louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01097837: Epilepsy Birth Control Registry
Official title: Epilepsy Birth Control Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Keywords: Epilepsy
Contraceptive
Birth Control
Seizure
This study is looking at the use of different birth control measures in women with epilepsy.
Lead sponsor: Neuroendocrine Associates P.C.
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2010-04-02
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are women with epilepsy between the ages of 18 and 47.

Brief summary: Despite the importance of birth control to women of reproductive age, there has been little formal investigation of the safety and effectiveness of birth control methods in women with epilepsy. To remedy this, doctors from Harvard and Columbia University Medical Schools have developed a website that offers a survey to help us gain more knowledge and some educational material that will be updated regularly to provide the latest information. The ultimate goal is to develop guidelines for the selection of safe and effective birth control methods and to make sure that the best forms of birth control become available to women with epilepsy in all communities of our society.

Go to www.epilepsybirthcontrolregistry.com take our survey and then catch up on the latest information about birth control for women with epilepsy.


Eligibility criteria: Inclusion Criteria:

* Women with Epilepsy between 18 and 47

Exclusion Criteria:

* Women without epilepsy
* Women under 18
* Women over 47

Primary outcomes:
measure: Number of seizures on hormonal versus non-hormonal contraception, stratified by antiepileptic drug category
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wellesley
country: United States
facility: Neuroendocrine Associates P.C.
state: Massachusetts
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Neuroendocrine Associates P.C.
name: Andrew G Herzog, M.D.,M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01649037: To Compare the Efficacy of Nor Adrenaline and Terlipressin vs Step up Terlipressin Therapy in Hepatorenal Syndrome
Official title: A Randomised, Open Label Study to Compare the Efficacy of Nor Adrenaline and Terlipressin vs Step up Terlipressin Therapy in Hepatorenal Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hepatorenal Syndrome
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2012-07-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: All consecutive patients with liver cirrhosis having Acute Kidney Injury at admission or during hospitalization will be included in the study.

The diagnosis of liver cirrhosis will be based on the clinical grounds including Laboratory tests, endoscopic evidence, imaging (Ultrasonography/computed tomography) findings, and liver histology, when available.


Eligibility criteria: Inclusion Criteria:

- Patients with Liver cirrhosis and acute kidney injury. Patients consented for the study protocol by signing the informed consent.

Exclusion Criteria:

- Age less than 18 years Cirrhotics with kidney injury managed as outpatients. Patients undergoing renal replacement therapy (hemodialysis/renal transplantation).

Post liver transplantation patients. Hepatocellular carcinoma. History of coronary artery disease, ischaemic cardiomyopathy, ventricular arrhythmia, or peripheral vascular disease.

Patients with obstructive uropathy. Patient who withdrew or non complaint to the study protocol.

Primary outcomes:
measure: the Response to treatment in each intervention group
timeFrame: 2 years
Secondary outcomes:
measure: Survival
timeFrame: 15 days
measure: Side effects of the drug
timeFrame: 3 months
measure: Complications and the predictors of the treatment response
timeFrame: 2 years
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT00811837: The Effect of Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers
Official title: The Effect of Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hyperalgesia
Keywords: Sunburn
Remifentanil
Hyperalgesia
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-12-19
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Treatment of chronic pain is a major clinical challenge since chronic pain is frequent and leads to deterioration of quality of life. An injury or wound can lead to long term changes in the nervous system that make the skin more sensitive at and near the injury; this is termed hyperalgesia and occurs through long term depotentiation (LTP), i.e., a change in the synaptic interaction between neurons.

Opioids are the gold standard for the symptomatic therapy of moderate to severe pain. Now, in animal studies the investigators have discovered previously unrecognized effects of opioids.

UV-B irradaition of the skin of the thigh is an established model of priamary and secondary hyperalgeisa in humans. The investigators want to test the influence of remifentanil, an ultra-short acting opioid, on hyperalgesia observed after UV-B irradiation in human volunteers in a double blind cross-over prospective active placebo controlled clinical trial.


Eligibility criteria: Inclusion Criteria:

* Body mass index between 15th and 85th percentile
* Normal findings in the medical history and physical examination
* Drug free for 1 week prior to the study day

Exclusion Criteria:

* Regular use of medication especially analgesics
* Abuse of alcoholic beverages, drug abuse
* History of asthma
* Participation in a clinical trial in the 2 weeks preceding the study
* Symptoms of a clinically relevant illness in the 2 weeks before the first study day
* Resting systolic blood pressure \> 135 mmHg or diastolic blood pressure \> 85 mmHg
* Acute skin diseases like sunburn on the relevant areas or skin lesions
* Pregnancy or breast feeding
* UV sensitive skin conditions, like Xeroderma pigmentosa

Primary outcomes:
measure: Area of pin prick hyperalgesia
timeFrame: 0-6 hours
Secondary outcomes:
measure: Stimulus-response (SR) function to a set of modified rigid von Frey filaments (8-512 mN)
timeFrame: 0-6 hours
measure: Heat pain threshold within the area of mechanical hyperalgesia
timeFrame: 0-6 hours
measure: Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush
timeFrame: 0-6 hours
measure: Adverse effects
timeFrame: 30 and 59 min after start of treatment
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Anaesthesia, Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Burkhard Gustorff, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01753037: Effects of Androgen Administration on Inflammation in Normal Women
Official title: Effects of Oral Androgen Administration on Hyperglycemia-Induced Inflammation in Lean Reproductive-Age Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperandrogenism
Keywords: Hyperandrogenism
Inflammation
Insulin sensitivity
Body composition
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-12-20
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The hypothesis of this study is that DHEA administration to increase male hormone in healthy normal-weight young women to levels present in women with Polycystic Ovary Syndrome will cause an inflammatory response in white blood cells in the fasting state, and in response to glucose ingestion.


Eligibility criteria: Inclusion Criteria:

* Acceptable health based on interview, medical history, physical examination and lab tests
* Ability to comply with requirements of the study
* Ability and willingness to provide signed, witnessed informed consent
* Between the ages of 18-40 years
* Body mass index between 18 and 25
* Normal regular monthly periods
* No clinical evidence of androgen excess
* No evidence of polycystic ovaries on ultrasound

Exclusion Criteria:

* Diabetes mellitus
* Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious and malignant disease
* High blood pressure
* Current or recent (within 30 days prior to study entry) use of any drugs known or suspected to affect reproductive function including oral contraceptives, metformin, gonadotropin releasing hormone agonists, or anti-androgens (spironolactone, flutamide, etc.)
* Use of medications that have an adverse drug interaction with DHEA therapy including antipsychotics, phenothiazines, lithium, selective serotonin reuptake inhibitors, triazolam, estrogen or testosterone formulations
* Known hypersensitivity to DHEA
* Two first-degree relatives with breast cancer or ovarian cancer
* Documented or suspected history of recent (within 1 year) illicit drug abuse or alcoholism
* Tobacco smoking
* Ingestion of any investigational drugs within 4 weeks prior to study onset
* Pregnancy or lactation (less than or equal to 6 weeks postpartum)

Primary outcomes:
measure: Nuclear factor kappa B (NFkappaB) activation
timeFrame: 0 and 2 hours after glucose ingestion
Secondary outcomes:
measure: Insulin sensitivity
timeFrame: 0 and 5 days after DHEA or placebo
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Frank González, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04745637: Managed Access Programs for INC424, Ruxolitinib
Official title: Managed Access Programs for INC424, Ruxolitinib
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Primary Myelofibrosis (PMF)
Post Polycythemia Myelofibrosis (PPV MF)
Thrombocythemia Myelofibrosis (PET-MF)
Severe/very Severe COVID-19 Illness
Polycythemia Vera (PV)
Steroid Refractory Acute Graft Versus Host Disease (SR AGVHD)
Steroid Refractory Chronic Graft Versus Host Disease (SR CGVHD)
Keywords: MAP
Manage Access Program
Primary Myelofibrosis (PMF)
Post Polycythemia Myelofibrosis (PPV MF)
Thrombocythemia Myelofibrosis (PET-MF)
Severe/very severe COVID-19 illness
Polycythemia Vera (PV)
Steroid refractory acute Graft versus Host Disease (SR aGVHD)
Steroid refractory chronic Graft versus Host Disease (SR cGVHD)
INC424
Ruxolitinib
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-02-09
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this registration is to list Managed Access Programs (MAPs) related to INC424, Ruxolitinib

Detailed description: CINC424A2405 - No longer available- Managed Access Program (MAP) Cohort Treatment Plan CINC424A2405 to provide access to Ruxolitinib for patients with Primary Myelofibrosis (PMF) or Post Polycythemia Myelofibrosis (PPV MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF)

CINC424A2001M - No longer available - Ruxolitinib Managed Access Program (MAP) for patients diagnosed with severe/very severe COVID-19 illness

CINC424B2002I - No longer available- Managed Access Program (MAP) Cohort Treatment Plan CINC424B2002I to provide access to Ruxolitinib for patients with Polycythemia Vera (PV)

CINC424C2001M - Available - Managed Access Program (MAP) Cohort Treatment Plan CINC424C2001M to provide access to ruxolitinib for steroid refractory acute and chronic Graft versus Host Disease (SR aGVHD and SR cGHVD).

Eligibility criteria: Inclusion criteria

1. An independent request was received from a licensed physician.
2. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
3. The patient is not eligible or able to enroll in a clinical trial or continue participation in such trial.
4. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
5. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
7. Managed Access provision is allowed per local laws/regulations.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02507037: Effect of Gum Chewing on Bowel Cleansing Before Colonoscopy
Official title: Effect of Gum Chewing on Bowel Cleansing Before Colonoscopy: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bowel Preparation Scale
Adenoma Detection Rate
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2015-07-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: In this randomized controlled study, consecutive outpatients scheduled for elective colonoscopy were randomized into two groups. Group A patients (n = 150) used 2 L PEG before colonoscopy. Patients in group B (n = 150) were additionally advised to chew sugarless gum plus 2 L PEG, The overall quality of colonoscopy cleaning was evaluated using the Boston Bowel Preparation Scale by endoscopists who was blinded to the intervention. Difficulty of procedure, patients' tolerance, and adverse events were also evaluated.


Eligibility criteria: Inclusion Criteria:

* All adults (18-65) who were referred for outpatient colonoscopy.

Exclusion Criteria:

* under 18 years or More than 65 years
* previous abdominal surgery
* major psychiatric disorders
* pregnancy
* presence of any contraindications for colonoscopy(eg, severe heart failure)
* recent inadequate colonoscopy history

Primary outcomes:
measure: Boston Bowel Preparation Scale
timeFrame: 2 days
Secondary outcomes:
measure: number of patient tolerability
timeFrame: 2 days
measure: number of patient willingness to repeat preparation
timeFrame: 2 days
measure: Adenoma Detection Rate
timeFrame: 2 days
Other outcomes:
Locations:
Study officials:
References:
citation: Sakin YS, Uygun A, Bagci S. Comment on: Efficacy and safety of gum chewing in adjunct to high-dose senna for bowel cleansing before colonoscopy: a single-blind randomized controlled trial. Saudi J Gastroenterol. 2015 Jan-Feb;21(1):56. doi: 10.4103/1319-3767.151233. No abstract available.
citation: Ergul B, Filik L, Kocak E, Dogan Z, Sarikaya M. Efficacy and safety of gum chewing in adjunct to high-dose senna for bowel cleansing before colonoscopy: a single-blind randomized controlled trial. Saudi J Gastroenterol. 2014 Nov-Dec;20(6):356-9. doi: 10.4103/1319-3767.145325.
citation: Ou G, Svarta S, Chan C, Galorport C, Qian H, Enns R. The effect of chewing gum on small-bowel transit time in capsule endoscopy: a prospective, randomized trial. Gastrointest Endosc. 2014 Apr;79(4):630-6. doi: 10.1016/j.gie.2013.08.038. Epub 2013 Oct 7.
citation: Fang J, Wang SL, Fu HY, Li ZS, Bai Y. Impact of gum chewing on the quality of bowel preparation for colonoscopy: an endoscopist-blinded, randomized controlled trial. Gastrointest Endosc. 2017 Jul;86(1):187-191. doi: 10.1016/j.gie.2016.05.051. Epub 2016 Jun 17.
Clinical trial NCT03773237: Intralipid Versus SMOFlipid in HPN Patients
Official title: Randomized Prospective Trial Comparing Intralipid Versus SMOFlipid in New HPN Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Short Bowel Syndrome
Intestinal Fistula
Crohn Disease
Intestinal Obstruction
Keywords: SMOF
Intralipid
Mixed oil emulsion
Intestinal failure
HPN
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Randomized Controlled
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will randomize all patients who are new to the Mayo Clinic HPN team to either standard lipid emulsion (Intralipid) or SMOFLipid.

Detailed description: Primary aim is to assess the impact to direct/indirect bilirubin.

Secondary aims will be to assess impact to other liver function studies, metabolic parameters, inflammatory marker, body weight, ability to meet caloric needs through TPN, and ability to obtain appropriate macronutrient composition.

Eligibility criteria: Inclusion Criteria:

* Newly initiated Mayo Clinic HPN patient
* Able to provide informed consent
* Anticipated duration of HPN greater than 3 months,
* Infusion company is able to provide Smoflipid

Exclusion Criteria:

* Age less than 18 years
* Pregnant and lactating women
* Failure to provide consent
* Patients with underlying liver dysfunction (defined as liver function studies equal to or more than 2 times upper limit of normal) or pathology as determined by primary investigator
* Patients with active malignancy
* Patients who are deemed to be on HPN for less than three months
* Patients who have previous proven addiction and dependence to alcohol/ heavy alcohol AND consumption/active use reported during last 12 months.
* Known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or excipients in Smoflipid
* Patients who will not be managed by the Mayo Clinic HPN team
* Patients who have active infection (as determined by the clinician) at the time of enrollment.
* Patients who have received Smoflipid greater than 4 weeks in the last 12 months prior to enrollment.
* Patients who have been on TPN greater than 4 weeks in the last 12 months prior to enrollment.
* Enrolled in another interventional study.
* Severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides more than 1,000 mg/dL.

Primary outcomes:
measure: Direct/Indirect Bilirubin Change is assessed
timeFrame: At 12 weeks weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Manpreet S Mundi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06045637: The Effect of Psychoeducation on Cognitive Emotion Regulation and Negative Emotional Symptoms
Official title: The Effect of Cognitive Behavioral Approach-based Psychoeducation on the Cognitive Emotion Regulation Strategies and Negative Emotional Symptom Levels of Emerging Adults Who Experienced an Earthquake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Earthquake
Keywords: emerging adulthood
cognitive emotion regulation
negative emotional symptoms
psychoeducation
cognitive behavioral approach
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This research was planned as a randomized controlled experimental study. In this research, pre-test, post-test and follow-up test will be performed and there will be 1 experimental and 1 control group created by randomization.
Primary purpose: OTHER

Brief summary: This research was planned to determine the effect of cognitive behavioral approach-based psychoeducation on the cognitive emotion regulation strategies and negative emotional symptom levels of emerging adults who experienced an earthquake. In this research, pre-test, post-test and follow-up test will be performed and there will be 1 experimental and 1 control group created by randomization.After the pre-test applied to the experimental and control groups, a 9-session cognitive behavioral approach-based psychoeducation program will be applied to the experimental group.Following this application, post-test and one-month follow-up tests will be administered to both groups and the effectiveness of the psychoeducation program will be compared.


Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study,
* Being in the 18-29 age group,
* Being at least a primary school graduate,
* Being exposed to/having experienced the Kahramanmaraş earthquake and living in the center of Osmaniye.

Exclusion Criteria:

* Having a hearing or speech disability that makes it difficult to answer surveys,
* Participating in a similar psychoeducation program,
* Presence of any psychiatric disorder and receiving treatment

Primary outcomes:
measure: cognitive emotion regulation scale
timeFrame: Two months
measure: Depression, Anxiety, Stress Scale
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep University
Study officials:
affiliation: Osmaniye Korkut Ata University
name: AHMET ÇAPAR, lecturer
role: PRINCIPAL_INVESTIGATOR
References: