louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02680873: Efficacy of SASI Bypass for Type-2 Diabetic Obese Patients
Official title: Efficacy of Single Anastomosis Sleeve Ileal (SASI) Bypass for Type-2 Diabetic Obese Patients: Loop Gastric Bipartition, a Novel Metabolic Surgery Procedure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2 in Obese
Keywords: type 2 diabetes , obesity , SASI
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 50
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: the investigator modified the Sanator's operation by performing a loop rather than Roux-en-Y bipartition reconstruction and the investigator are reporting the first clinical results of the outcomes of SASI bypass as a mode of functional restrictive and neuroendocrine modulation therapeutic option for obese type 2 diabetes mellituspatients.

Detailed description: All patients were subjected to thorough history, clinical examination and laboratory investigations including basic preoperative investigations, lipid profile, thyroid and suprarenal hormonal evaluation. In addition, patients may undergo further assessment for pulmonary functions or gastroesophageal disease including endoscope. . Abdominal ultrasound was done to exclude calcular cholecystitis and to evaluate the degree of fatty liver. Reduction the size of fatty liver was done by putting all patients on low-calorie protein diet for 6 weeks. Deep vein thrombosis prophylaxis started 12 h before surgery with low molecular weight heparin subcutaneous injections . Preoperative data included age, gender, initial weight, initial body mass index (BMI), obesity comorbidities and treatment medications used (chest problems, diabetes, arterial hypertension and cardiac ischaemia, hyperlipidemia, obstructive sleep apnea syndrome, gall stones, urinary stress incontinence, joint pain, depression, infertility and heart burn). Postoperative data included hospital stay, early postoperative complications during the first month (e.g. fever, collection, bleeding, vomiting, leak and port site problems .Long-term complications more than 1 month after surgery (e.g. nausea, vomiting, reflux, stricture, intestinal obstruction , hypoalbuminemia , anemia and calcium or iron or vitamin D , vitamin B12 deficiency and), excess weight loss and BMI were collected.

Eligibility criteria: Inclusion Criteria:Type 2 diabetic obese pateints -

Exclusion Criteria:patients age above 65 or below 18 years old, history of upper laparotomy, unfit for anesthesia or laparoscopy, major psychological instability and drug abuse.

-

Primary outcomes:
measure: excess weight loss
timeFrame: one year
measure: resolution of diabetes
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03168373: Effect of Intensive Language Therapy in Subacute Stroke Patients
Official title: Effect of Intensive Language Therapy in Subacute Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Rehabilitation
Language
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Early stroke rehabilitation is known to be an effective and essential therapy in gaining functional independence and preventing complications. However, there was no consensus of proper amount of language rehabilitation in stroke patients. In this study, the investigators investigated the effects of the intensive language rehabilitation during subacute phase to improve language function in patients with first-ever strokes.

Detailed description: Intensive language rehabilitation group - language rehabilitation therapy by language therapist for 1 hours on every working day for 4 weeks

Conventional language rehabilitation group

- language rehabilitation therapy by language therapist for 30 minutes on every working day for 4 weeks

Eligibility criteria: Inclusion Criteria:

* Acute first-ever stroke
* Left hemispheric stroke
* Korean version of Frenchay Aphasia Screening Test(K-FAST) \< 25 (less than 65 years old), K-FAST \<20 (65 years old and more than 65 years old) at 7 days after stroke onset
* Right handedness

Exclusion Criteria:

* Transient ischemic stroke

Primary outcomes:
measure: Korean version-Western Aphasia Battery (AQ)
timeFrame: Change of Korean version- Western Aphasia Battery after language rehabilitation for 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Yun-Hee Kim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang WH, Sohn MK, Lee J, Kim DY, Lee SG, Shin YI, Oh GJ, Lee YS, Joo MC, Han EY, Kim YH. Korean Stroke Cohort for functioning and rehabilitation (KOSCO): study rationale and protocol of a multi-centre prospective cohort study. BMC Neurol. 2015 Mar 25;15:42. doi: 10.1186/s12883-015-0293-5.
Clinical trial NCT00606073: The Influence of Different Concentrations of Glucose in Culture Media on Fertilization and Embryo Quality
Official title: The Influence of Different Concentrations of Glucose in Culture Media(i.e: ISM1 vs. IVF) on Fertilization and Embryo Quality
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fertility
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-02-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine whether incubation of human oocytes until pronuclear stage, in different culture media containing high and low concentrations of glucose affect fertilization differently, not only in standard IVF cycles, but also after intracytoplasmatic sperm injection.In addition, we wish to determine whether exposure of oocytes to different concentrations of glucose until pronuclear stage has further effect on embryo quality and development until the blastocyst stage.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing IVF treatment in our clinic during study period

Exclusion Criteria:

* Females older than 40 years
* Patients with less than 6 retrieved oocytes
* Male patients older than 50 years old
* Patients after testis biopsies

Primary outcomes:
measure: Fertilization rate and embryo quality
timeFrame: 6 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01252173: Measurement Of Endotracheal Tube Cuff Pressure In Emergency Department Patients
Official title: MEASUREMENT OF ENDOTRACHEAL TUBE CUFF PRESSURE IN EMERGENCY DEPARTMENT PATIENTS
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Intubation, Intratracheal
Keywords: endotracheal
intubation
tracheal
pressure
cufflator
Lead sponsor: Beth Israel Medical Center
Sponsor class: OTHER
First posted: 2010-12-02
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All emergency department patients, and all patients admitted from the ED

Brief summary: The purpose of this research is to measure the endotracheal tube cuff pressure in patients who have been endotracheally intubated emergently in the emergency department or in the field by prehospital personnel. Overinflation of ETTc pressure is associated with injury, and we seek to determine if the phenomenon of excessively inflated ETTc can be detected in endotracheally intubated patients in the ED.

There is no experimental aspect to this study, it is only descriptive. Measurement of ETTc pressure is already performed by respiratory therapy/respiratory care. We simply seek to assess these measurements to determine if any patients in fact have high ETTc pressure. If it is found that patients do have ETTc with high pressures, this might allow emergency department staff or prehospital personnel such as paramedics or EMTs to use this information to seek methods by which endotracheal intubation can be improved and patients can be intubated without excessive ETTc pressure.

This is a pilot study. We have conducted several in vitro studies, which have all demonstrated that paramedics, EMTs, and emergency department physicians practice endotracheal intubation in a method that might result in excessively inflated ETTc.


Eligibility criteria: Inclusion Criteria:

* Patient emergently endotracheally intubated with a cuffed endotracheal tube.

Exclusion Criteria:

* Endotracheal intubation procedure performed in a setting other than the prehospital (field) or emergency department of participating institution. This specifically excludes endotracheally intubated patients transferred from another hospital, chronic care facility, or other location.
* Non-emergent or elective endotracheal intubation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Beth Israel Medical Center
name: Robert Hoffman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03698773: Pain Relief Satisfaction With New Educational Materials
Official title: Satisfaction of Pain Relief During Labor and Delivery Following Access to New Educational Materials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Satisfaction
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study compares patient satisfaction after labor and delivery with access to either the default educational materials available, or to a table computer set to display an educational website, thepainlesspush.com.

Detailed description: This is a prospective randomized controlled study. The investigators hypothesize that parturients with access to the website will exhibit greater satisfaction with labor and delivery pain control.

Potential participants will be recruited from the University of New Mexico Hospital (UNMH) Labor \& Delivery floor. Patients will be enrolled following an oral consent process. They will be randomized into either control group or intervention group. Control group participants will have their standard of care visit with an anesthesiologist and routine hospital pain-relief information. Intervention group participants will have their standard of care visit with an anesthesiologist, plus one hour in which to view the patient education website thepainlesspush.com, on an iPad provided by the Anesthesiology department for this purpose. After their delivery and transfer to the mother/baby unit, participants will complete a satisfaction survey brought to them by a study team member. Participants will complete the survey following their delivery and prior to discharge. The primary team will notify us with expected discharge in which we will retrieve the survey from them in their room and answer any last questions. Their active participation in the study will be complete at this time. After a participant completes the satisfaction survey, research team members will collect demographic information and relevant obstetric/medical history information from the electronic medical record.

Eligibility criteria: Inclusion Criteria:

* All English- or Spanish-speaking patients who are admitted to UNMH Labor and Delivery for planned progression to active labor.

Exclusion Criteria:

* Age under 18 years
* Patients unable to provide consent for medical procedures
* Patients who do not speak either English or Spanish

Primary outcomes:
measure: Patient Satisfaction With Pain Control in Labor
timeFrame: Following delivery and prior to discharge, up to two days
Secondary outcomes:
measure: Epidural Analgesia Utilization Rate
timeFrame: On day of delivery
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Hospital
state: New Mexico
Study officials:
affiliation: University of New Mexico Health Sciences Center
name: Kathleen Reyes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03883373: Alveolar Bone Graft Cortical Nasal Floor
Official title: Comparison Between Alveolar Bone Graft With Only Cancellous Bone, and Alveolar Bone Graft With Cancellous Bone Combined With Nasal Cavity Floor's Reconstruction Using a Cortical Block
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alveolar Cleft Operated on an Alveolar Bone Graft
Keywords: alveolar graft
cancellous bone
cortical block
nasal floor
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 302
Sex: ALL
Minimum age (years): 3
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are suffering from clef lip and palate or alveolar cleft and had to have an alveolar bone graft with gingivo-periostoplasty in the pediatric plastic surgery unit of the Montpellier hospital from June 1999 to Mai 2016

Brief summary: Alveolar bone graft is one of the main step of the surgical care of the patients who are suffering from cleft lip and palate. They are usually performed before the lateral incisor eruption, at about 5 years old and using cancellous bone taken from the iliac crest.

The aim of the study is to show if adding a cortical graft to the cancellous cause more complications, which may be source of partial or total graft loss in the 6 month following the observation

Detailed description: This is an observational, retrospective and monocentric study. To be included, patients had to suffer from a clef lip and palate or alveolar cleft and had to have an alveolar bone graft with gingivo-periosteoplasty in the pediatric plastic surgery unit of the Montpellier hospital from June 1999 to Mai 2016. They were divided into two groups : the first with patients who had a cortical and cancellous bone graft and the second with patients who had a cancellous graft only.

Both groups were followed 6 mounts after the operation to look for the occurence of complications which lead to a graft loss. Bilateral cleft are seen as 2 graft events

Eligibility criteria: Inclusion criteria:

* Patients with a clef lip and palate or alveolar cleft
* Grafted in the Montpellier pediatric surgery unit from june 1999 to mai 2016
* Followed during 6 months of post operative follow up

Exclusion criteria:

* No post operative follow up
* other alveolar bone graft in the past medical history

Primary outcomes:
measure: Complication events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Guillaume CAPTIER, MD.PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05123573: Self-Perceived in Medical Students Undergoing Distance Learning
Official title: Self-Perceived Competence in Mexican Medical Students Undergoing Distance Learning During the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Educational Problems
Medical Students
COVID-19 Pandemic
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2021-11-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our study population will be medical students currently attending college in a distance learning modality.

Brief summary: Our primary objective is identifying the degree of self-perceived competence in medical students without clinical rotations during the COVID-19 pandemic to know how prepared the students could be when they are professionals because they lack clinical skills in front of an actual patient and can be affected to be accepted in hospitals because they will have to acquire a phase of training later. Without a clinical rotation, one can be deprived of the essential educational value.The study design is an observational cross-section study in which an anonymous survey will be shared online on Google Forms platform. Students will be asked for their participation; after obtaining verbal and consent, the survey will be distributed using social media groups such as foundation school groups. For this study, the Spanish version of the Self-Perceived Competence scale will be used (REF). This scale is comprised of 21 questions divided into five factors that assess: 1) demonstration of the essential clinical skills, 2) demonstration of clinical reasoning, decision making, and problem-solving skills, 3) management of life-threatening medical conditions, 4) management of common medical problems and 5) placing patients' needs and safety at the center of the care process. Each item has a Likert scale answers of 4 options ranging from "incompetent (1)", "somewhat incompetent (2)", "somewhat.


Eligibility criteria: Inclusion Criteria:

* Medical students currently attending college in a distance learning modality.
* \> 18 years

Exclusion Criteria:

* Medical professionals and specialists
* university students
* \< 18 years
* Medical students currently attending clinical rotations

Primary outcomes:
measure: Essential clinical skills
timeFrame: Day 1
measure: Clinical reasoning and problem-solving skills
timeFrame: Day 1
measure: Management of life-threatening medical conditions
timeFrame: Day 1
measure: Management of common medical problems
timeFrame: Day 1
measure: Placing the patients' needs and safety at the center of the care process
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Instituto Mexicano del Seguro Social
state: Jalisco
Study officials:
References:
Clinical trial NCT04134273: Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
Official title: A Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2019-10-22
Enrollment: 1260
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris.

Detailed description: The study objectives are to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo control.

Eligibility criteria: Inclusion Criteria:

* Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris
* Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects 12 to 17 years of age, inclusive, must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian).
* Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
* Subjects with a known hypersensitivity to clindamycin or lincomycin and/or any ingredients in the study drugs.
* Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).

Primary outcomes:
measure: Demonstration of Bioequivalence
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Catawba Research, LLC
state: North Carolina
Study officials:
References:
Clinical trial NCT02374073: Functional Massage of Teres Major Muscle
Official title: Effectiveness of Functional Massage of the Teres Major Muscle in Patients With Subacromial Impingement Syndrome. A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Impingement Syndrome
Trigger Points
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 58
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: Purpose: Subacromial impingement syndrome is the most common shoulder condition. Myofascial trigger points in teres major muscle can be associated with this syndrome. The investigators objective is to find out if adding manual therapy specifically for teres major trigger points can produce better results in these patients.

Method: A randomized controlled pilot study was carried out. Fifty people were randomly assigned to one of two groups: intervention group or control group. Both groups received a protocolized physical therapy treatment while the intervention group additionally received manual therapy for teres major trigger points.


Eligibility criteria: Inclusion Criteria:

* Age 18 years and over
* Clinical diagnosis of Subacromial Impingement Syndrome.
* Detectable trigger points in teres major muscle.
* Sign informed consent form.

Exclusion Criteria:

* Presence of wounds or cutaneous alterations in the shoulder region
* Previous surgery in the shoulder
* Presence of acute inflammatory process in the shoulder (\< 7 days),
* Being involved in litigation or compensation processes
* Not having a domain of the language that could make the informed consent not understandable.

Primary outcomes:
measure: Change in Pain Intensity (visual analogue scale)
timeFrame: Change from baseline to 3 weeks
Secondary outcomes:
measure: Change in Function (Abbreviated Constant-Murley score)
timeFrame: Change from baseline to 3 weeks
measure: Change in Active Range of Motion
timeFrame: Change from baseline to 3 weeks
Other outcomes:
Locations:
Study officials:
References: