louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04109469: Shark Screw® - Hand- and Foot Surgery Study
Official title: Retrospective Study on the Use of a Human Bone Graft (Shark Screw®) in Hand- and Foot Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthrodesis
Osteotomy
Lead sponsor: Klinik Diakonissen Linz GmbH
Sponsor class: OTHER
Collaborators: name: Surgebright Gmbh
First posted: 2019-09-30
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who underwent hand- or foot surgery with the application of a Shark Screw® transplant

Brief summary: This observational study aims to determine the efficacy and safety of the Shark Screw® transplant for osteotomy and arthrodesis in hand and foot surgery.

Detailed description: The Shark Screw® transplant (surgebright GmbH) is a human cortical bone allograft for osteosynthesis and can replace metal or bioabsorbable devices in various procedures. In total, the clinical records from 32 patients who had undergone surgical procedure at the hand or foot between October 2016 and January 2018 with the use of a Shark Screw® transplant for joint arthrodesis or for the stabilization of osteotomies serve as data sources for this study. The aim of this study is to evaluate the efficacy and safety of the Shark Screw® transplant in hand and foot surgery by analyzing the recovery, wound and bone healing process.

Eligibility criteria: Inclusion Criteria:

* Application of the human bone graft Shark Screw® in a Hand- or Foot surgical procedure between October 2016 and January 2018
* Data from at least 1 follow-up examination after surgery around the 6th post-operative week or other information about the health status of the patient in the first 6 post-operative weeks

Exclusion Criteria:

* not enough data for an objective analysis

Primary outcomes:
measure: Osseous consolidation of the transplant
timeFrame: 1 year
measure: Evaluation pre- and postoperative pain (VAS)
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of postoperative complication and soft tissue irritation
timeFrame: 1 year
measure: Incidence of surgical revision
timeFrame: 1 year
measure: Incidence of postoperative pseudarthrosis
timeFrame: 1 year
measure: Duration of post-operative analgesic medication
timeFrame: 1 year
measure: Cellular contact to the recipient bone
timeFrame: 1 year
measure: Resorptive processes in the recipient bone
timeFrame: 1 year
measure: Incidence of cracking or loosening of the screw
timeFrame: 1 year
measure: Patient satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Klinik Diakonissen Linz GmbH
Study officials:
affiliation: Klinik Diakonissen Linz
name: Klaus Pastl, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03658369: Effect of LANCONONE in Weight-bearing Joint Pain
Official title: To Assess the Lanconone® (E-OA-07) Efficacy in Weight-bearing Joint Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2018-09-05
Enrollment: 72
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The current study has been designed to primarily assess the effect of Lanconone® in comparison to placebo on pain in weight bearing joints.


Eligibility criteria: Inclusion Criteria:

1. BMI ≥ 25 and ≤ 29.9 kg/m2.
2. With unilateral or bilateral OA of the knee for at least greater than 3 months, as presented by pain in the knee at least for last 3 months.
3. Post-menopausal females (LMP at least 12 months prior to the screening).

Exclusion Criteria:

1. History of osteoarthritis for more than 3 years.
2. Systolic Blood Pressure ≥140 mm Hg and Diastolic Blood Pressure ≥ 90 mm Hg
3. FBS\>140 mg/dl.
4. Smokers or chronic alcoholics.
5. Participants planning to travel in the next 56 days or engage in any non-routine activity that is likely to strain the knees.

Primary outcomes:
measure: WOMAC (Western Ontario and McMaster universities Osteoarthritis Index) pain score
timeFrame: 56 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Ayush Nursing Home
state: Maharashtra
city: Mumbai
country: India
facility: Dinanath Nursing Home
state: Maharashtra
city: Mumbai
country: India
facility: K.K Medical Centre
state: Maharashtra
city: Mumbai
country: India
facility: Siddhant Clinic
state: Maharashtra
Study officials:
affiliation: Vedic Lifesciences
name: Shalini Srivastava, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04170569: Yoga on Posttraumatic Growth and Quality of Life
Official title: The Effect of Yoga on Posttraumatic Growth and Quality of Life in the Postpartum Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Growth
Quality of Life
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized Controlled trial with a prospective pretest-posttest experimental model
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to examine the effect of yoga on posttraumatic growth and quality of life. The birth action, which includes positive and negative experiences, can be an important opportunity to achieve posttraumatic growth and improve the quality of life.

This is a experimental model with pretest-posttest control group study. Two hundred and fifty-two women who met the criteria for inclusion in the study made up the research population. Three instruments were used to obtain the research data: Personal Information Form, Posttraumatic Growth Inventory (PTGI) and SF-36 Quality of Life Questionnaire (SF-36).

Detailed description: Failure in modern medicine approaches or side effects of treatments and drugs, as well as the woman's anxiety to hurt herself and her baby direct her and her relatives to try complementary therapies. Women should prefer natural ways in coping with these postpartum problems rather than seeking medical advice.

When yoga and meditation, which are included in the group of mind-body-based complementary therapies, are performed in the postpartum period, they will help to relieve tensions and distresses that accumulate during birth, strengthen the pelvic floor, heal perineum, bring reproductive organs back to their prepregnancy condition healthily, provide the mother and the infant a sleep pattern, and have an easier transition to sleep.

Eligibility criteria: Inclusion Criteria:

* Having a baby between 2 and 6 months
* First time mom
* No tissue deformity in extremities

Exclusion Criteria:

* Any gynecological disease
* Any psychiatric illness
* Using any psychiatric medication

Primary outcomes:
measure: The Effect of Yoga on Posttraumatic Growth in the Postpartum Period
timeFrame: 10 weeks
measure: The Effect of Yoga on Quality of Life in the Postpartum Period
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Hacer
state: Battalgazi
Study officials:
References:
Clinical trial NCT02189369: Diagnostic Test for Endometrial Receptivity 24 Hours Before Embryo Transfer
Official title: Clinical Validation of a Diagnostic Test Which Measures the Endometrial Prostaglandins Liquid 24 Hours Before Embryo Transfer and That is Capable of Predicting a State of Endometrial Receptivity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Lead sponsor: Igenomix
Sponsor class: INDUSTRY
First posted: 2014-07-14
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This clinical validation study is being carried out to validate the efficacy of a test measuring the clinical application of prostaglandins present in the endometrial fluid in patients, 24 hours before the embryonic transfer. This test is capable of predicting endometrial receptivity without the need of performing a biopsy.


Eligibility criteria: Inclusion Criteria:

* Any IVF patient being treated for single or double embryo transfer
* BMI: 20 - 30
* Normal ovarian response (7 - 8 ovocitos) in IVF treatment with AFC ≥ 8, (AFC = Antral Follicle Count)
* Elective embryo transfer
* Normal uterine cavity
* Age: ≤ 38 years old for patients with own oocytes; ≤ 50 years old for patients with donated oocytes.

Exclusion Criteria:

* Patients with recurrent miscarriages ( ≥ 2 biochemical miscarriages; ≥ 2 clinical miscarriage)
* Patients with severe male factor ( ≥ 2\*106 espermatozoides/ml).

Primary outcomes:
measure: endometrial receptivity
timeFrame: 24 hours before embryo transfer
Secondary outcomes:
measure: Implantation rate
timeFrame: 15 days
measure: Pregnancy rate
timeFrame: 15 days
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Fundación IVI
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
affiliation: Fundación IVI
name: Carlos Simon, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03619369: Circumcision and Breastfeeding
Official title: Timing of Circumcision and Breastfeeding Frequency: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding, Exclusive
Circumcision
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
Collaborators: name: United States Naval Medical Center, San Diego
name: Dartmouth-Hitchcock Medical Center
First posted: 2018-08-07
Enrollment: 150
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 1) To determine when the majority of male infants are being circumcised at 3 hospitals across the US (Brooke Army Medical Center, Naval Medical Center San Diego, and Dartmouth Hitchcock Medical Center. 2) To assess the breastfeeding patterns of circumcised male infants at the above-mentioned academic medical centers. Specifically, to determine if these babies are breastfeeding at the time of hospital discharge, at their newborn visit, their 2-week visit, and all subsequent well visits up until 6 months of age.

3) To determine if there is a significant relationship between the timing of newborn circumcision and breastfeeding initiation, establishment, and maintenance in the first 6 months of life. We hypothesize that the timing of circumcision will not be significantly associated with frequency of breastfeeding among mother-infant dyads during the initial months of life.


Eligibility criteria: Inclusion Criteria:

* All male infants born at the 3 participating sites

Exclusion Criteria:

* Gestational age \<38 weeks, twin/multiple deliveries, NICU admission, mothers who are strictly formula feeding their newborns from the time of delivery, and mothers under 18 years of age.

Primary outcomes:
measure: Breastfeeding Rates
timeFrame: From birth thru 6 months of age
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
References:
citation: Mondzelewski L, Mu T, Michalski A, Ward J, Cheng L, Chen M, Riffenburgh R, Holmes A. Timing of Circumcision and Breastfeeding Frequency: A Multicenter, Randomized Clinical Trial. Hosp Pediatr. 2022 Jun 1;12(6):555-560. doi: 10.1542/hpeds.2021-006400.
Clinical trial NCT03267069: Evaluating Alcohol Use in Alcoholic Liver Disease
Official title: Evaluating Alcohol Use in Alcoholic Liver Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alcoholic Liver Disease
Lead sponsor: New York Presbyterian Hospital
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: subjects with alcoholic liver disease

Brief summary: This prospective, analytic observational study will investigate alcohol recidivism in patients with alcoholic liver disease. All adult subjects presenting with alcoholic liver disease are considered for inclusion. Subjects able to give consent are included.

Detailed description: This is a longitudinal observational study. Subjects with a diagnosis of alcoholic liver disease (acute alcoholic hepatitis or alcoholic cirrhosis) who present to Weill Cornell Medical Center or Columbia University Medical Center New York Presbyterian Hospital or the Gastroenterology and Hepatology Clinic will be invited to join this study, which entails a survey at baseline and follow-up at 3, 6, 9, 12, 15, and 18 months and then at 2, 5, and 10 years. Follow-up will consist of a chart review, a phone or in person interview, and most recent clinic visit interview for alcohol recidivism. The clinical providers will be blinded to the survey results.

Eligibility criteria: Inclusion Criteria:

* alcoholic liver disease able to consent

Exclusion Criteria:

* without alcoholic liver disease unable to consent

Primary outcomes:
measure: alcohol recidivism assessed by questionnaire
timeFrame: 6 months
measure: alcohol recidivism assessed by clinical interview
timeFrame: 6 months
measure: alcohol recidivism assessed by urine ethyl glucuronide
timeFrame: 6 months
measure: alcohol recidivism assessed by blood
timeFrame: 6 months
Secondary outcomes:
measure: alcohol recidivism assessed by questionnaire
timeFrame: after 6 months
measure: alcohol recidivism assessed by clinical interview
timeFrame: after 6 months
measure: alcohol recidivism assessed by urine ethyl glucuronide
timeFrame: after 6 months
measure: alcohol recidivism assessed by blood
timeFrame: after 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center
state: New York
Study officials:
affiliation: New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center
name: Robert S Brown, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00449969: Out-of-hospital Cardiopulmonary Resuscitation and AED Feedback
Official title: Quality of Out-of-hospital Cardiopulmonary Resuscitation (CPR) With Real Time Automated Feedback: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Resuscitation
Keywords: AED (automated external defibrillation)
feedback
out of hospital resuscitation
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2007-03-21
Enrollment: 312
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 determine whether an online automatic feedback improved CPR quality (No-flow time, compression depth, short-term survival and one year follow up) in this prospective randomised study of out-of-hospital cardiac arrest


Eligibility criteria: Inclusion Criteria:

* cardiac arrest

Exclusion Criteria:

* age under 18 years

Primary outcomes:
measure: ratio of patients with spontaneous circulation
timeFrame: admission to the hospital
Secondary outcomes:
measure: length of hospital stay
timeFrame: hospital discharge
measure: neurological status
timeFrame: hospital discharge
measure: neurological status
timeFrame: one year after resuscitation
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Department of Anesthesiology and Intensive Care, University Hospital Muenster
Study officials:
affiliation: Department of Anesthesiology and Intensive Care, University Hospital Muenster
name: Thomas P Weber, MD
role: STUDY_CHAIR
References:
citation: Lukas RP, Sengelhoff C, Dopker S, Harding U, Mertens P, Osada N, Van Aken H, Weber TP, Bohn A. [Chest compression quality : Can feedback technology help?]. Anaesthesist. 2010 Feb;59(2):135-9. doi: 10.1007/s00101-009-1671-4. German.
citation: Bohn A, Weber TP, Wecker S, Harding U, Osada N, Van Aken H, Lukas RP. The addition of voice prompts to audiovisual feedback and debriefing does not modify CPR quality or outcomes in out of hospital cardiac arrest--a prospective, randomized trial. Resuscitation. 2011 Mar;82(3):257-62. doi: 10.1016/j.resuscitation.2010.11.006. Epub 2010 Dec 13.
Clinical trial NCT00353769: Comparison Study on Hair Apposition Technique Performed Between Nurses and Doctors in Emergency Department.
Official title: A Single-blinded Comparative Study on Hair Apposition Technique Performed Between Nurses and Doctors in Emergency Department.(HAT2 Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Scalp Laceration
Keywords: scalp laceration
tissue adhesive
wound care
cost effectiveness
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2006-07-19
Enrollment: 360
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness, complications and benefits of Hair Apposition Technique(HAT)performed by nurses or doctors.

Detailed description: Hair Apposition Technique (HAT) is a relatively new technique for treating certain scalp lacerations. It has been shown to be equally acceptable as compared to the standard toilet and suture. This procedure has been the technique of choice for suitable scalp lacerations in Department of Emergency Medicine, Singapore General Hospital (DEM, SGH) and Emergency Medicine Department, National University Hospital (EMD, NUH).

Currently HAT is being performed by doctors in the respective hospitals. Nurses, on the other hand, are routinely using tissue adhesives for minor wound closure. However, nurses in Kandang Kerbau Women and Children Hospital (KKWCH) have been routinely using HAT for 1 year now. Studies had been also been done by nurses in treating of minor wounds using various tissue adhesives as well as hair knotting technique.The trend of nurses handling minor wounds with tissue adhesives, hair knotting technique as well as HAT suggested the possibility of nurses performing HAT to a degree as competent as a doctor.

This study aims to compare the effectiveness, complications and benefits HAT performed between nurses and doctors in the Emergency Department.

Eligibility criteria: Inclusion Criteria:

* All age group
* Linear lacerations of scalp
* Lacerations less than 10cm in length
* Hair at least 3cm in length

Exclusion Criteria:

* Severely contaminated wounds
* Actively bleeding wounds
* Patients with unstable vital signs or altered mental state

Primary outcomes:
measure: Presence of any complications, namely infection, scarring, bleeding, wound breakdown and allergy
measure: Satisfactory wound healing
Secondary outcomes:
measure: Duration of procedure
measure: Pain perception
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Ong EH Marcus, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00868569: Transhepatic Arterial Chemotherapy (TAC) Versus Transcatheter Arterial Chemoembolization (TACE) Plus Folfox4 as the Treatment of Unresectable Liver Metastasis of Colorectal Cancer
Official title: TAC vs TACE Plus folfox4 as the Treatment of Unresectalbe Liver Metastasis of Colorectal Cancer With Resection of the Primary Tumor: a Prospective, Randomized, Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Liver Metastasis
Colorectal Cancer
Keywords: liver metastasis
colorectal cancer
oxaliplatine
transartery chemotherapy
embolision
Unresectable Liver Metastasis of Colorectal Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2009-03-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 investigate whether TAC plus FOLFOX4 or TACE plus folfox4 are able to improve resection rate and overall survival in patients receiving primary colorectal tumor resection than given FOLFOX4 only.

Detailed description: We administered three cycles FOLFOX4 plus TAC(oxaliplatin,FUDR and MMC) or FOLFOX4 plus TACE(oxaliplatin,FUDR,MMC and embolision) to primary colorectal tumor resected patients with unresected liver metastasis. The study endpoints were resection rate of liver metastasis, progression-free survival, overall survival as evaluated by intent-to-treat analysis.

Eligibility criteria: Inclusion Criteria:

* age \< 75 years with histologically proven adenocarcinoma of the colon or rectum
* no severe major organ dysfunction
* WHO performance status of 0 or 1
* no prior cancer therapy
* with measurable unresectableliver metastasis
* without other metastasis

Exclusion Criteria:

* age \>= 75
* severe major organ dysfunction
* WHO performance status of \>1
* prior cancer therapy
* with other metastasis

Primary outcomes:
measure: overall survival
timeFrame: 5 years after operation
Secondary outcomes:
measure: resection rate of liver metastasis progression-free survival
timeFrame: 5 years after operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: department of general surgery, zhongshan hospital, fudan university
name: jianmin xu, MD, PHD
role: STUDY_DIRECTOR
References: