louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01459133: Single Site, Single Subject, Treatment IND With Mannkind Corporation's Technosphere Inhalation System
Official title: Single Site, Single Subject, Treatment IND With Mannkind Corporation's Technosphere
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes
Keywords: investigational
inhaled insulin product
Lead sponsor: South Orange County Endocrinology
Sponsor class: OTHER
Collaborators: name: Mannkind Corporation
First posted: 2011-10-25
Enrollment: 0
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 program is to allow patients with diabetes and with specific medical needs which require them to use this investigational inhaled insulin product in order to adequately manage their diabetes. Treatment use of this investigational product is only anticipated when exceptional need is identified by a treating physician on a per patient case by case review.

Detailed description: This program is for patients who have been diagnosed with diabetes mellitus and has established a need for treatment with this investigational product documented by a health care professional. The treating doctor, or a member of his/her staff, will discuss the specific requirements for participation with the subject.

INVESTIGATIONAL PRODUCT DESCRIPTION:

Technosphere® Insulin Inhalation System includes Technosphere® Insulin Inhalation Powder and inhaler. The Inhalation Powder comes in 10 unit and 20 unit cartridges.

Eligibility criteria: Inclusion Criteria:

Documented diagnosis with diabetes mellitus and have established a need for treatment with the investigational product.

Local Ethics Committee approval has been documented, as needed. Patient has signed the Informed Consent Form for participation. Patient has successfully completed training on the Technosphere Insulin Inhalation System.

Exclusion Criteria:

Allergy to Insulin. Smoking in the previous 6-months. History of asthma or COPD or any other significant pulmonary disease, or exposure to pulmonary toxins.

Clinical significant abnormality in screening laboratory tests. Positive pregnancy test or the intention to become pregnant. Women of childbearing age without appropriate method of contraception.

Primary outcomes:
measure: Efficacy of Inhaled Insulin versus Subcutaneous Insulin in a patient who receives inadequate response from subcutaneous alone.
timeFrame: 12-months
Secondary outcomes:
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: South Orange County Endocrinology
state: California
Study officials:
References:
Clinical trial NCT05347433: Comparison of Fetal Thymus Volumes of Pregnant Women With In Vitro Fertilization (IVF) and Spontaneous Pregnant Women.
Official title: Comparison of 18-24 Week Pregnant Women With in Vitro Fertilization (IVF) and Pregnant Women With Spontaneous Pregnancy in the Same Week in Terms of Fetal Thymus Volume
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Fetal thymus volume
In vitro fertilization
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study group consisted of normal pregnant women who applied to the pregnancy clinic for routine pregnancy follow-ups

Brief summary: The purpose of the study was to compare the fetal thymus volumes of 18-24-week pregnant women with In Vitro Fertilization (IVF) and spontaneous pregnant women.


Eligibility criteria: Inclusion Criteria:

* pregnant between 18-24 weeks
* had no complaints
* between the ages of 18-35
* conceived with in vitro fertilization or spontaneously

Exclusion Criteria:

* history of endocrinopathies (including diabetes mellitus, hyperprolactinemia, Cushing's disease, and congenital adrenal hyperplasia), systemic diseases (e.g. asthma), collagen disorder, hypercholesterolemia, sickle cell anemia, or neoplasm,
* those who had a history of coronary artery disease, angina, or myocardial infarction, or a history of hypertension, coronary arteritis, and electrocardiographic changes that suggest any known history of vascular, infectious, or inflammatory disease, maternal autoimmune disease,
* use of any drugs other than those used for IVF (e.g. insulin sensitizing drugs, oral contraceptives, antiandrogens, statins, aspirin, and corticosteroids) in the 3 months before the pregnancy,
* multiple pregnancy,
* present cigarette and alcohol use,
* abnormal renal, hepatic, and thyroid function test results;
* refusing to participate in the study,
* abnormal fetal findings (fetal anomaly, increased nape transparency, first-second trimester screening test disorder),
* cases who did not meet the criteria for pregnancy after the first tube treatment (ICSI-ET) because of normoresponder, unexplained infertility, or male factor

Primary outcomes:
measure: measurement of fetal thymus volume
timeFrame: 18-24 week pregnant women
Secondary outcomes:
measure: frequency of pregnancy complications
timeFrame: during pregnancy and at delivery week
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University
Study officials:
References:
Clinical trial NCT04233333: Fixation of the Orogastric Tube: Which Method for the Newborn ?
Official title: Fixation of the Orogastric Tube: Which Method for the Newborn ?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Enteral Feeding
Gastric Emptying
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 30
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is recommended to respect the perioral zone by fixing the feeding tube only on the newborn's cheek, in order to promote oral acquisition and avoid repeated dislodgment of probes (HAS). This rule is easily applicable for nasogastric tubes. The difficulty is found for orogastric tubes. The "mustache" is usually used to fix it, but this interferes with the perioral zone and must be changed more often than necessary.

To achieve a more sustainable orogastric tube's fixation to the cheek, a German team directed by W. Krämer developed and tested an orogastric tube's fixing technique that was subsequently approved and used.

Using this German method, a randomized, monocentric superiority study, including 30 newborns and premature babies requiring an orogastric tube, will compared german probe's fixation method to the mustache.

The aim of the study is to ensure a more effective orogastric tube's fixation to reduce the number of fixation changes, probe placements and negative oral stimulations in newborns.


Eligibility criteria: Inclusion Criteria:

* Newborns admitted to neonatal intensive care unit
* Express consent of the holders of parental authority
* Orogastric tube indication (enteral feeding, digestive aspiration)

Exclusion Criteria:

* Newborns over 2 months of age corrected
* Indication of nasogastric tube
* Port of gastrostomy
* Pathology resulting in hypersalivation or hyper sweating
* Swallowing disorder
* Genetic disease
* Severe neurological impairment
* Cleft lip and / or palate
* Other malformation in the oral sphere or perioral area
* Sedation with morphine analgesics
* Anticonvulsant treatment
* Palliative care

Primary outcomes:
measure: Average duration of holding the fixation
timeFrame: 7 days
Secondary outcomes:
measure: Number of tube's dislodgements
timeFrame: 7 days
Other outcomes:
Locations:
city: Saint-Pierre
country: France
facility: Centre Hospitalier Universitaire de la Réunion
Study officials:
References:
Clinical trial NCT00574587: Trial for Locally Advanced Breast Cancer Using Vorinostat Plus Chemotherapy
Official title: Phase I-II Trial of Vorinostat Plus Weekly Paclitaxel (+/- Trastuzumab) Followed by Doxorubicin-cyclophosphamide in Patients With Locally Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Keywords: Vorinostat
Neoadjuvant Chemotherapy
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2007-12-17
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Vorinostat is a histone deacetylase (HDAC) inhibitor which is approved by the U.S. Food and Drug Administration for the treatment of a rare type of cancer involving the skin (cutaneous T cell lymphoma), but not for breast cancer. HDAC inhibitors work by unsilencing tumor suppressor genes and other genes in the cancer cells that are repressed; when the genes are turned back on by the drug, it leads to death of the cancer cells. HDAC inhibitors such as vorinostat have been shown to enhance the effects of chemotherapy and trastuzumab in experimental systems. The purpose of this trial is to determine the optimal dose of vorinostat to use in combination with standard chemotherapy alone (or in combination with plus trastuzumab for HER2-positive disease), and to determine whether vorinostat enhances the effectiveness of standard chemotherapy (+/- trastuzumab) in patients with locally advanced breast cancer.

Detailed description: This is a phase I-II trial in which patients with stage IIB-IIIC breast cancer will receive:

1. Neoadjuvant weekly paclitaxel (80 mg/m2 IV weekly x 12 weeks) plus vorinostat (200 or 300 mg PO BID on days 1-3 each paclitaxel dose) and trastuzumab (4 mg/kg loading dose, 2 mg/kg IV weekly x 12 total doses if HER2 positive, followed by:
2. Doxorubicin (60 mg/m2) plus cyclophosphamide (600 mg/m2) every 2 weeks x 4 cycles (plus G-CSF), followed by:
3. Surgery (lumpectomy or mastectomy)

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the breast associated with the following stages: IIB, IIIA, IIIB or IIIC.
* Tumor must be Her2/neu positive
* No prior chemotherapy, radiation or definitive therapeutic surgery

Exclusion Criteria:

* May not be receiving any other investigational agents
* Uncontrolled intercurrent illness

Primary outcomes:
measure: Recommended Phase II Dose of Vorinostat in Combination With Weekly Paclitaxel/Trastuzumab
timeFrame: 3 weeks
Secondary outcomes:
measure: Pathological Complete Response (CR) Rate in Patients With Her2/Neu Positive Locally Advanced Breast Cancer.
timeFrame: 6 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Joseph Sparano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05062187: Lower Extremity Proprioception Sensory and Functionality in Hemiparetic
Official title: Lower Extremity in Hemiparetic Proprioception Sensory and Functionality: A Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemiparesis Proprioceptive Disorders Gait, Hemiplegic, Healthy Individual, Comparative Study
Lead sponsor: Istanbul Aydın University
Sponsor class: OTHER
Collaborators: name: Pamukkale University
First posted: 2021-09-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Hemiparetic individuals Healthy individuals

Brief summary: The loss of sensorial feedback causes gait impairment in hemiparesis. The studies show that proprioceptive impairment of knee is related to falling in these patients. The aim of this study is to investigate the effects of proprioception on balance and gait functions in hemiparetic individuals.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 20-65 and discharged from the hospital,
* Diagnosed with hemiparesis at least 4 weeks ago,
* First time and unilateral hemiparesis,
* Modified Rankin Score ≤ 3,
* Hodkinson Mental Test ≥ 6,
* Individuals who agree to receive treatment will be included in the study.

Exclusion Criteria:

* Having vision and hearing problems,
* Having other accompanying neurological, psychiatric and/or orthopedic problems other than hemiparesis,
* Medically unstable,
* Diseases that will affect the lower extremity sense,
* Individuals with open wounds, circulation problems, and skin lesions in the area to be treated will be excluded from the study.

Primary outcomes:
measure: Sensorial Assessment-1
timeFrame: 2 minutes
measure: Sensorial Assessment-2
timeFrame: 2 minutes
measure: Sensorial Assessment-3
timeFrame: 2 minutes
measure: Balance assessment
timeFrame: 30 second
measure: Gait parameters
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Aydın University
Study officials:
References:
Clinical trial NCT00068887: Regional Fatty Acid Metabolism in Humans
Official title: Regional Fatty Acid Metabolism in Humans
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetes Mellitus, Type 2
Keywords: type 2 diabetes
some studies - family history of type 2 diabetes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2003-09-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: There are several studies looking at how dietary fat is metabolized by humans. We give special meals and collect blood, breath, urine and fat samples to study how people burn and store dietary fat.


Eligibility criteria: Inclusion Criteria: BMI\<25 Lean, sedentary with family history of DM2 and Lean, sedentary without family history of DM2 and Lean, active without family history of DM2. Non-smokers.

Exclusion Criteria: Known systemic illness, cardiac and vascular disease and BP\> 160/95 on HTN meds. Medications that affect fat metabolism.

We do not pay for travel expenses.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
Clinical trial NCT00207987: Changes in Cerebral Oxygenation During Deliberate Hypotensive Anesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypotension
Keywords: controlled hypotension
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: This is a study using cerebral oximetry to evaluate the safety of traditionally adopted hypotensive anesthesia.

Detailed description: The values of cerebral oximetry were analyzed between different stages of anesthetic management. The critical part of anesthetic management is to use the technique of controlled hypotension. The blood pressure was lowered to the level of MABP 50 or 60 mmHg depending on which group patients were assigned to.

The values of cerebral oximetry and side effects between 2 groups will be compared at the completion of data collection.

Eligibility criteria: Inclusion Criteria:

* 40 patients are going to receive complex spine surgery.

Exclusion Criteria:

* Neurologic diseases
* Hepatic or renal impairment
* Uncontrolled hypertension
* Cardiovascular diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Anesthetic Department, China Medical University Hospital
Study officials:
affiliation: Anesthetic Department, China Medical University Hospital
name: Yu C Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00963287: Trial of Chinese Prescription on Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Keywords: alternative medicine
traditional Chinese medicine
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2009-08-21
Enrollment: 200
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: The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription on Ulcerative Colitis.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ulcerative colitis
* Male of female patients between 18-65 years old
* Written informed consent

Exclusion Criteria:

* Combine with malignant pathology on epithelial dysplasia of mucosa
* Combined with severe heart, gallbladder, kidney, endocrine system, hemopoietic system or nervous system disease.
* Pregnancy or breast feeding women, or unwilling to have contraception.

Primary outcomes:
measure: Histopathological examination,enteroscopy,blood test,symptoms ,pulse tracings,tongue demonstration
timeFrame: 8 weeks
Secondary outcomes:
measure: Indicates of liver and renal function
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua hospital
state: Shanghai
Study officials:
affiliation: Shanghai University of Chinese Medicine
name: Xie Jianqun, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT00245687: A Research Study to Test (2) Two Different Types of Feeding Tubes Used in the Intensive Care Unit
Official title: A Comparative Study of the Tiger Tube Frictional Nasal Jejunal Feeding Tube and the Dubhoff Tube
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: no Primary Disease; ICU Patient Who Require Enteral Nutrition
Keywords: feeding tube, nutrition, gastric, jejunal
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2005-10-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the success rates of two types of feeding tubes, specifically the standard gastric feeding tube to a small bowel feeding tube.

Detailed description: Enteral nutrition has many advantages for critically ill patients including lower incidence of infections and a reduced hospital stay, however it is controversial whether enteral feeding via small bowel feeding tubes offers an advantage over gastric feeding tubes in terms of reducing aspiration risk, improving feeding tolerance or ensuring quicker attainment of nutritional goals. The advantages of a small bowel feeding tube over a gastric feeding tube is thought to be related to its post pyloric position, however the insertion of small bowel feeding tubes is technically challenging (most studies report a success rate of 15-30%), can take time and has complications not unlike those of the gastric feeding tube. Our hypothesis is that the small bowel feeding tube offers an advantage to the gastric feeding tube due to its ability to achieve post pyloric placement. Specifically we chose to compare the standard gastric feeding tube (Dubhoff) to a small bowel feeding tube which offers the advantage of having alternating flaps which allows the gut to drag this tube into the small bowel.

Eligibility criteria: Inclusion Criteria:

* all ICU patients requiring enteral nutrition

Exclusion Criteria:

* coagulopathy, esophageal or gastric, surgery, varices, trauma, ulcer, structure, rupture

Primary outcomes:
measure: success in placing feeding tube
Secondary outcomes:
measure: - rate of reaching nutritional goal, aspiration pneumonia, feeding tolerance, and pre-albumin
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital - MRICU
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Paul Marik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02411487: Meibomian Gland Dysfunction (MGD) and Tear Cytokines After Cataract Surgery According to Preoperative Meibomian Gland Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-04-08
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 55 eyes from 55 patients who underwent cataract surgery were included.

Brief summary: To investigate the possible mechanisms by which cataract surgery aggravates meibomian gland dysfunction (MGD), the investigators evaluated the changes in tear cytokines and ocular surface parameters after cataract surgery according to the preoperative MGD grade.


Eligibility criteria: Inclusion Criteria:

* males or non-pregnant females aged between 55 to 80 years-old.

Exclusion Criteria:

* had a history of ocular diseases, such as ocular infection, ocular allergy, and autoimmune disease, as well as patients with continuous use of topical ocular medications before surgery, or histories of ocular surgery or ocular injury.

Primary outcomes:
measure: inflammatory tear cytokine concentration
timeFrame: 1 month after cataract surgery
measure: ocular surface staining
timeFrame: 1 month after cataract surgery
measure: tear film break-up time,
timeFrame: 1 month after cataract surgery
measure: conjunctival injection,
timeFrame: 1 month after cataract surgery
measure: Schirmer's test I
timeFrame: 1 month after cataract surgery
measure: ocular surface disease index
timeFrame: 1 month after cataract surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Ophthalmology
Study officials:
References:
citation: Li XM, Hu L, Hu J, Wang W. Investigation of dry eye disease and analysis of the pathogenic factors in patients after cataract surgery. Cornea. 2007 Oct;26(9 Suppl 1):S16-20. doi: 10.1097/ICO.0b013e31812f67ca.
citation: Cyclin-dependent kinase inhibitory protein expression in human choroidal melanoma tumors. Mouriaux F,*(1) Maurage CA, Labalette P, Sablonniere B, Malecaze F, Darbon JM. Inv Ophthalmol Vis Sci 2000;41:2837-2843. Am J Ophthalmol. 2001 Jan;131(1):157. doi: 10.1016/s0002-9394(00)00922-3. No abstract available.