louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03243513: Abo Follow-up Study
Official title: Abortion Follow-up Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pregnancy Termination
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 1600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: De-identified charts of women who have had an induced abortion and are contacted by a nurse for a follow-up phone call.

Brief summary: The aim of the project is to identify an efficient and effective policy or procedure for identifying complications from surgical abortions through follow-up phone calls.

Detailed description: The aim of the project is to identify an efficient and effective policy or procedure for identifying complications from surgical abortions through follow-up phone calls. Key questions include, what is our complication-detection rate from these phone calls? How many patients are contacted? How many attempts are made and how much effort is expended by staff in routine follow-up practices? Additionally, the research would attempt to answer the question, is there any way to predict problems or complications? This study will help to determine if excessive resources and time are being expended on follow-up phone method to detect complications.

This study will consist of a retrospective chart review identifying the outcome of follow-up phone calls after an induced abortion.

Eligibility criteria: Inclusion Criteria:

* Reproductive-aged women
* women who have had an induced abortion, and are contacted by a clinical nurse for a follow-up phone call.

Exclusion Criteria:

-

Primary outcomes:
measure: Follow-up Phone Calls
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Lisa Hofler, MD, MBA, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05596513: Motor Learning Approaches From Working on a Vertical Surface in Hemiplegic Children's Upper Limb Motor Skills
Official title: Effectiveness of Intensive Motor Learning Approaches From Working on a Vertical Surface on Hemiplegic Children's Upper Limb Motor Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia
Spastic
Keywords: motor learning
vertical surface
hemiplegia
cerebral palsy
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: received the intensive motor-learning approaches that focuses on training of the affected hand (motor-learning approaches such as - constraint-induced movement therapy (CIMT) and hand-arm bimanual intensive training (HABIT) of the control group but from a vertical surface
Primary purpose: TREATMENT

Brief summary: Working on a vertical surface is one of the best activities children can do to make themselves more successful in many areas as an infant which builds all those foundational skills required for the all-important task of handwriting.

Detailed description: Motor-learning approaches such as - constraint-induced movement therapy (CIMT) offer an array of sensorimotor experiences in a playful yet repetitive and intense fashion.

A stable shoulder girdle is the co-contraction of muscles around the scapula and shoulder joint.

Depending on the activity, vertical surfaces will have kids moving their arms frequently; reaching up, down, out and around. This supports extension of the arm and an opportunity to strengthen those muscles.

Vertical surfaces facilitate wrist extension. When the wrist is extended, the ring and pinky finger tend to naturally find their way into the palm creating a more optimal grasp pattern. A child is going to be able to execute more precise and legible work when using a functional tripod or quadrupod grasp.

Eligibility criteria: Inclusion Criteria:

1. Children diagnosed with spastic hemiplegic cerebral palsy
2. Age 5 to 9 years
3. Manual Ability Classification System (MACS)19 scores I, II.
4. Children who can understand and cooperate with researcher's instructions
5. Children with no visual or hearing impairment

Exclusion Criteria:

1. Children with any surgical interference in the upper limb.
2. Intellectual disability such that simple tasks could not be understood or executed.
3. Inability to combine the study protocol with the regular school program

Primary outcomes:
measure: QUEST
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Badr
country: Egypt
facility: Badr University
state: Cairo
Study officials:
affiliation: lecturer
name: Omnya samy, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00068913: Evaluating the Effectiveness of a Dichloroacetate in MELAS Syndrome
Official title: Investigation of Clinical Syndromes Associated With mtDNA Point Mutations: MELAS/DCA Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: MELAS Syndrome
Keywords: Lactic Acidosis
Mitochondrial Disorder
Stroke
Seizure
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2003-09-11
Enrollment: 35
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Patients with the MELAS syndrome experience devastating mental impairment. This study will evaluate the effectiveness of the drug dichloroacetate (DCA) to reduce the symptoms of MELAS.

Detailed description: Although many organ systems are affected by mitochondrial (mt) DNA point mutations, the nervous system is particularly vulnerable. Maternally inherited mtDNA point mutations may cause chronic progressive encephalopathies and mental retardation. Patients with MELAS (mitochondrial myopathy, encephalopathy, lactic acidosis, and stroke-like episodes) syndrome have the A3243G point mutation and elevated brain lactate levels. Research has shown that lactic acidosis is associated with progressive impairment in patients with MELAS. This study will evaluate the effectiveness of DCA in lowering lactate levels and slowing the progression of MELAS.

Patients with the A3243G mitochondrial mutation and who have had either a stroke or a seizure will be enrolled in this study. Patients will be randomized to receive either DCA or a placebo. At a predetermined time point, patients receiving DCA will be switched to placebo and patients receiving placebo will be switched to DCA. Patients will have study visits every 3 months for 3 years. Study visits will include neurological exams, cognitive testing, nerve conduction tests, and MRIs. Study medicine, testing, hospitalization for research purposes, and travel expenses will be fully covered by the study.

Eligibility criteria: Inclusion Criteria

* A3243G mtDNA point mutation or maternally related to someone who has the mutation
* Symptomatic with MELAS, including previous seizure or stroke
* Certain laboratory values
* Ability to comply with the study protocol

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York City
country: United States
facility: New York Presbyterian Hospital
state: New York
Study officials:
affiliation: Columbia University
name: Darryl C De Vivo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02869113: Evaluation of the Stinging Potential of Sunscreen Products in Human Eyes
Official title: Evaluation of the Stinging Potential of Sunscreen Products in Human Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreen Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-08-16
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this study was to compare the human eye stinging potential of experimental formulas and an industry standard shampoo mixture. The study was conducted under the supervision of a Board Certified Ophthalmologist.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects, aged 18 to 60 years
* No medical conditions of the eyes as determined by the subjects' medical history and confirmed by ophthalmologist
* Subjects do not wear contact lenses or, if he/she does wear contact lenses, is willing to refrain from wearing these during the day of and day after the study
* Subject is willing to have the test materials instilled into the eyes and follow all protocol requirements
* Subject is willing to refrain from using false eyelashes of any type or any topical prescription, OTC or cosmetic products on their eyes, eyelids, eyelashes or the peri-orbital areas of the face on the day of the study.
* Subjects should refrain from use of make-up on testing day

Primary outcomes:
measure: Subjective discomfort in the eye was assessed based on questions by an Ophthalmologist to the subject using a 5-category intensity scale
timeFrame: up to 24 hours
measure: Tearing/Lacrimation was assessed by the Ophthalmologist using a 5-category assessment score
timeFrame: up to 24 hours
measure: Objective inflammation was assessed by the Ophthalmologist using a 5-category assessment score
timeFrame: up to 24 hours
measure: Post installation eye effects were assessed using a 5-category intensity score
timeFrame: up to 24 hours
Secondary outcomes:
measure: Number of adverse events as a measure of safety and tolerability
timeFrame: at 24 hours
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
state: Florida
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00002413: A Study of MKC-442 in HIV-Positive Patients
Official title: An Open Label Study of MKC-442 in at Least Triple Drug Combination in Patients Previously Treated With Nucleoside Reverse Transcriptase and Protease Inhibitors and Who Are Naive to Non-Nucleoside Reverse Transcriptase Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Anti-HIV Agents
Viral Load
MKC 442
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is safe and effective to give MKC-442 plus at least two other anti-HIV drugs to patients who have never been treated with nonnucleoside reverse transcriptase inhibitors but who have been treated with nucleoside reverse transcriptase inhibitors and protease inhibitors. This study also determines how long a drug combination including MKC-442 is effective.


Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

Based on medical history, medical condition, prior use of antiretroviral drugs, and genotypic analysis of the predominant strain of HIV-1 isolated from plasma, administration of at least 2 available antiviral agents by prescription may be given with MKC-422.

Patients must have:

- HIV infection with HIV-1 RNA greater than or equal to 2,000 by Roche Amplicor method, within 30 days of entry.

Prior Medication:

Allowed:

* Prior nucleoside reverse transcriptase and protease inhibitors.
* Cytotoxic chemotherapy more than 30 days prior to entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Malabsorption or severe chronic diarrhea within 30 days prior to entry, or inability to consume adequate oral intake because of chronic nausea, emesis, or abdominal or esophageal discomfort.
* Inadequately controlled seizure disorder.
* Acute and clinically significant medical event within 30 days of screening.
* Any clinical or laboratory abnormality greater than Grade 3 toxicity, with the exception of the listed laboratory values.

Prior Medication:

Excluded:

* Non-nucleoside reverse transcriptase inhibitor therapy.
* Any unapproved experimental antiretroviral therapy.

Prior Treatment:

Excluded:

* Radiation therapy within 30 days of entry, except to a local lesion.
* Transfusion of blood or blood products within 21 days of screening.

Risk Behavior:

Excluded:

Active substance abuse that may interfere with compliance or protocol evaluations.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01713413: Effects of an Oxymizer on Endurance Time in Patients With Chronic Lung Diseases
Official title: Effects of an Oxymizer Versus Conventional Nasal Cannula on Endurance Time in Patients With Chronic Obstructive Pulmonary Disease IV (COPD) or Interstitial Lung Disease (ILD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Interstitial Lung Disease
Keywords: Oxymizer
endurance time
exercise test
nasal cannula
COPD
ILD
oxygenation
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2012-10-24
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The Oxymizer pendant® is a special oxygen cannula that can be used to supply high flow long term oxygen therapy. It is compatible with a wide variety of oxygen sources. In a reservoir, the Oxymizer® stores pure oxygen so that the concentration of inhaled oxygen is increased.

The aim of this study is to investigate the potential benefit of the Oxymizer® with regard to the blood oxygenation during exercise testing. Given that the "endurance time" is very sensitive for little changes in exercise capacity, this test will be used to show the difference between the Oxymizer® and a conventional nasal cannula regarding exercise duration at 70% of peak Watt and oxygenation.

The tests will be accompanied by blood gas analysis, partial pressure of carbon dioxide and heart rate.


Eligibility criteria: Inclusion Criteria:

* COPD IV
* interstitial lung disease
* long-term oxygen therapy with oxygen flow rate \>= 2 L/min

Exclusion Criteria:

* acute cardial decompensation
* usual kontraindication for exposure test (higher-grad Hypertension (arterial and pulmonal), cardiac valve vitien, instabile angina pectoris, cardiac arrhythmia)

Primary outcomes:
measure: Difference between Endurance time with Oxymizer and conventional nasal cannula
timeFrame: From starting until stopping cycling, up to 60 minutes
Secondary outcomes:
measure: Difference in oxygen saturation with Oxymizer and with conventional nasal cannula
timeFrame: stopping cycling, up to 60 minutes
measure: Difference in PaCO2 with Oxymizer and with conventional nasal cannula
timeFrame: Stopping cycling, up to 60 minutes
Other outcomes:
Locations:
city: Berchtesgaden
country: Germany
facility: Klinikum Berchtesgadener Land
state: Bavaria
Study officials:
References:
Clinical trial NCT06804213: Student Wellness 2.0
Official title: A Randomized Controlled Study Evaluating Student Wellness Using the Roadmap MHealth App and Wellness Coaching
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Issue
Keywords: mobile health
wearable sensors
college students
wellness coaching
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: STEER for Student Athletes
First posted: 2025-02-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this randomized controlled study, investigators plan to assess the impact of a mobile health app with positive psychological combined with wellness coaching on college student mental health outcomes. The study aims to differentiate the effectiveness of combining mobile health and wellness coaching compared to wellness coaching on its own. The goal is to improve our understanding of the optimal combination of traditional in-person and digital interventions on diverse student populations, as well as better understand the causal impact of the mobile health app on well-being.

Detailed description: Study participants will be asked to:

1. Complete as many sessions of individual wellness coaching as they see fit
2. Install and interact with the Fitbit and Roadmap 2.0 apps on their smartphone
3. Complete longitudinal surveys at baseline, month 1, month 2, and end of study
4. Complete an exit interview at the end of the study

Eligibility criteria: Inclusion Criteria:

1. Must be at least 18 years old.
2. Students must be either enrolled at the University of Michigan OR in the STEER transition program.
3. Potential subjects must be able to provide a mailing address within the United States where they can receive study tools and be mailed study materials (e.g., Fitbit, compensation).
4. Possess a smartphone (Apple or Android).
5. Ability to understand and demonstrate willingness to remotely sign a written informed consent document

Exclusion Criteria:

1. People who are not enrolled in classes at the University of Michigan OR people who are not members of the STEER organization.
2. Unwilling or unable to comply with the study procedures

Primary outcomes:
measure: Evaluate the effectiveness of Roadmap 2.0 plus wellness coaching on college student mental health
timeFrame: From enrollment to the exit survey at 4 months
Secondary outcomes:
measure: Survey completion
timeFrame: From enrollment to the exit survey at 4 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Port Chester
country: United States
facility: STEER for Student Athletes
state: New York
Study officials:
affiliation: University of Michigan
name: Sung Won Choi, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02557113: Creation of a Small Cavity Reduces the Rate of Cement Leakage During Vertebral Body Augmentation
Official title: Creation of a Small Cavity in Vertebral Body Reduces the Rate of Cement Leakage During Vertebral Body Augmentation: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vertebral Body Fracture
Keywords: cement leakage
cement augmentation
vertebral body fracture
vertebral cavity
vertebroplasty
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2015-09-23
Enrollment: 36
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: Leakage of polymethylmethacrylate (PMMA) is the most common complication during vertebral body augmentation and can lead to serious patient morbidity. Any measure to reduce the rate of cement leakage is of value and makes the procedure safer.The aim of this study was to investigate the effect of the creation of a cavity on cement leakage during vertebroplasty. Investigators tested the hypothesis that the creation of a merely small and irregular cavity in vertebral body prior to cement injection would reduce cement leakage.


Eligibility criteria: Inclusion Criteria:

* Osteoporotic vertebral body fractures of the thoracolumbar spine (T9 to L4) that were classified as A1 fractures according to Arbeitsgemeinschaft Osteosynthesis (AO) Classification

Exclusion Criteria:

* More Than 2 Vertebral Body Fractures
* Fractures of Vertebral Body Based on Malignancy
* Previous Spinal Operation
* Spinal Infection
* Spinal Deformity (scoliosis)

Primary outcomes:
measure: CT-Scan evaluation
timeFrame: One week
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: 3 Months
Other outcomes:
Locations:
Study officials:
affiliation: Department of Orthopaedic Surgery University Hospital Frankfurt
name: Mohammad Arab Motlagh, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00179036: Biomagnetic Signals of Intestinal Ischemia II
Official title: Biomagnetic Signals of Intestinal Ischemia II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemia
Keywords: Blood supply
Mesentery
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2005-09-15
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The lack of blood flow to the small intestine causes mesenteric ischemia. Using a Superconducting QUantum Interference Device (SQUID) which measures the magnetic field of the small intestine, we are hoping to identify abnormalities without surgical intervention.

Detailed description: The electrical activity of the small intestine may contain important information that will help us diagnose gastrointestinal diseases. The major impediment to reducing mortality of mesenteric ischemia is the lack of a noninvasive diagnostic test that identifies the syndrome before extensive necrosis occurs. Mesenteric ischemia is caused by the lack of blood flow to the intestine. The Superconducting QUantum Interference Device (SQUID) measures the magnetic field of the intestinal smooth muscle. By comparing normal smooth muscle and that of patients with mesenteric ischemia, the investigators hope to identify abnormal disease states without surgery.

Eligibility criteria: Inclusion Criteria:

* Normal subjects and those with diagnosed mesenteric ischemia

Exclusion Criteria:

* Subjects who report a tendency toward claustrophobia

Primary outcomes:
measure: To observe a difference in the magnetic activity between the normal and diseased smooth muscle of the small intestine
timeFrame: 2010
Secondary outcomes:
measure: Create mathematical and computer models of electrical activity of smooth muscle
timeFrame: 2010
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: William O. Richards, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Somarajan S, Muszynski ND, Cheng LK, Bradshaw LA, Naslund TC, Richards WO. Noninvasive biomagnetic detection of intestinal slow wave dysrhythmias in chronic mesenteric ischemia. Am J Physiol Gastrointest Liver Physiol. 2015 Jul 1;309(1):G52-8. doi: 10.1152/ajpgi.00466.2014. Epub 2015 Apr 30.