louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00929669: Effect of Pasireotide Long Acting Release (LAR) on Gonadotroph Adenomas
Official title: Effect of Pasireotide LAR on Gonadotroph Adenomas: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Gonadotroph Adenomas
Keywords: pituitary tumor
endocrine
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2009-06-29
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if administration of pasireotide LAR for one year to three patients with gonadotroph adenomas and elevated serum FSH concentrations will reduce the serum follicle-stimulating hormone (FSH) to normal and reduce the adenoma size.

Detailed description: Gonadotroph adenomas are the most common pituitary macroadenomas. Currently no medical treatment as been found that decreases the size of these adenomas, so surgery is the only treatment. The reason to think that pasireotide might affect gonadotroph adenomas is that pasireotide binds avidly to somatostatin subtype 5 receptors, and gonadotroph adenomas express these receptors. For this study, three subjects who have gonadotroph adenomas, as judged by a macroadenoma of the pituitary and elevated serum FSH concentration, will be treated with a long-acting form of pasireotide once a month for one year. The effect of pasireotide on the size of the adenoma will be determined by MRI, and FSH secretion will be judged by the serum concentration.

Eligibility criteria: Inclusion Criteria:

* gonadotroph adenoma

Exclusion Criteria:

* visual impairment attributable to the adenoma
* radiation therapy
* active gallbladder disease
* uncontrolled diabetes

Primary outcomes:
measure: Number of Participants With Change in Size of the Adenoma by ≥3 mm in at Least Two Dimensions as Determined by MRI
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants With Change in Serum FSH Concentration (mIU/mL) in Patients Who Have Gonadotroph Adenomas Treated With Pasireotide.
timeFrame: 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Peter J. Snyder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03979469: Opioid Versus Non-opioid Anesthesia for Ambulatory Surgery in Children
Official title: Criteria Based Discharge in Ambulatory Surgery in Children Undergoing Opioid Versus Opioid Free Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Effect of Anesthesia in Postoperative Pain
Effect of Anesthesia in Extubation Time
Effect of Anesthesia in Discharge Time From Postanesthesia Care Unit
Effect of Anesthesia in Postoperative Adverse Events
Effect of Anesthesia in Discharge Time From the Hospital
Lead sponsor: Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators intend to study the safety and effectiveness of opioid free anesthesia compared to opioid anesthesia in ambulatory surgery in children, regarding postoperative pain, hemodynamic stability, agitation and discharge times. Quality of postanesthetic care was estimated in a 24h follow up.


Eligibility criteria: Inclusion Criteria:

* children,
* American Society Anesthesia I, II,
* ambulatory surgery

Exclusion Criteria:

* Allergy to anesthetic and analgesic drugs,
* history of neuromuscular,
* renal, neurological, hepatic disease,
* craniofacial anomalies,
* Obstructive Sleep Apnea,
* obesity,
* cardiopulmonary diseases

Primary outcomes:
measure: Discharge times from the hospital
timeFrame: 4 hours
measure: Severity of postoperative pain
timeFrame: 24 hours
measure: Severity of postoperative pain
timeFrame: 24 hours
Secondary outcomes:
measure: Extubation time
timeFrame: 30 minutes
measure: Discharge time from PACU
timeFrame: 60 minutes
measure: Cost effect
timeFrame: 24 hours
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Childrens Hospital P. and A. Kyriakou Anesthesiology Department
Study officials:
References:
Clinical trial NCT04613869: The Effect of Esketamine on Patients Undergoing Tumor Surgery
Official title: Effects of Esketamine on Postoperative Pain, Anxiety and Depression in Patients Undergoing Tumor Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tumor Surgery
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 282
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: Although the acute and chronic postoperative pain of surgical patients has gradually been paid attention to, it has not yet been better resolved.and, the incidence of anxiety and depression in cancer patients is constantly increasing，The new analgesic anesthetic esketamine hydrochloride was launched in China last year，however, in the domestic and foreign literature, there are still few reports of esketamine hydrochloride in postoperative analgesia, and most of them are retrospective and small samples.This study aims to investigate whether esketamine has advantages over traditional opioids in terms of postoperative analgesia, anxiety and depression in cancer patients.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old;
* Patients undergoing elective tumor surgery
* Use intravenous analgesia pump (PCIA) after operation

Exclusion Criteria:

* Patients with severe infection or respiratory system diseases;
* Severe arrhythmia, unstable angina or myocardial infarction, heart failure;
* Patients with severe diseases of liver, kidney, endocrine or immune system; ·Patients with fever before operation;
* One month before operation Patients receiving chemotherapy, radiotherapy or immunotherapy;
* Drug or alcohol dependence;
* Mental illness, disturbance of consciousness and communication difficulties or inability to understand the questionnaire or refusal to complete;
* Long-term use of antidepressant and anxiety drugs;
* High intracranial pressure High intraocular pressure

Primary outcomes:
measure: Incidence of moderate to severe pain
timeFrame: Within 72 hours after surgery
measure: Pain score
timeFrame: Within 72 hours after surgery
Secondary outcomes:
measure: Adverse reactions
timeFrame: Within 72 hours after surgery
measure: Postoperative analgesia
timeFrame: Within 48 hours after surgery
measure: Sedation
timeFrame: Within 48 hours after surgery
measure: Anxiety
timeFrame: Baseline (Before operation), 24 hours after operation, 72 hours after operation
measure: Depression
timeFrame: Baseline (Before operation), 24 hours after operation, 72 hours after operation
measure: Sleep condition
timeFrame: Within 72 hours after surgery
measure: Chronic pain
timeFrame: One month after surgery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University anesthesiology department
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Min Yan, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00235469: A Trial to Assess the Efficacy and Safety of SPM 927 in Subjects With Painful Distal Diabetic Neuropathy
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Assess the Efficacy and Safety OF 200, 400, AND 600 mg/Day SPM 927 in Subjects With Painful Distal Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetic Neuropathy
Keywords: PAINFUL DISTAL DIABETIC NEUROPATHY
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-10-10
Enrollment: 496
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This phase 2b trial is being conducted at approximately 60 sites in the US to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic neuropathy. Approximately 360 subjects will be randomized to placebo or one of three doses of lacosamide. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have an average pain intensity of ≥4 on an 11-point Likert scale (0-10 scale) during the 7 day period prior to start of treatment.

To determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity (morning and evening), pain interference with sleep (morning) and activity (evening). Use of rescue medication (acetaminophen) and subjects' quality of life will be investigated. In addition, safety and tolerability of the different doses of lacosamide will be investigated.


Eligibility criteria: Inclusion Criteria:

* Painful distal diabetic neuropathy

Exclusion Criteria:

* Must have an average pain intensity of ≥ 4 on an 11-point Likert scale

Primary outcomes:
measure: To investigate the efficacy of 200, 400, and 600 mg/day of lacosamide compared with placebo in reducing pain in subjects with painful distal diabetic neuropathy.
Secondary outcomes:
measure: To investigate the effect of lacosamide on subjects' perception of pain, sleep, activity, quality of life, as well as to investigate the pharmacokinetics and safety of lacosamide.
Other outcomes:
Locations:
city: RTP
country: United States
facility: Schwarz
state: North Carolina
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Wymer JP, Simpson J, Sen D, Bongardt S; Lacosamide SP742 Study Group. Efficacy and safety of lacosamide in diabetic neuropathic pain: an 18-week double-blind placebo-controlled trial of fixed-dose regimens. Clin J Pain. 2009 Jun;25(5):376-85. doi: 10.1097/AJP.0b013e318196d2b6.
Clinical trial NCT00332969: Efficacy of Octreotide Treatment in Patients With Primary Inoperable Thymoma
Official title: Efficacy of Medical Treatment With Octreotide in Patients With Primary Inoperable Thymoma to Reduce Tumor Size
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thymoma
Keywords: Open label
phase II
disease
clinical trial
Octreotide
thymoma
cancer
tumor
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-06-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate the efficacy of treatment with octroetide in patients with primary inoperable thymoma to reduce tumor size.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients aged \>18 years
2. Inoperability of thymic tumor. Inoperability is defined as at least adherence of the tumor to the neighbour organs, suspicious to infiltrate neighbour organs so that R0 resection cannot be expected.
3. Positive result in SMS-szintigraphy,
4. Thymomas of all WHO based histological subtypes (Rosai, 1999; Travis 2004) at Masaoka stage III based on histological examination of core biopsies or resection specimens.
5. Patients with and without thymoma associated paraneoplastic syndrome
6. Demonstrated tolerance to a test dose of s.c. octreotide injection at Visit 1.

Exclusion Criteria:

1. Performance status 0,1, or 2 (ECOG)
2. Symptomatic cholelithiasis,
3. Pretreatment with octreotide (longn acting release) within the 3 months
4. Patient has received any other investigational agents within 28 days of first day of study drug dosing
5. Patient is \< 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed
6. Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Shrinkage of tumor size and diameter of 3 respectively 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Resection status after 3 respectively 6 months
timeFrame: 3 - 6 months
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmeceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Kirzinger L, Boy S, Marienhagen J, Schuierer G, Neu R, Ried M, Hofmann HS, Wiebe K, Strobel P, May C, Kleylein-Sohn J, Baierlein C, Bogdahn U, Marx A, Schalke B. Octreotide LAR and Prednisone as Neoadjuvant Treatment in Patients with Primary or Locally Recurrent Unresectable Thymic Tumors: A Phase II Study. PLoS One. 2016 Dec 16;11(12):e0168215. doi: 10.1371/journal.pone.0168215. eCollection 2016.
Clinical trial NCT05409469: Clinical Characteristics, Management Patterns and Outcomes of Type A Aortic Dissection: A Sino-US Comparative Cohort Analysis
Official title: Clinical Characteristics, Management Patterns and Outcomes of Type A Aortic Dissection: A Sino-US Comparative Cohort Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Dissection
Keywords: Aortic Dissection
China
the United States
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: China Medical University, China
First posted: 2022-06-08
Enrollment: 11550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with aortic dissection in Jiangsu Aortic Registry system of China from January 2012 to December 2021 and all patients with aortic dissection in National Inpatient Sample database of the United States from January 2015 to December 2019.

Brief summary: This study constructed a retrospective cohort study by retrospectively analyzing the data of all patients with aortic dissection from January 1, 2012 to December 31, 2021 from the Cardiovascular Disease Registration System of Jiangsu Province in China and the data of similar diseases in recent years from National Inpatient Sample database in the United States


Eligibility criteria: Inclusion Criteria:

1.Clinical diagnosis of type A Aortic Dissection

Exclusion Criteria:

1. age\<18, age unknown,
2. diagnosis of aortic aneurysm, transfer out within 1 day,
3. unknown vital status at discharge;
4. unknown treatment type: cardioplegia, valve or cardiac repair only without aortic repair or two types of treatments on different days

Primary outcomes:
measure: Baseline data of patients with type A aortic dissection was assessed by SPSS 17.0
timeFrame: from 2015 to 2019
measure: The main efficacy indicators was assessed by SPSS 17.0.
timeFrame: from 2015 to 2019
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00703469: A Study of MDX-1106 to Treat Patients With Hepatitis C Infection
Official title: A Phase I, Double-blind,Multicenter,Randomized,Placebo-controlled,Safety and Pharmacokinetic Dose-escalation Study of a Single Intravenous Administration of MDX-1106, a Fully Human Monoclonal Antibody to PD-1, in Subjects With Active Hepatitis C Genotype 1 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Keywords: Hep C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-06-23
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study examines the safety, tolerability, and immunogenicity of a single dose of MDX-1106 in patients with active hepatitis C genotype 1 or mixed hepatitis C genotype infection.


Eligibility criteria: Inclusion Criteria:

* Infection with hepatitis C genotype 1 or mixed hepatitis C genotype;
* Asymptomatic or nearly asymptomatic from hepatitis C;
* Previous therapy with interferon and ribavirin or peginterferon and ribavirin without an SVR or relapsed following an SVR;or Interferon naive subjects
* Chronically infected (at least 6 months since diagnosis) HCV-positive subjects;
* No evidence of bridging necrosis or cirrhosis;
* Liver biopsy within the last 2 years

Exclusion Criteria:

* Acute hepatitis C infection
* History of prior malignancy, acquired or inherited immunodeficiency or autoimmune disease either documented or anecdotal;

Primary outcomes:
measure: safety, tolerability, and immunogenicity
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Clinical Resesarch Institute
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Springfield
country: United States
facility: Springfield Clinic Infectious Diseases
state: Illinois
city: Baltimore
country: United States
facility: John Hopkins University School of Medicine, Viral Hepatitis Center
state: Maryland
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Medicine
state: Pennsylvania
city: Dallas
country: United States
facility: The Liver Institute at Methodist Dallas
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Gardiner D, Lalezari J, Lawitz E, DiMicco M, Ghalib R, Reddy KR, Chang KM, Sulkowski M, Marro SO, Anderson J, He B, Kansra V, McPhee F, Wind-Rotolo M, Grasela D, Selby M, Korman AJ, Lowy I. A randomized, double-blind, placebo-controlled assessment of BMS-936558, a fully human monoclonal antibody to programmed death-1 (PD-1), in patients with chronic hepatitis C virus infection. PLoS One. 2013 May 22;8(5):e63818. doi: 10.1371/journal.pone.0063818. Print 2013.
Clinical trial NCT04509869: "Outcome of Varicocelectomy on Normal Semen in Patients Complaining of Orchialgia
Official title: Outcome of Subinguinal Varicocelectomy on Normal Semen in Patients Complaining of Orchialgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicocele
Pain
Fertility Issues
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 20
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: varicoclelectomy is done for subfertiltiy and varicocele induced orchialgia. The effect of varicocelectomy on semen analysis is controversial. Many articles report favorable outcomes and others do not.

Most study don't focus on varicocelectomy done for varicocele induced orchialgia,and those studies dont report on postoperative semen.

This study will focus on the effect of operation on the semen postoperatively .


Eligibility criteria: Inclusion Criteria:

1. Primary varicocele
2. Patient's age more than 19 years
3. Normal semen analysis (according to the WHO 5th guide to semen parameters where sperm concentration equal 15 million per ml , total sperm number 40 million per ejaculate ,normal morphology 4 % and motility A =25% or a+b = 32% is considered normal.
4. Scrotal pain after exclusion of other causes.

Exclusion Criteria:

* 1- Recurrent varicocele

Primary outcomes:
measure: sperm motility
timeFrame: 3 months postoperative is our aim
measure: sperm morphology
timeFrame: 3 months postoperative is our aim
measure: sperm number
timeFrame: 3 months postoperative is our aim
measure: pain of scrotum
timeFrame: 3 months postoperative is our aim
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit Medical School
state: Assuit
Study officials:
References:
citation: Chen SS. Factors predicting symptomatic relief by varicocelectomy in patients with normospermia and painful varicocele nonresponsive to conservative treatment. Urology. 2012 Sep;80(3):585-9. doi: 10.1016/j.urology.2012.05.014. Epub 2012 Jul 10.
citation: Abd Ellatif ME, Asker W, Abbas A, Negm A, Al-Katary M, El-Kaffas H, Moatamed A. Varicocelectomy to treat pain, and predictors of success: a prospective study. Curr Urol. 2012 May;6(1):33-6. doi: 10.1159/000338867. Epub 2012 Mar 18.
citation: Cho CL, Esteves SC, Agarwal A. Indications and outcomes of varicocele repair. Panminerva Med. 2019 Jun;61(2):152-163. doi: 10.23736/S0031-0808.18.03528-0.
citation: Maghraby HA. Laparoscopic varicocelectomy for painful varicoceles: merits and outcomes. J Endourol. 2002 Mar;16(2):107-10. doi: 10.1089/089277902753619627.
citation: Peterson AC, Lance RS, Ruiz HE. Outcomes of varicocele ligation done for pain. J Urol. 1998 May;159(5):1565-7. doi: 10.1097/00005392-199805000-00043.
citation: Yaman O, Ozdiler E, Anafarta K, Gogus O. Effect of microsurgical subinguinal varicocele ligation to treat pain. Urology. 2000 Jan;55(1):107-8. doi: 10.1016/s0090-4295(99)00374-x.
Clinical trial NCT05301569: Relation Between Serum IGF-1 & BMI In Acne Vulgaris
Official title: Relation Between Serum Insulin Like Growth Factor 1 and Body Mass Index in Acne Vulgaris
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Evaluation of Serum Level of Insulin Like Growth Factor 1
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 90
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acne vulgaris patients aged from 15 to 45 years old

Brief summary: cross-sectional study in which participants will be recruited at dermatology \& Andrology out-patient clinics in Assuit university hospital, Egypt after patients examination by dermatologists \& obtaining an informed consent


Eligibility criteria: Inclusion Criteria:

1. Patients aged from 15 to 45 years old suffering from acne vulgaris.
2. Both sexes.

Exclusion Criteria:

1. Insulin resistance and diabetic patients
2. Females with polycystic ovarian syndrome
3. Treatment with drugs that can influence IGF-1level such as corticosteroid, insulin, hypoglycemic agents, and isotretinoin within one year before the date of study.
4. Other causes of acne or acneform eruption as steroid-induced

Primary outcomes:
measure: Evaluation of serum level of insulin like growth factor 1 in acne vulgaris
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Rania Sallam
state: Qalubya
Study officials:
References: