial in patients with postpartum depression. Eligible subjects will be randomly assigned to active acupuncture or placebo acupuncture. The subjects will receive acupuncture treatment twice per week for 4 consecutive weeks. The acupuncturist of this trial will not participate in data collection and data entry. The trial assessor will be blind to the subjects' treatment allocation.

Eligibility Criteria:
Inclusion Criteria:

* Ethnic Hong Kong Chinese aged 18 years or above;
* Within 6 months of giving birth;
* Edinburgh Postnatal Depression Scale (EPDS) (Cox et al., 1987) score higher than or equal to 12 or being diagnosed as depressed by their obstetrician;
* Meeting the Diagnostic and Statistical Manual of Mental Disorders-IV diagnosis criteria for major depressive disorder;
* 17-item Hamilton Depression Rating Scale (HDRS17) (Hamilton, 1960) score of between 12 and 19 at screening and baseline assessment;
* Willingness to give informed consent and comply with trial protocol.

Exclusion Criteria:

* Suffering from other psychiatric disorders such as schizophrenia, other psychotic disorders, bipolar disorder or substance use disorder;
* Serious physical illnesses or mental disorders due to a general medical condition which are judged by the investigator to render unsafe;
* A significant risk of suicide according to the rating of HDRS17 item 3 (score higher than 2), i.e., presence of ideas or gesture of suicide;
* A presence of idea of self-harming according to the rating of EPDS item 10 (score higher than 0);
* A significant risk of infanticide according to the investigator assessment;
* Any acupuncture treatment during the previous 12 months prior to baseline;
* Valvular heart defects, bleeding disorders or taking anticoagulant drugs;
* Infection or abscess close to the site of selected acupoints;
* Herbal remedies or psychotropic drugs that are intended for depression are taken within the last 2 weeks prior to baseline or during the study.
* Receiving counseling or psychological therapies at baseline or during the study;
* Participation in any clinical trial within the previous 3 months prior to baseline;
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Japanese Subjects

This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* BMI (body mass index) between 19-29 kg/m\^2 (both inclusive)
* Fasting blood glucose between 3.8-6.0 mmol/L (both inclusive)
* Non-smokers

Exclusion Criteria:

* Subjects with a first-degree relative with diabetes mellitus
* Subjects smoke 5 cigarettes or more per day
Diabetes Prevention Program

The Diabetes Prevention Program is a nationwide clinical study to answer the question: Can Type 2 diabetes (also called noninsulin-dependent or adult-onset diabetes) be prevented or delayed? The study has recruited volunteers, who are at high risk of developing diabetes, at twenty-five medical centers in the United States. It is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, and other Institute and corporate sponsors. Researchers will evaluate the efficacy of a lifestyle intervention and a pharmacological intervention in preventing or delaying Type 2 diabetes in persons with impaired glucose tolerance (IGT). Each person in the study will be followed for 3 to 6 years.


Eligibility Criteria:
Inclusion Criteria:

* Impaired glucose tolerance (fasting plasma glucose 95-125 mg/dL and 2hr plasma glucose 140-199 mg/dL)
* BMI \>= 24 kg/m2

Exclusion Criteria:

* Underlying disease likely to limit life span and/or increase risk of interventions
* Conditions or behaviors likely to effect conduct of the DPP
* Diabetes or disordered glucose metabolism
* Suboptimally treated Thyroid disease
* Fasting triglyceride level \< 600 mg/dl
* Exclusions related to medications
Breath Analysis by Ion Mobility Spectrometry

Recognition of disease specific clusters of volatile organic compounds in patients with different lung diseases, using breath analysis with ion mobility spectrometry. Lung diseases of interest are:

* COPD
* tumors
* airway infection
* interstitial lung disease
* sleep apnea Hypothesis: Breath analysis with ion mobility spectrometry can differentiate pulmonary disorders.

Recruitment of patients with different lung diseases goes on. First sub-group analysis of patients with COPD,lung cancer and sarcoidosis is done in order to create a training set of VOC-clusters for further validation in a bigger population of patients.

Eligibility Criteria:
Inclusion Criteria:

* Any patient
* Ages 18-90 years old

Exclusion criteria:

- Patient who are not able to perform an exhalation manoever.
A Study to Assess the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Advanced Basal Cell Carcinoma (BCC)

This prospective, observational, cohort study is designed to assess the effectiveness and safety outcomes of vismodegib and to assess actual day-to-day disease and participant management by the physician.


Eligibility Criteria:
Inclusion Criteria:

* BCC that meets one of the study's pre-specified cohort definitions
* Physician's decision to treat participant with vismodegib as per local label
* Participant who has not participated in a clinical trial within 90 days prior to study enrollment, with the exception of participants who meet the criteria for Cohort 2 (No Gorlin Syndrome Participants With Prior HPI Exposure)

Exclusion Criteria:

* Female participants are excluded if they are pregnant or if they plan to become pregnant during treatment or within 2 years after end of treatment
* Male participants with female partners of childbearing potential are excluded if they plan to impregnate their partner during treatment or within 2 months after end of treatment
Comparison of Incision Angle of Mediolateral Episiotomy at 40 and 60 Degrees

The angle at which an episiotomy can be made is a continuous variable. If the investigators consider midline to be 0 degrees and a lateral episiotomy (never used today) to be 90 degrees, then it is theoretically possible to choose any angle from 0 to 90 degrees.

Episiotomy is a surgical incision to the perineum in order to enlarge the vaginal orifice during the second stage of labor. Although seven types of episiotomy have been described in the literature , the most frequently performed types are the mediolateral and median episiotomies, with the former being the most common one. Despite being a common obstetric practice, the exact definition of a "mediolateral" episiotomy is often unclear. Several studies and reports, however, stated that a significant proportion of the so-claimed mediolateral episiotomy were not actually mediolateral. The current trial compares two angles of mediolateral episiotomy , regarding the risk of third- and fourth-degree perineal tearing, episiotomy-related pain and dyspareunia in primiparous women at a large tertiary maternity center, namely Ain Shams University Maternity Hospital, Cairo, Egypt.

Eligibility Criteria:
Inclusion Criteria:

1. Primigravida with singleton pregnancy presenting by vertex.
2. Gestational age \> 37 weeks
3. No instrumental delivery.
4. No fetal distress or any emergency

Exclusion Criteria:

1. Women had an episiotomy because of fetal distress and for technical reasons (emergency or episiotomy incised prior to the fetal head crowning the perineum.
2. Inability to understand the informed consent.
Effect of Omega 3 on Periodontitis in Postmenopausal Women

The study was aimed to investigating changes in periodontal parameters and superoxide dismutase activity after root surface debridement with and without Omega 3 fatty acids (ω-3 FAs) supplementation in postmenopausal women. Adjunctive Omega 3 fatty acids supplements reduce periodontal inflammation and improve the status of systemic enzymatic antioxidants in postmenopausal women.

Fifty postmenopausal women with chronic periodontitis were divided randomly into two groups: Group 1 (n=25) were provided periodontal treatment in the form of scaling and root planing (SRP) plus placebo soft gelatin capsules while group 2 (n=25): patients were received SRP along with systemic administration of Omega 3 fatty acids. Clinical parameters and superoxide dismutase (SOD) activity in the gingival crevicular fluid were recorded at baseline, 3 and 6 months after therapy. The research has been conducted between July 2014 and June 2015. By the end of the study period, the Omega 3 treated group was able to achieve a greater mean probing pocket depth reduction, mean gain in clinical attachment level, as well as greater increase in SOD activity (P\<0.01) compared to SRP alone.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with generalized chronic periodontitis (clinical attachment loss more than 30% of the teeth)
* With probing pocket depth ≥ 5mm.
* The age ranged between 45 and 60 years (To avoid the wide variation between individual cases in order to make the sample more homogeneous. Furthermore elderly patients above 60 years are usually not willing to have periodontal treatment).
* Postmenopausal status for at least 1 year.
* Presence of at least six teeth in the mouth.

Exclusion Criteria:

* Any systemic disease that affect the periodontium.
* Women who take anti-inflammatory drugs, antibiotics or vitamins within the previous 3 month.
* Women who use mouth washes regularly
* Smoking
* History of alcohol abuse
* Participation in other clinical trials.
* Obese women (Body mass index (BMI) ≥ 30).
Pediatric Epilepsy Study in Subjects 1-24 Months

This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will be added to the subject's current epilepsy medications.


Eligibility Criteria:
Inclusion criteria:

* Must have completed the Open-Label Phase of protocol LAM20006 or meet criteria for LAMICTAL naive subjects as follows:
* A confident diagnosis of epilepsy.
* 4 or more partial seizures per month.
* current treatment with 1 or 2 anti-epileptic drugs.

Exclusion criteria:

* Has seizures not related to epilepsy.
* Has a surgically implanted and functioning vagal nerve stimulator.
* Has previously been treated with lamotrigine.
* Is currently taking felbamate, ACTH (adrenocorticotrophic hormone) or is on the ketogenic diet.
* Use of experimental medication within 30 days of enrollment.
Heart Failure Precision Medicine Study

The study aims to test the hypothesis that multi-omics studies can identify Heart Failure profiles at risk of adverse outcomes and evaluate a telemonitoring intervention in the optimization of guideline-directed medical therapy.

In the US, the estimated prevalence of Heart Failure (HF) is 6.2 million and increasing. The mortality approaches 50% within 5 years of diagnosis and HF is the main cause of hospitalization among patients over 65 years of age. Information on molecular states may enhance understanding of causes and pathophysiological processes, improve risk prediction, identify new therapeutic targets, and improve subclassification for targeted therapy. Time-dependent phenomapping has been used to identify clinical and genomic differences in a longitudinal fashion, which provides a mechanistic link underlying pathophysiology of the disease and associated outcomes. Studies including high-throughput molecular approaches (multi-omics) along with time-dependent phenomapping would likely be even more powerful. The overarching hypothesis of the study is that the integration of Multi-Omics studies with clinical variables can be implemented to identify patients at risk of adverse outcomes. To test this hypothesis we propose: (1) Longitudinal profiling based on clinical data; (2) Longitudinal Multi-Omics Profiling; and (3) randomized of a telemonitoring intervention (Sensor Profiling) and the effectiveness in the optimization of guideline-directed medical therapy. To achieve these aims we propose to: (1) recruit a cohort of 1000 participants; (2) perform cardiovascular clinical characterization from electronic medical records; (3) perform multi-omics studies and (4) randomization of a telemonitoring intervention in the optimization of guideline-directed medical therapy. Proving these hypotheses would identify different meaningful clinical groups of patients within a cohort of patients with similar clinical conditions, health care providers would have a better understanding of the heterogeneity of the disease and the need for different preventive and therapeutic approaches in the context of precision medicine.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Heart failure
* Objective evidence of cardiac abnormality of structure or function (abnormal ECHO) or elevated levels of B-type natriuretic peptide (\>100 pg/ml)
* HF stage B-D and class I-IV

Exclusion Criteria:

* Patients unable to consent
* Inability to comply with the protocol and follow-up requirements
* Patients unable to use a smartphone
* Patients assessed irregularly (less than two visits in one year)
* History of HTx
* Use of Mechanical circulatory support device (MCSD)
* Comorbidities that, according to the PI, have the potential to interfere with the interpretation of the results
Evaluation of Trials of Labor After Previous Cesarean Section in Ain Shams University Maternity Hospital

The purpose of the study to evaluate the practice and short term maternal and perinatal outcomes of trial of labor after cesarean section offered to women at Ain Shams University Maternity Hospital (ASUMH) during the 3-year period from January 2013 to December 2015.

This is a retrospective study that was performed at Ain Shams University Maternity Hospital.

The following data will be gathered (whenever available), tabulated and subjected to the proper statistical analysis:

History:

* Age
* Duration of marriage
* Inter-pregnancy interval
* Gestational age (by menstrual dates or US)
* Obstetric history (parity, mode of delivery, assisted vaginal delivery, previous vaginal birth after cesarean section, neonatal outcome)
* Present and past history of any medical, surgical or obstetric problems; history of infection after previous CS

General examination:

* General condition
* Vital data

Abdominal examination:

* Fundal level
* Estimated fetal weight (clinically or by US)
* Scar tenderness

Vaginal examination on admission:

* Cervical status
* Station of presenting part
* Membranes status
* Pelvic adequacy

Investigations performed:

* Complete Blood Count
* Ultrasonography

Intrapartum management:

* Progress and duration of labor according to partogram (or admission-delivery time)
* Intrapartum complications; placental abruption, uterine rupture, hysterectomy, complications during surgical intervention if any

Mode of delivery:

* Vaginal delivery (spontaneous, assisted, complications)
* Cesarean section (indication, scar dehiscence)

Postpartum Data:

* Postpartum hemorrhage
* Blood transfusion
* Neonatal outcome; fetal weight, birth trauma, Neonatal Intensive Care Unit admission, mortality

Eligibility Criteria:
Inclusion Criteria:

* Women admitted in labour
* One prior caesarean section
* Singleton pregnancy
* Vertex-presenting fetus

Exclusion Criteria:

* Prior high-risk uterine scar; uterine rupture, classical CS, hysterotomy or myomectomy
* Short inter-delivery interval (\<12 months)
* Complications in the previous CS (e.g. puerperal sepsis)
* Obstetric indication for CS (either elective or emergency):

  * Placenta praevia
  * Placental abruption
  * Documented evidence of cephalopelvic disproportion
  * Fetal macrosomia (estimated fetal weight \>4 kg)
  * Fetal anomalies interfering with vaginal delivery e.g. hydrocephalus
  * Fetal distress or non-reassuring Cardiotocography pattern