louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03053674: Impact of Explanation Given to Parents on Rate of Post-partum Influenza Vaccination
Official title: Impact of Explanation Given to Parents on Rate of Post-partum Influenza Vaccination
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Newborn Morbidity
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-02-15
Enrollment: 208
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Case-control study
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine whether an explanation to parents for the need for post-partum influenza vaccination will influence their compliance.


Eligibility criteria: Inclusion Criteria:

* All parents discharged from well-baby nursery

Exclusion Criteria:

-

Primary outcomes:
measure: Rate of post-partum influenza vaccination
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Amit Hochberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01121874: Suture Fixation System Versus Tendonous Reconstruction in Carpometacarpal (CMC) Arthroplasty
Official title: Suture Fixation System Versus Tendonous Reconstruction in Thumb Carpometacarpal Arthroplasty: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thumb Carpometacarpal Arthritis
Keywords: CMC arthritis
thumb carpometacarpal arthritis
basal joint arthritis
thumb CMC arthritis
Lead sponsor: J&M Shuler
Sponsor class: INDUSTRY
First posted: 2010-05-12
Enrollment: 53
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: Thumb carpometacarpal (CMC) arthritis affect 1 in 4 females and 1 in 12 males. Patients who fail to respond to conservative treatment may benefit from surgery; however, controversy exists over the most effective surgical technique. A popular technique, ligament reconstruction with tendon interposition (LRTI) involves a trapeziectomy, followed by reconstruction of the palmar oblique ligament using a harvested flexor tendon from the wrist.

We believe that use of a suture fixation system to reconstruct the palmar oblique ligament, instead of harvesting a wrist tendon, may provide a superior repair. The objective of this study is to compare functional outcome measurements among patients who receive CMC arthroplasty using a suture fixation system (investigational group) to those who receive LRTI surgery (control group). We hypothesize that patients in the investigational group will demonstrate superior functionality, compared to patients in the control group.


Eligibility criteria: Inclusion Criteria:

* Male or female patients aged \>18.
* Eaton Stage III or IV CMC arthritis
* Failure to respond to conservative treatment

Exclusion Criteria:

* Previous surgical interventions on that thumb
* Upper extremity neurological dysfunction
* Inability to effectively communicate with the research staff, due to hearing impairment, cognitive impairment, or a language barrier
* Unwilling or unable to provide written informed consent

Primary outcomes:
measure: Overall functionality
timeFrame: Baseline
measure: Overall Functionality
timeFrame: 6 wks
measure: Overall Functionality
timeFrame: 3 mos
measure: Overall Functionality
timeFrame: 6 mos
measure: Overall Functionality
timeFrame: 12 months
measure: Overall Functionality
timeFrame: 24 months
Secondary outcomes:
measure: Analog pain scale
timeFrame: Baseline, 2 wks, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
measure: Strength measures
timeFrame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
measure: Range of motion
timeFrame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
measure: Operative time
timeFrame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
measure: Scaphometacarpal distance
timeFrame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Other outcomes:
Locations:
city: Athens
country: United States
facility: Athens Orthopedic Clinic
state: Georgia
Study officials:
affiliation: Athens Orthopedic Clinic, PA
name: Michael Shuler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01228474: Single Embryo Transfer vs. Double Embryo Transfer in an Oocyte Donation Programme
Official title: A Prospective, Randomized, Controlled Trial Comparing SET vs DET in an Oocyte Donation Programme
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Oocyte Recipient
Single Embryo Transfer/Double Embryo Transfer
Cumulative Pregnancy Rate
Multiple Pregnancy
Lead sponsor: Fundacion Dexeus
Sponsor class: OTHER
First posted: 2010-10-26
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Experimental study to assess the efficacy of single embryo transfer (SET) with respect to double embryo transfer (DET) in an oocyte donation programme, 160 recipients will be randomized in two groups


Eligibility criteria: Inclusion Criteria:

* patients under their first or second cycle of a synchronous donation
* to have a minimum of 5 available embryos to transfer
* patients who accept transfers of frozen-thawed embryos

Exclusion Criteria:

* medical indications to transfer only one embryo (Turner Syndrome, uterine surgical history, uterine myomas,...)

Primary outcomes:
measure: Cumulative pregnancy rate
timeFrame: at 12 months of fresh embryo transfer (time considered enough in order to do a minimum of one frozen-thawed cycle if pregnancy is not achieved with the fresh cycle
Secondary outcomes:
measure: Cumulative live birth rate
measure: Multiple pregnancy rate
measure: Time needed to achieve the pregnancy
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Departamento de Obstetricia, Ginecología y Reproducción. Institut Universitari Dexeus
Study officials:
References:
citation: Soderstrom-Anttila V, Vilska S. Five years of single embryo transfer with anonymous and non-anonymous oocyte donation. Reprod Biomed Online. 2007 Oct;15(4):428-33. doi: 10.1016/s1472-6483(10)60369-0.
citation: Soderstrom-Anttila V, Vilska S, Makinen S, Foudila T, Suikkari AM. Elective single embryo transfer yields good delivery rates in oocyte donation. Hum Reprod. 2003 Sep;18(9):1858-63. doi: 10.1093/humrep/deg384.
Clinical trial NCT01613274: The Effect of Gum Chewing on Bowel Motility in Post-operative Colon Resection Patients
Official title: The Effect of Gum Chewing on Bowel Motility in Post-operative Colon Resection Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colon Resection
Keywords: colon resection
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2012-06-07
Enrollment: 80
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: The purpose of this study is to determine if chewing mint-flavored sugarless gum after colon resection surgery decrease the time to first flatus, bowel movement and length of stay in the hospital.

Detailed description: Post-operative colon resection patients experience decreased bowel motility, which may cause pain, nausea/ vomiting, impaired nutritional intake, and abdominal distention. Return of bowel function is a strong determinant in length of hospital stay. There are small studies that have shown that chewing gum post-operatively may enhance bowel motility thus minimizing complications and decreasing length of hospital stay. The purpose of this research study is to determine the effect of gum chewing on bowel motility as measured by time to first flatus, bowel movement and length of stay in patients following a colon resection.

Eligibility criteria: Inclusion Criteria:

1. Admitted to Unit 2600
2. Age 18-100 years of age
3. Alert and oriented
4. Post-operative open or laparoscopic colon resection
5. English speaking.

Exclusion Criteria:

1. Confused, or with cognitive disabilities that render the patient unable to answer questions about bowel motility.
2. Admitted to any other unit except 2600
3. Use of an epidural catheter for pain control post-operatively
4. Documented history of irritable bowel syndrome
5. Colostomy (new or old)

Primary outcomes:
measure: Time to first flatus
timeFrame: Every 4 hours following surgery until discharge, which is an average of 5 days
Secondary outcomes:
measure: Time to first bowel movement
timeFrame: Every 4 hours following surgery until discharge, which is an average of 5 days
measure: Length of stay in days
timeFrame: Patients will be followed until discharge, which is an average of 5 days
Other outcomes:
Locations:
city: St Paul
country: United States
facility: United Hospital
state: Minnesota
Study officials:
affiliation: United Hospital
name: Julie A Sabo, RN Mn CNS-BC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03220074: Linezolid for Treatment of Nontuberculous Mycobacterial Diseases
Official title: Efficacy and Tolerability of Linezolid for Treatment of Nontuberculous Mycobacterial Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-tuberculous Mycobacterial Infections
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Siam Pharmaceutical Ltd.
First posted: 2017-07-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open labelled study
Primary purpose: TREATMENT

Brief summary: A prospective open study to determine the efficacy and tolerability of oral linezolid 600mg./day for the treatment of 40 patients with nontuberculous mycobacterial diseases will be conducted at Siriraj Hospital, Mahidol University, Bangkok, Thailand.

Detailed description: This will be an open label clinical study of oral linezolid combination with another oral antimycobacterial drug as the maintenance treatment of nontuberculous mycobacterial diseases in adult.

The eligible patients will be treated and monitored for the efficacy and safety every 6 weeks until 6 months then every 3 months for a total duration of 18 months.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of non-tuberculous mycobacterial (NTM) diseases
* Active or stable diseases receiving either parenteral or oral antimycobacterial treatment
* Require at least more than 6 months of treatment from enrollment

Exclusion Criteria:

* Stable NTM diseases with a plan to discontinue treatment within 3 months
* History of allergy to linezolid
* Hemoglobin \< 7 g/dl) or total white blood count \< 3,000 /cu.mm. or thrombocytopenia \< 50,000 cells/cu.mm.
* Concomitant uses of serotoninergic drugs (SSRIs) or Monoamine oxidase inhibitor (MAOIs) within 30 days prior to enrollment
* Abnormal neurological findings such as numbness, abnormal vision etc.

Primary outcomes:
measure: cure rate
timeFrame: 6 months
Secondary outcomes:
measure: rate of common adverse event (AE)
timeFrame: 18 months
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Yupin Suputtamongkol, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01825174: Overweight Children - Musculoskeletal Consequences
Official title: Musculoskeletal Consequences of Pediatric Overweight - Efficiency of Different Interventions on Health, Motor and Psychosocial Development in Overweight and Obese Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Overweight
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: Heidelberg University
First posted: 2013-04-05
Enrollment: 137
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose was to investigate the consequences of pediatric overweight on the musculoskeletal system, postural control and proprioception, and to analyze prospectively the influence of ball games and nutrition counseling.


Eligibility criteria: Inclusion Criteria:

Overweight Children:

* BMI = or \> than the gender, race, and age specific 92nd percentile from the National Children Health and Nutrition Examination Survey

All participants:

- 6-11 y. old

Exclusion Criteria:

* severe impairment with functional restriction of the upper or lower extremities (due to injuries)
* neurological deficits/diseases compromising the postural control
* important communication problems due to another mother language

Primary outcomes:
measure: Change in error points in one legged-standing test
timeFrame: at baseline and 6 months later after intervention
Secondary outcomes:
measure: Change in angle deviation from target angle in angle reproduction test
timeFrame: at baseline and 6 months later after intervention
measure: Change in range of motion at the joints of the lower extremities
timeFrame: at baseline and 6 months later after intervention
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg
Study officials:
affiliation: University of Heidelberg/ ATOS Clinic Heidelberg
name: Holger Schmitt, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuni B, Ruhling NE, Hegar U, Roth C, Schmitt H. Ball games and nutrition counseling improve postural control in overweight children. BMC Pediatr. 2015 Dec 11;15:205. doi: 10.1186/s12887-015-0523-4.
Clinical trial NCT01307774: Survey of Predictors of Human Papillomavirus (HPV) Vaccination Among Parents of Rural Adolescent Girls in Mysore, India
Official title: Survey of Predictors of HPV Vaccination Among Parents of Rural Adolescent Girls in Mysore, India
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Human Papillomavirus
Cervical Cancer
Keywords: parental acceptability of HPV vaccine
Lead sponsor: Public Health Research Institute, India
Sponsor class: OTHER
Collaborators: name: Florida International University
First posted: 2011-03-03
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will survey attitudes of parents of adolescent girls attending 10 schools in rural Mysore Taluk in Mysore District.

Brief summary: To conduct a quantitative survey to measure knowledge about Human papillomavirus (HPV) and cervical cancer, and HPV vaccine acceptability among parents of rural adolescent girls in Mysore District, India.

Hypothesis: General knowledge and attitudes about the severity and treat ability of cancer will predict acceptability of HPV vaccination among parents of rural adolescent girls in Mysore, India.


Eligibility criteria: Inclusion Criteria:

* over 18 years of age
* parent of an adolescent girl (10 -15 years of age)
* able to speak English or Kannada
* willing to undergo informed consent process

Exclusion Criteria:

* Does not have the capacity to undergo informed consent process

Primary outcomes:
measure: Parental Acceptability of HPV vaccine
timeFrame: One year
Secondary outcomes:
measure: Knowledge about HPV and Cervical Cancer
timeFrame: One Year
Other outcomes:
Locations:
city: Mysore
country: India
facility: Public Health Research Institute of India
state: Karnataka
city: Mysore
country: India
facility: Public Health Research Institute of India
state: Karnataka
Study officials:
affiliation: Public Health Research Institute of India
name: Purnima Madhivanan, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Madhivanan P, Krupp K, Yashodha MN, Marlow L, Klausner JD, Reingold AL. Attitudes toward HPV vaccination among parents of adolescent girls in Mysore, India. Vaccine. 2009 Aug 20;27(38):5203-8. doi: 10.1016/j.vaccine.2009.06.073. Epub 2009 Jul 9.
citation: Krupp K, Marlow LA, Kielmann K, Doddaiah N, Mysore S, Reingold AL, Madhivanan P. Factors associated with intention-to-recommend human papillomavirus vaccination among physicians in Mysore, India. J Adolesc Health. 2010 Apr;46(4):379-84. doi: 10.1016/j.jadohealth.2009.10.001. Epub 2009 Nov 24.
Clinical trial NCT06928974: Functional Abdominal Wall Reconstruction
Official title: Functional Abdominal Wall Reconstruction in Patients With Prune Belly Syndrome
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prune Belly Syndrome
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
Collaborators: name: Górnośląskie Centrum Zdrowia Dziecka
First posted: 2025-04-15
Enrollment: 7
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients diagnosed with Prune Belly syndrome suffering from symptoms related to abdominal wall insufficiency

Brief summary: Assessement of outcomes of functional reconstruction of underdeveloped abdominal muscles with the use od pedicled Vastus Lateralis Muscle flaps.


Eligibility criteria: Inclusion Criteria:

* Patients diagnoes with Prune Belly Syndrome
* severe underdevelopment of rectus abdomini muscles
* patients who underwent microsurgical bipedicled vastus lateralis muscle flaps transposition
* patient undery 18 y.o.

Exclusion Criteria:

* Patient over the age of 18
* Patients who did not agreed for proposed microsurgical reconstruction of the abdominal wall

Exclusion Criteria: Patient over the age of 18

-

Primary outcomes:
measure: Electromyography
timeFrame: followup reached 96months
measure: Motor tests - performance of ''sit-up''-like movement
timeFrame: Followup reached 96 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gliwice
country: Poland
facility: Maria Sklodowska Curie Memorial National Cancer Center
Study officials:
References:
citation: Lopes RI, Baker LA, Denes FT. Modern management of and update on prune belly syndrome. J Pediatr Urol. 2021 Aug;17(4):548-554. doi: 10.1016/j.jpurol.2021.04.010. Epub 2021 Apr 24.
Clinical trial NCT04633174: Sous Vide Rewarming for Frostbitten Extremities
Official title: Clinical Utilization of Sous Vide Cooking Devices in the Acute Rewarming of Frostbitten Extremities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frostbite
Frostbite of Hand
Frostbite of Foot
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 1
Sex: ALL
Standard ages: CHILD
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 the efficacy of using sous vide devices for heating and maintaining the circulating warm water bath used in the rewarming of acute frostbite.


Eligibility criteria: Inclusion Criteria:

* Age 18 or up
* Age \<17 with parent or guardian consent
* Ability to understand English
* Ability to provide consent to the study
* Acute frostbite of the hands or feet

Exclusion Criteria:

* Children under age 18 without parent or guardian
* Frostbite that has already thawed
* Frostbite of tissue other than hands or feet
* Inability to understand English
* Inability to provide consent

Primary outcomes:
measure: Number of Limbs That Can be Rewarming Within 30 Minutes
timeFrame: 30 minutes
measure: Time to Rewarm in Minutes
timeFrame: Up to 90 minutes
Secondary outcomes:
measure: Ease of Use: Provider Review of the Investigational Device and Standard of Care
timeFrame: Immediately after rewarming, up to 90 minutes
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Nicholas Daniel, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01662674: BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered Alone
Official title: A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2012-08-10
Enrollment: 27
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics of the combinations of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison to each component administered in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Age between 20 to 45, healthy male subjects(at screening)
* Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
* FPG 70-125mg/dL glucose level(at screening)
* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

* Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
* Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
* Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)
* Subject who already participated in other trials in 3months
* Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months currently.
* Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)

Primary outcomes:
measure: AUClast
timeFrame: up to 48h post-dose
measure: Cmax
timeFrame: up to 48h post-dose
Secondary outcomes:
measure: AUEC
timeFrame: up to 48h post-dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Park SI, Lee H, Oh J, Lim KS, Jang IJ, Kim JA, Jung JH, Yu KS. A fixed-dose combination tablet of gemigliptin and metformin sustained release has comparable pharmacodynamic, pharmacokinetic, and tolerability profiles to separate tablets in healthy subjects. Drug Des Devel Ther. 2015 Feb 4;9:729-36. doi: 10.2147/DDDT.S75980. eCollection 2015.